Medical Marijuana Research News

MAPS Comment for the Public Record In Response to DEA Request for Information on “Controls to Enhance the Cultivation of Marihuana for Research”

On May 22, 2020, MAPS submitted a public comment to the Drug Enforcement Administration (DEA) in response to new rules proposed by DEA to govern their review and approval/rejection process for applications seeking permission to cultivate and provide marijuana for medical research and FDA drug development efforts. These proposed new rules mark the next chapter and are a potentially major step forward in our continued struggle to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of research-grade marijuana and help Professor Lyle Craker, Ph.D., obtain a DEA license to grow marijuana for clinical trials.

For nearly 20 years, MAPS has been working in association with Professor Lyle Craker, Professor Emeritus of Botany and Plant Sciences at University of Massachusetts, Amherst’s Stockbridge School of Agriculture. With MAPS’ assistance, Professor Craker has twice submitted applications for Drug Enforcement Administration (“DEA”) registration as a bulk manufacturer of marijuana (“DEA Registration”), seeking a legal pathway to produce a MAPS-owned (but still DEA-regulated) uninterrupted and consistent supply of marijuana for our privately-funded commercial medicinal cannabis botanical product FDA drug development efforts, a central component of MAPS’ institutional mission. DEA denied Professor Craker’s first application, filed in 2001, and has yet to act on his second, filed in early 2017.

This document was signed by the following contributors:

  • MAPS Founder and Executive Director Rick Doblin, Ph.D.
  • MAPS Attorney M. Allen Hopper
  • MAPS Policy and Advocacy Counsel Ismail L. Ali, J.D.
  • MAPS Policy and Advocacy Fellow Leslie Booher, J.D., M.B.A.

U.S. Attorney General William Barr Receives Formal Letter from Six U.S. Senators Regarding the Advancement of Research-Grade Marijuana Production

On April 2, 2019, six United States Senators sent Attorney General William Barr a formal letter to follow-up about pending applications to manufacture marijuana for scientific research. “Our nation’s need for meaningful federally sanctioned research is critical. Research and medical communities should have access to research-grade materials to answer questions around marijuana’s efficacy and potential impacts, both positive and adverse. Finalizing the review of applications for marijuana manufacturing will assist in doing just that,” according to U.S. Senators Brian Schatz, Dianne Feinstein, Lisa Murkowski, Cory Gardner, Christopher A. Coons, and Tim Kaine.

—Download and read the full letter.

U.S. Senators Schatz and Booker Formally Advocate for Expediting Approval of New Research-Grade Marijuana Manufacturers

On March 28, 2019, United States Senators Brian Schatz and Cory A. Booker of the Senate Judiciary Committee sent a formal letter to Attorney General William Barr regarding the delay of licensing new manufacturers to produce marijuana for scientific research, stating, "We believe the licensed production of marijuana for research is critically important. After two and a half years of delay, it is imperative that you advance the process for registering new manufacturers of research-grade marijuana."

—Download and read the full letter.

Grover Norquist Writes to Attorney General About Ending the NIDA Monopoly on Marijuana

On September 10, 2018, political activist Grover Norquist of Americans for Tax Reform sent a formal letter to United States Attorney General Jeff Session that explains why he is advocating for an end to the NIDA monopoly on research-grade marijuana.

I write urging you to implement the current Drug Enforcement Administration policy stance that allows for private cultivation of cannabis for federally approved research and drug development. This would allow new medicines and treatments to continue through the Food and Drug Administration process and open a multi-billion-dollar market to American researchers and industry.

In August of 2016, the DEA announced a policy change stating that 'persons may become registered with the DEA to grow cannabis not only to supply federally funded or other academic researchers, but also for strictly commercial endeavors funded by the private sector and aimed at drug product development.'

Download and read the full letter.

Eight U.S. Senators Support Ending the NIDA Monopoly on Marijuana, Letter Sent to Attorney General

On July 25, 2018, United States Attorney General Jeff Sessions received a formal letter from eight U.S. Senators advocating for an end to the NIDA monopoly on research-grade marijuana.

"We write to encourage you to finalize your review of applications submitted to the Drug Enforcement Administration (DEA) for licenses to manufacture marijuana for scientific research. Our nation's need for meaningful federally sanctioned research is critical. Research and medical communities should have access to research-grade materials to answer questions around marijuana's efficacy and potential impacts, both positive and adverse. Finalizing the review of applications for marijuana manufacturing will assist in doing just that.

For nearly fifty years, the University of Mississippi has had the sole contract with the National Institute on Drug Abuse (NIDA) to grow cannabis for research purposes. To expand the number of manufacturers, the DEA submitted a notice in the Federal Register on August 11, 2016, soliciting applications for licenses to manufacture marijuana for research purposes. Under this notice, DEA explained its legal authority to 'increase the number of entities registered under the Controlled Substances Act (C SA) to grow (manufacture) marijuana to supply legitimate researchers in the United States.' However, almost two years have passed since the DEA's notice without any new schedule I marijuana manufacturer registrations."

Download and read the full letter, which was signed by U.S. Senators Brian Schatz, Chuck Grassley, Cory Gardner, Kirsten Gillibrand, Amy Klobuchar, Christopher A. Coons, Orrin Hatch, and Tim Kaine.

PRESS RELEASE: DEA Eliminates 48-Year-Old Monopoly on Research-Grade Marijuana, Clearing Pathway for FDA Approval and Rescheduling

WASHINGTON, D.C. — Today, the Drug Enforcement Administration (DEA) announced their intention to grant licenses to additional marijuana growers for research, thereby ending the DEA-imposed 48-year monopoly on federally legal marijuana.  Since 1968, the University of Mississippi, under contract to the National Institute on Drug Abuse (NIDA), has maintained the only facility in the United States with federal permission to grow marijuana for research.

“It’s a complete and total end of the NIDA monopoly! There has been no production monopoly on any other Schedule I substance, like MDMA or LSD—only the cannabis plant. Licensing non-government cannabis producers, and thereby creating a path to FDA approval, will finally facilitate the removal of marijuana from Schedule I, and ultimately allow patients to receive insurance coverage for medical marijuana,” said Rick Doblin, Ph.D., Founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS).

MAPS has been working to eliminate this cannabis research blockade since 1999. NIDA’s marijuana is eligible for research, but cannot be sold as a prescription medicine, making it unacceptable to the Food and Drug Administration (FDA) for use in future Phase 3 studies.  Ending the monopoly finally allows for a pathway to FDA approval for marijuana, which would thereby trigger rescheduling.

In 2001, MAPS partnered with University of Massachusetts-Amherst Professor Lyle Craker, Ph.D., to apply for a DEA license and end the monopoly. In 2007, after years of bureaucratic delays and lengthy legal hearings, a DEA Administrative Law Judge (ALJ) recommended that it would be in the public’s interest to grant Craker the license. In 2009, after almost two more years of delays and less than a week before the inauguration of President Obama, former DEA Administrator Michelle Leonhart rejected the ALJ recommendation. In 2011, Craker sued the DEA in the U.S. First Circuit Court of Appeals. In its 2013 decision, the Court uncritically accepted the DEA’s arguments that NIDA’s monopoly provided “an adequate supply produced under adequately competitive conditions.”

Since the 2013 decision, Craker’s argument that NIDA does not have an adequate supply has become significantly more apparent. NIDA has been unable to provide the strains requested for MAPS’ long-delayed Phase 2 clinical trial of smoked marijuana to treat symptoms of posttraumatic stress disorder (PTSD) in 76 U.S. veterans. As a result, the study is proceeding with lower potency marijuana than what MAPS researchers requested.

The DEA has previously claimed that U.S. international treaty obligations under the United Nations Single Convention on Narcotic Drugs (Single Convention) require a federal monopoly, but in April 2016, the State Department released a statement clarifying that the Single Convention does not in fact limit the number of U.S. marijuana producers.

Furthermore, the DEA’s 2009 rejection of the ALJ recommendation to license Craker relied heavily on a U.S. Department of Health and Human Services (HHS) protocol review process, which was eliminated in 2015.

MAPS’ upcoming Phase 2 clinical trial of marijuana for PTSD in veterans is in collaboration with investigators in Phoenix, Arizona, and at Johns Hopkins University, the University of Colorado, and the University of Pennsylvania. The study is funded by a $2.15 million grant to MAPS from the State of Colorado. The study has received full regulatory approval, and will be the first randomized controlled trial of whole plant marijuana as a treatment for PTSD.

Founded in 1986, MAPS is a non-profit research and educational organization working to evaluate the safety and efficacy of botanical marijuana as a potential prescription medicine for specific medical uses approved by the FDA.

MORE INFORMATION

Additional information can be found at maps.org/research/mmj/dea-license.

CONTACT:
Rick Doblin, Ph.D., MAPS Executive Director
This email address is being protected from spambots. You need JavaScript enabled to view it.
617-276-7806

Natalie Ginsberg, MAPS Policy & Advocacy Manager
This email address is being protected from spambots. You need JavaScript enabled to view it.
917-520-5531

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Obama Administration Eliminates PHS Review for Marijuana Research

On June 22, 2015, the U.S. Department of Health and Human Services (HHS) announced that it had eliminated the redundant Public Health Service (PHS) review process for federally regulated marijuana research, removing a significant barrier to privately funded medical marijuana research. Since 1999, researchers seeking to study marijuana needed to obtain permission from PHS to purchase marijuana from the National Institute on Drug Abuse (NIDA), which maintains a monopoly on the supply of marijuana for research in the U.S. Now, researchers with Food and Drug Administration (FDA) clearance can request marijuana directly from NIDA without the additional PHS review process. MAPS is now working with Prof. Lyle Craker to prepare a new request asking the U.S. Drug Enforcement Administration (DEA) for permission to further open doors for medical marijuana research by opening a growing facility at the University of Massachusetts-Amherst. "We're hoping the overall political environment has shifted enough where we will actually get permission from the DEA to start this farm and then we won't have to go through NIDA at all," Brad Burge of MAPS told U.S. News and World Report. "It's a great opportunity for the Obama administration to show it's progressive on marijuana issues. We're pretty hopeful."

November is Medical Marijuana Research Month!

Medical Marijuana Research Month is a chance for customers at dispensaries and marijuana retail stores nationwide to make a donation during the month of November to support MAPS' research on whole plant marijuana a legal prescription treatment for PTSD. Twenty-five dispensaries and retail locations around the country have already signed up to help us raise funds for medical marijuana research. Visit one of our participating locations during the month of November and help complete vital medical marijuana research for veterans and many others searching for a safer, more effective treatment for PTSD. Do you manage or own a dispensary or retail establishment that would like to participate? Complete our Enrollment Form. Questions? Contact This email address is being protected from spambots. You need JavaScript enabled to view it..

HHS Denies Request from 30 Members of Congress to End Obstructive Review Process

On September 22, 2014, U.S. Department of Health and Human Services Secretary Sylvia M. Burwell formally rejected a request from 30 members of Congress requesting that HHS end the obstructive Public Health Service (PHS) review process for privately funded medical marijuana research. A 1999 HHS Guidance requires an additional review process for federally regulated research with marijuana, but not for any Schedule I drug. This additional review process makes it difficult or impossible for scientists in the U.S. to gain approval for whole-plant medical marijuana drug development research. On June 17, Rep. Earl Blumenauer (D-OR) and 29 other Congressional representatives sent a letter to HHS requesting that the PHS review process be eliminated. MAPS is now working with Rep. Blumenauer's office to prepare a letter to Sec. Burwell responding to her rejection letter, which ignores the substance of the 30 Congressional representatives' concerns and fails to justify the problematic PHS review process for medical marijuana research. Learn more...

DEA Notifies Court of Marijuana Rescheduling Case; Crakers Legal Team Responds

On January 22, 2013, the U.S. Drug Enforcement Administration filed a Notice of Supplemental Authority with the First Circuit Court of Appeals in Boston, Mass., in Prof. Lyle Craker's ongoing federal lawsuit against the DEA for denying him a license to grow marijuana for medical research. The filing was intended to bring to the Court's attention the outcome of a lawsuit against the DEA by Americans for Safe Access challenging the DEA's denial of a petition to reschedule marijuana, acknowledging its medical uses. In the ASA case, the Court protected the DEA's refusal to reschedule marijuana.

On January 30, 2013, Craker's legal team filed a response to inform the Court that the ASA case is not legally relevant to Craker's lawsuit.

The First Circuit Court's decision in Lyle E. Craker v. Drug Enforcement Administration is still pending.

Israeli Study Results Presented at Clinical Cannabis Conference

On April 28, 2012, the results of a recently completed exploratory study of medical marijuana in veterans with PTSD were presented (slides available here in PDF format) by Dr. Mordechai Mashiah, Deputy Director of the Abarbanel Mental Health Center in Israel, at the 7th National Clinical Conference on Cannabis Therapeutics, hosted by Patients Out of Time in Tucson, Ariz. The study was sponsored by the Israeli Ministry of Health.

MAPS Israeli Clinical Research Associate Mimi Peleg, Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., Clinical Research Assistant Linnae Ponté, and Executive Director Rick Doblin, Ph.D., assisted Dr. Mashiah with data analysis and preparation of his presentation and abstract. MAPS also allocated about $6,000 to assist Dr. Mashiah in analyzing and presenting his results, and will further support him in preparing of a paper for publication in a peer-reviewed scientific journal.

To date, there are still no published, placebo-controlled studies of the use of marijuana by people with PTSD. MAPS’ protocol for a study of the safety and effectiveness of marijuana for 50 veterans with PTSD has been approved by the FDA, but the National Institute on Drug Abuse has blocked the study, preventing it from proceeding (see MAPS’ point-by-point annotated response (PDF) to the NIDA review).

DEA Files Opposition Brief in Federal Lawsuit for Blocking Medical Marijuana Research

On March 22, 2012, the Drug Enforcement Administration (DEA) filed its first response brief (81-page PDF) to Prof. Lyle Craker's lawsuit in the First Circuit Court of Appeals, which he filed on December 15, 2011. Prof. Craker is objecting to the DEA's rejection of DEA Administrative Law Judge Bittner's recommendation that it would be in the public interest to license Prof. Craker to grow marijuana for federally-regulated research. Granting Prof. Craker this license would end the federal monopoly on marijuana for research and open the door for non-profit medical marijuana research. In their response brief, DEA lawyers (1) argue that the First Circuit Court of Appeals lacks jurisdiction in the case, (2) move to strike parts of our argument based on NIDA's September 2011 refusal to sell us marijuana for our FDA-approved protocol for veterans with PTSD, and (3) reiterate previous arguments claiming that international treaty obligations forbid granting Prof. Craker a license. Prof. Craker's lawyers are now developing what we believe will be an effective response to the jurisdictional issues as well as the substantive issues. The reply from Prof. Craker's legal team will be submitted in early May.

DEA Requests Extension for Filing Opposition Brief in Federal Lawsuit

On January 13, 2012, lawyers for the Drug Enforcement Administration called the lawyers representing Prof. Lyle Craker to request an extension until February 24 for filing their opposition brief in response to Craker's opening brief, which was filed in the 1st Circuit Court of Appeals on December 15, 2011. Craker's legal team granted the request for an extension. Craker's reply brief will now be due on March 9, two weeks after February 24, though the DEA lawyers indicated they would agree to an extension should it be requested. Once all opening briefs are filed, it's likely that oral arguments will be scheduled.

Craker's Legal Team Submits Opening Brief in Federal Lawsuit against the DEA

On December 15, 2011, the legal team representing Prof. Lyle Craker filed their opening brief in their much-anticipated lawsuit against the Drug Enforcement Administration for denying Craker's application to cultivate marijuana for medical research. The 232-page document (PDF) represents the combined efforts of Prof. Craker, the American Civil Liberties Union, Washington, D.C. law firm Covington & Burling LLP, and MAPS, and is a major challenge to DEA's politically-motivated decision to uphold the federal blockade on marijuana for research. The DEA's opposition brief is currently due January 20, though the agency may request an extension of a month or more. The brief was filed in the United States Court of Appeals for the First Circuit.

MAPS Receives Pro-Bono Representation to Appeal Craker Case in First Circuit Court of Appeals

MAPS has received a generous offer for pro-bono legal representation from the Washington, DC law firm Covington & Burling LLP, one of the foremost law firms representing the pharmaceutical industry, to appeal the DEA's August 15 final order in the First Circuit Court of Appeals. These legal actions would otherwise have cost MAPS an estimated $175,000 in legal fees, which we may or may not have been able to raise.

See MAPS' official press release and Medical Marijuana Research page for more information about MAPS' efforts to conduct privately-funded, FDA-reviewed medical marijuana research.

DEA Rejects Judge's Recommendation, Upholding Federal Marijuana Monopoly

On August 15, 2011, the Drug Enforcement Administration (DEA) issued its final order rejecting DEA Administrative Law Judge Mary Ellen Bittner’s 2007 recommendation that it would be in the public interest to grant University of Massachusetts, Amherst Prof. Lyle Craker a license to grow marijuana for federally regulated research. The rejection preserves the monopoly held by the National Institute on Drug Abuse (NIDA) on the supply of marijuana for Food and Drug Administration (FDA)-regulated research.

ALJ Bittner issued her recommendation to license Prof. Craker on February 12, 2007, after extensive hearings. On January 14, 2009, almost two years later and six days before President Obama’s inauguration, DEA Acting Administrator Michelle Leonhart rejected the ALJ recommendation. In response, Prof. Craker’s lawyers filed a series of objections, which were denied in the final order. Prof. Craker’s only recourse is to appeal the DEA final ruling in the First Circuit U.S. Court of Appeals.

For more information, see our Medical Marijuana Research page.

DEA Asks Administrator to Reject Judges Recommendation in Response to Final Brief

On April 1, 2011, the DEA filed its response to the final brief in Professor Lyle Craker's nearly decade-long lawsuit against the agency to end the federal government's monopoly on the supply of marijuana for research. After (presumably) reviewing the final brief, agency officials asked DEA Administrator Michele Leonhart to reject DEA Administrative Law Judge Mary Ellen Bittner's 2007 recommendation that Craker be allowed to start his own MAPS-sponsored medical marijuana production facility. We are now waiting for Leonhart to issue her final order, thus continuing to prevent the research from taking place. It may have been April Fool's Day, but this is no joke, and the American public is not laughing.

Crakers Lawyers File Final Brief in DEA Lawsuit to Grow Marijuana for Research

On March 7, 2011, Professor Lyle Craker, Director of the Medicinal Plant Program at the University of Massachusetts-Amherst and his lawyers at the American Civil Liberties Union and Washington, D.C., law firm Jenner & Block submitted their final brief in their marathon lawsuit against the Drug Enforcement Administration.

Right now, a lab at the University of Mississippi is the only facility in the U.S. with a license to grow marijuana for research. Any scientist who proposes a study of marijuana must purchase it from this lab, whether they’re interested in its risks or in its medical uses. Unfortunately, the National Institute on Drug Abuse—which funds the lab and therefore decides which studies get marijuana and which do not—only supports research into the potential harms of marijuana. That makes it practically impossible to do the research with the greatest potential for helping actual patients.

The only way to change the situation is to end NIDA’s monopoly, which is exactly what MAPS and Craker have been trying to do for nearly ten years. We’re expecting the FDA to allow us to proceed with our proposed study of the safety and effectiveness of smoked and/or vaporized marijuana for PTSD in war veterans, and NIDA (and its parent agency the Public Health Service) are the only ones standing in its way.

Read the MAPS press release announcing the latest developments in the case.

MAPS Hosts Mile High Marijuana Summit

MAPS hosted the Denver Mile High Marijuana Summit, which featured leading experts about marijuana policy:

  • MAPS Executive Director Rick Doblin, Ph.D.,
  • Ethan Nadelmann, Executive Director, Drug Policy Alliance, an national organization working to end the war on drugs by promoting policies based on science, compassion, health and human rights
  • Mason Tvert, Executive Director of SAFER, a Denver based organization responsible for Denver's 2005 and 2007 marijuana initiatives and Colorado State's 2006 initiative
  • Brian Vicente, Executive Director, Sensible Colorado, the organization is the primary resource for Colorado's licensed medical marijuana patients, and has engaged in successful litigation involving the "Test Cases" of Denver's I-100 Ordinance which removed penalties for adult possession of under an ounce of marijuana
  • Aaron Houston, Executive Director, Students for Sensible Drug Policy, an international organization with hundreds of autonomous chapters on college and high school campuses
  • Sue Sisley, M.D., private practice physician and medical marijuana activist from Phoenix will discuss the Arizona medical marijuana initiative
  • Jeff Jones, Co-founder of Oaksterdam University and lead proponent of California's Proposition 19, the tax and regulate Cannabis Initiative of 2010
  • Steve Fox, Director of Government Relations, Marijuana Policy Project, a national organization responsible for passing several state's medical marijuana laws

Video and audio of the conference is available here.

MAPS Hires Lobbyist for Marijuana Production Facility/Professor Craker Campaign

MAPS signed a contract with The Raben Group, a Washington, D.C., lobbying group. The Raben Group will initially review and analyze the political situation relating to the Craker case, then provide MAPS with recommendations on next steps for MAPS to consider. If MAPS and The Raben Group agree that securing the license is possible, The Raben Group will develop supporting materials; assist with outreach to other organizations or people willing to support MAPS’ efforts; schedule and staff meetings with the Department of Justice; and provide any necessary follow-up to Department of Justice staff as well as strategic counsel to MAPS. According to IRS rules, technically none of this work counts as lobbying since we are not trying to change any laws. Instead, we are working with a regulatory and enforcement agency, the DEA, to encourage it to follow the recommendations of DEA Administrative Law Judge Bittner. The judge determined that it would be in the public interest for DEA to issue a license to Prof. Craker to grow marijuana for MAPS for federally-regulated research.

MAPS Hires Lobbyist for Marijuana Production Facility/Professor Craker Campaign

On Sept. 22, MAPS signed a contract with The Raben Group, a Washington, D.C., lobbying group. The Raben Group will analyze the political situation related to the Craker case and then provide MAPS with recommendations for next steps. The Raben Group will develop supporting materials; assist with outreach to other organizations or people willing to support MAPS’ efforts; schedule and staff meetings with the Department of Justice; and provide any necessary follow-up to Department of Justice staff as well as strategic counsel to MAPS. According to IRS rules, technically none of this work counts as lobbying since we are not trying to change any laws. Instead, we are working with a regulatory and enforcement agency, the DEA, to encourage it to follow the recommendations of DEA Administrative Law Judge Bittner. The judge determined that it would be in the public interest for DEA to issue a license to Prof. Craker to grow marijuana for MAPS for federally-regulated research.

MAPS Intensifies Campaign For Crakers Marijuana Production License

MAPS has hired Chris Chiles and Stephen Morseman to coordinate a campaign to obtain a DEA license for Professor Lyle Craker of UMass Amherst to grow marijuana under contract to MAPS, and end the National Institute on Drug Abuse (NIDA) monopoly over the supply of marijuana available to the research community. Chiles and Morseman are attempting to have the issue brought up at the Senate Judiciary Committee’s confirmation hearing for the new DEA Administrator. President Barack Obama has nominated DEA Deputy Administrator Michele Leonhart, but she is a holdover from President Bush and her track record does not bode well for medical marijuana and marijuana research.

On February 12, 2007, DEA Administrative Law Judge (ALJ) Mary Ellen Bittner ruled it is in the public interest for the DEA to license Craker. However, on January 12, 2009, Leonhart rejected this recommendation. On January 30, 2009, Craker’s lawyers at the American Civil Liberties Union (ACLU) filed a Motion to Reconsider. The DEA has not responded. The ACLU has filed nine status updates (every 60 days) with the U.S. Court of Appeals, First Circuit, in case the DEA conclusively rejects the ALJ recommendation and a legal appeal is needed.

The goal of MAPS’ campaign is to push three key senators—Senators Patrick Leahy (D-Vermont), Sheldon Whitehouse (D-Rhode Island) and Al Franken (D-Minnesota)—to ask Leonhart during the confirmation hearing to grant Craker's motion and accept the administrative law judge's recommendation to end the federal monopoly on the supply of marijuana for federally regulated research.

High Times: Crop Blockers

This is an excellent expose about Dr. Mahmoud Elsohly's NIDA sponsored marijuana production facility at the University of Mississippi. The article discusses the federal government's blocking of research into the benefits of marijuana.

View the full article as a PDF here.

The UMass Amherst Medical Marijuana Production Facility Project

At present, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can be used in research, seriously hindering medical marijuana research. NIDA provides inferior, low-potency marijuana to researchers whose protocols it approves. NIDA has denied marijuana to FDA-approved protocols, including two sponsored by MAPS, preventing those studies from taking place.

No privately funded sponsor (such as MAPS, or alternatively, a for-profit pharmaceutical company) will invest significant sums in a realistic drug development research program aimed at obtaining FDA approval for the prescription use of marijuana without first obtaining its own independent source of supply of a drug whose quality, price and availability it determines. As far as we can tell, there has been no US-based privately-funded marijuana production facility since 1942, when marijuana was removed from the US Pharmacopoeia and its medical use was prohibited.

We have been involved in a long and daunting legal challenge with DEA to get a license to grow marijuana for Dr. Lyle Craker. Dr. Craker originally submitted the application for a license to DEA in June 2001. Six years later on February 12, 2007, after numerous court hearings and legal struggles, DEA Administrative Law Judge Mary Ellen Bittner presented a recommended ruling on our behalf to the DEA. Judge Bittner stated that it was in the public’s interest to end the monopoly on the supply of marijuana for research. In December of 2007, we completed a congressional sign-on letter campaign, gathering signatures from 38 members of Congress for a letter to DEA Administrator Karen Tandy expressing support for the proposed marijuana production facility. We also had the support of Senators Kerry and Kennedy. However, on January 14, 2009 the DEA overruled the recommendation from their judge and ruled against licensing Professor Craker.

On August 15, 2011, the DEA issued its final order rejecting ALJ Bittner's 2007 recommendation. MAPS, Professor Craker, and his lawyers at the American Civil Liberties Union and Covington & Burling LLP are now suing the DEA in the United States Court of Appeals for the First Circuit.

MAPS Planned Marijuana Production Facility and Legal Challenges

MAPS, in association with Prof. Lyle Craker, Director, Medicinal Plant Program, University of Massachusetts Amherst, Department of Plant and Soil Sciences, has been seeking DEA permission to establish a medical marijuana production facility to grow high-potency marijuana for FDA-approved research.

State Board of Pharmacy Reclassifies Marijuana

Oregon Board of Pharmacy
800 NE Oregon St., Suite 150
Portland, OR 97232-2162

News Release
For Immediate Release

Contact:            

Paige Clark, R. Ph.           
This email address is being protected from spambots. You need JavaScript enabled to view it. 

State Board of Pharmacy reclassifies marijuana

To implement S.B. 728, Board makes marijuana a Schedule II drug

Portland The Oregon State Board of Pharmacy acted today to remove marijuana from the list of Schedule I Controlled Substances, in accordance with a bill the legislature passed last year.

The new law, ORS 475.059 established by Senate Bill 728, requires marijuanas removal from a list of controlled substances that have a high abuse potential and no acceptable medical use in the United States.

The Board placed marijuana into Schedule II Controlled Substances, which contains substances that have a high abuse potential with severe psychological or physical dependence liability, but are accepted for medical use in the US and are available by prescription.  The Oregon Controlled Substances Act provides three additional schedules for substances that are progressively less serious or dangerous, Schedules III, IV and V.

The Board reviewed scientific and medical literature and heard testimony from experts and members of the public before voting to move marijuana into Schedule II. This action is consistent with Oregons assertion that marijuana does have an acceptable medical use.

Contact:
Gary A. Schnabel, Executive Director, Oregon Board of Pharmacy
971-673-0001

NPR. Can Marijuana Ease PTSD? A Debate Brews

This article reports on persons with PTSD, including veterans of war, who are using medical marijuana to ease anxiety and other symptoms, the debate within the Veterans Affairs, and the conflict between state laws and federal laws. Listen to this story at: http://www.npr.org/templates/story/story.php?storyId=126827410 "The Department of Veterans Affairs finds itself in a difficult position because some vets want to use marijuana to treat symptoms of post-traumatic stress disorder. Pot possession remains illegal under federal law. The VA says that as a federal agency its doctors can't recommend using it. The problem is especially acute in New Mexico, where one-fourth of the state's more than 1,600 medical marijuana patients are PTSD sufferers."

Continue Reading

Marijuana PTSD Study in the Works in Arizona

Marijuana PTSD Study in the Works in Arizona

MAPS is currently working with Principal Investigator Sue Sisley M.D., of Phoenix, Arizona to develop a new marijuana/PTSD protocol in order to get a marijuana study underway in the U.S. Weve already developed a protocol summary. Were anticipating that the protocol will be ready for submission to the Institutional Review Board (IRB) and the FDA this summer. Were sadly anticipating that this study is likely to be delayed for at least a year by NIDAs review process-- should they even approve it, which is doubtful. In addition, were asking for marijuana with THC and CBD in it, which NIDA does not have available.

There is not at yet a possibility of importing any marijuana into the United States that contains significant amounts of both THC and CBD. This shows clearly how the DEA support of NIDAs monopoly on the supply of marijuana for research is fundamentally obstructing drug development research aimed at transforming marijuana into an FDA-approved prescription medicine. The DEA/NIDA obstruction of FDA research is one of the primary reasons why state medical marijuana reform efforts are essential.

Professor Craker, UMass, and MAPS Efforts to Create a Privately-Funded Medical Marijuana Production Facility

Since 2001, MAPS has worked with Professor Craker at UMass Amherst to try to obtain a license for our own production facility of marijuana for FDA-approved research. NIDA currently has a monopoly on cannabis production for research purposes, and the DEA has been protecting that monopoly, which fundamentally obstructs drug development research for a number of reasons.

President Obama has recently nominated Michelle Leonhart as the new DEA Administrator, which will complicate the fate of our marijuana drug development efforts. Since 2004, Leonhart has been the Acting Deputy Administrator of the DEA, after being appointed by President Bush. Although she had several jobs, shes been in a leadership role at DEA, and has been behind the crackdown on the state medical marijuana patients, growers, and providers. Most significantly, she rejected the February 12, 2007, recommendation of DEA Administrative Law Judge Mary Ellen Bittner, who found that it would be in the public interest for Professor Craker to receive a DEA license for the production of marijuana for research.

Professor Crakers lawyers have filed a motion to reconsider to Michele Leonhart, with her response still pending. President Obamas nomination of her to be the Administrator of the DEA is not encouraging, even though President Obama has also ordered his Attorney General Eric Holder to stop the DEA raids on cannabis dispensaries in states that allow medical marijuana, so long as they are operating in compliance with state law. Were hoping that opening the door to scientific research is something that President Obama, his senior staff, members of Congress, and members of the Senate confirmation hearing will understand is a priority principle that Michele Leonhart needs to share to be confirmed as the next Administrator of DEA.

We expect the senate confirmation hearings to take place in the next month or two. We strongly encourage people to contact their Senators about the Michelle Leonhart confirmation, saying that she should not be confirmed unless theres a pledge to accept the recommendation of the Administrative Law Judge, or a pledge to facilitate medical marijuana research and not protect the NIDA monopoly.

New Marijuana/PTSD Study Initiated

Executive Director Rick Doblin, Ph.D., Research and Information Specialist Ilsa Jerome, Ph.D., and Clinical Research Associate Berra Yazar-Klosinski, Ph.D. Candidate are exploring funding and collaborating on a new study of medical marijuana for the treatment of posttraumatic stress disorder (PTSD) with principal investigator Sue Sisley, M.D. The study is tentatively titled "Placebo-controlled, double-blind study of the safety and efficacy of smoked cannabis in 30 veterans with PTSD."

This study is currently designed to enroll 32 veterans diagnosed with PTSD by the clinician administered PTSD scale (CAPS). Scores of 50 or higher can be included in a placebo-controlled, double-blind study of self-administered smoked cannabis for the treatment of PTSD symptoms. Study duration will be six weeks. Participants will be randomly assigned to one of four conditions, receive 2 grams per day of 1) placebo, 2) 6% THC, 3) 12% THC cannabis, or 4) 6%thc/6%CBD cannabis. The study will begin with an hour-long baseline assessment of PTSD symptoms and one 30-minute introductory session to prepare subjects for the use of marijuana. This will be followed by self-administration of cannabis for four weeks. PTSD symptoms will be assessed at four weeks, followed by a two week medication cessation period after the cannabis use has stopped, and a third 60-minute assessment of PTSD symptoms at six weeks. Participants who originally received the placebo can enroll in a second open-label segment following identical study procedures where they can choose to receive full doses of either 6% THC, 12 % cannabis, or 6%THC/6%CBD cannabis.

The proposed study has already received informal comments about the design from health personnel inside the Department of Veterans Affairs. MAPS has applied for grant from the Marijuana Policy Project to partially fund this study.

10 Reasons the U.S. Military Should (Officially) Use Pot

Medical marijuana may have a host of advantages over other treatments for traumatized vets, but the VA won't even study its efficacy. http://www.alternet.org/healthwellness/144838/10_reasons_the_u.s._military_should_(officially)_use_pot/?page=entire "Theres a lot of things Im passionate about, but getting a prescription for my marijuana from the VA is probably at the top of my list. Id be like a kid waiting up for Santa if I thought he might be bringing me one of those. Haha!" On top of a 100 percent disability rating with PTSD, "Charlie" -- who asked that his real name not be used -- came home from Afghanistan with a traumatic brain injury, a back injury and gastrointestinal problems. The VA pulled every magic trick out of its bag to treat him. But nothing worked. What did work was marijuana. Shirak-e-Mazar, the milk of Mazar, is what got Charlie through his deployment in Afghanistan. Shirak-e-Mazar is what Afghanis call the paper-thin sheets of hashish that sell for about $1.50 an ounce. Its a 5000-year-old recipe, perfected in the Mazar-e-Sharif region, for preparing the compressed resin glands of the marijuana plant, and unless things have changed since Charlie left Afghanistan in 2004, its available, well, just about everywhere. So was alcohol, but according to Charlie, it didn't provide the same kind of relief: "You get some drinks in you, you get nice and loose; you drop your inhibitions and think you're invincible. But you havent dealt with the stress; you've just kind of blocked it; you don't really understand the possible outcomes of what youre about to door you don't care. "Smoking though ... you can appreciate the stresses and understand everything that's going on, but youre still relaxed enough to do what you have to do, and do it well." Since he got home, he says he is smoking about one and a half grams a day, depending on how I'm doing. I go through an ounce in three to four weeks. I'm medicating for PTSD, but also a back injury and gastrointestinal problems, so if I had to do things like shovel the walk ... I would have to smoke a little more." Unfortunately, Charlie does not live in one of the 13 states that have authorized the use of medical marijuana. In the rest of the states, federal law still applies, and according to the United States Department of Agriculture (USDA) marijuana is still classified as a Schedule I drug. Schedule I drugs are those deemed most dangerous, more so than cocaine, oxycodone and methamphetamines, all of which are Schedule II. Me and the rest of my veterans' group talk about it all the time," he says. "Most of them also medicate with marijuana. If you asked any of us what, out of everything, was most effective in PTSD treatment, we would tell you marijuana." But the VA is a federal agency, so even in the 13 states where doctors are at liberty to suggest that patients try marijuana, they are prohibited from dispensing it. The first two years after he got home, Charlie and his wife were still active duty. Marijuana was too risky, so he drank. A lot. So much that he almost killed himself and his wife. "Alcohol seemed to exaggerate all the negative feelings, the anger, the rage, the depression, the desperation." Since Charlie was discharged in 2006, the VA has pulled an astonishing variety of medications out of its magic bag. Charlie's list is an impressive one that many, perhaps most, vets who have gone to the VA for help with post-combat stress and pain issues will recognize. Ive been on six different antidepressants, lorazepam for anxiety; two sleep aids, Ambien and something else; three medications for my stomach problems, including omeprazole; and Topomax and amyltriptomine for migraines. Even if the sleeping pills got me to sleep, Id still wake up in the middle of the night from nightmares. The only difference is that WITH the pills I'd wake up dizzy and disoriented. The disorientation made for a smooth transition into flashbacks, and if you want to see a vet have a bad episode, make sure he/she is completely disoriented and wake them suddenly in the dark. (Don't try this at home -- danger, danger!) The lorazepam was prescribed for the anxiety caused by the antidepressants, but it turned me into some kind of shuffling Ozzie Osborne zombie. I didn't have the physical energy to do anything but lay on the couch. Topomax and amyltriptomine turned me into a sloppy, silly bedlamite, groggy like Id had too much to drink and babbling like a face-painted Anna Nicole Smith. Oh, and the Topomax had me hurling up last year's Christmas dinner. "Ive gone through pain management more times than I can count on my hands, and I've had over twelve series of epidermal steroid injections done to my lower back. None of them ever did anything for me. Except of course make my stomach problems much worse. I started smoking [marijuana] again three years ago, and it's been the best pain management I've found. I can pick up my thirty-pound daughter for a while now, which might not seem like a big deal, but it is. Oh, as for helping with hypervigilance, it does, but given the current legal status of my medication of choice in this state, I am hypervigilant for the police." And not without cause. Even in states where medical marijuana has been approved, conflicting state and federal laws have provided law enforcement agencies with an excuse to prosecute according to personal prejudice. Recently, the Obama Department of Justice instructed prosecutors to leave legitimate growers of medical marijuana alone. That is a step in the right direction, but there are at least 10 reasons why they should be encouraged to continue moving toward saner and clearer policies. 1) Until proven otherwise, marijuana is the safest thing theyve got in their pharmacopoeia. Marijuana has been used worldwide to treat pain, stress and any number of other ailments since the third millennium BCE. It has been outlawed in the United States since 1937, but since 1970, with passage of the Controlled Substances Act, marijuana has been classified as a Schedule I drug, with a high potential for abuse, "no currently accepted medical use" and a "lack of accepted safety" for use of any kind. The Schedule I classification has meant that for the better part of 40 years, claims could be made that marijuana would turn you into a serial psycho-killer, a spotted owl or a socialist, and nobody could prove them wrong. Daunting layers of federal permits discouraged serious study of the substance's efficacy, and strictly controlled access to the only legally grown supply have meant that grants were awarded only to those folks who werent looking for anything nice to say about pot. Schedule I drugs can't even be the subject of research or study. But this November, the young guard at the American Medical Association (AMA) gleefully hip-checked the doomy, gloomy straight-laced old guard out of the way and voted to revisit marijuanas Schedule I classification. After reviewing all the reliable information available, their conclusion was this (PDF): "Adverse reactions observed in short-term randomized, placebo controlled trials of smoked cannabis to date are mostly mild without substantial impairment. Physicians who comply with their ethical obligations to first do no harm' and to 'relieve pain and suffering' should be protected in their endeavors, including advising and counseling their patients on the use of cannabis for therapeutic purposes." In taking that position, the AMA joined the American College of Physicians, the country's second largest physician group, which in February 2008, had adopted a similar resolution. As former Surgeon General Dr. Jocelyn Elders wrote in AlterNet in 2008, its time "to put science ahead of politics. 2) Reduce our dependence on foreign opioids. Chronic pain is the leading indication for medical marijuana use, accounting for 90 percent of the patients in Oregons medical marijuana program. Recently, research done both in Canada and the United States has demonstrated a synergistic interaction between cannabis and opioids. Patients who smoked a little weed along with their meds found they could decrease their opioid dose by between 60-100 percent. So consider that if the entrenched drug warriors were finally outflanked, VA doctors would be allowed to prescribe marijuana and our vets could reduce their consumption of opioids. 3) Restore the reputation of the VA among veterans. After all the criticism of the VA for limiting access, shredding claims, misdiagnosing illnesses as a cost-saving trick and using soldiers as uninformed guinea pigs to test pharmaceutical drugs linked to suicide and other violent side effects, veterans invited by the VA to knowingly participate in a marijuana study might be inclined to allow the euphorogenic qualities associated with cannabis to blur their outrage, even to the point of forgiveness. 4) Israeli rats have less stress than American soldiers. In an article published in the September issue of the Journal of Neuroscience, Israeli scientists revealed that injecting synthetic marijuana into the brains of rats allowed them to recover faster from trauma. In fact, it cancelled out the symptoms of stress." The researchers predicted that marijuana may help patients overcome life stresses that worsen reawakened trauma and other symptoms of post-traumatic stress disorder. 5) And then there is Sativex. Savitex is an oromucosal spray, developed by the British firm GW Pharmaceuticals, that has been called liquid marijuana" because it is derived from the entire botanical cannabis plant. In 2005, the Canadian government approved its use for relief of neuropathic pain and the FDA has agreed to trials in the U.S. prior to an approval application. It will be challenging to persuade patients that Sativex, which will surely cost more than what can be grown in your backyard, is the better choice. No pharmaceutical preparation, synthetic or natural, has yet proven as effective as the smoked plant. In fact, the only proven advantage of such medications is that they are legal. Those FDA trials, by the way, were supposed to be completed by the end of 2009. 6) We gave Big Pharma 40 years of government handouts and they came up with zilch. Instead of paying extortionist rates, imagine if the VA could say, Sorry, Bayer, but youre going to have to make it cheap and make it good, or theyll just grow their own." Its a piece of cake to go around Big Pharma on this one. All you need is a little sun, soil and TLC, or a grow-lamp in your basement. And the good fortune to get to your crop before the cops, the local kids or the deer. How easy? Since 2006, entrepreneurial Americans have grown enough marijuana to displace corn as the leading cash crop in America. 7) The growing process is itself demonstrably therapeutic. A recent study out of the Naval Postgraduate School and Stanford University predicts that as many as 35 percent of returning soldiers could have PTSD. The number of veterans who have already served in Iraq and Afghanistan has reached 1.8 million. Another study, courtesy of the Pentagon, estimates that as many as 360,000, or 20 percent of the veterans of these current wars have suffered traumatic brain injuries. Thats a lot of new fists that will be banging on the doors of an already overwhelmed VA asking for help. How serendipitous then, that a promising treatment option being offered to traumatized veterans across the country is gardening. 8. We could fill some budget gaps. Imagine the savings for states like Washington that are currently facing huge financial deficits. Washington announced this month that a bill to legalize marijuana altogether will be on the ballot in 2010. The circularity is sweet; the logic hopefully irresistible. Traumatized veterans could be hired by the state to garden, which relieves their post-combat stress symptoms and also affords them an income and the self-respect that comes with employment. The crop they grow will medicate their own psychic distress and that of other veterans, while at the same time replenish the state coffers when sold in state-run liquor stores. Rep. Mary Lou Dickerson, a Seattle Democrat who is sponsoring the legalization bill, said she expected legal sale of marijuana could bring in as much money as alcohol; more than $300 million a year. It will also challenge legislators in other cash-strapped municipalities to consider the billions of dollars worth of marijuana that is currently going untaxed, and whether they want to stand on principle or on solvency. 9) Suicide prevention. The National Center for Posttraumatic Stress Disorder acknowledges that there is disagreement whether pharmacotherapy should be considered a first-line treatment for PTSD." As illustration, their manual, "Treatment of the Returning Iraq War Veteran," states: We recommend SSRIs as first-line medications for PTSD pharmacotherapy in men and women with military-related PTSD." The Journal of Clinical Psychiatry reports that 89 percent of veterans with PTSD are prescribed antidepressants and 34 percent antipsychotics by the VA. Of the specific medications identified as potentially useful, all but two come with black box warnings of suicide or increased risk of death. In October, VA Secretary Eric K. Shinseki announced that, "(m)ore Veterans have committed suicide since 2001 than we have lost on the battlefields of Iraq and Afghanistaneach one a tragedy." Soldier suicides are at an all-time high and so are prescriptions for all kinds of new and dangerous drugs. Nobody can say for sure if there is a connection between those two facts, and I would never suggest that marijuana could or should take the place of SSRIs or any other drugs proven to be effective in managing PTSD. Or that marijuana could prevent soldier suicides. But the vast majority of drugs the VA prescribes for PTSD are known to worsen depression, increase suicidal thinking or increase risk of death in enough people to warrant the warning. The same is not true of marijuana. 10) It would bring some coherence to our nation's drug policies. It is just possible that Tim Leary was right when he said that "(p)sychedelic drugs cause paranoia, confusion, and total loss of reality in politicians that have never taken them." Daniel Robelo of the Drug Policy Alliance says, The federal government has a duty to help veterans receive the most effective treatment available for their combat-related conditions, and for PTSD and chronic pain, marijuana is often that treatment. All veterans (and non-veterans) who might benefit should have unfettered access to this effective medicine, which is well within the margin of safety for any drug, and in fact, much less dangerous than most drugs commonly used to treat PTSD and pain." Penny Coleman is the widow of a Vietnam veteran who took his own life after coming home. Her latest book, Flashback: Posttraumatic Stress Disorder, Suicide and the Lessons of War, was released on Memorial Day 2006. Her Web site is Flashback.

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Fifth Status Update Filed with Appeals Court in Craker Marijuana Lawsuit

The fifth status update in the ongoing attempt to license Professor Lyle Craker to grow marijuana for research at UMass Amherst has been filed with the United States Court of Appeals First Circuit. It has now been almost one year since the DEA rejected the recommended ruling of their own Administrative Law Judge Mary Ellen Bittner. Judge Bittner ruled in favor of licensing Craker and ending the U.S. governments supply of marijuana for research. We have been hopefully waiting for President Obama to appoint a new leader at the DEA who would adhere to the original ruling, rather than the ruling written by DEA acting administrator Michelle Leonhart.

President Obama: Free the Medical Marijuana Researchers!

By Doug Bandow Senior Fellow at the Cato Institute

Posted: December 13, 2009 01:33 PM

Originally appearing here.

The War on Drugs continues, four decades after President Richard Nixon commenced hostilities. President Barack Obama--the third president in a row to have used illicit substances in his youth--is no drug warrior. However, he seems unlikely to challenge the disastrous new prohibition.

The president has, however, ended the federal campaign against medical marijuana, ordering administration officials to respect state laws legalizing the drug for medicinal purposes. This policy will grow increasingly important as more states allow use of med-pot (for instance, in November Maine voters legalized medical marijuana dispensaries). Congress should approve legislation introduced by Rep. Barney Frank (D-Mass.), codifying administration policy into law.

Moreover, the president should order the Drug Enforcement Agency to make more pot available for research, moving the issue forward at another level.

Critics of medical marijuana argue that pot has no clinical value. Many doctors, nurses, and scientists disagree.

For instance, the Institute of Medicine (part of the National Academy of Sciences) concluded that "Cannabinoids likely have a natural role in pain modulation, control of movement, and memory." Two years ago San Francisco General Hospital reported that HIV-positive patients achieved marked pain relief by smoking marijuana. Numerous seriously ill patients, including such leading political conservatives as the late Lyn Nofziger, an aide to Ronald Reagan, also attested to the therapeutic value of pot.

Continued research is needed to resolve the dispute. Indeed, the Institute of Medicine recommended more study "into the physiological effects of synthetic and plant-derived cannabinoids and the natural function of cannabinoids found in the body." Moreover, the IOM pointed to the importance of reviewing "vaporization devices," since "Marijuana delivered in a novel way that avoids smoking would overcome some, but not all, of the regulatory concerns."

Barbara Roberts, formerly of the White House Office of National Drug Control Policy, suggested that the IOM study provided a blueprint "to investigate this and to put it to rest." Unfortunately, the Bush administration, whose drug czar, John Walters, compared marijuana users to terrorists, refused to follow the IOM's recommendations.

Scientific study is hampered by the Drug Enforcement Agency's control of marijuana production through the National Institute on Drug Abuse (part of the National Institutes of Health). NIDA has denied scientists access to marijuana to study the drug's impact on migraines and AIDS wasting syndrome, for instance.

The lack of sufficient legal marijuana poses a particular barrier to privately-funded pharmaceutical research. Without adequate evaluation of the safety and effectiveness of marijuana's chemical compounds in treating chemotherapy-induced nausea, glaucoma, multiple sclerosis, AIDS symptoms, and other diseases, medicine will be impossible to develop.

The Bush administration wanted to have it both ways. It publicly claimed that marijuana had no medical value while privately denying researchers the drugs necessary to research pot's medicinal possibilities.

Several years ago Professor Lyle Craker, Director of the Medicinal Plant Program at the University of Massachusetts (Amherst), requested a Schedule I license to produce marijuana for research purposes. The University of Mississippi had a monopoly cultivation contract and opposed Dr. Craker's petition; the DEA did nothing. So Dr. Craker filed suit, resulting in a nine-day hearing before agency Administrative Law Judge Mary Ellen Bittner. She issued an 87-page opinion in 2007 recommending approval of Craker's application.

Bittner concluded "that NIDA's system for evaluating requests for marijuana for research has resulted in some researchers who hold DEA registrations and requisite approval from the Department of Health and Human Servives being unable to conduct their research because NIDA has refused to provide them with marijuana. I therefore find that the existing supply of marijuana is not adequate."

The government complained that Craker "has not shown that his registration would result in a pharmaceutical company developing a drug product from plant marijuana," observed Bittner. But only additional research can determine marijuana's potential as a prescription drug.

Ruled Bittner: "Respondent [Craker] is not obligated to show that his registration will lead to a pharmaceutical product but, rather, that he will use his registration to produce marijuana that will be used in legitimate research. That, Respondent has done." She therefore recommended approval of Craker's application as being "in the public interest."

The agency filed several disengenous objections to Bittner's decision, which then went to DEA Administrator Karen Tandy. Tandy was not asked to legalize marijuana. She was not asked to approve marijuana for medical purposes. She was not even asked to confirm the potential medical benefits of the drug.

All she was asked was to do was increase research opportunities for marijuana research. Doing so would have allowed med-pot advocates to meet the challenge raised by her predecessor, Robert Bonner: "Those who insist that marijuana has medical uses would serve society better by promoting or sponsoring more legitimate scientific research, rather than throwing their time, money and rhetoric into lobbying, public relations campaigns and perennial litigation."

Tandy and the DEA ignored Craker's appeal until January 7, 2009, when the Bush administration's drug warriors were two weeks away from being pushed out the door. Deputy Administrator Michele Leonhart then rejected Bittner's recommendation, ruling "that the proposed registration is inconsistent with the public interest." Leonhart offered conclusions rather than justifications, suggesting that the last administration simply opposed allowing additional research which might result in politically incorrect conclusions.

President Obama campaigned to restore good science to policy making. The issue of medical marijuana requires just such an approach. All parties should be able to agree on the value of more "legitimate scientific research," in Bonner's words.
But the DEA continues to stand in the way. Mr. President, it's time for a change.

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Join Together. AMA Calls for More Research into Medical Use of Marijuana

News Feature
By Bob Curley

The federal government should consider moving marijuana out of Schedule I of the Controlled Substances Act in order to facilitate clinical research and development of cannabinoid-based medications, the American Medical Association (AMA) said in a new policy statement.

In adopting the policy on Nov. 10 (PDF), the AMA's House of Delegates backed away from the group's long-standing opinion that marijuana should remain in Schedule I as a drug with no accepted medical uses, with a report from the group's Council on Science and Public Health stating that smoked cannabis has been shown in short-term controlled trials to be effective in reducing neuropathic pain and improving appetite, and may also alleviate symptoms among patients with multiple sclerosis.

The Council's report noted that the future of cannabinoid-based medicine lies in the botanical-drug development as well as the design of molecules targeting the endocannabinoid system. "To the extent that rescheduling marijuana out of Schedule I will benefit this effort, such a move can be supported," the report said.

In February 2008, the American College of Physicians similarly called for an "evidence-based review of marijuana's status as a Schedule I controlled substance to determine whether it should be reclassified to a different schedule."

"This [AMA policy] shift, coming from what has historically been America's most cautious and conservative major medical organization, is historic," said Aaron Houston, director of government relations for the Marijuana Policy Project, which advocates for medical use of marijuana and has backed many of the state medical-marijuana campaigns in the U.S.



No Endorsement of State Medical-Marijuana Laws

However, the panel's report also called the patchwork of state-based medical-marijuana programs "woefully inadequate in establishing even rudimentary safeguards that normally would be applied to the appropriate clinical use of psychoactive substances," and the AMA resolution stated that the new policy "should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product."

The Obama administration reacted cautiously to the new AMA policy, restating the FDA's assessment that raw marijuana "has not met the standards for identity, strength, quality, purity, packaging and labeling required of medicine."
"The Office of National Drug Control Policy agrees with the AMA that the safety and efficacy of drug products should continue to be determined by scientific and regulatory review, and not by ballot initiatives or state legislative action," the White House agency said in a press statement.


A Dearth of Research

AMA officials said that research into the medical uses of marijuana has been lacking, and the AMA policy urges the National Institutes of Health to "implement administrative procedures to facilitate grant applications and the conduct of well-designed clinical research into the medical utility of marijuana," including assisting researchers on developing research protocols and safeguards, providing research funding, and providing adequate supplies of "marijuana of various and consistent strengths and/or placebo" via the National Institute on Drug Abuse (NIDA).

"Despite more than 30 years of clinical research, only a small number of randomized, controlled trials have been conducted on smoked cannabis," noted AMA board member Edward Langston, M.D.

Rick Doblin, Ph.D., executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), said the AMA policy shift demonstrates that there is "clearly more interest in medical marijuana in the medical community than ever before."

However, Doblin -- who has long contended that NIDA has worked to block medical-marijuana research through its gatekeeping role over supplies of marijuana for research -- said the policy will have "zero effect in getting NIDA out of the loop." Doblin said that a unique and open-ended Public Health Service (PHS) review process for medical-marijuana research, coupled with NIDA's monopoly on the drug supply, has prevented most basic research studies on smoked marijuana from getting off the ground.

Steve Gust, Ph.D., a special assistant to NIDA Director Nora Volkow, M.D., countered that the agency "has been and continues to be open to applications" for medical-marijuana research, but added that the agency has seen "no groundswell of interest from researchers" wanting to study the drug's medical uses. (NIDA funds research on drug abuse and addiction, not medical uses of drugs, so medical-marijuana studies, if approved, would be funded by other institutes within NIH.)

"The criticism about the so-called NIDA resistance to such research is completely unfounded, always comes from the same source, and in fact seems to be based on either a single example of a 10-year-old grant application to NIH or a request by MAPS that has reviewed by the PHS several times but has been technically deficient," said Gust. "The fact is that there has been more clinical research on medical marijuana in the last five years than the previous 20 -- almost all conducted by the Center on Medicinal Cannabis Research at the University of California at San Diego (UCSD), and with mostly positive results."

Gust noted that the marijuana for the UCSD studies was provided by NIDA. "I really don't understand why the critics are not celebrating this increase in research and positive findings rather than continually harping on the falsehoods about NIDA blocking research," he said.

This news feature has been revised to reflect the following correction:
Correction, Nov. 23, 2009: The original headline and first paragraph of this article incorrectly said that the policy adopted by the AMA stated that limited research has shown that marijuana has medicinal value. This conclusion was not part of the resolution adopted by the House of Delegates. It was included only in the advisory report from the AMA's Council on Science and Public Health, which stated, "Results of short term controlled trials indicate that smoked cannabis reduces neuropathic pain, improves appetite and caloric intake especially in patients with reduced muscle mass, and may relieve spasticity and pain in patients with multiple sclerosis."

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Israel Explores Possibilities of Permitting Medical Marijuana Sales

Under the direction of the Knesset (Israels legislative body), the Israeli Ministry of Health is considering allowing medical marijuana producers to sell marijuana to Ministry of Health approved patients. If this plan is implemented, the marijuana producers will be able to increase the amount they produce and the Ministry of Health will approve more patients. Furthermore, if the plan is implemented, Israel will become a model state for the safe distribution of medical marijuana to medical marijuana patients.

First Circuit Court of Appeals Third Status Update Submitted in Prof. Crakers Marijuana Production Facility Case

On September 4, 2009, Professor Lyle Craker, Ph.D.s ACLU Drug Law Reform Project lawyers filed the third Status Update with the U.S. Court of Appeals, First Circuit. The update reports on the DEAs lack of response to the witness and document list filed with the DEA on June 5, 2009, in support of Prof. Crakers Motion to Reconsider the DEAs Final Ruling. The lawyers are asking the Court to hold the appellate proceedings in abeyance until we learn the DEAs final decision. The DEAs final order was scheduled to go into effect July 1, 2009, but the DEA lawyers have previously indicated that it is not unusual to have a Motion to Reconsider still pending after the effective date of a final agency order.

For the first time since we began this court case in 2001, we are in alignment with the DEAs tactic of delay. We have read rumors that Obama is considering appointing new leadership at the DEA from outside of the current DEA. Hopefully, any new leadership replacing the Bush-holdovers who are still running the DEA will reverse the rejection of the Administrative Law Judge (ALJ)s recommendation to license Prof. Craker.

Crakers lawyers are required to file a status report with the Court of Appeals every 60 days until a decision is finalized by the DEA. These status report filings preserve Crakers right to appeal should the DEA deny him a license to grow marijuana for research purposes at UMASS Amherst, under contract to MAPS.

Israeli Medical Marijuana Production Status Update

Rick Doblin, Mike Corral Visit Israel to Help Medical Marijuana Program.

On August 24, 2009, MAPS Executive Director Rick Doblin, Ph.D. met with Israeli Ministry of Health official Yehuda Baruch, M.D. who is in charge of the Ministry’s medical marijuana program. Boaz Wachtel, an Israeli medical marijuana activist, was also at the meeting. They discussed various issues regarding the expansion of the Israeli medical marijuana program. Currently, there are a handful of marijuana producers licensed to grow marijuana and give the product away to about 500 licensed medical marijuana patients. In order to create a sustainable business model, there will need to be a transition to allowing the producers to sell their product. However, it seems that the transition to sales will not be imminent. There will need to be more work done to persuade the Ministry of Health that selling the medicine to patients is an appropriate course of action. Despite no guarantee of future sales, the various producers are taking on investors in hopes of building for-profit businesses. Consequently, MAPS has stopped donating money to Israeli production facilities. MAPS is still trying to help support medical marijuana research in Israel by urging the Ministry to approve sales as soon as possible.

Professor Crakers Attorneys File Second Status Update in Court of Appeals


On July 2, 2009, Professor Lyle Craker's ACLU Drug Law Reform Project lawyers filed the Second Status Update with the US Court of Appeals, First Circuit. The update reports on DEA's lack of response to the witness and document list filed with DEA on June 5, 2009, in support of Prof. Craker's Motion to Reconsider DEAs Final Ruling. The lawyers are asking the Court to hold the appellate proceedings inabeyance until we learn the DEAs final decision. DEA's final order was scheduled to go into effect July 1, 2009, but DEA lawyers have previously indicated that it is not unusual to have a Motion to Reconsider still pending after the effective date of a final agency order.

Crakers lawyers are required to file a status report with the Court of Appeals every 60 days until a decision is finalized by DEA. These status report filings preserve Crakers right to appeal should DEA deny him a license to grow marijuana for research purposes at UMASS Amherst, under contract to MAPS. We are currently comfortable with DEAs delay as we are hoping that new leadership at DEA will soon be appointed by the Obama administration. New leadership at DEA will hopefully be more likely to reverse the rejection of the Administrative Law Judge (ALJ)s recommendation to license Prof. Craker than the Bush-holdovers still running DEA who initially rejected the ALJs recommendation.

Crakers Lawyers Filed Witness and Document Lists

On June 5, Crakers lawyers filed potential witness and document lists regarding our pending Motion to Reconsider. On May 18, DEA filed an Interim Order requesting that Craker submit witness and document lists by June 5, 2009. DEA also extended the effective date of its final ruling to July 1, 2009, leaving it three weeks to consider whether or not to grant our Motion to Reconsider. On May 11, 2009, we asked the First Circuit, US Court of Appeals (where in a defensive maneuver we have filed a new lawsuit against DEA) to delay consideration of our case until after we learn how DEA responds to our pending Motion.

On April 29, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEAs final decision regarding Prof. Crakers application for a license to grow marijuana for research. This follows a similar letter sent on April 15 by Congressmen John Olver and Sam Farr requesting that Ogden intervene on behalf of Prof. Craker by asking the DEA to cease going forward on its May 1 deadline.

On April 13, the DEA filed its final response to Crakers March 11 Supplemental Motion To Reconsider and Exhibits submitted to DEA Deputy Administrator Michelle Leonhart, adding to a Motion to Reconsider filed January 30. These motions request a hearing to present opposing arguments to new evidence that DEA cited in its January 14, 2009, Final Order rejecting DEA Administrative Law Judge Bittner's February 12, 2007 recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Crakers facility would be built at the University of Massachusetts Amherst and would be sponsored by MAPS.

Rick Doblin, Mike Corral Visit Israel to Help Medical Marijuana Program

From April 19 to April 22, 2009, MAPS President Rick Doblin went to Israel to work with Ministry of Health-approved medical marijuana producer Yohai Golan and Golans investors. Ricks efforts in Israel involved consulting with the Ministry of Health about the possibility of allowing production facilities to sell marijuana to Ministry of Health-approved patients in order to create a sustainable system. Currently, the Israeli government has only given Golan, and several other producers, permission to give away the medicine they grow, but not to sell it. Rick is hopeful that the Ministry of Health will eventually permit sales of marijuana, but he recognizes that the wheels of bureaucracy turn slowly.

On Tuesday, May 12, 2009, Mike Corral--an experienced medical marijuana grower from the Wo/mens Alliance for Medical Marijuana--arrived in Israel to consult with three different growing facilities on techniques to maximize yield while reducing costs. An anonymous donor funds Mikes work in Israel through MAPS.

While in Israel Rick heard good news about several current studies investigating clinical applications for medical marijuana. Among the studies taking place are a study with patients with Crohn’s disease and patients with posttraumatic stress disorder (PTSD). The PTSD study will use THC drops as opposed to smoked marijuana. Raphael Mechoulam, Ph.D, who was a part of a team of scientist to first isolate and identify THC as the active ingredient in marijuana, developed the THC drops. Nearly three decades later he led a team that identified the endocannabinoid anandamide, part of an endogenous cannabinoid system in the human nervous system.

May 1st Comes and Goes Without DEA Action

May 1 Comes and Goes Without DEA Action - Craker's Marijuana Production Application Still Pending

On January 14, 2009, DEA issued a Final Order rejecting DEA Administrative Law Judge Bittner's February 12, 2007, recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Craker's facility would be built at the University of Massachusetts Amherst and would be sponsored by MAPS. Ending the federal monopoly on the supply of marijuana for research would be the beginning of a serious drug development effort aimed at transforming marijuana into an FDA-approved prescription medicine.

May 1, 2009, was the effective date of DEA's final ruling rejecting Prof. Craker's license. However, we have still heard nothing from DEA in response to Prof. Crakers Motion to Reconsider. Based on conversations between Allen Hopper, Prof. Crakers ACLU attorney, and Teresa Wallbaum, Acting Deputy Chief for Policy and Appeals, US Department of Justice, Criminal Division, Narcotic and Dangerous Drug Section, and also additional conversations between Senator Durbin's staff and DEA officials, we have learned that DEA review of the Motion to Reconsider is still pending and that DEA intends to issue a written order adjudicating the Motion. We also learned that it is not rare for Motions to Reconsider, like the one filed here, to be resolved even after so-called final orders have become effective. In other words, there is still some possibility that DEA may grant in part or in whole the still-pending Motion to Reconsider, which could significantly change the final order. As the saying goes, Its good to be the King, since you can ignore your own deadlines.

On May 11, 2009, Prof. Crakers lawyers filed an update in the First Circuit Court of Appeals. We have asked for a delay in consideration of our case until after we learn how DEA responds to our pending Motion, which they may accept or reject. On February 13, 2009, in a prescient defensive maneuver, Prof. Crakers attorneys filed a placeholder notice of appeal in the U.S. Court of Appeals for the First Circuit in Boston, preserving Prof. Crakers right to appeal just in case DEA eventually denies the Motion to Reconsider; such a denial would effectively end the administrative proceedings and retroactively finalize the already-published final order denying his application. On March 12, the Court granted Prof. Crakers attorneys request that the appeal be docketed but no further action be taken until such time as DEA rules on the Motion to Reconsider. The Court also ordered Prof. Crakers attorneys to file an update every 60 days about the status of the case, with May 11 being the due date for the first update. If DEA denies the Motion to Reconsider, the appeal process is already started and a briefing schedule will be set. If DEA grants in part or in whole the Motion to Reconsider, the attorneys will focus on presenting new information to DEA and can further postpone (or completely eliminate the need for) the appeal. We are hoping that new leadership at DEA appointed by President Obama will thoroughly review the administrative proceedings, perhaps allow the submission of additional information, and eventually grant Prof. Crakers application for a license to grow medical marijuana for FDA-approved research.

On April 29, 2009, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEA's final decision regarding Prof. Craker's application for a license to grow marijuana for research. This follows a similar letter sent on April 15 by Congressmen John Olver and Sam Farr requesting that Ogden intervene on behalf of Prof. Craker by asking DEA to cease going forward on its May 1 deadline. Since there has still been no final negative action by DEA, it appears these letters may have had an impact.

Now were back in waiting mode, with no deadline for DEA to file its decision regarding our Motion to Reconsider. Delay has always been DEAs preferred strategy. Until there is new leadership at DEA appointed by President Obama, delay is now our preferred strategy as well.

Productive Planning Produces Productive Pot Production in Israel

On Friday, March 6, MAPS brought Val Corral and Mimi Peleg of Wo/Mens Alliance for Medical Marijuana (WAMM) to Israel to work with Yohai Golan at his medical marijuana production facility. Joined by Rick Doblin, they had very productive meetings with the team that is producing marijuana for Israeli Ministry of Health-approved patients. Lester Grinspoon, MD, Donald Abrams, MD, and Rick Doblin agreed to be on the board of advisors for the production facility. The team is still negotiating with the Ministry of Health to obtain permission to sell their product to their patients; currently they are only legally allowed to supply the medicine free of charge. MAPS has arranged with the support of an anonymous donor for Mike Corral, a greenthumb gardener from WAMM, to go to Israel soon to further consult with the production facility in order to help maximize their yield.

Rick, Val, and Mimi were able to tour the facility, which includes a multi-acre greenhouse that is gradually filling up with medical marijuana plants in various stages of growth. Rick says, It is a tremendously exciting situation and we are looking forward to continuing to be involved in the project.

Furthermore, the Ministry of Health is granting licenses for people who have PTSD to use medical marijuana. Rick had a conversation with one of the doctors who prescribes marijuana to patients with PTSD. It is possible that we will become involved in a marijuana/PTSD study in Israel, which will complement and clarify our other MDMA/PTSD Studies.

LA Times: The Science of Pot

Los Angeles Times
March 10, 2009 Tuesday
Home Edition

EDITORIALS;
The science of pot

SECTION: MAIN NEWS; Editorial pages Desk; Part A; Pg. 24
LENGTH: 403 words

At the heart of the debate about marijuana's medicinal value is a dearth of
academic research into its therapeutic properties. For 40 years, the federal
government has frustrated such study by restricting cultivation of marijuana
for research to a single source, the University of Mississippi. Most
recently, the Bush administration denied the application of a well-regarded
botanist at the University of Massachusetts to establish another cultivation
facility, despite a ruling by an administrative law judge determining that
it should go forward.

For eight years, professor Lyle Craker has struggled to obtain a license
from the Drug Enforcement Administration to grow research-grade cannabis.
His proposal is to supply marijuana to DEA-approved researchers who have
undergone a rigorous review and approval process by the U.S. Public Health
Service, and whose protocols have been approved by the Food and Drug
Administration. The DEA, however, has behaved as if this serious scientist
wants to start a backyard plot for campus parties.

In February 2007, after nine days of testimony from expert witnesses and
administration officials, light broke through the DEA's bureaucratic murk:
Administrative Law Judge Mary Ellen Bittner issued an 87-page opinion saying
that the supply of marijuana from the University of Mississippi is
insufficient in quality and quantity and that Craker's project should go
forward. In a case study of governmental intransigence, the DEA dithered for
two years. Then, a few days before the Obama administration took power,
acting Administrator Michele Leonhart issued a final order denying Craker's
application.

Members of Congress have urged Atty. Gen. Eric H. Holder Jr. to amend or
overrule the order, and he should do so. Then he should go further and
change the culture of the agency. Instead of thwarting the advancement of
science, the DEA should encourage cannabis research. As California and the
U.S. government continue to debate the future of medical marijuana, what we
need is a body of work on the drug's efficacy in treating a variety of
illnesses and conditions.

Instead, we have a collection of small studies and individual testimony. On
Monday, President Obama signed a "scientific integrity presidential
memorandum" and promised that his administration would base its public
policies on science, not politics; the DEA is one of many federal agencies
ready for enlightenment.

Continue Reading

WAMM Movie

Wammovie is feature length documentary film that will show the human drama of facing disease, the end of life and a person's right to choose how they deal with both. This film is based on footage and interviews collected over the past four years of volunteer work with a collective of patients and caregivers called the Wo/men's Alliance for Medical Marijuana (WAMM).

Wammovie is the story of patients and caregivers fighting for their right to choose what medicine is most suitable for their particular circumstance. It is the story of faith in the power of collective compassion and one of ultimate loss. Wammovie is the account of Jackie, a caregiver who came to WAMM as a skeptic and emerged as an advocate. Jackie bakes medicinal muffins for her friends because she thinks that they deserve a break from nausea or constant pain. Even if the relief she provides is a brief moment it is worth every ounce of effort. It is the story of Jeremy, an HIV/AIDS patient who delights in helping others in need access their medicine. He was diagnosed over 20 years ago and has watched many friends succumb to a disease that he was sure would have taken him long ago. It is the story of Dianne who has battled breast cancer and won. She signifies her victory by transforming her mastectomy scar into a powerful image of beauty and strength. Her emergence as a survivor has inspired her to educate others about breast cancer.

Wammovie is about surviving and making positive experiences out of every moment but it is also about letting go and being present for the exquisite journey to the end of life. Lucy is dying of ovarian cancer; she has been for some time. She is afraid but struggling to hold things together for her 15-year-old daughter that she has been raising by herself. As Lucy's conditions worsen a team of her loved ones swing into action to provide round the clock care. Lucy's care team did not set out to nurse her back to health or even to extend her life. They were there to ensure that her quality of life was as best as possible and that the end was as she wanted it.

Wammovie is about the life that happens after the worst has been faced and there is nowhere left to go but forward. That is the time when being alive really is about the very moment of existence that you experience. In this story, a young woman, Lucy's daughter was forced to grow up too early; she lost her mother to ovarian cancer yet found another place to call home with her mother's friend and deathbed companion Valerie Corral.  In this story, Jackie finds love with another WAMM member and is married at a joyous occasion that takes the place of a previously planned triple memorial. According to Val, The connection between the marriage and the memorial is a transcendence into love. Wammovie is about our transcendence into love.

Congress to DEA: Reconsider Monopoly on Medical Marijuana Research

Americans for Safe Access (safeaccess.org)
For Immediate Release: February 6, 2009

Congress to DEA: Reconsider Monopoly on Medical Marijuana Research
Sixteen Members of Congress Urge Attorney General Holder to change DEA policy

Washington, DC -- Sixteen Members of Congress issued a letter yesterday to newly-seated Attorney General Eric Holder urging the Drug Enforcement Administration (DEA) to act "swiftly to amend or withdraw" an order that significantly curtails medical marijuana research in the United States. For more than forty years, the federal government has held a unique monopoly on the cultivation of marijuana for medical research, significantly impeding studies on the therapeutic qualities of medical marijuana and the ability to bring it to market. In February of 2007, DEA Administrative Law Judge Mary Ellen Bittner ruled to end that monopoly by claiming that expanded medical marijuana research was "in the public interest."

The Congressional letter sent to Attorney General Holder was authored by John Olver (D-MA) and states in part:
Since 2001, Prof. Lyle Craker, an experienced botanist of medicinal plants and soils, has been struggling to obtain a DEA license for a privately-funded facility located at the University of Massachusetts to grow cannabis (marijuana) exclusively for FDA-approved research protocols designed to evaluate its potential medical value. Forty-five members of the House of Representatives and Senators Edward Kennedy and John Kerry, as well as a broad range of scientific, medical and public health organizations including the Lymphoma Foundation of America, the National Association for Public Health Policy, and the Multiple Sclerosis Foundation have all written to DEA in support of Professor Craker's efforts.
Since 1968, the National Institute on Drug Abuse (NIDA) has contracted exclusively with the University of Mississippi to cultivate marijuana for medical research. Not only is this exclusive arrangement unlike that for any other Controlled Substance regulated by the federal government, but it is also unlike other countries that comply with the United Nations Single Convention Treaty on Narcotics. In her 87-page Opinion and Recommended Ruling, Administrative Law Judge Bittner concluded that the quality and quantity of marijuana supplied by NIDA was inadequate for the level of research that cannabis deserves.

"Given President Obama's commitment to end federal enforcement in medical marijuana states, it stands to reason that he would be in favor of expanded research into this important medication," said Caren Woodson, Director of Government Affairs with Americans for Safe Access. "His Department of Justice has the opportunity to place science above politics and to facilitate unfettered research into medical marijuana." The DEA took nearly two years to respond to Judge Bittner's ruling and with less than one week before a change in Administration, acting-DEA Administrator Michele Leonhart rejected the ruling and denied Professor Craker's application. The ACLU, which represents Professor Craker in this matter, is requesting reconsideration and an opportunity to respond to new evidence used by the DEA in its rejection.

Further information

  • Yesterday's letter from 16 Members of Congress to Attorney General Eric Holder: http://AmericansForSafeAccess.org/downloads/Olver_to_Holder_Letter.pdf or media/amherst.house.sign-on.to.holder.FINAL.pdf [permalink]
  • February 2007 DEA Administrative Law Judge ruling: https://web.archive.org/web/20080302223036/http://americansforsafeaccess.org/downloads/Craker_Ruling.pdf
  • DEA rejection of Professor Craker's application: http://www.aclu.org/drugpolicy/medmarijuana/38298lgl20090112.html
  • ACLU Motion to Reconsider: http://www.aclu.org/drugpolicy/medmarijuana/38648lgl20090130.html
  • With over 30,000 active members in more than 40 states, Americans for Safe Access (ASA) is the largest national member-based organization of patients, medical professionals, scientists and concerned citizens promoting safe and legal access to cannabis for therapeutic use and research. ASA works to overcome political and legal barriers by creating policies that improve access to medical cannabis for patients and researchers through legislation, education, litigation, grassroots actions, advocacy and services for patients and the caregivers.

    Congress and Professor Craker Respond to Bush Administration and DEA’s Obstruction of Scientific Freedom

    On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the Drug Enforcement Administration’s (DEA) final ruling, which was the Bush Administration's parting blow to medical marijuana research. Professor Craker rebutted DEA’s final order with the support of MAPS and the American Civil Liberties Union (ACLU) on grounds that new evidence was introduced in the final ruling that was not included during testimony in the case.

    On February 6, 2009, 16 members of the United States Congress sent a letter to new Attorney General Eric Holder urging him to have DEA “amend or withdrawal the Final Order in this matter to permit President Obama’s new Deputy Attorney General and DEA appointees to review Prof. Craker’s merits, once they are in office.” This letter was orchestrated by our sister organization Americans for Safe Access (ASA), who also distributed a press release. The 16 signatories are Representatives John Olver, Maurice Hinchey, Ron Paul, Tammy Baldwin, Raul Grijalva, Sam Farr, Robert Wexler, Ed Pastor, Neil Abercrombie, Gary Ackerman, Lynn Woolsey, William Delahunt, Barney Frank, Zoe Lofgren, Michael Capuano, and Dennis Kucinich.

    The motion of reconsideration and Congressional letter are responses to the Bush Administration’s last-minute obstruction of legitimate science on January 14th, when DEA filed in the Federal Register its final ruling refusing to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research. DEA’s final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. Her February 12, 2007, recommendation stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEA’s contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA’s monopoly fundamentally obstructs MAPS’ research aimed at developing smoked or vaporized marijuana into a prescription medicine.

    MAPS is hopeful that the Obama Administration will honor its commitment to science over ideology. The Obama administration should support MAPS’ efforts to sponsor research aimed at gathering evidence about marijuana to present to FDA, and should stop DEA’s and NIDA’s obstruction of our attempts to transform marijuana into an FDA-approved prescription medicine.

    There are several media articles about DEA’s ruling on the MAPS in the media page.

    Mimi Peleg Provides Guidance to Medical Marijuana Facility in Israel

    On Monday, January 26, MAPS funded Mimi Peleg of Wo/Mens Alliance for Medical Marijuana (WAMM) in Santa Cruz, CA, to travel to Victoria, British Columbia, Canada to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS). Mimi and Philippe are advising a MAPS-supported medical marijuana production facility in Israel, licensed by the Israeli Ministry of Health. MAPS donated $15,000 as a matching grant to Yohai Golan’s medical marijuana production facility that is giving marijuana away for free to Ministry of Health-approved patients under the Israeli Health Minister’s guidelines. MAPS is also sponsoring Mimi Peleg and WAMM’s founder and president Val Corral to visit Israel next month for in-person consultation. An anonymous donor is covering expenses and Val and Mimi’s trip to Israel.

    HHS Senior Public Health Advisor Sends a Letter to Chemic

    Gregory Goldstein, HHS Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic on January 23, 2009, saying that HHS would require a validation study showing that Chemic could reliably measure various cannabinoids before it would even review Chemic's November 6, 2008 reply to the June 18, 2008 PHS/NIDA critique of Chemic's January 16, 2008 protocol.

    However, there is no guarantee that PHS/NIDA would approve the protocol after funds for the validation study had been spent. Furthermore, a validation study could cost $40,000 and isn't really necessary for the sort of academic study we're seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as a medical device, a task best left to the manufacturer of that vaporizer. We're exploring a collaboration with Dutch scientists already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less then half the cost of the validation study.

    Chemic initially submitted a protocol in June, 2003, seeking to purchase 10 grams from NIDA. That protocol was rejected on July 27, 2005, more than two years later. Chemic's reply to that rejection was submitted on September 9, 2005, and was ignored by NIDA for over two years and four months, prompting us to submit a new protocol on January 16, 2008, to see if it might somehow catalyze a review process.

    Progress is slow in Chemic's efforts to purchase 10 grams of marijuana from the government's monopoly provider, NIDA. It's encouraging that the first hint in over 5 1/2 years that NIDA might actually sell Chemic 10 grams for its research took place on January 23, 2009, three days after Obama became President.

    The Bush Administration Struck a Parting Shot to Legitimate Science

    The Bush administration struck a parting shot to legitimate science on January 14th, as the Drug Enforcement Administration (DEA) refused to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research. DEA's final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. The prior recommendation on February 12, 2007, stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEAs contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA's monopoly fundamentally obstructs MAPS research aimed at developing smoked or vaporized marijuana into a prescription medicine.

    Medical Marijuana Donation Leveraged in Israel

    For the last several years, MAPS has provided financial support for the development of the compassionate use of marijuana in Israel, in conjunction with a program of medical access developed by the Israeli Ministry of Health. The Ministry reviews applications from physicians on behalf of their patients and has licensed four different medical marijuana production facilities. These facilities have permits from the Israeli Ministry of Health to provide marijuana for free to Ministry-approved patients. Since the production facilities can only give marijuana away, they rely on donations to cover costs. An excellent article on the Israeli medical marijuana program was published recently in an Israeli newspaper, and has been translated by Dana Peleg, MA.

    In November, MAPS offered $15,000 as a matching grant to Yohai Golan, who has one of the Ministry production licenses. In December, Yohai managed to obtain $15,000 as his match from Israeli donors and MAPS sent him our $15,000, provided by an anonymous donor. Over the last several weeks, Yohai has concluded negotiations with Israeli investors (not donors) who are providing sufficient funding (roughly $200,000 per year) to cover the provision of enough marijuana for 500 patients for the next two years. These investors are gambling that they can make money providing marijuana extracts to the pharmaceutical industry, since they can grow marijuana for this purpose as well as for free distribution to patients. In addition, they expect they will eventually be given permission to sell marijuana to patients, though how much research will have to be conducted first remains to be determined.

    As a side project to the production facility, Yohai’s team will be producing organic cannabis oil tinctures that can be used as a substitute for smoking for patients who prefer not to – or cannot – inhale smoke or vapors from a vaporizer. The tinctures will use donated fair-trade organic olive oil produced by Palestinians in the West Bank and Israelis in Israel.

    Yohai Golan has estimated that the value of the marijuana that they will give away is roughly $6 million per year, based on prices for legal Dutch medical marijuana and prices for medical marijuana in the US.

    MAPS colleagues Val Corral and Mimi Peleg from the Wo/Mens Alliance for Medical Marijuana (WAMM) will travel to Israel, probably in February, to help Yohai create a functional administrative system to distribute the medicine that will be harvested at the end of March. MAPS will pay for their travel through funds that have been donated and restricted to this project. Prior to going to Israel, Mimi Peleg will travel to Victoria, Canada, to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS), to learn about his approach to distribution and research. Previously MAPS has sponsored Philippe to consult with another medical marijuana production facility in Israel. 

    Yohai expressed his gratitude to MAPS President Rick Doblin PhD, “I would like to thank Rick for his constant support and late night chats helping me keep focused and looking ahead. Without his guidance and constant advice, I would not have come this far in Israel and would have given up.”

    MAPS is extremely gratified that our original funding of a mere $15,000 was the catalyst for this significantly larger investment!

    Bush Administration Last Minute Blow to Scientific Freedom

    Only 10 days before the Bush Administration leaves office, the DEA has issued a final ruling denying a license to Prof. Lyle Craker, UMass Amherst, to grow marijuana for MAPS-sponsored medical research. The DEA is responding to a February 12, 2007 recommendation by DEA Administrative Law Judge Mary Ellen Bittner who found after extensive legal hearings that it would be in the public interest for DEA to issue Prof. Craker a license.  The DEA is determined to protect the federal monopoly on the supply of marijuana that is legal for research that is held by the National Institute on Drug Abuse (NIDA). NIDA uses its monopoly to fundamentally obstruct research aimed at developing marijuana into an FDA-approved prescription medicine. For example, Chemic Labs has been seeking without success for over  5 1/2 years to purchase 10 grams of marijuana from NIDA for MAPS and CaNORML-sponsored research into the effectiveness of the Volcano vaporizer as a non-smoking drug delivery device.

    We have yet to see the DEA brief, which we have been told is 180 pages. We'll be formulating a new strategy as quickly as we can to deal with this last minute blow to scientific freedom from the Bush Administration.

    Israel Medical Marijuana Production Facility

    Israel Medical Marijuana Production Facility Receives $15,000 in Matching Funds: MAPS sent $15,000 to an Israeli medical marijuana production facility directed by Yohai Golan, who produces medical marijuana with a license from the Israeli Ministry of Health. This was a matching grant, which required Yohai to first raise $15,000, which he was able to do. The production facility has legal permission to grow and distribute marijuana to Ministry of Health-approved patients. However, the facility must give away the medicine for free and cannot sell it until marijuana has been approved as a prescription medicine by the Ministry of Health -which will require substantial clinical research. In the long run, this policy requiring the free distribution of medicine is an unsustainable model because the facility can only operate on donations while the patient base is steadily increasing. Meanwhile, some useful data is being gathered from the patients provided medicine by the facility and more doctors and patients are becoming comfortable with medical marijuana use.

    Slate Magazine: High Expectations

    Research into medicinal marijuana grows up.
    Slate Magazine
    By Amanda Schaffer
    Posted Thursday, Nov. 6, 2008, at 6:49 AM ET

    This summer, British and Italian researchers found that in a laboratory plate, molecules in marijuana can slay the superbug methicillin-resistant staphylococcus aureus, which recently infected seven babies and four employees in a Yonkers, N.Y., maternity ward, heightening fears of outbreaks in schools and locker rooms, as well as in its more familiar breeding grounds, hospitals and nursing homes. In theory, compounds derived from the cannabis plant could someday serve in topical creams for patients with MRSA or other antibiotic-resistant infections.

    This isn't the first time marijuana has tantalized the world as a possible wonder drug. In recent years, compounds in cannabis or related molecules have been shown to slow the growth of lung tumors in mice, decrease hardening of the arteries in rats, and boost the egg-binding capability of tobacco smokers' sperm. Research on the receptors that THC and other cannabis compounds attach to—and the nitty-gritty mechanisms by which they exert their effects—has been booming. So has work on native molecules, called endocannabinoids, that bind to the same sites. These molecular interactions affect a wide range of functions, from appetite to inflammation to the perception of pain.

    The onslaught of basic science has helped to separate cannabis from an association with hippies and recreational pot smokers. It has also spurred hopes that these molecules (or similar ones) might prove therapeutic for traumatic brain injury, inflammatory bowel disease, allergic contact dermatitis, atherosclerosis, osteoporosis, and Alzheimer's disease, among others. For all the razzle-dazzle, though, potential treatments frequently seem stuck in perpetual adolescence. Research on traumatic brain injury seemed promising but got mixed results in human clinical trials, while most of the others simply haven't gotten very far in the experimental process.

    Still, a few prospects show signs of inching toward adulthood. The most enticing are aimed at lessening pain associated with nerve damage and improving some symptoms of multiple sclerosis. Between 2007 and this summer, several randomized clinical trials have found that smoking marijuana can relieve pain in patients with nerve degeneration caused by HIV or other disorders. Compounds in cannabis also seem to reduce nerve pain and possibly decrease spastic movements in people with MS. A drug called Sativex—which delivers two cannabis compounds in a spray under the tongue—is now in late-stage clinical trials in Europe for MS patients. Much as we've heard the hype before, these findings deserve some notice even from the jaded.

    Studying the upside of marijuana can be a bureaucratic nightmare. In 1970, Congress deemed it a Schedule 1 drug, meaning that it has a high potential for abuse and "no currently accepted medical use"—making research on possible benefits a tough sell. In the 1980s, the Food and Drug Administration approved Marinol, an oral formulation of THC, the most psychoactive ingredient in cannabis, to treat nausea and vomiting associated with chemotherapy. Later, it also approved Marinol to boost the appetites of people with AIDS. But Marinol was never fully accepted by patients, says Donald Abrams, a professor of clinical medicine at the University of California-San Francisco. It took effect more slowly than smoked marijuana and was also more psychoactive. (When THC enters the bloodstream from the digestive tract, it is broken down by the liver into even more psychoactive molecules.) Nor has Marinol been approved in the United States to treat pain. Those who wished to push research further—whether by studying smoked marijuana, developing better formulations, or testing cannabis for other conditions—got no love from the federal government.

    Some did get a boost, however, from the state of California, which paid for the recent work on cannabis smoking and pain. In 2000, the state funded the University of California's Center for Medicinal Cannabis Research, which vets research proposals with an NIH-style review process, pays for projects, and helps scientists navigate state and federal regulations. The center helps researchers obtain cannabis cigarettes, for instance, and deal with federal rules for record-keeping and security—like making sure the safe in which the drug is stored is properly bolted to the floor, says director Igor Grant.

    The work has moved slowly, but it's finally paying off with a handful of publications. The first clinical-trial-based paper, which appeared in Neurology in 2007, was a randomized study of 50 patients with HIV-related nerve damage, which can cause discomfort often described as aching, painful numbness, or burning. Those who smoked cannabis each day reported a 34 percent decrease in chronic pain—an effect that's on par with medications often used for this condition, like anti-convulsants and antidepressants, says Abrams. Two other randomized clinical trials, published in June and August, found similarly clear benefits. The June study focused on patients with pain related to a range of neurological conditions, including spinal cord injury. The August paper focused again on HIV-related symptoms. Both found that patients who smoked cannabis reported significantly less pain than those who used dummy cigarettes. These studies were relatively small, but cumulatively they are persuasive.

    Other recent research suggests that cannabis can relieve MS-related pain and may be able to help other symptoms, too. Sativex, which contains THC and cannabidiol, a nonpsychoactive compound, and is absorbed through the mouth, is already approved in Canada for cancer-related pain and nerve pain associated with MS. In 2007, this randomized clinical trial of 189 MS patients found that those who took Sativex self-reported a significant decrease in involuntary muscle spasms. (The study was funded by GW Pharmaceuticals, the British company that developed the drug.) Researchers are now conducting a late-stage clinical trial of Sativex in MS patients across five European countries. The company has also begun a Phase II/III clinical trial in the United States for patients with cancer-related pain. Sativex may offer particular advantages because it is neither smoked nor swallowed: It does not introduce toxins to the lungs, as smoking does. It enters the bloodstream rapidly but does not pass initially to the liver, as oral formulations do, which prevents it from getting broken down as quickly and may make it less psychoactive. (GW Pharmaceuticals says that patients who take Sativex tend not to experience psychoactive side effects at normal dosage levels.)

    If these serious investigations and results continue, soon cannabis therapies may not, in fact, be bolted to the floor.

    Continue Reading

    Chemic Labs Submits Response to Vaporizer Protocol

    Chemic Labs submitted a response to a June 16, 2008, critique of our vaporizer protocol (PDF) by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). We submitted the protocol to NIDA/PHS on January 16, 2008, along with three letters of support from peer reviewers.

    We have now been trying without success for more than five years to purchase 10 grams of marijuana from NIDA for the expansion of our vaporizer research.

    The questions about our protocol raised by NIDA/PHS were unusually exhaustive, sometimes questioning design elements that had been added in response to suggestions from prior reviewers, and seemed to have been intentionally designed to delay our ability to move forward with this study--which they were successful in doing. The NIDA/PHS critique discouraged and demoralized Chemic Labs, who in turn were slow to respond to NIDA.

    Now that our response has been submitted, we are hopeful that NIDA will grant us permission to purchase government-grown marijuana for use in our vaporizer protocol. Unfortunately, we may need to wait another 6 months or so for NIDA/PHS to reply to our response to their critiques. There is no regulatory time limit governing the NIDA/PHS response. Weve already been waiting about three years for a NIDA/PHS response to our reply to their previous critique of an earlier protocol, which is why we went ahead and submitted our new protocol on January 16, 2008.

    Requesting MAPS Supporters to Actively Help Recruit Subjects for Vaporized Marijuana Study

     We are requesting that MAPS supporters actively help us recruit subjects for Dr. Abrams National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are already using opioid medications for pain. This is one of only two medical marijuana studies in patients currently taking place in the US. Dr. Abrams investigation was scheduled to conclude in Fall 2008, but the study completion date has been extended to January 9th, 2009, in order to provide more time to recruit subjects. The study (PDF) was designed for 24 subjects, 16 of which have completed the study and an additional 8 more are needed. MAPS is supporting this study by paying for travel and lodging for participants who live outside of the San Francisco Bay area, with funding donated to MAPS by California medical marijuana dispensaries Capital Wellness Collective, Harborside Health Center, and Green Door, as well as from Oaksterdam University. It is urgent that the study, finds the remaining subjects. Preliminary results are positive and the study will be more persuasive if the initially intended number of 24 subjects is actually enrolled. Supporters can help us by downloading flyers (PDF) and posting them at facilities such as medical marijuana dispensaries, and pain management centers. We would also appreciate it if people would post the text found in this link on appropriate web pages, blogs, and online forums. Subjects cannot have used marijuana within the previous 30 days, so pain patients on opiates from states without medical marijuana laws may be especially interested in volunteering for the study. If you would like more information about how you can help us recruit patients for this study, please contact: This email address is being protected from spambots. You need JavaScript enabled to view it.

    An anonymous donor has agreed to donate $5500 to support research

    An anonymous donor has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachi’s facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years David has also donated $15,000 as a matching grant to a second Israeli medical marijuana production facility, led by Yohai Golan. Current Israeli medical marijuana regulations require that marijuana providers not charge for medicine. Providers must give the medicine away for free to Ministry of Health-approved patients, which is why the project needs subsidies. Yohai has raised $25,000 in matching funds from Israelis in response to David’s $15,000 matching grant, so we are now seeking an additional $10,000 to match the additional Israeli matching funds. If any MAPS supporters are able to or know someone who would be interested in helping match the other $10,000, please contact us. David has also donated $5000 to Philippe Lucas of Vancouver Island Compassion Society (VICS) for research with patients who have been provided marijuana from VICS over the last several years. David had previously donated $8000 to this project. The goal of this research is to see if we can match demographics of patients with particular strains of marijuana, in order to see if particular strains are best for particular illnesses and medical needs.

    David Bronner donates $5500

    David Bronner, of Bronner’s Magic Soaps, has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachi’s facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years

    David has also donated $15,000 as a matching grant to a second Israeli medical marijuana production facility, led by Yohai Golan. Current Israeli medical marijuana regulations require that marijuana providers not charge for medicine. Providers must give the medicine away for free to Ministry of Health-approved patients, which is why the project needs subsidies. Yohai has raised $25,000 in matching funds from Israelis in response to David’s $15,000 matching grant, so we are now seeking an additional $10,000 to match the additional Israeli matching funds. If any MAPS supporters are able to or know someone who would be interested in helping match the other $10,000, please contact us.

    David has also donated $5000 to Philippe Lucas of Vancouver Island Compassion Society (VICS) for research with patients who have been provided marijuana from VICS over the last several years. David had previously donated $8000 to this project. The goal of this research is to see if we can match demographics of patients with particular strains of marijuana, in order to see if particular strains are best for particular illnesses and medical needs.

    Rocco's Story

    I have been struggling with back pain since 2000. Of course, everyone complains of a bad back these days and I was also one of those gym rats at the Y, who worked out like it was the Olympic trials, and also complained of a bad back to everyone who would listen. Then one morning everything changed. My alarm went off just as every morning at 6:00 AM. I attempted to lift myself up and was hit with the most excruciating pain of my life. Terrible sharp pains in my lower back and running down my legs. After x-rays, my primary care doc prescribed Motrin and rest. After a few weeks there was little progress. I was refereed to an orthopedic surgeon, who said I had spinal stenosis and herniated disks and needed a spinal fusion and a Laminectomy, but also said I should wait 6 months to see if symptoms changed. I had no intention of a spinal fusion or any other operation. I waited a few more months and went to another spine specialist. I asked him if he thought I needed phycial therapy and he said no. His contention was that I had a structural problem not sore muscles, (which would respond to therapy). I then went to a neurologist since I was having urinary problems and sexual problems due to the spinal stenosis. She said the same thing....surgery. As the months went by I was forced to make significant lifestyle changes. I could no longer go to the gym. I could no longer run in Central park. I needed a neighbor to buy grocery's for me since I could not walk to the market. In short I had gone from 45 year old to a 75 year old in one year. I started using a Cain and my weight went up 20 lbs. Finely, I decided to go to a pain specialist. I ended up at the Pain and Palliative center at Beth Israel hospital in New York City (one of the best pain centers in the country). Dr. kaplan tried me on various medications until we settled on MS-contin. MS-contin is a brand name for Morphine Sulfate. This medication has helped me lead a much more normal life. I can shower without pain. I can shop for my own groceries. I can take a short walk and go to the gym providing I don't do things that require pressure on my lower back. I can even tie my own shoes (an ability I always took for granted). The MS-contin brings me back to my real age. Without it, I become 30 years older.

    I first went to the pain clinic 5 years ago and have been a patient there ever since. I put surgery on the back burner and decided to just live my life. I was able to do that with the help of the morphine. In recent years my condition as been getting worse , requiring higher dose's of morphine. MS-contin has many side effects. It can make you drowsy and of course its addictive. It also has a nasty habit of lowering Testosterone in the blood, which can lead to impotency. This could also lead to low bone density and loss of energy. It is because of these symptoms that I decided to seek out a way to curb my intake of narcotics or at lease make it unnecessary to increase my dose. After a long Internet search I discovered an organisation called "The Marijuana Policy Project" This is an organization that works with all the states legislators to help to change the marijuana laws. I started a correspondence with Karen O'Keeffe who is Assistant Director of State Policies at MPP. I told her of my interest in Medical Marijuana and she told me about a study in San Fransisco that was doing research on medical marijuana so I inquired by calling Mr. Paul Couey at San Fransisco General Hospital. He interviewed me by phone and told me I fit the criterion to be a participant, which was being on either MS-contin or Oxycontin. I considered going but soon realized after looking into hotels and plane fare that I would not be able to afford such a venture. Months went by and I was contacted by Karen O'Keeffe who informed me that (MAPS) The Multidisciplinary Association for Psychedelic Studies was offering qualified applicants who cannot afford to travel to San Fransisco the chance to participate in this landmark study. I jumped at the opportunity. I called Rick Doblin, PH.D at MAPS and we talked logistics.

    Rick D. made all plane, and hotel reservations for me. All I had to do was print out the flight schedule cross my fingers.

    I arrived at San Fransisco General on Monday morning at 7:00 AM sharp. I was a bit apprehensive going into a study like this but my anxiety was short lived. Paul Couey, my contact at San Fransisco General went over details of the study with me.

    I would be there for 5 days 24/7. I would be given vaporized marijuana 3 times a day. The nurses would take my blood every 30 minutes the first day and every 30 minutes the last day. They would then compare the blood of the first day,(before any marijuana was in my system) to the blood of the last day(after 5 days of marijuana) to see how Marijuana affects the levels of pain meds in my blood. For example, if the blood shows an increase in Morphine after 5 days of marijuana this may indicate that marijuana increases the effects of the pain medicine and a patient my have increased relief without actually taking additional morphine.

    My Private room at the hospital had a flat screen TV, semi Private shower and bathroom and a bed. As a participant in the study I also received three meals and a snack at 8:30 pm every night. there was a computer and TV in a community room which I spent many hours. The nurse's and aids where very helpful and courteous.

    Marijuana seems to be helpful in producing an elevated mood thereby decreasing the perception of pain. I have arthritis in addition to my back issues and with the marijuana I feel increased flexibility. So far that would be my evaluation of how medical marijuana works based on my 5 days in this study. Unfortunately, I am not permitted to be active and go for walks since I am required to be on this unit 24/7. Walking, standing and being active brings about my pain so it would be advantages to take the marijuana at those times but for now I am restricted to this unit and the guidelines of the study.

    I also take a drug called Dilaudid, for what is called breakthrough pain. (Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by the patients usual medication). I am back in new york now but when I was in the study I did not need to take my dilaudid which I usually take every morning and sometimes during the day. I attribute this to the marijuana I took when I was in the study.

    With the help of MAPS, MPP, our legislators and individual citizens, marijuana will one day be legal in NY state but as of now it is not. I am back to popping my dilaudids throughout the day when I need it but it would be much better to have a non- narcotic alternative such as medical Marijuana. No one knows the long term side effects of these drugs as opposed to marijuana which is natural and has been around since the dawn of time. Thanks to this study, I now know I have an alternative to narcotics which up to this point has been my only outlet for pain relief. I also have Hep-C, and may be taking interferon as treatment soon. It would be helpful for me to have medical marijuana to combat the horrendous side effects of interferon, (which is basically poison) but as of now it is not legal and not an option in New York State.

    Many thanks to Rick Doblin and all the people at The Multidisciplinary Association for Psychedelic Studies (MAPS). Without them this trip would never have taken place and Also Karen O'Keeffe" Assistant Director of State Policies at (MPP) who introduced me to the people at MAPS.

    Rocco Puzzo

    Volcano Vaporizer Research Protocol Resubmitted to HHS

    On January 16, 2008, MAPS Volcano vaporizer research protocol was resubmitted to HHS for the required scientific review by the National Institute of Drug Abuse--Public Health Service (NIDA-PHS). The submission included three supportive letters from peer-reviewers (see 1, 2, 3), confirming the scientific merit of the study and urging NIDA-PHS to approve it. The goal of this study is to gather further information about the chemical constituents that are contained in the cannabis vapor stream.

    Licensed by the State of Israel

    • He travels between his secret grow site, where he caresses gently every bud with his own hands, and his living room, where he distributes the pot to tormented AIDS and cancer patients.
    • Funerals add to his busy schedule. "I stopped counting them," he says.
    • The only person in Israel who is licensed by the state to grow and distribute Medical Marijuana, is not yet thirty years old. He sees his work as a mission: "If I won't help them, nobody will."
    • Allowing a private entrepreneur to do this does not seem to a problem, says the Israeli Health Department: "It's the best solution possible today." 

    By Ariella Ayalon, Oded Shalom and Gideon Meron

    Published in Yedioth Aharonoth, Hamoosaf Le'Shabath (The Saturday Addition)
    on December 28th, 2007

    The smell hits you first. The sweet heavy scent. Then comes the sadness. The room, soaking with soft light, typical for an Israeli winter morning, is filled with pain. Wherever you look, you see torments of pain. A woman stands at the door. Her face is pale, it is evident she is under chemotherapy. Embarrassed she greets us with a short "Hello", lowers her eyes, takes a tiny bag, and hurries outside.

    The door is open and the traffic of people never ceases. From morning till night, patients and their family members come in and go out, most of them have met each other in former visits. Cancer, AIDS and Tourette patients.  They come from all over the country, mostly twice a week, sit on the couch and chairs, exchanging treatment and hospitalization stories. Some of them are at the end of the road, their doctors are helpless. All they can do is try to ease the pain.

    They come here for compassion – it's the only distribution point for Medical Marijuana in Israel, and this is the first time it's being exposed to the public.  It's the last stop for many of the people who enter this door. They yearn for the drug dosage that would save them, they reach out to as if was a magic potion, handed to them by an ancient Medicine Man.

    Last April the Health Department produced for the first time in the history of the State of Israel, "A license for growing, conveying and supplying a dangerous drug (Marijuana) following chapters 6, 7 of the Dangerous Drugs Ordinance," for a private non-patient entrepreneur. That "private entrepreneur" is the only person in Israel who grows and distributes medical quality Cannabis, under the Health Department license and with its blessing. The man to whom the Health Department handed the job of relieving terminal patient's pain is a single man, under thirty years old, whose eyes are shining with religious fire when he talks about his life mission.

    The people who knock on his door can only reach him through a referral authorized by an expert doctor.  The location of the house where he distributes the drug to the patients, as well as the location of the farm where he grows the plants is secret, so that criminals wouldn't be able to put their hands on the exquisite drug. Only patients get his phone number – from the Health Department. They call, make the appointment, arrive hesitantly to the secret "clinic" and leave it with an opaque bag with 5-10 grams (0.17-0.35 oz.) of excellent marijuana.

    The "Pharmacist's" hands are busy at work. He stands above a large tray, laden with green cannabis buds and fills bag after bag with pot, which is still considered a dangerous drug in Israel.  He is so young and fragile looking, but he already knows every kind of pain that exists in this world. He is a believer – he believes in God and in Cannabis. For him, marijuana is a gateway for a better world, calmer and more peaceful, that can change a terminal patient's life totally, relieve their pain and sometimes heal the pain.

    The patients' pain goes deep inside his soul. They feel that his heart is open and open up to him, confess their agonies to him, and he does his best to lend them a non-judgmental ear, to listen, say a warm word, and in most cases, to comfort them. "Since I started distributing pot, I absorb more and more pain," he says, "I'm now on the edge of my capability to witness human suffering."

    "I can't count the number of funerals I attended. I have to go, these people opened their soul to me. SO I stand there, absorb all the pain and sadness, then gets back here and the phone rings again, patients ask me when should they come." Several times during our conversation he couldn't hold himself. His eyes are full of tears.

    "It saves me"

    The TV set in "The Pharmacist"'s reception room is on, turned to the fashion channel, where beautiful healthy people project from the screen. A tray with cannabis buds is on the table, and the bookshelves contain the Zohar (A kabbalistic book, of Jewish mysticism) books and books of prayer, alongside books by K.Zetnik, the Holocaust survivor author who wrote about his experience when he was treated with L.S.D, the hallucinatory drug that helped him quiet his nightmares from the concentration camps.

    Yossi Boozaglo, 49, an AIDS patient, sits on the couch. "Do me the favor," he pleads to the 'pharmacist,' with a choked voice, "help me with this mucus." The "pharmacist" treats him to a joint soaked in cannabis oil he produced. The cannabis oil enhances the drug's affect on the body. "the Cannabis saves me, just like that," says Boozaglo. "Thanks to the Cannabis I can eat. I gained some weight and I look more or less like a human being. It helps me take my medication. I don't vomit and I'm more relaxed."

    About 60 patients in Israel hold a license for using Marijuana. In some cases they are permitted to grow it, i.e., to produce it, by themselves, for no more than ten plants. But most of the patients don't grow them by themselves. Many tried and gave up, some because they didn't manage to grow anything, or because the low quality of the drug. People tormented with dying pains  don't have the energy to garden.

    Boozaglo was the first patient in Israel who received a license to grow, keep and use Cannabis. It happened in 2000, following a campaign that Boaz Wachtel from Alé Yarok party  (Israeli Legalization party) held for him. Even prior to that, Boozaglo had a recommendation for Cannabis usage for four years, and each time he needed it, he had to go to a dangerous criminal neighborhood to get it. He paid a hefty price for these trips: 25 police records of dealing dangerous drugs.

    "On the one hand they gave me permission to use, on the other hand they told me to get it on my own, that is, obtain it illegally," says Boozaglo. "The growing license I got didn't make sense either. I take the cocktail for AIDS, 20 pills, twice a day. That's torture. The pills make cause me nausea, degeneration, legs paralysis, lack of appetite, most terrible suffering. Who has energy to look after the seedlings?"

    "I couldn't wait until something would sprout in my pots. I'm a hairdresser, I used to design haircuts. What did they think? That I would turn into a farmer in one day?! Now, when we have the "Pharmacist" here, I don't need to meet criminals, I don't need to spend the little money I have, it's a very heavy burden that's off my back now. Truth is, without the "Pharmacist" I wouldn't have made it this year."

    In many cases, the family members are those who encourage the Cannabis usage. A cancer patient's daughter we met at the "Pharmacist" told us that her mother wasn't willing to hear about smoking pot. "My mom used to smoke a cigarette a week maybe, and had many years when she didn't smoke at all. For her pot was a hard drug, just like Heroin. It took me two years to convince her to smoke Cannabis. She didn't want to hear about it."

    "After a radiation treatment, she couldn't leave her bed for two weeks. She suffered terrible fatigue, constant nausea, emotional 'downs'. She had non-stop pain in the abdomen and the back. She felt like shit most of the time. An absolute catastrophe. Two weeks ago she received her medical Marijuana license and she is a different person now. It reduced her nausea radically, eased her pains significantly. It relieves her. She can breathe and eat. She started whining recently that she was gaining weight."

    A regular client is a father of a fourteen year old cancer patient. He comes to pick up a cannabis bag for his son.  "Ten month ago he was diagnosed with a brain stem tumor," he shares. "After radiation and chemotherapy he lost his appetite. The boy couldn't eat anything. Every week he lost two pounds. Except for water, he couldn't put anything in his mouth. He wanted to eat, he said he missed his grandmother's cooking, but he wasn't capable of eating. Four months ago his ward director gave him a recommendation for Cannabis usage."

    Q: how did the boy react?

    A: "He was very surprised. He didn't get it at first, but we convinced him it would help him."

    Q: You didn't have any problem with it?

    A: "Not at all. Life saving demands adjustment sometimes. Since he started smoking his blood test are fine, his weight is stable and he has gotten his appetite back. I will never forget the first night he smoked. I came home with the bag I got from the "Pharmacist", and I rolled him a joint for the night. Who would believe I'd do such a thing? After a short while he asked for Dulmas. Seeing him eat and enjoy his food after all these month was amazing, and very very thrilling.

    The "Pharmacist" tells us about parents of small children for whom this is the last hope. They take the buds to their kids, whose suffering is immense, and blow the smoke into their faces to relieve their pain a little.

    The Forbidden Garden of Eden

    The patients see him as their angel, and he makes the best medicine for them. He redeems them, and seeks redemption himself, while seeing his occupation as a merely spiritual one. When we drove with him to the growing site, somewhere in Israel, he noticed a holy place suddenly, and asked us to stop, "to bless the whole world, my patients, me, and you too." He encircled the place seven times until he clamed down, after which we continued.

    The growing site is secured and surrounded by a high fence. The "Pharmacist"'s facility is one of the most advanced ones in the world: Exquisite seeds, organic farming, a special lighting for the fifty plants, a highly efficient irrigation and an extremely  accurate air conditioning – all these give the plants an opportunity to grow in a five star environment. The green potted plants, arranged in lines, bloom beautifully, and the whole place is charged with the intoxicating smell of the Cannabis flowers. A forbidden Garden of Eden, that is permitted here, with a special license from the Health Department.

    He knows every plant, cares for each bud like a baby. Touches, pets and checks the leaves. Caresses with his hand and puts to his nose. The smell tells him all about the bud. A woman in a white robe is the gardener. A devoted student of the "Pharmacist", she is a biologist who sees the growing as a mission, a Mitzva (a religious duty).

    "The Pharmacist" shows us a diploma from a Dutch medical institute for growing Cannabis, that confirms he indeed studied how to grow Cannabis. Turns out he was a very good student. The guy grows Cannabis of an incomparable quality. 23% active ingredient, according to the laboratory of Prof. Raffi Meshulam, who won the Israel Prize for his life long study of medical Cannabis. The Cannabis distributed by "The Pharmacist" to his patients is the best organic quality that has been ever examined officially in a laboratory.

    For example, the Marijuana that is grown by Bedouins in Sinai and smuggled into Israel, the rate of the active ingredients is not more than 4%. Marijuana that is grown by drug dealers in Israel it might get to 12%, the same as the pot one can purchase at the coffee shops in Holland. It takes 165 or more of active ingredients to make a Cannabis bud into a medical one.

    The expenses are enormous: Electricity, water, organic farming and all the rest. The Health Department supplies him with a license, sends people to him, but does not pay a penny, and does not participate in the growing expanses. "The Pharmacist" doesn't ask the patients to pay either, he gives the drug for free. It sounds dubious, but "The Pharmacist" claims he does it for love, because he needs to help people.

    "This is the way I was brought up," he explains. "I grew up with parents who gave and gave. For me, money is only on the fanfare, although I live on the overdraft the bank lets me have, and my expanses get bigger and bigger."

    Q: how come you took charge of the whole thing, including growing and distributing? You took a role that should be taken by the state.

    A: "It didn't happen in one day. A few years ago I lived in California, where 600,000 patients have a license to use Cannabis. I knew a patient there, who had a license and took me to a compassion club, where the stuff was distributed. When you visit such a place and see the patients who go there, in which state they are and how they sit and smoke and suddenly smile, relieved a little from the pain, you can't remain indifferent to it."

    Q: And still, why did you take charge?

    A: Because when I returned to Israel I had to make a decision. Do I take the path of ordinary life and work, or do I do something significant? When I returned to Israel it I already had a passion for it.  I researched the topic briefly and realized there was nothing here. That the very ill people have nowhere to go. Even if they have a license, they can't obtain high quality Cannabis. And for that matter, only medical quality Cannabis can relieve pains and improve the quality of life for the chronically and terminally ill.

    "So I went to Holland to study how to grow, knowing that I am going to return to Israel, to grow for patients. When I got back I started going to the cancer wards of the big hospitals in Israel. I talked to patients, and told them about the Cannabis and its benefits. In some places the doctors threw me out, claiming that I came to drug the patients.

    "You go looking at the hospitals and realize that the state deserts people when they get sick.   You see people in pain who continue suffering. You try to help, but you can't do much. If I won't give them a hand, nobody will. People at the end of their life, at the last stop on their journey, need compassion. I took charge of that mission.

    Pot with a police Certificate

    The official connection between "The Pharmacist" and the Health Department started about four years ago. The young "Pharmacist" turned to Dr. Yehuda Baruch, who heads currently the mental hospital Abarbanel, and formerly the head of healthcare services in the Health Department and the person who is in charge of producing the medical Marijuana licenses in the last six years.

    "The Pharmacist" introduced himself and asked to take part in the department's activities. "I came out of Dr. Baruch's office with a permission to help the Medical Cannabis association. It was a small non-profit group of patients who tried to grow it themselves, but with the treatments and their own problems, they couldn't afford to do that seriously. Working with them was hard and we lost touch, but I continued to visit the hospices in the hospitals regularly."  

    Last January the cooperation between him and the Health Department was upgraded to a new stage. "The Pharmacist" initiated, produced and organized a medical Cannabis conference in Abarbanel hospital in Bat Yam. With Dr. Baruch's permission and blessing. The conference features talks by the Health Department's CEO, Dr. Boaz Lev, Prof. Raphael Meshulam and other experts from Israel and abroad. AIDS, cancer and pain patients talked about the improvement that occurred in their life following the usage. After the conference "The Pharmacist" submitted an official application for a growing and supplying license.

    Dr. Baruch discussed the application with the members of the consulting committee, who recommend giving licenses to qualifying patients. The discussion included other high officials form the Israel Police and other units of the Health Department. After the consultation they decided to allow "The Pharmacist" to grow and supply medical Marijuana, on one condition: The approval of the Israel Police.

    "They let the Police run a check on me, and they researched my past thoroughly," says "The Pharmacist", but of course I have no criminal record. Since that time, every six months I am obligated to send the Health Department  a confirmation from the Police that states that I don't have any criminal record.

    Ever since it became official, Dr. Baruch's office refers all the licensed patients to "The Pharmacist". His office manger, Hannah Daniel, is the one who refers the patient to the distributor. Dr. Baruch doesn't see the fact that the Health Department has handed the task of relieving terminal patient's pain to a private entrepreneur. He doesn't find the fact that in a socialized medicine country such as Israel, the state does not fund the Cannabis problematic.

    "In the original license we produced, we decided to allow the patients to produce the drug for their own needs," he explains, "however, since the patient found growing difficult, and the number of Cannabis patients grew larger, the State had to come up with a solution."

    Q: So, is it the best possible solution?

    A: "There are too many issues and problems we have to solve before we completely settle it officially. The main factor here is the best interest of the patient. If somebody is willing to grow and supply, I'm willing to give him a license, after I checked him."

    From that point of view, "The Pharmacist" is a godsend to the Health Department. "The Health Department  won't fund him, because apparently there's a legal problem here," elaborates dr. Baruch. "Look, it's a complicated situation. We acknowledge him, and therefore we gave him a permission to works with the government, and we let the Police know about it."

    Q: What do you know about "The Pharmacist" and his capability?

    A: "the Police confirmed that he has no criminal record and this is all I know about him. My job is to make sure the patients get a service, and I need to find a legal supply of the stuff, and I don't have a problem with it. Everything is done in the light of day . It's none of my business if he served in the military or if he is mentally fit."

    Having said that, Dr. Baruch admits that "in a way, I feel uncomfortable. I don't avert my eyes, and I'm aware to the fact that he wants his business to grow, and have a status of an approved supplier for the USA."

    Q: Did you look for other resources?

    A: "Nowadays the Health Department is negotiating with another entrepreneur who might get a license for growing Cannabis, because the state can't depend on one supplier only."

    Until about a month ago, the Police supervised "The Pahrmacist""s grow facility. Once a week a police officer used to come to count the plants and make sure he obeyed the license restrictions, that he didn't grow more than he is allowed and that he didn't sells the surplus. A few weeks ago the supervision was transferred to the County Pharmacist. "The Police didn't like this job. On the one hand they chase Marijuana dealers, on the other, supervising a growing facilty. In cooperation with them, we decided to take charge of the supervision."

    The Police reports: "The Health Department is the one that can permit growing medical Marijuana by law. The department chooses the grower, set the terms, and it's the Health Department that supervise the extent of the growing, the number of the patients and their free supply by the grower."

    "The Pharmacist" swears that all the plants he grows by permission go to the licensed patients only. "I have never sold Cannabis for money. Never in my life."

    Doctors for Smoking

    Despite the problematic procedures, the medical community agrees almost unanimously about the benefits of medical Marijuana. Dr. Itay Gur- Arie, who is the head of the Department of Anesthesiology at the Sheba Medical Center and the head of the Israeli Pain Association is an ardent supporter. "Many patients, some of them terminal, take all kinds of Morphine to deal with the pain, but in many cases, in spite of the high dosage, it doesn't affect them. In addition to that, these substances have dangerous and serious side effects. In some of these cases, mainly when the Morphine treatments has failed, the medical Marijuana does a perfect job."

    "Some conservatives still oppose treating patients with this drug, that unlike Morphine, that is produced from Opium, wasn't approved legally. Those opponents stick to a common notion, that is not necessarily progressive, that says: 'Give the patients Morphine, anything but Marijuana.' That's like saying: 'Don't give your kids pot, give them Heroin'. In the recent years, there's a new understanding of this matter, and surprisingly enough, it comes from the regulator, the Health Department. It doesn't come from the HMOs or the  companies. It shows that they are open. It's enlightened and right."

    Prof. Raphael Meshulam of the Hebrew University, chairperson of Natural and Medicine Sciences in the Israeli Science Academy, who supervises the Israeli universities, supports the usage of pot for medical purposes, but also points out that such usage is not problem-free. "In nature, there is no problem-free substance, not even vitamins, and the same thing can be said about medical Marijuana, that is produced from Cannabis."

    "A high dosage of medical Marijuana can cause changes in the emotional, perceptual systems and in a person's judgment, AKA 'High'. Nevertheless, when it is taken through the mouth, by smoking or inhaling, it is absorbed well and is highly effective. Therefore we have found that taking it naturally is much more beneficial than the processed version. That is to synthesize it in a laboratory and make it into a pill."

    In the meantime, "The Pharmacist"'s enterprise is threatened due to lack of funds. "I don't know how I'll be able to continue growing and supplying the Cannabis to the patients, when the costs are growing bigger, and I'm too busy to have a proper job that brings a regular salary.  I received $5,000 from the www.maps.organization that promotes using drugs as medicine and used it to build the fence around the facility, and I'm negotiating with them for a possible regular financial support. Support comes through my own personal connections. The Health Department is not involved in this."

    "Even if I have permission to sell Marijuana to patients for money, that's not the answer. Patients who come to me can't purchase the medicine themselves, because they can hardly afford the treatments costs. I'm willing to get the funds for the patients from the state or medical insurance companies. In any case, the patients must be able to receive the medicine free and safely. After all, they are the ones who really suffer."  

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    Court Rejects North Dakota Farmers’ Bid to Grow Industrial Hemp

    This press release discusses the North Dakota Supreme Court's rejection of the 8 year bid of North Dakota farmers to grow industrial hemp as well as the signing of a Memorandum of Understanding between North Dakota State University (NDSU) and the ND Supreme Court.

    BISMARCK, ND – Two North Dakota farmers, who filed a federal lawsuit in June to end the U.S. Drug Enforcement Administration’s (DEA) ban on commercial hemp farming in the United States, had their case dismissed by federal Judge Daniel Hovland yesterday. In a 22-page decision, Judge Hovland wrote that the problem facing state-licensed hemp farmers David Monson and Wayne Hauge needs to be addressed by Congress if they hope to ever grow the versatile crop which is used in everything from food and soap to clothing and auto parts. The decision can be read at: http://www.votehemp.com/legal_cases_ND.html.

    Lawyers working on behalf of the farmers are considering an appeal on a number of issues. In particular, the Court ruled that hemp and marijuana are the same, as the DEA has contended for years. However, scientific evidence clearly shows that not only is industrial hemp genetically distinct from the drug marijuana, there are also absolutely no psychoactive effects from ingesting it.

    “Obviously we are disappointed with the decision,” says Eric Steenstra, President of Vote Hemp, a grassroots group working to bring industrial hemp farming back to the U.S. “The Court’s decision shows it understands that the established and growing market for industrial hemp would be beneficial for North Dakota farmers to supply. Yet the decision overlooks Congress’s original intent – and the fact that farmers continued to grow hemp in the U.S. for twenty years after marijuana was banned. If the plaintiffs decide to appeal the case, we would wholeheartedly support that effort. We are not giving up and will take this decision to Washington, DC to prompt action by Congress on HR 1009, the Industrial Hemp Farming Act of 2007, which would clarify a state’s right to grow the crop,” adds Steenstra.

    In a related development, Vote Hemp has learned that the DEA has sent a “Memorandum of Agreement” to North Dakota State University (NDSU) which, if signed by the school, would clear the way for industrial hemp research there. NDSU filed an amicus brief in support of the farmers’ lawsuit which highlighted the university’s eight-year struggle to secure a license from the DEA to grow industrial hemp for research as mandated by state law. “It seems our arguments about the DEA’s delay in processing NDSU’s application have resulted in the agency finally taking positive action to allow research,” comments David Bronner, President of the Hemp Industries Association (HIA) and Dr. Bronner’s Magic Soaps, a manufacturer of soap and other body care products using hemp oil imported from Canada.

    Vote Hemp, the nation's leading industrial hemp advocacy group, and its supporters are providing financial support for the lawsuit. If it is ultimately successful, states across the nation will be free to implement their own hemp farming laws without fear of federal interference. More on the case can be found at: http://www.VoteHemp.com/legal_cases_ND.html.

    # # #

    Vote Hemp is a national, single-issue, non-profit organization dedicated to the acceptance of and a free market for low-THC industrial hemp and to changes in current law to allow U.S. farmers to once again grow this agricultural crop. More information about hemp legislation and the crop's many uses may be found at www.VoteHemp.com or www.HempIndustries.org. BETA SP or DVD Video News Releases featuring footage of hemp farming in other countries are available upon request by contacting Adam Eidinger.

    See PDF's of the Memorandum of Agreement and the Order Granting Defendents' Motion to Dismiss

    Synopsis of DEA Rescheduling Dronabinol

    In late September, DEA proposed a new rule that would effectively place dronabinol (the active chemical in MARINOL) in Schedule III.

    Wait a second, isn’t MARINOL already in Schedule III?

    It is. When MARINOL was first marketed, it was placed in Schedule II. Once DEA was shown that it had a low potential for abuse, they agreed to place it in Schedule III. But the narrow language only places in Schedule III MARINOL’s specific formulation (synthetically derived dronabinol, suspended in sesame oil). All other formulations remain in Schedule I.

    Now that the MARINOL patent is almost up, Professor ElSohly (yes, the same man who runs the only federally-approved marijuana growing facility) has a contract to supply would-be generic manufacturers of MARINOL. They petitioned DEA to re-schedule ALL formulations of dronabinol, whether or not the chemical is suspended in sesame oil, and whether or not the chemical is sourced from whole-plant marijuana. That’s right, folks! DEA may soon allow an FDA-approved medication to be derived from the marijuana plant.

    In order to applaud this change in thinking, and to insist that the NIDA monopoly be lifted, MAPS submitted a public comment to the Federal Register about the proposed new rule. The focus of the comment is the issue of fairness; namely, it is absolutely ridiculous that DEA would re-schedule the active ingredient in MARINOL at the behest of a private producer for private profit, all the while refusing to approve Professor Craker’s bid to grow marijuana for non-profit, research purposes.

    See a PDF of MAPS Public Comment on Docket No. DEA-308P; 72 Fed.Reg. 54226 (Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols).

    American Psychiatric Association Assembly Unanimously Backs Medical Marijuana

    Originally appearing here.


    Published on November 7, 2007 at 9:21 AM
    on Salem-News.com
    By Tim King

    A major move by one of the nation's top medical groups, they are backing medical marijuana and they want the federal government to leave doctors alone.

    (WASHINGTON, D.C. ) - In a unanimous vote, the Assembly of the American Psychiatric Association has approved a strongly worded statement supporting legal protection for patients using medical marijuana with their doctor's recommendation.

    "This is a very large and important medical organization, it isn't some fringe group," said Bruce Mirken from the Marijuana Policy Project.

    He told Salem-News.com, "This move debunks a lot of the nonsense from some of the anti-medical marijuana groups. They have been aggressively using false information tactics. These groups allege that there are various links between mental illness and marijuana, ignoring the fact that it is well documented that medical marijuana can be therapeutic".

    The APA action paper, which must be approved by the APA Board of Trustees when it meets in December, notes that 12 states now have medical marijuana laws, and states, "The threat of arrest by federal agents, however, still exists. Seriously ill patients living in these states with medical marijuana recommendations from their doctors should not be subjected to the threat of punitive federal prosecution for merely attempting to alleviate the chronic pain, side effects, or symptoms associated with their conditions or resulting from their overall treatment regimens. ... [We] support protection for patients and physicians participating in state approved medical marijuana programs."

    This is not the first, but the second action paper calling on the government to facilitate "well-designed clinical research into the medical utility of marijuana" were adopted Saturday with no dissenting votes by the APA Assembly, which represents the group's 74 district branches and 16 allied professional organizations.

    "This vote is a landmark, and a proud day for our profession." said Abraham L. Halpern, M.D., professor emeritus of psychiatry at New York Medical College and past president of the American Academy of Psychiatry and the Law. "As physicians, we cannot abide our patients being subject to arrest and jail for using a physician-recommended treatment that clearly relieves suffering for many who are not helped by conventional treatments."

    "This unanimous vote shows the growing acceptance of medical marijuana by organized medicine," said Rob Kampia, executive director of the Marijuana Policy Project in Washington, D.C. "Members of Congress who have opposed efforts to protect patients from federal prosecution have tried to portray medical marijuana as a fringe issue. But the APA Assembly vote, along with other recent endorsements including the Leukemia and Lymphoma Society, shows that it's those who want to arrest the sick and suffering who are on the fringe."

    With 40,000 members and 16 allied organizations (including the American Academy of Psychiatry and the Law, American Academy of Child and Adolescent Psychiatry, American Association for Social Psychiatry, American Academy of Addiction Psychiatry, and the American Association of Emergency Psychiatrists), the American Psychiatric Association is the main professional organization for psychiatrists in the United States.

    Mirken says the the Assembly of the American Psychiatric Association's trustees will vote on the matter in December.

    With more than 23,000 members and 100,000 e-mail subscribers nationwide, the Marijuana Policy Project is the largest marijuana policy reform organization in the United States. MPP believes that the best way to minimize the harm associated with marijuana is to regulate marijuana in a manner similar to alcohol. For more information, please visit MarijuanaPolicy.org.

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    Teens Who Smoke Pot But Not Tobacco Function Well

    Published on 05/11/2007
    On Drugsense.org Blog

    According to a new study by Swiss researchers, teenagers who smoke marijuana but not tobacco appear to be more likely to get good grades, play sports and live with both parents than those who also use tobacco. Moreover, the study found that teens who smoke pot were more likely to have a good relationship with their friends than teens who smoked neither tobacco nor pot, found the study published in the November issue of Archives of Pediatrics & Adolescent Medicine.

    Originally appearing here.


    Teens who smoke pot but not cigarettes appear to be more likely to get good
    grades, play sports and live with both parents than those who also use
    tobacco, finds a surprising new study from Switzerland.

    What's more, the study found that teens who smoke pot were more likely to
    have a good relationship with their friends than teens who smoked neither
    tobacco nor pot, found the study published in the November issue of Archives
    of Pediatrics & Adolescent Medicine.

    To conduct the study Dr. J. C. Suris and colleagues at the University of
    Lausanne, Switzerland, analyzed data from a 2002 national survey of almost
    5,300 Swiss students aged 16 to 20 years. Of the group, 455 smoked marijuana
    exclusively, 1,703 smoked marijuana and tobacco, and 3,105 abstained from
    both substances.

    The survey also found that, compared with students who used both substances,
    students who smoked marijuana only were more likely:

    to be male (71.6 per cent vs. 59.7 per cent),
    to play sports (85.5 per cent vs. 66.7 per cent)
    to live with both parents (78.2 vs. 68.3)
    to have good grades (77.5 vs. 66.6).

    As well, the researchers noted that students who smoked marijuana only were
    less likely: to have been drunk in the past 30 days (40.5 per cent vs. 55
    per cent) to have started using cannabis before the age of 15 years (25.9
    per cent vs.
    37.5 per cent) to have smoked marijuana more than once or twice during the
    previous 30 days (44 per cent vs. 66 per cent) to use other illegal drugs
    (8.4 per cent vs. 17.9 per cent).

    Those who smoked marijuana only used it less often than those who smokes
    both cigarettes and pot. About half of the tobacco-and-marijuana group had
    used pot 10 times or more in the previous month, compared to about half in
    the marijuana-only group who had used the drug only once or twice in the
    same time period.

    Compared to teens who abstain from smoking pot or cigarettes, pot-only
    smokers are more likely to skip class, but still have the same level of good
    grades. And although they were more likely to report having a relationship
    with their parents, they are not more likely to be depressed than
    abstainers.

    The study did not explain the reasons behind any of its findings.

    The authors note that although teens who smoke both marijuana and tobacco
    seem to have more psychosocial problems, those who smoke marijuana only
    should be monitored closely too. They note as well that marijuana use has
    increased in recent years among teens in Switzerland and other European
    countries.

    "The situation of those adolescents who use cannabis but who declare not
    using tobacco should not be trivialized," the authors conclude.

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    Senior US Senators Agree to Send a New Letter to DEA

    Senior US Senators Edward Kennedy and John Kerry have agreed to send a new letter to DEA Administrator Karen Tandy urging her agency to accept the recommendation of DEA Administrative Law Judge Mary Ellen Bittner to grant a Schedule I license to University of Massachusetts professor Lyle Craker, PhD, for his proposed MAPS-sponsored medical marijuana production facility. An independent supply of research-grade medical marijuana is the key prerequisite for MAPS' plan to conduct the clinical trials necessary to develop marijuana into a legal US FDA-approved prescription medicine. In 2004, before our successful lawsuit against DEA, the duo of Massachusetts Senators sent a similar letter to DEA urging the agency to license Prof. Craker. In the coming months, MAPS and our allies will be targeting several key Senators to add their names to Kerry and Kennedy's letter, building on the momentum of last month's letter from 45 US Representatives to DEA in support of Prof. Craker's proposed facility.

    The DEA has no deadline to decide whether to accept or reject Judge Bittner's non-binding ruling. As a result, we expect that DEA will continue to use its best weapon against medical marijuana research -- inaction.

    Orange County Agrees to Medical-Marijuana ID Cards Just As the DEA Cracks Down on Dispensaries in L.A.

    Orange County Agrees to Medical-Marijuana ID Cards Just As the DEA Cracks Down on Dispensaries in L.A.: Every Positive Step Seems to Be Met With a Step Backward

    Published on Sunday, 12 Aug 2007
    In the Orange County Register, The (CA) ( http://www.ocregister.com/)
    By Alan Bock (Sr. editorial writer)

    Originally appearing here.


    Eleven years after California voters, by passing Proposition 215, created exceptions to the marijuana prohibition laws for medical patients using marijuana, or cannabis, with the recommendation of a licensed physician, the issue of safe access to this medicine is still in turmoil. Orange County just became the most recent county in California to comply with California law and begin the process of setting up a voluntary ID cards program for patients. The Los Angeles City Council has declared a temporary moratorium on new medical cannabis dispensaries, but under the leadership of Dennis Zine, a former policeman, it has declared its clear intention to set up a regulatory and licensing regime for them.

    After endless hassles from the federal government, a UC San Francisco research team finally got the go-ahead from the federal government to conduct rigorous scientific studies on limited aspects of the medicinal efficacy of cannabis. Its double-blind study against a smoked placebo showed that HIV patients experienced a significant reduction in the chronic foot pain associated with the disease; those who smoked cannabis got a 72 percent reduction in pain as opposed to 15 percent for those who smoked the placebo.

    Doctors at the University of Massachusetts-Amherst are making steady progress in their quest to have the federal government permit them to grow their own cannabis for scientific research; researchers have complained that the cannabis from the federal government's pot plantation in Mississippi - the only legal source for scientific experiments - is of erratic and sometimes low quality. Allowing botanists in Massachusetts to grow their own should open the way to more extensive scientific research. Research from Europe has shown efficacy against multiple sclerosis and even against certain kinds of cancer.

    So we see steady progress in discovering and documenting medicinal uses for cannabis and sometimes halting but still encouraging progress in providing patients with reliable ways to get access to medicine while differentiating the medicinal market from the recreational black market. Against this backdrop, however, the federal government has continued to deny officially that cannabis has any medicinal uses at all, and the Drug Enforcement Administration has started playing hardball with patients and dispensaries, especially in California.

    On July 6, the Los Angeles office of the DEA sent letters to as many as 150 landlords who rent to cannabis dispensaries, noting that their tenants are breaking federal laws and that as accessories to crime the landlords could receive 20 years in prison and have their property forfeited - stolen under color of law. Most, though not all, of the landlords gave their tenants eviction notices. The same day, in an apparently unrelated action, the DEA closed a chain of seven medical cannabis cooperative dispensaries in central California, as well as dispensaries in Bakersfield, Morro Bay and Corona. Meanwhile, Anaheim joined six other Orange County cities by passing an ordinance prohibiting - not creating rules for, but prohibiting - cannabis dispensaries.

    On July 25 the DEA raided 10 more medical cannabis clinics in Los Angeles and arrested five people. That was the same day, coincidentally or not, that the L.A. City Council was voting to impose a temporary moratorium on new cannabis clinics, with the intention of developing regulations so the clinics - which had been proliferating like weeds - could operate in a more controlled, clearly legitimate fashion. The council also passed a resolution urging Congress to approve the Hinchey-Rohrabacher amendment, which was being considered in the House of Representatives that same day.

    Hinchey-Rohrabacher is an amendment to the appropriations bill covering the Justice Department that would deny funds for enforcement activities against patients, growers or distributors in those states - 12 since New Mexico, with the active support of Gov. (and Democratic presidential candidate) Bill Richardson, approved one in May - that have passed medical marijuana laws. Some medical marijuana advocates have tried to spin the fact that it got more votes this year than last year - from 163 to 165 - as an encouraging sign. In fact, it was a deep disappointment.

    Last year Republicans held the majority, while Democrats are in charge now. House Speaker Nancy Pelosi had supported Hinchey-Rohrabacher in the past. Democratic presidential candidates, including Hillary Clinton and John Edwards, were on record opposing DEA raids in states with medical marijuana laws. Hinchey-Rohrabacher would get a lot more votes and maybe even pass this year.

    Didn't happen. Obviously the leadership didn't push the measure (Pelosi didn't record a vote). As Bruce Mirken, communications director of the Marijuana Policy Project advocacy outfit in Washington told me, a number of freshman Democrats, especially in traditionally conservative or marginal districts, were unwilling to stick their necks out on what they believed could be an attack point in their reelection campaigns.

    To be sure, even if Hinchey-Rohrabacher had passed the House it probably wouldn't have passed the Senate, and in the unlikely event it passed the Senate President Bush would probably have vetoed it. But the fact that it did so poorly in a Democrat-controlled House suggests that the feeling among the political class is still that any move toward even modest loosening of the nation's drug laws is the political kiss of death.

    That shouldn't be the case. National polls consistently show 70 percent to 80 percent support for allowing the medicinal use of marijuana. Gerald McNerney, the only San Francisco Bay area Democrat to vote against Hinchey-Rohrabacher - a freshman who took the 11th District from Republican Richard Pombo - got more criticism than congratulations for his vote. And Paul Broun, a Republican with impeccable conservative credentials who just won a special election in Georgia and was a surprise "yes" vote, got more favorable than unfavorable publicity.

    A comment from Tom Riley, spokesman for the White House Office of National Drug Control Policy, was both galling and encouraging. "More and more people are realizing there is a con going on," he said, "that a lot of people who are behind this aren't really interested in sick people who need medicine, they're interested in marijuana legalization, and they're playing on the suffering of sick people to get it."

    It's telling that Mr. Riley would rather demonize his opposition than deal with the substance of the issue. But if he's sincere, there's a way to call the bluff of these demon legalizers - carve out an exception for medical use in federal law and focus on enforcement against "recreational" users without the distraction of all those grandmothers in wheelchairs and other sympathetic sick people to give the other side an emotional advantage.

    In fact, this would be in line with federal law as written. The Controlled Substance Act says that for a drug to be on Schedule I, which mandates no legal use and where marijuana is currently placed, it has to meet these criteria: A) "a high potential for abuse"; B) "no currently accepted medical use in treatment in the United States"; and C) "a lack of accepted safety for use of the drug or other substance under medical supervisions."

    As affirmed most recently by the 1999 government Institute of Medicine report, cannabis meets none of these criteria. So if the drug warriors were really interested in the law, they would take marijuana off Schedule I today.

    Francis Young, a DEA administrative law judge, strongly recommended just that in 1988. The most recent petition to "reschedule" marijuana, by activist Jon Gettman, dates from 2002. The Catch-22 is that the administrator of the DEA makes the final decision, and in response to several petitions in recent years it has always been made on political rather than scientific grounds.

    Despite setbacks, however, there's an active medical-marijuana community that is growing in sophistication and is not going away. At the Orange County supervisors hearing last month on medical marijuana ID cards, one man got up and announced he heads a cooperative of 600 patients that has operated under the radar, but since the cards would be so helpful to the patients he was going public for the first time. Dale Gieringer, head of California National Organization for Reform of Marijuana Laws (NORML), told me his sources know of at least 400 cannabis dispensary operations in Los Angeles County, so even if the DEA closes as many as 150 of them, hundreds will still be in operation.

    Americans for Safe Access, a patient advocacy group headquartered in Oakland, is pursuing an interesting lawsuit. The recently passed Data Quality Act requires that government policies and statements be based on sound current science and provides avenues for challenging those that aren't. The Department of Health and Human Services says in several of its publications and on its Web site that marijuana "has no currently accepted medical use in treatment in the United States." ASA started with administrative petitions and has been rebuffed, but it's now in court to require HHS to change that statement to: "Adequate and well-recognized studies show the efficacy of marijuana in the treatment of nausea, loss of appetite, pain and spasticity," backing up its filings with a three-inch stack of medical studies. Spokesman Kris Hermes told me the next brief will be filed Friday.

    Ethan Nadelmann, executive director of the Drug Policy Alliance in New York, told me allies in Congress are considering a proposal to take away the final determination of what drugs go on what schedules from the DEA administrator, giving it to an independent medical panel. There's also the possibility of a law that would prohibit the use of forfeiture where a building's use is in compliance with state law.

    One would think that the federal government would not be able to dig in its heels forever against sound science and public opinion. But prohibitionism is a religion more than a policy, so the true believers won't give in without a struggle.

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    An anonymous donor has pledged $10,000 to MAPS

     An anonymous donor has pledged $10,000 to MAPS to enable MAPS to provide technical assistance to a small, legal medical marijuana production facility in Israel. The facility will be directed by an Israeli medical marijuana advocate, and has been authorized by the Israeli Ministry of Health to provide marijuana only to medical marijuana patients formally approved by the Ministry. MAPS is working to provide technical assistance to create an organic, hydroponic, standardized production facility, which will start small and give marijuana away for the next several months. Once a successful track record has been established, the Ministry will determine whether to permit the facility to produce medical marijuana on a commercial basis.

    MAPS is bringing Canadian medical marijuana researcher and activist Philippe Lucas, founder of the Vancouver Island Compassion Society, to Israel in August to consult on the project. Mr. Lucas is currently a Center for Addictions Research of British Columbia graduate research fellow at the University of Victoria, and is currently involved in a number of research projects related to medical cannabis access and use. His experience as both a federally-licensed medical cannabis user and cultivator should prove useful to this new national program.

    MAPS Receives $10,000 Donation to Provide Technical Assistance to Israel Medical Marijuana Production Facility

    An anonymous donor has pledged $10,000 to MAPS to enable MAPS to provide technical assistance to a small, legal medical marijuana production facility in Israel. The facility will be directed by an Israeli medical marijuana advocate, and has been authorized by the Israeli Ministry of Health to provide marijuana only to medical marijuana patients formally approved by the Ministry. MAPS is working to provide technical assistance to create an organic, hydroponic, standardized production facility, which will start small and give marijuana away for the next several months. Once a successful track record has been established, the Ministry will determine whether to permit the facility to produce medical marijuana on a commercial basis.

    MAPS is bringing Canadian medical marijuana researcher and activist Philippe Lucas, founder of the Vancouver Island Compassion Society, to Israel in August to consult on the project. Mr. Lucas is currently a Center for Addictions Research of British Columbia graduate research fellow at the University of Victoria, and is currently involved in a number of research projects related to medical cannabis access and use. His experience as both a federally-licensed medical cannabis user and cultivator should prove useful to this new national program.

    Los Angeles Times Publishes a Strongly Supportive Editorial in Favor of MAPS and Prof. Craker

    Federal officials should allow competition in growing the drug for needed studies on its medical use.

    Published in the LA Times, Editorial Pages Desk; Part A; Pg. 26
    on Thursday 31 May, 2007

    LENGTH: 420 words

    http://www.latimes.com/news/opinion/la-ed-marijuana31may31,0,987800.story?coll=la-opinion-leftrail

    DISCUSSION OF medical marijuana has always been heavy on rhetoric, elisions and grandiose claims. What it has lacked is reliable research that might bring some of the discussion into line with reality. This is because access to the government's monopoly supply of research-grade marijuana is so restricted that the necessary research is effectively impossible. Now the Drug Enforcement Administration's chief administrative law judge is recommending that the federal drug police allow competition in growing marijuana for research purposes. The administration should follow her recommendation.

    At issue is the supply of research-grade marijuana produced at the University of Mississippi and overseen by the National Institute on Drug Abuse. This supply is supposed to be made available to DEA-registered researchers who have undergone a rigorous review and approval process by the U.S. Public Health Service. However, both medical marijuana advocates and scientists say the institute routinely refuses to make its supply available even to licensed researchers for properly authorized studies. There are at least two FDA-approved studies that cannot go forward because no research samples are available.

    This leaves researchers -- and the 12 states that have so far approved marijuana for medical purposes -- in a Catch-22: Drug warriors object that there is no research demonstrating marijuana's efficacy while preventing such research from being done. Since 2001, a scientist with the University of Massachusetts Amherst has vainly petitioned the DEA for permission to produce, under conditions that even the DEA acknowledges present little risk of diversion for illicit use, another supply of research-grade marijuana.

    In a recent ruling, Judge Mary Ellen Bittner agreed that that request would be in the public interest. Given its narrow confines, Bittner's recommendation makes sense. It has no bearing on the DEA's licensing of researchers, which would remain in place, nor would it remove the burden of proof on scientists who want access to research-grade marijuana. It would merely prevent situations in which, the judge noted, legitimate researchers who have completed all due diligence are still refused access to research samples.

    The benefits of medical marijuana may turn out to be less impressive than advocates hope. All the more reason that research should be allowed to go forward, so that we can base the discussion on evidence rather than on the two sides' vehement -- but factually unsupported -- claims.

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    The Economist: Joint Action

    Published March 1st 2007
    From The Economist print edition

    A victory for American cannabis researchers

    FOR almost six years Lyle Craker, a researcher who studies medicinal plants at the University of Massachusetts, has been trying to grow pot. Quite a long time, one might think, for a professor of agronomy—his students, presumably, have far less trouble. The difficulty for Dr Craker, though, is that he would like to grow marijuana legally, but the Drug Enforcement Administration (DEA) has so far refused to give him a licence.

    Last month a judge appointed by the Department of Justice recommended that it would be in the public interest for Dr Craker to grow the drug. Mary Ellen Bittner said that the government's monopoly on the legal growing of cannabis is hindering legitimate research and that there is a need for a second licensed facility to grow and supply it to authorised researchers.

    Dr Craker's case is backed by the American Civil Liberties Union and the Multidisciplinary Association for Psychedelic Studies, a not-for-profit group that supports research into the medicinal benefits of unapproved drugs. Lawyers for the groups argued that if cannabis is to be successfully licensed as a medicine by the Food and Drug Administration, a stable and secure supply is necessary. Moreover this supply is not available from the National Institute on Drug Abuse, the only body licensed by the DEA to grow it.

    The lawyers pointed to the case of Donald Abrams, a professor of clinical medicine at the University of California, San Francisco. He tried for many years to get cannabis from the national institute in order to conduct research on how it might help AIDS patients. This research was approved by all the necessary authorities—yet he was still refused cannabis. Later, when he changed his research to investigate whether it was dangerous for AIDS patients, his demand was supplied.

    Why is there such resistance? The DEA declined to comment on the case because it is ongoing. However Allen Hopper, a senior attorney based in Santa Cruz who works for the American Civil Liberties Union, says that the reasons for the lack of supply are political rather than scientific.

    Dr Craker's fight is by no means over. The decision on whether he can have his licence still rests with the deputy administrator of the DEA. The agency's decision must be as carefully argued as the judicial ruling. Even if it turns down Dr Craker's application, he will be free to take the decision to a court of appeal.

    The grass elsewhere is most certainly greener. The British government has encouraged research into cannabis medicines, with the result that a new drug, Sativex, based on an extract of cannabis, is now being used for the relief of nerve pain by multiple-sclerosis patients in Britain, Canada and Spain.

    In January GW Pharmaceuticals, the British producer of Sativex, announced research which suggests that a version of the drug might relieve pain in conditions other than multiple sclerosis. Back in America, an article published last month in the journal Neurology showed that smoking cannabis relieved chronic HIV-associated nerve pain—a condition that is often impervious to other treatments.

    For a long time many politicians in America have argued that cannabis has no proven medicinal value. At the same time, legitimate research has been hindered by supply problems. The only way to resolve whether marijuana has useful medical properties is to test it. The DEA should grant Dr Craker his licence.

    , approving dangerous drugs , and not performing follow-up on approved drugs. Now, add to this list the fact that the FDA throws science out the window and makes decisions that have no basis in reality. This bureaucracy recently stated that smoked marijuana has no currently accepted or proven medical use in the United States... This statement was made apparently without any research and demonstrates that the needs of cancer patients play little if any role in the decisions of this disgraceful organization.

    In 1999, the governments own prestigious Institute of Medicine looked at this issue and published a report titled: Marijuana and Medicine: Assessing the Science Base. Their conclusions included, The accumulated data indicate a potential therapeutic value for cannabinoid drugs, particularly for symptoms such as pain relief, control of nausea and vomiting, and appetite stimulation. The therapeutic effects of cannabinoids are best established for THC, which is generally one of the two most abundant of the cannabinoids in marijuanaThe combination of cannabinoid drug effects (anxiety reduction, appetite stimulation, nausea reduction, and pain relief) suggests that cannabinoids would be moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting.

    In fact, there are literally hundreds of articles that appear in the peer reviewed medical and scientific literature that discuss marijuanas effects in pain relief, control of nausea and vomiting, and appetite stimulation. Just last month an article in the concluded that, Cannabinoids present an interesting therapeutic potential as antiemetics, appetite stimulants in debilitating diseases (cancer and AIDS), analgesics, and in the treatment of multiple sclerosis, spinal cord injuries, Tourette's syndrome, epilepsy and glaucoma.

    Beyond ameliorating the side-effects of chemotherapy, research also suggests that marijuana may play a role in killing cancer cells. Recent journal articles have discussed how the chemicals in marijuana (i.e. delta9-THC) suppress or inhibit the growth of a variety of cancer cells invitro including breast cancers cells, brain cancer (glioblastoma cells), and leukemia cells. See for example:

    Breast Cancer Cannabinoids and cancer

    Brain Cannabinoids selectively inhibit proliferation and induce death of cultured human glioblastoma multiforme cells.

    Leukemia Targeting cannabinoid receptors to treat leukemia: role of cross-talk between extrinsic and intrinsic pathways in Delta9-tetrahydrocannabinol (THC)-induced apoptosis of Jurkat cells.

    In fact, the knowledge that cannabinoids suppress Lewis lung carcinoma cell growth has been known for 30 years .

    The FDAs illogical position not only ignores peer reviewed medical research, but also disregards nearly 5,000 years of history. Cannabis has been used for medicinal purposes for over 4,800 years. Surviving texts from China, Greece and Persia confirm that its psychoactive properties were recognized, and the ancient doctors used it for a variety of illnesses and ailments. These included a whole host of gastrointestinal disorders, insomnia, headaches and as a pain reliever, frequently used in childbirth. In fact, cannabis was listed in the United States Pharmacopeia from 1850 until 1942.

    The legal situation is now as confused as the political one. There is a split between the US federal and state governments over medical marijuana policy. On June 6, 2005, the Supreme Court, in Gonzales v. Raich, ruled in a 6-3 decision that Congress has the right to outlaw medicinal marijuana, thus subjecting all patients to federal prosecution even in states where the treatment is legalized. Not all Feds agree. In 1988, Francis L. Young, an administrative law judge with the Drug Enforcement Agency, declared that, Marijuana, in its natural form, is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within a supervised routine of medical care. See In The Matter of Marijuana Rescheduling Petition Of Docket No. 86-22, September 6, 1988, pp. 58-59. Currently, there are eleven states with medical marijuana laws on the books: Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Rhode Island, Vermont, and Washington.

    Obviously smoking marijuana is not risk-free especially to respiratory organs and tissue. However, compared to the risks of a typical chemotherapy agent such as cytoxan which includes: urinary bladder, myeloproliferative, or lymphoproliferative malignancies, potential sterility, urinary system hemorrhagic cystitis, hematuria, cardiac toxicity, anaphylactic reactions, significant suppression of immune responses, and sometimes fatal, infections; the risks of marijuana pale in comparison. And for cancer patients with advanced cancers who want to improve the quality of their life, a risk versus benefit analysis weighs heavily on the benefit side. Unfortunately, the FDAs unsupportable position will only slow down the progress in researching the applications and efficacy of this plant in cancer.

    The New York Times Publishes a Letter to the Editor from Jerry Epstein of the Drug Policy Forum of Texas

    The New York Times published a letter to the editor from Jerry Epstein of the Drug Policy Forum of Texas, in which he cites the federal governement's obstruction of Dr. Lyle Craker's proposed MAPS-sponsored medical marijuana production facility as an example of its "insane policy against the medical use of marijuana".

    From the New York Times
    Sunday May 21

    Originally appearing here.

    To the Editor:
    Your article about the rising costs of diabetes serves to highlight our insane policy against the medical use of marijuana.

    Hadassah University Hospital in Jerusalem just reported an experiment with marijuana cannabinoids that significantly reduced the prevalence of Type 1 diabetes in mice from an incidence of 86 percent in non-treated controls to an incidence of only 30 percent.

    Meanwhile, even powerful figures like Senators John Kerry and Edward M. Kennedy, working with the University of Massachusetts at Amherst on behalf of would-be researchers, cannot break through the barriers to research thrown up by the federal government.

    The witch hunt on marijuana has endured for years; we got past the Salem witch trials a lot faster.

    Jerry Epstein

    Houston, May 17, 2006

    The writer is a board member, Drug Policy Forum of Texas.

    Medscape General Medicine: Medical Marijuana; Politics Trumps Science at the FDA

    Medscape General Medicine
    2006: 8(2):46, Posted 05/17/2006


    Originally appearing here.


    Gregory T. Carter MD; Bruce Mirken

    For a Food and Drug Administration (FDA) increasingly mired in controversies over the politicization of scientific and regulatory decisions, the agency's April 20, 2006 statement regarding medical use of marijuana may represent an all-time low point.[1] Politics, it appears, has now completely trumped science at this once proudly independent agency. The FDA has announced that "no sound scientific studies" support the medical use of marijuana, contradicting an increasingly large body of scientific literature. To those of us who do research in this area, this is a personal affront.

    Even the federal Drug Enforcement Agency's (DEA) own Administrative Law Judge, the Honorable Francis Young, stated in 1988, "Marijuana is the safest therapeutically active substance known to man..." He went on to say, "The evidence clearly shows that marijuana is capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. . .it would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance."[2] Perhaps more remarkable were the conclusions of President Nixon's Shafer Commission, who were appointed to investigate marijuana's available scientific and medical evidence. To the shock and dismay of President Nixon, the Commission found enough evidence to recommend that marijuana be decriminalized.[3]

    The FDA's announcement is puzzling at many levels. It makes no mention of any recent FDA analysis or investigation, regulatory filing, or any other activity within the normal scope of the agency's work that led to this policy change. Thus, there is no indication as to why the agency chose to issue this opinion at this particular moment. Rather than being based on new data or analysis, the statement appears to have been issued in response to the repeated requests from US Rep. Mark Souder (R-IN), a vehement opponent of medical marijuana use. Souder wrote to acting FDA Commissioner Andrew C. von Eschenbach on January 18, 2006, saying, "I am exasperated at the FDA's failure to act against the fraudulent claims about 'medical' marijuana." He urged that the FDA "post accurate information about the claims of 'medical' marijuana on its website."[4] After 2 months he renewed the request, taking an impatient tone: "I have yet to receive a response from the Food and Drug Administration regarding my January 18, 2006 letter to you about the FDA's failure to provide any meaningful information on its website about the dangers of marijuana. I am quite concerned that the FDA does not take seriously the threat posed by marijuana, our nation's most abused drug."[5] The FDA's missive appears to be just what Souder wanted; it asserts that there is a lack of evidence regarding the medical value of marijuana and argues that state laws permitting medical use of marijuana without criminal penalty "are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process." The statement concludes by saying that the FDA, along with 2 nonmedical agencies, the DEA and the White House Office of National Drug Control Policy, "do not support the use of smoked marijuana for medical purposes."

    We beg to differ with Mr. Souder, who, to our knowledge has no scientific background or medical training. The scientific studies that document the medical efficacy and safety of smoked marijuana are published in peer-reviewed medical journals and are available through the National Library of Medicine. In our experience, the medical peer-review process is very harsh and stringent. Thus, it is not likely that the hundreds of peer-reviewed scientific articles published documenting the benefits of marijuana contain "fraudulent claims."

    Moreover, maybe the FDA and Mr. Souder are not aware that The National Institutes of Health (NIH) and the Institute of Medicine have previously issued statements of support for medical marijuana and have called for further investigation.[6,7] The Institute of Medicine reviewed the issue a second time at the request of the White House Office of National Drug Control Policy, resulting in a 1999 report which declared, "Nausea appetite loss, pain and anxiety are all afflictions of wasting, and all can be mitigated by marijuana." While expressing concern over the risks of smoking, the Institute noted that for some patients -- particularly those with terminal conditions or who do not respond to standard therapies -- those risks would be "of little consequence." The report added pointedly, "We acknowledge that there is no clear alternative for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain or AIDS wasting."[8]

    This was, in fact, the prior stance taken by the FDA itself, before this sudden turnaround.[9] Perhaps the FDA has forgotten that doctors can prescribe dronabinol (Marinol), which is 100% pure synthetic delta(9)-tetrahydrocannabinol (THC). This is the most powerful psychoactive compound in marijuana, and it is placed in the same category as the prescription strengths of ibuprofen (schedule III), meaning a physician can phone in the prescription. Furthermore, the recent discovery of an endogenous cannabinoid system with specific receptors and ligands has increased our understanding of the actions of marijuana.[10] The cannabinoid system appears to be intricately involved in normal human physiology, specifically in the control of movement, pain, memory and appetite, among others. Widespread cannabinoid receptors have been discovered in the brain and peripheral tissues. The cannabinoid system represents a previously unrecognized ubiquitous network in the nervous system. There is a dense receptor concentration in the cerebellum, basal ganglia, and hippocampus, accounting for the effects on motor tone, coordination, and mood state.[11] There are very few cannabinoid receptors in the brainstem, which may explain marijuana's remarkably low toxicity. There has never been a lethal overdose of marijuana reported in humans. In addition, we have shown that marijuana can be dosed, much like other prescribed drugs.[12] Moreover, in some instances patients report it as more therapeutic and better tolerated than other medications.[13,14]

    Despite all of this scientific documentation, following the recent Supreme Court ruling [Gonzales v. Raich], Drug Czar John Walters commented, "The medical marijuana farce is done." He then added, "I don't doubt that some people feel better when they use marijuana, but that's not modern science. That's snake oil." But isn't the very definition of palliative care the abatement of suffering in order to make patients "feel better"? Isn't that what doctors and other health professionals are supposed to do for a living?[15]

    In what appears to be an effort to justify the issuance of a statement on medical marijuana with no evident scientific or regulatory reason to do so, the FDA misrepresents the nature and purpose of state medical marijuana laws, stating, "A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation," suggesting that such laws "seek to bypass the FDA drug approval process." If that were the case, the FDA might arguably have an interest in opining about such laws. But as a general rule, the 11 state medical marijuana laws do not make marijuana available or in any way address the issue of marketing or sales. Rather, they simply protect patients who meet certain conditions (usually including a physician recommendation and/or diagnosis with a qualifying condition) from arrest and punishment under state laws that otherwise forbid marijuana possession or cultivation, Indeed, the lack of a legal means for patients to obtain marijuana for medical use has been a source of controversy in some states that have adopted medical marijuana laws.[16,17]

    One wonders: Does the FDA not understand the difference between licensing a drug for marketing and simply choosing not to arrest individuals who possess that drug under certain conditions? Does the agency believe that arrest and imprisonment are appropriate ways of dealing with a patient's choice to self-treat with an herbal product not approved as a medicine by the FDA?

    The recent change of heart by the FDA is disappointing on many levels. This is certainly not the first time the FDA has been accused of letting politics trump science.[18-20] However, it is the duty of the FDA to be an impartial scientific body and not rent itself out to political agendas. Arguably, marijuana is neither a miracle compound nor the answer to everyone's ills. Yet it is not a compound that deserves the tremendous legal and societal commotion that has surrounded its use. Over the past 30 years, the United States has spent billions in an effort to stem the use of illicit drugs, including marijuana, with limited success. Some very ill people have had to fight long court battles to defend themselves for having used a compound that has helped them. There is no evidence that recreational marijuana use is any higher in states that allow for its medicinal use.[21] Moreover, prohibition strategies have never proven terribly effective at limiting the use of a substance - whether it be alcohol or other compounds -- for any reason.

    Rational, apolitical minds need to take over the debate on marijuana, separating myth from fact, right from wrong, and responsible, medicinal use from other, less compelling usages. However one feels about nonmedical use of marijuana, in our opinion, the medicinal marijuana user should not be considered a criminal in any state. The scientific process continues to document the therapeutic effects of marijuana through ongoing research and assessment of available data. With regard to the medicinal use of marijuana, our federal government and legal system should take a similar approach, using science and logic, rather than politics, as the basis of policymaking. This recent change of policy by the FDA, with politics apparently taking precedence over science, is disappointing and unwarranted.

    Readers are encouraged to respond to George Lundberg, MD, Editor of MedGenMed, for the editor's eye only or for possible publication via email: This email address is being protected from spambots. You need JavaScript enabled to view it.

    References

    1. U.S. Food and Drug Administration. Inter-Agency Advisory Regarding Claims that Smoked Marijuana is a Medicine. April 20, 2006.
    2. U.S. Department of Justice, Drug Enforcement Administration. In the Matter of Marijuana Rescheduling Petition: Opinion and recommended ruling, findings of fact, conclusions of law and decision of administrative law judge. Docket no. 86-22; pp 67-68; September 6, 1988.
    3. National Commission on Marihuana and Drug Abuse, "Marihuana: A Signal of Misunderstanding; First Report, Washington, DC: U.S. Govt. Printing Office; 1972, p 151. The report of the Shafer Commission is available online at: www.druglibrary.org/schaffer/library/studies/nc/ncmenu.htm. Souder M. Letter to Andrew C. von Eschenbach. January 18, 2006.
    4. Souder M. Letter to Andrew C. von Eschenbach. March 15, 2006.
    5. Institute of Medicine. Division of Health Sciences Policy. Marijuana and Health: Report of a Study by a Committee of the Institute of Medicine, Division of Health Sciences Policy. Washington, DC: National Academy Press; 1982.
    6. Hollister LE. Interactions of cannabis with other drugs in man. In: Braude, MC, Ginzburg HM, eds. Strategies for Research on the Interactions of Drugs of Abuse. National Institute on Drug Abuse Research Monograph 68. DHHS Pub. No. (ADM)86-1453. Washington, DC: Supt. of Docs., U.S. Govt. Printing Office; 1986, pp 110-116.
    7. Joy JE, Watson SJ, Benson JA. Marijuana and Medicine: Assessing the Science Base. Institute of Medicine. Washington, DC: National Academy Press; 1999.
    8. FDA Guideline for the Clinical Evaluation of Analgesic Drugs. DHHS Pub. No. 93-3093. Rockville, Md: U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration; 1992.
    9. Carter GT, Weydt P. Cannabis: old medicine with new promise for neurological disorders. Curr Opin Investig Drugs. 2002;3:437-440. Abstract
    10. Carter GT, Ugalde VO. Medical marijuana: emerging applications for the management of neurological disorders. Phys Med Rehabil Clin N Am. 2004;15:943-954. Abstract
    11. Carter GT, Weydt P, Kyashna-Tocha M, Abrams DI. Medical marijuana: rational guidelines for dosing. IDrugs. 2004;7:464-470. Abstract
    12. Carter GT, Rosen BS. Marijuana in the management of amyotrophic lateral sclerosis. Am J Hosp Palliat Care. 2001;18:264-270. Abstract
    13. Amtmann D, Weydt P, Johnson KL, Jensen MP, Carter GT. Survey of cannabis use in patients with amyotrophic lateral sclerosis. Am J Hosp Palliat Care. 2004;21:95-104. Abstract
    14. Gonzales v. Raich. Federal case no. 03-1454; June 2005.
      Marijuana Policy Project. State-by-state medical marijuana laws: how to remove the threat of arrest. Washington, DC: Marijuana Policy Project 2004.
    15. Associated Press. New law doesn't say where patients will get pot. January 13, 2006. Gorelick KJ, Marcus DM, Cohen FJ, Jenny-Avital ER. What ails the FDA? N Engl J Med. 2005;352:2553-2555.
    16. Burstein PD, Stanford JB, Hager WD, et al. The FDA, politics, and plan B. N Engl J Med. 2004;350:2413-2414.
    17. Emergency contraception: Politics trumps science at the U.S. Food and Drug Administration. Obstet Gynecol. 2004;104:220-221. Abstract
    18. Aggarwal S, Carter GT, Steinborn J. Clearing the air: what the latest Supreme Court decision regarding medical marijuana really means. Am J Hosp Palliat Care. 2005; 22:327-329. Abstract


    Gregory T. Carter, MD, Clinical Professor of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington. Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

    Bruce Mirken, Director of Communications, Marijuana Policy Project, Washington, DC.

    Disclosure: Gregory T. Carter, MD, has disclosed no relevant financial relationships.

    Disclosure: Bruce Mirken has disclosed no relevant financial relationships

    LA Times: Puffing is the Best Medicine

    Originally appearing here.

    The LA Times published "Puffing is the Best Medicine", an opinion piece by Lester Grinspoon supporting smoking as an effective means of taking medical marijuana in response to a recent statement on this topic from the FDA.



    LESTER GRINSPOON is an emeritus professor of psychiatry at Harvard Medical School and the author of "Marijuana, the Forbidden Medicine" (Yale University Press, 1997).

    THE FOOD AND Drug Administration is contradicting itself. It recently reiterated its position that cannabis has no medical utility, but it also approved advanced clinical trials for a marijuana-derived drug called Sativex, a liquid preparation of two of the most therapeutically useful compounds of cannabis. This is the same agency that in 1985 approved Marinol, another oral cannabis-derived medicine.

    Both Sativex and Marinol represent the "pharmaceuticalization" of marijuana. They are attempts to make available its quite obvious medicinal properties - to treat pain, appetite loss and many other ailments - while at the same time prohibiting it for any other use. Clinicians know that the herb - because it can be smoked or inhaled via a vaporizer - is a much more useful and reliable medicine than oral preparations. So it might be wise to consider exactly what Sativex can and can't do before it's marketed here.

    A few years ago, the British firm GW Pharmaceuticals convinced Britain's Home Office that it should be allowed to develop Sativex because the drug could provide all of the medical benefits of cannabis without burdening patients with its "dangerous" effects - those of smoking and getting high.

    But there is very little evidence that smoking marijuana as a means of taking it represents a significant health risk. Although cannabis has been smoked widely in Western countries for more than four decades, there have been no reported cases of lung cancer or emphysema attributed to marijuana. I suspect that a day's breathing in any city with poor air quality poses more of a threat than inhaling a day's dose - which for many ailments is just a portion of a joint - of marijuana.

    Further, those who are concerned about the toxic effects of smoking can now use a vaporizer, which frees the cannabinoid molecules from the plant material without burning it and producing smoke.

    As for getting high, I am not convinced that the therapeutic benefits of cannabis can always be separated from its psychoactive effects. For example, many patients with multiple sclerosis who use marijuana speak of "feeling better" as well as of the relief from muscle spasms and other symptoms. If cannabis contributes to this mood elevation, should patients be deprived of it?

    The statement that Sativex, "when taken properly," won't cause intoxication hinges on the phrase "when taken properly." "Properly" here merely means taking a dose - by holding a few drops of liquid under the tongue - that is under the level required for the psychoactive effect. As with Marinol, people who want to use Sativex to get high will certainly be able to do so.

    One of the most important characteristics of cannabis is how fast it acts when it is inhaled, which allows patients to easily determine the right dose for symptom relief. Sativex's sublingual absorption is more efficient than orally administered Marinol (which requires 1 1/2 to two hours to take effect), but it's still not nearly as fast as smoking or inhaling the herb.

    That means "self-titration," or self-dosage, is difficult if not impossible. Further, many patients cannot hold Sativex, which has an unpleasant taste, under the tongue long enough for it to be absorbed. As a consequence, varying amounts trickle down the esophagus. It then behaves like orally administered cannabis, with the consequent delay in the therapeutic effect.

    Cannabis will one day be seen as a wonder drug, as was penicillin in the 1940s. Like penicillin, herbal marijuana is remarkably nontoxic, has a wide range of therapeutic applications and would be quite inexpensive if it were legal. Even now, good-quality illicit or homegrown marijuana, which is, at the very least, no less useful a medicine than Sativex, is less expensive than Sativex or Marinol.

    The "pharmaceuticalization" of marijuana has promise. No doubt the industry could produce unique analogs of the naturally occurring cannabinoids that would be useful in ways smoked cannabis is not. But for now, medicines such as Sativex provide only one advantage over the herb: They're legal.

    I have yet to see a patient who preferred Marinol to smoked marijuana. Similarly, the commercial success of Sativex will largely depend on how vigorously the marijuana laws are enforced. It is not unreasonable to believe that drug companies have an interest in sustaining the prohibition against the herb.

    Geoffrey Guy, who founded GW Pharmaceuticals, claims his aim was to keep people who find marijuana useful out of court. There is, of course, a way to do this that would be much less expensive - both economically and in terms of human suffering.

    Congress Letter to FDA Acting Commissioner re statement on medical marijuana

    The text of the letter from Hinchey and his House colleagues to FDA Acting Commissioner von Eschenbach follows:

    April 27, 2006

    Andrew C. von Eschenbach, M.D.
    Acting Commissioner
    Food and Drug Administration
    5600 Fishers Lane
    Rockville, Maryland 20857

    Dear Dr. von Eschenbach:

    We are troubled by the FDA's April 20th press release in which the agency states that "[N]o sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." The timing and the lack of substantial information included in this release lead us to conclude that this was a politically motivated statement rather than one based on scientific evidence and fact.

    Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise. We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials. In conjunction with the lack of scientific evidence, it is troubling that your release seemed to defer to the DEA's medical opinions on the drug despite the fact that determining the medical importance of a drug is not in the DEA's jurisdiction.

    After deferring to the DEA, your release reads that, "FDA is the sole federal agency that approves drug products as safe and effective for intended indications." Why then has the FDA failed to respond to the 1999 Institute of Medicine (IOM) report which concluded that marijuana's active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials? It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM's findings seven years after the study's publication date. Additionally, this release failed to make note of the FDA's Investigational New Drug (IND) Compassionate Access Program, which allowed patients with certain medical conditions to apply with the FDA to receive federal marijuana. Currently, seven people still enlisted in this program continue to receive marijuana through the federal government. The existence of this program is an example of how the FDA could allow for the legal use of a drug, such as medical marijuana, without going through the "well-controlled" series of steps that other drugs have to go through if there is a compassionate need.

    In light of our concerns over this release, please inform us if there is new scientific information that disputes the IOM study, including the results of the evaluation, any scientific paperwork generated in the study, the length of time the evaluation occurred, and whether the DEA or any other federal agencies aside from the ones mentioned in the letter had a role in the evaluation. If, as the press release leads us to believe, there is in fact no evaluation, please let us know what motivated the FDA to write a release that lacks scientific review. It disheartens us to see the FDA veer off course in this area of public health especially at the expense of many terminally ill Americans. We understand that FDA's mission is to protect public health, which is why we respectfully request that you respond to these questions on this very important issue.

    Sincerely,

    Maurice Hinchey
    Ron Paul
    Barney Frank
    Sam Farr
    Tammy Baldwin
    Raul Grijalva
    Robert Wexler
    Dennis Kucinich
    John Conyers
    Maxine Waters
    Dana Rohrabacher
    Jim McDermott
    Tom Lantos
    Jerrold Nadler
    John Olver
    Lois Capps
    Julia Carson
    Peter Stark
    Jan Schakowsky
    George Miller
    Zoe Lofgren
    Tom Allen
    Barbara Lee
    Gary Ackerman

    Continue Reading

    24 Members Say Agency Needs To Start Responding To Science & Not To Political Pressure

    Office of Maurice Hinchey (D-NY)
    April 27, 2006

    Hinchey Leads Bipartisan House Coalition In Calling For FDA To Explain Baseless Anti-Medical Marijuana Policy .

    Washington, D.C. - One week after the Food and Drug Administration (FDA) issued a baseless, one page press release claiming that marijuana had no medical benefits, Congressman Maurice Hinchey (D-NY) led a bipartisan group of 24 House members in calling on the agency to explain its reasoning and show scientific proof to support its view. Hinchey, who has offered an amendment in the House three times that would bar the federal government from prosecuting medical marijuana patients, doctors, and suppliers in states where medical marijuana is legal, and his colleagues said the FDA's action appears to be politically motivated and defies the results of a White House-commissioned Institute of Medicine (IOM) study from 1999 that detailed the benefits of medical marijuana use.

    "Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise. We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials," Hinchey and his colleagues wrote in a letter sent today to FDA Acting Commissioner Andrew von Eschenbach. "It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM's findings seven years after the study's publication date."

    On April 20, the FDA issued a one-page press release without any documentation to back up its claim that, "...No sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." This statement fails to take into account the IOM report from 1999, which found that marijuana's active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials.

    "We saw it with the agency's decision on the emergency contraceptive, Plan B, and we're seeing it again with medical marijuana: the FDA is making decisions based on politics instead of science," Hinchey said. "The FDA should not be a political entity. Rather, the agency should be in the business of ensuring all Americans have access to safe and effective drugs, including medical marijuana."

    Hinchey and his colleagues noted in their letter to von Eschenbach that the FDA has an Investigational New Drug (IND) Compassionate Access Program, which allowed some Americans with certain medical conditions to apply to the agency to receive marijuana from the federal government. Seven people are currently still in the program and routinely receive marijuana from the federal government. The House members suggest that the IND is an example of how the FDA could allow for the legal use of marijuana without having to go through the series of steps many other drugs go through before getting approved.

    Hinchey intends to offer his medical marijuana amendment for a fourth time when the House takes up the Science, State, Justice, and Commerce Appropriations bill for Fiscal Year 2007. The measure would prohibit the U.S. Department of Justice from spending any funds in its budget to prosecute patients, doctors, and others who are associated with the use of medical marijuana in states that allow the drug from medical purposes.

    The text of the letter from Hinchey and his House colleagues to FDA Acting Commissioner von Eschenbach follows:

    April 27, 2006

    Andrew C. von Eschenbach, M.D.
    Acting Commissioner
    Food and Drug Administration
    5600 Fishers Lane
    Rockville, Maryland 20857


    Dear Dr. von Eschenbach:

    We are troubled by the FDA's April 20th press release in which the agency states that "[N]o sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." The timing and the lack of substantial information included in this release lead us to conclude that this was a politically motivated statement rather than one based on scientific evidence and fact.

    Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise. We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials. In conjunction with the lack of scientific evidence, it is troubling that your release seemed to defer to the DEA's medical opinions on the drug despite the fact that determining the medical importance of a drug is not in the DEA's jurisdiction.

    After deferring to the DEA, your release reads that, "FDA is the sole federal agency that approves drug products as safe and effective for intended indications." Why then has the FDA failed to respond to the 1999 Institute of Medicine (IOM) report which concluded that marijuana's active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials? It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM's findings seven years after the study's publication date. Additionally, this release failed to make note of the FDA's Investigational New Drug (IND) Compassionate Access Program, which allowed patients with certain medical conditions to apply with the FDA to receive federal marijuana. Currently, seven people still enlisted in this program continue to receive marijuana through the federal government. The existence of this program is an example of how the FDA could allow for the legal use of a drug, such as medical marijuana, without going through the "well-controlled" series of steps that other drugs have to go through if there is a compassionate need.

    In light of our concerns over this release, please inform us if there is new scientific information that disputes the IOM study, including the results of the evaluation, any scientific paperwork generated in the study, the length of time the evaluation occurred, and whether the DEA or any other federal agencies aside from the ones mentioned in the letter had a role in the evaluation. If, as the press release leads us to believe, there is in fact no evaluation, please let us know what motivated the FDA to write a release that lacks scientific review. It disheartens us to see the FDA veer off course in this area of public health especially at the expense of many terminally ill Americans. We understand that FDA's mission is to protect public health, which is why we respectfully request that you respond to these questions on this very important issue.

    Sincerely,

    Maurice Hinchey
    Ron Paul
    Barney Frank
    Sam Farr
    Tammy Baldwin
    Raul Grijalva
    Robert Wexler
    Dennis Kucinich
    John Conyers
    Maxine Waters
    Dana Rohrabacher
    Jim McDermott
    Tom Lantos
    Jerrold Nadler
    John Olver
    Lois Capps
    Julia Carson
    Peter Stark
    Jan Schakowsky
    George Miller
    Zoe Lofgren
    Tom Allen
    Barbara Lee
    Gary Ackerman

    The Economist: "Reefer Madness: Marijuana is Medically Useful, Whether Politicians Like It or Not"

    The critical backlash against the FDA's transparent politicization of science continued with a thorough and well-documented article in The Economist entitled "Reefer Madness: Marijuana is medically useful, whether politicians like it or not." The article discusses Prof. Lyle Craker's proposed MAPS-sponsored medical marijuana production facility and his ongoing MAPS-supported DEA lawsuit.

    San Diego Union-Tribune: Politics Trumps Science at the FDA

    San Diego Union-Tribune
    April 26, 2006

    Originally appearing here.

    The San Diego Union-Tribune published an Op Ed piece by Stephen Sidney and Bruce Mirken on the FDA statement on medical marijuana.

    All Americans, whether or not they have any interest in medical marijuana, should be concerned by the Food and Drug Administration's recent statement claiming there is no evidence that marijuana is medically beneficial. The FDA's pronouncement tells us little about medical marijuana, but it says much about how politics appears to be trumping science at the agency we all depend on to protect our health.

    The FDA's missive, issued late in the day on April 20, proclaims that no sound scientific studies support medical use of marijuana and condemns state medical marijuana laws.

    But why, one wonders, did the FDA issue this statement now? It cites neither new scientific data, nor even any new analysis of old data. The FDA did not, as it often does when addressing difficult issues, convene an advisory committee of independent experts. Indeed, the document appears to be nothing but a rehash of the federal government's long-standing position.

    And it's a selective rehash, to put it gently. Back in 1995, the American Public Health Association cited nearly two dozen studies reporting marijuana's safety and efficacy against pain, nausea, vomiting, seizures and other serious symptoms. The APHA urged the government to expeditiously make marijuana available to patients through the Compassionate Investigational New Drug program that the first Bush administration had closed to new applicants in 1991, declaring, Greater harm is caused by the legal consequences of [marijuana's] prohibition than possible risks of medicinal use.

    Four years later, in a massive review commissioned by the White House, the Institute of Medicine (a branch of the National Academy of Sciences) found significant evidence of therapeutic benefit, stating: Nausea, appetite loss, pain and anxiety are all afflictions of wasting, and all can be mitigated by marijuana. While expressing concern over the risks of smoking, it noted that for some patients particularly those with terminal conditions or not responding to standard therapies those risks would be of little consequence. The Institute of Medicine report added pointedly, We acknowledge that there is no clear alternative for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain or AIDS wasting.

    The FDA simply ignored this mass of data. Indeed, the federal government has long been hiding from such information. As Dr. John Benson, one of three lead authors of the Institute of Medicine report, told The New York Times last week, the government loves to ignore our report. ... They would rather it never happened.

    It is true that the volume of research data on medical marijuana is not as great as any of us would like. But the relative lack of large, controlled trials of marijuana is almost entirely due to government obstructionism.

    The federal government has not only refused to fund medical marijuana research, it has put in place a set of legal and bureaucratic obstacles that have kept the flow of even privately funded medical marijuana studies to a trickle. So with one hand, our government tells us there's no data, while with the other hand it works to ensure there will never be enough data.

    So why did the FDA issue this questionable document, containing no new information whatever, at this particular moment? The only apparent explanation is politics. Rep. Mark Souder, R-Ind., perhaps the most vehement opponent of medical marijuana in the Congress, has been hectoring the agency for months to issue a statement condemning medical marijuana.

    On Jan. 18, in a letter to acting FDA Commissioner Andrew C. von Eschenbach, Souder wrote, I am exasperated at FDA's failure to act against the fraudulent claims of 'medical' marijuana. He renewed the request two months later, in even more impatient terms. And Souder's agenda fit perfectly with the administration's stand on the issue, so all the political winds were blowing in the same direction. Science, it appears, took a back seat.

    For the FDA to do its job as protector of our nation's health, it must be free from commercial or political pressure. When politics trumps science at the FDA, we are all in danger.

    Sidney is associate director for clinical research for Kaiser Permanente's Division of Research in Oakland. His opinion reflects his personal views and not those of the Kaiser Permanente Medical Group.

    Mirken is director of communications for the Marijuana Policy Project.

    Chicago Tribune: Dissembling on Medical Pot

    Chicago Tribune
    April 23, 2006

    Originally appearing here.

    The Chicago Tribune responded to the FDA's recent statement concerning the medicinal potential of cannabis with an editorial, "Dissembling on Medical Pot" that quotes Prof. Lyle Craker of the University of Massachusetts at Amherst, saying "The reason there's no good evidence is that they don't want an honest trial."



    The federal government has a long and dismal record of fighting the idea that marijuana has any medical value, and it is not about to let mere facts force a change in policy.

    The Food and Drug Administration's new pronouncement on the subject is just the latest disgraceful effort to maintain an unconvincing position that has long been rejected by most Americans--not to mention 11 states that have legalized medical marijuana. Besides failing to offer any new evidence for denying cannabis to patients who might benefit from it, the agency also ignores the best information available.

    The FDA statement came in response to a request from Rep. Mark Souder (R-Ind.), chairman of the House Government Reform subcommittee, an opponent of medical marijuana. It declares that "no human or animal data supported the safety or efficacy of marijuana for general medical use." Measures allowing it, says the agency, "would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products."

    Souder, who perceives efforts to permit cannabis therapy as a Trojan horse for legalizing the drug entirely, seconded the FDA. Marijuana can't be a good treatment, he asserted, "because it adversely impacts concentration and memory, the lungs, motor coordination and the immune system."

    It may surprise Souder to learn that all sorts of valuable, federally approved medicines may have serious adverse effects, which is not grounds for banning them entirely. As it happens, there is ample evidence that pot can ameliorate some serious ailments that don't always respond to conventional treatments.

    A 1999 analysis by the Institute of Medicine at the National Academy of Sciences concluded that it is "moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting." Medical marijuana has earned the endorsement of The New England Journal of Medicine, the American Academy of Family Physicians and numerous oncologists.

    Its side effects, meanwhile, are exaggerated. In 1988, Francis Young, the Drug Enforcement Agency's own administrative law judge, called cannabis "one of the safest therapeutically active substances known to man."

    The FDA stoically pretends all this expert analysis doesn't exist. Its statement is equally dishonest when it says there are no scientific studies proving the value of marijuana--without acknowledging that the government has generally declined to cooperate with scientists who want to conduct clinical trials.

    It's a classic scam. Says University of Massachusetts agronomist Lyle Craker, who was refused permission to grow marijuana for his research, in place of the low-quality stuff offered by the government, "The reason there's no good evidence is that they don't want an honest trial."

    There is plenty of room for serious debate about the therapeutic potential of cannabis. But the government clearly thinks that what it doesn't know can't hurt it.

    New York Times: The Politics of Pot

    Originally appearing here.

    The New York Times published an editorial, "The Politics of Pot" that refers to the FDA statement on the medicinal value of marijuana as "disingenuous," and ending with this statement, "It's obviously easier and safer to issue a brief, dismissive statement than to back research that might undermine the administration's inflexible opposition to the medical use of marijuana."

    Associated Press: FDA Rejects Marijuana for Medical Uses

    Associated Press
    April 21, 2006

    By Lou Kesten
    Associated Press Writer

    WASHINGTON (AP) -- The Food and Drug Administration said Thursday that it does not support the use of marijuana for medical purposes.

    The FDA said in a statement that it and other agencies with the Health and Human Services Department had "concluded that no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use."

    A number of states have passed legislation allowing marijuana use for medical purposes, but the FDA said, "These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective."

    The statement contradicts a 1999 finding from the Institute of Medicine, part of the National Academy of Sciences, which reported that "marijuana's active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting and other symptoms, and should be tested rigorously in clinical trials."

    Bruce Mirken, director of communications for the Marijuana Policy Project, said Thursday: "If anybody needed proof that the FDA has become totally politicized, this is it. This isn't a scientific statement; it's a political statement."

    Mirken said "a rabid congressional opponent of medical marijuana," Rep. Mark Souder, R-Indiana, asked the FDA to make the statement.

    Souder, chairman of the House Government Reform subcommittee on drug policy, has said the promotion of medical marijuana "is simply a red herring for the legalization of marijuana for recreational use. Studies have continually rejected the notion that marijuana is suitable for medical use because it adversely impacts concentration and memory, the lungs, motor coordination and the immune system."

    The FDA statement noted "there is currently sound evidence that smoked marijuana is harmful." It also said, "There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana."

    Mirken responded, "There is abundant evidence that marijuana can help cancer patients, multiple sclerosis patients and AIDS patients. There is no scientific doubt that marijuana relieves nausea, vomiting, certain kinds of pain and other symptoms that don't respond well to conventional drugs, and does it more safely than other drugs.

    "For the FDA to ignore all that evidence is embarrassing," Mirken said. "They should be red-faced."

    Read the official FDA statement on smoked marijuana as medicine.

    FDA Criticizes Attempts To Legalize Marijuana

    Washington Post
    April 21, 2006
    http://www.washingtonpost.com/wp-dyn/content/article/2006/04/20/AR2006042001786.html

    FDA Criticizes Attempts To Legalize Marijuana

    The Food and Drug Administration will publish a statement today criticizing state measures to legalize the medical use of marijuana, calling them attempts to bypass scientific review.

    The agency said it was posting the statement in response to requests from lawmakers and others, but advocates for legalizing marijuana said the FDA was making an unusual and inappropriate foray into politics.

    "In response to inquiries, including from Congress, we are clarifying our position on the science," said FDA spokeswoman Susan Bro in an interview.

    But Bruce Mirken of the Marijuana Policy Project said he was puzzled by the FDA's decision. "It's fascinating that they are making what strikes me as essentially a political move here," Mirken said.

    The issue of the medical use of marijuana has been long contested on the state and federal level. Some patients with diseases such as cancer, multiple sclerosis and glaucoma say only the herb provides relief, and sometimes their doctors agree.

    But the federal government maintains that FDA-approved drugs, including a synthetic form of the active ingredient in marijuana, are adequate for these patients.


    Read the FDA statement on medical use of smoked marijuana.

    FDA Issues Statement Indicating that Marijuana has No Currently Accepted Medical Uses

    The FDA issued a statement indicating that marijuana had no currently accepted medical uses. Stories in the New York Times, the Washington Post and the Associated Press reported on this statement and responses to it within and outside the medical community. Prof. Lyle Craker is quoted discussing his lawsuit against the DEA for refusing to issue him a license for a marijuana production facility. NIDA’s marijuana was criticized for poor quality, but not for the more comprehensive lack of an "adequate and uninterrupted" supply that is the basis of Prof. Craker’s lawsuit. FDA’s statement wasn’t that marijuana had no medical uses. Rather, what the statement actually means is that due to a lack of research data from large Phase III studies, which won’t take place until NIDA’s marijuana monopoly is broken, FDA will consider marijuana to have no currently accepted medical uses. This statment points yet again to the need for large-scale, privately-funded Phase III studies with smoked and vaporized marijuana, which DEA is blocking by refusing to issue Prof. Craker his license.

    FDA Dismisses Medical Benefit From Marijuana

    New York Times
    April 21, 2006
    http://www.nytimes.com/2006/04/21/health/21marijuana.html?hp&ex=1145678400&en=73c0a8f9ab6a3c7e&ei=5094&partner=homepage

    F.D.A. Dismisses Medical Benefit From Marijuana

    Gardiner Harris

    WASHINGTON, April 20 The Food and Drug Administration said Thursday that "no sound scientific studies" supported the medical use of marijuana, contradicting a 1999 review by a panel of highly regarded scientists.

    The announcement inserts the health agency into yet another fierce political fight.

    Susan Bro, an agency spokeswoman, said Thursday's statement resulted from a past combined review by federal drug enforcement, regulatory and research agencies that concluded "smoked marijuana has no currently accepted or proven medical use in the United States and is not an approved medical treatment."

    Ms. Bro said the agency issued the statement in response to numerous inquiries from Capitol Hill but would probably do nothing to enforce it.

    "Any enforcement based on this finding would need to be by D.E.A. since this falls outside of F.D.A.'s regulatory authority," she said.

    Eleven states have legalized medicinal use of marijuana, but the Drug Enforcement Administration and the director of national drug control policy, John P. Walters, have opposed those laws.

    A Supreme Court decision last year allowed the federal government to arrest anyone using marijuana, even for medical purposes and even in states that have legalized its use.

    Congressional opponents and supporters of medical marijuana use have each tried to enlist the F.D.A. to support their views. Representative Mark Souder, Republican of Indiana and a fierce opponent of medical marijuana initiatives, proposed legislation two years ago that would have required the food and drug agency to issue an opinion on the medicinal properties of marijuana.

    Mr. Souder believes that efforts to legalize medicinal uses of marijuana are a front for efforts to legalize all uses of it, said Martin Green, a spokesman for Mr. Souder.

    Tom Riley, a spokesman for Mr. Walters, hailed the food and drug agency's statement, saying it would put to rest what he called "the bizarre public discussion" that has led to some legalization of medical marijuana.

    The Food and Drug Administration statement directly contradicts a 1999 review by the Institute of Medicine, a part of the National Academy of Sciences, the nation's most prestigious scientific advisory agency. That review found marijuana to be "moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting."

    Dr. John Benson, co-chairman of the Institute of Medicine committee that examined the research into marijuana's effects, said in an interview that the statement on Thursday and the combined review by other agencies were wrong.

    The federal government "loves to ignore our report," said Dr. Benson, a professor of internal medicine at the University of Nebraska Medical Center. "They would rather it never happened."

    Some scientists and legislators said the agency's statement about marijuana demonstrated that politics had trumped science.

    "Unfortunately, this is yet another example of the F.D.A. making pronouncements that seem to be driven more by ideology than by science," said Dr. Jerry Avorn, a medical professor at Harvard Medical School.

    Representative Maurice D. Hinchey, a New York Democrat who has sponsored legislation to allow medicinal uses of marijuana, said the statement reflected the influence of the Drug Enforcement Administration, which he said had long pressured the F.D.A. to help in its fight against marijuana.

    A spokeswoman for the Drug Enforcement Administration referred questions to Mr. Walters's office.

    The Food and Drug Administration's statement said state initiatives that legalize marijuana use were "inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the F.D.A. approval process."

    But scientists who study the medical use of marijuana said in interviews that the federal government had actively discouraged research. Lyle E. Craker, a professor in the division of plant and soil sciences at the University of Massachusetts, said he submitted an application to the D.E.A. in 2001 to grow a small patch of marijuana to be used for research because government-approved marijuana, grown in Mississippi, was of poor quality.

    In 2004, the drug enforcement agency turned Dr. Craker down. He appealed and is awaiting a judge's ruling. "The reason there's no good evidence is that they don't want an honest trial," Dr. Craker said.

    Dr. Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, said he had studied marijuana's medicinal effects for years but had been frustrated because the National Institutes of Health, the leading government medical research agency, had refused to finance such work.

    With financing from the State of California, Dr. Abrams undertook what he said was a rigorous, placebo-controlled trial of marijuana smoking in H.I.V. patients who suffered from nerve pain. Smoking marijuana proved effective in ameliorating pain, Dr. Abrams said, but he said he was having trouble getting the study published.

    "One wonders how anyone" could fulfill the Food and Drug Administration request for well-controlled trials to prove marijuana's benefits, he said.

    Marinol, a synthetic version of a marijuana component, is approved to treat anorexia associated with AIDS and the nausea and vomiting associated with cancer drug therapy.

    GW Pharmaceutical, a British company, has received F.D.A. approval to test a sprayed extract of marijuana in humans. Called Sativex, the drug is made from marijuana and is approved for sale in Canada. Opponents of efforts to legalize marijuana for medicinal uses suggest that marijuana is a so-called gateway drug that often leads users to try more dangerous drugs and to addiction.

    But the Institute of Medicine report concluded there was no evidence that marijuana acted as a gateway to harder drugs. And it said there was no evidence that medical use of marijuana would increase its use among the general population.

    Dr. Daniele Piomelli, a professor of pharmacology at the University of California, Irvine, said he had "never met a scientist who would say that marijuana is either dangerous or useless."

    Studies clearly show that marijuana has some benefits for some patients, Dr. Piomelli said.

    "We all agree on that," he said.


    Read the FDA statement on medical use of smoked marijuana.

    Continue Reading

    Daily Nexus: Activists Assemble for Cannabis Conference

    Originally appearing here.

    The Daily Nexus published Activists Assemble for Cannabis Conference, announcing The Fourth National Clinical Conference on Cannabis Therapeutics at Santa Barbara City College, which features lectures from doctors, health care researchers and patients, as well as talk show-host and medical marijuana advocate Montel Williams.



    By Ryan Grandov - Staff Writer
    Friday, April 7, 2006
    Daily Nexus
    Doctors, health care professionals and a famous talk-show host will gather in Santa Barbara this weekend in an attempt to smoke out the truth about medicinal marijuana use.

    The Fourth National Clinical Conference on Cannabis Therapeutics, hosted by Santa Barbara City College, began on April 6 and runs through April 8. The conference meets from 7:30 a.m. to 4:30 p.m. everyday and will feature lectures from doctors, health care researchers and patients, such as talk show-host and medical marijuana advocate Montel Williams.

    Allan Byrne, co-founder of the nonprofit organization Patients Out of Time, said the main goal of the event is to educate health care professionals on the medical benefits of cannabis and lend scientific validity to the use of medical marijuana.

    Byrne said Patients Out of Time, the organization coordinating the conference, advocates the legalization of medical marijuana in order to help the terminally ill patients who need it.

    "These patients aren't hippies; they could be your uncle or dad," Byrne said. "They use marijuana medically because they need it. They're not using it recreationally just to get stoned."

    The conference opened yesterday with a kickoff dinner hosted by UCSB's chapter of the National Organization for the Reform of Marijuana Laws at Fess Parker's DoubleTree Resort and Hotel. During the 7:30 p.m. dinner, NORML gave an award to Dr. Todd Mikuriya for his work advocating for the legalization of medical marijuana.

    This weekend, the conference will feature nine guest speakers from seven countries where research on marijuana is being conducted, Byrne said.

    "We're having lectures from doctors from Israel, the Netherlands, Spain, Canada, the UK - anywhere you can think of," Byrne said. "The United States is so woefully behind the curve in research that we need to look internationally for education."

    Rick Doblin, Founder of the Florida-based Multidisciplinary Association of Psychedelic Studies, will speak at the conference as well. Doblin said he will discuss the government's monopoly on the production of marijuana for research. He said he was unable to receive marijuana for his research, even after the Food and Drug Administration approved his proposed studies.

    "We're probably the only people in America that can't buy 10 grams," Doblin said. "Scientists can obtain LSD and MDMA for research, but we can't get any marijuana."

    Byrne said the conference will link anecdotal evidence from patients such as Williams with scientific research to show that marijuana serves a valid, medicinal purpose.

    "We're accredited and blessed by the American Medical Association, [so] how could [marijuana] not be a medicine?" Byrne said.

    Registration information and a schedule of lectures and events for the conference is available at www.medicalcannabis.com/conference.

    Ninth Circuit Asks Probing Questions at Raich Hearing

    By Dale Gieringer
    Cal NORML

    PASADENA, Mar. 27th - A Ninth Circuit panel asked probing questions about Angel Raich's appeal for a federal injunction to protect her use of medical marijuana. Her attorney, Prof. Randy Barnett, emphasized that the case was about Angel's "fundamental right to life," since the uncontested record showed that she suffered severe, life-threatening medical problems that had proven intractable to all other treatments except marijuana. Barnett argued that her right to use marijuana was accordingly constitutionally protected under the 5th & 9th amendments, as well as by the common law doctrine of medical necessity.

    Justice Arlen Beam, who had been in the minority of the panel's prior 2-1 ruling for Raich, which was subsequently overturned by the Supreme Court, immediately posed a critical question about Raich's standing in the case, namely whether she had ever been prosecuted or threatened with prosecution. He noted that Diane Monson, who had been a co-defendant in the first case and who had in fact been raided by the DEA, was no longer in the case; and that in any event she had never been prosecuted, but had only had her medicine seized. Justices Paez & Pregerson chimed in, asking if other patients had been prosecuted for possession of medical marijuana. Barnett hemmed and hawed, saying that he couldn't name any other patients who had been prosecuted, but would provide a list. (The California NORML website lists dozens of federal 215 prosecutions http://www.canorml.org/news/fedmmjcases.html , but virtually all of them involve manufacture for others, not simple possession).

    Beam went on to note that amicus briefs from MPP and MAPS indicated there was a need for more research on medical marijuana, implying that there existed substantial disagreement about marijuana's medical benefits, and thus undercutting Raich's claim.

    Pregerson questioned whether Angel's claim of a medical necessity defense was applicable in the absence of a criminal prosecution. He expressed concern that the court's prior OCBC decision had precluded a necessity defense for medical marijuana. Barnett replied that the OCBC decision was applicable only to third-party providers, and that the court's justices had been split on whether it applied to individual patients.

    Barnett pointed out that his client's essential claim involved the right to life, not medical necessity. Justice Beam suggested that Raich's claim was precluded by previous decisions where the courts had ruled that patients did not have a right to the (quack) anti-cancer drug laetrile. Barnett replied that the right to life had never been explicitly raised in the laetrile cases.

    US Attorney Mark Quinlivan argued that Raich's claim to a fundamental right to life was derived from decisions protecting a woman's right to abortion and were thus inapplicable to drugs. He stressed that the 9th Circuit's Carnohan decision regarding laetrile ruled out any right for patients to use government-unapproved drugs.

    Pregerson questioned this logic: supposing that a patient faced unbearable suffering that could only be relieved by a pill that was on the government's black list, would not that patient have a right to use the drug?

    Quinlivan hemmed and hawed, finally saying that it would be up to Congress' determination, and that in this case Congress had determined that marijuana was not allowable.

    Quinlivan went on to claim erroneously that government regulation of marijuana dated back to the Harrison Act of 1914 (in fact, marijuana was first regulated by the Marihuana Tax Act of 1937). Pregerson noted that medical use of marijuana had been legal up until passage of the Controlled Substances Act of 1970. He joked that he had gone to high school in East LA at a time when marijuana use wasn't illegal, and "as a consequence of that, no one ever used it."

    Quinlvian said there was no long-standing tradition of using drugs, but Pregerson pointed out that laudanum had been used for "years and years" in the days of Sherlock Holmes and Queen Victoria. Quinlivan had never heard of laudanum (an opium tincture that was a popular household analgesic), and professed not to know about the history of drugs.

    Quinlivan warned that if Raich prevailed, much of the New Deal legislation would have to be thrown out. "That won't happen," scoffed Pregerson.

    Paez asked if it was possible that Raich would be prosecuted. Qunlivan replied that it would be "incredibly unlikely," since the DEA was interested in large scale manufacture. However, he refused to offer any guarantees of amnesty, especially if patients flaunted their use in public.

    Beam ventured that Angel would have a winning case IF she were in a criminal prosecution and presented a medical necessity defense to a jury. "I'd be amazed if the Supreme Court didn't think the evidence would carry the day," he said, "The problem is, we don't have standing in my view on this particular question."

    In a closing response, Barnett was asked how, if the court ruled for Raich, the use of marijuana could be properly restricted. Barnett emphasized that his client was fully willing to concede extensive government regulation, including possible medical interviews to determine whether marijuana was really necessary, and whether the patient had tried other alternative treatments. He proposed that patients could present evidence at a civil trial, or alternatively, that the government set up a new regulatory system or reclassify marijuana in schedule 2.

    The hearing closed with no easy answers from either side. However the court decides, further litigation is certain.

    Medical Marijuana Research Update: March 2006

    Lawyers from both sides of the case have filed motions to extend the deadline to April 27 for the submission of final legal briefs in Prof. Lyle Craker's MAPS-supported lawsuit against the DEA for obstructing a MAPS-sponsored medical marijuana production facility. DEA Administrative Law Judge Mary Ellen Bittner is now expected to make a decision three to six months after the briefs have been submitted.

    Medical Marijuana Research Update: January 2006

    Our lawyers learned today that DEA has decided not to hold the final hearing that had been scheduled for January 17, solely in order to cross-examine under oath our rebuttal witness, Al Byrne. Perhaps DEA lawyers read my commentary posted on the MAPS website on December 20, 2005, in which I suggested that it would be wise for them not to call Al as a witness since he would have persuasively testified to the low quality of NIDA marijuana and to the veracity of the picture of the seeds and stems in three NIDA marijuana cigarettes that Prof. ElSohly had foolishly challenged as being somehow not accurate. Probably, DEA lawyers were just trying to intimidate Al into withdrawing his affidavit in order to avoid having to testify under oath inside DEA headquarters. When that failed, they decided to cancel the hearings regardless of my suggestions, which they haven't taken in other instances anyway. In any case, there will now be no more courtroom drama, only dueling legal briefs. At this point, I guess that the final briefs will be due in several months and that DEA Administrative Law Judge Mary Ellen Bittner will issue her recommendation to DEA Administrator Karen Tandy in late Spring or early Summer 2006.

    The New York Daily News Washington Bureau: City Pols Vs. Feds Over Medical Pot

    The New York Daily News Washington Bureau published a succint and informative article about the DEA Lawsuit.

    WASHINGTON - An unusual alliance that includes liberal New York congressmen and one of President Bush's most powerful conservative advisers is trying to bust a government monopoly on growing marijuana for research.

    Several medical groups, the United Methodist Church and 38 members of Congress, including Manhattan Democrats Jerrold Nadler and Carolyn Maloney, are backing activist Rick Doblin's call for the feds to allow privately funded scientists to test medical marijuana.

    Doblin argues that the sole lab growing weed for government research at the University of Mississippi is not looking into different strains and different potencies. And he's received important backing from Grover Norquist, the president of Americans for Tax Reform and a National Rifle Association board member, who is also urging licensing of the first privately funded program.

    "The bipartisan support is important," said Doblin, head of the Multidisciplinary Association for Psychedelic Studies.

    But it may not be enough for the Drug Enforcement Administration, which contends the Mississippi lab can provide enough weed to researchers studying the healing capacity of medical marijuana for people with AIDS, glaucoma and other ailments. The lawyers also question whether privately funded labs will keep the pot from the streets.

    Doblin is teaming with botanist Lyle Craker, a University of Massachusetts plant scientist with no history of involvement in the legalization movement. Craker argued at DEA hearings earlier this month that his project would provide researchers with multiple strains of marijuana with varying potency levels.

    The DEA will decide in the next several months whether to grant a license to grow research pot.

    DEA Hearing Report by Rick Doblin, Ph.D., MAPS

     

    I'm back home after a week in DC for the DEA hearings. Our lawyers and I are convinced that the DEA witnesses ended up helping our case substantially more than the DEA's case. The hearings are now almost all over except for one additional witness who is scheduled to testify on January 17. The story of this final witness will help explain the DEA's self-destructing case (though whether the DEA Administrative Law Judge Mary Ellen Bittner will recommend that Prof. Craker receive his license is too difficult to predict).

    The DEA called Mahmoud ElSohly, NIDA's grower at UMiss, as a witness on both Monday and Tuesday. He claimed that he could provide marijuana of any potency and CBD content and thus no alternative source of supply was needed. At one point, he was looking at a document that contained information on the marijuana in NIDA's inventory. We managed to ask to see it and then get it introduced into evidence. There is nothing in the inventory with a CBD content more than about half of what the Dutch government is offering, and only small amounts of high-THC content marijuana, which have even lower amounts of CBD. There is nothing comparable to a strain offered by the Dutch government, containing 18% THC and 0.8% CBD.

    ElSohly consistently defended the quality of NIDA's marijuana. He was quite sensitive about the quality of his product and explained proudly about the new equipment that can take the seeds and the stems out of NIDA's marijuana cigarettes. One of his mistakes was to get defensive about the picture of the seeds and stems from 3 of NIDA's cigarettes that was published in Dr. Ethan Russo's article about the study of the Compassionate Use patients. He got so defensive that he ended up stating that the picture couldn't have been from NIDA's cigarettes but could have been from the raw material, prior to the seeds and stems being taken out. He even said that the seeds looked larger than they should have compared to the size of the stems and came as close as you could to claiming the photo was fraudulently doctored without actually saying the word fraud.

    After ElSohly's testimony, I contacted Al Byrne, who was in the room when the picture was taken, and ask Al if he would testify. After ACLU lawyer Allen Hopper had a conversation with Al's lawyer, Al agreed to submit a signed affidavit that we tried to introduce into evidence on Friday. The affidavit was submitted to DEA lawyer Brian Bayly and the Judge. The Judge then asked Mr. Bayly whether he had any objections to introducing the affidavit as rebuttal evidence. At this point, one of the most telling moments in the entire hearing took place, the classic pregnant pause. Mr. Bayly was silent and stared at the letter for an extended period of time. Nobody in the courtroom said a word for more than a minute, a long, slow period of time. We could tell that Mr. Bayly was struggling to figure out how to object to this affidavit, and was perhaps also cursing ElSohly for making such foolish and unnecessary statements. He remained still for so long that Judge Bittner felt it necessary to speak again, asking him once more if he had any objections. He then shook off his paralysis and went over the letter paragraph for paragraph, line for line, trying to exclude whatever background information that wasn't directly about the photograph itself. Our attorney, Julie Carpenter, did a great job of arguing that the background information was helpful to provide context. The Judge then ruled to admit the letter in its entirety! We now have ElSohly claiming that NIDA marijuana can't possibly be as bad as it really is, and we have photos and witnesses to prove that it is indeed that bad.

    Then, in what seems like an example of pulling an even greater defeat out of the jaws of a significant defeat, Mr. Bayly said that he wanted to cross-examine Al Byrne! All the other testimony is over, but the Judge was compelled to schedule another hearing date on January 17 just to bring in Al to be placed under oath on the witness stand. Al is eager to have his day in court in order to be able to tell the Judge all he knows about the low quality of NIDA's pot. What I think Bayly was hoping is that Al wouldn't want to be called to testify, and we'd withdraw the affidavit. Once Bayly learns that Al can't be intimidated into withdrawing his testimony, we suspect that Bayly will decide to cancel his testimony.

    ElSohly also was forced to explain his personal commercial interests in marijuana-based products, such as his THC suppository and his new DEA license permitting him to grow marijuana to extract THC for sale to the pharmaceutical company, Mallincrodt, to manufacture generic Marinol, which is now off-patent. We established that ElSohly has a major conflict of interest if he were to be the sole supplier of marijuana to MAPS for prescription use, if such use were permitted by FDA.

    ElSohly also claimed that if marijuana were to be approved by FDA using marijuana provided by NIDA, that we would have no trouble just switching to another product with similar THC levels. Testimony on Friday by DEA's expert on pharmaceutical drug development blew this apart, as I'll explain below.

    In the DEA hearing on Wednesday, we got several very important admissions out of Steve Gust, Assistant Director of NIDA. First off, he said that the PHS/NIDA review of protocols, after FDA review, takes between 3-6 months. This is incredibly damning since time delays in pharmaceutical drug development are very expensive and substantially impede the process. Alternatively, FDA has just 30 days to respond to protocol submissions. Then Steve Gust said that there is no formal appeal process but that if an appeal is made, it might take another 3-6 months! He couldn't explain why the PHS/NIDA review of Chemic's vaporizer protocol and request for 10 grams took more than two years. Furthermore, he admitted that unlike normal peer-review processes, the PHS/NIDA peer review process is composed entirely of government employees, with no outside experts. He also claimed that there were FDA staff on the Chemic review committee but couldn't name anyone from FDA and had to back off that claim. He then said there is no clear way to obtain a list of the reviewers. These sorts of delays, on top of the arbitrary nature of the review process, are more than enough to persuade any funders of marijuana research that it isn't worth investing millions of dollars in a serious drug development effort. The problems with the NIDA review process provide a strong argument for the research-restricting nature of NIDA's monopoly on the supply of marijuana legal for FDA-approved research.

    Steve Gust said that the purpose of NIDA's review was to make sure that the protocols were scientifically meritorious, and that FDA just reviewed for safety. Unfortunately for him, the official HHS statement of policy about the provision of marijuana to privately-funded studies says in no uncertain terms that FDA reviews Phase I studies primarily for safety but reviews Phase II and Phase III protocols for scientific merit! We directed Steve Gust to that portion of the guidelines and got him to admit, reluctantly, that FDA doesn't just review for safety but also for scientific merit. He wouldn't say it but this makes the NIDA review clearly duplicative and unnecessary.

    We also got Gust to acknowledge that the priorities of the HHS guidelines for providing marijuana to researchers are clearly skewed away from research aimed at developing marijuana into a medicine in its plant form, with the guidelines even using the word "must" be aimed at developing marijuana extracts. He tried to dodge saying that it wouldn't make any difference to NIDA if protocols were aimed at developing the marijuana plant itself into a prescription medicine, but he couldn't explain away the clear language of the guidelines.

    Also on Wednesday, we were able to enter into the official exhibits the updated Congressional sign-on letter to DEA urging approval of Prof. Craker's license, which 38 Reps. have now signed. In order to try to minimize and discredit it, DEA attorney Brian Bayly remarked first off that if we got another several hundred or so, the hearings wouldn't be necessary. Then he said that all the signatories were probably Democrats, as if their support didn't indicate a significant public interest in ending NIDA's monopoly on supply but were only indicative of partisan sniping. We replied that we had two Republicans and also a letter of support from Grover Norquist.

    Thursday, the DEA had no witnesses and there were no hearings

    Friday, the first DEA witness was Dr. Eric Voth, prominent and long-time prohibitionist. Even though he was supposed to talk about the risks of diversion, and not directly about the risks and/or benefits of marijuana, he couldn't help but talk about the risks of marijuana and compared marijuana smoke to tobacco smoke. That gave us an opportunity to get something into evidence that we'd been looking to do ever since my testimony in August, when I'd failed to find a way to mention Dr. Donald Tashkin's new study showing that marijuana wasn't linked to lung cancer, and actually had a slight protective effect. We asked Dr.Voth about the comparison he made between marijuana and tobacco smoke and he discussed Tashkin's results in a rather accurate manner, getting on the record that there is no scientific evidence linking marijuana to lung cancer! We also got him to admit that the cannabinoids have anti-tumor properties while nicotine does not.

    Voth then made claims about the dangers of high-potency marijuana and stated that there was no evidence that people self-titrated high-potency marijuana in a way that enabled them to inhale less smoke. He made other claims about the addictive nature of marijuana, the link to mental illness, etc. This enabled us to ask that a chapter from Lester Grinspoon's Marijuana-The Forbidden Medicine, "Measuring the Risks," be entered into evidence as rebuttal, even though the DEA had previously requested, and the Judge had agreed, to block us from entering Lester's book since the risks and benefits of marijuana wasn't at issue in this case. The Judge now agreed to let us provide this information as rebuttal evidence, and Lester's excellent chapter is now officially in evidence in this case, contradicting Voth's testimony in numerous ways.

    Voth's main point was that marijuana has so many ingredients that it can't possibly be made into a medicine. He testified that it was extremely difficult to standardize marijuana since different plant strains could be so different from each other, implying that blocking us from doing marijuana research doesn't matter since there is no way that the FDA would accept the marijuana plant as a prescription medicine. This is the sort of argument that was more persuasive up until about 10 years ago, before the FDA developed guidelines for the investigation of botanical medicines.

    Later in the day, over strenuous DEA objections, we were able to enter into evidence FDA statements saying that FDA welcomes research protocols aimed at evaluating whether the marijuana plant is safe and efficacious and deserved to be available as a legal prescription drug. Once again, FDA's willingness to place science over politics was of major assistance to our efforts.

    DEA's final witness, Dr. Auslander, was an expert in pharmaceutical drug development. His entire testimony ended up substantially helping our case. He started by reinforcing the view expressed by Dr.Voth that it was extremely difficult to standardize a plant and that different strains might look similar but had significantly different "fingerprints" of the chemical composition. He admitted that cloned plants had identical genetic fingerprints. Most importantly, at the end of his testimony, we asked him if the difference in fingerprints of different strains was something that FDA would be concerned about. He said yes, definitely. We then asked him if it would be problematic for a pharmaceutical company if it did research with one strain of a plant, got FDA approval to market it, but then tried to market a different strain with a different fingerprint. He said this would matter quite a bit to FDA and could require replication of some clinical studies which are very expensive. What he didn't realize was that this is the exact opposite of what ElSohly testified to, saying we could conduct research with NIDA marijuana and then just switch to another plant strain if we didn't want to get marijuana for prescription use from him, of the same strain he grew for NIDA. ElSohly was not presented to the Court as an expert in pharmaceutical drug development, but Dr. Auslander was. His testimony therefore is more important on these points. Dr. Auslander thus supported one of our main points, that conducting research with NIDA marijuana from ElSohly isn't reasonable since NIDA's mission doesn't include providing marijuana for prescription sales, just research. Therefore, if we use NIDA marijuana in research and prescription use is approved, we either have to obtain the same strain from ElSohly, who has major conflicts of interest since he has other products for which smoked or vaporized marijuana would compete plus since he would lack competition could charge anything he wanted, or we could try to obtain FDA approval to market a different strain from a new manufacturer. However, switching to a new manufacturer would present new difficulties due to the different fingerprints of the different strains, even if we matched THC levels (though in our opinion we should also have to match CBD levels since this is a pharmacologically active cannabinoid). In any case, there is no alternative supplier with a DEA license and starting a new facility would take a substantial amount of time, easily a year or more, with these time lags being very costly after investing millions in research. In response to our final questions, Dr. Auslander testified very helpfully that pharmaceutical companies would want to be assured of a reliable and consistent supply of a drug that could be used in research and also be available for prescription sales. This is what we have been saying all along and is something that isn't guaranteed as long as NIDA retains its monopoly.

    We ended the week thankful for DEA's witnesses, eagerly looking forward to the final testimony on January 17, though we would not be surprised if DEA decides to cancel the cross-examination of Al Byrne.

    The Daily Journal: Ole Miss Marijuana Monopoly Under Fire

    Originally appearing here.

    The Daily Journal published Ole Miss marijuana monopoly under fire, reporting on the University of Mississippi's insistence that their marijuana is of an acceptable grade.

    12/17/2005
    Daily Journal
    By Andy Kanengiser

    OXFORD - University of Mississippi leaders are battling a legal challenge that threatens to end the school's legal monopoly to grow marijuana for research purposes.

    "We will not give up without a fight," said Andy Mullins, executive assistant to Ole Miss Chancellor Robert Khayat. Critics of the Ole Miss research are just trying to get the federal contract, he said Friday.

    For 36 years, Ole Miss has been the only school nationwide with the federal government's OK to manufacture marijuana under the supervision of the National Institute on Drug Abuse.

    But the Washington Post reported this week that some researchers are complaining about the quality of the Ole Miss-produced pot. They want a federal judge to allow others to legally produce pot for research.

    During a hearing this week, DEA attorneys defended the marijuana at Ole Miss. Research professor Mahamoud ElSohly, who runs the program, said the marijuana inventory is more than adequate.

    A decision on the case before Drug Enforcement Administration Law Judge Mary Ellen Bittner is months away.

    Professor: End the monopoly

    University of Massachusetts professor Lyle Cracker is part of the group asking the judge to stop the federal government's marijuana monopoly.

    "The government's marijuana just isn't strong enough," said Richard Doblin, a Cracker supporter who directs the Massachusetts-based Multidisciplinary Association for Psychedelic Studies.

    Mullins said the accusations of low-quality marijuana at Ole Miss simply are unfounded.

    "We know it is not the case and the federal government knows it is not the case," he said. "The government is arguing to keep it here.

    "We feel like we are doing an excellent job and have a long history of doing an excellent job," Mullins said when reached by phone at his Oxford office.

    The marijuana research program is a key component of the Ole Miss School of Pharmacy. Ole Miss grows the pot on a field west of the main campus. The university uses dedicated scientists with a worldwide reputation, he said.

    Retired Ole Miss history professor David Sansing said the Oxford-based university has studied the pharmacology of plants for decades before it was awarded the first marijuana contract about 1970. "Our pharmacy school has always been recognized as a first-rate school," he said.

    It also didn't hurt Ole Miss that the late 1st District U.S. Rep. Jamie Whitten was chairman of the powerful House Appropriations Committee when federal government grants for research programs were doled out. In the 1970s Whitten "was at the apex of his power at that time," Sansing said.

    Join Together: Researchers Seek New Source of Marijuana

    Join Together
    12/15/2005

    Saying the research-grade marijuana grown by the federal government is low-quality, researchers are asking a federal judge to allow others to legally produce pot for scientific studies, the Washington Post reported Dec. 12.

    For the last 36 years, the University of Mississippi has had sole federal authority to grow marijuana for research. But scientists have long complained about the poor quality of marijuana produced by the school under the supervision of the National Institute on Drug Abuse (NIDA).

    University of Massachusetts at Amherst professor Lyle Craker is part of a group that has asked an administrative-law judge to break the government's marijuana monopoly; Craker has volunteered to grow his own marijuana for research if the Drug Enforcement Administration (DEA) would allow it.

    "Our work is focused on finding medicinal uses of plants, and marijuana is one with clear potential," said Craker. "There's only one government-approved source of marijuana for scientific research in this country, and that just isn't adequate."

    The DEA and NIDA oppose granting a license to anyone else to grow marijuana, saying it could lead to more drug use. The agencies also contend that the Mississippi program already supplies all the marijuana needed by researchers.

    "By controlling who can research marijuana and how they can do it, the DEA has greatly limited promising research that could lead to [government] approved medications," said researcher Richard Doblin, president of the Multidisciplinary Association for Psychedelic Studies, who led the effort to challenge the policy in court. "I believe the DEA policy is one of delay, and they've succeeded in essentially blocking marijuana development for 30 years."

    Even if the judge agrees with Doblin and Craker, however, the DEA will not be forced to grant a license to grow marijuana or change its policies.

    Prof. Questions Govt Monopoly on Marijuana

    Prof. questions gov't monopoly on marijuana

    ANDREW MIGA
    Associated Press

    WASHINGTON - Put this in your pipe and smoke it: A University of Massachusetts professor says the medical marijuana grown by the federal government isn't very good. He wants a permit to cultivate his own pot, saying it will be better for research.

    Lyle Craker, a horticulturist who heads the school's medicinal plant program, is challenging the government's 36-year-old monopoly on research marijuana. Craker's suit claims government-grown marijuana lacks the potency medical researchers need to make important breakthroughs.

    "The government's marijuana just isn't strong enough," said Richard Doblin, a Craker supporter who heads the Massachusetts-based Multidisciplinary Association for Psychedelic Studies.

    A hearing before a federal administrative judge at the Drug Enforcement Administration got under way Monday and is expected to last all week.

    Craker's suit also alleges there isn't enough of the drug freely available for scientists across the country to work with.

    The DEA contends that permitting other marijuana growers would lead to greater illegal use of the drug. They have also said that international treaties limit the United States to one marijuana production facility.

    A lab at the University of Mississippi is the government's only marijuana growing facility.

    DEA attorneys defended the government's marijuana, contending its Mississippi growing center provides adequate quality and quantity for legitimate researchers across the country.

    "Whatever material is needed could be provided under (the) process that is already in place," said Mahmoud ElSohly, a research professor who runs the cultivation program at the school for government agencies, including a 1,200-square-foot "growing room."

    The government's official stockpile at the facility is about a metric ton, he estimated.

    "We have quite a bit of inventory," ElSohly said.

    Most of it is stored in bulk in barrels lined with federally approved plastic bags.

    The most powerful marijuana is stored in a walk-in freezer, part of the facility's storage vault, to maintain its potency.

    The National Institute on Drug Abuse oversees the Mississippi facility.

    Craker, who has been fighting the government for four years, did not attend the hearing. Doblin, whose group hopes to fund Craker's marijuana growing, said they have confidence in their case, which has the support of nearly 40 members of Congress, including Massachusetts Sens. John Kerry and Edward Kennedy.

    "How do you defend the government's case against the public interest that there needs to be more research?" said Doblin, whose group aims to expand medical research on psychedelic drugs, including so-called "Ecstasy" or MDMA. Doblin said he believes there is great promise in the use of "vaporized" marijuana as a health aid. There was a moment of levity in the DEA hearing room when ElSohly was explaining how the marijuana is sometimes rolled into cigarette form, asking the judge if she understood what he meant.

    "I have no idea," replied DEA Administrative Law Judge Mary Ellen Bittner with a smile.

    Both sides expect that a decision in the case is months away.

    Continue Reading

    The Associated Press: Prof. Questions Gov't Monopoly on Marijuana

    The Associated Press published Prof. questions gov't monopoly on marijuana, a positive article about the DEA Lawsuit.

    WASHINGTON - Put this in your pipe and smoke it: A University of Massachusetts professor says the medical marijuana grown by the federal government isn't very good. He wants a permit to cultivate his own pot, saying it will be better for research.

    Lyle Craker, a horticulturist who heads the school's medicinal plant program, is challenging the government's 36-year-old monopoly on research marijuana. Craker's suit claims government-grown marijuana lacks the potency medical researchers need to make important breakthroughs.

    "The government's marijuana just isn't strong enough," said Richard Doblin, a Craker supporter who heads the Massachusetts-based Multidisciplinary Association for Psychedelic Studies.

    A hearing before a federal administrative judge at the Drug Enforcement Administration got under way Monday and is expected to last all week.

    Craker's suit also alleges there isn't enough of the drug freely available for scientists across the country to work with.

    The DEA contends that permitting other marijuana growers would lead to greater illegal use of the drug. They have also said that international treaties limit the United States to one marijuana production facility.

    A lab at the University of Mississippi is the government's only marijuana growing facility.

    DEA attorneys defended the government's marijuana, contending its Mississippi growing center provides adequate quality and quantity for legitimate researchers across the country.

    "Whatever material is needed could be provided under (the) process that is already in place," said Mahmoud ElSohly, a research professor who runs the cultivation program at the school for government agencies, including a 1,200-square-foot "growing room."

    The government's official stockpile at the facility is about a metric ton, he estimated.

    "We have quite a bit of inventory," ElSohly said.

    Most of it is stored in bulk in barrels lined with federally approved plastic bags.

    The most powerful marijuana is stored in a walk-in freezer, part of the facility's storage vault, to maintain its potency.

    The National Institute on Drug Abuse oversees the Mississippi facility.

    Craker, who has been fighting the government for four years, did not attend the hearing. Doblin, whose group hopes to fund Craker's marijuana growing, said they have confidence in their case, which has the support of nearly 40 members of Congress, including Massachusetts Sens. John Kerry and Edward Kennedy.

    "How do you defend the government's case against the public interest that there needs to be more research?" said Doblin, whose group aims to expand medical research on psychedelic drugs, including so-called "Ecstasy" or MDMA. Doblin said he believes there is great promise in the use of "vaporized" marijuana as a health aid. There was a moment of levity in the DEA hearing room when ElSohly was explaining how the marijuana is sometimes rolled into cigarette form, asking the judge if she understood what he meant.

    "I have no idea," replied DEA Administrative Law Judge Mary Ellen Bittner with a smile.

    Both sides expect that a decision in the case is months away.

    Governments Medical Pot Just Isnt Strong Enough Professor Sues For Permit To Grow Marijuana

    The West Palm Beach Florida News published Government's Medical Pot 'Just Isn't Strong Enough'.

    WPBFNews.com (West Palm Beach Florida)
    Professor Sues For Permit To Grow Marijuana For Research

    December 13, 2005

    WASHINGTON -- A University of Massachusetts professor said he'd do a better job than the government growing medical marijuana.

    Lyle Craker said government-grown marijuana isn't very good. He's suing for a permit to grow.

    The horticulturalist heads the school's medicinal plant program. He said government marijuana isn't potent enough for research.

    The head of a group calling itself the Multidisciplinary Association for Psychedelic Studies backs Craker and said the government's product "just isn't strong enough."

    A hearing before a federal administrative judge at the Drug Enforcement Administration is due to last all week. The DEA said giving more people permission to grow would increase illegal use of the drug.

    A lab at the University of Mississippi is the government's only marijuana growing facility. A research professor who runs that program said there's "quite a bit of inventory."

    Authorities Raid 13 San Diego-Area Marijuana Dispensaries

    Drug agents have raided 13 San Diego-area medical marijuana dispensaries in one of the largest such actions seen in the state.

    The DEA contends the centers were "nothing more than a front for distributing marijuana."

    The DEA said it began an investigation six months ago, partly due to neighbors' complaints that marijuana was being sold to young adults who walked out smoking joints.

    The group Americans for Safe Access said the raids are federal government harassment because dispensaries are legal under California law, but not U.S. law.

    Executive Director Steph Sherer said the DEA should resolve the dispute in court, not through raids. She accused the agents of seizing patient records.

    Sherer said patients were detained for awhile, but no one was arrested.

    Copyright 2005 by The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

    The Washington Post publishes an article about the DEA Lawsuit

     


    Lyle Craker from the University of Massachusetts at Amherst would like to grow marijuana for pharmaceutical research. He is challenging the government's control of the substance. (By Bob Stern -- (Springfield, Mass.) Republican)
    Federal Marijuana Monopoly Challenged
    Researchers Want to Grow More Plants and Find More Medicinal Uses

    By Marc Kaufman
    Washington Post Staff Writer
    Monday, December 12, 2005; A02

    For decades, the federal government has been the nation's only legal producer of marijuana for medical research. Working with growers at the University of Mississippi, the National Institute on Drug Abuse has controlled both the quality and distribution of the drug for the past 36 years.

    But for the first time the government's monopoly on research marijuana is under serious legal challenge. The effort is being spearheaded by a group that wants to produce medicines from currently illegal psychedelic drugs and by a professor at the University of Massachusetts who has agreed to grow marijuana for the group if the government lets him.

    In a hearing due to start today before an administrative law judge at the Drug Enforcement Administration, professor Lyle Craker and his supporters will argue for a DEA license to grow the research drugs. It is the climax of a decades-long effort to expand research into marijuana and controlled drugs and of Craker's almost five-year effort to become a competing marijuana grower.

    "Our work is focused on finding medicinal uses of plants, and marijuana is one with clear potential," said Craker, director of the medicinal plant program of the university's Department of Plant, Soil and Insect Sciences in Amherst, Mass., and editor of the Journal of Herbs, Spices and Medicinal Plants. "There's only one government-approved source of marijuana for scientific research in this country, and that just isn't adequate."

    The DEA, which has to license anyone who wants to grow marijuana, disagrees.

    The agency, as well as the National Institute on Drug Abuse, which formally runs the marijuana research program, argues that it is not in the public interest to have more than one source of marijuana, in part because it could lead to greater illicit use. What's more, they said in legal briefs, the Mississippi program supplies all the marijuana that researchers need. Agency officials declined to comment further.

    In his suit against the DEA for a license to grow marijuana, Craker has backing from 38 members of Congress, the two senators from Massachusetts, numerous medical societies and even Grover Norquist, the president of the conservative Americans for Tax Reform.

    The effort has been organized by Richard Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS) and a longtime advocate of medical research into controlled drugs. It was Doblin who recruited Craker after the association concluded it would never get a dependable supply of government marijuana.

    "Dr. Craker has no goal here except to advance scientific research into marijuana, and our goals are the same," said Doblin, whose group is also sponsoring research into other controlled drugs, including MDMA (better known as "ecstasy") and the psychedelic mushroom psilocybin.

    "By controlling who can research marijuana and how they can do it, the DEA has greatly limited promising research that could lead to [government] approved medications," Doblin said.

    The problems, he said, are not limited to winning approval to buy the Mississippi marijuana. Doblin and other researchers contend that the government marijuana is low in quality and potency and could never be a stable source of basic ingredients if the Food and Drug Administration ever did approve a marijuana-based medication.

    Marijuana, or cannabis, is now listed as a Schedule I drug -- with no medicinal use -- under the Controlled Substances Act. Its use was initially restricted in 1937 and eliminated from medicinal practice in 1942. On its Web site, the DEA lists marijuana as the most frequently abused illicit drug in America.

    Since the 1970s, however, researchers have found potential uses for marijuana, or its active ingredient THC, in relieving nausea and vomiting associated with chemotherapy and to help with appetite loss in AIDS patients. A synthetic form of marijuana's active ingredient has been made into a prescription drug, Marinol.

    Doblin said there are potentially many other medicinal uses of marijuana, including the treatment of multiple sclerosis and AIDS-related neuropathy. He also said researchers believe that if they can perfect a method of "vaporizing" marijuana -- allowing it to be inhaled rather than smoked -- it would be easier to administer as medicine.

    But because of fears of illicit use, he said, the agency has essentially blocked the research. "I believe the DEA policy is one of delay, and they've succeeded in essentially blocking marijuana development for 30 years," Doblin said.

    In its filings with Administrative Law Judge Mary Ellen Bittner, the DEA disputes the charge that it is standing in the way of marijuana research.

    It says that medical marijuana research is underway in California using its Mississippi supply, and that the drugmaker Mallinckrodt Inc. has a contract with the Mississippi supplier to produce extracts of cannabis for its drug development program. In addition, DEA lawyer Brian Bayly told the law judge in August, when the first five days of testimony were heard, that the quality and potency of the government's marijuana was acceptable to the researchers his agency surveyed.

    The hearing is expected to continue through the week, with a decision several months later. If Craker and his team prevail, however, the DEA is not obliged to give him a license or change its policies. And as a result, Craker and his team plan to continue lining up political support, such as the Nov. 22 letter sent by Norquist to the DEA.

    "The use of controlled substances for legitimate research purposes is well-established, and has yielded a number of miracle medicines widely available to patients and doctors," Norquist wrote. "This case should be no different. It's in the public interest to end the government monopoly on marijuana legal for research."

    Federal Marijuana Monopoly Challenged



    Lyle Craker from the University of Massachusetts at Amherst would like to grow marijuana for pharmaceutical research. He is challenging the government's control of the substance. (By Bob Stern -- (Springfield, Mass.) Republican)
    Federal Marijuana Monopoly Challenged
    Researchers Want to Grow More Plants and Find More Medicinal Uses

    By Marc Kaufman
    Washington Post Staff Writer
    Monday, December 12, 2005; A02

    For decades, the federal government has been the nation's only legal producer of marijuana for medical research. Working with growers at the University of Mississippi, the National Institute on Drug Abuse has controlled both the quality and distribution of the drug for the past 36 years.

    But for the first time the government's monopoly on research marijuana is under serious legal challenge. The effort is being spearheaded by a group that wants to produce medicines from currently illegal psychedelic drugs and by a professor at the University of Massachusetts who has agreed to grow marijuana for the group if the government lets him.

    In a hearing due to start today before an administrative law judge at the Drug Enforcement Administration, professor Lyle Craker and his supporters will argue for a DEA license to grow the research drugs. It is the climax of a decades-long effort to expand research into marijuana and controlled drugs and of Craker's almost five-year effort to become a competing marijuana grower.

    "Our work is focused on finding medicinal uses of plants, and marijuana is one with clear potential," said Craker, director of the medicinal plant program of the university's Department of Plant, Soil and Insect Sciences in Amherst, Mass., and editor of the Journal of Herbs, Spices and Medicinal Plants. "There's only one government-approved source of marijuana for scientific research in this country, and that just isn't adequate."

    The DEA, which has to license anyone who wants to grow marijuana, disagrees.

    The agency, as well as the National Institute on Drug Abuse, which formally runs the marijuana research program, argues that it is not in the public interest to have more than one source of marijuana, in part because it could lead to greater illicit use. What's more, they said in legal briefs, the Mississippi program supplies all the marijuana that researchers need. Agency officials declined to comment further.

    In his suit against the DEA for a license to grow marijuana, Craker has backing from 38 members of Congress, the two senators from Massachusetts, numerous medical societies and even Grover Norquist, the president of the conservative Americans for Tax Reform.

    The effort has been organized by Richard Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS) and a longtime advocate of medical research into controlled drugs. It was Doblin who recruited Craker after the association concluded it would never get a dependable supply of government marijuana.

    "Dr. Craker has no goal here except to advance scientific research into marijuana, and our goals are the same," said Doblin, whose group is also sponsoring research into other controlled drugs, including MDMA (better known as "ecstasy") and the psychedelic mushroom psilocybin.

    "By controlling who can research marijuana and how they can do it, the DEA has greatly limited promising research that could lead to [government] approved medications," Doblin said.

    The problems, he said, are not limited to winning approval to buy the Mississippi marijuana. Doblin and other researchers contend that the government marijuana is low in quality and potency and could never be a stable source of basic ingredients if the Food and Drug Administration ever did approve a marijuana-based medication.

    Marijuana, or cannabis, is now listed as a Schedule I drug -- with no medicinal use -- under the Controlled Substances Act. Its use was initially restricted in 1937 and eliminated from medicinal practice in 1942. On its Web site, the DEA lists marijuana as the most frequently abused illicit drug in America.

    Since the 1970s, however, researchers have found potential uses for marijuana, or its active ingredient THC, in relieving nausea and vomiting associated with chemotherapy and to help with appetite loss in AIDS patients. A synthetic form of marijuana's active ingredient has been made into a prescription drug, Marinol.

    Doblin said there are potentially many other medicinal uses of marijuana, including the treatment of multiple sclerosis and AIDS-related neuropathy. He also said researchers believe that if they can perfect a method of "vaporizing" marijuana -- allowing it to be inhaled rather than smoked -- it would be easier to administer as medicine.

    But because of fears of illicit use, he said, the agency has essentially blocked the research. "I believe the DEA policy is one of delay, and they've succeeded in essentially blocking marijuana development for 30 years," Doblin said.

    In its filings with Administrative Law Judge Mary Ellen Bittner, the DEA disputes the charge that it is standing in the way of marijuana research.

    It says that medical marijuana research is underway in California using its Mississippi supply, and that the drugmaker Mallinckrodt Inc. has a contract with the Mississippi supplier to produce extracts of cannabis for its drug development program. In addition, DEA lawyer Brian Bayly told the law judge in August, when the first five days of testimony were heard, that the quality and potency of the government's marijuana was acceptable to the researchers his agency surveyed.

    The hearing is expected to continue through the week, with a decision several months later. If Craker and his team prevail, however, the DEA is not obliged to give him a license or change its policies. And as a result, Craker and his team plan to continue lining up political support, such as the Nov. 22 letter sent by Norquist to the DEA.

    "The use of controlled substances for legitimate research purposes is well-established, and has yielded a number of miracle medicines widely available to patients and doctors," Norquist wrote. "This case should be no different. It's in the public interest to end the government monopoly on marijuana legal for research."

    2005 The Washington Post Company

    Continue Reading

    DEA to Argue Against U. Mass Growing of Medicinal Cannabis at Administrative Hearing December 12-16

    A press release was issued today, "DEA to Argue Against U. Mass Growing of Medicinal Cannabis at Administrative Hearing December 12-16: Grover Norquist, Medical Groups and 35 Members of Congress Tell DEA They Support Expanded Research."

    ALEXANDRIA, VA Lawyers representing the Drug Enforcement Administration (DEA) will make oral arguments before DEA Administrative Law Judge Mary Ellen Bittner on December 12-16 to support a decision to deny Professor Lyle Craker a license to grow medicinal cannabis for research at the University of Massachusetts at Amherst, under contract to a non-profit organization. The hearings, which will last five days, will feature only DEA witnesses. Among them will be Dr. ElSohly of the University of Mississippi who is the only person in the U.S. with a license to grow marijuana for research. Dr. ElSohly is under contract to the National Institute on Drug Abuse (NIDA), which has been widely criticized for refusing to supply marijuana to some privately-funded research projects, and for the low quality and limited variety of the crop.

    While the legal battle has been fought for over four years, thirty-eight Members of Congress have recently signed a letter to the DEA urging the granting of Professor Crakers license. In the letter they wrote,

    At present, the National Institute on Drug Abuse (NIDA) has an unjustifiable monopoly on the production of marijuana for legitimate medical and research purposes in the United States , grown under contract to NIDA at the University of Mississippi. Federal law clearly requires adequate competition in the manufacture of Schedule I and II substances. (See 21 U.S.C. 823(a)(1); see also 21 C.F.R. 1301.33(b).) The licensing of Prof. Craker's facility would provide privately-funded sponsors of FDA-approved research the necessary opportunity to conduct studies with a strain of marijuana of their own choosing, with immediate access to the strain for all FDA-approved studies and for possible prescription use. None of this is the case under NIDA's monopoly. Until an alternative source of supply is available, important privately-funded research into the therapeutic effects of marijuana for patients undergoing chemotherapy or suffering from AIDS, glaucoma, multiple sclerosis, or other diseases will not be initiated.

    Other groups including Americans for Tax Reform, American Medical Students Association, California Medical Association, Lymphoma Foundation of America, New Mexico Nurses Association, North Carolina Nurses Association, United Methodist Church (with more than eight million members) and Wisconsin Nurses Association have written the DEA in support of Crakers license. Grover Norquist, President of Americans for Tax Reform wrote recently,

    Scientific research on agricultural products should not be influenced by politics. If the test subject in question were dandelions, there would be no controversy here. The fact that some choose to abuse the cannabis plant illegally is immaterial. The use of controlled substances for legitimate research purposes is well-established, and has yielded a number of miracle medicines widely available to patients and doctors. This case should be no different. Its in the public interest to end the government monopoly on marijuana legal for research.

    The case is heading into a final phase and a recommendation is expected to be made early next year on whether the DEA should have approved Professor Crakers application. More background on the case including transcripts from earlier hearings may be found here. The public may attend the hearing at the Judges discretion. To attend, call Nicole Stodutl at 202-307-8188 for security clearance.

    MAPS and MPP file an amicus curiae brief

     MAPS and MPP file an amicus curiae brief in the on-going Raich v. Gonzales case. On June 6, 2005, the US Supreme Court rejected the decision of the 9th Circuit Court of Appeals that there was no interstate commerce, and thus affirmed federal jurisdiction over state medical marijuana laws. However, a new lawsuit making other legal arguments has been filed. The amicus curiae brief describes the federal obstruction of MAPS’ efforts to conduct federally-approved medical marijuana research.

    MAPS and MPP File an Amicus Curiae Brief

    MAPS and MPP file an amicus curiae brief in the on-going Raich v. Gonzales case. On June 6, 2005, the US Supreme Court rejected the decision of the 9th Circuit Court of Appeals that there was no interstate commerce, and thus affirmed federal jurisdiction over state medical marijuana laws. However, a new lawsuit making other legal arguments has been filed. The amicus curiae brief describes the federal obstruction of MAPS' efforts to conduct federally-approved medical marijuana research.

    NORML.org: NIDA's Pot Monopoly To Resume Next Month

    NORML.org published NIDA's Pot Monopoly To Resume Next Month.

    Originally appearing here.

    NORML News
    November 29, 2005 - Washington, DC, USA

    Administrative hearings challenging the US National Institute on Drug Abuse's (NIDA) exclusive control of the production and distribution of cannabis for clinical research are scheduled to reconvene next month. The hearings, which began in August, were originally scheduled to resume in September, but were postponed at the request of attorneys for the Drug Enforcement Administration (DEA). The second round of hearings is now scheduled to take place the week of December 12, 2005.

    At issue in the case is whether the DEA improperly rejected an application from the University of Massachusetts at Amherst to manufacture cannabis for FDA-approved research. The DEA waited more than three years before officially denying the University's request, stating that the establishment of such a facility "would not be consistent with the public interest." Respondents in the case the Multidisciplinary Association for Psychedelic Studies (MAPS) and Lyle Craker, director of the UMass-Amherst Medicinal Plant Program are challenging the DEA's denial, arguing that a private production facility is in the public interest (as defined by the US Controlled Substances Act) because it would encourage competition in the marketplace and promote technological and scientific advancement in the field of medicine.

    "This lawsuit is really our last hope for trying to take marijuana - whether it's smoked or vaporized - through the FDA regulatory system," MAPS Executive Director Rick Doblin said.

    Earlier this week Grover Norquist, President of the conservative think-tank Americans for Tax Reform, sent a formal letter to DEA Administrator Karen Tandy urging the agency to allow for a private production facility for research-grade cannabis. "Scientific research on agricultural products should not be influenced by politics," states the letter.

    "If the test subject in question were dandelions, there would be no controversy here. The fact that some choose to abuse the cannabis plant illegally is immaterial. The use of controlled substances for legitimate research purposes is well established, and has yielded a number of miracle medicines widely available to patients and doctors. This case should be no different. It's in the public interest to end the government monopoly on marijuana legal for research."

    For more information, please contact either NORML Executive Director This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it., NORML Senior Policy Analyst, at: (202) 483-5500. Additional background regarding MAPS' administrative law challenge is available online at: https://maps.org

    Case for a Sign-on Letter

     

    GENERAL POLICY ISSUE: Should the controversy over the medical use of marijuana be resolved through FDA-approved scientific research or through legal and political struggles? Should the federal government facilitate or obstruct scientific research?

    SPECIFIC POLICY ISSUE: Is it in the public interest for DEA to license Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant, Soil and Insect Sciences, University of Massachusetts Amherst, to establish a privately-funded facility to produce marijuana exclusively for federally-approved and privately-funded research, or should the federal government, through the National Institute on Drug Abuse (NIDA), retain its unique monopoly on the supply of marijuana that can legally be used in research?

    CONTEXT: On June 6, 2005, the US Supreme Court ruled, in Gonzales v. Raich, that the federal government can arrest patients who use marijuana with their doctor’s recommendation even if it is legal under state law. On June 29, 2005, the US House of Representatives defeated the Hinchey Amendment, 161-264, which would have prohibited the use of federal funds for the prosecution of medical marijuana users in states that have passed laws allowing medical marijuana programs.

    Currently, the only process that could result in marijuana becoming legal as a medicine under federal law is for privately-funded sponsors to conduct scientific research with the aim of obtaining FDA approval for its use as a prescription medicine. Unfortunately, NIDA’s monopoly on the supply of legal marijuana is a fundamental obstruction to privately-funded research, none of which is currently taking place despite strong interest. The DEA wants to have it both ways, denying that marijuana is a medicine because the FDA has not approved it while simultaneously blocking research by refusing to allow the University of Massachusetts Amherst to manufacture marijuana for medical research.

    NIDA’s monopoly is against the public interest and may be contrary to federal law, which clearly requires adequate competition in the manufacture of Schedule I and II substances for research purposes. [See 21 U.S.C. § 823(a)(1); see also 21 C.F.R. § 1301.33(b).] Researchers have unobstructed access to other Schedule I and II drugs and marijuana should be no exception. Professor Craker is suing the DEA in a DEA Administrative Law Judge hearing, but the DEA can approve the project at any time.

    MONOPOLY PROBLEMS: NIDA’s monopoly results in arbitrary and lengthy delays or refusals in providing research material. Chemic Labs, a DEA-licensed analytical lab, was made to wait over two years for a reply to its request to purchase 10 grams for research into vaporizers, a non-smoking delivery system which the Institute of Medicine report recommended be developed. On July 27, 2005, NIDA refused to sell Chemic Labs the 10 grams, preventing the study from taking place. NIDA has also refused to provide marijuana to two FDA-approved protocols (Dr. Abrams, UC San Francisco, marijuana for AIDS wasting syndrome-IND #43-542; Dr. Russo, U. Montana, marijuana for migraines –IND #58,177). NIDA’s monopoly prevents sponsors from conducting research with the strain of marijuana they believe has the most potential. Furthermore, NIDA can legally provide marijuana for research but is not authorized to provide it for prescription use, should FDA approve such use. As a result, the strain of marijuana NIDA provides for research might not even be available for prescription use, an unacceptable uncertainty to sponsors.

    RECOMMENDATION: The FDA cannot consider approving marijuana for medical use until the federal government’s unique monopoly on the production of marijuana for medical research is broken. Members of Congress should sign onto a letter to DEA Administrator Karen Tandy urging the DEA to approve Professor Craker’s application in order to facilitate medical marijuana research.

    Background on the Craker Lawsuit

     

    The University of Massachusetts-Amherst (Dr.Lyle Craker, Director, Medicinal Plant Program, UMass Amherst Department of Plant and Soil Sciences) in association with Multidisciplinary Association for Psychedelic Studies (MAPS) is in the midst of the process of seeking DEA permission to establish a medical marijuana production facility to grow high-potency marijuana for FDA-approved research.

    At present, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can be used in research, seriously hindering medical marijuana research. NIDA provides inferior, low-potency marijuana to researchers whose protocols it approves and denies marijuana even to FDA-approved protocols it doesn't approve, preventing those studies from taking place.

    No privately-funded sponsor (such as MAPS or alternatively a for-profit pharmaceutical company) will invest significant sums in a realistic drug development research program aimed at obtaining FDA-approval for the prescription use of marijuana without first obtaining its own independent source of supply of a drug whose quality, price and availability it determines. There have been no US-based privately-funded marijuana production facilities since 1942, when marijuana was removed from the US Pharmacopoeia and its medical use was prohibited.

    Dr. Lyle Craker originally submitted the application for a license to DEA in June 2001. In December 2001, DEA claimed it was lost. Subsequently a photocopy was resubmitted but UMASS/MAPS were told in February 2002 that the photocopied application was invalid since it didn't have an original signature. In July 2002, the original application was returned, unprocessed, with a DEA date stamp showing it had been received in June 2001. Dr. Craker resubmitted the original application to DEA on August 20, 2002, which DEA finally acknowledged receiving.

    UMASS/MAPS worked with the Marijuana Policy Project on a Congressional sign-on letter to the DEA expressing support for the UMass Amherst license. The letter was submitted to DEA Administrator Asa Hutchinson on June 6, 2002 (attached).

    DEA Administrator Asa Hutchinson responded in a letter to Rep. Barney Frank on July 1, 2002 (attached). DEA questioned whether this new facility would be in the public interest, since NIDA currently grows marijuana for research. In response, MAPS drafted a document explaining why it would be in the public interest for DEA to grant a license for the UMass Amherst facility, and submitted the document to DEA, the Office of National Drug Control Policy (ONDCP) and NIDA.

    The DEA has also indicated that granting such a license might conflict with US international treaty obligations, specifically the Single Convention on Narcotic Drugs. In response, UMASS/MAPS worked with Graham Boyd of the ACLU Drug Policy Litigation Project and Peter Barton Hutt and Alexei Silverman, of the DC law firm Covington & Burling, on the development of a legal document detailing why US international treaty obligations do not prevent the licensing of the UMass Amherst facility.

    On July 24, 2003, DEA finally filed a notice in the Federal Register about Prof. Craker's application, with a public comment period ending on September 23, 2003. On October 23, 2003, Senators Kennedy and Kerry wrote a letter to the Administrator of the DEA expressing their strong support for DEA licensing of the facility. UMASS/MAPS expected DEA’s approval or rejection of Dr. Craker's application sometime before the end of 2003 but that did not occur as DEA delayed any decision as long as possible.

    On July 21, 2004, MAPS, Prof. Craker and Valerie Corral filed lawsuits against DEA and also against HHS/NIH/NIDA for obstructing medical marijuana research. On July 29, 2004, MAPS filed a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA. Shortly thereafter, on November 22, 2004, the Court required DEA to respond by December 22, 2004 to the portion of the lawsuit against DEA about the UMass Amherst marijuana production facility.

    On December 3, 2004, MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 ½ months to their applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research.

    On December 10, 2004, DEA finally rejected the application from Dr. Lyle Craker, UMass Amherst, seeking a license to establish a MAPS-sponsored facility to produce marijuana for federally-approved research, 3 and 1/2 years after the application was initially filed.

    On February 28, 2005, DEA filed its pre-hearing statement in the DEA Administrative Law Judge (ALJ) hearing. In DEA's initial "Order to Show Cause" explaining its rationale for rejecting Prof. Craker's application, DEA claimed that it would be against the public interest for it to approve the license, and that, in any case, US international treaty obligations prevented DEA from issuing the license.

    On April 22, 2005, UMass (Prof. Lyle Craker) filed his pre-hearing statement to the DEA Administrative Law Judge for the hearing with assistance from lead lawyer Julie Carpenter of Jenner & Block, Allen Hopper of the ACLU Drug Law Reform Project, and Emanuel Jacobowitz, Steptoe & Johnson, all working on a pro-bono basis.

    On August 15, 2005, Chemic Laboratories received an official letter indicating that NIDA refused to sell it10 grams of marijuana for MAPS-sponsored research into the use of marijuana vaporizers. Chemic Labs had applied to purchase the 10 grams more than two years before.

    The initial round of hearings took place August 22-26, 2005, with an additional week December 12-16, 2005, for DEA to present its witnesses

    During the August hearings, DEA seemingly abandoned the claim that US international treaty obligations prevent it from licensing Prof. Craker’s facility, with a DEA official testifying on the stand that there is nothing in DEA law or policy that prevents it from licensing individual researchers from growing different strains of marijuana. The central issue remaining is whether it is in the public interest for DEA to license the UMass Amherst facility or whether NIDA should retain its monopoly on supply, a monopoly that clearly obstructs research.

    Mother Jones Magazine: Respectable Reefer

    Originally appearing here.

    October 19, 2005. Mother Jones Magazine publishes, "Respectable Reefer," an excellent article about medical marijuana by Gary Greenberg that discusses GW Pharmaceuticals, MAPS and drug war politics.

    Sativex, a Cannabis-Based Medicine, Significantly Reduces Central Neuropathic Pain

    Sativex, a Cannabis-Based Medicine, Significantly Reduces Central Neuropathic Pain in People with Multiple Sclerosis

    Neurology Medical Journal

    London, United Kingdom, 27th September 2005: The cannabis based medicine, Sativex, is effective in reducing central neuropathic pain and sleep disturbance in people with Multiple Sclerosis (MS) in a UK study published today in the medical journal, Neurology1. This randomised, controlled trial demonstrates that Sativex was significantly superior to placebo in reducing the mean intensity of pain (p=0.005) and sleep disturbance (p=0.003) amongst people with MS.

    The study was conducted in 66 patients, 65% of whom required support to walk or were wheelchair bound and were suffering from moderate to severe central neuropathic pain which had not been alleviated by currently available medications. Patients continued to take their existing medication throughout the trial.

    Sativex was administered as an oromucosal spray allowing flexible dosing which is ideally suited to the variable nature of MS. Sativex was generally well tolerated in the study.

    Dr Carolyn Young, principal investigator and Consultant Neurologist based at the Walton Centre for Neurology and Neurosurgery in Liverpool said, "Central neuropathic pain occurs frequently in people with MS. It can be tremendously debilitating and unresponsive to existing therapies. Our findings demonstrate that Sativex was effective in reducing both central pain in MS and pain-related sleep disturbance in a population with moderate to severe central pain inadequately relieved by existing medication".

    Sativex has been developed by UK-based GW Pharmaceuticals plc and is currently approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is marketed in Canada by Bayer HealthCare. An ongoing clinical trial programme is currently being undertaken to support regulatory approval in the UK. Upon UK approval, Sativex will be exclusively marketed by Bayer HealthCare.

    Continue Reading

    Congressional Signers

    Contact your local congressional representative, urging them to sign-on to the letter to DEA Administrator Karen Tandy expressing support for the proposed UMASS-Amherst medical marijuana production facility.

    Read more info here.

    Robert Andrews (D - NJ)
    Tammy Baldwin (D - WI)
    Sherrod Brown (D - OH)
    Michael Capuano (D - MA)
    John Conyers, Jr. (D - MI)
    Peter DeFazio (D - OR)
    Rosa DeLauro (D - CT)
    Sam Farr (D - CA)
    Barney Frank (D - MA)
    Raul Grijalva (D - AZ)
    Maurice Hinchey (D - NY)
    Mike Honda (D - CA)
    Jesse Jackson, Jr (D - IL)
    Sheila Jackson-Lee (D - TX)
    Dennis Kucinich (D - OH)
    Barbara Lee (D - CA)
    John Lewis (D - GA)
    Zoe Lofgren (D - CA)
    Carolyn Maloney (D - NY)
    Jim McDermott (D - WA)
    James McGovern (D - MA)
    George Miller (D - CA)
    Jim Moran (D - VA)
    Jerrold Nadler (D - NY)
    James Oberstar (D - MN)
    John Olver (D - MA)
    Ed Pastor (D - AZ)
    Ron Paul (R - TX)
    David Price (D - NC)
    Dana Rohrabacher (R - CA)
    Martin Sabo (D - MN)
    Janice Schakowsky (D - IL)
    Pete Stark (D - CA)
    John Tierney (D - MA)
    Edolphus Towns (D - NY)
    Henry Waxman (D - CA)
    Robert Wexler (D - FL)
    Lynn Woolsey (D - CA)

    The Sacramento Bee Washington Bureau published Clash over pot research gets personal, an article about the DEA-Craker lawsuit proceedings including a quote from Rick Doblin.

    By Michael Doyle -- Sacramento Bee Washington Bureau
    Published 2:15 am PDT Thursday, August 25, 2005
    Story appeared on Page A5 of The Bee

    ARLINGTON, Va. - The Bush administration is using hardball and ridicule this week as it fights efforts to expand medical marijuana research.

    Former California legislator John Vasconcellos caught the ridicule, with derisive inquiries into his past work on self-esteem. Others faced hardball, with questions about their pot smoking. It's all part of a high-stakes fight as a reluctant Drug Enforcement Administration reconsiders a researcher's application to grow high-quality pot.

    "We're the only people in America who can't get 10 grams of marijuana," research advocate Rick Doblin testified Wednesday.

    The DEA's administrative law courtroom is far from the limelight, and only about one-quarter of the spectator seats were taken Wednesday afternoon. Still, the hearing that's likely to last several more weeks is the most important legal proceeding on the issue since the Supreme Court ruled in June that federal authorities can pursue medical marijuana users in California.

    That 6-3 ruling in Gonzales v. Raich did not overturn the medical marijuana provisions approved in California and other states, but it did expose users to potential federal prosecution.

    It's still unclear how aggressively U.S. Attorney General Alberto Gonzales may pursue medical marijuana users. There's no question, though, that the administration disputes marijuana's potential worth as a medicine. That's what makes the new hearing so crucial, and it may also help explain some of the courtroom tactics.

    After years of delay, the DEA's administrative law judge is being asked to help overturn the agency's rejection of a marijuana researcher's application first filed in 2001. University of Massachusetts plant physiologist Lyle Craker had sought approval to grow 25 pounds.

    "We (look) at marijuana as we would do any other medicinal plant," Craker testified.

    Craker said the limited marijuana now grown under federal supervision at a 12-acre University of Mississippi site is weak and filled with stems and seeds. Craker, the editor of the Journal of Herbs, Spices and Medicinal Plants, said his more potent pot would help test new vaporizers as a healthier means for patients to ingest the smoke.

    The American Civil Liberties Union is supporting Craker's effort, as are several law firms working on a pro bono basis.

    "We're not doing marijuana research because we can't seem to get marijuana," said Doblin, head of the nonprofit Multidisciplinary Association for Psychedelic Studies, "so we're spending money on litigation."

    Drug enforcement officials reply that the University of Mississippi's inventory already contains some 1,500 kilograms of marijuana. Officials say that stash, combined with rolling machines that can crank out 1,000 marijuana cigarettes every minute, can more than meet existing research needs for a drug the government considers dangerous.

    "Marijuana," the DEA said in court filings, "has no currently accepted medical use in treatment in the United States."

    The government's existing marijuana stocks supplied scientists, for instance, at the University of California Medical Cannabis Research Center. While in the state Senate, Vasconcellos drafted the bill creating the research center.

    That's why Vasconcellos was called to testify on Craker's behalf this week, but that's not what DEA attorney Imelda Paredes wanted to ask him about.

    Instead, in an apparent effort to undercut the former Democratic legislator's credibility, Paredes pressed Vasconcellos on the California self-esteem task force that finished its work 15 years ago.

    "Haven't research studies shown that in academic terms, self-esteem curricula are worse than useless?" Paredes asked.

    Paredes also noted Vasconcellos' place in a conservative author's book titled "One Hundred People Who Are Screwing Up America."

    Vasconcellos' testimony ended shortly after he defended the self-esteem programs.

    On Wednesday, DEA attorney Brian Bayley took a different tack with Doblin, by pressing him repeatedly about his own marijuana use. Over his lawyer's objections, Doblin acknowledged he had begun smoking marijuana in the early 1970s and still smokes it recreationally about once a week.

    Bayley then asked him who he bought his pot from; at that point, the judge said the DEA had gone far enough.

    The hearing will continue through Friday and then resume next month. The administrative law judge will make a recommendation but cannot order the DEA to grant the application.

    About the writer:

    The Sacramento Bee's Michael Doyle can be reached at (202) 383-0006 or This email address is being protected from spambots. You need JavaScript enabled to view it..

    The DEA Administrative Law Judge Hearings

    The DEA Administrative Law Judge hearings took place, starting with witnesses for Prof. Lyle Craker and including one DEA witness. Transcripts are available of each day's hearing. For various legal motions since the hearing, see Timeline section below. The second round of DEA hearings will take place December 12-16, with additional DEA witnesses. For further details, see the Congressional sign-on letter campaign, in which over 34 members of the U.S. House of Representatives have signed on to a letter to DEA Administrator Karen Tandy urging her to issue a license to Prof. Craker.

    Dr. Lester Grinspoon Wrote an Excellent Paper, "The History of Cannabis as Medicine"

    Dr. Lester Grinspoon wrote an excellent paper, "The History of Cannabis as Medicine" for the DEA Administrative Law Judge (ALJ) hearing starting August 22, 2005. The ALJ agreed with a DEA motion to exclude his testimony because the fundamental issue is whether Prof. Craker' facility or NIDA's monopoly is most in the public interest, since DEA doesn't dispute the need for marijuana research. That's progress!

    Medical Marijuana Research Update: August 2005

    DEA Administrative Law Judge Mary Ellen Bittner issued a ruling granting the government's motion to exclude several of our witnesses, Angel Raich and Valerie Corral, and limited the testimony of Dr. Lester Grinspoon, on the grounds that they would have testified about the medical uses of marijuana which was irrelevant to the issue of whether Prof. Craker's facility would be in the public interest since both sides have stipulated that research is ongoing and can be conducted under current regulations. This seems reasonable to us and in some senses favorable since we don't need to argue about the scientific research. Judge Bittner rejected the government's request to exclude our witness, Dr. Irwin Martin, who will testify about how the pharmaceutical drug development process normally takes place, with the sponsor of research selecting and producing the drug to be tested. This also is a reasonable ruling.

    Chemic Laboratories Receives Response Letter from Department of Health and Human Services

    Chemic Laboratories receives a response letter from the Department of Health and Human Services (view as html), rejecting the vaporizer protocol and recommending that NIDA not sell Chemic 10 grams of laboratory-grade marijuana for the vaporizer studies. This response took more than two years and arrived, coincidentally and conveniently, just one week before the start of the DEA Administrative Law Judge hearings over DEA refusal to grant a license to Prof. Craker, UMass Amherst, for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Chemic's reply to the critiques was sent to HHS/NIDA on September 9, 2005.

    DEA Administrative Law Judge Mary Ellen Bittner Issues a Ruling

    DEA Administrative Law Judge Mary Ellen Bittner issued a ruling granting the government's motion to exclude several of our witnesses, Angel Raich and Valerie Corral, and limited the testimony of Dr. Lester Grinspoon, on the grounds that they would have testified about the medical uses of marijuana which was irrelevant to the issue of whether Prof. Craker's facility would be in the public interest since both sides have stipulated that research is ongoing and can be conducted under current regulations. This seems reasonable to us and in some senses favorable since we don't need to argue about the scientific research. Judge Bittner rejected the government's request to exclude our witness, Dr. Irwin Martin, who will testify about how the pharmaceutical drug development process normally takes place, with the sponsor of research selecting and producing the drug to be tested. This also is a reasonable ruling.

    The DEA Filed a Supplemental Prehearing Statement

    The DEA filed a supplemental prehearing statement, indicating that under DEA law and policy, a researcher (though not Prof. Craker) might be allowed to grow various strains of marijuana for medical marijuana research. DEA seems to have abandoned the argument that international treaty obligations prevent it from issuing a license to anyone other than a NIDA-sponsored grower.

    Controlling Medical Pot is Not Such an Out-of-control Idea

    Controlling medical pot is not such an out-of-control idea
    Ethan Nadelmann
    San Francisco Chronicle
    Tuesday, July 26, 2005

    If medical marijuana seems tough to regulate in San Francisco, blame the federal government.

    The feds are in a fix. More than two-thirds of Americans support the legalization of marijuana for medical purposes. Every state ballot initiative, beginning with California's Proposition 215 in 1996, has passed, often by wide margins. Medical marijuana bills are passing in state legislatures, often with support from Republican governors and lawmakers.

    The feds can try to trip up these bills but know they can't stop them. The White House has been able to keep Republican members of Congress in line so far, but many don't feel they're voting their conscience when they vote against medical marijuana.

    The fallback federal obstructionist strategy is to maintain its indefensible monopoly on marijuana for research purposes; to refuse to allow it to be legally prescribed as a Schedule II drug; to reject efforts by state and local governments to regulate its production and distribution; and to intimidate local authorities who want to bring medical marijuana fully within the law.

    Keep this in mind: the medical cannabis dispensaries, or "pot clubs," exist only because the federal government won't permit this particular medicine to be legally produced, regulated, prescribed by doctors and sold by pharmacies. Change federal law to allow all this and dispensaries as such disappear.

    So what's San Francisco to do until federal law is reformed?

    -- First, ensure that medical marijuana patients are not arrested, harassed or criminalized for using their medicine. The Schwarzenegger administration's announcement last week that it is reinstating and expanding the medical marijuana ID-card program is good news. So is the Drug Enforcement Administration's recent declaration that it has no intention of going after the sick and dying.

    -- Second, ensure reasonable access to the medicine. Pot clubs provide an important service. They should be easily accessible to patients, including those dependent on public transit, while respecting the legitimate concerns of neighbors. Many club operators want to collaborate with local authorities, but that requires a real commitment by these officials not to collaborate with federal police and prosecutors in targeting clubs that make a good-faith effort to adhere to local regulations. Trust is essential.

    -- Third, keep looking for ways for the city to establish local cultivation and distribution collectives, as mandated by Proposition S, approved by 62 percent of the city's voters in 2002. This will require both creative thinking and courage from San Francisco's leaders.

    The history of Dutch cannabis policy is instructive. The "coffee shop" model in the Netherlands, where retail (but not wholesale) sale of cannabis is de facto legal, was not legislated into existence. Rather, it evolved in fits and starts following the decriminalization of cannabis by Parliament in 1976, as consumers, growers and entrepreneurs negotiated and collaborated with local police, prosecutors and other authorities to find an acceptable middle ground. "Coffee shops" now operate throughout the country, subject to local regulations. Troublesome shops are shut down, and most are well integrated into local city cultures. Cannabis is no more popular there than in the United States and other western countries, notwithstanding its de facto legalization.

    I need not belabor the analogy. All good-faith participants in San Francisco's medical marijuana dialogue must keep in mind that they are engaged in a historical process, embedded in the gray area of the law, that requires balancing the human rights of patients, neighborly concerns and the often unreasonable demands of outside political forces.

    For millions of Americans, marijuana is akin to the beer, wine or martini at the end of the workday, or the prescribed drug to alleviate depression or anxiety, or the sleeping pill, or the aid to sexual function. More and more Americans are apt to describe some or all of their marijuana use as "medical" as the definition of that term evolves and broadens. Their anecdotal experiences are increasingly backed by new scientific research into marijuana's essential ingredients, the cannabinoids. The Lancet Neurology, a subsidiary of Britain's leading medical journal, speculated whether marijuana might soon emerge as the "aspirin of the 21st century," providing a wide array of medical benefits at low cost to diverse populations.

    More and more people can now obtain a doctor's recommendation for marijuana as easily as they obtain prescriptions for pharmaceutical drugs, and purchase it from a club as easily as they purchase pills from a pharmacy. What once flourished underground is now surfacing, where it can better be taxed, controlled and regulated. That evolution needs to be managed and encouraged, not impeded, because it may provide the best answer -- at least in the United States -- to the question of how best to reduce the substantial costs and harms of marijuana prohibition without inviting significant increases in real drug abuse.

    San Francisco had led the nation on medical marijuana. It may ultimately have no choice but to also lead the nation in showing how to regulate rather than prohibit this troublesome but remarkable product.

    Ethan Nadelmann is the founder and executive director of the Drug Policy Alliance.

    Continue Reading

    Medical Marijuana Research Update: July 2005

    U.S. Congressional Representatives John Olver (D-MA) and Michael Capuano (D-MA) have sent a letter to DEA Administrator Karen Tandy urging DEA to issue a license to Prof. Craker for his MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. This letter will be sent to other members of Congress seeking additional signatures.

    Prof. Lyle Craker Filed His Updated Witness List

    Prof. Lyle Craker filed his updated and final prehearing statement in his DEA Administrative Law Judge hearing regarding DEA refusal to issue him a license to establish a MAPS-sponsored facility to grow marijuana for federally-approved research. DEA also filed an updated prehearing statement with additional witnesses, demonstrating that DEA will spare no expense in trying to show that blocking medical marijuana research is somehow in the public interest. Testimony begins on August 22, 2005.

    Vaporized fumes said to be cleaner, almost toxin-free

    San Francisco Chronicle

    'Smokeless' medicinal pot has its advocates
    Vaporized fumes said to be cleaner, almost toxin-free

    Joe Garofoli, Chronicle Staff Writer

    Monday, June 20, 2005

    The future of medicinal marijuana is floating in a plastic, 2-foot- long turkey roasting bag, being sucked into the lungs of grandmas and AIDS patients at cannabis dispensaries and homes across the country.

    The allure to the sick -- and the health-conscious looking for a cleaner high -- is that the toke is nearly smokeless.

    The device that generates the smokeless drag is called a marijuana vaporizer. Medical cannabis advocates hope these devices -- which stand slightly larger than a blender and can cost close to $500 -- will help legitimize marijuana's medicinal use and take a swipe at its reputation as the devil's weed.

    By heating cannabis to a point where vapors are formed but before the herb combusts, a vaporizer creates a clear substance that, advocates say, is practically free of many of the toxins found in marijuana smoke.

    Becoming smoke-free, they hope, will make marijuana more palatable as a medicine to federal officials, scientists and regulators who are dubious about the health value of a smoked drug.

    "The smoke aspect is a real problem in making the case for medicinal marijuana," said Dale Gieringer, a Berkeley resident who is executive director of the California branch of the National Organization for the Reform of Marijuana Laws and one of the early evangelists of vaporizing technology.

    The Bay Area has become the intellectual hub of vaporization -- from a just-completed UCSF study on the technology's effectiveness to Alameda County health officials' plans to allow the devices in new cannabis dispensaries.

    In the past two years, more than a dozen manufacturers have sprung up as vaporizers have wafted to the surface of the culture. Which explains the bumper sticker in an Oakland cannabis cooperative: "Got vape?"

    But federal officials and scientists involved in cannabis research aren't ready to OK firing up the devices.

    "It's clear that smoked marijuana has not passed the health and safety standards of the (Food and Drug Administration)," said Jennifer Devallance, spokeswoman for the Office of National Drug Control Policy, home of the White House drug czar.

    "Until an application comes out that changes that and is approved by the FDA, marijuana will continue to be classified as a Schedule I drug," Devallance said, meaning that federal law considers it to have a high potential for abuse and that there is "no currently accepted medical use in treatment in the United States."

    Medical cannabis advocates rallied behind the vaporizer technology after Stanley Watson, co-principal investigator of a 1999 National Academy of Science's Institute of Medicine study on medicinal cannabis, concluded: "Marijuana has potential as medicine, but it is undermined by the fact that patients must inhale harmful smoke."

    Steven Childers, an investigator with the study, said in a recent interview that he was intrigued by the "concept of an improved delivery system for medical marijuana. And vaporization sounds like a significant upgrade from smoking."

    But until there are significant scientific studies on pot ingestion via vaporizers, too many questions remain about everything from its health effects to how well it delivers the drug, said Childers, a pharmacology professor at Wake Forest University school of medicine in Winston-Salem, N.C.

    Courts and federal politicians continue to rebuff medical marijuana. The Supreme Court ruled this month that the federal government could prosecute medical cannabis patients, and on Thursday the House rejected a measure to protect users from federal arrests.

    Jane Weirick, who has consulted with several cannabis clubs in California, said federal actions "won't change anything to people who need medical cannabis." Weirick, who suffers from neurological disorders and back injuries and uses a wheelchair to get around, offered her analysis to reporters at a South of Market cannabis club and punctuated it with a theatrical act of defiance for the cameras: She sucked a giant hit of medicinal pot out of a vapor-filled turkey roasting bag.

    Not only have the chronically ill embraced vaporization devices, so have younger, recreational pot smokers raised on anti-smoking campaigns. Both groups say vaporizers eliminate the initial rush that's common after inhaling a hit of pot, and the post-hit hacking cough is less severe.

    "You don't have the harshness you get from smoking, no next-morning cough, no shortness of breath," said Kathy Gagne, a 56-year-old Oakland resident who began vaporizing medicinal cannabis five years ago to treat her depression. "I could run around Lake Merritt the morning after I vaporize."

    Plus, many users say, vaporizers use less marijuana than other smoking devices, so they are saving money in the long run.

    As various companies and advocates refine the technology, the Bay Area is becoming the center of the smokeless revolution.

    The nation's first clinical human study on vaporization was just completed by a professor of medicine at UCSF, Donald Abrams, a longtime AIDS and cancer researcher.

    The two-year study, the results of which are still being compiled, compared the level of cannabis absorbed using a vaporizer with that of smoking a marijuana cigarette. Abrams hopes that the study of 18 healthy, regular marijuana smokers will shed light on how well vaporization delivers the palliative goodies found in cannabis.

    Though he was mum on the results, Abrams made one casual observation: A couple of study participants missed the communal joy of passing around a joint. "Handling a turkey roasting bag with a stopper on the end just didn't do it for them," he said.

    While the science trickles in, the vaporizer market is steaming ahead.

    In early July, a West Oakland loft will become home to the only U.S. office of Storz and Bickel America, a German company that makes a popular high- end vaporizer. Its metallic, cone-shaped "Volcano" is a 5-pound device that is roughly the size of a blender.

    The reason the company opened in Oakland: Roughly a third of the firm's U. S. sales are in the Bay Area, said Jrgen Bickel, the firm's chief executive officer in this country.

    The $535 Volcanoes are flying out of the Oakland Cannabis Buyers' Cooperative, said cooperative executive director Jeff Jones.

    "It's the Mercedes-Benz of vaporizers," he said.

    Alameda County supervisors are expected to give final approval to an ordinance Tuesday that will permit vaporization in cannabis clubs, making the county the first government body in the nation to recognize the delivery system.

    "It is basically about harm reduction," said county health officer Tony Iton, who will be responsible for approving vaporization devices in dispensaries after developing a set of protocols in the next few months.

    Iton said the county is trying to educate pot users in pain about the new technology, even if only limited research has been done on its effects.

    "Ruling out vaporization wouldn't be prudent at this point," he said.

    While the Volcano is at the top end of the price scale, smaller, soda-can- size vaporizers can be purchased for as little as $22 and plugged into an automobile cigarette lighter.

    E-mail Joe Garofoli at This email address is being protected from spambots. You need JavaScript enabled to view it..

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    The Medical Pot Hysteria

    June 13, 2005
    The Medical Pot Hysteria
    by Cathy Young

    WITH EVERYTHING else going on in the world, it's good to know that the federal government is being vigilant when it comes to the really dangerous people: those unrepentant chronic-pain patients who viciously insist on using marijuana to relieve their suffering. Last week in Gonzales v. Raich, the Supreme Court ruled that federal drug laws supersede the laws several states have passed in recent years legalizing the production and use of marijuana for medicinal purposes. Apparently, the actions of a sick woman in California growing pot in her basement for her medical needs affect ''interstate commerce," which means that the Constitution says it's all right to bring in the feds.

    The ruling is bad legal reasoning; commentators such as Boston University law professor Randy Barnett, who argued the case before the Supreme Court last November, point out that it directly contradicts several of the court's decisions in recent years narrowing the scope of federal powers. It is also bad moral reasoning. Whether you use personal autonomy or compassion as your standard, denying seriously ill men and women access to a drug that could help them is repugnant. Moreover, as Dr. Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute, writes in The New York Times, research on therapeutic uses of marijuana has been held back by ideologically motivated restrictions.

    All this is the latest example of how the war on drugs has addled our brains. Yes, drug abuse is a serious problem. But the demonization of illegal drugs -- even mild ones such as marijuana, which tens of millions of Americans have indulged in with consequences no worse than for legal intoxicants -- has created a climate that is just as dangerous.

    The persecution of medical marijuana users is one example. Here's another: Under a congressional bill proposed by Republican Representative James Sensenbrenner of Wisconsin, if you are aware of any drug use or sale on a college campus or in a home with children and fail to report it within 24 hours, you will face a minimum two-year prison sentence. Maybe we could call it Uncle Joe's Law, since it has a distinct flavor of the Stalin-era Soviet Union where people could be imprisoned for failing to report political crimes. I'm not fond of Soviet parallels for the actions of democratic government, but this parallel does suggest itself. It's all the more galling since this proposed Draconian measure is not directed at terrorists who want to kill us, but at college kids who want a few hits of pot.

    This isn't a conservative-versus-liberal, Republican-versus-Democrat issue: Both parties are drug war parties. (It was the Clinton administration in the 1990s that decided to use federal authority to thwart new state laws legalizing medical marijuana: In 1996, Clinton approved a plan to subject doctors who prescribe the drug to federal prosecution.) It's hard to tell which side is more guilty of hypocrisy. What happened to the conservatives' commitment to the principles of states' rights and limited government? What happened to liberals' concern for the rights of defendants and to the right to privacy?

    The libertarian solution to this problem is to legalize or at least decriminalize drug use, at least for adults. There are solid arguments for this: In a free society, people should generally be able to decide what substances they put in their bodies. On a pragmatic level, decriminalization would take drug profits for organized crime and even terrorism out of the equation. The obvious counterargument is that it will lead to more drug abuse, since obtaining drugs will be far easier. But the most likely result would be a small increase in casual use: when drugs are illegal, it stands to reason that the kind of people who obtain them are also more prone to addiction. Drug prohibition is based on the idea that the diabolical power of drugs robs people of the ability to make choices. Yet, as Satel persuasively argued earlier this month at an American Enterprise Institute conference on neuroscience and morality, this isn't true: addicts can and do choose to quit.

    Satel believes that marijuana should be treated no differently from alcohol, with generally tougher drunk driving penalties. However, she does not support drug legalization; for one, she told me, it is a political nonstarter that diverts attention from practical solutions (such as more emphasis on treatment rather than prosecution). That's almost certainly true. But maybe we should start by just saying no to drug hysteria. Then, in a saner climate, we can start thinking about solutions.

    Cathy Young is a contributing editor at Reason magazine. Her column appears regularly in the Globe.

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    Legal Pots No Pipe Dream

    Legal Pot's No Pipe Dream
    Wired Magazine 02:00 AM Jun. 08, 2005 PT

    The Supreme Court handed a major defeat to state medical marijuana laws this week, but pro-pot advocates said a little-noticed lawsuit wending its way through the courts might yet make legal pot a reality.

    The suit hinges on a Food and Drug Administration regulation that says the agency can't approve marijuana -- or any other substance -- as a medicine unless research shows it's safe. But the government, which controls the only legal crop in the country, won't give scientists any marijuana to test, according to researchers who want to perform safety studies.

    The impasse led to a lawsuit in July 2004 pitting the Multidisciplinary Association for Psychedelic Studies, or MAPS, against the Drug Enforcement Agency as well as the Department of Health and Human Services and the National Institute on Drug Abuse, or NIDA, for obstructing medical marijuana research.

    "The energy in the legal arena is now going to shift to our effort to break the monopoly on supply," said Rick Doblin, founder and president of MAPS. "Now that (law enforcement) can go after high-profile targets, the only safety for patients is going to be to have it available through the FDA."

    NIDA refused to comment on the lawsuit because the agency addresses abuse of marijuana rather than its medical uses, a spokeswoman said. But since the agency is the gatekeeper to the only legal source of the drug from a small farm at the University of Mississippi, researchers who want to study the drug's medicinal qualities have no choice but to query NIDA.

    Doblin said the government pot is not only scarce but also low-quality. Patients have to smoke up to four times more than they would if they bought it on the street or in a buyers' club, and it's full of sticks and seeds.

    After several years of rejections and revised protocols, Dr. Donald Abrams, now chief of hematology and oncology at San Francisco General Hospital, managed to gain NIDA's permission in 1997 to perform a study testing marijuana in AIDS patients. It found that the patients' viral load did not increase while smoking the drug.

    Abrams recently completed a second study on 16 AIDS patients with painful nerve damage in their hands and feet. Preliminary results suggest that marijuana eased their pain, he said.

    "I'm trying to generate some data so we can have some real evidence in this discussion," said Abrams, who is awaiting approval for one more study that if approved will examine the interaction between cannabis and opioids in cancer patients with persistent pain.

    Doblin thinks the government is purposely setting up roadblocks to make it impossible to get enough data for FDA approval. Abrams' studies have involved 62 and 16 patients respectively -- far too few to garner FDA approval -- and Doblin said government agencies know that Abrams doesn't have the resources to perform a larger trial.

    MAPS is also suing NIDA for ignoring its 2003 application to buy 10 grams of marijuana -- a small amount worth no more than $100 -- for a study that would examine the chemical makeup of vaporized marijuana, which it believes could be an alternative delivery method. The test would not involve human subjects.

    "Supposedly that's what everyone wants -- that this issue should be solved through science rather than through politics and that's what we're saying as well," Doblin said. "The problem is, when we try to do the science we find out the government is not really that interested in solving the issue through science."

    The first hearing regarding the DEA suit is scheduled for late August.

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    Good to Grow

    Op-Ed New York Times
    Good to Grow

    By SALLY SATEL

    Published: June 8, 2005
    Washington

    RELIEF for medical marijuana patients was snatched away this week. In Gonzales v. Raich, the Supreme Court ruled that such patients will be subject to federal prosecution even if their own state's laws permit use of marijuana. Now, short of Congress legalizing medical marijuana, the only way that its users can avoid stiff financial penalties or jail is if it is turned into a prescription medicine approved by the Food and Drug Administration. Justice Stephen G. Breyer said as much during oral arguments last November with his comment that "medicine by regulation is better than medicine by referendum."

    Fair enough. The problem is that the very agencies integral to facilitating the research and development of medical marijuana have actually been impeding progress.

    The first obstacle is ideological. The Drug Enforcement Administration has fought marijuana's use as a medicine, maintaining that it has no therapeutic value. (It hasn't helped that activists have tried to use medical marijuana as a wedge to liberalize drug laws.)

    But scientific consensus says otherwise. Surveying a range of findings, a federally commissioned Institute of Medicine report issued in 1999 noted the active ingredients in marijuana, cannabinoids, can relieve chemotherapy-induced nausea, stimulate appetite and suppress pain in patients who have failed to get relief from conventional treatments. Other countries have embraced such findings. Last April, for example, regulators in Canada approved a marijuana extract delivered in an oral spray for relief of symptoms of nerve pain associated with multiple sclerosis.

    A more imposing obstacle to developing medicine in the United States is that there is only one legal source of research marijuana: a farm in Mississippi run by the National Institute on Drug Abuse, part of the National Institutes of Health. As gatekeeper of the supply, the drug abuse institute must review and approve all proposed marijuana research projects, a hurdle for researchers that is both onerous and redundant: they already must undergo at least three other oversight evaluations (from the Food and Drug Administration, the D.E.A. and their own institutions) before they can enroll their first subject.

    One scientific team has been trying for two years to get a mere 10 grams of marijuana from the drug abuse institute for its effort to develop a device that heats marijuana but doesn't burn it, thereby providing nontoxic and immediate relief to patients.

    Since the drug abuse institute's mission does not include the development of marijuana into a commercial prescription medicine, any expanded studies with the marijuana plant must be privately financed. But, in a Catch-22, private resources are out of reach as long as only federal marijuana - which is notoriously weak and poorly manicured - can be used.

    After all, a pharmaceutical development team must have a stable source of raw material with adequate purity. Researchers need to be able to control the ratio of active to inert compounds in the plant by manipulating growing conditions. Unless a pharmaceutical company could be sure of producing a drug or device for commercial sale, it won't invest millions of dollars in clinical trials.

    One solution is to get the National Institute on Drug Abuse out of the marijuana supply business. Let researchers get marijuana directly from the government-approved Mississippi farm or from overseas sources like the Dutch Office of Medicinal Cannabis. Better yet, permit a privately financed D.E.A.-approved farm, like the kind that Lyle Craker, a medicinal plants expert at the University of Massachusetts, has been hoping to create for the last three years. In addition to producing higher-potency, cleaner marijuana, such a farm could offer strains with varying levels of cannabinoids that may contribute to marijuana's therapeutic effects.

    Developing cannabis into an approved and effective prescription medication can be a goal within reach. But it will take a federal government that is truly open to the research that it claims to value. Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute, is the co-author of "One Nation Under Therapy: How the Helping Culture Is Eroding Self-Reliance."

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    Let Terminally Ill Ease Their Pain by Smoking Pot

    Let terminally ill ease their pain by smoking pot

    By Rekha Basu
    Des Moines Register Columnist
    June 8, 2005

    First the good news: People with debilitating illnesses are finding relief in doctor-prescribed marijuana. They say it eases their pain, boosts their appetites, curbs their nausea, and in those ways, extends their lives.

    Now the bad news: The U.S. Supreme Court says the federal government can prosecute them even if their states allow them to use it.

    So in one more way, terminally ill people are damned if they do and damned if they don't.

    They can't look forward to a cure through the only channel that now holds promise: embryonic stem-cell research.

    They can't seek relief from their symptoms in one of the only substances that offers any: marijuana.

    They can't even find a legal exit strategy when the pain or infirmity becomes too overwhelming, through physician-assisted suicide.

    That's happening even though a majority of the public has shown support for all three options, either through national polls or state referenda.

    The president has vowed to veto any bill to fund embryonic stem-cell research. The administration has sued to stop Oregon's assisted-suicide law, which was approved by 60 percent of Oregon voters. And with Monday's ruling in the government's favor, federal authorities can prosecute people even where state law permits medical marijuana and their doctors prescribe it.

    Purely as a question of federal rights over state ones, the ruling has merit. Federal law supersedes state law. Who can forget that it took federal intervention to enforce school desegregation over states' resistance?

    But the government's stance against medicinal marijuana is another case in which this administration lags behind both the public will and the most humane approach for sick people. States and their voters have tried, in frustration, to take matters into their own hands, with laws permitting physician-assisted suicide and medicinal marijuana. Now those efforts are being undermined, too. It remains to be seen what will happen to California's effort to fund its own embryonic stem-cell research.

    The administration's argument that the safety and effectiveness of medicinal marijuana haven't been proven is a particular Catch-22. Scientists who think they can prove it either can't get federal approval for their studies or can't get marijuana of adequate quality and potency through the government.

    Case in point: A professor at the University of Massachusetts in Amherst, Lyle Craker, has applied and been turned down by the Drug Enforcement Agency for permission to grow a research-grade marijuana, at private expense, to explore potential health benefits. The American Civil Liberties Union has sued the DEA on Craker's behalf.

    Supreme Court Justice Stephen Breyer proposed patients ask the Food and Drug Administration to reclassify marijuana for medical use. But as the ACLU argues, that's not possible when the government has stood in the way of the studies.

    "But they'll give money to show how dangerous it is," argues ACLU attorney Allen Hopper, who accuses the administration of elevating ideology over science.

    On the other hand, the federal government is supplying and allowing seven people to use marijuana medicinally under an ongoing "compassionate use" program. By doing so, it acknowledges the benefit to them.

    The ACLU is trying to put the best face on the Supreme Court ruling, noting that the court didn't overturn state medicinal marijuana laws and that less than 1 percent of marijuana prosecutions are federal.

    But whether federal law is enforced or not, the fact remains that people using marijuana on their doctors' orders and in accordance with state laws can be arrested and prosecuted by the feds.

    The issue will ultimately have to be resolved with the passage of federal law. And though the ideological makeup of the present Congress doesn't favor that, elected officials are sensitive to re-election pressures. There is hope only if enough Americans push their representatives for legalization of medicinal marijuana and for more unbiased research that could show its benefits.

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    Marijuana Patients Remain Defiant

    THE NATION

    Marijuana Patients Remain Defiant
    By Eric Bailey, LA Times Staff Writer

    SACRAMENTO — Californians who use medical marijuana remained defiant Monday in the face of a Supreme Court decision that allows the federal government to prosecute patients who use the drug with a doctor's recommendation.

    The decision caused ripples across the state, the first in the nation to approve medical marijuana with passage of Proposition 215 in 1996.

    Few expected to see federal drug authorities renew an aggressive war on medical marijuana in the Golden State. "This would be like the Oakland Police Department focusing on busting jaywalkers," said Steph Sherer of Americans for Safe Access, a medical marijuana advocacy group.

    Indeed, federal officials were quick to say after Monday's decision that they did not expect to begin routine prosecutions of individual marijuana users.

    But advocates of medical marijuana, and some patients, expressed worry about what might happen to the organizations that have sprung up to distribute the drug in the state. The court victory might embolden federal prosecutors to go after such groups, they said.

    Dr. Frank Lucido, a Berkeley family practitioner who specializes in medical marijuana recommendations, predicted the federal government might raid a few "high-profile clubs, probably those with lower standards."

    California has about 120 medical marijuana cooperatives. An additional 300 organizations are scattered around the nation, mostly in the nine other states with laws legalizing the herb with a doctor's recommendation, Sherer said.

    Valerie Corral, founder of a Santa Cruz medical marijuana collective known as WAMM, said the ruling will mean the end of the group's wind-swept communal garden up the coast. Federal agents raided the garden in 2002.

    After that raid, outraged Santa Cruz officials let ill and infirm members of the collective ceremoniously distribute medical marijuana on the steps of City Hall. Corral said the group, which has seen 155 members die of AIDS, cancer and other illnesses over a dozen years of operation, will split up the responsibility of growing marijuana among its members.

    "It's not as if this decision wipes out cancer and ends AIDS and everyone in a wheelchair can now get up and dance," Corral said. "Where are people supposed to go if we shut down?"

    Authorities in San Francisco were grappling with how to plan for tighter regulations on cannabis clubs. Regulating an enterprise that the federal government considers criminal could place the city in a difficult legal situation, they said.

    "This puts us in a state of temporary paralysis," said Supervisor Ross Mirkarimi. "I don't want to flout the law, but at the same time it would be irresponsible of us to turn our backs on patients."

    Keith Vines, a former San Francisco deputy district attorney who had to retire last year because of complications from AIDS, said he worries that the dispensary where he purchases medical marijuana could be shut down.

    "How would I get it?" wondered Vines, who smokes pot a few times a week to slow the wasting effects of AIDS. "I don't think you'd see me out on the street corner trying to buy it. There's too much risk."

    Some government officials also expressed concern the decision would slow a state program, approved in 2003, to provide identification cards for patients whose doctors have prescribed marijuana for their ailments.

    On the other hand, some activists expressed hope that the decision could actually help in their long fight to legalize medical marijuana in the U.S.

    "Medical marijuana advocates have been urging the federal government for years to have an objective, science-based, sane conversation about marijuana as medicine," Sherer said. "Now the Supreme Court is urging them along as well."

    Angel Raich of Oakland, one of two women who sued to keep her medical supply, said she planned to carry the battle to Congress in hopes of seeing federal laws changed so physicians can prescribe medicinal pot.

    "I've still got some breath in my body, so I'm going to stand up and fight," said Raich, who smokes pot every few hours to counteract the effects of a brain tumor and other illnesses. "I can't stop using this medicine. I don't have that choice."

    Legislation before Congress would prohibit the use of federal tax dollars for raids on medical marijuana dispensaries, a past target of U.S. drug agents. In addition, a petition before U.S. health officials would allow doctors in all 50 states to consider prescribing marijuana to patients in need. A decision could come as soon as this summer. Given the Bush administration's strong opposition to medicinal use of marijuana, both efforts face long odds.

    California Atty. Gen. Bill Lockyer urged the public to pressure Congress to look anew at legalizing medical marijuana.

    "Taking medicine on the recommendation of a doctor for a legitimate illness should not be a crime," Lockyer said. "There is something very wrong with a federal law that treats medical marijuana the same as heroin."

    In the nearly nine years since California approved Proposition 215, Sherer said, the federal government has prosecuted about 30 medical marijuana cases against individuals and organizations.

    Timeline

    Here is a chronology of efforts to legalize the use of cannabis for medical purposes in California:

    1992: A few cities approve the use of medical marijuana for people with AIDS, cancer and other chronic diseases.

    November 1996: California voters pass Proposition 215, legalizing the drug's use for seriously ill people.

    August 2000: The U.S. Supreme Court bars Californians from legally dispensing the drug.

    May 2001: The U.S. Supreme Court rules 8 to 0 that federal law leaves no room for compassionate exceptions and prohibits giving marijuana to seriously ill patients, invalidating measures by the states.

    July 2002: The California Supreme Court unanimously upholds Proposition 215.

    October 2002: Angel Raich, two growers who give her free marijuana, and Diane Monson, another medical pot patient, seek an injunction to stop the federal enforcement efforts.

    December 2003: A U.S. 9th Circuit Court of Appeals panel rules 2 to 1 against federal prosecution of patients who receive free marijuana on a physician's advice.

    May 2004: A federal judge in San Francisco issues a preliminary injunction to protect Raich, Monson and the two marijuana suppliers from prosecution.

    June 2005: The U.S. Supreme Court rules that federal law prevails over state laws in upholding the pot ban, effectively weakening medical marijuana laws.

    Sources: Los Angeles Times, San Jose Mercury News; Times research by John Tyrrell

    Marijuana: the dope

    Marijuana: the dope
    by Mark Peplow
    This email address is being protected from spambots. You need JavaScript enabled to view it. attempts to round up the facts after the US Supreme Court ruling against medical marijuana.

    The Supreme Court of the United States ruled on 6 June that medical use of marijuana is illegal under federal law, even though 11 individual states allow it. The judgement is the result of an appeal by Bush's government over a case against two women in California who use the drug medicinally. The pair may now be arrested.

    Technically, the ruling means that federal authorities may prosecute the doctors, patients and suppliers involved in medicinal marijuana use, although lawyers point out that federal enforcement is likely to be lax.

    The ruling is seen as a victory by those who dispute the medical benefits of marijuana use. "The medical marijuana farce is done," says John Walters, the White House's anti-drug tsar. "I don't doubt that some people feel better when they use marijuana, but that's not modern science. That's snake oil," he says.

    Patients' advocates hope that things won't change much for those who use the drug and find it helps with their illnesses. They note that Congress has the capacity to change the law to allow medical use of marijuana.

    This email address is being protected from spambots. You need JavaScript enabled to view it. answers some key questions behind the medical marijuana debate.

    Where is marijuana use legal?

    Thousands of people are thought to use marijuana medicinally in North America.

    Medical use of marijuana has been allowed in Canada since 2001, and the Netherlands since 2003. Although it is strictly illegal in Britain, legal authorities have generally taken a lenient attitude towards medicinal users. In most countries, certain marijuana extracts are also available on prescription.

    California's Compassionate Use Act of 1996 ensures that "seriously ill Californians have the right to obtain and use marijuana for medical purposes". Similar acts allow limited marijuana use in Alaska, Arizona, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont and Washington. These state laws remain in effect, so prosecution of users would have to be a federal undertaking. How many people use it medicinally?

    Marijuana is the most frequently used illegal drug in the United States. According to federal statistics, nearly 95 million Americans over the age of 12 have tried marijuana at least once.

    It is commonly said that thousands of people in North America use marijuana for medicinal purposes, but the numbers are difficult to assess. In Canada, where there is a federally sanctioned process for getting marijuana on prescription, a surprisingly small number of people actually have permission to use the drug: 821, to be precise, as of April 2005. The Canadian government currently receives about 40 applications a month for 'authorization to possess' the drug.

    What is in marijuana?

    The dried leaves of the plant Cannabis sativa contain more than 60 active chemicals. The most psychoactive is delta-9-tetrahydrocannabinol (9-THC), which scientists believe stimulates the brain to release the neurotransmitter dopamine. This drug, often known as cannabis, is also available as a resin or oil made from the plant.

    The quality of the drug as bought on the street varies widely. Experts in the United States say that today's marijuana is generally much stronger that it was in the 1960s. The average strength of cannabis in Europe seems to have remained fairly steady at around 6-8% THC1.

    How do patients get it?

    In Canada there is a federally sanctioned operation that grows plants in a controlled environment in an abandoned mine. Patients have to go through their doctors to get permission to use it.

    Before the US government prohibited the use of marijuana in 1937, many medicines containing the drug were legally available. Today, other cannabinoids are available on prescription. In April this year, Canada approved the use of a cannabis spray called Sativex (marketed by Bayer), which contains THC and cannabidiol, to give pain relief to people who suffer from multiple sclerosis. Marinol, which contains synthetic THC called dronabinol and is marketed by Solvay, can be prescribed in the United States to control nausea and appetite loss.

    But many medicinal users buy their cannabis from the same sources as recreational users do.

    Does marijuana have medical benefits?

    Many people use cannabis to treat pain. Others use it to increase appetite and suppress nausea, which can be a side-effect of HIV or cancer treatments. And many multiple sclerosis sufferers say that it helps to ease the tremors and pain associated with the disease. Some small clinical trials have shown that cannabis can have these medical benefits (see 'Cannabis study shows small MS benefit').

    An influential US Institute of Medicine report from 1999 concluded that no health benefits were yet proven, and called for more research in the area.

    Is it bad for you?

    Taking cannabis can induce panic attacks and paranoia. A study from the Institute of Psychiatry in London showed that cannabis significantly increases the risk of schizophrenia, and exacerbates symptoms in people who already have mental health problems (see 'Cannabis boosts risk of psychosis'). Long-term use can affect memory and sap a user's motivation.

    Because most patients smoke cannabis, the increased risk of lung cancer and other diseases is at least as much as for cigarette smokers. Sativex and Marinol were formulated as oral drugs to avoid this problem.

    Is it addictive? Does it lead to more drug use?

    Although there is still debate around whether marijuana is physically addictive, people can certainly become compulsive users of the drug. The UK Department of Health says that "cannabis is a weakly addictive drug but does induce dependence in a significant minority of regular users". Some users can experience withdrawal symptoms such as cramps and shaking when they stop taking the drug.

    The 1999 US Institute of Medicine report found no evidence that marijuana led to use of harder drugs, or that allowing medical use would markedly increase wider recreational use.

    Are people continuing to research marijuana?

    Absolutely. The National Institute on Drug Abuse, which is the only legal source of cannabis in the United States, supports research on the drug's effects, although researchers have sometime found it difficult to get approval for medicinal trials (see 'Marijuana researchers reach for pot of gold' ).

    Other research projects abound. The University of California's Centre for Medicinal Cannabis Research is conducting clinical trials on pain relief. And the Multidisciplinary Association for Psychedelic Studies, based in Sarasota, Florida, has spent more than $2 million since 1995 on education and research into medical marijuana use.

    Do other recreational drugs have medicinal purposes?

    Yes. There are a number of ongoing studies into the possible benefits of MDMA, the active ingredient in ecstasy, for treatment of stress-related syndromes (see 'The ups and downs of ecstasy' ).

    The hallucinogenic peyote cactus, which is traditionally used by some Native Americans to cure drug addiction and alcoholism, contains the promising drug mescaline. Researchers are investigating its effects.

    And there are some trials involving psilocybin, the active ingredient in 'magic' mushrooms. These aim to see whether it can manage symptoms of obsessive-compulsive disorder or relieve anxiety in terminally ill cancer patients.

    References
    King L. A., An overview of cannabis potency in Europe, Office for Official Publications of the European Communities (2004).
    Institute of Medicine report 'Marijuana and Medicine', http://books.nap.edu/html/marimed/ (1999). Sridhar K. S., et al. J. Psychoactive Drugs, 26. 285 - 288 (1994). | PubMed | ChemPort |

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    A Guide to Gonzales vs. Raich

    Ryan Grim, Salon Magazine, publishes his article A guide to Gonzales vs. Raich, What the medical marijuana ruling means for patients, the commerce clause, marital sex, Antonin Scalia's career and more. Ryan writes "But if the Supreme Court told us nothing else on Monday, it was that if this drug quagmire is ever going to end, it'll have to be stopped by the ones who started it: members of Congress. Until then, we'll gradually build our way to a society where half the population is locked in prison and the other half is guarding the prisoners."

    What the medical marijuana ruling means for patients, the commerce clause, marital sex, Antonin Scalia's career and more.

    By Ryan Grim, Salon Magazine

    June 7, 2005 | Before Monday's 6-3 Supreme Court ruling in Gonzales vs. Raich, federal agents had the authority to break down the doors of medical marijuana patients and haul them off -- and they still can. But should cancer patients who smoke pot worry about federal agents sending them to the clink? The reality is that more than 99 percent of all marijuana arrests are made at the state or local level. So if you live in California, where marijuana has been legal for medical purposes since the Compassionate Use Act of 1996, your medical marijuana card makes you pretty safe. (That is, unless your name is Angel Raich and you just sued the federal government.)

    Raich and her co-defendant, Diane Monson, were not the only two watching this case. Legal scholars and court watchers from across the political spectrum have been anticipating the Raich ruling as one of the most important tests of the reach of federal power in roughly a decade. Now that it's here, what does it mean? Whom does it affect, and how?

    As the plaintiffs, Raich and Monson aren't off to jail (yet) as a result of the ruling. In fact, pretty much every media outlet has so far missed the fact that the Supremes didn't rule definitively on their case. Rather, the majority ruled that the 9th Circuit had incorrectly applied the Constitution's "commerce clause" and ordered the case remanded back, with instructions. The plaintiffs still have two avenues -- due process and medical necessity -- that neither the Supreme Court nor the 9th Circuit ruled on. As for pot smoking, the two vowed to continue despite the court's ruling.

    If you live in one of the 10 states (Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Washington and Vermont) that effectively allow medical patients to use marijuana, rest easy for now. The high court's ruling doesn't change state law whatsoever; as long as you only run into state and local cops, you're fine. David Michael, a co-counsel for the plaintiffs, explains it this way: "People don't understand how horrendous this is in its implications ... This ruling allows the feds to effectively -- effectively, not legally -- dismantle state laws that differ from federal laws." But, says Michael, if you're growing a few plants in your backyard on the recommendation of your doctor, "you may be safe. [The federal government] will attack growers, distributors and all the instrumentalities of the medical marijuana system, but leave the personal growers alone." On the day of the decision, Oregon stopped issuing medical marijuana cards but is likely to resume issuing them soon. California Attorney General Bill Lockyer called for calm, telling reporters, "People shouldn't panic. There aren't going to be many changes. Nothing is different today than it was two days ago, in terms of real-world impact." Whether or not the feds will go after Grandma is not yet clear, but these are the same people who locked up Tommy Chong for his Los Angeles novelty shop Chong's Bongs.

    Monday was a good day for the commerce clause in the Constitution. The section that gives Congress the authority to "regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes" now stretches to include, according to Clarence Thomas' dissent, "virtually anything." Antonin Scalia, voting with the majority, clarified: "Where necessary to make a regulation of interstate commerce effective, Congress may regulate even those intrastate activities that do not themselves substantially affect interstate commerce."

    In Raich, the two women were using California seeds and plants were following California law. No money changed hands. As Thomas writes, "By holding that Congress may regulate activity that is neither interstate nor commerce under the Interstate Commerce Clause, the Court abandons any attempt to enforce the Constitution's limits on federal power." So what can't the federal government regulate?

    "Maybe marriage," says Orin Kerr, an associate professor at George Washington University law school and a former clerk for Justice Anthony Kennedy. "It's hard to tell what's non-economic." Randy Barnett, lead counsel for the plaintiffs and a Boston University law professor, takes it further. "Under the reasoning in the majority opinion, Congress can regulate whatever it wants."

    Monday was not a good day for federalists. "Scalia went off the reservation," says George Mason University law professor and libertarian David Bernstein. Kerr says this case shows that "federalism is style over substance. When the rubber hits the road, the five votes aren't there." That may be a little harsh; as Barnett points out, "Three justices completely agreed with us," even though the case centered on marijuana, never an easy way to win conservative hearts. For Bernstein, the failure for federalists can be chalked up to politics. "There's no political support for [federalism]. [Republicans on Capitol Hill] don't even talk about limiting federal power," he says. "Why waste political capital when the real goal is overturning Roe v. Wade? Scalia's eye is on the prize, and the prize is Roe." Adding to the anti-federalist insult, the majority opinion was based on Wickard vs. Filburn, a 1942 ruling -- the bane of originalists -- that forbade a wheat farmer from growing more than his quota of wheat on his farm, even though it was for personal consumption. "You want to say [Scalia] just looked at the law," says Bernstein, "but it's difficult ... I don't know a single serious originalist who thinks Wickard was decided right." Well, not until Monday, anyway. So what was Scalia thinking? Don't worry, he gets his own heading down below.

    Last November, during oral arguments in Raich, Barnett, the plaintiffs' lead counsel, momentarily silenced the stodgy courtroom. Think about prostitution and marital sex, Barnett said, not having to ask twice. In that case, he went on, the same act is regulated under some circumstances but not under others, even though the two influence each other. The less marital sex someone has, Barnett argued, the more times someone will seek out a prostitute. So by regulating that married couples have more sex, the state could reasonably expect to reduce the occurrence of prostitution. But surely the federal government can't regulate the number of times a couple must have sex in a week, Barnett concluded.

    Monday, I asked him if Congress could now regulate marital sex. "Yes," he said, "under the reasoning of the majority opinion." Kerr wasn't sure: "It's my hope that Congress never tries."

    It's a strange day when two seriously ill women are told they may face arrest and incarceration for using a medicine their doctor legally recommends under state law and we can say that's a victory for liberals. The anti-federalist bloc -- John Paul Stevens, David Souter, Ruth Bader Ginsberg and Stephen Breyer -- held together even in the face of the plaintiffs' tear-jerking medical histories. "We knew that the liberal bloc would be against us," said Barnett, "but hoped they'd look at the compassionate side and make an exception. To their credit, they were not result-oriented. Their commitment to federal power overrode their compassion for the patients in this case ... You have to admire their principled stand." The liberal bloc, though, did have a way out, which Justice Sandra Day O'Connor pointed them toward in her dissent, joined by Thomas and William Rehnquist. "The states' core police powers have always included authority to define criminal law and to protect the health, safety, and welfare of their citizens." The liberals, haunted by the ghost of Jim Crow, weren't buying. Medical marijuana is probably most well known for its ability to reduce nausea and increase appetite. Just try to find someone who doesn't know pot gives you the munchies. It may seem minor, but to someone undergoing powerful rounds of chemotherapy, something that can stop you from throwing up and give you a bit of an appetite can be the difference between life and death. So was Chief Justice William Rehnquist puffing medical marijuana to combat the side effects of chemotherapy?

    "I don't have any particular evidence of that, of course," said Robert Raich, Angel's husband and a co-counsel. "But when a person is terminally ill and suffering, they might have a deathbed conversion of sorts." It wouldn't be the first speculation of a personal motive behind a Rehnquist decision. Linda Greenhouse, in an Op-Ed in the New York Times in 2003, tried to explain his anti-federalist ruling in Nevada vs. Hibbs. The Family and Medical Leave Act was on trial, and many expected the Supreme Court to strike it down on federalist grounds. It didn't happen, partially thanks to Rehnquist. Greenhouse speculated that Rehnquist's daughter, a single mother, may have played into his thinking, adding that he left court early several times that term to pick up his granddaughters from school.

    Barnett doesn't buy it. "I think the fact that we got Rehnquist shows that our case was reasonable ... and when you get O'Connor, you're supposed to win." Rehnquist, Barnett added, is no softy on drugs, having had a significant role in the original drafting of the Controlled Substances Act, back when he was assistant attorney general under President Nixon in 1970. Also, insiders have speculated that Rehnquist made the decision to join the 6-3 Hibbs majority so that he would write the majority opinion instead of Stevens. That doesn't leave much room for the "Rehnquist the converted stoner" theory -- which shouldn't stop us from tossing it around anyway.

    Perhaps the biggest loser on Monday was our nation's least-loved constituency, fans of child porn. "The most immediate effect," says Kerr, "is on [the] child pornography cases kicking around in the lower courts." Apparently, folks have been arguing that federal laws against child pornography are unconstitutional because there's no interstate commerce involved. With Raich's extension of federal power, the argued distinction between inter- and intrastate commerce is now too slim for these child-porn fans to slip through. Something need not cross state lines to be considered interstate, and need not be bought or sold to be considered part of commerce. And just when you thought it was safe to buy child porn ... Antonin Scalia's dilemma was perhaps the trickiest of all. In the thick of his campaign for chief justice, he had to stick somewhere near his expressed principles, not piss off Republicans in Congress and the White House -- and, of course, make sure there are no hippies smoking legal marijuana anywhere in his United States. "Scalia tends to be more interested in originalism when it fits into his Catholic social conservatism," says Bernstein, "or when he's using it to bludgeon the left."

    "It all comes down to morality," says plaintiff co-counsel Michael. And Scalia made his moral position clear during oral arguments. At one point, Scalia dove back in his chair, threw up his arms and nearly shouted, "There are some communes that grow marijuana for the medical use of all of the members of the communes!" -- shuddering in horror at the idea that the government (state, federal, whatever) would allow a bunch of deadbeats living on a commune to legally grow marijuana. "I was struck by Scalia's emotional reaction," said Barnett. "I didn't know what he was talking about. Had I known he was talking about the cooperatives, I could have corrected him."

    Not much of doctrinal interest should be culled from Scalia's decision, however, since his vote in the 6-3 decision didn't matter. Had Scalia dissented on principle, he would have been sending a signal that he wants to curb congressional power, never a good idea when you may soon need congressional confirmation. At the same time, he may have been trying to assuage the left, showing that he's not some nutball who wants to roll back the clock to 1789. With the filibuster alive to fight another day, every vote counts.

    Monday wasn't a good day for America's million-plus imprisoned nonviolent drug offenders. Last summer in Minnesota, 63-year-old Air Force vet Jerome Schaffer was arrested on his way home from the hospital, where he'd received treatment for side effects of the chemotherapy he was receiving to combat colorectal cancer. He spent the night puking in a jail cell and afterward was forced to take drug tests to make sure he wasn't using marijuana to combat his symptoms. If that's how the government treats veterans like Schaffer, it doesn't look too good for the rest of us.

    Fortunately, those liberal slaves of principle in the court's majority -- who compassionately lamented the "respondents' strong arguments that they will suffer irreparable harm" if deprived of medical marijuana -- have some sage advice for the millions of victims of the war on drugs. "Perhaps even more important," croons Stevens at the end of his opinion, "is the democratic process, in which the voices of voters allied with these respondents may one day be heard in the halls of Congress."

    That one day could come as early as next week, when Congress is likely to vote on the Hinchey-Rohrabacher amendment, which would prohibit the federal government from spending money to arrest, prosecute or incarcerate patients who use medical marijuana on the advice of their doctors in states where it is legal. Polls have shown upward of 80 percent support for this amendment in past years, so, of course, it loses every year by 100-plus votes. But if the Supreme Court told us nothing else on Monday, it was that if this drug quagmire is ever going to end, it'll have to be stopped by the ones who started it: members of Congress. Until then, we'll gradually build our way to a society where half the population is locked in prison and the other half is guarding the prisoners.

    A Defeat For Users Of Medical Marijuana

    The Washington Post reports on today's Supreme Court decision supporting Federal power over State's rights in medical marijuana law: A Defeat For Users Of Medical Marijuana. The article quotes John Walters, President Bush's director of national drug control policy, who said: "Our nation has the highest standards and most sophisticated institutions in the world for determining the safety and effectiveness of medication. Our national medical system relies on proven scientific research, not popular opinion."

    However, the WP article fails to adequately address Federal obstruction of all attempts to engage in research to demonstrate the medical efficacy of marijuana, exemplified by the difficulty MAPS has in obtaining Federal approval for The Amherst MMJ production facility project.

    Statement by Steve Fox, Director of Government Relations, MPP

    Statement by Steve Fox, Director of Government Relations, MPP

    The Marijuana Policy Project is the nation’s largest marijuana policy reform organization. At MPP, we are intimately involved in the effort to enact medical marijuana laws on the state and federal level. From this perspective, we are keenly aware that the U-Mass situation is part of a pattern of obstruction and delay by the federal government that has been ongoing for more than 30 years.

    In 1972, medical marijuana supporters filed a petition to reschedule marijuana with the DEA. 16 years later – which in itself demonstrates the extent to which the federal government has delayed action on medical marijuana – the DEA’s chief administrative law judge declared [and I quote]: “Marijuana, in its natural form, is one of the safest therapeutically active substances known...[T]he provisions of the [Controlled Substances] Act permit and require the transfer of marijuana from Schedule I to Schedule II…It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance.” Despite this ruling, the political powers at the DEA, then and thereafter, have refused to place marijuana in a less restrictive schedule than Schedule I. In fact, this petition touched every administration – from Carter to Reagan to Bush the first to Clinton, whose DEA issued a final denial of the petition in 1994.

    In 1999, the Clinton Administration was again forced into action on this subject by the enactment of state medical marijuana laws and by a National Academy of Sciences’ Institute of Medicine report acknowledging the therapeutic potential of marijuana. In response, the Department of Health and Human Services issued new guidelines for the study of marijuana in this country. But those hoping that research would be spurred forward by these new guidelines were sorely disappointed. The guidelines not only ensured that NIDA would retain sole control over the legal production and supply of marijuana in this country, but also ensured that researchers hoping to study the therapeutic benefits of marijuana would face bureaucratic obstacles that NO other researchers face – not researchers of other Schedule I drugs, and not researchers of new, potentially hazardous drugs. Marijuana – despite its known relative safety profile – is literally in a class by itself with respect to research approval.

    For 30 years, the federal government has played games to prevent research on the therapeutic benefits of marijuana. Over those 30 years, perhaps millions of patients who might have benefited from the use of marijuana have suffered needlessly. This is a moral outrage and it needs to be stopped. The approval of the U-Mass application would be the first step in that direction.

    -- Steve Fox, Director of Government Relations
    -- Marijuana Policy Project
    -- P.O. Box 77492 -- Capitol Hill -- Washington, D.C. 20013
    -- http://www.mpp.org -- This email address is being protected from spambots. You need JavaScript enabled to view it.
    -- phone 202-462-5747, ext. 106 -- fax 202-232-0442

    Please visit http://www.mpp.org/subscribe to sign up for MPP's free e-mail alerts.

    Statement of Allen Hopper, Attorney With the ACLU Drug Law Reform Project

    The ACLU has joined in the representation of Professor Craker because we believe that scientists and doctors should be free to pursue the truth about all drugs and to conduct legitimate research without government obstruction or censorship based on the politics of the drug war. We believe that the public has a right to know the truth about the drugs and medicines they consume. And we believe that sick people have a right to safely access the medicines their doctors say they need to save their lives or alleviate pain; they should not have to buy these drugs off the street. Patients throughout America are already benefiting from medical marijuana, but we need further research to turn that into a safe, affordable, predictable and reasonably attainable treatment.

    We anticipate a decision from the U.S. Supreme Court any day now in the Raich v. Ashcroft case. During the Raich oral arguments in November of last year, Justice Breyer told one of Angel Raich’s attorneys that his clients should ask the Food and Drug Administration to reclassify marijuana as appropriate for medical use. Justice Breyer said, "I guess medicine by regulation is better than medicine by referendum."

    We’d like to take Justice Breyer up on his suggestion. The problem, though, is that the federal government has set up a classic Catch-22: They say we need more research to establish the safety and efficacy of marijuana as a medicine, yet at the same time they obstruct that very research. One of the primary ways in which the federal government has kept medical marijuana research from moving forward is through the monopoly the National Institute of Drug Abuse has on marijuana that can legally be used for research. No other controlled substance – LSD, ecstasy, psilocybin – is subject to this absurd NIDA monopoly. All other controlled substances can be procured by scientists from any number of DEA-licensed laboratories once their research protocol has been approved by the FDA. Yet with marijuana, even after the FDA approves a research protocol and grants permission for a study to go forward, NIDA has virtually unfettered discretion to decide whether or not to provide the marijuana necessary for the research. And time after time we’ve seen NIDA refuse to provide marijuana for legitimate, FDA-approved research due to the politics of the government’s "war on drugs."

    Under the current regulatory scheme, the only realistic way that scientists will be able to conduct the research necessary to evaluate marijuana’s safety and effectiveness as a medicine is to develop an alternative source to NIDA for providing marijuana for research. That is what Dr. Craker is seeking permission to do. It’s allowed under the law, if the DEA will grant Dr. Craker the license he seeks, which the DEA is required to do if granting the license would be in the public interest. We intend to prove through the testimony of scientists, doctors and patients that it is indeed in the public interest to grant Dr. Craker’s application.

    The government is afraid of the truth about marijuana: that it may be safe and effective under some circumstances for medical purposes. The government is placing ideology above science and above the safety and well-being of sick and dying patients. With Dr. Craker’s legal challenge we hope to expose and begin to change that sad but true fact.

    Medical Marijuana Research Update: May 2005

    A prehearing conference took place today between the DEA Administrative Law Judge, our lead lawyer Julie Carpenter of Jenner and Block, and DEA's lawyer. The Judge set the dates for the hearing as August 22-26, 2005, with two additional weeks if needed, those being September 26-30 and December 12-16. We have the burden of proof and have to go first. Supplemental pre-hearing statements are due July 26, with any new exhibits.

    Cannabis Culture: Waiting to Inhale

    Originally appearing here.

    Cannabis Culture offers an article on medical marijuana patient Angel Raich's struggle in the Supreme Court

    In the end, it comes down to eight or nine men and women wearing black robes. They spent a few hours in November, 2004, listening to two women's attorneys argue against a squadron of US government attorneys in the decade's most important medical marijuana case yet.

    How many souls in wheelchairs, street protests, prisons, courtrooms, hospitals, and graveyards stand as comrades to Angel Raich and Diane Monson in their historic attempt to force the federal government to abandon nearly 70 years of lies about marijuana, to allow majority-rule democracy to win out against the forces of federal prohibition?

    The Raich Supreme Court case has led to months of speculation and hope as tens of thousands of people wait for the Court to issue its decision on whether the democratic decision of California voters, rendered in 1996 when voters legalized medical marijuana via Proposition 215, will actually be allowed to stand.

    For three years, journalists, legal analysts, prohibitionists and pundits have chattered about the landmark medical cannabis issues and political issues raised by Raich and Monson.

    Now, people are beginning to wonder why it's taking so long for the Supremes to issue their ruling. In most circumstances, the judges issue a ruling within one to three months after hearing arguments. Courtwatchers expected the court to have issued a ruling by late March at the latest. Some thought the Court would go for irony, and issue its ruling on 4-20, perhaps even issuing the ruling at 4:20 pm on 4-20. It didn't happen. Still there is no decision in Gonzales v. Raich (it used to be Raich versus Ashcroft, but Gonzales is now the US Attorney General so his name, as new plaintiff, now goes first). Why is it taking so damned long?

    At heart, the case seems simple enough, although there are plenty of nuances being argued by people well-versed in the details of how the US constitution envisions the balance of power between federal institutions, federal law, and state law.

    On one side of the issue, fighting the federal government, are two women and two anonymous marijuana growers. Angel Raich is a mother of two children who has a plethora of disabling illnesses for which she uses doctor-recommended medical marijuana. Raich believes marijuana is the best and only medicine for her, and that she would literally die without it.

    Diane Monson is a 40-something Butte County, California accountant who has a doctor's recommendation to use marijuana for back pain and spasms. The two anonymous marijuana growers are "designated caregivers" as defined by Proposition 215. Caregiver status confers legal immunity to the growers as long as they only cultivate marijuana for Raich or others whose doctors have recommended cannabis.

    Raich initiated a lawsuit against the feds in October, 2002, because she feared the DEA would raid her grower caregivers, thus depriving her of her yearly supply of marijuana.

    The DEA had been raiding California medpot clubs that she relied on, and she felt she had to take legal action to prevent the feds from interfering with her supply of medicine. Raich and her doctors say she will die without medical marijuana; the government in opposing her lawsuit has asserted otherwise. In fact, the government asserts that marijuana has no medical value and is as dangerous as heroin.

    Raich's lawsuit was directed at the Justice Department, which was at the time headed by gospel singer John Ashcroft; it argued that the federal government had no right to attack Californians who were in compliance with California's medical cannabis law.

    Monson joined in the lawsuit after her rural Northern California home was raided by DEA in August, 2002. The raid became international news when Butte County District Attorney Mike Ramsey, who had been known as a staunch opponent of medical marijuana and Prop. 215, told Butte County sheriff's deputies accompanying the DEA to stop the DEA from stealing Monson's six marijuana plants.

    Ramsey wanted the raid scene "frozen" until he had time to explain to a federal official that his state's voters had legalized what Monson was doing, and that she was in compliance with a local medical marijuana policy that Ramsey himself had helped create and implement.

    Ironically, Ramsey had been meeting with an interagency drug task force when he received an emergency call from the sheriff's marijuana eradication team, which was at Monson's house with the DEA. The DEA was there because they'd busted a major grow-op in a house that Monson and her husband formerly owned.

    Ramsey and local police had recently formalized a policy that allowed patients to grow six plants and possess a pound of pot. Sheriff's Lieutenant Jerry Smith said his officers had no problems with Monson or her plants. But the DEA did.

    "My investigator said, 'I think we have a problem here,'" Ramsey recalls. "I told him, 'Everybody is frozen in place until I get back to you. If anybody makes a move against those plants, arrest them. Is that clear?' My investigator answered, 'Yes,' and added, "I don't detect any note of levity in your voice.' He knew that I meant it. If the feds had done something to the plants, well, there would have been trouble, by God!"

    Ramsey called US Attorney John Vincent, arguing in vain that Monson's plants were legal under state law.

    Ramsey told Vincent that DEA interference with Prop. 215 was "wrong-headed, stupid and high-handed."

    "I was very angry about it, and Vincent apologized several times while insisting that DEA agents had to seize Monson's plants because the US government does not recognize Prop. 215," Ramsey said. "Finally, I had to call my people and tell them to back away, if the feds are gonna do what they are gonna do, let 'em do it alone."

    And while the feds hacked away at Monson's medicine, she read them the entire text of Prop. 215.

    "I thought they might need to hear it," she explained. "I couldn't believe they were taking my plants. I mean, this is totally against what the will of the people of the state of California is. I wasn't doing anything against the law."

    Ramsey says Vincent assured him the Monson case was an "isolated incident," but those assurances turned out to be hollow- federal agents continued to raid legal medical marijuana patients in California. That's why Monson joined with Raich in suing the federal government.

    Bittersweet

    On December 16, 2003, the 9th Circuit Court of Appeals ruled in favor of Raich and Monson, and issued a preliminary injunction that prevents the DEA from enforcing the federal Controlled Substances Act (CSA) in California if the CSA is in conflict with state medpot law.

    The ruling stated that the court believed Raich and Monson had validly argued that the CSA was an "unconstitutional exercise" of Congressional power. The Court issued an injunction, as follows:

    "[The Justice Department], and their agents and officers, and any person acting in consort with them, are hereby enjoined from arresting or prosecuting Plaintiffs Angel McClary Raich and Diane Monson, seizing their medical cannabis, forfeiting their property, or seeking civil or administrative sanctions against them with respect to the intrastate, noncommercial cultivation, possession, use, and obtaining without charge of cannabis for personal medical purposes on the advice of a physician and in accordance with state law, and which is not used for distribution, sale or exchange."

    The injunction, along with a favorable ruling regarding the Wo/Myn's Alliance for Medical Marijuana (WAMM) in Santa Cruz, opened up a flood of medical marijuana business in Western states where the 9th circuit has jurisdiction. Local and federal law enforcement agencies seem to have decided not to raid medpot clubs or gardens until the Supreme Court decides the issue once and for all. Growers, patients and pot club owners decided to function as if state medical marijuana laws protected them from federal intervention.

    On April 20, 2004, that's right, on 4-20, the Federal government appealed the 9th Circuit's decision to the Supreme Court. The Court heard oral arguments regarding that appeal on November 29, 2004. Courtroom observers said both sides argued competently, but that the Court's liberal and conservative judges were openly hostile to the pro-marijuana attorneys.

    Courtwatchers that day, and in subsequent months, said they believed the court would unanimously rule against medical marijuana and in favor of the feds. Raich's lawyers argued well, and the force of morality and law is on their side, but the Supreme Court has found a way to rule against marijuana before, and it is expected to rule against it again, regardless of the facts, the legal issues, and the effect on patients.

    Of special significance was that several Justices seemed to indicate that they did not think Prop. 215 and medical marijuana issues belonged in the Supreme Court. Maybe even Congress doesn't have the right to regulate marijuana, some Justices suggested. Maybe marijuana should just go through what other proposed medicines go through, a supposedly neutral scientific review, and then become a legit medicine via regulatory approval.

    Justices seemed to suggest that the med cannabis issue was in the wrong venue, and that medical marijuana advocates should go to the FDA, DEA and other federal regulatory agencies and get marijuana officially classified as a medicine.

    Raich's lawyers responded that the federal government has repeatedly blocked clinical research necessary to get a fair regulatory evaluation of cannabis as medicine, that state voters have settled the issue, and that the federal government had no right to regulate medical cannabis when it had already been legalized by state voters for state residents who do not engage in interstate marijuana commerce.

    Some of the written briefs filed on behalf of the medical marijuana activists came from state governments of Alabama, Louisiana, and Mississippi- states not known for liberal attitudes towards marijuana. The reason that these conservative Southern states got involved in the case is that they have an interest in reducing the amount of power that the federal government has over state laws and citizens.

    Indeed, Raich's legal argument does not rely on "medical necessity," which was a losing argument in the Oakland Cannabis Buyer's Club case, argued in front of the Supreme Court by Raich's attorney husband, Rob, who is also part of his wife's legal team. In that case, the Court ruled that a patient's medical need for marijuana does NOT give legal protection to medical cannabis dispensaries serving such patients.

    Raich's argument is founded on the competition between "state's rights" (the right of individual states to pass state laws regulating activities within the state), and the US constitution's Interstate Commerce Clause, which gives Congress the right to regulate some interstate transactions and issues by making federal law. A prime example of such regulation is the Controlled Substances Act, in which Congress stipulates that marijuana is a dangerous drug with no medical usefulness and a high potential for "abuse."

    The US Constitution does not give police powers to the federal government. It gives the feds only the power to "regulate commerce with foreign nations, and among the several states, and with the Indian tribes." Until recently, courts have given the government broad commerce clause powers, which is why Congress believed it could regulate marijuana and why the DEA believes that federal law is more important than state law.

    Raich asserts that because her marijuana is grown for her in California by growers operating not for profit in accordance with state law, that there is no "interstate" commerce for Congress to regulate. In her view, the CSA has no jurisdiction over Californians protected by Prop. 215.

    In the view of the Bush administration and many in Congress, the CSA invalidates Prop. 215 and all other state medical marijuana laws. It doesn't matter that the majority of citizens in 11 states have legalized medical marijuana, Raich's opponents argue, the federal government still has the right to enforce federal marijuana law anywhere in the US.

    Is sex next?

    When the case was argued orally at the Supreme Court in late 2004, federal attorneys put forward a twisted, seemingly disingenuous set of arguments. Their main premise rested on a 1942 agricultural law case, Wickard v. Filburn, which the feds claim provides a rationale for regulating individual actions inside states, even if those actions do not involve commerce between people in different states.

    Filburn was an Ohio farmer who got in trouble for violating the federal Agricultural Adjustment Act by growing more wheat than Congress allowed him to grow. It's bizarre that Congress even has the "right" to dictate how much wheat a farmer grows on his land, but the Supreme Court ruled that Congress had a right to regulate Filburn's wheat growing because other farmers might also grow "too much" wheat, thus affecting Congress's ability to influence national wheat prices by setting limits on wheat production.

    Raich's lawyers tore the argument apart during the Supreme Court hearing. First of all, Congress is not regulating marijuana growing for the purpose of controlling marijuana's commodity price. And Filburn was selling some of the wheat he raised. He was also feeding wheat to his cows, and selling some of the cows' milk. Raich's lawyers pointed out that Raich's growers don't sell marijuana, and that farmers were allowed to grow wheat for personal use.

    The federal government's attorneys told the Supreme Court that medical cannabis users growing cannabis undermines the goals of the Controlled Substances Act, and that the growing of marijuana in eleven medpot states would affect interstate commerce by creating an "aggregate" situation in which legal medical growers create a bigger supply of cannabis nationwide, thus affecting the interstate marijuana market in general.

    If Raich and Monson could not grow their own marijuana, the government argued, they would have to buy it on the black market. If they no longer have to buy it because they and thousands of other medpot consumers are growing their own, then demand for marijuana might decrease and black market prices might come down. Besides, the government's attorneys said, marijuana is a product that is bought and sold, therefore "all" marijuana activity is "economic" activity with interstate implications. The government estimated the total value of all US marijuana commerce as being worth $11 billion annually.

    Some of the other arguments presented by government lawyers revealed usually hidden agendas. Government lawyers said that if people are allowed to grow and use cannabis, they'd be less likely to use prescription pharmaceutical medicine, and that pharmaceutical companies would be less likely to create new prescription drugs. This is an almost blatant admission on the part of the government that its marijuana policies are meant to further the profits of private medical corporations.

    An analysis of recent trends in relevant Supreme Court cases indicates the "conservative" Supreme Court is increasingly hostile to Congressional over-reaching. In the 1995 case US v. Lopez, which was further elucidated in another case (US v. Morrison), the Court ruled that Congress could only regulate "channels of commerce, instrumentalities of commerce, and action that substantially affects interstate commerce."

    In Lopez, the Court overturned a Congressional law banning possession of firearms near schools, saying Congress had no right to criminalize legal possession of firearms when there was no commerce involved.

    In Raich, the federal government has essentially claimed that as long as an activity is related in some way to other activities that might be part of interstate commerce, then Congress has the power to determine the bounds of any subclasses at its own whim. This is an extraordinarily broad definition and would essentially give Congress unlimited power to determine the degree to which it can interfere in state law.

    To use a rather unusual analogy, the federal government's contention that the commerce clause justifies regulation of private legal medical marijuana could also justify Congressional regulation of sexual activity between married people. Sex can be a commodity- bought and sold on the illegal prostitution market. If you follow the government's twisted logic, the legal activity of sex within marriage could affect prostitution commerce. Thus, sex in marriage could be regulated as part of Congress's interstate commerce jurisdiction.

    In other words, if Congress has the right to regulate private, legal behavior such as a citizen's medpot use, because such use might have a faint connection with or affect on some for-profit business somewhere else, then Congress can regulate sex and virtually everything else.

    Raich's lawyers argue that federal regulation and federal intervention in a legal non-commercial California cannabis garden is a violation of the constitution. One of Raich's lawyers, Randy Barnett, sees this case as a massive test of the power of the federal governmenta test of whether there will be limits on the power of the central government. If the Court upholds the Justice Department by ruling against Raich, experts argue, the precedent will be a huge expansion of the Commerce Clause, and will give the federal government power to regulate almost anything, no matter how private, no matter how non-commercial, no matter what voters have voted.

    A win for the feds would erase the distinction between what is national and what is local, and create a completely centralized government run from Washington, DC. In other words, it would create a dictatorship!

    "A ruling for the government in Raich wouldallow Congress to [regulate] whatever activity it chooses provided that its statutory scheme was sufficiently large enough. In other words, by the government's theory, the more power that Congress claims, the more justified is its claim of power," Barnett says.

    Supreme wimps

    The Supreme Court doesn't like to overturn established laws of Congress, and the current Court has been hostile to marijuana for many years.

    Even if Justices wanted to rule in favor of Raich, they'd have to worry about the anti-judge sentiment festering in Congress.

    Right-wing Republicans like House Leader Tom DeLay (who is enmeshed in a corruption scandal) are gunning for federal judges. DeLay recently criticized Republican-appointed Supreme Court Justice Anthony Kennedy by name, which is an unprecedented attack on the nation's highest court by a member of Congress.

    DeLay, who is a bull-faced brutal bastard of a politician and a former exterminator, said Supreme Court Justice Anthony Kennedy's judicial opinions are "incredibly outrageous," especially since Kennedy was appointed by a Republican and was supposed to do whatever Republican politicians told him to do. DeLay has threatened near-violence against federal judges who disagree with him.

    "We've got Justice Kennedy writing decisions based upon international law, not the Constitution of the United States? That's just outrageous," DeLay said. "And not only that, but he said in session that he does his own research on the Internet? That is just incredibly outrageous."
    International law and the Internet outrage DeLay?! How much more outraged would Boss DeLay be if Kennedy and a majority of his colleagues ruled in favor of Raich?

    Perhaps that's one reason the Raich decision is taking so long. Courtwatchers say the Justices are starting from the assumption that they can't get away with affirming medical marijuana laws, but they don't have good legal reasoning to back up their rejection of medpot. So they are working extra hard on the decision, trying to figure out some way to cover their asses with legal arguments that get rid of medpot while leaving the Commerce Clause intact, honoring state's rights, and sending marijuana proponents home unhappy.

    It's a tough job, but the Justices are lawyers, and lawyers are taught to make weak arguments sound legit. They are taught to lie cleverly; in the service of the drug war, they are likely to do so with Raich as they have done before to other marijuana advocates. Indeed, other drug war decisions made by the Supremes have created a "drug war exception" to the Bill of Rights.

    So the betting is that Raich loses. And observers say that if the Court rules for the feds, then the DEA and other law enforcement agencies will again start busting medpot growers, clinics, and patients soon thereafter. The federal war on medical marijuana will begin all over againwith more raids, more pain, more jail terms, more cut plants.

    There are two other possibilities. The nine-member Court could offer a 4-4 split decision: Chief Justice Rehnquist is the Court's 9th member and he is expected to sit out this decision, making it possible for a 4-4 split. If there is a tie, the benefit goes to Raich, Monson and all other medpot patients in states under the jurisdiction of the original court, which means most of the 11 states that have formally legalized medpot.

    If the Court gives an outright majority ruling in favor of Raich and Monson, medical marijuana growers and patients in any state with legalized medpot would be safe from federal attack. This ruling would completely change American marijuana policy, and would be a giant step towards a more rational cannabis policy in general.

    Few medpot people are openly optimistic about Raich's chances; many marijuana industry insiders expect defeat. If the Court goes against Raich, the medical marijuana community will have nowhere to turn, except for civil disobedience, and regulators.

    The Coalition to Reschedule Cannabis has already started forcing the feds to review marijuana's legal status so it can be treated more like a medicine. This review was boosted by Canadian pharmaceutical approval of the natural cannabinoid extract medicine called Sativex.

    The Coalition's goal is to force the feds to admit that cannabis is a medicine. On the other hand, some marijuana activists fear that Sativex and other non-smoked cannabis drugs could hurt Raich's case. They say the government could refuse to legalize whole marijuana while claiming to demonstrate "compassion" by allowing corporate marijuana extracts marketed by pharmacists and doctors.

    Regardless, the Supreme Court must hand down its Raich ruling by the end of June. Courtwatchers say that the longer it takes, the more chance there is that medical marijuana could emerge victorious.

    If Raich is victorious, California and the other medpot states in the 9th circuit will become safer for pot patients and their growers than Vansterdam or Amsterdam.

    If regulators won't change medpot regulations and if the Supremes refuse to affirm voter rights and medical marijuana rights, then marijuana will continue to be totally illegal in the US as it has been since 1937.

    Acting against the wishes of the majority of Americans, the federal government will implement its anti-marijuana regime with more zeal than ever before. Tens of thousands more people will go to jail, be deprived of medicine, and be otherwise terrorized by federal prohibition of one of the most effective medicines known to humanity.

    Visit Angel Raich's website: www.angeljustice.org

    The American Civil Liberties Union: "Science, not Politics, Should Govern Medical Research"

    "Science, not politics, should govern medical research," says ACLU in challenge to the DEA's marijuana policy. The American Civil Liberties Union (ACLU) issued a press release about the filing of the prehearing statement in the lawsuit against the U.S. Drug Enforcement Agency (DEA) filed by University of Massachutes-Amherst Professor Lyle Craker, objecting to DEA's refusal to issue him a license for a MAPS-sponsored facility to produce marijuana for federally-approved research.

    For more information, see the ACLU statement by Allen Hopper and the MPP statement by Steve Fox.

    ACLU Enters Marijuana Research Dispute

    Washington, DC, Apr. 22 (UPI) -- The American Civil Liberties Union Friday challenged the Drug Enforcement Administration's refusal to allow an alternative source of research marijuana.The ACLU said it filed a statement with a federal administrative law judge opposing the DEA's refusal to allow University of Massachusetts Professor Lyle Craker to grow the alternative source of research-grade marijuana.A hearing before the judge is slated to begin this summer.

    Fox News: Painkiller Warnings Rekindle Debate Over Medical Marijuana

    Originally appearing here.

    Tuesday, April 19, 2005
    By C. Spencer Beggs, FOX NEWS

    [MAPS Notes by Ilsa Jerome]

    The months of recalls and warnings surrounding popular prescription painkillers have done more than frighten consumers, batter drug makers' bottom lines and raise questions about the procedures and criteria by which the Food and Drug Administration approves medications.

    The fact that so many legal drugs pose serious health risks is also reigniting a debate over the medicinal value of other substances illegal drugs, particularly marijuana and what critics believe is the government's continuing resistance to studying their possible benefits.

    Frustrated researchers say the question is not whether marijuana could serve legitimate medical purposes. Marijuana has been looked at for a variety of medical applications. It can relieve intraocular pressure (search) caused by glaucoma (search), and it has been touted as an appetite stimulant for patients undergoing chemotherapy, suffering from AIDS wasting syndrome (search) or dementia.

    Marijuana Fast Facts: Historic Highs and Lows

    More recently, it has been looked at to relieve the neuropathic pain (search) the so-called "phantom pain" of patients with multiple sclerosis.

    The question, researchers say, is whether the benefits of marijuana outweigh the risks of its negative side effects, or whether the maladies can be better treated by other drugs. That's the very question the FDA used to evaluate Vioxx, Bextra and Celebrex, and one that researchers say the government won't let them answer about marijuana.

    "I honestly think they're looking at my age and theyre hoping that if they wait a little bit longer, Ill be retired and someone will have to start this process all over again," said Lyle Craker, 64, director of the Medicinal Plant Program at the University of Massachusetts, who has been trying to get government approval to produce marijuana for federally approved studies since 2001.

    Why Not Pot?

    After years of steadfast refusals, the federal government has been slowly easing restrictions on pharmaceutical research into the medical benefits of some of the countrys most abused recreational drugs. In 2004, the FDA approved two separate studies into medicinal uses of MDMA (search) also known as the psychedelic party drug Ecstasy.

    [MAPS note: Many researchers consider MDMA to belong to a different drug class called the entactogens.]

    A clinical trial at Harvard University will examine whether MDMA can help terminally ill cancer patients talk to their families about their illness and ultimate death. A psychiatrist in South Carolina is studying the drug's effects on women who are victims of rape or other sexual assaults in a private study.

    [MAPS' Note: 1) The study of MDMA-assisted psychotherapy in people with PTSD is open to both men and women who have PTSD as a result of crime victimization, or combat-related PTSD that has lasted for no longer than five years. 2) Both of the studies described above are solely supported through MAPS. However, the study in South Carolina is taking place outside of a university, research institution or hospital, whereas the study of MDMA-assisted therapy in people with cancer-diagnosis related anxiety will take place at a university-affiliated hospital.]

    But researchers who want to study the nation's most abused recreational drug marijuana are still in last place in the research race. Many researchers blame government bureaucracy and the conflicting missions of different government agencies that make obtaining marijuana for medical research nearly impossible.

    "The FDA has approved marijuana studies and, if it were possible to get marijuana in order to conduct the studies, there would be a lot more research proposed and the FDA would approve more," said Steve Fox, director of government relations for the Marijuana Policy Project (search), a lobbying group that seeks to legalize medical marijuana and reform drug-related crime laws. "Our problem is that the [Drug Enforcement Agency] is blocking effective research from moving forward."

    Dr. John Halpern, the psychiatrist who is heading up Harvard University's study of MDMA's effects on anxiety in dying cancer patients, said that the government's system for distributing marijuana for medical use creates difficult hurdles for researchers.

    For example, the MDMA Halpern is using in his study is produced by companies that are contracted by the government, and given the appropriate licenses, to do so. The job of contracting and overseeing the production of cannabis for the government, however, is the domain of the National Institute on Drug Abuse. But critics say the NIDA has a conflict of interest because its mission is to prevent the use of marijuana regardless of the purpose.

    [MAPS' Note: MAPS contracted the manufacturer of the MDMA that is used by Michael Mithoefer MD, and that will be used by John Halpern MD, and not the government. However, it is true that people conducting research with any scheduled substance save marijuana can rely one anyone with the license to manufacture the drug.]

    "[NIDA's] mission statement isnt to look into any therapeutic effect from the drug of abuse, its to look into the harms," Halpern said. "So [they see the marijuana it controls as being] diverted to a non-NIDA funded study, and NIDA has that marijuana earmarked for more important things from their perspective."

    Like Ecstasy, marijuana is classified as a Schedule I drug under the 1970 Controlled Substance Act, a group that includes heroin and LSD, and has been deemed by the government to have no medical benefit and to be highly addictive. But unlike other Schedule I drugs, which can be obtained through government-licensed contractors, marijuana can be legally obtained for research only from the NIDA.

    Craker filed his application to produce medical marijuana for federally approved studies in 2001. He finally received a rejection in 2004, despite strong showings of support from Senators John Kerry, D-Mass., and John Edwards, D-N.C.

    "The DEA is attempting to follow their mandate, which I am sure is to keep marijuana off the streets for recreational use and they're doing the best they can there," Craker said. "They think the medical marijuana we produce would be for street use, which is not true, but I think thats their opinion."

    Craker and other researchers frustrated by the government's handling of medical marijuana research applications filed a suit against the DEA and the National Institute on Drug Abuse in July of 2004.

    The FDA, DEA and Department of Health and Human Services declined to comment for this story.

    Of course, researchers like Halpern emphasize that the scheduling system was put in place with the intentions of protecting the public from junk science studies and keeping illicit drugs away from the public. But advocates for the research say political pandering, corporate greed and the power and influence of the pharmaceutical industry corrupt the system. The race to bring new drugs to the market is not only concerned with the health of the populace, they say, but also with the health of drug companies' stock portfolios, and a drug that patients can produce and use without their help is not good for drug makers' bottom line.

    "The federal government sits by while the FDA approves Vioxx, which leads to the death of many people, while marijuana in its history has never caused an overdose death," argues Fox.

    Greg Lewis, co-author of the self-help book "End Your Addiction Now," says that with the pharmaceutical industry spending $38.8 billion on research and development in 2004, medical marijuana is superceded by drugs produced through proprietary research.

    Lewis, however, is skeptical that research into medical marijuana amounts to much more than backdoor legislation for groups whose real agenda is legalizing the drug across the board.

    "With just an absolute cornucopia of pharmacological substances out there for the purposes of dulling pain and making pain tolerable, its unimaginable to me that marijuana would be the only way that certain people can get relief from their pain," Lewis said.

    A Controversial History

    Controversy surrounding the medical benefits of marijuana dates back to 1937, when cannabis was officially prohibited by the federal government. Prior to that, THC (search), the active ingredient in pot, was used in at least 27 legal medications and was one of the primary ingredients in commercial painkillers until the commercial production of aspirin began in 1899.

    Since it was outlawed by the feds, government opposition has largely prohibited research into the medical efficacy of marijuana. But interest in its medicinal potential was rekindled in the 1990s, when anecdotal reports surfaced that marijuana helped treat the nausea, loss of appetite and chronic pain suffered by AIDS patients.

    In 1997, the FDA, in conjunction with the DEA, gave researchers at the University of California the OK to perform the first medical marijuana study in 15 years.

    Currently there are 13 clinical studies and sub-studies of medical marijuana underway in the U.S., according to the Center for Medicinal Cannabis Research.

    The U.S. drug company Indevus, based in Lexington, Mass., is testing a pain reliever derived from marijuana that lacks the psychotropic effects of the smoked plant.

    More research is moving forward overseas. A British company, GW Pharmaceuticals, is on the verge of getting the Canadian governments stamp of approval to market a marijuana-based mouth spray to treat nerve pain experienced by multiple sclerosis patients.

    And trials of a synthetic marijuana-derived painkiller, ajulemic acid, are going ahead in France and Germany.

    But in the U.S., the research still faces a steep uphill battle, not likely to be helped along by the resounding defeat voters in several states delivered to ballot initiatives to decriminalize marijuana in 2004. A March 2005 report by the Substance Abuse and Mental Health Services Administration showing a rising trend in the number of people seeking treatment for marijuana addiction is not likely to benefit research advocates either.

    Meanwhile, the government is waging its war on drugs as vigorously as ever, and no one expects the government to revise its position on pot.

    Yet, some troops who have returned from the front lines of the drug war are doing just that.

    Jack Cole, a 26-year veteran of the New Jersey state police who served 14 of those years in the narcotics bureau, now serves as director of Law Enforcement Against Prohibition, a lobbying group of former drug-busters who believe the U.S. "war on drugs" has failed and supports sweeping reforms of the nation's drug policy.

    Cole contends that scheduling creates a system that discourages objective research into drugs and their medical effects.

    "There are certainly enough people out there who are already using Schedule I drugs [for medical purposes], who would benefit from being in a government study of their use," Cole said.

    New York Times: Medicinal Marijuana On Trial

    Originally appearing here.

    The New York Times published "Medicinal Marijuana On Trial", discussing medical marijuana research and Ashcroft v. Raich.

    March 29, 2005 New York Times
    By DAN HURLEY

    Note on medical marijuana research in the US

    Medical marijuana is now legal in 11 states, and bills to legalize it are pending in at least 7 more. The drug is also at the heart of a case being considered by the United States Supreme Court.

    Yet there remains much confusion over whether marijuana in fact has any significant medical effect.

    "People subjectively report benefits," said Dr. Joseph I. Sirven, an epilepsy specialist and associate professor of neurology at the Mayo Clinic College of Medicine in Scottsdale, Ariz. "There's a whole Internet literature suggesting what a wonderful thing it is. But the reality is, we don't know."

    In an editorial last year in the journal Neurology, Dr. Sirven pointed out that the best studies of marijuana's effects on humans have so far shown little objective evidence of benefit in patients with epilepsy or multiple sclerosis. And a growing body of research indicates that, at least in teenagers, heavy marijuana use over a period of years significantly increases the risk of developing psychosis and schizophrenia.

    In the Supreme Court case, two California residents, Angel McClary Raich and Diane Monson, brought a suit against federal officials in October 2002 to defend their use of marijuana after six of Ms. Monson's marijuana plants were seized and destroyed by the Drug Enforcement Administration.

    The federal government, which considers marijuana illegal under the Controlled Substances Act, asked the Supreme Court to overturn a Court of Appeals ruling that supported the two women. Oral arguments were heard just after Thanksgiving, and a ruling could come any day.

    Ms. Raich's physician, Dr. Frank Henry Lucido of Berkeley, Calif., asserted in an affidavit that Ms. Raich risked death if she was denied the marijuana to treat nausea, anorexia, severe chronic pain and other disorders brought on by a variety of illnesses, including post-traumatic stress disorder, asthma and an inoperable brain tumor. On a Web site created on her behalf, www.angeljustice.org, Ms. Raich says she joined the lawsuit "in order to save my life."

    While little scientific evidence supports such a lifesaving role for marijuana, many studies have found modest benefits in patients' subjective measures of pain, sleep, nausea, appetite, tremors and muscle spasms.

    "There's nothing better for nerve pain than marijuana," said Phillip Alden, 41, a writer in Redwood City, Calif.

    Twice a month, he spends about $200 to buy a half ounce of high-potency marijuana from one of San Francisco's medical marijuana buyers' clubs.

    He smokes it three or more times a day to treat pain from a back injury, and to improve his appetite and reduce nausea associated with AIDS and the antiviral drugs he takes for it. It has even checked the progression of his peripheral neuropathy, he said.

    Two recent surveys, also published in Neurology, have documented widespread use of marijuana among Canadian patients and a widespread belief in its benefits.

    The first survey, of 220 patients with multiple sclerosis, found that 36 percent had used marijuana to treat their symptoms, and that 14 percent were using it at the time of the survey.

    The second survey, of 136 patients attending the University of Alberta Epilepsy Clinic, found that 21 percent had used marijuana in the previous year. Just over two-thirds of the active users said it decreased the severity of their seizures and slightly more than half reported a decreased frequency of seizures.

    But the lead author of the epilepsy study said it proved only that some patients believed in marijuana, not that it or its active ingredients, called cannabinoids, actually worked.

    "There's not been a randomized, controlled trial demonstrating that marijuana or any cannabinoid is any more effective in controlled seizures than a placebo," said Dr. Donald W. Gross, director of the University of Alberta's adult epilepsy program.

    Although doctors may now prescribe marijuana in Canada for certain disorders, including epilepsy, Dr. Gross said he had never done so. "It's terribly complicated from a physician's standpoint, and somewhat frustrating," he said. "We have a product that has been legitimized without any evidence of efficacy."

    A large body of research in test tubes and animals supports the view that cannabinoids have anticonvulsive properties. But while a 2003 study of 657 patients with M.S. published in the journal Lancet found significant improvements in subjective reports of muscle spasms and pain, it found no improvement by objective measures after 15 weeks.

    A follow-up report on the same group of patients did show modest benefit after 12 months, but the researchers said that the results should be interpreted cautiously, because the study had been intended to test only short-term benefits.

    Dr. David Baker, a professor at the Institute of Neurology in London, has found beneficial effects of cannabinoids in mice who have an artificially induced type of multiple sclerosis. But, he said, "Showing clinical benefit in humans has been an elusive beast."

    "At best there is a narrow therapeutic effect before the side effects become unacceptable for many people," he said. " What is clear is that there have been no dramatic improvements overall."

    Dr. Kenneth P. Mackie, a professor of anesthesiology at the University of Washington, has devoted 15 years to studying the brain's response to cannabinoids through specialized brain receptors called CB1 and CB2.

    "There's a whole bunch of theoretical reasons suggesting there would be a benefit for marijuana on a variety of conditions relating to pain and neuroinflammation," Dr. Mackie said. "But the clinical studies just aren't there."

    Far stronger evidence exists for a harmful effect of marijuana in teenagers who use it early and often. "We know that cannabis is a contributory cause of schizophrenia," said Dr. Robin M. Murray, a professor at the Institute of Psychiatry in London and the co-editor of a new book, "Marijuana and Madness: Psychiatry and Neurobiology."

    In a 2002 study published in the British medical journal BMJ, Dr. Murray reported that New Zealand teenagers who started smoking marijuana before age 15 and continued doing so on a daily basis raised their risk of developing psychosis and schizophrenia from about 2 percent to as much as 10 percent.

    The study, he said, ruled out the possibility that the teenagers who used marijuana were also those who were more likely to develop schizophrenia, whether or not they used the drug.

    Still, "You have to take a lot to go psychotic," Dr. Murray said. "But with five joints a day for five years, an amount that is increasingly common in Europe, you're seriously increasing your risk of schizophrenia."

    He added that even so, the risk dropped sharply as people aged, so that most chronically ill people who used marijuana for medical purposes were unlikely to experience psychosis as a result.

    Research in the United States has been greatly hampered by legal restrictions.

    In 1997, Dr. Donald Abrams, an oncologist and assistant director of the Positive Health Program at the University of California at San Francisco, became the first doctor authorized by the National Institute of Drug Abuse to receive marijuana to conduct research to determine if it provided medical benefits.

    Now more than a dozen California researchers are studying it under the auspices of the University of California's Center for Medicinal Cannabis Research.

    "Cannabis has a 5,000-year history of medical use," Dr. Abrams said. He said he had completed three studies in patients with H.I.V. that showed no negative effects on their immune systems or on the functioning of the protease inhibitor drugs they were taking.

    He is now trying to show that marijuana has a beneficial effect on immune functioning, he said.

    The patients were brought into the hospital to smoke marijuana under medical supervision.




    Note on Medical Marijuana Research in the US
    One point not mentioned in this piece is that currently, all researchers interested in conducting medical research with marijuana must use cannabis supplied by National Institute on Drug Abuse (NIDA), which has a monopoly on marijuana permitted for use in research in the US. MAPS has been seeking to create an alternative source of marijuana for medical research, a process that has been stymied by the DEA's denial of approval for the proposed facility. MAPS has initiated a lawsuit against the DEA seeking to pressure DEA to reverse its decision and issue a license to Prof. Lyle Craker, UMass Amherst, for a MAPS-sponsored marijuana production facility.

    Read more about MAPS' efforts to support medical marijuana research.

    DEA Files Prehearing Statement in the DEA Administrative Law Judge Hearing

    DEA files its prehearing statement in the DEA Administrative Law Judge (ALJ) hearing. The ALJ hearing is taking place because of a lawsuit that Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant and Soil Sciences, has filed against DEA for refusing to grant him a license for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. In DEA's initial "Order to Show Cause" explaining its rationale for rejecting Prof. Craker's application (see entry for Dec. 10, 2004), DEA claimed that it would be against the public interest for it to approve the license and that, in any case, US international treaty obligations prevented DEA from issuing the license. Surprisingly, the prehearing statement speaks only to the issue of public interest and says nothing about DEA's international treaty claims. Could it be that DEA realizes it has a weak case on that point? Prof. Craker has until April 22 to file his prehearing statement. Then the ALJ will schedule a conference to meet with lawyers for both parties to discuss the case and set the date for the formal hearing itself.

    Medical Marijuana Research Update: February 2005

    A new medical marijuana DEA Administrative Law Judge hearing was formally launched on Monday, February 7. Prof. Lyle Craker, UMass Amherst, filed a request for a hearing about DEA's proposed rejection of his application for a license to establish a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Our goal is to break the government's monopoly on the supply of marijuana that can be used in FDA-approved research, thereby creating the proper conditions for a $5 million, 5 year drug development effort designed to transform smoked and/or vaporized marijuana into an FDA-approved prescription medicine.

    MAPS has arranged for a consortium of lawyers to represent Prof. Craker on a pro-bono basis. These lawyers include lead counsel Julie Carpenter of Jenner and Block (DC law firm), Allen Hopper, ACLU Drug Law Reform Project, and Emanuel Jacobowitz of Steptoe & Johnson (DC law firm). The estimated value of this pro-bono support is more than $100,000.

    Within about a week, the DEA ALJ office will issue a timetable for the submission of prehearing statements, with DEA being given 3 weeks and Prof. Craker being given 6 weeks, ending about March 28 or so. The ALJ will then review the prehearing statements and schedule a meeting with the lawyers to discuss the scope of the case, probably taking place sometime in April. At that meeting, the date for the hearing itself will be set. Most likely, the hearing will take two days and take place in DC in late spring/early summer.

    The two main issues to be argued are 1) whether it is in the public interest for there to be a facility at UMass Amherst producing marijuana for federally-approved research and 2) whether US international treaty obligations permit DEA to issue a license to a privately-funded production facility.

    It took suing the DEA for "unreasonable delay" in the DC Circuit Court of Appeals to get DEA to finally reject Prof. Craker's application, after 3 1/2 years of delay. We're delighted to have finally gotten the opportunity to argue this issue on the merits.

    New Scientist: Cannabis: Prescribing the Miracle Weed

    Originally appearing here.

    The New Scientist publishes "Cannabis: Prescribing the Miracle Weed" by Clare Wilson. The initial MAPS-sponsored medical marijuana research efforts of Dr. Donald Abrams are discussed though MAPS is not mentioned.

    New Scientist (UK)
    Page: 38
    Author: Clare Wilson

    The Drug Can Be a Lifeline, and a Fortunate Few May Soon Get It on Prescription. but Why Has It Taken So Long?

    I have had patients commit suicide because they said life had no meaning for them any more," says William Notcutt, an anaesthetist at James Paget Hospital in Great Yarmouth, Norfolk, on England's east coast. Notcutt specialises in treating patients in severe long-term pain. The causes are varied, ranging from spinal injuries to multiple sclerosis, but most of the patients have one thing in common: existing medicines don't help them.

    "It's not just the pain, it's also what it does to your life," Notcutt says. "You've lost your job, you have financial problems, your spouse is fed up. I hear these heart-rending stories of people whose lives are crap."

    If there is one thing more frustrating for a doctor than being unable to deal with a patient's problem, perhaps it is knowing that there is a drug that could help - but they are not allowed to prescribe it. For Notcutt that drug is cannabis. Many patients with difficult-to-treat conditions use cannabis to relieve their symptoms, but in most parts of the world that makes them criminals. Otherwise law-abiding citizens dislike having to get their treatments from drug dealers. And the quality of the medication they get that way is variable to say the least.

    But in the next few weeks Canadian regulators will decide whether to approve an under-the-tongue cannabis spray called Sativex for multiple sclerosis (MS) patients. As the world's first prescription pharmaceutical made from marijuana, it would at last allow patients to get their therapy in a safe and consistent formulation. The product could become available in the UK in a year or so, and its British manufacturer, GW Pharmaceuticals, is expected to file for approval soon in Australia and New Zealand.

    Sativex will not bring any miracle cures, and in countries like the US where official hostility to marijuana is ingrained, patients may have a longer wait for its benefits. All the same, the availability of a cannabis preparation as a prescription medicine will mark a milestone in a decades-long battle by doctors and patients for public acceptance of medical cannabis use.

    Marijuana use has a long history. For thousands of years, people have been harvesting the seeds for food and oil, and making rope from the fibres.

    The plant is used in traditional medicine all over the world to relieve pain and muscle spasms, to prevent seizures and to aid sleep. It may also alleviate nausea - though it can sometimes trigger nausea in new users - and it can boost appetite.

    But the drug is best known for its effects on the mind: it is an intoxicant that makes people feel happy and relaxed, and over the past century its recreational use has become increasingly popular in the west. Cannabis is not very addictive and its harmful effects are mainly on the lungs, from smoking. In some users it can trigger delusions and hallucinations, and there is debate about whether it can cause longer-term psychiatric problems in a small minority. In the early 20th century, most western governments responded to what they saw as the growing menace of marijuana by outlawing it.

    As for medicinal use, cannabis came to be seen as an obsolete herbal remedy with unpredictable potency. It disappeared from the US Pharmacopeia and National Formulary in 1941, and the British National Formulary in 1971.

    Until the late 1980s, when Notcutt began investigating the medicinal use of cannabis, research on the drug was focused mainly on establishing its dangers to people who used it recreationally, or its effects on animals.

    Notcutt's interest grew out of his wish to find something new to deal with his patients' chronic pain. He found repeated references to the drug in historical medical texts on pain relief, and a growing body of research on animals showed that the main active chemical of cannabis, tetrahydrocannabinol (THC), bound to specific receptors in the brain.

    In 1982 a form of synthetic THC had been licensed for relieving nausea after cancer chemotherapy, so Notcutt's first step was to investigate this for pain.

    He began a small trial in his worst-affected patients, mostly people with spinal injuries. Some of them said THC helped; some of them said it made them feel dreadful. Others said it wasn't as good as the "real stuff". Thus Notcutt was introduced to the underground world of medical marijuana use. Even in sleepy Norfolk he found a small subculture of people who were getting what they viewed as an essential medicine from their local drug dealers.

    Notcutt began seeing growing number of MS patients, who said cannabis relieved their pain and muscle "spasticity" - spasms and stiffness - and helped them sleep. The next step, Notcutt says, was to find a better way to give the patients what they wanted. In the early 1990s he and his team began exploring how they might carry out a clinical trial of cannabis.

    They immediately ran into difficulties, because of the drug's illegal status and the resulting haphazard supply chain. "Are you going to use any old thing that comes off the Felixstowe docks?" he asks. "What's the quality, how do you standardise it?" They also failed to come up with a safe and effective way to administer the drug. Taken orally, marijuana's potency varies markedly and it doesn't become effective for at least an hour.

    Smoke it, and you inhale a bunch of cancer-causing chemicals just as you do when smoking tobacco.

    In California, Donald Abrams, an HIV specialist at San Francisco General Hospital, was facing similar problems. He was interested in the possibility that cannabis could help people with AIDS stave off catastrophic weight loss. "They'd get loss of appetite and diarrhoea and just sort of waste away," Abrams says. "It was a terrible way to go." In 1992, synthetic THC was licensed for combating the nausea that is a symptom of AIDS, but, as with MS patients, many found marijuana more effective. Like the English patients, they faced supply problems. After a 70-year-old volunteer helper at his clinic was arrested for giving patients cannabis-laced brownies, Abrams decided to carry out a formal trial of marijuana.

    If anything, he faced even stiffer opposition than Notcutt. In 1994 the team asked permission from the US Drug Enforcement Administration to obtain cannabis from a Dutch firm called Hortapharm but was turned down. They next approached the National Institute on Drug Abuse (NIDA), the only domestic body allowed to provide marijuana for research. Again they were rejected, partly because officials said they feared patients might sell their drugs on the street, and partly because the institute was more interested in investigating the harm from recreational cannabis use. A third proposal to NIDA, in 1996, was also turned down.

    By then, official attitudes in the UK were showing signs of becoming more favourable to medicinal marijuana. Paradoxically, this stemmed partly from anti-drug sentiment. Increasing numbers of MS patients using marijuana were ending up in court, and many were given light sentences or effectively let off. Concerned that this was bringing drug laws into disrepute, the government started to make positive if cautious noises about legalising medicinal cannabis if a pharmaceutical form of it could be developed.

    At the same time, medical research into cannabis was gaining respectability globally as details began to emerge about the cannabinoids our own bodies produce (see "Natural high"). But such research was almost entirely carried out by academics. What pharmaceutical firm would want to risk investing in such a politically controversial and financially uncertain field?

    Enter Geoffrey Guy, a businessman with a background in pharmaceuticals who was looking for his next venture. Cannabis's long history ruled out the normal route for making money from a drug: by patenting it as a therapy. But Guy realised he could gain market exclusivity by developing a drug from cloned cannabis subspecies to which he owned the plant-breeders rights. Guy recalls that when he approached government officials for a licence to research his idea, they needed little convincing. "They were almost relieved that a company had turned up," he says. "I was pushing on a door that sprung open."

    His new company, GW Pharmaceuticals, bought several strains of cannabis with consistent high drug yields from Hortapharm and by the late 1990s was growing and harvesting a crop of 5000 plants. To avoid the variable absorption of ingested cannabis, the firm decided to produce a spray to be applied under the tongue, where it would be quickly absorbed into the bloodstream. And so Sativex was born.

    Notcutt agreed to carry out a clinical trial. But despite increasing public acceptance of the idea of using cannabis medicinally, he found it hard to get the study approved by his hospital.

    It took about a year to get the go-ahead for a small three-month study in people, some with MS, for whom existing treatments were ineffective against chronic pain. The results, published last year (Anaesthesia, vol 59, p 440), showed that Sativex provided significant pain relief for 28 of the 34 patients in the study. GW began larger trials on people with MS or chronic pain, as well as pilot studies in people with cancer.

    At this point GW began looking for a pharmaceutical company with the muscle and money to help market Sativex. Rumours circulating at the end of 2002 suggested that Guy was in talks with a major-league company, perhaps GlaxoSmithKline or AstraZeneca. Guy won't say, because before the deal was done, the firm got cold feet. They were spooked by the "c-word", Guy says. Cannabis was too controversial for the American board members. GW had to find another partner, and in May 2004 it finally struck a deal with the German-based multinational Bayer.

    In the meantime, the larger clinical trials were starting to yield positive results. GW has applied for a licence from the Medicines and Healthcare Products Regulatory Agency (MHRA) to sell the drug in the UK. The MHRA has asked for a "confirmatory study", to prove that the reduction in muscle spasticity seen with Sativex brings meaningful benefits to patients. GW says this will take several months.

    But it is in Canada, where patients can legally use cannabis for medicinal purposes, that Sativex is closest to being licensed. The preparation was given preliminary approval in December, and GW and the Canadian regulatory agency are now thrashing out exact terms for a licence to allow Sativex to be sold as a prescription drug. Assuming they reach agreement, Sativex could reach pharmacies within a couple of months. GW says it will be applying for licences in "other Commonwealth countries", probably Australia and New Zealand.

    It may not be long before Sativex is joined by other cannabis preparations. A non-profit group, the Institute for Clinical Research in Berlin, Germany, is developing oral cannabis capsules, called Cannador. In November 2003 a study in 630 MS patients produced equivocal results (The Lancet, vol 362, p 1517). While the formal scoring system for measuring muscle spasticity indicated that Cannador performed no better than a placebo, the patients themselves felt it helped. Martin Schnelle, who conducted the trial, says that there are widely acknowledged problems with the formal scoring system used. "There are medicines that are already licensed for treating spasticity that have failed on this scale," he says. The group is planning a further study this year in which the patients' reports will be the main measure by which the drug's effectiveness is judged.

    In the US, the NIDA has become more open to research on the benefits of cannabis, and Abrams is studying its ability to ease pain due to nerve damage in HIV, and nausea and vomiting after cancer chemotherapy. He is investigating a device called the Volcano, which heats cannabis to the point of vaporisation without burning it, which he says is less harmful than smoking it in a joint because it releases fewer carcinogens. While Abrams welcomes products like Sativex, he suggests that some people will always prefer marijuana to a commercial preparation - not least because they can grow it themselves.

    But however cultural attitudes to street or home-grown cannabis change, its availability in standardised, licensed preparations such as Sativex and perhaps Cannador will be the key to its wider medical use. GW is planning studies of its possible benefits for people with a range of conditions from Crohn's disease to rheumatoid arthritis and heroin addiction. If positive, Canada's decision will signal a big change in the status of cannabis, says Philip Robson, the firm's medical director. "It's the dawning of a new clinical research era."




    Read more about MAPS support of medical marijuana research in the US.

    Common Sense for Drug Policy

    Common Sense for Drug Policy just placed an ad in 6 or 7 major political magazines (Nation, New Republic, Weekly Standard, etc) about MAPS' lawsuits v. DEA/HHS.NIDA.

    The Drug Enforcement Administration (DEA) Recently Turned Down a Research Bid

    The Drug-Free America Foundation, Inc. reports on its website on the DEA rejection of the UMass Amherst application for a license to establish a facility to produce marijuana for federally-approved research.

    The Drug Enforcement Administration (DEA) recently turned down a research bid from the University of Massachusetts asking to grow their own marijuana for medical research testing. Researchers at the University of Massachusetts complained that the marijuana used for research that is supplied by the government is weak and very difficult to access, which is why they requested permission to grow their own. They need approval from the DEA for this to happen. The Food and Drug Administration (FDA) has approved capsulated forms of tetrahydrocannabinol (THC), one of the active ingredients in marijuana, for cancer and AIDS patients suffering nausea and appetite loss. Proponents of medical excuse marijuana claim that the inhaled form is more effective and contains more active ingredients that aid in the relief of the above mentioned symptoms. However, there is no scientific evidence showing this to be the case. The American Medical Association and every major health organization in the country have rejected marijuana as a medicine. Check out the marijuana section for more information.

    The Oregonian: Stop Blocking Marijuana Research

    The Oregonian
    January 7, 2005

    An editorial published by The Oregonian, "Stop Blocking Marijuana Research", supports the UMass Amherst project.

    The agencies that can give permission to conduct research into medicinal marijuana are most hostile to that research


    Oregonians have made clear, in elections and in public opinion polling, that they favor careful use of marijuana for medicinal purposes. They also made clear, in the 1998 Ballot Measure 67 and the 2004 Ballot Measure 33, that they are uninterested in going beyond current state law to legalize marijuana for nonmedicinal purposes.

    It will be hard for medicinal marijuana to be properly evaluated and applied if legitimate researchers can't get legal supplies for human studies to assess the health effects of the drug and unless versions of the drug can be standardized for sale if recommended by doctors.

    It is our strong impression that the federal Drug Enforcement Administration is conducting a rear-guard action against useful research efforts. This occurs despite two federal court actions in 2003 that, in effect, affirm that the federal Controlled Substances Act doesn't trump state medical marijuana laws or allow federal agents to revoke the licenses of doctors who legally recommend marijuana.

    The delay continues also despite U.S. Supreme Court Justice Stephen Breyer's recent advice in Ashcroft v. Raich that patients seek Food and Drug Administration approval for marijuana as a medicine. But for the FDA to approve marijuana, researchers would need to test marijuana identical to what would be sold to patients -- from the same source, the same genetic strain and grown under the same conditions.

    The National Institute on Drug Abuse is the only legal source for marijuana for research, but NIDA's marijuana is available only for research, not for distribution -- leaving scientists with no way to test the same product that would be sold. An effort by the University of Massachusetts to solve this problem by establishing a facility to grow marijuana specifically for research aimed at developing it as a prescription drug was blocked by the federal DEA on Dec. 10 (www.mpp.org/pdf/DEA.pdf).

    The bottleneck for legitimate researchers is that the agencies that are hostile to medicinal marijuana are the gatekeepers of its supply. Two suggestions:

    Federal agencies such as the DEA should stop blocking legitimate research that is conducted with proper security.

    Until the agencies stop erecting unreasonable barriers, the Supreme Court and federal appeals courts should recognize that FDA approval is not currently a viable option, so patients need to be afforded full protection of their states' laws.




    Read more about MAPS' support of medical marijuana research, including the proposed marijuana-growing facility at UMass Amherst.

    Dr. Lyle Craker has received a 30-day extension

    Dr. Lyle Craker has received a 30-day extension on the deadline for submitting a request for a DEA Administrative Law Judge hearing concerning DEA's decision to deny his application for a license to establish a MAPS-sponsored marijuana production facility at UMass Amherst. The new deadline is February 8, 2005. While we were extremely reluctant to be responsible in any way for further delays in this process, which DEA has successfully managed to delay already for 3 1/2 years, we do not as of yet have our complete legal team assembled. We are seeking pro-bono representation which takes time to obtain. We have been assured that Dr. Craker's request for a hearing will definitely be granted once we submit it, so it's all the more important that we have our legal team ready to work on the case before we submit the request for the hearing.

    San Diego City Beat: Feds v. Meds

    San Diego City Beat
    January 5, 2005

    Originally appearing here.

    The San Diego City Beat published a discussion and analysis of a recent legal challenge to the HHS to change how marijuana is scheduled, with the legal challenge relying on a 2002 law, the Data Quality Act, originally crafted to benefit the tobacco industry and other corporate interests.


    by Dean Kuipers

    A little-known law may finally challenge the feds' 30-year stall in recognizing medical marijuana. But it also raises a big question: Who decides what is medicine?

    By now, America has heard a lot about Oakland, Calif., medical marijuana patient Angel McClary Raich. In arguments Nov. 29 before the U.S. Supreme Court, Raichpossibly the most sympathetic party to ever come before the High Court, a 38-year-old mother of two with a list of ailments including an inoperable brain tumor, wasting syndrome, uterine fibroid tumors, scoliosis, paralysis, endometriosis, and moregot her chance to nail outgoing U.S. Attorney General John Ashcroft et al. for trying to take away the only medicine that has helped her. Her case has pitted California's Compassionate Use Act of 1996, which legalized limited medical use of marijuana, against the federal Controlled Substances Act, under which all marijuana is illegal. For Raich, cannabis is the only treatment (out of 35 medicines tried) that has allowed her to keep her weight up, and her doctor says that losing it would be a death sentence.

    The case is a mighty test of states' rights, which this court has favored, but the barrage of questions with which the justices peppered Raich's lawyer, Boston University professor Randy Barnett, revealed more than the possible end of their so-called "federalist revolution." They revealed the interior machinations of a kind of regulatory fever dream in which no government agency will confront the increasingly embarrasing mass of scientific evidence in favor of pot's accepted use as medicine.

    Justice Stephen Breyer highlighted the problem in his questioning, suggesting this wasnt a matter for the courts. If Raich et al. were unhappy with the federal Drug Enforcement Administration kicking down their doors and throwing them in jail, possibly to die, he argued, why didn't they go to the Food and Drug Administration (FDA) "and take marijuana off the list that would be the obvious way to get what they want." In other words, it should be left to the regulatory agencies. "Isnt medicine by regulation better than medicine by referendum?" he quipped.

    "They don't let you answer any of the questions in any detail, so I basically pointed him to our amicus brief, which chronicles the obstructions that the government has put in the way of medical cannabis research," says Barnett. Holding up both this and a 1999 report by the Institute of Medicine, commissioned by drug czar John Walters at the White House Office of National Drug Control Policy, which goes into some detail about marijuana's therapeutic effects and the way research has been stymied for political reasons, Barnett stood in the courtroom and stared at an impossible tautology: the courts don't want to rule on medical pot because it should be a regulatory matter, and the regulatory agencies refuse to review it, forcing it repeatedly into the courts. Meanwhile, the lives of otherwise law-abiding citizens hang in the balance.

    For more than 30 years, activists and federal regulators have been locked in a slow and outlandishly tortuous legal struggle over the medical use of marijuana and who, if anyone, has the authority to change marijuana's status under the 1970 Controlled Substances Act from a Schedule I narcotic, meaning it has "no accepted medical use," to one of four less-restrictive categories. Even though comments like Breyer's make it seem as though there is a clear procedure for this, and a DEA judge even ruled in 1988 that it would be illegal not to reschedule given the preponderance of evidence, the DEA has dug its heels in and. defying logic, science, and, apparently, the law, mutely refused to budge.

    Three months ago, however, a new challenge to this chronic obstruction was filed under a little-known 2002 law called the Data Quality Act (DQA) that may turn out to be the pry bar that gets the feds to act. The act is designed to force regulatory agencies to base decisions on the best available science. Although it's not part of the Raich case and has received relatively little notice in comparison, it may turn out be her salvation.

    "I hope that what this does is wake them up to doing a fair review of the current [rescheduling petition]," says Hilary McQuie, campaign director for Americans for Safe Access, who filed the Data Quality Act petition. "Because I don't feel like I should have to take a regulatory agency to court. I feel like they should do a full scientific review.

    "When everyone's saying the FDA should just do this, do they not know that the DEA is in the way of the FDA doing this?" adds McQuie. "It shouldn't be this hard. It shouldn't be law enforcement agencies that make medical scientific decisions. But right now it is set up that way."

    "Their gimmick is that they won't let researchers have cannabis for research," says Barnett. Though the FDA's recommendations regarding drugs can allegedly force the DEA to at least consider rescheduling marijuana, the two agencies work together to make that impossible. Every potential avenue is only a loop. No legal pot, no research; no research, no legal pot. "That's the game that's played: if you object to the regulatory process, they say, 'Yeah, but there's judicial review.' If you get to judicial review, they say, 'Oh, well, look back at the regulatory process; they're the experts, not us.'"

    Signed by President Bill Clinton on his way out the door as part of the Paperwork Reduction Act, the DQA was a corporate gimme that was meant to help industries fight meddlesome regulations. Written by former U.S. Office of Management and Budget head Jim Tozzi and backed by a load of big-tobacco money, it was meant to thwart or delay decisions that cost industries money. Manufacturers, for example, could use the DQA to delay environmental regulations that were based on the Precautionary Principle, protecting people before the scientific testing of toxins or whatnot were complete, which could take years. The act was designed to risk public health while it saved industry a lot of hassle and money.

    But the idea that regulatory agencies can only act on the best science, which made many environmental and consumer groups nervous, was also easily turned to activist purposes. In 2003, Americans for Safe Access began studying the law for the potential to force the U.S. Department of Health and Human Services (HHS) - the FDA's parent agency - to change its statements about pot having no accepted medical value. The group filed its petition with HHS on Oct. 4 and, by way of press conference, staged a civil disobedience at the doors of the HHS building on Oct. 5, where 14 patients and advocates chanted "Schedule I to Schedule III, cannabis is helping me" and promptly got arrested.

    "It certainly seems like a novel approach," says Paul Armentano, spokesperson for the National Organization for the Reform of Marijuana Laws (NORML). "In theory, it presses all the right buttons. But when you're talking about marijuana, there's 'in theory' how these things should work and then there's 'in practice' how they do work. But I believe it's the first time that the DQA has been used in such a manner."

    The Data Quality Act's key provision, which makes it an improvement on the Administrative Procedures Act that predated it, is that the DQA is time-limited, so there's less foot-dragging allowed. HHS has 60 days from the date of filing to give an answer, or at least file for a limited extension to make a decision. That date was Dec. 6. It also provides for judicial reviewyes, 'round and 'round and then back in the courts. But this time, it's back to the ASA's home court, the 9th Circuit in California, which is perceived as a friendly court.

    This is the court that ruled in favor of Angel Raich, and that made medical marijuana legalagainin California.

    At least, that's what they think will happen. No one's really totally sure. No Data Quality Act case has ever gotten that far.

    A Legal Quagmire

    The Dec. 6 deadline came and, as expected, HHS asked for a 60-day extension, which is evidently the most they can get before the legal wrangling begins. Americans for Safe Access Executive Director Steph Sherer met with representatives for HHS Secretary Tommy Thompson, and was informed of the extension and that the petition is under review by the FDA in consultation with National Institute of Health's National Institute on Drug Abuse (NIDA).

    Spokespersons for both the FDA and NIDA declined to comment, saying they hadn't been briefed on the petition. Activists say that NIDA's involvement is a bad sign, however, as the petition didn't ask for a refutation of pot's potential for addiction (which is what NIDA monitors), and NIDA has been one of the most active agencies trying to keep pot on the list of the most dangerous drugs.

    It's a stall, but under the DQA, the stall can only last so long. Frustrating though it may be, this slog is infinitely speedier than any of the attempts at rescheduling that have come before.

    Consider the first petition, filed in 1972. Only two years after marijuana was lumped with LSD, heroin and mescaline in Schedule I, NORML filed the first petition with the Bureau of Narcotics Enforcement, the predecessor to the DEA, which stalled for three years, and then denied to hear the petition. A court forced them to hear it, then the DEA (formed in 1973) killed it without any hearings. A higher court of appeals again forced them to hear it, but it was easily killed off once more. Finally, in 1986, after another exhaustive, grinding court fight, the DEA caved in and assigned the investigation to its own DEA administrative law judge, Francis L. Young.

    Young spent two years hearing the testimony of scores of scientists, doctors, medical marijuana patients, law enforcement officers, agents, corrections officials and the like, and in 1988 came back with a stunning verdict. In one of the most celebrated documents in the history of pot activism, Young issued a 100-plus-page ruling, saying not only that the DEA must move pot to Schedule II, to have controlled medical use like cocaine and opium, but that "the evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence of this record."

    "And he's one of them!" cries Joe Elford, staff attorney for Americans for Safe Access, the chief author of the group's DQA petition. "Anyone who does administrative law generally thinks of it as a kangaroo court. It's one of their boys ruling on one of their issues, and you basically expect to lose, and hopefully you might get some relief from a real court down the line. But it was absolutely astounding that a DEA administrative law judge would make such findings and certainly to make 'em so forcefully."

    Of course, the DEA swept it all under the rug. It decided that Young had applied the wrong standard, that the testimony of doctors and patients didn't show "a currently accepted medical use." The record had to show controlled scientific testingwhich neither the FDA nor the DEA would allow by law.

    That decision went through five appeals before it was finally dead, in 1994, 22 years after the petition had been filed. But the movement to reschedule marijuana saw cracks in the feds' armor and picked up steam. Dr. Jon Gettman, then the director of NORML, filed a new rescheduling petition in 1995. This was finally denied in 2001it only took seven years this timebut the reasons why it was denied were more specific and attackable. The phrase "arbitrary and capricious" began to resonate. It's a magic set of words among lawyers, epecially those fighting regulatory agencies. The FDA, for instance, has to set criteria to define "currently accepted medical use," and if it departs from them, it has abused its discretion, which is against the law.

    That's where the DQA comes in. The new petition filed by Americans for Safe Access invokes the DQA to charge that the FDA abused its discretion on three of its five criteria in denying Gettman's 1995 rescheduling petition. Whenever the FDA deviates from its own criteria, it seems they made an arbitrary and capricious decision. That's the legal basis for the case. Plus there's more.

    "That process requires, by statute, a full and scientific medical review," says Gettman, who now has a new rescheduling petition before HHS as part of a coaltion. "That review is supposed to cover both the scientific evidence in the petition and everything else that's relevant. Now, what ASA is doing with the Data Quality Act, as I understand it, is that they're arguing that HHS's review of this 1995 petition of mine was inadequate and that it didn't cover all the available information."

    For instance, how could the FDA have reviewed the 1999 Institute of Medicine study, which found marijuana useful "for pain relief, control of nausea and vomiting, and appetite stimulation," and still deny accepted medical use? It's the White House's own study. Not to mention the massiveand growingraft of other medical evidence available before 2001, like the discovery of the receptor sites in the brain that show exactly how tetrahydrocannabinoids work to relieve pain.

    If the FDA is shown to have abused its discretion, this should require the DEA to consider a new rescheduling procedure.

    At least, in theory. "It gets complicated, and the trouble is that the courts are still sorting it out," says Elford. "The law's only a couple of years old. There have been, at this point, only a handful of published decisions dealing with this case."

    Indeed, in a ruling that came down on Dec. 3, a U.S. District Court judge found that Data Quality Act challenges were not judicially reviewable. Publishing on that ruling, Sean Moulton, senior policy analyst at good-government group OMB Watch, says, The activists "are facing an uphill battle at this point. It's not outside the realm of possibility to get a precedent overturned, depending on where they're going to file. But I think that a lot of the points that [this judge] made about standing would apply to many other DQA cases that might get filed in court."

    Joe Elford knows he's in for a long fight. He expects both HHS and the DEA will try every available dodge. It will take months. There's no set procedure for judicial review. But if it all goes through, it could go to the 9th Circuit.

    "We're going to get a much better shake in the Northern district of California," he says a little dreamily. "And from there to the 9th Circuit Court of Appeals, and then from there, possibly the U.S. Supreme Court. But I'm certainly not holding my breath."

    Scheduling the Rescheduling

    With another month to stew while the FDA and NIDA look at their petition, Americans for Safe Access Executive Director Steph Sherer says they'll be turning up the heat, trying to keep this moving, badgering members of Congress, running a nationwide sign-on campaign to join the 7,000 doctors who've already endorsed ASA's effort. You might want to look at that number of doctors again: 7,000. That's a potential blizzard of prescriptions. Sherer, who's recently been working Capitol Hill relentlessly, can feel HHS beginning its long stall.

    "The bureaucrat's favorite game is the stalling game," says Sherer. "And we don't have time for that. We have patients who are facing jail; we have patients who are living in fear of arrest. If they're not going to accept the petition, they need to deny it quickly so we can move on to the next step."

    "Just delaying it doesn't help anybody," says the ASA's McQuie. "It's particularly ironic after Justice Breyer's comment that this should be in the hands of regulators, and that Angel Raich should have just taken this to the FDA and then challenged them in court if they denied it. That's exactly what we're trying to do, but they just make it as difficult as possible."


    The government players: Who's who?

    Drug Enforcement Administration (DEA)

    Agency that has the final say on whether marijuana has acceptable medical use. Researchers wanting to test the medical validity of marijuana must first get permission from the DEA, which is rarely granted. For example, in December, the DEA rejected University of Massachusetts Amherst Professor Lyle Craker's 2001 request for a license to grow marijuana for FDA-approved research.

    Department of Health and Human Services (HHS)

    Arm of the government responsible for writing up the opinions that tell the DEA which drugs should be considered controlled substances.

    Food and Drug Administration (FDA)

    An HHS underling agency whose Center for Drug Evaluation and Research runs clinical studies to determine which drugs are "safe and effective" for consumer use. CDER has said it supports independent research into the medical benefits of marijuana, but that those researchers must go to the NIDA to obtain that marijuana.

    National Institute on Drug Abuse (NIDA)

    The go-to place for supplies of marijuana to be used for research. Unfortunately, researchers claim that NIDA provides low-potency marijuana and is prejudicial in its decisions on whom to dole it out to. And if researchers want to grow their own marijuana, they must get permission from the DEA (see above).




    Read more about MAPS' support of medical marijuana research.

    The Providence Journal: Drug Warriors Make Millions off Marijuana

    The Providence (RI) Journal published an excellent op-ed about the financial reasons why drug warriors don't want to see the licensing of the UMass Amherst production facility..

    The Providence Journal
    December 19, 2004

    by Froma Harrop

    THE MONEY IN illicit drugs doesn't all go to bad guys carrying AK-47s and driving BMWs. About $69 billion of it last year went to police, federal agents, judges, jailers and other drug-law enforcers across the United States. These are the good guys, but most are not so good that they will admit that the war on drugs is a waste of money and lives.

    The war is how they make a living.

    Supreme Court Justice Stephen Breyer wasn't thinking about the billions when he played the innocent during the recent arguments on medical marijuana. Breyer conceded that he didn't really know whether marijuana helped cancer patients in ways that pills do not.

    But it puzzled him, he said, that the patients' lawyers didn't just go to the federal Food and Drug Administration and insist, "You must take it off the list [of banned drugs] if it has an accepted medical use and it isn't lacking in safety."

    Sounds like common sense: Make a scientific evaluation of medical marijuana, and then decide whether or not it belongs in the people's medicine cabinets.

    But that's not going to happen. A week later, the federal Drug Enforcement Administration told Prof. Lyle Craker, a horticulturist at the University of Massachusetts, that he couldn't grow marijuana for the purpose of making such an evaluation.

    Craker is an expert on medicinal plants. (Over 25 percent of all prescription medicines are plant-based.) He wanted to grow the type of marijuana needed for secondary clinical trials -- which are run by DEA-licensed medical professionals.

    Observe how DEA bureaucrats draw a perfect circle of frustration. They say that researchers should instead use marijuana grown at a University of Mississippi lab. But the marijuana there is low-quality and worthless to the scientists.

    Then they tell Craker that there's no need for his improved marijuana, because no one is doing secondary trials, anyway. But people aren't doing secondary trials because they can't get the plant material to do them with. "It's kind of silly here," Craker concludes.

    DEA officials are not biologists and have no idea what distinguishes one type of marijuana from another. But that's not the point of the exercise. The point is to stop any activity that might eventually hurt business.

    Do the math: The DEA has nearly 11,000 employees and a $2 billion budget. America last year arrested 1.6 million people for nonviolent drug offenses. Half were for marijuana (with 80 percent for possession).

    The number of marijuana arrests, 734,000, nearly equaled the population of South Dakota. Imagine what legalizing marijuana would do to the DEA's cash flow.

    Marijuana has yet to kill anyone, yet anti-drug advocacy groups like the Partnership for a Drug-Free America portray it as a scourge. And why not? Condemning marijuana helps score $20 million in annual revenues for the Manhattan-based nonprofit.

    Its president makes a quarter of a million, and the next five highest-paid employees rake in close to $200,000 apiece.

    There's far less money in opposing the war on drugs. Just ask Jack Cole, a former undercover narcotics agent who helped found a group called Law Enforcement Against Prohibition.

    The members are mostly cops, judges, corrections officers and former DEA agents who think that the "war" amounts to throwing $69 billion down the rat hole.

    In his 26 years with the New Jersey State Police, Cole saw the drug problem getting worse, as spending on the war mushroomed. The prohibition on drugs has created "obscene profits" for criminals, he notes.

    For example, the value of heroin increases 17,000 percent from the time it leaves the farmer in Afghanistan to when it sells on American streets.

    "When I arrested someone for robbery or rape, I was taking someone dangerous off the streets," Cole says. "When I arrested someone for selling drugs, I was creating a job opening."

    Cole's group offers a simple plan: Legalize all drugs. The federal government could give addicts the drugs they crave, then treat them.

    "Medical marijuana would be Drug Policy Reform 101," Cole says. "This is the very least anybody can do for anyone."

    But the smallest retreat is billions in lost revenues for the warriors.

    And that's why the bureaucrats and every player in this war will fight against legalizing medical marijuana, for as long as it takes.

    Froma Harrop is a Journal editorial writer and syndicated columnist. She may be reached by email at This email address is being protected from spambots. You need JavaScript enabled to view it..

    DEA Upholds Growers Marijuana Monopoly

    Counterpunch, December 18 / 19, 2004
    Pot Shots
    DEA Upholds Grower's Marijuana Monopoly

    By FRED GARDNER

    The Drug Enforcement Administration has turned down an application by a University of Massachusetts botanist seeking to grow cannabis for research purposes.

    Mahmoud ElSohly, PhD, remains the only DEA-licensed cannabis grower in the U.S. ElSohly, who supervises a l.5-acre garden at the University of Mississippi, provides cannabis to the National Institute on Drug Abuse for use by researchers allowed to test it in clinical trials, and to patients in the federal "compassionate use" program begun by President Carter in the late '70s (and closed to new patients by George H.W. Bush when the AIDS epidemic hit). ElSohly also holds the patent on a suppository that delivers cannabinoids up the... but we won't go there.

    Patients who have compared ElSohly's cannabis to cannabis grown for medical use in California say the latter is highly preferable -no sticks and seeds and much higher potency, meaning you can use less. Seriously ill people want the best medicine obtainable. The perceived inadequacy of NIDA's cannabis has resulted in several FDA-approved clinical trials funded by California's Center for Medicinal Cannabis Research failing to attract test subjects. Why smoke ElSohly's when you can get "Blueberry?"

    In 2000 an activist academic, Rick Doblin, PhD, encouraged botanist Lyle Craker, PhD, to apply for a DEA license to cultivate cannabis at UMass, Amherst. Doblin founded and runs a non-profit called the Multidisciplinary Association for Psychedelic Studies (MAPS). Craker is Director of the Laboratories for Natural Products, Medicinal and Aromatic Plants, Department of Plant and Soil Sciences at UMass.

    Their application was filed in the spring of 2001. When at last the evaluation process began (after a year of various petty stalls), ElSohly claimed in a letter to the DEA that his Mississippi operation produced "enough cannabis, both qualitatively and quantitatively, to satisfy any possible needs of the research community."

    Doblin responded: "Unfortunately, that statement is false. For example, Chemic Labs requires marijuana with higher levels of THC and CBD than Dr. ElSohly can provide. Chemic Labs is conducting MAPS-sponsored laboratory research into the constituents of vapors produced when marijuana has been heated but not burned in a device known as a vaporizer. As you are probably aware, Chemic Labs has applied to DEA for a permit to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis of the SIMM 18 variety. This product contains 13.2% THC and 7.6% CBD, cannabinoid levels that NIDA does not have available.

    "In a rather humorous indication of just how unaware NIDA and Dr. ElSohly are about what some members of the research community require, Dr. ElSohly acknowledged that he and NIDA didn't consider it a significant issue that for over 20 years, low-potency material was provided that included seeds and sticks! At least Dr. ElSohly said that seeds and sticks have supposedly been eliminated from current production.

    "Even assuming that NIDA could satisfy any possible needs of the research community, NIDA's monopoly serves to obstruct privately-funded research. As long as NIDA and Dr. ElSohly retain a monopoly on the supply of marijuana, sponsors of privately-funded research are prevented from choosing the strain of marijuana they would prefer to research. Different strains have different ratios of the cannabinoids, THC and CBD, with NIDA offering low-potency, low-quality material.

    "NIDA's monopoly also makes privately-funded sponsors dependent on NIDA for price and availability. This is problematic since NIDA has twice refused to provide marijuana to protocols it didn't like even though FDA approved the protocols. Furthermore, NIDA is limited by law to providing marijuana for research but cannot provide it for prescription use. As a result, NIDA's monopoly forces sponsors to conduct research with a plant strain provided by NIDA that cannot be guaranteed to be available for prescription use.

    "No rational private sponsor will invest the millions of dollars needed to conduct the research required by FDA with the limitations imposed by NIDA's monopoly on supply. Dr. ElSohly also didn't comment on how NIDA's monopoly is inconsistent with US law requiring competition in the production of scheduled materials for use in research.

    * * *

    Keep a-knockin' but you can't come in
    Keep a-knockin' but you can't come in
    Keep a-knockin' but you can't come in
    Come back tomorrow night and try it again.

    -American folk song

    As of this summer, the DEA still had not acted on the Craker application. MAPS and Valerie Corral of the Wo/man's Alliance for Medical Marijuana filed a suit charging "unreasonable delay." The DC Circuit Court of Appeals gave the DEA until Dec. 22 to justify the delay. Instead, on Dec. 10 the DEA issued an Order denying Craker's application as "not consistent with the public interest." The main reason:

    "Current marijuana research has not progressed to Phase 2 of the clinical trials because current research must utilize smoked marijuana, which ultimately cannot be the permitted delivery system for any potential marijuana medication due to the deleterious effects and the difficulty of monitoring the efficaciousness of smoked marijuana."

    Doblin comments, "DEA is saying that since it can prejudge the outcome of FDA-approved research and knows that smoked marijuana ultimately cannot be permitted, denying us the opportunity to do the research in the first place isn't against the public interest. What makes this all the more ludicrous is that the DEA lawyers don't even understand the FDA drug review process enough to know that there are currently several Phase II studies with smoked marijuana underway and already approved by DEA!

    "DEA focus on 'smoked marijuana' also ignores the whole concept of vaporization as an alternative non-smoking delivery system that MAPS has already studied. Vaporization uses the marijuana plant and heats it to less than the temperature of burning, sufficient to generate a steam that contains cannabinoids but without the products of combustion which are of health concern. For the last 17 months, DEA has been blocking our efforts to import 10 grams of marijuana from the Dutch, and HHS/NIDA has been blocking our efforts to purchase 10 grams of marijuana from NIDA, both requests seeking marijuana for further laboratory research with vaporizers."

    The DEA Order also asserted, " In accordance with the Single Convention (treaty), the Federal Government has to limit marijuana available for clinical research to one source."

    U.S. narco-diplomats promoted this treaty and bullied other countries into signing. It could be revised to reflect current understanding of the benignity of cannabis. Or, as is the Bush Administration's wont, abrogated unilaterally. Moreover, as Doblin points out, "GW Pharmaceuticals, a private producer of marijuana in England, which is also a signatory to the same international treaties that the US has signed. The International Narcotic Control Board, which monitors compliance with the treaties, has never once objected to the British Home Office licensing of GW's production facility, which took place more than six years ago in 1998."

    The DEA's third basis for rejecting Craker's application was: "FDA has not received any new drug application for the development of a prescription drug containing marijuana or a constituent of marijuana... DEA should not register another marijuana manufacturer at this time on such a speculative basis."

    Doblin explains the Catch-22: "We are saying that unless we can have access to our own independent source of marijuana, we can't even do the research necessary to present an NDA to the FDA. DEA says that unless there is a need for marijuana for prescription use, it doesn't see a need to make marijuana available for research. It is possible to get permission for research, the FDA is open to research. It's the NIDA monopoly which is the key factor obstructing research."

    Craker and his backers are planning to appeal the DEA rejection to an administrative law judge. They have 30 days to do so. Doblin defines the DEA's rejection as progress towards the ultimate showdown, the hearing before the ALJ. He has asked Covington and Burling, an elite D.C. law firm that, for free, helped draft Craker's argument with respect to U.S. treaty obligations to stay involved. He has also asked the ACLU to come in.

    If you think we've been to this movie before, you're right. In the late 1980s a DEA administrative law judge named Francis Young conducted a hearing on a petition by NORML and a patient named Robert Randall to have marijuana moved from Schedule 1 (harmful drugs with no medical use) to Schedule 2. After extensive testimony and evidence presented by doctors, patients and public officials, Young called for immediate rescheduling. "Marijuana in its natural form is one of the safest therapeutically active substances known to man," he wrote in his opinion. "Many people find marijuana to have... accepted medical use in treatment in the United States."

    But administrative law judges don't rule, they weigh the evidence and recommend a course of action to the agency involved. DEA Administrator Jack Lawn formally rejected Young's recommendation (after 15 months of not acting on it at all). Some of the doctors and patients who testified, Lawn observed, were affiliated with NORML and supported full legalization -as if that discredited their testimony! Rescheduling marijuana, Lawn ruled, "would be unreasonable, arbitrary and capricious."

    In the late '90s Francis Young's daughter sent a letter to a journalist who had written about her father's futile recommendation to reschedule marijuana. Young had died a protracted, painful death from cancer, she wrote, aware all the while that marijuana might provide relief. But he didn't want any obtained for him; he had always been a man of the law and he chose to abide by the law till the end.

    Fred Gardner can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it.

    Continue Reading

    MAPS Comments on DEA's "Order to Show Cause"

    DEA finally rejected the application from Prof. Lyle Craker, UMass Amherst, seeking a license to establish a MAPS-sponsored facility to produce marijuana for federally-approved research, 3 and 1/2 years after the application was initially filed. DEA acted under pressure from MAPS' July 21 lawsuit arguing "unreasonable delay" and the DC Circuit Court of Appeals Nov. 22 decisionwhich gave DEA until Dec. 22 to reply. Just as we'd hoped, the lawsuit forced DEA to issue its ruling, which we can now challenge in the context of Administrative Law Judge hearings.


    DEA's "Order to Show Cause" says that we have 30 days to submit an appeal for an Administrative Law Judge (ALJ) hearing and that if we don't, the application will be rejected. We will, of course, appeal and will launch yet another ALJ hearing. The "Order to Show Cause" gives DEA's explanations for its decision. After reading how weak and fallacious DEA's arguments are, it's easy to understand why DEA didn't want to issue this ruling and had to be sued in order to force it to do so, 3 and 1/2 years after the application was initially filed.

    DEA considers the application to be not consistent with the public interest. My favorite DEA rationale is that despite our claim that NIDA's monopoly obstructs our efforts to do research, DEA says that its rejection of the application doesn't violate the public interest since "Current marijuana research has not progressed to Phase 2 of the clinical trials because current research must utilize smoked marijuana, which ultimately cannot be the permitted delivery system for any potential marijuana medication due to the deleterious effects and the difficulty in monitoring the efficaciousness of smoked marijuana." [See 8 (a) on page 4 of DEA's Order.]

    Basically, DEA is saying that since it can prejudge the outcome of FDA-approved research and knows that smoked marijuana "ultimately cannot be permitted," therefore denying us the opportunity to do the research in the first place isn't against the public interest. What makes this all the more ludicrous is that the DEA lawyers don't even understand the FDA drug review process enough to know that there are currently several Phase II studies with smoked marijuana underway and already approved by DEA!

    DEA focus on "smoked marijuana" also ignores the whole concept of vaporization as an alternative non-smoking delivery system that MAPS has already studied. Vaporization uses the marijuana plant and heats it to less than the temperature of burning, sufficient to generate a steam that contains cannabinoids but without the products of combustion which are of health concern. For the last 17 months, DEA has been blocking our efforts to import 10 grams of marijuana from the Dutch, and HHS/NIDA has been blocking our efforts to purchase 10 grams of marijuana from NIDA, both requests seeking marijuana for further laboratory research with vaporizers.

    DEA's claims that US international treaty obligations prevent it from issuing the license to UMass Amherst are false, as the example of GW Pharmaceuticals proves. GW is a private producer of marijuana in England, which is also a signatory to the same international treaties that the US has signed. The International Narcotic Control Board (INCB), which monitors compliance with the treaties, has never once objected to the British Home Office licensing of GW's production facility, which took place more than six years ago in 1998. For a document submitted July 24, 2002, to DEA Administrator Asa Hutchinson analyzing US international treaty obligations, written by Peter Barton Hutt and Alexei M.Silverman of DC law firm Covington & Burling (which helped on the Ashcroft v. Raich case pro-bono), and Graham Boyd, American Civil Liberties Union, Drug Policy Litigation Project, see mmj/treatyanalysis.pdf.

    Souder is Right: Lets Prove that Marijuana is Safe

    December 7, 2004

    Souder is Right: Let's Prove that Marijuana is Safe

    Dear Colleague:

    Representative Souder recently circulated a Dear Colleague letter announcing the introduction of the "Safe and Effective Drug Act," a bill directing the National Institute for Drug Abuse to examine the available scientific data regarding the safety and effectiveness of marijuana and requiring the FDA to post this information and distribute it to those public health entities that advocate or recommend patients smoke marijuana.

    I would urge all Members to cosponsor this legislation, IF it were truly designed to produce an honest evaluation of the scientific data available. I am, however, skeptical that this will be the case, given that the bill only refers to "smoked" marijuana and is proposing that the examination be carried out by the National Institute on Drug Abuse -- an agency which is actively blocking medical marijuana research (see below) while consistently highlighting and exaggerating the drug's negative consequences.

    An honest evaluation of marijuana, if carried out, would be guaranteed to lead to the same conclusion reached by the DEA's chief administrative law judge, Francis L. Young, who wrote in 1988, after a two-year study:

    "Marijuana, in its natural form, is one of the safest therapeutically active substances known...It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance."

    An honest evaluation would also discover:

    There has never been a documented case of overdose death from marijuana In contrast, many Americans die each year from overdoses of over-the-counter drugs such as aspirin and Tylenol. (Acetaminophen, the active ingredient in Tylenol, is estimated to cause 458 deaths from acute liver failure each year.)

    Even putting these facts aside, Rep. Souder's focus on "smoked" marijuana ignores the fact that many medical marijuana patients are now using vaporizers, which heat marijuana to the point just below combustion so that patients may inhale the therapeutic vapors without the potentially harmful carcinogens contained in smoked material. Shockingly, for the past 17 months, the National Institute on Drug Abuse has refused to provide researchers with a requested 10 grams of marijuana from the government's supply in order to study the effectiveness of these vaporizers. This is a study that would not even involve human subjects. Why should we think that NIDA, under the Souder bill, will study what it has already been able to study for the last year and a half, but wouldn't?

    The federal government has done everything in its power to prevent medical marijuana research from proceeding. In fact, it is the federal government's obstructionism that has lead directly to states passing their own medical marijuana laws. Despite this obstructionism, there is still ample evidence to show that marijuana is a safe and effective medicine. I applaud Rep. Souder for seeking the truth - but the truth must come from objective sources, not an agency already proven disposed to blocking the truth about marijuana

    Sincerely,
    REP. SAM FARR

    Rochelle Dornatt
    Chief of Staff
    Rep. Sam Farr

    Continue Reading

    Representative Souder's Letter Announcing the Introduction of the "Safe and Effective Drug Act"

    Rep. Sam Farr (D-CA) has sent out a 'Dear Colleague letter' to all member of the US House of Representatives, in response to a bill filed by U.S. Rep. Mark Souder that seeks to have the National Institute on Drug Abuse (NIDA) write a report about the "medical" uses of marijuana for FDA to distribute. Rep. Souder is the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources and the author of the much criticized bill that denies federal student loans to anyone convicted of a drug-related crime. Rep. Farr's letter questions whether NIDA is unbiased and cites NIDA's refusal in over 17 and 1/2 months to provide 10 grams of marijuana for vaporizer research (sponsored by MAPS and CaNORML). Federal obstruction of medical marijuana research is starting to get more attention. This may help generate pressure to break NIDA's monopoly on supply, which it uses to obstruct research. December 7, 2004

    Dear Colleague:

    Representative Souder recently circulated a Dear Colleague letter announcing the introduction of the "Safe and Effective Drug Act," a bill directing the National Institute for Drug Abuse to examine the available scientific data regarding the safety and effectiveness of marijuana and requiring the FDA to post this information and distribute it to those public health entities that advocate or recommend patients smoke marijuana.

    I would urge all Members to cosponsor this legislation, IF it were truly designed to produce an honest evaluation of the scientific data available. I am, however, skeptical that this will be the case, given that the bill only refers to "smoked" marijuana and is proposing that the examination be carried out by the National Institute on Drug Abuse -- an agency which is actively blocking medical marijuana research (see below) while consistently highlighting and exaggerating the drug's negative consequences.

    An honest evaluation of marijuana, if carried out, would be guaranteed to lead to the same conclusion reached by the DEA's chief administrative law judge, Francis L. Young, who wrote in 1988, after a two-year study:

    "Marijuana, in its natural form, is one of the safest therapeutically active substances known...It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance."

    An honest evaluation would also discover:

    There has never been a documented case of overdose death from marijuana In contrast, many Americans die each year from overdoses of over-the-counter drugs such as aspirin and Tylenol. (Acetaminophen, the active ingredient in Tylenol, is estimated to cause 458 deaths from acute liver failure each year.)

    Even putting these facts aside, Rep. Souder's focus on "smoked" marijuana ignores the fact that many medical marijuana patients are now using vaporizers, which heat marijuana to the point just below combustion so that patients may inhale the therapeutic vapors without the potentially harmful carcinogens contained in smoked material. Shockingly, for the past 17 months, the National Institute on Drug Abuse has refused to provide researchers with a requested 10 grams of marijuana from the government's supply in order to study the effectiveness of these vaporizers. This is a study that would not even involve human subjects. Why should we think that NIDA, under the Souder bill, will study what it has already been able to study for the last year and a half, but wouldn't?

    The federal government has done everything in its power to prevent medical marijuana research from proceeding. In fact, it is the federal government's obstructionism that has lead directly to states passing their own medical marijuana laws. Despite this obstructionism, there is still ample evidence to show that marijuana is a safe and effective medicine. I applaud Rep. Souder for seeking the truth - but the truth must come from objective sources, not an agency already proven disposed to blocking the truth about marijuana

    Sincerely,
    REP. SAM FARR

    Rochelle Dornatt
    Chief of Staff
    Rep. Sam Farr

    Decision on MAPS' Claim of "Unreasonable Delay" in MAPS' Applications to NIDA

    We have a decision regarding MAPS' lawsuits against DEA and against HHS/NIH/NIDA regarding our claim of "unreasonable delay" in responding to MAPS-sponsored applications to NIDA to purchase 10 grams of marijuana for vaporizer research (submitted June 24, 2003), to DEA to import 10 grams of marijuana for vaporizer research from the Dutch Office of Medicinal Cannabis (submitted June 24, 2003), and to DEA for a license to grow marijuana for research at UMass Amherst (submitted June 2001). MAPS's lawyer's assessment: The decision is very particular about the applications delayed, so they obviously read & at least partially understood what was what. Unfortunately, 17 months delay to the court (unlike patients needing pain relief) is no biggie, so we lose on compelling action on the application to HHS/NIDA to purchase 10 grams for research and on the application to DEA to import 10 grams. The 3 1/2 year delay in DEA non-response to the UMass Amherst application for a license to grow marijuana for research trips the further inquiry wire at DEA, however, so there apparantly is a chance for some oversite. Reconsideration (of the outright denials) must be filed within 14 days [5pm Dec. 6], which we will file.

    Dated: Nov. 22, 2004 (Judges Sentelle, Henderson and Tatel).


    PER CURIAM ORDER filed [861222] denying petition writ of mandamus [837907-1] in 04-1243 without prejudice because petitioners have not shown that HHS delay in acting on research protocol and application to purchase marijuana is so unreasonable as to warrant mandamus; denying petition in 04-1246 without prejudice to extent it seeks to compel DEA to act on application for registration to import marijuana, because petitioners have not shown that DEA's delay has been so unreasonable as to warrant mandamus; to extent the petition seeks to compel DEA to act on application for registration to manufacture marijuana, DEA is directed to file response to mandamus petition, 30 pp, within 30 days of date of order; petitioner may file reply, 15 pp, within 40 days of date or order; response and reply should address factors in TRAC. No mandate shall issue in 04-1274. [861222-1] .Before Judges Sentelle, Henderson, Tatel. [Entry Date: 11/22/04] [04-1247] (mam) [04-1246 04-1247]

    MAPS' Lawyer's notes


    mandamus: an order compelling the agency to act by a date certain.

    TRAC: Telecom. Research and Action Center v. FCC, 750 F.2d 70, 80 (D.C.Cir. 1984) provides useful guidance in assessing claims of agency delay: (1) the time agencies take to make decisions must be governed by a rule of reason, PEPCO, 702 F.2d at 1034, MCI, 627 F.2d at 340; (2) where Congress has provided a timetable or other indication of the speed with which it expects the agency to proceed in the enabling statute, that statutory scheme may supply content for this rule of reason, PCHRG v. FDA, 740 F.2d at 34-35; PCHRG v. Auchter, 702 F.2d at 1158, n. 30; PEPCO, 702 F.2d at 1034; (3) delays that might be reasonable in the sphere of economic regulation are less tolerable when human health and welfare are at stake; PCHRG v. FDA, 720 F.2d at 34; PCHRG v. Auchter, 702 F.2d at 1157; see also Blankenship v. Secretary of Health, Education, and Welfare, 587 F.2d 329, 334 (6th Cir. 1978); (4) the court should consider the effect of expediting delayed action on agency activities of a higher or competing priority, see, e.g., PCHRG v. FDA, 740 F.2d at 34; PCHRG v. Auchter, 702 F.2d at 1158; (5) the court should also take into account the nature and extent of the interests prejudiced by delay, PCHRG v. FDA, 740 F.2d at 35; and (6) the court need not find any impropriety lurking behind agency lassitude in order to hold that agency action is unreasonably delayed. PCHRG v. FDA, 740 F.2d at 34.

    Slate: Dude, Wheres My Integrity?

    Originally appearing here.

    Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.



    Slate
    Monday, Nov 29, 2004
    By Dahlia Lithwick

    Stamaty illustration If medical science conspired to construct, at the submolecular level, the world's most sympathetic plaintiff, it could do no better than Angel McClary Raich. Raich suffers from a host of painful wasting diseases, including fibromyalgia, endometriosis, scoliosis, uterine fibroid tumors, paralysis, asthma, and rotator cuff syndrome. She has an inoperable brain tumor, seizures, and struggles to consume enough calories to live. In her brief before the Supreme Court, an affidavit from her doctor enumerates not only Raich's staggering list of illnesses, but also the 35 alternative medicines she has tried without success. He adds that she "may suffer rapid death" if forced to stop using the marijuana she consumes (via pipe, massage oils, and quantities of pot-spiked zucchini bread) every two waking hours of the day.

    Lucky for Raich, she resides in California which passed the Compassionate Use Act of 1996. Unlucky for Raich, and for her co-plaintiff, Diane Monson, California is still part of the United States, in which the federal drug laws draw no distinctions between the deathly ill and the merrily stoned. Ashcroft v. Raich pits the federal Controlled Substances Act which makes marijuana a Schedule I drug with no legitimate medical use against California's legalization of that drug for sick people under a doctor's care. In the simplest sense this is a states' rights, or federalism, case. But it's also a case full of twists and inversions, endless electric guitar solos, tie-dyed mayhem, and strange bedfellows. And that's not just among the folks camped out on the courthouse steps for oral argument this morning many of whom were probably later rounded up and forced to pee in small cups outside John Ashcroft's office.

    Acting Solicitor General Paul Clement represents Ashcroft in this case, and he is arguing that states' rights are a good thing, unless the state in question is one of the 10, 11, or 12 states (depending on how you count them) that have legalized medicinal marijuana. His opening comments are quickly interrupted by Justice Sandra Day O'Connor, asking whether the Supreme Court's recent federalism rulings in United States v. Lopez (1995) and United States v. Morrison (2000) cast doubt on his case.

    Before Lopez and Morrison, the Supreme Court mostly kicked back and enjoyed a lengthy period of deference to Congress' view of the limits on its so-called "commerce clause" powers. Article 1, Section 8 of the U.S. Constitution empowers Congress to "regulate Commerce with foreign nations, and among the several states," and starting in the late 1930s and into the '40s interstate commerce began to include just about anything Congress wished to regulate, like employment and wages, right on up to just about any conduct save for interstate burping. The Rehnquist court put a stop to all that madness with Lopez and Morrison striking down, respectively, a federal gun law and a law creating a federal cause of action for female victims of violence as straying far beyond the commerce-clause power. Suddenly, "interstate" and "commerce" were words with meaning again.

    Clement tells O'Connor that those federalism cases can be distinguished from the marijuana one, but O'Connor shoots back with a question about , the classic commerce-clause case from 1942. Wickard involved a farmer who owned a family dairy farm and exceeded the annual wheat quota then allowed by the federal government. The farmer argued that his wheat was for his own consumption and that Congress had exceeded its commerce-clause powers in setting quotas. The Supreme Court disagreed. O'Connor points out that the wheat grown in Wickard entered a national market. Whereas pot grown on a windowsill by dying women or their caregivers does not. Or, to quote Ruth Bader Ginsburg: "Nobody's buying anything. Nobody's selling anything."

    Clement responds that it's impossible to know which pot is grown by individuals and which comes from illegal markets. O'Connor, still bogarting the oral argument, insists that the state of California can be trusted to enforce its own drug laws and crack down on illegal markets. Clement retorts, "There's no reason to believe California will have some unnatural ability to keep only one part of a fungible market separate."

    Justice Antonin Scalia is in something of a tight spot today. One the one hand, he voted with the states'-rights majorities in Lopez and Morrison. On the other hand, he isn't going to go off tripping lightly to the land of Cheech and Chong with those loonies on the 9th Circuit (who ruled the federal drug laws unconstitutional as applied to Raich and Monson). So he toys with Clement, suggesting that the rationale in Wickard doesn't really apply here. In Wickard, Congress wanted to regulate all interstate commerce in wheat. In this case, Congress wants to stop all interstate drug trafficking. Justice John Paul Stevens is in a mirror image of that same tight spot. He frickin' hates Lopez and Morrison. But his sweet old heart bleeds for the folks who would die if their pot was taken away.

    Justice Anthony Kennedy asks if this case is easier or harder than Wickard, given that the buying and selling of wheat is lawful, whereas the mere possession of pot is not. Clement replies that this is an easier case. If Congress can prohibit something from interstate commerce altogether, it should be able to "excise out any small island of unlawful possession that would compromise its goals."

    Ginsburg asks whether there would be any lawful recourse if these two particular plaintiffs were prosecuted under the federal drug laws. Clement quite cheerfully points out that in the 2001 medicinal marijuana case, United States v. Oakland Cannabis Buyers' Cooperative, the court held 8-0 that there was no implied medical necessity exception to the federal drug statutes. So no, these women would pretty much have to suffer, die, or move to Amsterdam.

    Kennedy asks, in what sounds suspiciously like his pre-Christmas shopping voice: "If we rule for the respondents in this case, do you think the street price of marijuana would go up or down?" And Stevens asks whether the court is bound by Congress' findings that there is no medical use for marijuana or could follow some other entity's findings (say, the Institute of Medicine's 1999 study finding that marijuana holds promise for alleviating nausea and vomiting in people undergoing chemotherapy and shows potential for improving severe weight loss caused by AIDS). Clement replies that it's as easy as petitioning Congress to reclassify marijuana as a non-dangerous drug. He adds, amazingly, that Congress considers marijuana nonmedicinal "because smoking is harmful."

    Professor Randy Barnett represents Raich and Monson. But this doesn't keep the liberal justices from beating up on him for curtailing congressional power while the conservatives beat up on his doper clients. Barnett warns that if the court finds for Ashcroft, this case will come to "replace Wickard as the most far-reaching case of interstate regulation." He adds that just because some product may have an interstate market (and what really doesn't, aside from phlegm, perhaps?) can't mean its possession implicates interstate commerce. Scalia notes that mere possession of ivory tusks or eagle feathers is illegal regardless of what market they come from.

    Barnett says there is no market if the marijuana is entirely isolated and policed by the state of California. "Isolated?" cries Scalia. "I understand some communes grow marijuana for medical usage!" Everything inside him recoils in horror. Federalism be damned.

    Justice Stephen Breyer tries to generate a list of really dangerous items that can be grown privately, in which the feds may still maintain a regulatory interest. He comes up with "heroin, cocaine," and "tomatoes with genomes in them"the ones who may someday have dangerous "tomato children." And Justice David Souterwho clearly has never been high on anything stronger than yogurt says it's clear that most Californians will go out and buy their medical marijuana "on the street." That would mean tens of thousands of Californians on chemotherapy and many more recreational users pretending to be. He adds, "every kid buying a bag or whatever you'd call a small quantity ... they're not getting prosecuted."

    Scalia insists this case can't be distinguished from Wickard. Barnett says this would be like Wickard if the farmer was eating all the wheat he grew, as opposed to feeding it to his livestock and replanting itactivities that implicate interstate commerce. Breyer disagrees: Wickard said a farmer's consumption of homegrown wheat, "though not commerce, may still be regulated so long as there's an interstate effect on commerce. I take it Justice Scalia is exactly right." Never comforting words for an oral advocate.

    Breyer concludes with the suggestion that the plaintiffs in this case should have gone to the FDA and said "take marijuana off the list ... that would be the obvious way to get what they want." He adds, "Medicine by regulation is better than medicine by referendum." Catchy. Barnett urges him to read the amicus briefs describing government obstruction of even basic cannabis research.

    Clement concludes his rebuttal with his best argument: California law undermines enforcement of the entire federal drug regime. There is no way to distinguish between those in genuine medical need and those who are exploiting the system. He cites a case mentioned in the briefs in which a man was busted with pot in his backpack, his pocket, his other pocket, and another pocket. And some scales. The appellate court nevertheless found that he might have legitimately been buying the pot for medicinal reasons; he was just carrying the scales to "keep from being ripped off."

    In a tribute to the chief justice, who missed oral argument again today, Angel Raich sought to woo him with empathy saying she hoped his chemotherapy treatments "would soften his heart about the issue."

    "I think he would find that cannabis would help him a lot," said Raich. Can't you just imagine it: William H. Rehnquist spooning Cheez Whiz right out of the jar and sewing gold armbands onto all his bathrobes?

    Are these women just a little weird? Yes. But should the court's staunchest conservatives get away with being for states' rights only when the state in question isn't California? No. Will they? Oh, you can bet your bong on it.

    Dahlia Lithwick is a Slate senior editor.

    Illustration by Mark Alan Stamaty.



    [MAPS' Note: The amicus briefs described above were filed by MAPS and the Marijuana Policy Project (MPP) on October 13, 2004. MAPS continues to support and fight for medical marijuana research.

    Medical Marijuana Research Update: November 2004

    MAPS initiates work on a legal motion for expedited scheduling of our lawsuits against DEA and against HHS/NIH/NIDA. It's now been more than 3 1/2 months since July 21, 2004, when MAPS, Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana (WAMM) in Santa Cruz, California, and Prof. Lyle Craker, UMass Amherst, filed a lawsuit against DEA, and MAPS and Valerie Corral filed a lawsuit against HHS/NIH/NIDA.

    The lawsuits claimed that the agencies were engaging in unreasonable delay in not responding to MAPS-sponsored requests to grow, import and purchase marijuana for a program of scientific research designed to develop marijuana into an FDA-approved prescription medicine. We hope the motion for expedited scheduling will get this case before the judge sooner than if we were to do nothing. The lawsuits have been filed in the United States Court of Appeals for the District of Columbia Circuit.

    Medical Marijuana Research Update: October 2004

    MAPS and MPP filed our amicus curiae brief today in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research. The goal of the brief is to educate the Supreme Court judges so that they don't rule against medical marijuana patients under the false assumption that the FDA drug development approach is a viable alternative to state medical marijuana initiatives and legislative actions. As long as the obstruction of MAPS' medical marijuana research efforts continues, the only way that patients can obtain legal access to the medical use of marijuana is through the decision of the 9th Circuit Court of Appeals, which decided that there was no interstate commerce involved when patients or caregivers grow marijuana for patients' personal medical use. That decision prohibited the federal authorities (DEA) from enforcing the Controlled Substances Act prohibitions against the use of marijuana, which the 9th Circuit judges declared unconstitutional when applied against patients or caregivers growing marijuana in states that had approved such use. MAPS and MPP's brief transforms our failure to obtain the necessary permissions and supply of marijuana for MAPS' research efforts into a weapon against the forces of repression (DEA and the Drug Czar ).

    Medical Marijuana Advocates Likely to Get a Break Under Kerry

    Medical marijuana advocates likely to get a break under Kerry
    Democrat says he would stop pot club raids pushed by Bush
    San Francisco Chronicle, Sunday, October 10, 2004

    http://sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2004/10/10/MNG0996S2L1.DTL

    by Bob Egelko
    Chronicle Staff Writer

    Sen. John Kerry hasn't tried to make medical marijuana an issue in his presidential campaign, but he has some differences with President Bush on the subject.

    Kerry says he would end the raids that have been a feature of the Bush administration's crackdown on medical marijuana in California, where voters approved the use of the drug for medical purposes in 1996. The Massachusetts senator has also signed a letter urging the administration to stop blocking medical marijuana research at the University of Massachusetts.

    Perhaps most importantly, Kerry said at a campaign forum last year that his "disposition is personally favorable'' to marijuana as medicine, but that he would await further scientific studies before taking a definitive stand. He also criticized mandatory minimum prison sentences for first offenders and called for more drug education and treatment.

    That's not nearly as far as activists would like him to go. Kerry hasn't endorsed legalizing medical marijuana at the federal level or leaving the issue up to the states and hasn't backed legislation, currently stalled in Congress, that would allow patients and suppliers to use their state laws as a defense against federal charges.

    But Kerry's position and tone suggest that he would take a different approach than Bush, who has escalated the federal war against state medical marijuana laws launched by his predecessor, Bill Clinton.

    Where the Clinton administration focused on civil suits to shut down the nonprofit clubs that supplied marijuana to California patients, the Bush administration has used criminal prosecutions against growers and suppliers, has sent federal agents to seize a patient's six homegrown marijuana plants and is preparing for a high-stakes U.S. Supreme Court battle against two seriously ill Northern California women.

    The president hasn't mentioned medical marijuana during the campaign. But in his last campaign, during a 1999 appearance in Seattle, he answered questions about the issue by saying, "I believe each state can choose that decision as they so choose.''

    Bush, who regularly portrays his rival as a flip-flopper, has yet to explain his own apparent turnabout on this subject. Asked by The Chronicle about the president's views, now and in the past, Bush's campaign office reiterated his opposition to medical marijuana.

    The issue may not have much effect on the presidential election. But the outcome of the election is likely to affect the future of medical marijuana, in part because of the case scheduled to be argued in the Supreme Court term that begins next month.

    The two plaintiffs, Angel Raich of Oakland and Diane Monson of Oroville (Butte County), want court orders barring the federal government from interfering with their doctor-approved use of marijuana as therapy for their conditions, Raich's brain tumor and wasting syndrome and Monson's back spasms.

    A federal appeals court ruled last December that the federal ban on marijuana couldn't be constitutionally applied to patients who obtain the drug without charge from within the state in which they live, if the state allows marijuana use for medical purposes. The ruling had the potential to shield local marijuana cooperatives from federal prosecution, but the Supreme Court granted the Bush administration's request to review the case.

    If the government wins, it will be free to target patients as well as their suppliers in the nine states that have legalized medical marijuana. That decision would be up to the incoming administration, a circumstance that adds significance to Kerry's comments at an August 2003 town hall meeting in New Hampshire.

    Asked by a local activist about marijuana, the senator said, according to a transcript, "My disposition is personally favorable but ... I want to get that scientific review to make certain that there's a way to manage it effectively. ... I certainly would put a moratorium on the raids until that has happened.''

    Kerry has said on other occasions that he would halt medical marijuana raids, sometimes specifying raids on patients. Dale Gieringer, California coordinator for the National Organization for the Reform of Marijuana Laws, says Kerry told him at a fund-raiser last year that he favored keeping federal agents out of medical marijuana clubs.

    With regard to research, Kerry and his Massachusetts colleague, Sen. Edward Kennedy, signed a letter to the Drug Enforcement Administration last October urging approval of the University of Massachusetts' proposal to grow marijuana for its own federally approved medical research. When the DEA did not respond, researchers and advocates filed suit this July.

    Kerry's campaign did not respond to requests from The Chronicle to spell out his position on medical marijuana.

    Similar inquiries were made to the Bush campaign, including references to Bush's 1999 statement on leaving the issue to the states. The campaign's response didn't mention the 1999 comment, but instead accused Kerry of "flip- flopping on medical marijuana'' by saying he was open to the issue but was withholding final judgment until research was completed. The campaign did not explain how those positions were inconsistent.

    Bush's campaign also supplied a statement from then-press secretary Ari Fleischer at a 2001 press briefing. He said Bush "does not believe that it's appropriate to allow what is a controlled substance to be given to people in terms of medical marijuana. There are other effective ways, the president believes, to help people who suffer illness.''

    Contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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    Reuters: British, French Drug Firms Lead in Marijuana Tests

    Reuters News Service published a story stating "British, French Drug Firms Lead in Marijuana Tests", noting that US drug development is hampered by marijuana's schedule 1 status and government control over the supply of marijuana researchers must use for their studies..

    Reuters News Service
    Sept 30, 2004
    By Leonard Anderson

    SAN FRANCISCO (Reuters) Sept 30 - British and French pharmaceutical companies are racing ahead of their U.S. counterparts to develop new drugs containing marijuana to relieve pain and treat a wide range of illnesses because marijuana is illegal in the United States, scientific researchers said on Wednesday.

    "The plant that nature gave us has significant potential therapeutic effects," said Dr. Donald Abrams, professor of clinical medicine at the University of California-San Francisco and a marijuana researcher.

    But Abrams and two other scientists said drug development in the United States is lagging because the federal government has made marijuana -- Cannabis sativa -- an illegal "controlled substance."

    The U.S. government restricts medical research involving marijuana and fights to shut down groups dispensing it to cancer patients and others with chronic pain or other diseases, the scientists noted.

    They reviewed research and development of drugs based on marijuana and its active ingredient, tetrahydrocannabinol or THC, at the Biophex 2004 conference in San Francisco.

    Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies, which sponsors clinical studies of marijuana-based drugs, said, "It is more difficult to research marijuana than psychedelic drugs like Ecstasy."

    Doblin said he has been waiting more than one year to get 10 grams of marijuana from the National Institute on Drug Abuse for a research study at the University of Massachusetts-Amherst.

    "The government controls the legal supply," he said.

    MARIJUANA FOR MIND AND BODY

    In France, however, drugmaker Sanofi-Aventis has a synthetic marijuana-based drug in phase III clinical trials to treat obesity, memory loss and drug dependence, Billy Martin, department chairman of pharmacology and toxicology at Virginia Commonwealth Medical Center, told the conference.

    Human bodies have unique "receptors" where marijuana can go to work, relieving pain and inflammation, stimulating appetite, boosting the immune system and helping muscle control, Martin said.

    Britain's GW Pharmaceuticals, a biotechnology company in a marketing deal with Germany's Bayer AG, is developing an oral spray drug, based on the marijuana plant, to treat symptoms of multiple sclerosis and severe pain. It could be sold in Britain and Canada if approved by regulators.

    Abrams, a pioneer in the 1980s in fighting AIDS, found that marijuana increased patients' appetites and he began to widen his research on the plant.

    Studies show new marijuana drugs have the potential to shrink tumors, enhance the effects of morphine in cancer patients, and treat depression, among other conditions, Abrams said.

    "I'm also looking at other botanicals," Abrams added.

    Medicines based on the marijuana plant and synthetic marijuana drugs may be delivered to patients in drops, sprays and vaporizers, which could ease fears that smoking the plant may cause lung cancer, the researchers said.



    Read more on MAPS support of medical marijuana research.

    Medical Marijuana Research Update: September 2004

    The second subject is enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The first subject was enrolled on September 21, 2004. This study is now well underway!

    First Subject Enrolled in Dr. Donald Abrams' FDA-Approved Study

    The first subject was enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The study requires subjects to live on an in-patient ward for 6 days, with each day involving either smoking marijuana or using the vaporizer. The research involves the use of 3 different marijuana cigarettes, one with 1.7 % THC, one with 3.5% THC and one with 7% THC. The cigarettes are cut in half and used in a randomized, double-blind manner, with half of each cigarette being smoked and the other half unrolled and the marijuana placed in the vaporizer.

    In response to an inquiry to DEA from Prof. Lyle

    In response to an inquiry to DEA from Prof. Lyle Craker, Mr. Wayne Raabe, DOJ Criminal and Dangerous Drug Division, called Prof. Craker and said that DOJ is making a decision this week on which division will be handling the case. He promised to call and let Prof. Craker know as soon as the decision on handling the case was made. Taxpayer money would be much better spent if, instead of working on responding to the lawsuit from MAPS and Prof. Craker, DEA and DOJ would just make a decision on the application for a license to establish a facility to grow marijuana exclusively for federally-approved research, which Prof. Craker submitted over three years ago! Yet more evidence that the Bush Administration is actively working to obstruct medical marijuana research.

    Joint Suits Aim to Weed Out Agencies Red Tape

    Nature
    Joint suits aim to weed out agencies' red tape
    Published online: 28 July 2004; | doi:10.1038/430492a
    Helen Pearson

    US researchers upset over limited access to medical marijuana.

    New York -

    Strong blow: federal agencies are being sued for hampering researchers' access to marijuana.D. REEDE/SPL Frustrated with the slow pace of research into medicinal marijuana, researchers have launched a pair of lawsuits accusing US government agencies of obstructing attempts to obtain supplies of the plant.

    In order to study marijuana for its ability to ease pain, nausea or symptoms of AIDS, US researchers procure the drug from a small farm at the University of Mississippi, under contract from the National Institute on Drug Abuse (NIDA). But some complain that the red tape and long delays involved in getting the plant through NIDA, the Drug Enforcement Administration (DEA) and other agencies are unacceptable.

    The lawsuits, filed on 22 July, were coordinated by the Florida-based campaign group Multidisciplinary Association for Psychedelic Studies (MAPS).

    In one lawsuit, MAPS is demanding a decision on an application filed in 2003 to buy 10 grams of NIDA marijuana a tiny amount worth just $70, the group says. The researchers plan to use the plant in testing a vaporizer, an alternative method of delivery to smoking. The test would look at the chemical constituents of the vapour and would not involve human subjects.

    The second lawsuit contends that the DEA has stalled an application to set up a separate farm to grow marijuana for research, filed in June 2001 by botanist Lyle Craker of the University of Massachusetts at Amherst. If successful, this would be the first official alternative US marijuana source for medical researchers.

    MAPS president Rick Doblin argues that the NIDA supply of marijuana is of low quality and potency, and that researchers will be unable to get clinical approval for drugs derived from it unless they can grow a pharmaceutical-grade crop themselves. He would like to see a situation like that in Britain, where Salisbury-based GW Pharmaceuticals, under licence from the Home Office, has established its own greenhouse facility to grow marijuana for clinical trials.

    The US Department of Health and Human Services, NIDA and the DEA would not comment on the lawsuits. But those behind the legal action claim that the agencies are sitting on the applications because they go against the federal government's hard line on drugs. "It's politically unacceptable to say yes," says Craker (see Nature 430, 394395; 2004).

    Other researchers in the field agree that the bureaucratic application process for marijuana studies has contributed to sluggishness in the field. "The pace has been slower than one would like," says mental-health researcher Stanley Watson of the University of Michigan, Ann Arbor, who co-authored a 1999 Institute of Medicine report urging clinical trials into medicinal marijuana.

    But that does not mean that NIDA is doing anything illegal, Watson says. The agency's remit is to study research linked to the abuse of drugs, he points out, not their medicinal use. "It's going to be a tough one for MAPS to win," says Watson. Others add that there could be scientific problems with the MAPS applications that are holding things up.

    Watson suggests that researchers might best forge ahead by improving the design of their trials, or perhaps by negotiating marijuana supplies from other countries.

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    Marijuana Research Lawsuits to be Filed

    MARIJUANA RESEARCH LAWSUITS TO BE FILED
    Author: Holly Angelo; Published: Thursday, July 22, 2004
    Copyright: 2004 The Republican (Springfield, MA)
    Website: http://www.masslive.com/republican/ Amherst --

    All Lyle E. Craker wants to do is grow marijuana in his lab at the University of Massachusetts to supply other scientists with the plant so studies about its medicinal benefits can take place. But after filing an application with the federal Drug Enforcement Administration in June 2001 to establish a facility on the Amherst campus to produce marijuana for U.S. Food and Drug Administration-approved research, he hasn't received a yes or no.

    To get an answer, Craker has teamed with two other parties as plaintiffs in one of two lawsuits scheduled to be filed today that accuses the federal government with obstructing medical marijuana research.

    "I'm hoping the lawsuit will bring a response," Craker said from his office in Stockbridge Hall yesterday, where he is the director of the medicinal plant program and member of the department of plant, soil and insect sciences. "It's unfortunate, but the issue probably has to be forced here (in the courts)."

    The two suits are supposed to be filed in the U.S. Court of Appeals in Washington, D.C. The first suit is filed by the Multidisciplinary Association for Psychedelic Studies; Craker and Valerie Corral, a California-licensed medical marijuana patient and caregiver, against the Drug Enforcement Administration. It seeks a decision on Craker's request and a request by Chemic Laboratories of Canton to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis, for use in a medical marijuana research project investigating the safety advantages of a nonsmoking delivery device for marijuana by a vaporizer.

    The second suit is filed by the association and Corral against the federal Department of Health and Human Services, the National Institute on Drug Abuse and the National Institutes of Health. It also seeks a final ruling by the agencies on Chemic's request for marijuana and the vaporizer study.

    The Drug Enforcement Administration and National Institute on Drug Abuse would not comment on the suits.

    "We're arguing unreasonable delay," said Rick E. Doblin, president of the association, based in Sarasota, Fla. "We are blocked from growing our own (marijuana) at UMass Amherst. We are blocked from importing from the Dutch Office of Medicinal Cannabis, and we are blocked from purchasing from the government's supply."

    U.S. Senators John F. Kerry and Edward M. Kennedy sent a letter to the Drug Enforcement Administration in October 2003 expressing support for the UMass-Amherst marijuana research production facility.

    Continue Reading

    Medical Marijuana Research Update: June 2004

    NIDA Director Dr. Nora Volkow responds to MAPS' letter of May 19, as well as MAPS' May 24, 2004 letters to HHS Secretary Tommy Thompson and Director of the National Institutes of Health Dr. Elias Zerhouni. Dr. Volkow writes, "As you know, NIDA is just one of the participants on the HHS review panel...It is not NIDA's role to set policy in this area...Moreover, it is not NIDA's mission to study the medicinal uses of marijuana or to advocate for the establishment of facilities to support this research. Therefore, I am sorry but I do not believe that we can be of help to you in resolving these concerns."

    Conspicuously missing from Dr. Volkow's letter was any information whatsoever about where in the process is the review of the vaporizer protocol. As a result, MAPS is now considering a lawsuit against HHS/NIDA claiming "unreasonable delay" under the Administrative Procedures Act.

    Medical Marijuana Research Update: May 2004

    MAPS has sent a letter to NIDA Director Dr. Nora Volkow, and all members of NIDA's National Advisory Council on Drug Abuse (NACDA), asking them to expedite the NIDA/HHS review of Chemic's vaporizer research protocol. Chemic initially submitted the protocol to NIDA on June 24, 2003, as part of a request to purchase 10 grams of NIDA's marijuana needed for the study. MAPS' letter explains that there has so far been an eleven month delay in MAPS' research agenda, while MAPS waits to see if NIDA/HHS considers the protocol to be "scientifically meritorious" and therefore worthy of the privilege of purchasing NIDA's low-potency marijuana. The letter protests that this is an unreasonable delay of MAPS' efforts to conduct research to evaluate marijuana's potential use as an FDA-approved prescription medicine. The letter informs Dr. Volkow and the members of the NACDA that NIDA/HHS is doing its best to provide clear and persuasive evidence that NIDA's monopoly on the supply of marijuana for research is a fundamental obstruction that must end, preferably with DEA licensing of the UMass Amherst production facility.

    Congressman Mark Souder Holds Hearing

     Congressman Mark Souder, Chairman of the U.S. House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources, held a hearing about "Marijuana and Medicine: The Need for a Science-Based Approach." MPP Executive Director Rob Kampia testified (video and transcript) and answered questions (video and transcript). During his comments, he discussed the importance of MAPS’ vaporizer research efforts as well as the UMass Amherst project.

    Medical Marijuana Research Update: February 2004

    The Ninth Circuit federal appeals court has refused to reconsider its Raich-Monson decision that allows Californians to grow and use marijuana to treat their illnesses.Not a single judge on the circuit voted to accept the government’s request for reconsideration. The government’s only recourse to revers the Raich-Monson decision is to appeal to the Supreme Court. The government has 90 days to file a petition for certiorari. An article about this decision by Dean Murphy appeared in the New York Times.

    Pot Proponent Just Says No

    Pot Proponent Just Says No, by Bill Breen, Fast Company Online.

    Medical marijuana’s elder statesman is not convinced that the therapeutic benefits of cannabis can be separated from the psychoactive effects -- or that cannabis should be "pharmaceuticalized."

    The Cannabis Conundrum by Bill Breen, Fast Company Online.

    As the founder of a British Pharmaceutical company put it, if it weren’t called Marijuana there would be an entire biotech business built around this plant. And that’s just what is starting to happen (but not for the US drug industry or the patients these medicines might help).

    John Gilmore donates $100,000 to MAPS

    John Gilmore donates $100,000 to MAPS for the creation of a start-up fund to assist new research projects in getting off the ground, with the first project being the UMass Amherst medical marijuana production facility. John’s intention is for the start-up fund to be used as a catalyst to start the UMass Amherst project, with the money to be replenished if the UMass Amherst project becomes fully funded so that the funds can then be used again to help catalyze another research project.

    Pipe Dream?

    Pipe Dream? Rick Doblin has a prescription for fixing NIDA’s ailing medical-marijuana program: establish an alternative. By Bill Breen, Fast Company. An excellent article about MAPS’ UMass Amherst project.

    Medical Marijuana Research Update: December 2003

    Medical marijuana patient Angel McClary Raich and her caregivers and Diane Monson won in an historic Ninth Circuit decision in their injunction against Ashcroft, the DEA Chief, and the Federal Government. The Court declared the Controlled Substances Act unconstitutional for violating rights under the Commerce Clause if the marijuana isn’t sold, transported across state lines or used for non-medicinal purposes.

    MAPS, MPP and Dr. Ethan Russo filed an amicus curiae brief in this case, which can be found here. We testified about Executive branch obstructionism of medical marijuana research and concluded, "The Court should not rule against patients’ constitutional rights to use cannabis based on the illusion of a well-functioning FDA-approval process. Executive branch obstructionism has made it necessary for patients to assert their constitutional rights to use cannabis as a legal ’safety net’ for a limited number of patients."

    In its decision, the Court noted, "The appellees also contend that granting the appellants’ requested injunction would create a slippery slope as other plaintiffs seeking use of other schedule I controlled substances would bypass the statutory process established by Congress. The appellees claim that the appellants’ proposed injunction therefore has the potential to significantly undermine the FDA drug approval process. Our holding is sufficiently narrow to avoid such concerns." Though the Court didn’t point this out, it’s totally hypocritical for the Bush Administration to accuse Angel Raich of undermining the FDA drug approval process when DEA, with ONDCP support, is obstructing privately-funded medical marijuana research by not granting a license to grow marijuana for research to Prof. Craker at UMass Amherst (Read this for more details).

    Fortunately, the Court’s decision will increase pressure on the Bush Administration to approve the UMass Amherst marijuana production facility by making it more obvious that a denial just increases the need for patients like Angel to grow their own medicine free from federal persecution.

    The Court’s decision is here. Click on "opinions" at the upper left. Then select Raich vs.. Ashcroft Download the major pleadings from the litigation (Raich v. Ashcroft) here and here.  Also read the Dec. 16, 2003, Associated Press article, "Federal Appeals Court OKs Medical Marijuana in Some Cases".

    MAPS sent a letter today to NIDA Director Nora Volkow, Ph.D

    MAPS sent a letter today to NIDA Director Nora Volkow, Ph.D., responding to a November 18, 2003 letter from Dr. Volkow to Rick Doblin. This exchange of letters was part of a package of material that MAPS sent today to members of NIDA’s National Advisory Council on Drug Abuse (NACDA) requesting that NACDA recommend to NIDA that it write to DEA expressing support for Prof. Craker’s application for a license for a marijuana production facility at UMass Amherst.

    Dr. Volkow indicated in her thoughtful but careful letter that since NIDA’s mission doesn’t include the medical use of marijuana, that it wasn’t appropriate for NIDA to recommend that DEA license the UMass Amherst facility. In reply, Rick Doblin noted that, "it is precisely because NIDA’s mission doesn’t include the study of the medicinal uses of marijuana that NIDA’s monopoly on the supply of marijuana for FDA-approved medical research is so inappropriate. I request you reconsider your decision not to recommend a change in the status quo."

    Medical Marijuana Research Update: November 2003

    Several days ago, as a result of its Freedom of Information Act (FOIA) request, MAPS received a copy from DEA of the one public comment about Prof. Craker’s application for a license to produce marijuana that was filed with DEA during the public comment period that ended September 22, 2003. The comment was submitted by Professor Mahmoud ElSohly, Director of NIDA’s marijuana farm at the University of Mississippi, who strongly opposed DEA licensing of Prof. Craker’s facility. MAPS’ reply to Prof. ElSohly’s letter was sent today to DEA. Basically, Prof. ElSohly wants to retain his monopoly.

    Rather hilariously, he explains that he and NIDA didn’t consider it a significant issue that the marijuana cigarettes made available to researchers for the last twenty years or so contained seeds and stems. Nevertheless, they have installed "custom-manufactured deseeding equipment that rids the plant material of any seeds and small stems prior to the manufacturing of the cigarettes." One day, we can perhaps look forward to NIDA’s coming to understand the value of growing female plants that aren’t permitted to go to seed.

    WBUR: Positive Story on Medical Marijuana and the UMass Amherst Project

    WBUR, the Boston NPR station, broadcast a long, positive story about medical marijuana and the UMass Amherst project, with interviews with Rick Doblin, UMass Amherst Prof. Lyle Craker, and ONDCP’s Dr. Andrea Barthwell. The story, "Massachusetts Considers Medical Marijuana," is by Rachel Gotbaum and begins by stating, "Governor Mitt Romney is expected to decide later this month whether he will join Senators Kennedy and Kerry and urge the federal drug enforcement administration to allow a Massachusetts professor to grow marijuana for medical research."

     Letter from Dr. Volkow to Rick Doblin

    WBUR Story

    WBUR, the Boston NPR station, broadcast a long, positive story about medical marijuana and the UMass Amherst project, with interviews with Rick Doblin, UMass Amherst Prof. Lyle Craker, and ONDCP’s Dr. Andrea Barthwell. The story, "Massachusetts Considers Medical Marijuana," is by Rachel Gotbaum and begins by stating, "Governor Mitt Romney is expected to decide later this month whether he will join Senators Kennedy and Kerry and urge the federal drug enforcement administration to allow a Massachusetts professor to grow marijuana for medical research."

     Letter from Dr. Volkow to Rick Doblin

    New York Times: Doctors Tread a Thin Line on Marijuana Advice

    A New York Times article on doctors and the law discusses the legal situation faced by physicians who recommend marijuana to their patients.

    By David Tuller, New York Times, October 28, 2003

    For doctors who want to discuss using medical marijuana with their patients, the line between advice and advocacy remains almost as blurred as it was before a recent court decision guaranteed a physician's right to address the issue openly.

    Some doctors are relieved that the United States Supreme Court let stand a lower-court decision two weeks ago that barred the federal government from punishing doctors who advised patients that marijuana might ease some symptoms.

    But some doctors are also perplexed, and even inhibited, by part of the underlying court decision at the center of the case. That decision essentially affirms the federal government's right to hold physicians accountable if they actually take steps to help patients obtain marijuana.

    "This decision says that it's fine and appropriate to talk with patients about medical marijuana, and I can even say, `I think you can benefit from it,' said Dr. Steve O'Brien, who estimates that a fifth of his H.I.V. patients at the East Bay AIDS Center in Oakland, Calif., use marijuana for medical purposes. "But does that mean I can now sign a form from a medical pot club or write, `I recommend marijuana,' on a prescription pad? I don't know. It's still kind of murky."

    The governing language is found in a decision in 2002 by the United States Court of Appeals for the Ninth Circuit. Of the nine states in that circuit, seven have laws on medical marijuana. The court stated unambiguously that doctors had a First Amendment right to discuss with patients the possible benefits of marijuana for relief of pain, nausea and other symptoms suffered by people with ailments like cancer, H.I.V. and glaucoma.

    The court also clearly left open the possibility that doctors could be charged under federal drug statutes. "If, in making the recommendation," the court wrote, "the physician intends for the patient to use it as the means for obtaining marijuana, as a prescription is used as a means for a patient to obtain a controlled substance, then a physician would be guilty of aiding and abetting the violation of federal law."

    The ruling stemmed from a suit by California physicians and patients after the federal government had threatened legal action against doctors who recommended medical marijuana. The government issued the warnings in 1996, after voters had approved Proposition 215, the initiative that protected the right of patients to use marijuana for medical indications.

    Although doctors are regulated by the states, they receive their authority to prescribe controlled substances through the federal Drug Enforcement Administration.

    Dr. Jack Lewin, chief executive of the California Medical Association, acknowledged that the Ninth Circuit's decision and the Supreme Court's refusal to review it left some questions unresolved. Dr. Lewin said he hoped that at least some concerns about discussing marijuana with patients would be reduced.

    "The verbal position of the Department of Justice," he said, "was very threatening and put an absolute chilling effect on doctors' communications with their patients. And most did not want to talk about marijuana, much less recommend it."

    Doctors in states with medical marijuana laws have long tried to balance state and federal laws that conflict. This month, Gov. Gray Davis of California signed a bill that establishes a state-sponsored identification card for users of medical marijuana, to protect them from arrests, even as the federal government insists that doctors cannot help their patients obtain it. Because of the legal uncertainties, doctors, as well as medical organizations, have struggled to devise ways to avoid running afoul of the law.

    The Oregon Medical Association has advised doctors to record only on patients' charts any suggestion that marijuana could help with some symptoms If patients photocopy that part of the medical record and use the documents to obtain marijuana, the president of the association, Dr. Colin Cave, said, the doctor cannot be held responsible.

    "We have told physicians to avoid at all costs writing it anywhere else," Dr Cave said. "They should not write it on a prescription pad. They should not write it on a separate letter, because that leaves them absolutely vulnerable to prosecution by the Drug Enforcement Administration."

    The language in the Ninth Circuit ruling, Dr. Cave said, does nothing to change those recommendations.

    "The D.E.A.," he said, "is still out there, and we know the federal government is not going to give up on this."

    With some doctors fearful or reluctant to address the issue, 12 or so physicians from California have in the last few years emerged as consultants on medical marijuana. Those doctors routinely issue recommendations to hundreds of patients who see them expressly for that purpose.

    Their activities have drawn intense scrutiny from the Medical Board of California, which regulates medical licenses for the state. The board has investigated at least nine physicians, according to Ana Facio, its deputy chief of enforcement.

    The Supreme Court action has no direct bearing on these cases, Ms. Facio said, because the board respects California law and is not seeking to prevent doctors from recommending marijuana. But the board's mandate is to ensure that doctors behave ethically and follow correct standards of care, she added.

    "I don't know that I would consider it appropriate medicine to simply sit there and issue recommendations for a fee without a medical history and a physical," Ms. Facio said.

    Some doctors view the board's inquiries as overzealous. Dr. Tod Mikuriya of Berkeley, who said he had issued about 20 marijuana recommendations a week, called the investigation of his practice a vendetta. Dr. Mikuriya said he had conducted an extensive review of medical history for each patient and had required documentary proof of illness.

    "The prosecutorial mind is boundless in its ways of applying different parts of the law," said Dr. Mikuriya, whose case is still pending before an administrative law judge.

    In the region covered by the Ninth Circuit, seven states Alaska, Arizona, Hawaii, Nevada, Oregon and Washington, as well as California have medical marijuana laws. Despite the lingering questions, some doctors in the region consider the Supreme Court decision not to review the appellate ruling as an unmitigated victory.

    "I'm home free now," said Dr. William Wenner, 77, a retired surgeon who lives on Hawaii's Big Island and estimates that he has issued more than 400 "certifications" to use medical marijuana in the last few years.

    "Who's going to come and get me, and for what?" Dr. Wenner asked. "I'm listening to these people and evaluating their complaints, and I've got three file drawers with their charts."

    Three states outside the Ninth Circuit ( Colorado, Maine and Maryland ) have some form of medical marijuana law. Although the ruling is not strictly binding outside the Ninth Circuit, advocates for medical marijuana predict that it will strongly influence authorities elsewhere, especially given the Supreme Court decision to let it stand.

    "Frankly, lawyers are ready to pounce on the government as soon as they start harassing doctors anywhere outside the Ninth Circuit," said Daniel Abrahamson, a lawyer for the plaintiffs who is legal affairs director of the Drug Policy Alliance.

    Federal officials have promised to continue enforcing the drug laws, reiterating their view that Marinol, an oral prescription drug that includes a form of THC, the psychoactive component of marijuana, precludes the need for using marijuana itself as a medication.

    Marijuana contains dozens of ingredients besides THC, and doctors say many patients report that smoked marijuana works better and has fewer side effects than the drug.

    "Smoking marijuana is shorter acting, and it's easier to control the dose," Dr. Stephen Becker, an H.I.V. physician in San Francisco, said. "But I'm not indiscriminate. I have to be convinced that the patient has failed the conventional pharmacopeia. I think physicians have a responsibility not to abuse this and get themselves and their colleagues and patients in trouble."

    Some doctors are pressing forward with research into medical marijuana, hoping to strengthen the scientific basis for proclaiming its medicinal benefits.

    Dr. Donald Abrams, a professor of clinical medicine at the University of California at San Francisco, is one of several investigators with the Center for Medicinal Cannabis Research, which is affiliated with the University of California. Dr. Abrams is studying whether marijuana can relieve the sharp pains that some people with H.I.V. experience in the feet and hands. He is also recruiting cancer patients for a clinical trial on whether marijuana can increase the analgesic effects of other painkillers.

    Dr. Abrams said he had discussed medical marijuana with patients since beginning his practice more than 20 years ago.

    "People have been using marijuana as medicine for thousands of years," he said. "It's only been in the last 60 years that it hasn't been available in the United States."

    MAPS Sends a Memo

    MAPS sends a short memo to David Murray, special assistant to ONDCP Director John Walters, outlining the reasons why ONDCP and DEA should support the licensing of Prof. Craker’s UMass Amherst marijuana production facility, sponsored by MAPS. This report was requested by David Murray.

    Both US Senators from Massachusetts Support UMass Amherst Project

    Today, MAPS received a copy of an Oct. 20, 2003, letter that Senators Kennedy and Kerry signed and sent to DEA Administrator Karen Tandy, expressing their strong support for the UMass Amherst marijuana production facility. The letter was fantastic and will make it significantly more difficult for DEA to reject the application.

    The Senators’ wrote:

    "We are writing to express our strong support for the application by the University of Massachusetts Amherst for registration as a bulk manufacturer of marijuana for distribution to researchers in clinical investigations authorized by the Food and Drug Administration and non-clinical investigations at DEA-licensed laboratories.... We believe that the National Institute on Drug Abuse facility at the University of Mississippi has an unjustifiable monopoly on the production of marijuana for legitimate medical and research purposes in the United States...The current lack of such competition may well result in the production of lower-quality research-grade marijuana, which in turn jeopardizes important research into the therapeutic effects of marijuana for patients undergoing chemotherapy or suffering from AIDS, glaucoma, or other diseases."


    This is a major step forward in MAPS’ efforts to create the conditions necessary for a serious medical marijuana drug development effort aimed with FDA-approval of the prescription use of marijuana, with the two essential elements being an independent source of supply of high-potency marijuana and FDA-approval of the use of vaporizer in clinical research.

    To show what an incredible accomplishment it was to obtain support from Senator Kerry for medical marijuana research, see the text of a letter he sent on October 21, 2003 to a constituent in which he expresses his reasons for supporting the current criminalization of the non-medical use of marijuana.

    MAPS Sends a Letter

    > MAPS sends a letter to all members of the National Institute on Drug Abuse’s National Advisory Council on Drug Abuse, requesting that it recommend that NIDA support Prof. Craker’s application to DEA for a privately-funded medical marijuana production facility as an alternative source of supply to NIDA. (also available in Word format)

    Journal of Cannabis Therapeutics: A Requiem

    Dr. Ethan Russo writes A Requiem for the Journal of Cannabis Therapeutics. (also available in Word format)

    It is with great regret, but sense of pride, that we now "close the book" on this journal and allow it to stand on its previous offerings. This represents a decision that has been very difficult, but considered after extensive consultation with numerous Editorial Board members. I would like to outline issues we have faced, the background of this decision, and review the accomplishments of the journal in its brief history.

    A History of Our Goals

    The Journal of Cannabis Therapeutics began as an idea advanced by Lester Grinspoon upon our first meeting in Washington, DC in November 1998. I immediately saw the logic of his concept: a place to publish the emerging abundance of information about clinical cannabis, the newly discovered endocannabinoid system that turns out to modulate so many vital physiological functions, as well as explore the offerings of synthetic cannabinoids. We envisioned a publication that would highlight the developing science, and hopefully serve as an educational resource for physicians and scientists, as well as interested members of the lay public.

    I seized upon Lester's idea, and advanced it to my friend, mentor and editor of the Haworth Herbal Press, the late Dr. Varro (Tip) Tyler, who paid it and me the ultimate compliment, by saying that it was an idea whose time had come, but he would only support the concept if I were to be its Editor-in-Chief. Next to consult was Bill Cohen, the president and publisher of Haworth Press. He was wisely skeptical, but agreed to educate himself on the issue. To his surprise, the available information convinced him of the advisability to proceed. Within three weeks, the idea became a concept. Bill's subsequent support has been unwavering.

    Very quickly, a distinguished group of physicians and scientists agreed to take part as a core editorial advisory. A perusal of our contingent, 24 strong, reads as a "Who's Who" of influential authorities and authors in the area. Again, many voiced doubts, but agreed to lend their support. To their credit, there have been no defections from their ranks in the life of the journal.

    From the beginning, I set a number of goals. I felt that the journal should establish itself or cease publication after three years. We have just crossed that threshold, but barely. I naively thought at the time that JCANT might be rendered superfluous within this time-frame by a widespread acceptance of the concept of clinical cannabis. That, obviously, will take a little longer.

    One benchmark I set was for a building subscriber base of 1000 or more. Another was acceptance in major university libraries. Finally, was the gold standard: we sought acceptance by Index Medicus for that critical accolade of acceptance of listing in that publication and the National Library of Medicine database.

    We also wanted to be a home for expansive concepts and discussions on the topic; the kind of article that would never gain acceptance in "mainstream" medical journals. Annual theme double-issues would be co-published in book form.

    Obstacles and Realities

    After a year of planning, and gathering material, JCANT's charter issue was released in early 2001, to critical surprise and reward. Subsequently, numerous copies were circulated at major meetings, to numerous compliments, including two letters of thanks from members of the US Supreme Court as they were considering the landmark Oakland Cannabis Buyers' Club case. I will treasure those.

    Advanced subscriptions were respectable in number, but despite the endorsements, rose but slowly over time. Our 2001 theme issue became Cannabis Therapeutics in HIV/AIDS, which remains today the only book of its kind beyond the late Bob Randall's 1991 Marijuana & AIDS. More acclaim followed, but the numbers did not follow suit. North American physicians have been particularly slow to familiarize themselves with the new literature, and to attempt to understand what is motivated their patients to employ clinical cannabis, frequently without their knowledge or endorsement.

    In 2002, we employed a generous grant from the Marijuana Policy Project to attempt to enter the realm of medical libraries. Free sample issues were offered to every such facility in the USA and Canada. Few actual subscriptions resulted. A reality of modern publishing is that such institutions have little shelf-space, and much sparser budgets for the new. Even the University of Montana asked me what current journal should be discontinued to make room for this offering. Mass mailings were met with similar ennui. The year was capped off with our second theme issue, Women and Cannabis: Medicine, Science and Sociology, ably co-edited by Melanie Dreher and Mary Lynn Mathre. Once more, it was a unique offering on a previously taboo topic.

    A similar scenario played out in 2003: critical acclaim and encouragement, but little advancement in subscriber base. Our initial application for Index Medicus recognition was turned aside negatively. The quest for double-blind controlled studies, the gold-standard of current medical proof, continued, but quite expectedly, the small numbers of available studies went to recognized large circulation publications. The year was completed with our last theme issue: Cannabis-From Pariah to Prescription that documents the current state of the art with respect to phytocannabinoids, endogenous and synthetic cannabinoids, and advances our knowledge thereof as the first products approach marketing and acceptance in Europe.

    By this time, a critical juncture was reached. Although the threshold of prescription clinical cannabinoids as a reality was nearing, the available pool of articles that would advance the knowledge and might lead to greater recognition has diminished. Prospects for additional database listing seem less than promising, and subscriber numbers have not risen despite additional grants-in-aid.

    I am experiencing some major life transitions of my own at this time: moving our household and leaving neurology practice after 20 years to accept a position as Senior Medical Advisor to GW Pharmaceuticals. I had voiced my personal concerns about possible conflicts of interest with the publisher, and numerous editorial board members, and am pleased with their reassurance and vote of confidence. That, ultimately, has had no bearing on the decision to cease publication at a time when JCANT has maintained its quality on a consistent basis, rather than witness its possible diminution over time.

    Our Accomplishments

    I believe that the Journal of Cannabis Therapeutics has in its short sojourn, advanced knowledge and acceptance of this emerging field. We have gained notice beyond the apparent numbers. Although JCANT may not have influenced the Supreme Court to accept clinical cannabis, our articles have been cited in major national commissions, including A Report of the National Commission on Ganja in Jamaica in 2001, and even more prominently in Cannabis: Our Position for a Canadian Public Policy, the report of the Canadian Senate in 2002. Both commissions strongly endorsed public access to clinical cannabis.

    I was very pleased that our lead article of volume 1, number 1, was a review of the current state of cannabis therapeutics as conceived by Leo Hollister, the American dean of scientific study of the herb, but was saddened that it came to be his final publication. Another landmark of the inaugural edition was the study of Musty and Rossi describing the success of smoked cannabis in allaying nausea in several hundred subjects in state-sponsored studies of previous decades that had never before been published.

    Innovative articles on therapeutic possibilities of cannabis and cannabinoids followed, including music appreciation, an examination of ancient and ethnobotanical evidence, and many more. Surveys of clinical cannabis use in various countries were offered, as well as closer examinations of non-cannabinoid components, endogenous cannabinoids, and novel delivery systems. Volume 2 saw the publication of the "Chronic Use Study" in which for the first time, information was made available concerning the benefits and side effects of cannabis for a small cohort of legal patients in the US Compassionate Use Investigational New Drug Program. This study has had an influence far beyond the subscribers, and has lead to many associated news stories and publicity about the issues. Further evolutionary ideas concerning cannabis were provided by many authors. Volume 3 continued in a similar vein, with more information on use surveys, vaporization technology, pharmacokinetics, and the advent of cannabis-based medicine extracts and oro-mucosal delivery.

    The Future

    I envision that the fields of cannabis and cannabinoid therapeutics will flourish in the coming decade as our understanding of the key role of endogenous mechanisms unfolds, and governments slowly accept the wisdom that these medicines can play in alleviating human suffering from legion complaints. The advancement of that concept should properly occur in venues with greatest accessibility and visibility, and I will be working toward that goal. I hope and expect to continue to publish review material in book form with the continued largesse and support of Haworth Press.

    Franjo Grotenhermen, the founder and president of the International Association of Cannabis as Medicine, has graciously agreed to expand the newsletter so that topical reviews and new ideas that might not see publication in mainstream sources will have an outlet.

    We will make further efforts to ensure that the useful legacies of the Journal of Cannabis Therapeutics will endure and be accessible. Currently, portions of the content are available online, and we will secure additional availability at intervals after publication as time progresses. Eventually, we would essay to make the entire body of the work available electronically to all.

    In closing, I would like to thank Lester for his idea, Tip for his support that has sustained me beyond his passing, Bill for his enduring encouragement, Dale Gieringer, Franjo Grotenhermen, John McPartland for their multitudinous submissions, GW Pharmaceuticals for their commitment to the future of cannabinoid therapeutics, and all the remaining board members and subscribers for their attention and largesse. For this, I am extremely grateful.

    Sincerely,
    Ethan Russo, MD
    Editor-in-Chief, Journal of Cannabis Therapeutics
    October 2003

    Snake-oil Salesmen

    Snake-oil salesmen
    Why does the Bush administration seem so intent on denying medical marijuana to adults in extreme discomfort? by Kristen Lombardi

    LAST RESORT: Linda Macia tried every prescription drug to ease her arthritis pain, but nothing helped -- except marijuana. 'I'm tired of people playing God when they don't have a clue what they're talking about,' she says.

    THE WHITE HOUSE Office of National Drug Control Policy (ONDCP) ? whose anti-pot road show blew through Boston last week ? wants you to believe that everything about marijuana is bad, bad, bad. That the plant?s promising medicinal benefits are simply a "Trojan-horse issue," perpetrated by drug-reform advocates who are taking advantage of sick and dying people to advance a decriminalization agenda. That legalizing medical marijuana would confuse the "just say no" message for adolescents and cause them to glamorize debilitating diseases like cancer, AIDS, and multiple sclerosis.

    It?s a lot to concede if you?re a responsible adult who has taken the occasional (or even frequent) toke. It?s especially difficult to concede if you?re a responsible adult who smokes to ease the physical symptoms of glaucoma, epilepsy, or asthma, among other diseases. But that pretty much sums up the tenor at the ONDCP-sponsored New England Anti-Drug Summit, which took place at Faneuil Hall on October 8. Headed by ONDCP director John Walters ? a/k/a the nation?s "drug czar" ? the event was part of a 25-city tour aimed at helping local leaders with three things: "stopping drug use before it starts; healing those who are using drugs; and disrupting the market for drug use," according to the ONDCP Web site. To date, Walters and his entourage have traveled to San Diego, Seattle, Detroit, and Denver. Here in Boston, the Just Say No brigade met with New England governors, as well as health-care and law-enforcement personnel. They talked about the region?s heroin problem (see "Baby Talk," page 27). They introduced President George W. Bush?s "Access to Recovery Treatment Initiative," a three-year, $600 million drug-treatment program pending before Congress. And then, they let loose on the subject of medical marijuana.

    Unlike the day?s other debates, this three-person panel ? Andrea Barthwell, an ONDCP deputy director; Mark Kraus, president of the Connecticut Society of Addiction Medicine; and Billy Martin, pharmacology chief at Virginia Commonwealth University ? paraded reams of disinformation. Forget about meaningful discussion. Indeed, in keeping with the Bush administration?s general assault on patients who smoke pot to manage their illnesses (see "Domestic Stealth Bombs," News and Features, February 28), the federal government will go to extreme lengths to prevent the push for legalizing medical marijuana ? and last week?s panel was no exception. If anything, it amounted to a one-sided exercise suggestive of propaganda such as Reefer Madness (1938), whose characters are driven insane by taking a puff of a joint. As Scott Mortimer, a Brookline resident and medical-marijuana user who attended the October 8 summit, put it: "The event reminded me of a West Virginia liar?s contest, with panelists spinning elaborate tall tales. The [ONDCP] policy concerning medical marijuana is always rooted in ridicule and scorn."

    IT'S NOT AS IF Mortimer, who suffers from paralyzing back pain, and other proponents of medical marijuana didn?t see the propaganda fest coming. By 9 a.m. last Wednesday, he and two dozen or so patients and drug-reform advocates had gathered outside Faneuil Hall to protest what they dubbed the ONDCP?s "whitewash." After all, no one in favor of legalizing marijuana for medicinal purposes had been included on the list of handpicked speakers. This, despite the fact that the Marijuana Policy Project (MPP), in Washington, DC, had hounded the ONDCP for a chance to be heard. Local MPP members had suggested panelists. They?d offered to submit testimony. They?d asked to sit in the audience. Yet their requests were denied. Says MPP communications director Bruce Mirken, "[ONDCP officials] clearly know there will be opposition wherever they go, and they?re trying to avoid it."

    And the opposition at Faneuil Hall specifically set out to counter the slanted rhetoric flowing from summit speakers. They held signs that read IT IS EVIL TO DENY SICK PEOPLE MEDICAL MARIJUANA and STOP ARRESTING PATIENTS FOR MEDICAL MARIJUANA. They bellowed, "John Walters is coming to town to spread lies!" while handing out fliers to preoccupied professionals and tourists. They lectured wayward passers-by on the miracle of pot for people suffering from chronic pain, nausea, and physical tremors.

    Inside the hall, the ONDCP set the tone straightaway. Barthwell, who?s become the ONDCP mouthpiece on medical marijuana by penning op-eds against the cause for newspapers such as the Los Angeles Times, the Kansas City Star, and Newsday, kicked off her remarks with a blunt statement of opposition. Medical marijuana, she said, is "the worst scam" drug legalizers have perpetrated on this country. She went on to dissect the scientific research. Interestingly, she and her fellow panelists fixated on the fact that patients who use marijuana for medicinal purposes typically have to smoke it ? a delivery method that, they claimed, isn?t "scientifically proven." Smoking weed, they reasoned, goes against modern medicine, which shuns cigarettes, and which has an arsenal of legal prescription drugs that alleviate pain and nausea at its disposal.

    As Barthwell declared, "No legitimate 21st-century physician would recommend that patients smoke or chew opium." Yet "frauds in white coats," she said, are encouraging seriously ill patients to inhale dope rather than participate in the latest drug regimens. "Is that the best that 21st-century medicine has to offer?" she demanded. The idea that crude pot has medicinal value, she added, "is an insult" to modern medicine.

    Kraus, of the Society of Addiction Medicine, echoed the sentiment. "For each disease that?s been treated by smoking marijuana," he insisted, "there?s an accepted and more effective alternative treatment." Even Marinol, a synthetic pill of the tetrahydrocannabinol (THC) compound found in marijuana, which the federal Food and Drug Administration (FDA) has approved for cancer patients undergoing chemotherapy, is better than weed. The raw plant, he said, "has not passed the rigors of scientific examination."

    Only one panelist, Virginia pharmacology professor Martin, had the courage to buck the status quo by acknowledging that marijuana has, in fact, helped patients. But he quickly got back on message. He noted the lack of research proving pot?s medicinal benefits. "We have a choice," he explained, "and it?s a simple one." Do we want to devote money and effort to determine whether marijuana has a place in medicine or not? As he sees it, the issue isn?t "worth the resources."

    On closer scrutiny, the panel itself is what doesn?t seem worth it. The primary argument that smoking marijuana has no medicinal benefit comes across as disingenuous, to say the least. For one thing, it ignores published research ? more than 8858 medical articles? worth ? on marijuana. Most of these studies have examined the medicinal effects of the plant?s cannabinoids, including THC, CBN, and CBD. Many of them detail research involving patients in countries like the Netherlands, Canada, and Great Britain. In the US, one of the more definitive surveys came in 1999, after former drug czar Barry McCaffrey commissioned the National Institute of Medicine to conduct a two-year examination of the matter. The study, "Marijuana and Medicine: Assessing the Science Base," concludes that cannabinoids have clear therapeutic benefits, "particularly for symptoms such as pain relief, control of nausea and vomiting, and appetite stimulation." Thus, it boggles the mind that panelists would try to say smoking pot has no medicinal value, since it still delivers cannabinoids. Steve Fox, the MPP?s director of government relations, likens the contention to "saying smoked cigarettes don?t give people nicotine. It doesn?t make sense."

    If there isn?t enough definitive US-based scientific evidence to satisfy the ONDCP, that?s at least partly because the federal government has blocked any substantive research on marijuana since the mid 1980s. The Drug Enforcement Administration (DEA) and the National Institute on Drug Abuse (NIDA) grow and maintain the only legal supply of pot, which means that researchers must navigate a cumbersome application process just to obtain the plant. At the same time, researchers have complained that the DEA?s and NIDA?s marijuana contains low "bioactive ingredients," or cannabinoids. When researchers test pot with inadequate levels of cannabinoids, they cannot determine if the plant has little therapeutic value ? or is just ineffective. "It?s a way to sabotage research," says Rick Doblin, who heads the Belmont-based Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit pharmaceutical-research organization. "The federal government has a monopoly on shitty pot and, as a result, you can?t do a serious drug-development program."

    Take, for example, Doblin?s latest project at the University of Massachusetts at Amherst. In 2001, he offered to donate $5 million over a five-year period to Lyle Craker, a UMass Amherst professor of plant and soil sciences, for a medical-marijuana-research project. Craker would apply to the DEA for a license to grow high-potency marijuana, which, in turn, he would distribute to researchers to study the plant?s therapeutic effects. It?s taken Doblin and Craker two years to appeal to the DEA for a license ? and they?re still waiting. Their experience shows that if there is a dearth of research it can?t be put down to lack of interest. Explains Craker, "We need a fair and honest trial. We haven?t had that" thus far.

    Of all the pseudoscientific arguments at the summit, perhaps the most foolhardy was the idea that pills never fail. Mortimer, the Brookline resident, can certainly attest to the contrary. The 35-year-old former managing consultant had to quit his job because chronic pain prevents him from sitting at a desk for eight hours straight. His back condition is the result of an unsuccessful 1986 spinal operation. After years of popping pain killers that rendered him "a zombie," he tried anti-inflammatory medications. They seemed to work ? until, in 1995, he collapsed in the shower. He was rushed to the hospital, where doctors determined that Mortimer?s wonder drug had eaten through his stomach lining. To this day, he cannot physically tolerate oral medications. But his chronic pain hasn?t subsided. So every night, he inhales several tokes of marijuana to manage his symptoms. Why, he wonders, shouldn?t he be allowed this relief? Does his adverse reaction to pills mean that he doesn?t get an alternative? As he says, "Does the drug czar get to pick which of my organs" ? his lungs or his stomach ? "will be harmfully affected by medicine?"

    Linda Macia, a 50-year-old Manchester resident who uses marijuana to manage the chronic pain of degenerative arthritis, relays a similar experience while at the October 8 demonstration. Seated in a wheelchair, her strawberry-blond hair hiding her tired eyes, Macia explains she?s tried every prescription drug she could find to ease the searing pain that lasts all day, every day. OxyContin. Demerol. Morphine. Codeine. Methadone. The list goes on. Yet the drugs have left her nauseated, or knocked out, or battling hot-and-cold flashes and fevers. "I live with no answers to my pain," Macia says. She endured a radical procedure whereby a super cocktail of pain relievers was injected into her spine. But even that didn?t work.

    So she started smoking marijuana ? and found it helps. It doesn?t magically cure her pain, but it allows her brain to focus on other things. It gives her a reprieve from the mind-numbing jolt that shoots up her legs and along her spine. She, like Mortimer, expresses bewilderment ? and resentment ? at the ONDCP panelists who insist that smoking a joint does not alleviate her pain. "I?m tired of people playing God when they don?t have a clue what they?re talking about," she says. "I?m an exception to the prescription-drug rule. So what am I supposed to do?"

    THE UNTRUTHS about scientific research spewed by last week's medical-marijuana panelists seemed bad enough ? until the "debate" turned to the subject of kids. The ONDCP?s Barthwell raised the specter of "the children" by suggesting that even considering the idea of legalizing marijuana for medicinal purposes sends the wrong message to adolescents ? who could come to believe that marijuana is "good for them." The governors soon picked up on the theme. Connecticut governor John Rowland, for instance, invoked his own parenting experiences. "One of my five teenagers begins every paragraph of every conversation by saying, ?Dad, don?t tell me that you didn?t do it,?" he said. He urged parents in the audience to get behind the anti-drug campaign. "Mixed messages are a mistake," he said. "We need to say, ?Marijuana is for losers. We are against drugs.?"

    Mr. Drug Czar seized the moment to mention his two kids. "I was shocked to find out my fellow parents and neighbors were relatively accepting of drugs and alcohol," Walters noted. Medical marijuana, he said, will only tell his children and others that "we?re too soft on drugs."

    Rhode Island governor Donald Carcieri also chimed in with the rather puzzling observation that his grandchildren, like most teens, rebel "no matter what." For that reason, he said, it?s "a good idea" to keep marijuana illegal ? otherwise, kids might end up snorting coke instead.

    The whole discussion amounted to a false argument. "It?s just baloney" is how the MPP?s Mirken describes it. In California, the first state to legalize marijuana for medicinal purposes, teen pot use had grown steadily from 1991 to 1995 ? from 19 percent to 34 percent. But since the medical-marijuana referendum was passed in 1996, California has witnessed a drop in the percentage of teens who smoke weed. Among ninth graders, for example, the numbers fell from 34 percent in 1996 to 19 percent in 2002 ? a drop of approximately one-third. The statistics show that the state?s law hasn?t left California teens any more eager to smoke pot because their ailing elders are allowed to.

    If the ONDCP officials were honest with themselves, of course, they?d see that the just-say-no approach to drugs has failed kids far more than those who want to legalize medical marijuana have done. Consider the results of the national Parents Resource Institute for Drug Education (PRIDE) survey of American teens, one of two surveys designated by Congress to provide official measures of the drug czar?s success. Kids took the test after Walters saturated the airwaves with commercials telling teens that if they light up a joint, they?re likely to commit date rape and shoot their friends. What happened? The proportion of eighth graders using marijuana in the past month jumped from 7.2 percent to 10.2 percent ? a 43 percent increase. Obviously, as Mirken says, "what the ONDCP is doing now isn?t working."

    Still, that didn?t faze the folks at the anti-drug summit, where the only worthwhile question was one raised by Massachusetts governor Mitt Romney. Why, Romney wondered, isn?t marijuana treated the same way as any other pharmaceutical drug? "Would it not be appropriate to subject marijuana to this same [drug-testing] process?" he asked, setting off a wave of applause among proponents. Yet it is precisely this sort of question that routinely goes ignored by Washington?s anti-drug pooh-bahs. (It took all he had for Doblin, of MAPS, to refrain from calling out from the audience, "We?d like to do more research, but the drug czar is holding us back.")

    Meanwhile, John Baldacci, the governor of Maine ? the only New England state to approve a medical-marijuana law in 1999 ? sounded wishy-washy and apologetic. Though he recognized that the legislation "doesn?t appear to be a widespread problem" for either the state police or the children of Maine, he failed to defend the initiative. He failed to hold it up as a successful model for the rest of New England. He failed to challenge the ONDCP?s empty rhetoric.

    IN THE END, the anti-drug summit was a disservice to New Englanders. Medical marijuana, after all, is no longer a fringe issue. Just this week, the US Supreme Court turned down the Bush administration?s request that it consider whether the federal government can punish doctors for even talking about the medicinal benefits of pot ? thereby paving the way for state laws that legalize marijuana for medicinal purposes. To date, nine states have enacted such legislation. Maine may be the only state in the region to do so, but the rest of the area isn?t far behind. Last year, a medical-marijuana bill made it to the desk of former Vermont governor Howard Dean, who vetoed it. Already, the bill has been refiled. Connecticut drug reformers are pushing to expand a 1981 state law allowing doctors to prescribe patients marijuana ? a law that Rowland, then a state representative, supported. Though the effort failed last summer, advocates plan to re-introduce amendments to protect medical-marijuana patients next February. In Massachusetts, a similar bill that would create legal protections for medical-marijuana patients is now pending before the legislature. And New Hampshire advocates are ambushing Democratic presidential candidates to get them on record about the issue. (The most favorable? Dennis Kucinich, who?s promised to sign an executive order legalizing pot for medicinal purposes if he?s elected president.)

    Given the issue?s momentum in New England, the ONDCP panel could have engaged in much-needed debate. Yet panelists refused to consider the real questions. And the governors failed to take the issue seriously. Instead, the summit toed the Bush-administration line. It was easy for New England governors to do that in a gilded hall huddled together with the drug czar, as Robert Rooke, who heads the Connecticut drug-reform group A Better Way Foundation, points out. "But to do that in a room full of patients who need marijuana and have to go underground to get it is a whole other story."

    Additional research by Camille Dodero. Kristen Lombardi can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it.

    Issue Date: October 17 - 23, 2003

    Continue Reading

    MAPS files FOIA request

    MAPS files FOIA request with DEA. MAPS learned through a phone call to DEA that only one public comment about Prof. Craker’s application for a license to produce marijuana was filed with DEA during the public comment period that ended September 22, 2003. However, we also learned that we could see that comment only by filing a formal Freedom of Information Act (FOIA) request, which we did today.

    Nature: Marijuana Researchers Reach for Pot of Gold

    Nature publishes an excellent article on medical marijuana research (also available in pdf format).

    October 2003 Volume 9 Number 10 p 1227
    Nature
    Apoorva Mandavilli

    The words 'medical marijuana' instantly conjure images of agitated politicians and emotional patients, each heatedly arguing their point of view. Thanks to marijuana's popularity as a recreational drug, the debates are usually informed more by moral and cultural beliefs than by rigorous scientific evidence.

    But the real story is quietly unfolding behind the politics, where cannabis research has been seeping into mainstream neuroscience. Since the discovery of the first endocannabinoid (the body's own chemical that resembles those found in cannabis) in 1992, scientists have been busy unraveling what appears to be a major neurotransmitter system with an astounding panoply of effects.

    What they've found so far suggests that the endocannabinoid system has an important role in nearly every paradigm of pain, in memory, in neurodegeneration and in inflammation. "There is no major biological system where these compounds are not involved," says Israeli researcher Raphael Mechoulam, who is credited with several seminal findings in the field.

    If cannabinoids are crucial to so many biological processes, it follows that their clinical potential is enormous. Until recently, however, most of the evidence for cannabinoid use had been anecdotal because many countries are reluctant to fund research on its medical potential.

    Marijuana has been banned in the US since 1937 and in the UK since 1971. A few countries support its medical use: Mechoulam gets his 'hash' from the Israeli police, Canada legalized medical marijuana in 2001, and the Netherlands sanctioned its use in September.

    Cannabis sativa contains more than 60 active compounds, the most active of which is delta-9-tetrahydrocannabinol (THC). People have used cannabis to treat all manner of pain, nausea, muscle cramps, glaucoma, asthma, strokes and insomnia. A few small clinical trials have confirmed its efficacy in managing some of these.

    Critics point to marijuana's ability to induce anxiety, panic and paranoia. But a recent meta-analysis concluded that there is no substantial effect of its long-term use on the brain. "Compared to many of the drugs doctors prescribe to their patients, marijuana is a pretty harmless substance," says Donald Abrams, professor of medicine at the University of California in San Francisco (UCSF).

    Abrams' experience with clinical trials illustrates how inextricably marijuana research is linked with politics. Abrams first applied to the National Institute on Drug Abuse, the only legal source of marijuana in the US, for funds to study marijuana's effects on AIDS patients. After twice being rejected, he reworded his proposal to highlight the drug's potential negative effects. He received nearly $1 million in funding.

    The US government has not initiated a study evaluating medical marijuana in two decades. Because marijuana is classified as a schedule I drug (with a high potential for abuse and no medical use) cannabis research faces scrutiny by four federal agencies.

    "I can go out and get cannabis on the street easier than [I can get] candy," says Roger Nicoll, a pharmacologist at UCSF. "There is a total disconnect between the use of marijuana and the way in which the government is controlling it."

    Most researchers say the scales may tip in marijuana's favor if researchers can find a way to deliver therapy free of its 'high'. The key may lie in basic research on the cannabinoid receptors.

    There are two known cannabinoid receptors, CB1 and CB2. CB1 is the most abundant G-protein-coupled receptor in the brain, and its distribution there hints at intriguing functions: it is ubiquitous in the cerebellum, but in the hippocampus (the memory center) it is only found in a subclass of neurons that regulate memory storage and retrieval.

    CB2, in contrast, is found only in peripheral sites with immune functions. Some researchers suggest that using CB2-specific compounds may be one way to avoid psychotropic effects. Mechoulam, at Hebrew University in Jerusalem, has developed one such compound unevocatively called HU308, and a US team has reported preliminary results with another molecule.

    Mechoulam is also focusing on cannabidiol, the second biggest ingredient in cannabis and the least psychoactive. Cannabidiol is known to be a potent agent against rheumatoid arthritis. Based on a synthetic cannabidiol developed by Mechoulam, the Israeli company Pharmos is conducting clinical trials of the compound's effects on brain injury. UK-based GW Pharmaceuticals is testing cannabis extracts with different ratios of THC and cannabidiol.

    Cannabidiol's mechanism of action is unknown, in part because it does not bind to the known receptors. But Mechoulam suggests there may be more receptors (as well as endocannabinoids) to be found, opening up possibilities for specific manipulation of the system.

    Delivery technologies for cannabis are another avenue of research. Many patients prefer to smoke cannabis because it takes effect quickly and they can titrate the doses better. But some scientists are uncomfortable with the idea of a smoked therapeutic. "There isn't a single drug that is being smoked, and for good reasons," says Mechoulam.

    GW has developed a cannabis extract in a mouth spray. It is also working on nasal inhalers and tablets that dissolve under the tongue.

    As evidence of marijuana's potential mounts and scientists discover ways to minimize its downside, governments are reconsidering their stance. A US National Institutes of Health report in 1997 and a report from the Institute of Medicine in 1990 both recommended more research to evaluate marijuana's medical potential. Based on the reports, California funded the first Center for Medicinal Cannabis Research.

    Abrams, one of the researchers at the center, now runs three clinical trials. "The science is fascinating enough to keep my attention," Abrams says. "I'll leave the politics to other people."

    UMass Professor Seeks OK to Grow Marijuana Legally

    UMass professor seeks OK to grow marijuana legally
    Marcella Bombardieri
    Boston Globe
    August 29, 2003
    For more than 30 years, University of Massachusetts professor Lyle Craker has worked in obscurity, experimenting with medicinal plants like black cohosh, goldenseal, and maca.

    Now he wants to grow a far more controversial plant in his Amherst lab: the strongest research marijuana in the country.

    Craker is awaiting a decision from the US Drug Enforcement Administration that could make UMass the second institution in America to grow marijuana legally. A public comment period on his application ends next month.

    Currently, the University of Mississippi provides all the marijuana plants for medical researchers, who are experimenting with the drug as an antidote to pain for patients with such diseases as AIDS and cancer. Craker says he could grow a stronger, higher-quality product, and do it without government funding.

    "When you have a complete monopoly you have no incentive to improve the material," said Craker. "In science there needs to be friendly competition in order to push the frontiers. It's the capitalist system, you could say."

    UMass officials including Chancellor John V. Lombardi have approved Craker's quest for permission. Five members of the Massachusetts congressional delegation urged the DEA in a letter last year to allow privately funded facilities to produce marijuana (The signers were Representatives Barney Frank, John W. Olver, James P. McGovern, William D. Delahunt, and Michael E. Capuano.)

    Yet Craker is fighting an uphill battle. Former DEA chief Asa Hutchinson responded to the congressmen with a letter saying that as long as the University of Mississippi ' continues to meet the nation's need for research-grade marijuana while maintaining the highest level of safeguards against diversion," an international treaty and US law "dictate that it remain the sole domestic producer."

    But Craker's proposal would not violate the treaty or the law, say his supporters -- including the American Civil Liberties Union, which sent the DEA an eight-page letter to that effect last year.

    Craker said his lab is prepared to take extraordinary precautions, including hiring a 24-hour guard and installing security cameras. He said that all plant materials, as small as a single fallen leaf, would have to be carefully catalogued and destroyed under his proposal, which was first reported in the Daily Hampshire Gazette.

    Craker would not do the research himself, but rather make the marijuana available to federally approved scientists. Researchers would pay for the plant, although Craker shied away from saying he was "selling" marijuana.

    "I know that UMass is desperate for money, but I can just see the headlines," he said, adding that the money would partly go simply to pay for the lab's guards. "It's going to be expensive," said Craker, who works in the department of plant and soil sciences.

    If the DEA rejects Craker's bid after the public comment period ends Sept. 22, the professor can appeal to a federal administrative judge.

    He has already received a small grant from an advocacy group called the Multidisciplinary Association for Psychedelics Studies. The group's president, Richard Doblin, could not be reached yesterday because he was at the Burning Man festival in Nevada.


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    UMass Prof Seeks Pot Permit

    UMass prof seeks pot permit
    Mary Carey
    GazetteNet
    August 28, 2003
    A University of Massachusetts plant and soil sciences professor has applied to the federal government to grow high-quality marijuana for medicinal research.

    The U.S. Department of Justice Drug Enforcement Administration is seeking comments by Sept. 22 - but only from a limited category of people - before ruling on the proposal.

    If approved, UMass would be the only other legal grower of marijuana for research purposes besides the University of Mississippi, which has supplied the National Institute on Drug Abuse with marijuana for 30 years.

    Lyle Craker, director of the medicinal plant program at UMass, first applied to the DEA in June 2001, for permission to grow an initial 25 pounds of high-potency marijuana. It would be supplied to government-approved researchers working on therapies for treating symptoms of AIDS, glaucoma and multiple sclerosis and in alleviating pain and other side effects of chemotherapy.

    Craker proposes to grow the marijuana, a more potent grade than that grown in Mississippi, in a secure building on campus. He would receive funding from the Multidisciplinary Association for Psychedelic Studies, a Florida-based nonprofit research and educational organization that seeks to develop marijuana as a prescription medication approved by the U.S. Food and Drug Administration.

    "My current thought is that there has not been sufficient testing to tell whether this is a drug that can help people or not," Craker said. "If I look at this as a potential medicinal plant, than it is our responsibility to see that this plant material is investigated, so that the questions of whether it has medical significance or not can be answered."

    Craker said he has been working closely with DEA officials from Connecticut, some of whom visited the Amherst campus in December to review the specifics of his application, but it is unclear how or when the DEA will rule. "There is a lot of pressure (to oppose his application), and they're trying to respond to that in an honest way," Craker said.

    Public notice of Craker's application in the July 24, 2003, Federal Register limits those people who may file comments or objections to his plan to "any person who is presently registered with DEA to manufacture such substances..."

    Massachusetts Congressmen John Olver, Barney Frank, James McGovern, William Delahunt and Michael Capuano, who support Craker's proposal, wrote to DEA Administrator Asa Hutchinson in June 2002, urging the agency to license privately funded sources of marijuana.

    In a prepared statement issued Wednesday, Olver said, "I urge the Drug Enforcement Administration to grant UMass Amherst a license to manufacture marijuana for scientific and medical uses approved by the FDA and DEA. Further scientific research into the risks and benefits of the potential uses of marijuana would be in the best interest of all medical patients and their families."

    Referring to the potential therapeutic benefits of marijuana, Olver added, "I believe that individuals who are seriously ill should have access to marijuana in order to ease their pain. Common sense dictates that we should do everything in our power to provide treatment for victims of diseases like cancer and AIDS, including allowing them to have access to this treatment that has been shown to relieve suffering."

    But in his July 1, 2002, response addressed to Frank, Hutchinson argued against expanding the number of marijuana producers, saying that, "For more than 30 years, the University of Mississippi has produced an adequate supply to meet the entire United States demand for research-grade marijuana. There is no indication that this supply is currently inadequate or will become inadequate in the future."

    Mary Carey can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..


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    JAMA Article About CMCR

    The JAMA article on CMCR showed how important it is to obtain alternative sources of funding for medical marijuana research, since Center Co-director Andrew Mattison makes it clear that the ultimate goal is not FDA approval of marijuana but the development of "new molecules that interact with the body’s built-in cannabinoid receptors." Even Stage #2, which is the development by CMCR of non-smoking delivery systems, was described in the article as focusing primarily on products like the GW Pharmaceutical mucosal spray, which requires a marijuana extract, rather than the vaporizer, which can be used with the marijuana plant itself.

    Short-Term Medical Cannabis Does Not Harm HIV+ Patients

    Dr. Abrams and team publish an article in the Annals of Internal Medicine, claiming "Short-Term Medical Cannabis Does Not Harm HIV+ Patients"! For more details, see MAPS’ Comments and UCSF Press Release.

    On Monday, August 18, at 5:00 PM EDT, UC San Francisco issued a press release about the publication by Dr. Donald Abrams and co-authors of an article in the Annals of Internal Medicine discussing the results of their study of the effects of marijuana in HIV+ subjects. Here's the headline, "Short-Term Medical Cannabis Does Not Harm HIV+ Patients," with the rest of the press release at the end of this message.

    This is the first publication of the results of a double-blind, controlled study of the effects of smoked marijuana in a patient population in twenty years. It took MAPS and Donald's group five and a half years to get this study started, with help from MPP lobbying NIDA. We leveraged a $10,000 donation to MAPS from Peter Lewis, used to support work by Donald's group preparing protocols, into a $1 million NIDA grant for a compromised but still worthy study. In order to obtain NIDA marijuana, we had to agree to conduct a safety study in HIV+ subjects who didn't suffer from AIDS-wasting, instead of going forward with our FDA-approved safety and efficacy study in treatment-resistent AIDS-wasting subjects. When it came time to report the results, the paper was rejected by several journals that weren't comfortable with its conclusions. Finally, the Annals of Internal Medicine had the courage to publish it.

    Now we have yet another response to Dr. Andrea Barthwell, deputy director of ONDCP, who concluded her July 22, 2003 Op-Ed against the medical use of marijuana by saying, "The overarching charge to any physician is: "First, do no harm." That is the test smoked marijuana cannot pass." On the contrary, this new study demonstrates that it has passed that test, at least sufficiently so that Dr. Barthwell's only ethical option is to encourage research into marijuana's potential beneficial uses in patient populations and to recommend that DEA license the UMass Amherst facility to produce high-potency marijuana for medical research.

    Here's the rest of the press release:

    UC SAN FRANCISCO
    Corinna Kaarlela, News Director
    Source: Jeff Sheehy, (415) 597-8165
    E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
    Web: http://www.ucsf.edu

    EMBARGOED FOR RELEASE

    5:00 PM, EDT, August 18, 2003

    TO COINCIDE WITH PUBLICATION IN THE ANNALS OF INTERNAL MEDICINE

    UCSF Study Finds No Harm to HIV+ Patients with Short-Term Medical Cannabis.

    UCSF researchers found no harmful changes in HIV virus levels in patients on combination antretroiviral therapy in a safety study looking at both smoked marijuana and dronabinol, an oral medical cannabinoid.

    "People with HIV are a vulnerable population, so successfully addressing the safety concerns allows us to move on to effectiveness studies, three of which are currently underway here," said study author Donald Abrams, MD, professor of clinical medicine in the UCSF Positive Health Program at San Francisco General Hospital Medical Center (SFGHMC).

    The findings, which appear in the August 19, 2003 issue of the Annals of Internal Medicine, mark the first publication of a randomized, controlled study involving medical marijuana in a major peer-reviewed journal in several years.

    Sixty-two HIV-infected patients on antiretroviral regimens containing a protease inhibitor completed the 25 day inpatient study. Patients were randomized to three groups--20 received smoked marijuana, 22 received dronabinol, and 20 received an oral placebo.

    The study measured changes in HIV virus levels in blood (rising levels tend to indicate disease progression) and CD 4 and CD 8 T lymphocyte cell counts. These disease- fighting white blood cells are essential for defending against infections and are targeted and destroyed by the HIV virus.

    The study investigated whether cannabinoids would alter the levels of the virus either by changing the levels of the protease inhibitor medication or by a direct effect on the immune system. Fifty-eight percent of the participants entered the study with levels of HIV virus circulating in their blood below the limit currently detectable by the usual tests. They ended the study with no change in their undetectable status. In all three arms, patients with detectable levels of virus saw no change in the levels of HIV in their blood over the three-week study period.

    There was no significant change in CD 4 or CD 8 T-cell counts for the placebo group over the course of the study. CD 4 T-cell counts rose by about 20 percent for both the smoked marijuana and the dronabinol group. CD 8 T-cell counts rose by 20 percent in the smoked marijuana group and by 10 percent in the dronabinol group. "The change in lymphocyte counts for the smoked marijuana group is intriguing. At a minimum, it contradicts findings from previous studies suggesting that smoked marijuana suppresses the immune system," said Abrams.

    While not the primary objective of the study, weight gain was observed in all three groups, possibly due to regularly scheduled meals and snacks. Statistically significant weight gain occurred in both the smoked marijuana and the dronabinol arms compared with the placebo arm, though the gain was fat, not in the desired lean body mass compartment.

    Co-authors of the study are Joan F. Hilton, DSc, MPH, UCSF associate professor of epidemiology and biostatistics; Roslyn J. Leiser, RN, clinical nurse, Starley B. Shade, MPH, senior statistician, Steven G. Deeks, MD, UCSF associate professor of medicine, and Thomas F. Mitchell, MPH, program director, all in the UCSF Positive Health Program at SFGHMC; Tarek A. Elbeik, PhD, UCSF associate researcher in laboratory medicine at SFGHMC; Francesca T. Aweeka, PharmD, UCSF professor of clinical pharmacology; and Neal L. Benowitz, MD, UCSF chief of the division of clinical pharmacology and vice chair of the department of biopharmaceutical sciences. Also, Barry M. Bredt, MA, specialist, and Morris Schambelan, MD, UCSF professor of medicine and director, General Clinical Research Center at SFGHMC; Bradley Kosel, PharmD, visiting postdoctoral scholar in clinical pharmacology at UCSF; Judith A. Aberg, MD, associate professor of medicine at Washington University, St. Louis, Mo.; Kathleen Mulligan, PhD, UCSF associate professor of medicine at SFGHMC; and Joseph M. McCune, MD, PhD, UCSF professor of medicine at the Gladstone Institute of Virology and Immunology.

    The study was supported by a research grant from the National Institute on Drug Abuse, a part of the National Institutes of Health, which also supplied the marijuana cigarettes for the trial. The dronabinol and placebo were supplied by Roxane, Inc., Columbus, Ohio.

    An Update From Geoffrey Guy

    An Update From Geoffrey Guy
    Fred Gardner
    Anderson Valley Advertiser
    July 25, 2003
    Geoffrey W. Guy, MD, is a successful British pharmaceutical entrepreneur who in 1998 founded a company, G.W. Pharmaceuticals, to produce and market medically useful extracts from the cannabis plant. Guy, now 50, had never used cannabis himself; his interest had been piqued by British multiple sclerosis patients asserting that marijuana eased their painful spasms.

    Guy's business plan was straightforward: grow plants under controlled conditions in which various cannabinoids of interest (THC, CBD, and several others) predominate. Then blend uniform, pharmaceutical-grade extracts containing different cannabinoid ratios and provide them to investigators for use in clinical trials. To date GW has successfully tested three extracts -high-THC (which GW has dubbed "Tetranabinex"), high-CBD ("Nabidiolex"), and a 50-50 mix ("Sativex").

    This spring, right on schedule, GW filed its "research dossier" with the Medicines and Healthcare Products Regulatory Agency (the British equivalent of the FDA). It included data on successful clinical trials involving chronic pain patients and MS and spinal-cord-injury patients.

    Soon after filing the application, GW signed a deal allowing Bayer AG to market one of its extracts in the UK under the Sativex(r) brand. Bayer also optioned marketing rights in Europe, New Zealand, and Canada. GW gets cash to spend on research, production, and clinical trials plus a cut of future sales proceeds. Bayer is betting that the MHRA will approve Sativex or return the application dossier to GW with readily-met requirements. A decision is expected by the end of the year.

    This interview was conducted at the NAV Conference Center in Cornwall, Ontario, 6/29/03, at the end of the International Cannabinoid Research Society's 13th annual meeting. Two papers and a poster had described successful trials of GW extracts.

    C'Notes: How large is the GW workforce?

    GWG: We have about 130 employees, but we subcontract a lot of work. So the overall program in full-time equivalents is higher than 140. Last year we engaged our first contract grower, a major commercial grower who grows food for supermarkets at enormous scale. Their glasshouses dwarf ours.

    C'Notes: How much are you producing?

    GWG: At present we are producing between 50 and 60 tons, wet weight. We are licensed to produce 100 tons, which we will be doing within the next year. That's 10 tons or more of dried, herbal cannabis.

    C'Notes: Could you describe the basic cultivation cycle?

    GWG: We take cuttings and place them in a growing medium. They root very nicely -we get about a 95+% rate on our cuttings. One operative during the day can take 2,000 cuttings... At the end of two weeks the plant is potted up into an organic compost-type growing medium that we alter to provide optimum aeration. The pots are lined up on very large trays, each tray contains about 200 plants. They're on rails so they can move down the line. Every week the process is the same. So as you look down the glasshouses, you see, stepwise, week-by-week, one week's worth of growth, the next week's worth of growth, and so on, exactly the same... Starting with cuttings on one side of the production line, ending with ready-to-harvest on the other side.

    C'Notes: How tall are they at harvest? GWG: They're roughly one meter high. We've done quite a lot of research on optimal morphology. Our objective is to produce the maximum amount of consistent cannabinoid material per growth cycle. We have six cycles per year, so we grow for a short maturation period.

    Typically, the THC plants are more bushy, 100-150 flowering heads, whereas the CBD variety is more of a bottle-brush variety, a little bit taller. So we plant our CBD variety at a greater density than the THC variety. If it's too dense, of course, the leaves don't get enough airflow, humidity can build up under the canopy, you can't work with them. And if they're too tall they'll stop light falling on other plants. So density has been worked out for optimal air and light... The cuttings are always taken to provide us a special shape. We always procure a single apical bud so we don't get branched or abnormally shaped buds. The technique we use now gives us a very consistent shape and output. The shape of the plant is determined by the shape of the cutting.

    There's no pruning... We wanted to have a standardized, automated process. We've basically produced what is a fabrication dossier for growing a cannabis plant. If one pharmaceutical company develops a synthetic molecule, and they want it to be made by another company, they produce a fabrication document. We did that. And when we transferred the technology to our contractor last year, the very first crop they produced came within the specifications. Their plant looked slightly different, and we've tuned in on the reasons and they have better control now.

    C'Notes: What pests have you encountered and what do you do about them?

    GWG: There are only two, really: thrips and red spider mites, both of which we control with friendly mites. We don't spray at all. Thrips on the whole are not an economical problem unless they get out of hand. When we've brought in cannabis materials from other places, the spider mite burden has been enormous, so we have a quarantine situation where nothing comes in from outside unless it's been isolated. The red spider mite is the one that, if we see it, we immediately remove plants. We'll have no hesitation in removing that whole week's worth of material from the cycle. As it is, we tend to identify sickly plants, and we've really kept things under control.

    The only other mite we had was a Chinese bamboo mite. We use bamboo canes to keep the plants upright. and the mites came with the canes.

    C'NOTES; Is extraction the next step?

    GWG: Next comes drying -each strain is dried separately. Then extraction, by means of ethanol. Waxes remain in the crude extract, which have to be removed in a separate step. Then we take those two crude extracts and we formulate them together to achieve precisely the desired ratio... I took the view that the way to arrive at a very consistent product is exactly the way that burgundy winemakers produce Burgundy -they blend to a standard based on a previous great year.

    When I made this decision, I wasn't able to know how precise the plant is. We've been really quite shocked at how precise the plant is in producing the same cannabinoid ratios, provided the genetics are the same. So, in the early days, the decision was made to grow plants that are rich in one cannabinoid or the other, extract and concentrate the components. Quality-control procedures enable us to determine the exact composition of the extracts, and we blend them to give us an absolute final ratio that meets our specifications.

    With these two preparations you can produce all the ratios in between instead of having to grow a new plant for each blend. In dossiers (for government approval in the UK and elsewhere) we supply extensive information on the consistency and quality, the toxicology and pharmacology of each extract. They're then brought together in the manufacturing process, and at that point we generate the clinical data.

    C'Notes: what percentage of the plant do the cannabinoids account for?

    GWG: That would depend on the variety and the subvariety. We find that for optimum growth and optimum use,12 to 15% is the comfortable range. Bear in mind that's the leaf as well as the bud. It's not the content of a manicured bud. We could produce plants with far higher cannabinoid content, but they're not as reliable, they become extremely sticky, they're difficult to handle, they're more prone to bugs...

    C'Notes: And what percentage of the cannabinoids in your high-THC strain is THC?

    GWG: 97%.

    C'Notes: What's the level in your high-CBD strain?

    GWG: Near 95% of the cannabinoid content is CBD. The rest is THC and some minor cannabinoids; the variation is minute. The plant is producing these materials at a level of purity that you wouldn't find in the first 10 or 12 steps of a synthetic process. Plus, it's stereospecific, it produces the correct isomer.

    C'Notes: When researchers at this (ICRS) conference thank GW Pharmaceuticals for providing the CBD used in their studies, are they talking about pure CBD or your high-CBD extract?

    GWG: It depends on what they requested and how early they asked us. We had to produce internal standards. We found that the existing standard for THC wasn't accurate enough... We have now produced highly purified internal standards for all our analytical equipment. These reference standards are 99.9 percent pure and we've done that for most of our leading cannabinoids: THC, CBD, THC-V, CBC, CBD-V, CBG and CBN.

    A researcher can specify whether they want pure CBD, pure THC, pure CBC, pure CBG, or 98% pure, 97%, 95%, or the actual extract -the two components. It's the extract that's eventually going to be the medicine, so the pharmacology we want to look at is the extract. But we appreciate that there are a lot of laboratory in vitro systems that can only discern anything when exposed to single molecules. As soon as you put more than one molecule into the system, you just get a gray scale of results. The extracts are interesting to us, because that's what patients take; but we're also happy to provide either fractions of the extracts or purified components of the extracts. C'Notes: Are you conducting additional clinical trials while awaiting government approval? GWG: The trials program so far has mainly covered patients with neuropathic pain and neuropathic disfunction. We are conducting five more trials in those areas... We are conducting a trial involving 130 or 140 patients with cancer pain. These are very difficult trials to run because the patients have to have an advanced-stage cancer requiring regular opiate therapy, but not so advanced that they can't participate in the trial, and their condition has to remain stable for at least the two weeks of the trial. Recruitment for such studies is always difficult but we've done very well. We're running a study in the UK and countries in Europe as well. We are awaiting results by the end of the year. Some of the results of our clinical trials have now been been published in peer-reviewed publications. Peer-review publication of clinical-trial results tends to take longer than publication of pre-clinical work. Analyzing a clinical trial requires an army of people. We have a clinical department of 45 people that organize and monitor our clinical trials. Every piece of data has to be checked. It's a massive undertaking. Even a small clinical trial involving a few dozen patients requires a lot of checking up. And if any of the data items are missing, or fall outside normal ranges or fall outside acceptable ranges, our monitor has to visit the site and confirm or find the correct number and revise accordingly. This is pharmaceutical requirement. This is Good Clinical Practice. You have to ensure that your data set is absolutely right. The data is entered into our databases by a double-entry system to catch any inaccuracies. Then, for each trial, we create a trial-specific database with all the relevant information. Because these trials are early-stage, we're collecting a lot more information than we would in later stage trials that are looking into specific endpoints. Safety is everything in these trials. The real judge of whether a product will be approved is safety first, efficacy second. C'Notes: Have any red lights flashed with respect to safety? GWG: No, what has been said about the safety of cannabis in journals, what has been said about the therapeutic index, it's all been borne out in our trials. We're very pleased, of course, and it's a major part in our presentations, because it's so striking.

    C'Notes: Will your label warn of side effects?

    GWG: The label for our product - subject to approval by the authorities - will probably mention "mild intoxication," which is transient and occurs during the titration phase.

    In our clinical trials, patients are invited to explore the optimal dose and it's really not a problem on an ongoing basis, it doesn't interfere with day-to-day living. We certainly can differentiate between beneficial effects and psychoactive effects. There are some patients who do have some problems, who continue to seek benefit when they're moving into levels that cause intoxication. Some of these patients can alter their daily living around that. We'll probably deal with them by offering different ratios and different delivery modalities in due course.

    The second issue is dry mouth.

    The third issue is some nausea because of the taste of the material.

    Our label may also contain a warning about vasovagal episodes [light-headedness, dizziness, fainting]. Some patients who are very sensitive and take too high a dose may experience a fainting episode with tachycardia [rapid heartbeat]. But all of these are well known from the vernacular reports. We had a concern early on that people going out of their way to use illicit materials might tend to under-report adverse effects, so there might be some information about cannabis that had been concealed. Our methodology was designed to pick up and report every adverse effect, whether or not it's related to the drug. So my question was, would we begin to see some side-effect profiles that had not been recognized heretofore? We really haven't. We had a few patients who reported panic. We found that the easiest thing to do is to advise the patient what they might feel, and that if they did, in their titration phase, overdose a little bit, we advised them to sit down, relax, and not fight it.

    We've become more careful in the initial titration. Early on in the phase-2 studies we were finding MS or spinal-cord injury patients who'd had marked intractable symptoms which were refractory and resistant to all other therapies -pain, for example-that were markedly relieved or, in some notable cases, disappeared by lunchtime on the first day of treatment. So I think we became gung ho until we encountered some patients who were exquisitively sensitive. And then we introduced a regimen that allowed us to accommodate all levels of sensitivity -which means that nobody's going to get a lot of symptom relief on the first day.

    We now increase dosage by slight increments over a two or three day period. Once they've finished that, they're onto free titration. Free titration has been very helpful. In North America people think of titration as the amount the patient takes -how much. What is more important is the rate of change of blood levels. The quicker the rate of change in blood levels, the more likely you are to get a psychoactive effect. The slower you trickle the drug in, the higher the levels you can achieve without psychoactive effect. The risk is, bypassing the very innocuous, un-damaging intoxicating effects, the patient can be exposed to the vasovagal effects. We actually find in the titration process that the very mild progress of intoxication -and we have to be very careful when we use this word, we're talking about very low levels, levels that would be disappointing to a recreational user- as soon as the patients get that signal, they know that they're already at a satisfactory therapeutic level. That's what we postulated five years ago and that's clearly what happened.

    What is most important for patients to get into that therapeutic window is to be able to alter the dosage. Some of our patients will take their medicine three times a day, morning, noon and evening. Some will just take it in the evening. But some find it best to just take small doses often during the day - maintaining their blood levels, topping off, if you will, so they don't experience peaks and troughs.

    C'Notes: In the study by Steven McKerral [describing the use of GW extracts in the treatment of pain stemming from nerves being torn away from the spinal cord] somebody dropped out because of a side effect called "disguesia," which was a new one to me. Does your product taste disgusting? And how serious a problem is that going to be?

    GWG: The cannabinoids, we understand from our patients -especially if they're not used to cannabis-have a really quite strong taste. Some people find the taste not very pleasant. But that's true of many drugs. With a drug that's delivered by a spray under the tongue, which is a very sensitive area, the issue is magnified. Some patients reported a stinging sensation. We're now advising patients that it can be sprayed anywhere in the mouth.

    C'Notes: Aren't there food chemists who specialize in making things taste better?

    GWG: We've given it a peppermint flavor and we have all sorts of flavorings to look at. But you'd be surprised, trying to solve taste issues can delay a drug development program by two or three years. I took the view that, in the political climate in which we first started, producing a sweet-tasting, very pleasant drug would not help us win approval. So it wasn't high on our agenda. And it really isn't a major problem... I think that patient was the only one who dropped out (of a GW study).

    As I told you a few years ago, we chose this formulation because it's not exotic. There are so many hurdles to overcome in taking cannabis through the approval process... We're developing a product that is not the norm in the modern pharmaceutical industry. So I wanted to keep all other issues and potential problems to a minimum. That's why we chose a straightforward dosage form, an ethanolic-based formulation. You have to apply a lot of technology to keep it stable, and the stabilizers have been a challenge, but we've got there now... Behind the first product we have a whole range of line extensions -new, improved formulations, and those will address each of these other issues. In the UK, the social, moral and medical imperative in the UK - -and the political imperative-was to obtain approval for a product as soon as possible. And that does not allow one the luxury of thinking 'Does it taste nice or not?' But that will certainly be addressed...

    Formulation and application are side issues. The main point is, the side effects listed on our label are those you might see on the mildest over-the-counter medicines. If you consider that patients with MS are taking drugs with marked side effects, drugs that can damage the liver, the pancreas, the kidneys.... Opiates that in acute overdose can induce respiratory failure and death... In comparison, the side-effect profile for our materials is absolutely excellent.

    One has to look at what happens in patients and how well they tolerate the medicine. Whatever the side-effects of cannabis, they are minor compared to the side effects of medicines patients are currently taking. The risk-benefit equation is everything to the patients.

    C'Notes: What else can you say about your research pipeline?

    GWG: There will be another wave of studies. We are particularly interested in the effects of cannabinoids in response to inflammation. We're not simply talking about the cannabinoids as an anti-inflammatory in the classical sense, like a non-steroidal. We'reinterested in the mechanism of action and the effect of different cannabinoid ratios... We have a phase II study in rheumatoid arthritis running at the moment. The beneficial modifying effects of CBD are very clearly seen in our arthritis program... We are moving on into inflammatory bowel, where what we know about antispasmodic effects will be applicable... We are interested in malnutrition issues. Senile anorexia. Issues of air hunger (sleep apnea, for example). I'd like to move on to epilepsy fairly soon; that's the one area where I wish we'd made more progress... We're working with a group in Brazil to look at schizophrenia and bipolar disorder.

    The important thing is not to have six or seven different indications one-third completed at this stage; the important thing is to have our product approved. And that's where we've focused. The dossier is in and running. We've recently signed the agreement with Bayer for the UK, and they have an option for Europe, Canada and New Zealand. The rewards of that are, the company has been able to sustain itself. Friday in London we announced that we'd raised 20 million pounds for the R&D program. So to date my fundraising is up to 100 million US Dollars -a very significant research war chest.

    We've just completed a small trial on glaucoma. Our interest in glaucoma is not strictly to drop the pressure. We're looking at the neuroprotective effects on the retina...

    The cannabinoids seem to be inhibiting angiogenesis in tumors, but possibly promoting angiogenesis in damaged nerve cells. They are modulators. If some level is too high the cannabinoids take it down, if something is too low they pick it up. That's why the effect of cannabinoids depend on the status of the receptor, the health status of the patient, and the extent to which receptor recruitment or redundant systems are compensated.

    C'Notes: Please explain for the layman (c'est moi).

    GWG: Two patients may have the same symptom. One may have just started to use compensating mechanisms. The other may be at the point where the compensating mechanisms are giving way to decompensating mechanisms. To determine the effect of the cannabinoids, one has to take into account, "What is the position when the cannabinoids reach that system?" We have to build a bridge between some of the in vitro systems which don't take into account the in vivo feedback...

    C'Notes: So much seems to have gone according to plan. What has surprised you?

    GWG: A lot of observers were prepared to see trials that might show that yes, cannabis medicines do have a medical effect, and therefore one could make the case that they deserve a place in the medical armamentareum... What we're showing is much more dramatic than that. Cannabis medicines have enormous pharmacological capabilities. There are a myriad systems that they modulate. They have a unique capability to address, in a disease like multiple sclerosis, a whole range of symptoms. Heretofore, each patient has had at least one drug per symptom, and sometimes more than one, and then a host of drugs to take care of the side effects of those drugs. We're seeing that cannabis medicines can address a wide range of symptoms with incredibly low side effects. And what is in prospect -David Bacon has reported that cannabinoids are almost able to arrest the progression of MS in his animal models. That would be startling.

    I think we're just about to move into a very interesting period. You've seen the tone of this meeting. Five years ago, presenter after presenter would describe their work and sit down with nobody really making a link between them. The innuendo was that each of thee mechanisms might in some way be contributing to some terrible, nasty effect of cannabis. Five years ago you'd see studies that didn't use any cannabis -that used synthetic cannabinoids with ingredients that weren't in the cannabis plant- and the results were used to say something (bad) about cannabis. That seems to have stopped. Five years ago the tide was going against therapy. The "therapeutic potential" speakers at our first meeting in Montpelier were sort of tolerated. This year I really felt for the first time that I was at a meeting describing the basic science around a number of therapeutic opportunities. The papers are now talking about the science as it may relate to therapy. And the audience is almost entirely focused on beneficial effects.

    At one of the question sessions (at the ICRS meeting) somebody said, "there's no report in the literature..." What that actually means is, "there's no report in the literature that they've read!" But there's plenty of good stuff in the literature. In four and a half years, we've made good progress.


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    Privatizing Pot - Can The Marijuana Monopoly Be Broken?

    Privatizing Pot - Can the marijuana monopoly be broken?
    Jacob Sullum
    Reason
    July 11, 2003
    "The question of whether marijuana has any legitimate medical purpose should be determined by sound science and medicine." That is the federal government's official response to the medical marijuana movement, as expressed in November 2001 by Asa Hutchinson, then head of the Drug Enforcement Administration (DEA). Since California and Arizona passed the first medical marijuana initiatives in 1996, both the Clinton and Bush administrations have insisted that the therapeutic value of cannabis should be judged by the Food and Drug Administration (FDA) based on careful research, not by voters or state legislatures based on emotional appeals.

    Several years ago, Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS), decided to take the government at its word by promoting the kind of research that could ultimately lead the FDA to approve marijuana as a prescription drug. But along with the usual obstacles posed by the notoriously arduous FDA approval process, MAPS encountered problems unique to marijuana. In particular, it found that the only legal source of marijuana for U.S. research was the National Institute on Drug Abuse (NIDA).

    As its name implies, NIDA focuses on marijuana's dangers rather than its potential benefits. Hence getting its permission for research on the drug's medical utility has been tricky. Although a few researchers have managed to obtain marijuana from NIDA, two studies approved by the FDA have been rejected by NIDA, and those examples have discouraged other researchers from bothering to apply. The additional layer of approval, which is not required for any other Schedule I drug, makes an already daunting process even more intimidating. Doblin's audacious but sensible solution is to cut NIDA out of the picture by establishing a private source of cannabis for research (which already has been done in the U.K.).

    To accomplish that goal, MAPS needs permission from the DEA, which it has been trying to get since June 2001. The history of this effort, described in detail on the MAPS Web site, demonstrates the disingenuousness of drug warriors who say their opposition to the medical use of marijuana is based on scientific concerns. At the same time that they are complaining about the lack of adequate evidence, they are blocking attempts to obtain it.

    MAPS wants to fund a marijuana production facility at the University of Massachusetts in Amherst that would be overseen by Lyle Craker, a professor in the school's Department of Plant and Soil Sciences who has extensive experience with medicinal plants. In addition to eliminating the gratuitous obstacle created by NIDA's marijuana monopoly, such a facility could provide better cannabis that would meet researchers' specifications and eventually be used as a legal medicine.

    NIDA's pot, grown under contract at the University of Mississippi for the last three decades, is of relatively low potency and quality. Its THC content ranges from 2 percent to 7 percent. "To improve the safety profile of its product," Doblin writes, "MAPS requires marijuana with a THC content in the 12-15% range, thereby reducing the amount of particulate matter inhaled per unit of THC and improving the risk/benefit ratio of the product." The risks of marijuana use can be further reduced with vaporizers, which heat cannabis to release THC rather than burning it. Doblin says these devices, the subject of MAPS-sponsored research, work especially well with high-potency marijuana.

    Dr. Ethan Russo, one of the researchers whose FDA-approved protocols were rejected by NIDA, interviewed patients who receive NIDA's marijuana under the government's "compassionate use" investigational new drug program (closed to new applicants since 1992). "Each of the Compassionate Use IND patients," he reports, "indicated to me that they would prefer to have properly manicured, seedless, unfertilized cannabis of a higher grade so that they might be able to smoke less material to obtain relief of their medical symptoms." He notes that NIDA's marijuana is not comparable to the cannabis typically used by patients in Europe, Canada, or the United States.

    In addition to producing higher-potency, cleaner marijuana, the University of Massachusetts operation proposed by MAPS could offer strains with varying levels of cannabinoids other than THC, some of which may contribute to marijuana's therapeutic effects. More important, a new supplier would allow companies trying to get marijuana approved as a medicine to test the same product they planned to market, as required by the FDA. NIDA's mandate is to produce marijuana for research, not for medicinal use. "There is no guarantee that marijuana provided by NIDA for research would be available for commercial use," Doblin notes. "NIDA-supplied marijuana is therefore inadequate for use in a privately funded drug development plan... No rational pharmaceutical company would invest millions of dollars in Phase III clinical trials of a drug that it cannot be certain it could produce for commercial sale should safety and efficacy be demonstrated to the satisfaction of the FDA."

    After an 18-month delay, the DEA responded to Lyle Craker's application for a license to produce marijuana with a series of specious objections. First it said licensing the University of Massachusetts facility would violate international drug treaties, an argument demolished in an analysis prepared by Graham Boyd, director of the American Civil Liberties Union's Drug Policy Litigation Project, and two Washington attorneys. Then the DEA said there's no evidence the current marijuana supply is inadequate.

    Dismissing Ethan Russo's points out of hand, the DEA insisted on seeing complaints from researchers who are currently using NIDA's marijuana. "While I recognize that the primary researchers now receiving plant material may openly state to you that they are satisfied with the current source," Craker replied, "I am sure you appreciate that in private conversations these same researchers indicate a fear of having the current supply eliminated if they complain about the available source material." The DEA's official record also does not reflect the researchers who would be interested in studying marijuana if a better supply were available and the approval process were less cumbersome.

    In short, the odds of breaking NIDA's marijuana monopoly do not look good. But the attempt has at least demonstrated that the drug warriors are not really interested in the thorough scientific investigation they claim to favor. "As long as NIDA is the sole source of supply" for cannabis, Doblin observes, "the FDA process will rightly be perceived by the public as obstructed, further fueling efforts by states to circumvent federal authority over the medical uses of marijuana through ballot initiatives or state legislation." The DEA's intransigence thus will validate state attempts to make marijuana available as a medicine regardless of what the federal government says.

    Jacob Sullum, a senior editor at Reason, is the author of Saying Yes: In Defense of Drug Use, forthcoming in May from Tarcher/Putnam.


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    MAPS, MPP and Dr. Ethan Russo Filed an Updated Version

    MAPS, MPP and Dr. Ethan Russo filed an updated version of this amicus curiae brief in the US Court of Appeals for the Ninth Circuit case of Angel Raich et al. v. John Ashcroft as Attorney General and Asa Hutchinson, Administrator of the DEA. (PDF Format)

    Dr. Russo has abandoned his struggle to conduct FDA-approved research. Instead, he has designed a basic safety study of the few patients remaining alive who legally receive marijuana from NIDA as part of the Compassionate IND program that was closed by HHS in 1992. MAPS donated $10,000 to this study, which started in May 2001. Preliminary results of the study show therapeutic benefits, with no significant adverse effects. The final paper about the study, reference below, reports on the study in detail.

    [ Russo E, Mathre ML, Bryne A, Velin R, Bach P, Sanchez-Ramos J, Kirlin K. Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis. Journal of Cannabis Therapeutics Vol. 2 (1) (2002): 3-57. ]

    View Dr. Russo’s powerpoint presentation, "Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of the Benefits and Adverse Effects of Legal Clinical Cannabis" (IE4+ required to view this presentation)

    Read about the struggle to begin medical marijuana research in the 90’s.

    PDF File

    April 25, 2003. MAPS publishes "DEA and the UMass Amherst Medical Marijuana Production Facility: An Update" by Rick Doblin, Ph.D. (pdf format) in the MAPS Bulletin, Spring 2003; Volume XIII, Number 1

    Dr. Donald Abrams and Dr. Ethan Russo Report on Their Medical Marijuana Research at the Marijuana Policy Project (MPP)/Students for a Sensible Drug Policy Conference

    Dr. Donald Abrams and Dr. Ethan Russo report on their medical marijuana research at the Marijuana Policy Project (MPP)/Students for a Sensible Drug Policy (SSDP) conference in Anaheim, California.

    View Dr. Abrams’ powerpoint presentation, "Clinical Trials of Cannabis in California." (IE4+ required to view this presentation)

    View Dr. Russo’s powerpoint presentation, "Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of the Benefits and Adverse Effects of Legal Clinical Cannabis" (IE4+ required to view this presentation)

    In addition to supporting Dr. Abrams’ protocol investigating the effects of marijuana in HIV+ subjects, the first study in 15 years to investigate the therapeutic application of cannabis, MAPS has supported the efforts of Dr. Ethan Russo, University of Montana, for expenses involved in preparing NIH grant applications for the study of the use of marijuana in the treatment of people whose migraines fail to respond to conventional medications. This study continues to face difficulties in getting started. In 1997, MAPS submitted an application to the Food and Drug Administration’s Office of Orphan Drug Products requesting that cannabis be designated an Orphan Drug for the treatment of AIDS wasting syndrome. This effort recently came to fruition. MAPS has also co-funded studies of medical marijuana potency and water pipes and vaporizers.

    MAPS, MPP and Dr. Ethan Russo filed an updated version of this amicus curiae brief in the US Court of Appeals for the Ninth Circuit case of Angel Raich et al. v. John Ashcroft as Attorney General and Asa Hutchinson, Administrator of the DEA. (PDF Format)

    Dr. Russo has abandoned his struggle to conduct FDA-approved research. Instead, he has designed a basic safety study of the few patients remaining alive who legally receive marijuana from NIDA as part of the Compassionate IND program that was closed by HHS in 1992. MAPS donated $10,000 to this study, which started in May 2001. Preliminary results of the study show therapeutic benefits, with no significant adverse effects. The final paper about the study, reference below, reports on the study in detail.

    [ Russo E, Mathre ML, Bryne A, Velin R, Bach P, Sanchez-Ramos J, Kirlin K. Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis. Journal of Cannabis Therapeutics Vol. 2 (1) (2002): 3-57. ]

    View Dr. Russo’s powerpoint presentation, "Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of the Benefits and Adverse Effects of Legal Clinical Cannabis" (IE4+ required to view this presentation)

    Read about the struggle to begin medical marijuana research in the 90’s.

    Is Pot Good For You?

    This article by Time magazine discusses the potential risks and benefits of marijuana.

    Is Pot Good For You?

    Well, no. But the latest research suggests the health risk from occasional use is mild, and it might ease certain ills
    John Cloud
    Time.com
    October 27, 2002

    I never smoked pot in junior high because I was convinced it would shrivel my incipient manhood. This was the 1980s, and those stark this-is-your-brain-on-drugs ads already had me vaguely worried about memory loss and psychosis. But when other boys said pot might affect our southern regions, I was truly terrified. I didn't smoke a joint for the first time until I was 21.

    By 12th grade, about half of young Americans have tried marijuana, which put me in the geeky other half. I used to think this was a good thing, since I never developed a taste for pot and avoided becoming dependent. But as the medical-marijuana movement flowered and weed's p.r. improved, I often wondered if I shouldn't have relished it as a kid, before I had a personal trainer to tsk-tsk my every vice. Shrinking testicles? Mushy brains? I came to see these as grotesqueries invented by antidrug propagandists.

    It turns out that the study of marijuana's health effects is at once more complex and less advanced than you might imagine. "Interpretations [of marijuana research] may tell more about [one's] own biases than the data," writes Mitch Earleywine in Understanding Marijuana: A New Look at the Scientific Evidence, published in August by Oxford. For example: "Prohibitionists might mention that THC [delta-9 tetra-hydrocannabinol, the smile-producing chemical in pot] often appears in the blood of people in auto accidents. Yet they might omit the fact that most of these people also drank alcohol. Antiprohibitionists might cite a large study that showed no sign of memory problems in chronic marijuana smokers. Yet they might not mention that the tests were so easy that even a demented person could perform them."

    The science of marijuana--especially its potential medical uses--is malleable because it's so young and so contradictory. Although preliminary data are promising, scientists haven't definitively shown that the drug can safely treat nausea or pain or anything, really. Some experts claim the U.S. government has sabotaged medical-marijuana research, and there is evidence to support them. Even so, in the past few years scientists have made rapid advances in their basic understanding of how Cannabis sativa works. By 1993, researchers had found the body's two known receptors for cannabinoids, the psychoactive chemicals in the plant (thc is the main one, but there are at least 65 others). Since then, there has been important new work in several fields that users, potential users and former users should know about--and that voters should take into account before deciding whether to legalize pot.

    So much new research has appeared that in November the Journal of Clinical Pharmacology and the National Institute on Drug Abuse will publish a 100-page supplement devoted entirely to marijuana. The Journal gave Time an advance look; it's a comprehensive review that will annoy both sides in the drug war. You won't find clear evidence that pot is good or evil, but the research sheds light on some of the most important questions surrounding the drug:

    Can it kill you?

    No one has ever died of THC poisoning, mostly because a 160-lb. person would have to smoke roughly 900 joints in a sitting to reach a lethal dose. (No doubt some have tried.) But that doesn't mean pot can't contribute to serious health problems and even death--both indirectly (driving while stoned, for instance) and directly (by affecting circulation, for example). A paper published last year in the journal Angiology found 10 odd cases in France of heavy herbe smokers who developed ischemia (an insufficient blood supply) in their limbs, leading in four cases to amputations. It's not clear that marijuana caused the decreased blood flow, but the vascular problems did worsen during periods of heavy use. Another 2001 paper, in Circulation, found a nearly fivefold increase in the risk for heart attack in the first hour after smoking marijuana--though statistically that means smoking pot is about as dangerous for a fit person as exercise.

    Does it make you sick?

    Marijuana may directly affect the immune system, since one of the body's two known receptors for cannabinoids is located in immune cells. But the nature of the effect is unclear. A recent study showed that THC inhibits production of immune-stimulating substances. But cigarette smokers may do greater harm to their immunity than pot users, who tend to smoke less. A study published earlier this year found that tobacco smokers but not marijuana smokers had high levels of a type of enzyme believed to inflame the lungs. Dr. Donald Abrams, professor of clinical medicine at the University of California, San Francisco, found that short-term cannabis use doesn't substantially raise viral loads of HIV patients. (People with HIV sometimes smoke marijuana to stimulate appetite.) In fact, his study participants who smoked pot enjoyed significantly higher increases in their lymphocytes (cells that help fight disease) than those who took a placebo.

    Can it give you cancer?

    Data on cancer also generate mixed conclusions. A 1999 study of 173 patients with head and neck cancers found that pot smoking elevated the risk of such cancers. (Smokers of anything should also worry about lung cancer.) But it's not clear that THC is carcinogenic. The latest research suggests that THC may have a dual effect, promoting tumors by increasing free radicals and simultaneously protecting against tumors by playing a beneficial role in a process known as programmed cell death.

    Is it addictive?

    Those who believe you can't become physically or psychologically dependent on marijuana are wrong. At least three recent studies have demonstrated that heavy pot smokers who quit can experience such withdrawal symptoms as anxiety, difficulty sleeping and stomach pain. On the other hand, the risk of becoming dependent on marijuana is comparatively low. Just 9% of those who have used the drug develop dependence. By comparison, 15% of drinkers become dependent on alcohol, 23% of heroin users get hooked, and a third of tobacco smokers become slaves to cigarettes.

    Does it make you stupid?

    Potheads are dumber than nonusers, but only a little. Earlier this year, the Journal of the American Medical Association published a study of 102 near-daily marijuana users who wanted to quit. The authors found that the longer subjects had toked up, the worse their memories and attention spans. But they were hardly like Gobi, the Saturday Night Live wastoid who is so ruined he can barely talk. Participants who had used cannabis regularly for an average of 10 years fared significantly worse on only two of 40 indices of cognitive functioning (they had particular trouble estimating how much time had passed during a test). Those stout folks who had been smoking pot for an average of 24 years did significantly worse on 14 of the tests. But scientists can't say that marijuana causes such problems. "These long-term users may have been worse off in the first place, before they ever smoked marijuana," says Dr. Harrison Pope, a Harvard psychiatrist who wrote an editorial accompanying the study arguing that "we must live with uncertainty" on whether pot causes long-term cognitive impairments.

    What about sex?

    The latest studies suggest I needn't have fretted so much about pot's gonadal consequences. "Marijuana might interfere with [kids'] ability to go through puberty," says Dr. Adrian Dobs, co-author of a paper on the endocrine effects of the drug in the upcoming Journal of Clinical Pharmacology. "But the abnormalities seen are not really clinically significant." Despite tales of male potheads growing breasts, the long-term effects on adult glands are uncertain.

    Do the sick really benefit?

    So if marijuana can be harmful to healthy people--but usually isn't -- could it actually be good for the sick? This is where the science gets scraggier -- and in the absence of data, politics takes over. What we know is that healers have accumulated copious anecdotes on weed's powers over the past 4,700 years. Understanding Marijuana author Earleywine credits a (possibly mythical) Chinese emperor with introducing the plant as a treatment for gout around 2700 B.C. But the emperor also thought his pot potion would help memory, making him the first of many fans to aggrandize the drug's medical potential. The ancient Greek doc Galen even used the drug to treat flatulence.

    The A.M.A. issued a report last year summarizing the body of knowledge about medical marijuana. It's shockingly slim. Dr. Abrams in San Francisco has produced some of the clearest evidence to date of pot's therapeutic value. Even though his clinical trial was designed merely to investigate whether marijuana is safe for HIV patients, he also turned up data that anyone who ever had the munchies already knew: pot makes you hungry. Test subjects who smoked marijuana gained an average of 6.6 lbs. during the trial, compared with 2.4 lbs. for the group taking the placebo. Some other findings from the A.M.A. report:

    NAUSEA - Patients who are HIV-positive or undergoing chemotherapy can have trouble keeping food down, so anything that helps them eat is significant--though not necessarily for the reasons marijuana boosters think. Pot's ability to enhance appetite may have more to do with its high and less to do with any direct effects on nausea. Only 20% to 25% of patients in two 1980s trials could completely control vomiting with marijuana; other drugs work better for emesis. Still, the A.M.A. recommended more studies on marijuana for those who don't respond to the other drugs, and it notes that for those feeling sick, inhaling a substance may be more palatable than swallowing a pill.

    GLAUCOMA - Marijuana does reduce pressure on the eyeball, about 25%, but the drug isn't always practical as a glaucoma treatment. Many who have the disease are elderly and can't tolerate pot's tendency to raise heart rates.

    SPASTICITY - Marijuana can help people with spasticity (extreme muscle tension) and tremor due to multiple sclerosis and trauma. But the drug hasn't been rigorously compared with the standard antispastic treatments.

    PAIN - In patients with postoperative pain, THC is more effective than a placebo, and some reports suggest smoking pot may reduce the need for highly addictive opioids. But the A.M.A. says better-designed studies are needed to properly evaluate pot as a painkiller. Several are under way. In California, five teams of researchers are conducting studies of marijuana as an analgesic, particularly for cancer and nerve pain.

    The A.M.A. concludes that the lack of "high-quality clinical research ... continues to hamper development of rational public policy" on medical marijuana. Which raises the question, Why, after five millenniums, doesn't such research exist? Two possible answers: First, the government may have rejected cannabis studies to avoid any challenge to its view that pot is dangerous and medically useless. Second, pot may just be dangerous and medically useless.

    The drug wasn't always so controversial in the scientific establishment. The U.S. Pharmacopeia, a doctors' listing of remedies begun in 1820, first included cannabis in 1870. The Pharmacopeia didn't drop pot until its 1942 edition, the first published after cannabis was outlawed in 1937. Eventually most physicians began to view the drug as little more than a crude intoxicant. They tended to favor new-fashioned drugs that were refined by pharmaceutical firms into pure chemicals. Raw marijuana contains some 400 compounds.

    It wasn't until the '70s that modern methods were applied to test the medicinal effects of cannabis. As Earleywine recounts, a UCLA study designed to confirm police reports that pot dilates pupils found instead a slight constriction. That's how doctors discovered the drug could help glaucoma sufferers by reducing intraocular pressure. In the years after that discovery, 26 states opened therapeutic research programs.

    But the Federal Government, which by then controlled the only legal supply of marijuana, had just passed the Controlled Substances Act of 1970. That law placed marijuana in Schedule I, the designation for drugs without valid medical use. State health officials found it difficult to persuade their federal counterparts to give them cannabis for research, as doing so would undermine the law, at least in spirit, by suggesting there were medical uses. (Only seven states got pot. One was Tennessee, which is why Al Gore's sister was able to try the drug before losing her battle with lung cancer in 1984.)

    Then, in 1985, the Food and Drug Administration (FDA) approved dronabinol, an oral form of synthetic THC, to treat chemotherapy-induced nausea. Many doctors believed dronabinol, marketed as Marinol, could provide the benefits of the plant without the impurities. By the mid-'80s, the availability of Marinol and the escalating drug war had killed the state research programs. But Marinol turned out to have shortcomings. Because it enters the blood through the stomach, it doesn't work as fast as smoked marijuana. Because it is essentially pure THC, its users can get too high. "Marinol does tend to knock people out," says Abrams, the San Francisco doctor who has conducted trials with both Marinol and pot. "Our patients [taking Marinol] spent a lot of time in bed, and that wasn't the case with those smoking marijuana." Such problems appeared in only "a small portion of the patients in our clinical trials," says Dr. Hjalmar Lagast, a vice president for Solvay Pharmaceuticals, which makes Marinol. He notes that the drug comes in three strengths, allowing doctors to pick the right dose. By the early '90s, at the height of the U.S. AIDS epidemic, many patients so preferred marijuana to Marinol that they would use the street drug regardless of legality or safety. Abrams and a few others began pushing the government to permit new studies of marijuana to find out what these patients were doing to themselves.

    Officials again resisted, and some researchers became convinced the government would never allow evidence of pot's possible benefits to emerge. In 1999, Paul Consroe, a professor of pharmacology at the University of Arizona, failed to win FDA approval for a clinical trial of marijuana for AIDS and cancer wasting. He believes the FDA turned him down because of political pressure. "If you want to study its harmful effects, you can get all the money you want," says Consroe. "But for this one, I would have spun my wheels forever." (An FDA spokeswoman declined to comment.)

    It took Abrams five years, but he finally pushed his study through. A stubborn and irreverent oncologist who had watched hundreds of AIDS patients suffer brutal nausea, he won government approval in 1997 for the first clinical trial of marijuana in more than a decade. Marijuana proposals at the time required the approval of three agencies--the FDA, the Drug Enforcement Administration and the National Institute on Drug Abuse--and the DEA and NIDA had resisted. A DEA official worried in a letter about the political fallout if Abrams found positive results. "The government is saying there are no studies proving the medical benefits," Abrams fumed in 1996. "But they're also not letting studies be conducted."

    Not true, says Steven Gust, special assistant to the director of NIDA, who has worked at the agency 15 years. "Ever since I've been here, there's been no prejudice against studying the medical applications of marijuana. Frankly, good proposals weren't coming in. The people you've talked to had a bad experience getting approval, and that's going to color their perception."

    Whatever the case, Abrams and Gust agree that the government and medical-marijuana researchers are now working together. Abrams has two approved studies under way, and the State of California has founded a new, grander version of its old therapeutic research program. The Center for Medicinal Cannabis Research, which opened at the University of California two years ago with a yearly budget of $3 million, currently supports 11 studies that have received federal approval.

    To be sure, many scientists--especially in the government--still squirm at the very idea of medical-marijuana research. Despite encouraging anecdotal reports, the National Institute of Health hasn't initiated a study of cannabis therapeutics in two decades, leaving California's young center as the only U.S. research institution doing the basic science.

    Marijuana remains the only drug that researchers must acquire directly from the feds. If the FDA and DEA approve, scientists can get even ecstasy from outside labs, but NIDA is the sole source for cannabis, requiring a third bureaucratic layer. "In an era of privatization, it's shocking that the government insists on a monopoly so that it can choose not to provide marijuana to projects it doesn't like," says Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies, a nonprofit pharmaceutical firm. (For 18 months, Doblin's association and the University of Massachusetts Amherst have unsuccessfully sought a license to grow research-grade cannabis at the university.)

    Not every country is as pot-phobic as the U.S. Scientists in Britain, which has effectively decriminalized personal use of small amounts of pot, have moved well beyond the preliminary work being done in the U.S. Britain's GW Pharmaceuticals plans to publish results of a large study of its new marijuana product, a whole-cannabis extract rendered into a mouth spray. That way, patients avoid the lung damage of smoking. The British government is likely to make the spray available for prescription if published results are as good as the company promises.

    In this country, new drug products like GW's spray rarely appear without cordial cooperation among pharmaceutical companies, research institutions and government officials. Such partnership could take years to develop. But the politics has leaped well ahead of the science, meaning voters will decide long before physicians whether medical marijuana is an oxymoron.

    British Medical Journal: "Netherlands to Run Trials of Marijuana in Patients with Multiple Sclerosis"

    The Dutch government has announced a small scale cross over trial into the effect of three sorts of medical marijuana, plus a placebo, on 16 patients with multiple sclerosis.

    Two foundations in Rotterdam, the Institute for Medical Marijuana and Maripharm, have been contracted by the government to produce the drug to a standard quality and provide metal pipes for inhalation.

    A Bureau for Medical Cannabis, set up by the ministry and the Amsterdam’s Free University medical centre, will run the year’s trial.

    The bureau also intends to make medicinal cannabis available through pharmacists on prescription by spring 2003. The Dutch cabinet recently agreed to change the law to permit this.

    Four trials of cannabis are taking place in the United Kingdom. The cannabis in multiple sclerosis (CAMS) study, which is sponsored by the Medical Research Council, started at Derriford Hospital, Plymouth, last year and aims to take in 660 participants in 40 centres.

    Three smaller phase II trials - in Guernsey, Oxford, and Norfolk - have been under way since autumn 2000, examining a sublingual spray developed from plants grown by G W Pharmaceuticals in Kent. The researchers expect to extend these trials to 2000 patients over two years and to enroll not only people with multiple sclerosis but also patients with various chronic pain syndromes, such as neuralgia and lower back pain.

    After Two-Decade Halt, Marijuana Research Is Set

    Comment from Rick Doblin: The article reports that medical marijuana research is about to begin for the first time in nearly two decades. However, the article makes a distinction that readers are not likely to understand between medical marijuana efficacy studies in patients and medical marijuana safety studies in patients. The article doesn't mention the recently completed study by Dr. Donald Abrams, UC San Francisco, which primarily examined the safety of marijuana in AIDS patients but also gathered preliminary information about caloric intake and weight gain. MAPS and Dr. Abrams worked closely together for about 5 1/2 years to obtain permission for that study, which obtained final approval in 1997. This was the first medical marijuana study of any type in any patient population in over 15 years. The final patient in Dr. Abrams' study was treated in May 2000. For more information about this study, see here.

    The article also doesn't mention the San Mateo county study of marijuana and AIDS patients, which is not primarily designed as an efficacy study but is primarily a study to determine patient participation and compliance. For more information about this study, see Medical Marijuana Research.

    After Two-Decade Halt, Marijuana Research Is Set
    By Philip J. Hilts
    The New York Times
    December 15, 2001


    Research on the medical uses of marijuana is scheduled to begin early next year, for the first time in nearly two decades, now that the government has approved new experiments to test whether smoking it can help patients who have multiple sclerosis or who suffer from pain in their limbs as a result of AIDS.

    The new approvals, granted on Nov. 28 by the Drug Enforcement Administration, do not make it legal for doctors to give their patients marijuana as treatment; they merely provide for limited use in scientific experiments. In some states, state law allows doctors to prescribe or recommend marijuana; federal law prohibits the practice, however, even in those states.

    The D.E.A. approved two experiments when it acted late last month, and expects to approve a third soon. Officials at the agency said the approvals did not amount to a policy change, since experiments to discover medical uses of marijuana had never been prohibited. Rather, said Terry Woodworth, deputy director for diversionary control, scientists and the public agencies that finance research have changed their attitudes about the value of such experiments.

    But Paul Armentano, a spokesman for the National Organization for the Reform of Marijuana Laws, or Norml, said the approvals "have ended a two-decade-long federal de facto prohibition on medical research on marijuana." "This is not much yet," Mr. Armentano added, "but it is a recognition by the federal government that it cannot prevent all work from going forward." Marijuana experiments require the approval of several federal agencies; the D.E.A.'s approval is the final one, providing the licensing of the researchers.

    The two experiments already given that approval, the third expected to get it soon and eight others now wending their way through the state and federal approval pipeline are all scheduled to take place in California and have been financed by the Center for Medicinal Cannabis Research run by the University of California.

    One of the two studies already approved will concern multiple sclerosis patients. Some of those patients say they have muscle rigidity that is not relieved effectively by other drugs, and in any case those drugs have unwanted side effects. Dr. Jody Corey-Bloom, who will lead this study, at the University of California at San Diego, cites anecdotal accounts that marijuana can relieve that muscle pain and rigidity. In the other approved study, also at the San Diego campus, Dr. Ronald Ellis will try to determine whether marijuana can relieve a kind of pain in the hands and feet, known as peripheral neuropathy, that sometimes affects H.I.V. patients.

    Dr. Donald Abrams will also study that condition at the University of California at San Francisco, in the experiment due for final approval soon. Dr. Abrams, who has long sought to carry out marijuana studies in AIDS patients, said that among the most important factors in getting the research approved were referendums five years ago in which the voters of California and Arizona made it state law for patients to be allowed to get marijuana for their illnesses.

    After those proposals had passed, scientific committees at the government-chartered Institute of Medicine and at the National Institutes of Health reported that there was little evidence that marijuana had medical usefulness, but that rigorous studies would be worthwhile. The coming experiments will compare the effects of marijuana cigarettes with the effects of placebo cigarettes (those with the active ingredients of marijuana removed).

    The marijuana cigarettes will come from a supply grown at the University of Mississippi under the auspices of the National Institute on Drug Abuse, said Richard Doblin, president of the Multidisciplinary Association for Psychedelic Studies, a group that advocates research into the medical uses of psychoactive drugs. He said one problem with the new research was that the Mississippi marijuana was very low in potency, a factor that might hamper the medical effects.

    Marinol, an approved prescription drug that has been available for some years, contains an active ingredient from marijuana plants. But researchers say natural plants contain many psychoactive agents that are missing from the commercial product. In addition, Dr. Abrams said, it takes hours for the full effects of the capsules to be felt, whereas smoking marijuana produces effects in minutes; the capsule, then, may not be the best way to deliver the drug.

    Experiments using marijuana to stimulate appetite and prevent nausea were conducted in the United States until the early 1980's. After that, Mr. Doblin said, disapproving attitudes in the federal government and among research agencies led scientists to believe that financing of medical marijuana studies would be difficult to find.

    But after the referendums in California and Arizona in 1996, the focus shifted to the question of whether such medical use could be supported by scientific evidence.

    University of California at San Diego Gets Approval for Medical Marijuana Study

    "University of California at San Diego Gets Approval for Medical Marijuana Study"

    A California university has received final approval from the federal government for a study on medical marijuana.

    Two professors of neurology at the University of California at San Diego Medical Center plan to study the effects of marijuana on patients with multiple sclerosis and those who suffer neuropathy, or nerve pain, associated with AIDS.

    The studies will be the first to emerge out of the university’s Center for Medicinal Cannabis Research (CMCR), a program created by the state Legislature in 1999.

    Since California became the first state to approve medical marijuana in 1996, six other states have followed suit. Federal law, however, prohibits the sale of marijuana for medical uses.

    The Drug Enforcement Administration granted the final approval Wednesday, saying it hoped to introduce some science into what has been an emotionally charged debate. The agency maintains that past studies have shown no medical benefit to smoking marijuana.

    "The question of whether marijuana has any legitimate medical purpose should be determined by sound science and medicine," DEA Administrator Asa Hutchinson said in a statement.

    MAPS, MPP and Dr. Ethan Russo Filed Amicus Curiae Brief

    MAPS, MPP and Dr. Ethan Russo filed an Amicus Curiae brief in the medical marijuana case, US v. Oakland Cannabis Buyers’ Cooperative. Even though FDA approved Dr. Russo’s MAPS-supported protocol to study the use of smoked marijuana in treating patients suffering from migraines, NIDA refused to supply the marijuana. As a result, Dr. Russo’s study never took place. We have tried to turn our frustrating experience with NIDA to the advantage of medical marijuana patients by letting the U.S. Supreme Court know that the FDA drug development process is politically obstructed. Our brief’s basic point is that these obstructions create more of a need for the medical necessity defense for patients who run into conflict with the police over their use of marijuana as medicine.

    NIH Workshop on the Medical Utility of Marijuana

    MAPS report(Turning Protests into Protocols: Dr. Harter´s Legacy) to NIDA’s Expert Panel on Medical Marijuana Research - submitted February 25, 1997 following the February 19-20, 1997 NIH Workshop on the Medical Utility of Marijuana held at the NIH Campus in Bethesda, MD. Five recommendations to proactively expedite medical marijuana research.

    FDA-Regulated Research and the Effort to Begin It

    Dr. Donald Abrams’ FDA-approved research protocol, (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.

    Medical Marijuana Clinical Plan

    A comprehensive clinical plan developed by MAPS in consultation with the FDA for the investigation of marijuana’s medical use in the treatment of the HIV-related wasting syndrome. This Clinical Plan was submitted with Dr. Donald Abrams’ research protocol (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.It is designed to also be adapted for indications other than the wasting syndrome. Originally printed in the Summer 1994 MAPS Newsletter.

    Minimum Informational Requirements for Establishing an FDA Drug Master File for Cannabis - Questions To Be Answered by Potential Manufacturers.

    Senators Hatch and Harris Call on DOJ to Stop Blocking Medical Marijuana Research

    On April 12, 2018, United States U.S. Senators Orrin Hatch and Kamala Harris advocated for an end to the NIDA monopoly on research-grade marijuana in a letter to Attorney General Jeff Sessions.

    "US Senators Orrin Hatch (R-UT) and Kamala Harris (D-CA), both members of the Senate Judiciary Committee, sent a letter today to US Attorney General Jeff Sessions urging the Drug Enforcement Administration (DEA) to cease efforts to slow medical marijuana research, following reports that the Department of Justice was blocking medical marijuana research efforts by delaying approvals for manufacturers growing research-grade medical marijuana.

    Expanded research has been called for by President Trump’s Surgeon General, the Secretary of Veterans Affairs, the FDA, the CDC, the National Highway Safety Administration, the National Institute of Health, the National Cancer Institute, the National Academies of Sciences, and the National Institute on Drug Abuse. There are currently two bipartisan bills before the Senate Judiciary Committee that would streamline the cumbersome process for researchers to receive federal permission to study marijuana."

    Read the full letter