DEA Lawsuit Timeline

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.

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

###

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

DEA Eliminates Federal Monopoly on Marijuana for Research

On August 11, 2016, the Drug Enforcement Administration (DEA) announced their intention to grant licenses to additional marijuana (cannabis) growers for research purposes, thereby ending the 48-year monopoly on marijuana legal for research. 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.

MAPS has been working to eliminate this marijuana research blockade for over 15 years. NIDA's marijuana can be used for research but not sold as a prescription medicine, making it unacceptable for use in future Phase 3 studies.

"There was no production monopoly on any other Schedule I drug, such as 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., MAPS Founder and Executive Director. Read the press release... | Learn more...

U.S. First Circuit Court Upholds NIDA Monopoly on Marijuana for Research

On April 15, 2013, the United States Court of Appeals for the First Circuit rejected University of Massachusetts-Amherst Prof. Lyle Craker’s lawsuit against the Drug Enforcement Administration for denying him a license to grow marijuana for privately funded medical research. With its decision, the Court has ensured that the debate over the medical use of marijuana will continue to take place through political battles rather than through scientific research. In 2007, A DEA Administrative Law Judge, after two weeks of testimony, recommended that it would be in the public interest for DEA to issue a license to Prof. Craker, but DEA rejected that recommendation. The decision brings to an end Craker’s 12-year effort to end the National Institute on Drug Abuse’s monopoly on the supply of marijuana for research. A laboratory at the University of Mississippi under contract to the National Institute on Drug Abuse is currently the only facility in the U.S. permitted to grow marijuana for research. Prior to Craker’s application, NIDA had refused to sell marijuana to two FDA- and Institutional Review Board-approved protocols sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), preventing them from taking place. In September 2011, NIDA refused to sell marijuana to a third FDA-approved MAPS-sponsored protocol in 50 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).

DEA Lawsuit Reply Brief Submitted, Oral Arguments Scheduled for May 11, 2012

On May 4, 2012, the legal team representing Prof. Lyle Craker submitted their reply brief (PDF) in his federal lawsuit against the Drug Enforcement Administration for rejecting a DEA administrative law judge’s 2007 recommendation that it would be in the public interest to grant Prof. Craker a license to grow marijuana under contract to MAPS for federally-regulated research. Oral arguments in the case of Lyle E. Craker v. Drug Enforcement Administration will be presented on Friday, May 11, 2012 at around 9:30 A.M. at the U.S. First Circuit Court of Appeals in Boston, Mass. For more information, download our official press release (PDF).

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 Federal Court

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.

The US Senate Unanimously Confirmed Michele Leonhart as New DEA Administrator

On December 22, 2010, the U.S. Senate unanimously confirmed Michele Leonhart as new DEA Administrator. The implications for DEA licensing of Prof. Craker are obvious and disappointing since Leonhart rejected the DEA Administrative Law Judge (ALJ) recommendation that it would be in the public interest for Prof. Craker to be licensed to grow marijuana for federally-regulated research. Prof. Craker's lawyers have until March 7, 2011 to submit a final brief to Leonhart, after she rejected our Motion to Reconsider on 12/5/10.

DEA's obstruction of medical marijuana research was not mentioned by a single Senator during her confirmation hearing and all US Senators voted in favor of her confirmation, despite efforts against her nomination by a combination of drug policy reform groups.

Crakers lawyers file eleventh update with U.S. Court of Appeals, First Circuit

 

On December 13, 2010, Craker’s lawyers file eleventh update with U.S. Court of Appeals, First Circuit. The update reports to the court: "DEA issued an order amending its original order in minor respects, denying petitioners request to present additional witnesses, denying judicial notice as to certain documents and taking judicial notice of certain others, and - most significantly for purposes of the timing of the instant Petition for Review - inviting petitioner Craker to submit additional evidence and and briefing to the DEA by March 17, 2011. The government will have the opportunity to respond within 30 days. As the administrative process continues, Petitioner requests that the Court continue to hold the appellate process in abeyance."

DEA Administrator Explains Denial of Request to Reopen Craker Case

Professor Lyle Craker, Ph.D., of the University of Massachusetts at Amherst, with assistance from MAPS, continues to pursue his lawsuit against the Drug Enforcement Administration (DEA) for rejecting his application for a license to grow marijuana for federally regulated research under contract to MAPS and in doing so to break the monopoly held by the National Institute on Drug Abuse (NIDA). On January 30, 2009, lawyers for Prof. Craker filed a Motion to Reconsider the DEA’s January 14, 2009, final order rejecting the DEA Administrative Law Judge’s February 12, 2007, recommendation that it would be in the public interest for the agency to license Prof. Craker. On December 6, 2010 (nearly two years later), we received a memorandum from DEA Administrator Michele Leonhart (who was recently confirmed by the US Senate) detailing the reasons why our request to reopen the trial was rejected. Leonhart did, however, grant us the opportunity to submit another written brief objecting to her final order. Prof. Craker will be submitting his brief on or before the deadline of March 7, 2011. The DEA could take days, months, or years to reply.

Re: Professor Lyle Craker, Ph.D., Docket No. 05-16

Administrative Law Judge Mary Ellen Bittner
Drug Enforcement Administration
Office of Administrative Law Judges
Washington, D.C. 20537

Re: Professor Lyle Craker, Ph.D., Docket No. 05-16

Dear Judge Bittner:

I am writing in the matter of Craker v. DEA, Docket No. 05-16, to express our view that it is in the public interest for the DEA to issue research licenses to appropriate researchers and facilities to produce marijuana exclusively for federally-approved research.

The United Methodist Church (UMC) is the second largest Protestant denomination in the United States, with more than eight million members. Our positions on sociopolitical issues are established through resolutions passed by the General Conference, comprised of up to 1,000 delegates half clergy, half lay from throughout the world.

On May 4, 2004, the General Conference passed a resolution with by a vote of 877 to 19, which reads: "Some countries permit the use of marijuana in medicines. Recently, some states in the United States have passed legislation permitting the medical use of marijuana. The medical use of any drug should not be seen as encouraging recreational use of the drug. We urge all persons to abstain from all use of marijuana, unless it has been legally prescribed in a form appropriate for treating a particular medical condition."

The United Methodist General Board of Church and Society (GBCS), on which I serve as General Secretary, is the international social witness and advocacy agency of the UMC, charged by the denomination to speak its convictions, interpretations and concerns to the Church and to the world.

Shortly after the passage of the resolution by the UMC General Conference affirming that marijuana may be used as a legitimate medicine, the GBCS joined several other denominations in signing a statement of principle on the role of the criminal justice system in this matter: "Licensed medical doctors should not be punished for recommending the medical use of marijuana to seriously ill people, and seriously ill people should not be subject to criminal sanctions for using marijuana if the patient's physician has told the patient that such use is likely to be beneficial." This position is grounded in the moral values of justice and compassion.

On several occasions, we have petitioned the U.S. Congress and several state legislatures to stop persecuting medical marijuana patients and providers. We are committed to pursuing all legal channels to end this cruel and counterproductive war on patients. One avenue is the FDA approval process; indeed, this would be the obvious route for obtaining the approval of a medicine, if not for the misguided barriers erected by the federal government. For mercys sake, it is time to tear down these walls.

In particular, the National Institute on Drug Abuse currently maintains a monopoly on the supply of marijuana for research in the United States. This has made it nearly impossible for researchers to obtain the substance to conduct the kind of studies that would lead to natural marijuana being approved by the FDA as a prescription medicine.

Marijuana should not be more difficult to research than any other potentially therapeutic substance, all of which have risks and dangers. Therefore, we urge the DEA to license Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant and Soil Sciences, UMass Amherst, to establish a privately-funded facility to produce marijuana exclusively for FDA-approved and privately-funded research.

Sincerely,

Jim Winkler

Crakers Lawyers file update in First Circuit, U.S. Court of Appeals

 On May 11, 2009, Prof. Craker’s 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. Cracker’s attorneys filed a “placeholder” notice of appeal in the U.S. Court of Appeals for the First Circuit in Boston, preserving Prof. Craker’s 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. Craker’s 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. Craker’s 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.

Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden

 On April 29, 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.

DEA lawyers file their final document post motions

 DEA lawyers file their final document seeking to counter arguments made by Prof. Craker's lawyers requesting a hearing to rebut new evidence and false claims made in DEA Acting Administrator Leonhart's January 14, 2009, Final Order. DEA's Final Order rejected DEA Administrative Law Judge Bittner's February 12, 2007, recommendation that it would be in the public interest for DEA to issue Prof. Craker, UMass Amherst, a license for a medical marijuana production facility. DEA's Final Order goes into effect May 1, unless a hearing or opportunity for written testimony is granted.

Final Order goes into effect, but DEA review of Motions to Reconsider still Pending

 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. Craker’s Motion to Reconsider.  Based on conversations between Allen Hopper, Prof. Craker’s 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.

DEA Lawyers Extend to April 13 their reply to Prof. Crakers Supplemental Motion to Reconsider

 On March 25, DEA lawyers filed a motion extending to April 13 the deadline for DEA's reply to our Supplemental Motion to Reconsider, with the final order now going into effect April 24, unless our Motion to Reconsider is granted. We now have several more weeks to lobby the Obama Administration to accept ALJ Bittner's recommendation that it would be in the public interest for DEA to issue a license to Prof. Craker.

Lawyers for Prof. Craker Submit Supplemental Motion to Reconsider to the DEA

  On March 11, 2009, lawyers for Prof. Craker submitted a powerful Supplemental Motion To Reconsider and Exhibits 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. Craker’s facility would be sponsored by MAPS. Unless DEA grants the motion to reconsider, the final order becomes effective April 1, 2009.

DEA Extends Deadline to March 11 for Response to Final Order Rejecting Craker Marijuana License

 DEA Deputy Administrator Michelle Leonhart, in response to a compelling Motion to Reconsider filed by Prof. Craker’s lawyers and to a letter to new AG Eric Holder from 16 Congressional Representatives, agreed in a February 9, 2009, Order in Response to Respondent’s Request to extend to March 11, 2009, the deadline for a response to DEA’s January 14, 2009 Final Order. In that Final Order, DEA rejected ALJ Bittner’s February 12, 2007 recommendation that it would be in the public interest for DEA to license Prof. Craker to grow marijuana for federally-licensed research. Prof. Craker’s facility would be sponsored by MAPS.

ASA gets 16 Members of the United States Congress to Sign a Letter to the Attorney General

 Sixteen members of the United States Congress sent a letter Sixteen 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 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.

DEA Refuses to End the Government Monopoly Over the Supply of Marijuana for FDA-Sanctioned Research

 The Bush administration struck a parting shot to legitimate science on January 14th, as the Drug Enforcement Administration (DEA) published in the Federal Register a 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. 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 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.

Massachusetts Senators Kerry and Kennedy Commit to Send New Letter to DEA in Support of Prof. Craker

 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.

MAPS Files a Freedom of Information Act Request with DEA

MAPS files a Freedom of Information Act (FOIA) request with DEA to find out whether there have been any comments to the DEA regarding Prof. Craker's application. MAPS learns that only one public comment was filed with DEA during the public comment period and that MAPS could see that comment only by filing the (FOIA) request. The FOIA later revealed that the one comment submitted to DEA was from Dr. El Sohly, the director of NIDA's marijuana facility.

45 U.S. Representatives Send Letter to DEA in Support of Medical Marijuana Research

 

On September 19, a letter signed by 45 members of the U.S. House of Representatives will be delivered to U.S. Drug Enforcement Administration (DEA) Administrator Karen Tandy urging her agency to license UMass-Amherst professor Lyle Craker to establish the nation's first privately funded research-grade marijuana production facility. This letter demonstrates to DEA that there is a growing political will to end the federal government's monopoly on the supply of marijuana that can be used in FDA-approved research.

The bipartisan letter (pdf), co-sponsored by Reps. John Olver (D-MA) and Dana Rohrabacher (R-CA), urges DEA to follow Administrative Law Judge Mary Ellen Bittner's February, 2007 ruling in favor of Prof. Craker. The law judge's ruling is non-binding and DEA has no deadline to decide whether to accept or reject it.

Craker's applications for regulatory approval, legal efforts, and proposed facility are sponsored by MAPS, which plans to design, fund, and obtain government approval for the clinical trials necessary to determine whether marijuana meets FDA requirements for medical safety and efficacy.

ONDCP and DEA Officials Grilled on MAPS/Craker Case at Hearing on DEAs Regulation of Medicine

On July 12, in the new Congress's first oversight hearing on the federal government's role regarding medical marijuana, Reps. Bobby Scott (D-VA) and Jerrold Nadler (D-NY) grilled officials from ONDCP and DEA on their role in obstructing Prof. Lyle Craker's MAPS-sponsored medical marijuana production facility. Rep. Nadler asked a series of pointed questions about NIDA's unique monopoly on the supply of marijuana for FDA trials, Judge Bittner's recent ruling in favor of MAPS and Prof Craker, and the DEA's timeline for issuing a decision on whether to accept or reject Judge Bittner's "Recommended Ruling."

First, Nadler asked Rannazzisi why marijuana is the only Schedule One drug for which the federal government has a monopoly on supply. Rannazzisi cited international treaty obligations, a line of reasoning already disproved in court. Then, Nadler asked if the DEA would make a decision on Judge Bittner's ruling in favor of Prof. Craker by the end of Bush's term. When Rannazzisi couldn't answer, Nadler asked how long the DEA normally takes to process a recommendation from an administrative law judge. Rannazzisi said it varies from case to case, but Nadler wasn't satisfied, and continued the line of questioning by asking whether it takes closer to one year, two years, or five years. Rannazzisi asked to answer in writing following the hearing. Nadler insisted that he wanted a commitment that the decision would be made on Prof. Craker's application before the end of Bush's term in January, 2009.

To read the written transcript of this oversight hearing in HTML click here (html), or to read as a PDF click here (pdf).

DEA and NIDA's obstruction of medical marijuana research is becoming increasingly difficult for those agencies to hide from politicians -- and from the public, as evidenced by the increased media scrutiny of DEA's obstruction of MAPS and Prof. Craker:

Nature:
"Scientists Stir the Pot for Right to Grow Marijuana"

The Economist editorial in support of Prof. Craker:
"Joint Action: A Victory for American cannabis researchers"

Los Angeles Times editorial in support of Prof. Craker:
"Ending the Marijuana Monopoly"

Associated Press (As published in the Boston Globe)
"UMass professor seeks to grow medical marijuana"

Washington Post (Also appeared in the San Francisco Chronicle)
"Researchers Press DEA to Let Them Grow Marijuana"

New York Times (online edition)
"Marijuana Researchers Make Progress in the Lab, but not in Washington"

Honolulu Star Bulletin
"Editorial: Medical Marijuana Research Should Not Be Hampered"

Organizations Writing to DEA Supporting Prof. Craker

 

American Medical Students Association
California Medical Association
Lymphoma Foundation of America
Multiple Sclerosis Foundation
National Association for Public Health Policy
New Mexico Nurses Association
North Carolina Nurses Association
Texas Medical Association
United Methodist Church (UMC), with more than eight million members
Wisconsin Nurses Association
Leukemia & Lymphoma Society
Citizen Outreach Project
Republican Liberty Caucus
Pain Relief Network
American Association for Social Psychiatry
US Bill of Rights Foundation
Americans for Tax Reform
The Drugs and the Law Committee of the Association of the Bar of the City of New York
Doctors for Open Government
New Grady Coalition
Center for Financial Privacy and Human Rights
Center for Liberty and Community
Ethics in Government Group
Natural Solutions Foundation
Student Health Integrity Project
Multiracial Activist
Coalition Against Prosecutorial Misconduct
Liberty Coalition
Citizens for Health
Mothers Against Misuse and Abuse
The AIDS Institute
National Association of People with AIDS
HIVictorious, Inc.
United Church of Christ
Unitarian Universalist Association of Congregations
Union for Reform Judaism
Women for Reform Judaism
Presbyterian Church (USA)
American Academy of HIV Medicine
L.A. Gay & Lesbian Center
Americans for Safe Access
HIV Medicine Association of the Infectious Diseases Society of America
Community HIV/AIDS Mobilization Project
Compassion and Choices
Downsize DC Foundation
Drug Policy Alliance
Reason Foundation
South Carolina Campaign to End AIDS
Velvet Revolution
National Lawyers Guild

Final Legal Brief Filed in the Craker vs. DEA Case

  Prof. Craker, assisted by a great legal team led by Julie Carpenter, Jenner & Block, Allen Hopper, ACLU, and Emanuel Jacobowitz, Steptoe & Johnson, and including Christina Alvarez, ACLU and Lauren Payne, MAPS, filed the final legal brief today in the Craker v. DEA case. This brief is a strong response to the DEA's "exceptions" to ALJ Bittner's recommendation that it would be in the public interest for DEA to register Prof. Craker as a bulk manufacturer of marijuana, to produce marijuana sponsored by MAPS.

The Sacramento Bee Published an Excellent Op-Ed About MAPS DEA Lawsuit

 The Sacramento Bee published an excellent op-ed by Claire Cooper entitled, "Rejected in Court, Medical Pot Advocates Turn to DEA." The op-ed is an excellent summary of the legal and political issues regarding our DEA lawsuit. It's a new world now that DEA Administrative Law Judge Bittner has recommended that it would be in the public interest for DEA to issue Prof. Craker a license for a MAPS-sponsored medical marijuana production facility.

DEA Attorney Submits Exceptions to ALJ Opinion

 DEA Attorney Charles Trant submitted DEA's "exception" to the February 12, 2007 opinion of ALJ Bittner. Trant objected to ALJ Bittner's recommendation that it would be in the public interest for DEA to give Prof. Lyle Craker a license for a MAPS-sponsored medical marijuana production facility. Lacking much in the way of a good argument, Trant spent lots of time talking about international treaty obligations, and criticizing MAPS President Rick Doblin, at one point comparing him to Pablo Escobar.

A detailed rebuttal is being prepared by Prof. Craker's legal team, to be submitted to the ALJ's office by May 4, 2007. A few weeks or so after that, ALJ Bittner will forward her recommendation, along with the dueling legal documents, to DEA for a formal ruling. A coalition of medical marijuana and drug policy reform groups will try to generate pressure on DEA from Congress, seeking Representatives and Senators willing to sign a letter to DEA Administrator Tandy, urging her to accept ALJ Bittner's recommendation. Unfortunately, DEA has no time limit for when it must issue its final ruling.

DEA Lawyers to File Objections March 26, 2007

 The DEA's lawyers have requested requested an extra 20 days to file their objections to the Judge's decision. In doing so, they also granted MAPS' lawyers an additional 20 days. This means that the earliest the DEA will begin to process the Judge's recommendation will be in mid-May. At that point, the DEA Deputy Administrator has an unlimited amount of time to decided whether to accept or reject the Judge's non-binding recommendation to grant Prof. Craker a Schedule I license for his MAPS-sponsored marijuana production facility. We expect the decision could come from the DEA anywhere between 3-15 months from May.

Since the Judge's decision is non-binding, MAPS must coordinate another Congressional lobbying campaign after the DEA's lawyers file their objections on March 26. Our aim will be to generate sufficient pressure on the DEA to accept the Judge's recommendation by granting Prof. Craker a Schedule I license, thus breaking NIDA's marijuana research monopoly and finally paving the way for putting marijuana through FDA clinical trials.

MAPS Press Release Following Favorable Recommendation from Judge Bittner

 

Contact Jag Davies, MAPS Director of Communications
(831) 336-4325 or This email address is being protected from spambots. You need JavaScript enabled to view it.

For Immediate Release
February 13, 2007

DEA Judge Recommends End to Government Obstruction of Medical Marijuana Research
Historic Step Toward Nation's First Privately-Funded Marijuana Production Facility

Washington, D.C. - University of Massachusetts-Amherst Professor Lyle Craker, MAPS, the ACLU, and a broad array of medical and public policy groups nationwide enthusiastically supported today's official recommendation by Drug Enforcement Administration (DEA) Administrative Law Judge Mary Ellen Bittner that Prof. Craker be permitted to grow research-grade marijuana for use in privately-funded government-approved studies that aim to develop the marijuana plant into a legal, prescription medicine. Judge Bittner ruled that it is in the public interest to end the federal government's monopoly, which it has maintained for over six decades, on the supply of marijuana that can be used in FDA-approved research.

"This ruling is a victory for science, medicine and the public good," said Prof. Craker. "I hope the DEA abides by the decision and grants me the opportunity to do my job unimpeded by drug war politics."

The 87-page Opinion and Recommended Ruling by Judge Bittner, who is appointed by the U.S. Department of Justice, marks a unique window of opportunity in the six year struggle by MAPS and Prof. Craker to gain a Schedule I DEA license to grow research-grade marijuana for use by scientists in MAPS-funded, DEA- and FDA-approved studies.

"For decades, politicians have said that marijuana has no proven medical value while scientists have been denied the ability to prove otherwise," said Rick Doblin, Ph.D., president and founder of MAPS.

The court¹s ruling is only a recommendation to DEA Deputy Administrator Michele Leonhart, however, not a binding ruling; thus, the DEA retains final decision-making authority. In response, scientists, researchers, doctors and medical marijuana patients nationwide are joining MAPS and the ACLU by encouraging the DEA to comply with the court¹s finding and to halt federal obstruction of medical marijuana research.

Prior to this recent ruling, organizations that had already written to DEA in favor of Prof. Craker's application included the Multiple Sclerosis Foundation, the Lymphoma Foundation of America, the National Association for Public Health Policy, the United Methodist Church, Americans for Tax Reform, the American Medical Students Association, several state nurses' associations, the Massachusetts Dept. of Public Health, Massachusetts Senators Kerry and Kennedy, 38 members of the US House of Representatives, and the California and Texas State Medical Associations, the two largest US state medical associations.

If the DEA grants Prof. Craker a Schedule I license, his proposed research-grade medical marijuana production facility will be funded by MAPS, a non-profit research organization that plans to design, fund, and obtain government approval for the clinical trials necessary to bring marijuana to market as a fully legal, prescription medication. MAPS has had two FDA-approved marijuana studies blocked by NIDA, and would require a reliable, high-quality supply of research material to justify the time and expense to sponsor FDA-approved clinical research evaluating the risks and benefits of marijuana as a potential FDA-approved medicine.

The ACLU and the Washington D.C. law firm Jenner & Block, LLP are co-counsel for the case and are assisted by Steptoe & Johnson, LLP.

MAPS and DEA File Final Briefs for DEA Lawsuit

 

Today, a final brief (PDF) was submitted to DEA Administrative Law Judge (ALJ) Mary Ellen Bittner by lawyers for Prof. Lyle Craker a final brief was submitted to DEA Administrative Law Judge (ALJ) Mary Ellen Bittner by lawyers for Prof. Lyle Craker (lead lawyer Julie Carpenter, Jenner & Block, assisted by Allen Hopper, ACLU and Emanuel Jacobowitz, Steptoe & Johnson). Prof. Craker's lawsuit against DEA is for refusing to permit him to establish a MAPS-sponsored medical marijuana growing facility at the University of Massachusetts-Amherst. DEA also filed its final brief today. We anticipate that DEA ALJ Judge Bittner will issue her recommendation to DEA Administrator Karen Tandy within the next two to four months.

If ALJ Bittner issues an unfavorable recommendation, DEA wins and there will probably be no privately-funded medical marijuana research effort ever started until a more reasonable President is in office. If ALJ Bittner does issue a favorable recommendation, we will need to organize a major coordinated campaign to obtain letters of support from members of Congress, especially Republicans, urging DEA Administrator Karen Tandy to accept the favorable recommendation. Tandy will probably take several months to study the recommendation before issuing her final ruling. During that time is our period of maximum opportunity. In these turbulent times, it does seem within our reach for us to mobilize sufficient pressure on DEA to force the acceptance of a favorable recommendation. If ALJ Bittner does issue a favorable recommendation and Tandy rejects it, we can still sue DEA in the DC Circuit Court of Appeals, but that will take more time and money and will continue DEA's strategy of delay. Still, if DEA rejects a favorable recommendation, we should be able to inflict a significant blow to whatever remains of the credibility of DEA and ONDCP by showing the hypocritical nature of blocking research while supposedly objecting to medical marijuana on the basis of there not being enough research to prove that it should become an FDA-approved prescription medicine. DEA rejection of a favorable recommendation will also strengthen the case for state-level reforms.

FDA Statement Disputes Claims for Medical Use of Marijuana

 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.

The Drugs and the Law Committee of the Association of the Bar of the NYC Sends a Letter to DEA Admin

 The Drugs and the Law Committee of the Association of the Bar of the City of New York has sent a tremendous letter to DEA Administrator Karen Tandy urging her to issue a license to Prof. Lyle Craker for a MAPS-sponsored marijuana production facility. The letter, signed by Chair John H. Doyle III, Esquire, cites specific testimony from the hearings to support a series of legal arguments that make a compelling case for DEA's legal obligation to issue the license.

Final Brief Report by Rick Doblin, Ph.D., MAPS

 Lawyers from both sides of the case have agreed 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. Prof. Craker's facility is a prerequisite to beginning MAPS-sponsored clinical trials into the risks and benefits of marijuana as a potential FDA-approved prescription medicine.

DEA Administrative Law Judge Mary Ellen Bittner is expected to make a decision three to six months after the briefs have been submitted. If Judge Bittner issues an unfavorable recommendation, obtaining a license for Prof. Craker's facility would require an Act of Congress or much more political pressure on DEA than we have brought to bear to date. If Judge Bittner issues a favorable recommendation, DEA Administrator Karen Tandy would probably take several months to prepare her ruling. During this time, MAPS would help initiate a major collaborative campaign to obtain letters of support for Prof. Craker's license from many members of Congress, focusing primarily on Republicans, using the letter of support we have already obtained from Republican strategist Grover Norquist.

On March 2, MAPS learned that it was awarded a grant of $35,500 from the Marijuana Policy Project (MPP) to cover legal expenses for the DEA lawsuit.

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

 Our lawyers learned 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.

Sign-on Letter

Click for a copy of the final letter sent December 6, 2005, PDF Format

DEA Administrator Karen P. Tandy
Drug Enforcement Administration
Mailstop: AXS
2401 Jefferson Davis Highway
Alexandria, VA 22301

Dear Administrator Tandy,

We are writing to express our strong support for the application from Professor Craker, of the University of Massachusetts-Amherst, for licensing as a bulk manufacturer of marijuana for distribution exclusively to federally-approved researchers. We believe the DEA licensing of Prof. Craker's privately-funded facility would be in the public interest.

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.

The University of Massachusetts-Amherst is one of the nation's distinguished research universities, and it is highly qualified to manufacture marijuana for legitimate medical and research purposes with effective controls against diversion. NIDA's monopoly makes very little sense given that the DEA has licensed privately-funded manufacturers of virtually all other Schedule I drugs, including LSD, MDMA (Ecstasy), and psilocybin.

As one of your predecessors, DEA Administrator Robert Bonner, stated, "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." We urge you to grant Prof. Craker's application for registration as a bulk manufacturer so that such legitimate and privately-funded scientific research can be conducted.

Respectfully,

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)

Grover Norquist Letter to DEA

 

PDF Version | MS WORD Version

November 22, 2005
DEA Administrator Karen P. Tandy
Drug Enforcement Administration
Mailstop: AXS
2401 Jefferson Davis Highway
Alexandria, VA 22301

Dear Administrator Tandy:

I am writing today to urge the DEA to license a privately-funded medical marijuana production facility, thus ending the government monopoly on the supply of marijuana legal for FDA and DEA-approved research. This would allow more controlled medical research using cannabis plants. When in a controlled laboratory facility, any agricultural product should be fair game for research and experimentation.

Over four years ago, Prof. Lyle Craker, University of Massachusetts-Amherst, sought permission from DEA to grow cannabis for privately-funded medicinal research. As a controlled substance, the DEA has discretion to grant permission to grow the cannabis plant. The licensing of this facility would provide privately-funded sponsors of FDA-approved research the necessary opportunity to conduct studies with a strain of cannabis of their own choosing, with immediate access to that strain for all FDA-approved studies and for possible prescription use.

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. It’s in the public interest to end the government monopoly on marijuana legal for research.

Sincerely,

Grover Norquist
President, Americans for Tax Reform
www.atr.org

Case For A Sign-On Letter to DEA Administrator Karen Tandy

November 2, 2005

Karen P. Tandy, Administrator
Drug Enforcement Administration Office
Mailstop: AXS
2401 Jefferson Davis Highway
Alexandria, VA 22301

Dear Administrator Tandy,

I am Leonides G. Cigarroa Jr., MD, chair of the Texas Medical Association (TMA) Council on Scientific Affairs. TMA represents over 40,000 physicians in Texas. I am writing in the matter of Craker v. DEA, Docket N0. 05-16.

TMA believes that the medical use of marijuana is an issue that should be resolved through scientific research. As a result, TMA recommends that Drug Enforcement Administration (DEA) grant a license to produce marijuana exclusively for federally-approved research to Professor Lyle Craker, Director of the Laboratories for Natural Products, Medicinal and Aromatic Plants, Department of Plant and Soil Sciences, University of Massachusetts Amherst.

TMA has formal policy supporting more scientific research into the risks and benefits of the medical uses of marijuana. By issuing a license to Prof. Craker, the DEA can demonstrate that it will facilitate, rather than obstruct, the privately-funded scientific evaluation of marijuana's potential medical uses.

TMA agrees with the letter submitted to you by Dr. Jack Lewin, CEO and Executive Vice-President of the California Medical Association (CMA), which stated, "I am writing in the matter of Craker v. DEA, Docket No. 05-16 to express our view that it is in the public interest for the DEA to issue research licenses to appropriate researchers and facilities to produce marijuana exclusively for federally-approved research."

If you would like to contact me for any reason, I can be reached at (956) 722-2777. Or feel free to contact Barbara James, BSN, RN, TMA Director of Science and Quality, at (512) 370-1400.

Sincerely,

Leonides G. Cigarroa Jr., MD
Chair, Council on Scientific Affairs

cc. Robert Gunby, MD, President

View letter in PDF format

Statement Of Frederic M. Scherer

 

Statement Of Frederic M. Scherer

in re Professor Lyle Craker
Drug Enforcement Administration Docket No. 05-16
September 15, 2005

1. I have been asked by representatives of Professor Craker to submit this analysis in connection with the Docket 05-16 proceedings before the Drug Enforcement Administration (DEA). I do so pro bono publico. I am professor emeritus at the John F. Kennedy School of Government, Harvard University, and visiting professor at Haverford College, teaching a course on the economics of industry. Copies of my short-form biography and a list of my testimony in judicial and regulatory proceedings are attached as Appendices A and B.

2. The issue, as I understand it, is fourfold. First, DEA has the legal authority to designate production sources for the lawful production of such controlled substances as marijuana and is mandated under by 21 U.S.C. 823(a)(1) to "limit the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes." Second, I understand that DEA has licensed a single source, Professor El Sohly at the University of Mississippi, to produce marijuana under contract to the National Institute on Drug Abuse (NIDA), the output of which is allocated by NIDA. Third, DEA has recently licensed Professor El Sohly to grow marijuana for lawful commercial purposes under contract to private industry. Fourth, I understand that Dr. Craker is seeking authorization to establish an alternative competitive source at the University of Massachusetts, whose output is to be used solely for lawful experimental purposes. That application has been denied, but is under review by the DEA in this proceeding.

3. I have been asked to address the testimony on August 25, 2005, of Mr. Matt Strait of DEA. Mr. Strait testified in effect that a problem of deficient competition does not exist because the DEA-licensed University of Mississippi source "provides marijuana to researchers at a not for profit basis.... I just don't necessarily see the argument for competition." In other words, because supplies are provided at cost, there is no lack of competition, since, according to Mr. Strait, the words used in the Code of Federal Regulations "all seem to be geared around the economics."

4. My interpretation of this rather imprecise testimony is that, since the University of Mississippi source prices its supplies of marijuana at cost rather than above cost, there is no monopoly problem; the requisites of competition are satisfied.

5. My understanding is that, in addition to providing only marijuana of relatively low potency, NIDA has in the past denied applications for marijuana supplies to be used solely for legitimate research. For those applications, the supply is constrained to zero. When there is a market demand for a commodity and there is no supply, any reputable economist would agree that the true price is the so-called shadow price, also called the implicit price, that is, the price consistent with finite demand but zero supply. Under the circumstances here, the shadow price is infinity for certain demand functions, i.e., those derived from Cobb-Douglas utility functions (Paul Douglas was a U.S. senator in the 1950s), or in other special cases, the price just above the price at which the demander's demand is choked off to a quantity of zero. In either case, such a shadow price is higher, usually much higher, than the price at which a monopoly would maximize its profits. And the monopoly price is higher than a competitive price. Thus, when a monopoly supplier denies supplies to legitimate demanders, there is a very significant impairment of competition -- more significant than if the supplier merely levied a monopoly price.

6. Scholars of all ideological shades who accept the basic premises favoring a market economy agree that refusal to supply by an entity with monopoly power is at least as undesirable as supplying at a monopoly price. As Friedrich A. Hayek observed in his book, The Road to Serfdom (1976 University of Chicago revised edition, p. 93):

Our freedom of choice in a competitive society rests on the fact that, if one person refuses to satisfy our wishes, we can turn to another. But if we face a monopolist we are at his mercy. And an authority directing the whole economic system would be the most powerful monopolist conceivable. While we need probably not be afraid that such an authority would exploit this power in the manner in which a private monopolist would do so, while its purpose would presumably not be the extortion of maximum financial gain, it would have complete power to decide what we are to be given and on what terms... The power conferred by the control of production and prices is almost unlimited.

Professor Hayek's book is considered the bedrock of contemporary conservative economics. And I hardly need to say that Hayek abhorred the kind of power he was describing. On the more liberal side (by a modern, not 19th Century, definition of the term), consider the 1959 treatise by Carl Kaysen and Donald F. Turner, Antitrust Policy: An Economic and Legal Analysis, p. 14:

The demand for limiting business power springs more often from those who feel themselves at a disadvantage in interbusiness transactions than it does from households ... Competition in this context is desirable because it substitutes an impersonal market control for the personal control of powerful business executives, or for the personal control of government bureaucrats. The impersonality of market regulation makes it fair in the eyes of those subject to it; the sense of fairness is greater when the same restriction on conduct is imposed by the market than when it is viewed as the result of a personal decision by a powerful individual.

Shortly after publishing the book, Kaysen became an economic adviser to President Kennedy; Turner was Assistant Attorney General for Antitrust during the Johnson Administration.

7. In declaring under 21 U.S.C. 823(a) that controlled substances should be supplied under "adequate competitive conditions" for lawful purposes, the U.S. Congress was following a four-century legal tradition. The seminal case is Darcy v. Allein, 1603, which is reprinted in my compendium, Monopoly and Competition Policy, vol. I, pp. 6-11. It condemned as contrary to the common law a grant by Queen Elizabeth I of a monopoly over the supply of playing cards in England. That and other High Court decisions led the Parliament in 1623 to pass the Statute of Monopolies, which singled out patents and copyrights as the sole allowable monopoly grants government could make under English law. That policy was implicitly endorsed by the U.S. Founding Fathers when they authorized Congress in Article I, Section 8, of the Constitution to grant for limited times the exclusive right to authors and inventors in their writings and discoveries, but articulated expressly no other situations in which the government was to confer exclusive rights.

8. It is my understanding that no exclusive patent rights limit the supply of marijuana to lawful scientific users. Even for the principal type of monopoly grant sanctioned in the U.S. Constitution, Congress declared an explicit exemption in the Hatch-Waxman Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417). The so-called Bolar amendment exempts would-be generic suppliers of a drug from the exclusive rights of drug product patent holders for the purpose of carrying out clinical trials in advance of patent expiration so that their generic products can be ready for marketing at the time valid patents expire.

9. A considerable part of my professional career has been devoted to studying the relationships between market structure and technological progress. One of my most important findings has been that innovation, quality, and diversity of product characteristics satisfying consumers' demands are more likely to be achieved when there are multiple producers than when there is only one, i.e., a monopoly. For a summary, see F. M. Scherer and David Ross, Industrial Market Structure and Economic Performance (3rd edition: 1990), pp. 600-607 and 639-660.

10. To conclude, I believe Mr. Strait is quite wrong in testifying that there is no impairment of competition when legitimate supplies of marijuana are sold at cost to authorized customers. Competitive problems emerge when costs are higher than those of alternative sources, or when supplies are denied -- i.e., the quantity supplied is zero -- to other would-be buyers who meet the scientific and/or medical criteria of the Food and Drug Administration (FDA) or, in the case of laboratory research, have the necessary DEA licenses. Denial of a license to the University of Massachusetts to produce marijuana for lawful scientific and medical purposes is contrary to both the spirit of 21 U.S.C. 823(a)(1) and to sound public policy.

11. I swear that the statements in para. 1-10 above are true to the best of my knowledge.



Frederic M. Scherer

New York Times Op-Ed, Marijuana Pipe Dreams, by John Tierney

 

Marijuana Pipe Dreams

John Tierney
August 27, 2005
New York times

When the Supreme Court ruled in June that states could not legalize marijuana for medical uses, Justice Stephen Breyer voted with the majority. But during oral arguments, he suggested an alternative way for patients to get it: let the federal Food and Drug Administration decide if marijuana should be a prescription drug.

"Medicine by regulation is better than medicine by referendum," he said. In theory, that sounds reasonable. But what if the officials doing the regulation are afflicted with a bad case of Reefer Madness?

If you doubt this possibility, you should have been at a hearing that began this week at the Drug Enforcement Administration's headquarters. Lyle Craker, a professor of plant and soil sciences at the University of Massachusetts, asked an administrative judge to overrule the agency so he could grow marijuana for F.D.A.-approved research projects by other scientists.

Dr. Craker is a well-regarded agronomist who's being supported by the American Civil Liberties Union and both of his senators, Edward Kennedy and John Kerry. But for four years he's been stymied by the D.E.A., which first stalled and then finally denied his request for a permit.

There are precedents for his re quest, because researchers already get supplies of other drugs - like heroin, LSD and Ecstasy - from independent laboratories licensed to make them. But researchers who want marijuana have only one legal source: a crop grown in Mississippi and dispensed by the National Institute on Drug Abuse.

Scientists say they need an alternative partly because the government's marijuana is of such poor quality - too many seeds and stems - and partly because the federal officials are so loath to give it out for research into its medical benefits.

Discovering benefits, after all, would undermine the great anti-marijuana campaign that has taken hold in Washington. Marijuana is deemed to be such a powerful "gateway" to other drugs that it's become the top priority in the federal drug war, much to the puzzlement of many scientists, not to mention the police officers who see a lot of worse drugs on the streets.

People with glaucoma and AIDS have sworn by the efficacy of marijuana, and there have been studies by state health departments showing that smoking marijuana is especially good at controlling nausea. Scientists would like to test these effects, but they can't do good studies until they get good marijuana.

Critics of medical marijuana say that it's unnecessary because patients can obtain the benefits of its active ingredient, THC, through a drug that's already available, Marinol. But many patients say it doesn't work as well. They point to the case of the writer Peter McWilliams, who said smoking marijuana was the only way to control the nausea brought on by the mix of drugs he took for AIDS and cancer.

He was forced to switch to Marinol after a D.E.A. investigation led to his conviction for violating federal laws against marijuana. In 2000, several weeks before he was to be sentenced, he was found dead in his bathroom. He had choked on his own vomit.

Phillip Alden, a writer living in Redwood City, Calif., told me that marijuana was a godsend for him in dealing with the effects of AIDS. He said it eased excruciating pains in his fingertips, controlled nausea and enabled him to avoid the wasting syndrome that afflicts AIDS patients who are unable to eat enough food.

But Mr. Alden said only some kinds of marijuana worked - not the weak variety provided by the federal government, which he smoked during a research study.

"It was awful stuff," he said. "They started out with a very low-grade plant, rolled it up with stems and seeds, and then freeze-dried it so that they probably ruined any of the THC crystals. All it did was give me headaches and bronchitis. The bronchitis got so bad I had to drop out of the study."

Mr. Alden was scheduled to testify at this week's hearing, but he told me he had to withdraw because the D.E.A. refused to give him legal immunity if he admitted using marijuana not from the government. It's a shame the judge will be making a decision without hearing him, but I can understand Mr. Alden's hesitancy.

D.E.A. officials have already shown they're quite capable of persecuting someone who uses marijuana to deal with AIDS, and they may well be even more eager to go after someone who encourages research into their least favorite drug. When it comes to marijuana research, the federal policy is "Just Say Know-Nothing."

MAPS/Craker/DEA Hearing Transcripts

 


The ACLU Assists in Appeal Process

The ACLU becomes co-counsel with Washington D.C. law firms Jenner & Block, LLP and Steptoe & Johnson, LLP to represent Prof. Lyle Craker in his appeal to before the DEA's Administrative Law Judge. The ACLU files an initial pre-hearing statement on behalf of Prof. Lyle Craker and 12 other experts.


UNITED STATES DEPARTMENT OF JUSTICE
DRUG ENFORCEMENT ADMINISTRATION

In the Matter of: Docket No. 05-16 LYLE E. CRAKER, PH.D.

RESPONDENT'S PRE-HEARING STATEMENT [INITIAL] In response to the ALJ's Order of Feb. 8, 2005, Respondent respectfully submits his initial pre-hearing statement.

  1. ISSUE

    Whether granting Dr. Craker's application to cultivate cannabis for use in researching and developing a pharmaceutical product whose therapeutic properties could be available to patients is in the public interest, as defined by 21 U.S.C. - 823(a).
    Whether DEA's denial of the application properly concluded that issuing a license to Dr. Craker would not be in the public interest for the reasons stated in its denial.

  2. PROPOSED STIPULATIONS AND ADMISSIONS OF FACT
    1. Numerous studies have concluded that cannabis offers therapeutic benefits to some patients.
    2. Research continues about how cannabis may be of therapeutic benefit to patients.
    3. It is in the public interest to research both already identified therapeutic benefits and as-yet-unidentified therapeutic benefits available from cannabis.
    4. It is in the public interest to research different systems for delivering therapeutic benefits from cannabis to patients.
    5. Because THC (one of the components of cannabis) offers therapeutic benefits to some patients, the FDA has approved a synthetic version of THC, called dronabinol, in the form of a pill for use as therapeutic drug.
    6. Some patients are unable to use dronabinal (brand name Marinol); many patients are prescribed Marinol for nausea and because of the nausea, they cannot keep a pill down.
    7. NIDA and the FDA have approved numerous Phase II studies involving cannabis.
    8. Ten states have adopted laws that permit, under state law, the use of medical cannabis in some circumstances. Those states are Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont, and Washington.
    9. Thirty states have classified cannabis to recognize its therapeutic potential, or immunized patients from prosecution if they are participating in statutorily- authorized therapeutic research program.
    10. There is currently in effect a federal injunction prohibiting the United States from prosecuting some patients in California who grow and use marijuana for medical purposes.
    11. The federal government has established and maintained a compassionate use program under which it provides marijuana cigarettes to some patients for their medical use.
    12. GW Pharmaceuticals, operating in England, currently holds a United Kingdom license to grow, and does grow, cannabis for medical research and development.
    13. England is a signatory to the Single Convention [insert full name].
    14. GW Pharmaceuticals has developed a cannabis-based oral spray, trademarked and patented as "Sativex," as a means of delivering the therapeutic benefits of cannabis to patients. As of April, 2005, that product has been approved for marketing in Canada.
    15. Until 1941, cannabis was listed in the United States Pharmacopoeia and National Formulary, the official US compendia of acceptable standards for strength, quality, purity, packaging, labeling and storage for drugs and excipients
    16. Until 1970, it was not illegal, as a matter of federal law, to possess or use cannabis for medical purposes.
  3. PROPOSED WITNESSES.

    Lyle E. Craker, Ph.D.
    University of Massachusetts
    Department of Plant and Soil Science
    Amherst, Massachusetts

    Richard Doblin, Ph.D.
    Multidisciplinary Association for Psychedelic Studies
    3 Francis Street
    Belmont, MA 02478-2218

    Irwin G. Martin, Ph.D.
    Ann Arbor, MI

    Angel Raich
    Oakland, CA94619

    Valerie Corral
    Butte County, California

    Irvin Henry Rosenfeld 
    8500 NW 51st St
    Lauderhill, FL33351

    Philip Alden
    400 Baltic Cir. Unit 440
    Redwood City, CA 94065

    Dr. Donald Abrams
    Community Consortium
    3180-18TH Street, Suite 201
    San Francisco, CA94110

    Lester Grinspoon
    35 Skyline Dr
    Wellesley, MA 02181

    One or more Drug Policy Experts
    (Respondent has discussed testimony with several potential experts, but has not yet determined which will testify. Respondent will supplement this Pre-Hearing Statement to identify such witnesses as soon as possible.)

    Representative From One Or More Medical Associations
    (Respondent has communicated with a group of medical associations, but has not yet confirmed which ones will give the proffered testimony. Respondent will supplement this Pre- Hearing Statement to identify such witnesses as soon as possible.)

    Researchers interviewed by DEA/NIDA whose names appear on the reports of telephone interviews conducted by the government. 
    (Respondent has just this week received copies of those interviews and has not yet had an opportunity to speak with these just-identified researchers. Respondent will supplement this statement as soon as it determines which, if any, of those researchers it will call.)

  4. SUMMARY OF TESTIMONY

    Proposed Testimony of Dr. Lyle Craker

    Dr. Craker will testify about his education, training, and background in plant and soil sciences, about his current position as a professor at the University of Massachusetts. Dr. Craker is editor of the professional, scientific journal, The Journal of Herbs, Spices and Medicinal Plants. He is also Chairman of the Medicinal and Aromatic Plant Section in the International Society for Horticultural Science, and the founding organizer of the Herb, Spice, and Medicinal Plant Working Group in the American Society for Horticultural Science. Dr. Craker will testify about plant development research he has conducted, and about his particular interest in the control of mechanisms regulating essential oil synthesis and composition of plants, especially as related to increasing production and quality of plant extracts. He will testify that he has long been involved in researching and growing plants that have medical uses. He will also testify that he has received a variety of funding, including government funding, to support this research.

    Dr. Craker will further testify as to why providing him with a DEA license to grow particular strains of cannabis with particular ratios of plant components is in the public interest. First, he will testify that the Multidisciplinary Association for Psychedelic Studies approached him to determine whether he would be able to grow cannabis that would be suitable for use in FDA- approved trials, as part of an attempt to develop cannabis as an FDA-approved drug for particular conditions. In particular, MAPS was interested in developing a strain of cannabis that could be used in conjunction with a vaporizer, so that the therapeutic effects of marijuana could be delivered without smoking, as well as in comparing the efficacy and safety of various delivery systems.

    Dr. Craker will further testify that he meets all the criteria for issuing a DEA license. He will testify that he will fully comply with both federal and state law, as he has always done in the past. He will testify that granting the license will promote technical advances, because the cannabis he seeks to grow is for use in the research and development of a vaporization delivery system. Further, that government-approved research may lead to additional discoveries as to other delivery systems, or other therapeutic benefits available through cannabis. If Dr. Craker does not obtain a license, MAPS researchers are less likely to be able to obtain the type of cannabis they need when they need it, and MAPS will be largely prevented from developing a medical product that could be approved by the FDA. Dr. Craker will further testify that he has never had any criminal convictions, and that he has both researched and grown plants for their potential medical purposes.

    Finally, Dr. Craker will testify that issuing the DEA license to him will allow increased research into important public health matters. He will testify that he is willing to provide the same security measures as are currently in place at the University of Mississippi, which holds a similar license. Those measures will protect public safety from any concern with diversion, which can be DEA's only legitimate interest in denying this license.

    Proposed Testimony of Dr. Irwin G. Martin, Ph.D.

    Dr. Martin will testify about his extensive experience in the area of how new drugs are developed, and will offer testimony as to conditions that must be met before a company can begin to develop a particular new drug.

    Dr. Martin will discuss the fact that the major developed regions of the world have unified the requirements for the approval of new drugs and biologics. Generally speaking, the US, Europe and Japan have agreed on these requirements through the International Congress on Harmonization (ICH). ICH requirements are grouped into three broad areas: safety, efficacy and quality. Safety includes pre-clinical animal testing while efficacy relates primarily to the results of human clinical studies in patients. Quality, the most relevant to the concern of this case, involves the manufacture and quality control of the product to be tested or consumed.

    Dr. Martin will testify that the FDA follows the ICH guidelines for the approval of new drugs and biologics. FDA approval is based on safety and efficacy of new drugs and biologics. Safety, in FDA terminology, includes the quality issues from ICH.

    As Dr. Martin will testify, quality means the ability to assure that the drug product is consistent, unadulterated, and manufactured under strict quality standards. Typical assays for testing of product include potency and purity. The ability to control these variables is essential in measuring the dose given during clinical studies and, eventually, the dose that prescribing physicians choose for their patients. To provide proper care of patients, physicians must be able to confidently choose doses based on data derived from carefully controlled clinical studies that used drug product of known potency that delivered a known dose to the patient. Based on these data and the needs of the patient, a physician should then be able to choose a product that delivers a desired dose. Because of the need for consistency between doses, manufacturers of generic versions of branded pharmaceuticals must show that their products deliver a consistent and similar dose of medication to that of the originator's product. The same expectations exist for clinical trial material.

    Dr. Martin will also testify that prior to development of a new drug candidate, there are several critical questions that must be answered. One of the first, assuming that further studies support continued development, is the source of the new drug, and whether the company can obtain the amounts they will need at a level of purity that will satisfy the requirements of drug development. One of the biggest delays in drug development is due to the change in the drug product, either due to a new formulation or a change in purity. The ability to use data from earlier studies is often lost due to the inability to show equivalence after changes are made in the manufacture of the drug product. Repetition of studies is expensive and costly; as a result, most companies will do everything possible to assure a consistent quality and quantity of product from the beginning of development. Included in these early calculations are the ability to scale up the product to a full manufacturing size without a change in the products quality or purity as well as the ability to control the cost of goods when doing so. Further, no company would undertake the expensive process of trying to bring a new drug to market without taking steps to assure that if research demonstrates safety and efficacy, they will have sufficient access to the quantify and quality of product that will meet worldwide approval standards and launch the product into the marketplace.

    Finally, Dr. Martin will testify that a company developing a new drug must also be free to choose the formulation of the product and control the ratios of active and inert components that the product will contain as well as how the product will be delivered. If there are constraints, the effect is to increase the likelihood the new drug product would be abandoned during development. Where there are significant questions about availability of the new drug product that affect the time required to move from one study to the next, continued development becomes questionable. Thus, a company must be confident that it can manufacture the product when it needs it.

    Proposed Testimony of Rick Doblin, Ph.D.

    Rick Doblin, Ph.D., will testify about his organizations attempts to research both the therapeutic benefits available from cannabis, and the technical advance of providing those benefits through a vaporization technique, which may be a safer delivery system than smoking for many patients. Indeed, it was largely to conduct clinical trials and to research the vaporization technique that led Dr. Doblin to sponsor Dr. Craker in developing a facility that could produce particular strains of cannabis that appear to be most likely to be successful in the vaporization process. In addition, Dr. Doblin seeks to compare the safety and efficacy of various delivery systems and of various strains of cannabis with differing ratios of components, including not only THC, but also other components of cannabis which research suggests may enhance therapeutic benefits. Dr. Doblin will also testify about the substantial federal obstruction of his efforts over more than a decade to sponsor a privately-funded, non-profit, FDA-approved drug development effort consisting of a series of scientific studies investigating the safety and efficacy of the cannabis plant for specific medical indications.

    Dr. Doblin has a Ph.D. in Public Policy from the Kennedy School of Government at Harvard University. He works to develop cannabis and other substances into FDA-approved prescription medicines and is the founder and director of a non-profit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS holds the only Orphan Drug designation granted by the FDA for any medical use of cannabis, for the AIDS Wasting Syndrome. MAPS promotes scientific research into the risks and benefits of Schedule I substances in treating various medical and psychological conditions. MAPS provides financial, regulatory and scientific assistance to researchers who MAPS helps to design, fund and obtain the necessary approvals to conduct their studies, as well as providing support during the research and evaluation process.

    Unlike research with other Schedule I drugs, such as MDMA, LSD, and psilocybin, for which private suppliers exist, the federal government, through the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can legally be used in research. NIDA has its marijuana grown at the University of Mississippi under the direction of Prof. Mahmoud El-Sohly.

    As Dr. Doblin will testify, based on substantial evidence demonstrating that cannabis offers therapeutic benefits to patients with a variety of conditions, MAPS seeks to develop cannabis as an FDA-approved medication. To that end, it seeks to further research the possibility of delivering cannabis through vaporization, and comparing those results with those obtained through smoking or other delivery methods. Although it stands ready to sponsor research, and has made arrangements for that research to take place, MAPS cannot obtain the cannabis it needs from the one currently existing cannabis provider. Moreover, even if it could obtain what it needs for testing purposes from the one currently existing cannabis provider, neither MAPS nor any rational drug developer could enter into an expensive research and development phase for a product that is not available for, and that may not meet FDA standards for, prescription use. In addition, no new drug developer can develop a product when it cannot be confident it has access to the product it requires. Thus, it has sponsored Dr. Craker in his efforts to establish a cannabis farm at which the kinds of cannabis MAPS needs can be grown under the conditions necessary to assure the availability and consistency of product necessary to pursue FDA approval.

    Dr. Doblin will also testify about MAPS' experiences in assisting Dr. Donald Abrams, Dr. Ethan Russo, and Chemic Labs with their attempts to conduct cannabis research sponsored by MAPS, about MAPS efforts to assist Professor Lyle Craker of the University of Massachusetts at Amherst in developing a research cannabis farm to be sponsored by MAPS, and about MAPS' interaction with NIDA, DEA, the FDA and NIH surrounding these processes.

    MAPS-sponsored researchers are currently unable to purchase marijuana from NIDA, import marijuana from the Dutch Office of Medicinal Cannabis, contract with Dr. El-Sohly to grow marijuana, or obtain permission to grow its own marijuana. MAPS' privately-funded drug development effort is fundamentally compromised by NIDA's monopoly on supply.

    MAPS' Experience Assisting Dr. Donald Abrams with his Cannabis Research 
    Dr. Doblin will testify that he and MAPS approached Dr. Donald Abrams in 1992 and offered him support for becoming involved in conducting research into the risks and benefits of the medical use of cannabis in treating the AIDS wasting syndrome. He will testify that the research protocol for this study was approved by the FDA in the summer of 1994, but that when Dr. Abrams submitted an application to NIDA for the research cannabis, NIDA summarily rejected this request, after failing to communicate with him to offer either critiques or assistance for nine months.

    In May 1995, MAPS tried to contract with Prof. Mahmoud El-Sohly, Director of NIDA's University of Mississippi cannabis farm, to provide cannabis for Dr. Abrams' FDA-approved study, but Prof. El-Sohly would not provide MAPS with the cannabis. Dr. Doblin will testify that Dr. Abrams submitted a revised protocol to NIH in May 1996, after NIDA began requiring that medical cannabis proposals be submitted to NIH for peer review. This protocol was formally rejected in August 1996. Dr. Doblin will testify that Dr. Abrams submitted a revised protocol to NIH in May 1997. In the revised protocol, Dr. Abrams changed his focus from a study on the safety and efficacy of medical cannabis to treat AIDS wasting syndrome to a study assessing the risks of cannabis in HIV patients who did not suffer from the AIDS wasting syndrome. On September 18, 1997, Dr. Abrams finally received a NIDA grant of $978,000 to conduct his research along with the marijuana required to conduct the study.

    Dr. Doblin will testify that the results of Dr. Abrams' study demonstrate that HIV patients taking protease inhibitors do not experience adverse short-term effects from using cannabinoids. In addition, while all three groups in the study (placebo, the group receiving oral dronabinol, and the group receiving smoked cannabis) gained weight, the smoked cannabis group gained an average of 3.51 kilograms, as compared to 3.18 kilograms with oral dronabinol, and 1.30 kilograms in the placebo group.

    Dr. Doblin will testify that NIDA's refusal to sell marijuana for Dr. Abrams' FDA-approved protocol convinced him that until MAPS could obtain permission to establish its own source of supply, that the federal resistance to research created so much uncertainty over supply that it would be practically impossible for MAPS to initiate its drug development program.

    MAPS' Experience Assisting Dr. Ethan Russo with his Cannabis Research 
    Dr. Doblin will testify that MAPS also provided assistance to Dr. Ethan Russo in obtaining FDA approval for a study on the use of cannabis in the treatment of migraines. Dr. Russo was not able to obtain cannabis with which to perform the FDA-approved study, due to NIDA's refusal to supply cannabis for his independently-funded research.

    In 1999, MAPS helped Dr. Russo to submit a research proposal to the Food and Drug Administration (FDA) to study the effects of smoked cannabis in treating migraine headaches. This study aimed to compare the treatment efficacy of smoked cannabis as compared to that of oral dronabinol (Marinol) and of injected sumatriptan (Imitrex - the most effective of non- cannabis treatments for migraine used at the time the study was submitted). On May 14, 1999, the FDA formally critiqued Dr. Russo's proposal, and on October 1, 1999, the FDA approved the study.

    Dr. Doblin will testify that following FDA approval, Dr. Russo's study needed to undergo a Public Health Service (PHS) review in association with the National Institute on Drug Abuse (NIDA), in order to obtain a cannabis supply from NIDA to perform the study. No substance other than cannabis, including cocaine, heroin, and MDMA, requires a PHS review in addition to FDA approval. As a result, any study approved by the FDA with the exception of those involving cannabis can proceed directly from FDA approval to clinical trials.

    Dr. Doblin will testify that in February of 2000, NIDA responded to Dr. Russo, explaining that the PHS review committee had criticisms of his research design, and therefore would not allow him to purchase cannabis from NIDA for his privately-funded study. Dr. Doblin will testify that NIDA's refusal to supply cannabis for this study has effectively prevented it from going forward.

    Dr, Doblin will also testify that NIDA's refusal to provide Dr. Russo with marijuana for his study further convinced him that MAPS needed to obtain its own independent source of supply prior to initiating a drug development program for marijuana.

    MAPS' Experience Assisting Chemic Labs in Performing Vaporizer Research A MAPS-funded and CaNORML-funded study by Chemic Laboratories, requiring 10 grams of cannabis to analyze the contents of the vapor stream from a cannabis vaporizer, has also been stalled by executive branch obstructionism. Dr. Doblin will testify about MAPS experience working with Chemic to enable this study to go forward. On June 24, 2003, Chemic submitted separate applications to the U.S. Department of Health and Human Services (HHS) and to the Drug Enforcement Administration (DEA), in order to obtain the marijuana that was required to perform the study. Chemic applied to HHS to approve its research protocol so that it could purchase 10 grams of cannabis from NIDA. Chemic also applied to DEA to register to import 10 grams of medical cannabis from the Dutch Office of Medical Cannabis (DOMC), part of the Dutch Ministry of Health, as the DOMC offers a quality of cannabis that is required for part of the study but is unavailable from NIDA. Regarding the DEA application, Dr. Doblin will testify that DEA advised MAPS and Chemic that it would not process the application until after HHS determined the merit of the protocol, and that DEA did not publish a notice in the Federal Register upon the filing of the application as required by law. Regarding the HHS application, Dr. Doblin will testify that HHS has failed to decide on the scientific merit for 22 months (as of April, 2005). Chemic did not receive any communication from HHS until October, 2003, more than three months after the initial application. At that time HHS indicated that there was insufficient information in the application, although MAPS and Chemic had filed according to HHS specifications. MAPS and Chemic refilled a revised protocol on January 29, 2004. Despite numerous inquiries, HHS did not give any answer or further information about the status of the application, with the exception of one email in March, 2004, stating that the application was awaiting PHS review.

    Dr. Doblin will testify that on June 9, 2004, he received a letter from NIDA rejecting his request for help in this process, on the basis that NIDA's mission is not to study the medical uses of marijuana and that NIDA has no control over the PHS review. On July 14, 2004, MAPS, along with others , filed a lawsuit against HHS and DEA alleging unreasonable delay in processing Chemic and Prof. Lyle Craker's applications (see below). The lawsuit was dismissed without prejudice. However, following the lawsuit, DEA announced in December 2004 that Chemic needed a research license in addition to its analytical lab license, although the criteria required to receive each license are identical. Chemic applied immediately for the license but did not hear until early March 2005 that its research license was being processed. HHS also notified Chemic in early March that its protocol was finally being reviewed.

    Chemic has thus been blocked for over 21 months from conducting any MAPS-sponsored vaporizer research, fundamentally obstructing MAPS' drug development plan. Chemic has been unable to purchase or import marijuana for its proposed research.

    Dr. Doblin will testify that Chemic's inability to purchase 10 grams of marijuana or to import 10 grams convinced him that as long as NIDA retained a monopoly on the supply of marijuana that is legal for research, that no drug development effort for marijuana would take place.

    MAPS' Experience Attempting with Prof. Lyle Craker to Arrange for an Independent Supply of Research Cannabis

    MAPS is sponsoring Prof. Lyle Craker, Director of the Medicinal Plant Program in the Department of Plant and Soil Sciences at the University of Massachusetts at Amherst, in developing a cannabis farm to supply cannabis exclusively for FDA- and DEA-approved research into the medical uses of the cannabis plant. Dr. Doblin will testify that in June 2001, Prof. Craker applied to DEA for a license to establish this facility. He will testify about the several years of delay tactics that DEA used in the processing of this application. The first direct response to the application did not come until March 4, 2003, more than 20 months after the initial application was submitted, at which time DEA required that Prof. Craker demonstrate that research needs were not adequately met by NIDA's supply of cannabis. Prof. Craker responded to this request on June 2, 2003.

    DEA also failed to publish a notice of Prof. Craker's application in the Federal Register until July 2003, more than two years after the initial application. Dr. Doblin will testify that there was no comment during the sixty-day comment period required by law other than an objection by Prof. Mahmoud El-Sohly, Director of NIDA's cannabis farm. In order to help expedite the processing of Prof. Craker's application, MA Senators Kennedy and Kerry wrote a letter to DEA Administrator Karen Tandy on Oct. 20, 2003, expressing their strong support for the UMass Amherst marijuana production facility.

    Prof. Craker and MAPS filed a lawsuit against DEA on July 21, 2004, alleging unreasonable delay in processing Prof. Craker's application. After the court issued a show cause order, DEA rejected Prof. Craker's application on December 10, 2004. Dr. Craker challenges that denial in this proceeding.

    Proposed Testimony of Irv Rosenfeld

    Mr. Rosenfeld is one of the seven remaining living participants in an FDA Compassionate Investigational New Drug (IND) Program, closed to new entrants in 1992, that provides NIDA marijuana for free to people who demonstrated that nothing else worked for relief of their symptoms and a qualified physician believed that marijuana did. Irv Rosenfeld suffers from a rare bone disorder called multiple congenital cartilaginous exostoses, which is marked by bony protrusions that cause chronic pain. Mr. Rosenfeld will testify about his condition, and how marijuana provides him relief.

    Mr. Rosenfeld will testify that he has been in the program since November, 1982, and every month receives at his pharmacy about 300 marijuana cigarettes, with a THC level less than 4%.

    He will testify that in 2001, he was one of four of the seven official patients who participated in Dr. Ethan Russo's privately-funded "Chronic Cannabis Use in the Compassionate Investigational New Drug Program Study." That study showed "very few adverse effects in the patients" and documented reported medical benefits.

    Mr. Rosenfeld will testify that neither the FDA nor NIDA showed the slightest interest in studying his case in 22 years and that Dr. Russo's study generated important information. He will testify that that there is a compelling public interest in further research into the potential medical uses of marijuana, both smoked and vaporized, as well as marijuana extracts and other forms of delivery.

    Proposed Testimony of Angel Raich

    Ms. Raich is a patient whose board-certified doctor has recommended the use of cannabis to relieve painful symptoms of several chronic diseases, and to suppress the wasting syndrome that threatens her life. In fact, her doctor has tesified that it is his opinion that without medical cannabis, Ms. Raich will likely die. Ms. Raich will testify as to how medical cannabis has helped her when all other medications failed. She will testify that it is in the public interest to increase research into the medical effects of cannabis, and to research various means of delivering the medication. Ms. Raich will also testify that she has a federal court injunction precluding the federal government from prosecuting her for her medical use of cannabis.

    Proposed Testimony of Valerie Corral

    Ms. Valerie Corral is a medical marijuana patient who will testify that marijuana has been helpful to her for the treatment of brain damage, epilepsy and migraines. She will testify that she founded The Wo/Men's Alliance for Medical Marijuana (WAMM), a collective of seriously ill patients who work to educate the general public regarding the medical benefits of marijuana, and to insure that patients, who have a recommendation from their physician, have safe access to legal under California law, and natural supply of Marijuana for the treatment of terminal and debilitating illness. WAMM works closely with local law enforcement and the legal community.

    Ms. Corral will testify that, although the WAMM marijuana was grown legally under California law, on September 5, 2002, the DEA raided the WAMM garden and, using chainsaws, destroyed the medicine belonging to 250 patients, 85% of them terminally ill. WAMM has since filed charges against the Federal Government and has obtained an injunction, permitting the WAMM garden to operate pending the resolution of the Raich v. Ashcroft case.

    Ms. Corral will testify that it is in the public interest for there to be more research into the risks and benefits of the medical use of marijuana, both smoked and vaporized, and that the UMass Amherst facility will facilitate privately-funded research.

    Proposed Testimony of Phillip T. Alden

    Mr. Alden will testify that he is a person living with AIDS. He will testify that he has used medical marijuana for the past eight years to combat nerve pain from Peripheral Neuropathy and to boost his appetite and calm the nausea resulting from his Antiretroviral Therapy. He usually gets his medicine from one of the California medical cannabis distribution facilities in San Francisco.

    Mr. Alden will testify that his doctor, Dennis Isrealski, at the Edison Clinic in San Mateo, wanted to do a clinical study involving medical marijuana, and that Mr. Alden was the first patient to qualify for the study. The study used marijuana obtained from the federal government.

    According to the pharmacist Mr. Alden was working with, the marijuana was freeze-dried before it came into his possession, and he had to thaw it out for twenty-four hours before Mr. Alden could obtain it.

    Mr. Alden will testify that when he first received the government-grown marijuana, he noticed it was rolled with cigarette paper. The product tasted terrible upon lighting up, and was very harsh on his throat and lungs. In addition, the government-rolled product contained stems and seeds. The seeds popped when ignited and made the marijuana taste much, much worse.

    Mr. Alden will testify he was required to smoke a lot of the government-grown marijuana every day for the study. At the request of the study coordinator, he stopped using the medical cannabis he had previously obtained.

    Mr. Alden will testify that he was forced to drop out of the study two weeks early because the harshness of the government marijuana gave him bronchitis. Its THC content was very low, and as such, it did not work very well. Once off the government-grown product, his bronchitis cleared up and he went back to using the effective medical cannabis from the medical cannabis distributors in San Francisco.

    Proposed Testimony of Dr. Donald Abrams

    Dr. Donald Abrams, a researcher into the medical benefits of cannabis, will testify about the process of getting approval to conduct a pilot study on the use of cannabis to treat AIDS wasting syndrome. He will testify that he submitted to the FDA, with MAPS' assistance, an initial protocol design, which the FDA approved in the summer of 1994. Dr. Abrams then submitted an application to NIDA to obtain the cannabis needed to conduct the study. NIDA took no action on this application for nine months and did not contact Dr. Abrams with any suggested modifications to his proposal. Dr. Abrams received a letter dated April 19, 1995 from NIDA's Director, Alan Leshner, summarily rejecting his request. Dr. Abrams replied nine days later, on April 28, 1995, to Dr. Leshner, criticizing NIDA for its failure to communicate with him for nine months or to offer him any opportunity to revise his proposal into one that NIDA would approve. Dr. Abrams submitted a revised protocol to NIH in May 1996. This protocol was formally rejected in August 1996.

    Dr. Abrams will testify that he changed his protocol from a study on the safety and efficacy of medical cannabis to treat AIDS wasting syndrome to a study assessing the risks of cannabis in HIV patients who did not suffer from AIDS wasting syndrome. Dr. Abrams submitted that revised protocol to NIH in May 1997. On September 18, 1997, Dr. Abrams finally received a NIDA grant of $978,000 to conduct his research.

    Dr. Abrams will testify that the results of his study demonstrate that HIV patients taking protease inhibitors do not experience adverse short-term effects from using cannabinoids. Dr. Abrams will also testify about his research with marijuana vaporizers as compared with smoking marijuana, evaluating the potential use of vaporizers as a non-smoking delivery system.

    Proposed Testimony of Dr. Lester Grinspoon

    Dr. Lester Grinspoon is a faculty (emeritus) of the Harvard Medical School in the Department of Psychiatry. He will testify that he has been studying cannabis since 1967 and have published two books on the subject. In 1971 Marihuana Reconsidered was published by Harvard University Press. Marihuana, the Forbidden Medicine, coauthored with James B. Bakalar, was published in 1993 by Yale University Press; the revised and expanded edition appeared in 1997.

    Dr. Grinspoon will testify generally about the history of cannabis as medicine; whether there is "accepted medical use" of cannabis; the difficulties caused by NIDA having the monopoly on marijuana for research purposes, and the role of various entities in furthering medical marijuana research and development.

    Proposed Testimony from One or More Drug Policy Experts

    One or more drug policy experts will discuss how the public interest is served by facilitating scientific research into the potential risks and benefits of the medical uses of marijuana, either smoked, vaporized or in other delivery systems. As DEA Administrator Robert Bonner stated, "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." -(Federal Register Vol. 57, No. 59 / Thursday March 26, 1992, p. 10503).

    The person or persons will testify about how the federal monopoly on the supply of marijuana for research acts to inhibit privately-funded research and how the licensing of the UMass Amherst facility would help to catalyze privately-funded research on the important public health issue of medical marijuana. The testimony will emphasize the strong public interest in having questions of medical drug policy resolved as a matter of science.

    Proposed Testimony from Representative of One of More Medical Associations

    Representatives from one of more medical associations will testify that their associations have reviewed the relevant literature and studies relating to the medical effects of marijuana on sick patients, and that they strongly support continuing scientific studies relating to the medical benefits of marijuana. They will testify further that marijuana should be studied under the same conditions as any other substance is studied, with private development of cannabis-based medicines being the most likely path to approved medicines and new discoveries.

  5. DOCUMENTS
    1. Marijuana And Medicine: Assessing The Science Base, Janet E. Joy, Stanley J. Watson, Jr., and John A. Benson, Jr., Editors, Division of Neuroscience and Behavioral Health, Institutes Of Medicine, National Academy Press Washington, D.C. 1999
    2. Transcript of argument before the United States Supreme Court in Raich v. Ashcroft, No. 03-1454
    3. U.N. Single Convention on Narcotic Drugs (1961) (as amended)
    4. Dr. Craker's Curriculum Vitae
    5. Various drafts of Dr. Mahmood El-Sohly's comments in response to Dr. Craker's application for a DEA license, and e-mail correspondence relating to those drafts:
      • Email dated 9/2/03 from Hari Singh to Mahmoud ElSohly
      • Email dated 9/8/2003 from Steve Gust to Mahmoud A. ElSohly (with draft)
      • Email dated 9/9/03 from Mahmoud A. ElSohly to Walt Chambliss and others (with draft)
      • DRAFT #3 of letter dated 9/9/03 to DEA from Mahmoud A. ElSohly
      • Email dated 9/11/03 from Mahmoud ElSohly to Walt Chambliss and others (with draft attached)
      • Email dated 8/29/03 from Mahmoud ElSohly to Steve Gust and others (with draft attached)
    6. Letter dated 5/25/99 from The Department of Health and Human Services/FDA to Rick Doblin, granting "orphan drug" designation for marijuana.
    7. Letter dated June 9, 2004 from Nora Volkow, Director, NIDA to Rick Doblin.
    8. Letter dated May 25, 2004 to Nora Volkow from Rick Doblin.
    9. Letter dated April 28, 1995 from Dr. Donald Abrams to Alan Leshner, Director, NIDA
    10. Federal Register Vol. 57, No. 59 / Thursday, March 26, 1992, p. 10503
    11. Lester Grinspoon, Marihuana, the Forbidden Medicine (Harvard University Press 1971)
    12. Grinspoon, Bakalar, Marihuana Reconsidered (Yale University Press, rev. 1997)
    13. Any documents received from NIDA or DEA in the course of this proceeding (currently requested but not received under the Freedom of Information Act)
    14. Any documents received from the United Kingdom Home Office relating to a license to cultivate cannabis (currently requested but not received under UK Freedom of Information Act)
    15. Various Medical Cannabis Studies, including:
      • David Baker et al., Cannabinoids Control Spasticity and Tremor in a Multiple Sclerosis Model, 404 Nature 84 (2000) (finding therapeutic potential in the use of cannabis to control the debilitating symptoms of MS)
      • William J. Martin, Basic Mechanisms of Cannabinoid-Induced Analgesia, Int'l Ass'n for the Study of Pain Newsletter, Summer 1999, available at http://www.halcyon.com/iasp/TC99Summer.html (noting that cannabinoids can reduce pain)
      • Richard E. Doblin & Mark A.R. Kleiman, Marijuana as Antiemetic Medicine: A Survey of Oncologists' Experiences and Attitudes, 9 J. Clinical Oncology 1314 (1991) (reporting that a majority of oncologists surveyed thought marijuana should be available by prescription)
      • H.M. Meinck et al., Effect of Cannabinoids on Spasticity and Ataxia in Multiple Sclerosis, 236 J. Neurology 120 (1989) (concluding from a neurological study that herbal cannabis provided relief from both muscle spasms and ataxia, a combined benefit not found in other available medications)
      • Vincent Vinciguerra et al., Inhalation Marijuana as an Antiemetic for Cancer Chemotherapy, 88 N.Y. St. J. Med. 525 (1988) (finding that 78% of patients who were unresponsive to standard antiemetics responded positively to cannabis).
      • University of California Center for Medicinal Cannabis Research, Research,at http:// www.cmcr.ucsd.edu/geninfo/research.htm (listing fourteen cannabis studies).
      • Ethan Russo, et al., 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
      • de Jong, B.C., Prentiss, D., McFarland, W., Machekano, R., and Israelski, D.M. (2005) Marijuana use and its association with adherence to antiretroviral therapy among HIV-infected persons with moderate to severe nausea. Journal of Acquired Immune Deficiency Syndrome, 38, (1), 43-46
      • Giuffrida A, Leweke FM, Gerth CW, Schreiber D, Koethe D, Faulhaber J, Klosterkotter J, Piomelli D. Cerebrospinal Anandamide Levels are Elevated in Acute Schizophrenia and are Inversely Correlated with Psychotic Symptoms. Neuropsychopharmacology. 2004 Nov;29(11):2108-14.
      • Carroll CB, Bain PG, Teare L, Liu X, Joint C, Wroath C, Parkin SG, Fox P, Wright D, Hobart J, Zajicek JP. Cannabis for dyskinesia in Parkinson disease: a randomized double-blind crossover study.. Neurology. 2004 Oct 12;63(7):1245-50.
      • John Macleod, Rachel Oakes, Alex Copello, Ilana Crome, Matthias Egger, Mathew Hickman, Thomas Oppenkowski, Helen Stokes, and George Davey Smith. Psychological and social sequelae of cannabis and other illicit drug use by young people: a systematic review of longitudinal, general population studies.. "The Lancet" Vol. 363 May 15, 2004, pages 1568, 1569, 1579-1588.Feb;107(3):267-75.
      • A.M. Papanastassiou, H.L. Fields, I.D. Meng. Local application of the cannabinoid receptor agonist, WIN 55,212-2, to spinal trigeminal nucleus caudalis differentially affects nociceptive and non-nociceptive neurons.. Pain. 2004 Feb;107(3):267-75.
      • Diane Prentiss, MA, MPH, Rachel Power, PhD, Gladys Balmas MD, MPH, Gloria Tzuang, MPH, and Dennis M. Israelski, MD. Patterns of Marijuana Use Among Patients With HIV/AIDS Followed in a Public Health Care Setting. JAIDS Volume 35, Number 1, January 1, 2004
      • P. B. Sparling, A. Giuarida, D. Piomelli, L. Rosskopf and A. Dietrich. Exercise activates the endocannabinoid system. Lippincott Williams & Wilkins Vol 14 No 17 2 December 2003
      • John Zajicek, Patrick Fox, Hilary Sanders, David Wright, Jane Vickery, Andrew Nunn and Alan Thompson Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. The Lancet, Volume 362, Issue 9395 , 8 November 2003, Pages 1517-1526
      • Mohab M. Ibrahim, Hongfeng Deng, Alexander Zvonok, Debra A. Cockayne, Joyce Kwan, Heriberto P. Mata, Todd W. Vanderah, Josephine Lai, Frank Porreca, Alexandros Makriyannis, and T. Philip Malan, Jr. Activation of CB2 cannabinoid receptors by AM1241 inhibits experimental neuropathic pain: Pain inhibition by receptors not present in the CNS. University of Arizona College of Medicine, Tucson, Communicated by John H. Law , July 9, 2003
      • Aline Quartilho, B.S., Heriberto P. Mata, B.S., Mohab M. Ibrahim, M.S., Todd W. Vanderah, Ph.D., Frank Porreca, Ph.D., Alexandros Makriyannis, Ph.D., T. Philip Malan, Jr., Ph.D., M.D. Inhibition of Inflammatory Hyperalgesia by Activation of Peripheral CB2 Cannabinoid Receptors. Anesthesiology 2003; 99:955-60
      • Matthias Karst, M.D., PhD, Kahlid Salim, MS, Sumner Burstein, Ph.D.,Ingomar Conrad, M.D., Ludwig Hoy, Ph.D, and Udo Scheneider, M.D. Ph.D. Analgesic Effect of the Synthetic Cannabinoid CT-3 on Chronic Neuropathic Pain, JAMA 2003; 290:1757-1762. R.Mechoulam and A.H. Lichtman. Stout Guards of the Central Nervous System, Science Magazine 2003; 302: 65:67.
      • Giovanni Marsicano, Sharon Goodenough, Krisztina Monory, Heike Hermann, Matthias Eder, Astrid Cannich, Shahnaz C. Azad, Maria Grazia Cascio, Silvia Ortega Gutierrez, Mario van der Stelt, Maria Luz lopez-Rodriguez, Emilio Casanova, Gunther Schutz, Walter Zieglgansberger, Vincenzo Di Marzo, Christian Behl, and Beat Lutz. CB-1 Cannabinoid Receptors and On- Demand Defense Against Excitotoxcity, Science Magazine 2003; 302: 84-88
      • Donald I. Abrams, Joan F. Hilton, Roslyn J. Leiser, Starley B. Shade, Tarek A. Elbeik, Francesca T. Aweeka, Neal L. Benowitz, Barry M. Bredt, Bradley Kosel, Judith A. Aberg, Steven G. Deeks, Thomas F. Mitchell, Kathleen Mulligan, Peter Bacchetti, Joseph M. McCune, and Morris Schambelan Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection: A Randomized, Placebo-Controlled Clinical Trial. Ann Intern Med, Aug 2003; 139: 258-266.
      • Roberta Pacifici, Piergiorgio Zuccaro, Simona Pichini, Pere N. Roset, Sandra Poudevida, Mag’ Farrz, Jordi Segura, and Rafael de la Torre. Modulation of the Immune System in Cannabis Users. JAMA 2003 289: 1929-a-1931-a.
      • Joep Killestein, Bernard M. J. Uitdehaag, and Chris H. Polman. Cannabinoids and Immune Function. JAMA 2003 290: 754-a.
      • Grant, I., Gonzalez, R., Carey, C., Natarajan, L., and Wolfson, T. (2003). Non-acute (residual) neurocognitive effects of cannabis use: A meta-analysis study. Journal of the International Neuropsychological Society, 9, 679-689.
      • Baker, D., Pryce, G., Giovannoni, G., Thompson, A.J. The therapeutic potential of cannabis. Lancet Neurology 2003; 2: 291-98.
      • Iversen, L. Cannabis and the brain. Brain 2003: 126; 1252-1270.
      • Khalsa, J.H., Genser, S., Francis, H., and Martin B. (EDS.). (2002). Clinical Consequences of Marijuana. The Journal of Clinical Pharmacology, 42 (11, Suppl.). Gonzalez R., Carey, C., and Grant, I.: Nonacute (Residual) Neuropsychological Effects of Cannabis Use: A Qualitative Analysis and Systemic Review. J Clin Pharmacol 2002: 42; 48S- 57S.
  6. OTHER MATTERS

    Respondent is aware of no other matters at this time.

  7. DESIRED LOCATION

    Respondents have no objection to the hearing being held in Arlington, Virginia.

  8. BEST ESTIMATE AS TO TIME

    Depending in part on what additional documents and information Respondent obtains from DEA, and depending on whether Respondent and DEA can come to agreement on stipulations, Respondent's initial estimate as to the time required to present its case is 3 to 5 days.

Respectfully submitted,
Lyle E. Craker

__________________________

By his attorneys
Julie M. Carpenter
JENNER & BLOCK, LLP
601 13th Street, N.W.
Washington, DC 20005
(202) 639-6029

Alan Hopper
ACLU Drug Law Reform Project
1101 Pacific Avenue
Suite 333
Santa Cruz, CA 95060
(831) 471-9000

Dated: April 22, 2005

CERTIFICATE OF SERVICE

I hereby certify that on April 22, 2005, I caused a copy of the foregoing Respondent's Pre-Hearing Statement [Initial] to be served on the following by U.S. Mail, first-class postage prepaid:

Brian Bayley, Esq.
Office of the Chief Counsel
Drug Enforcement Administration
Washington, DC 20537

[ signed ]
___________________________________
Julie M. Carpenter

ACLU Assists MAPS in Petitioning the DEA

ACLU assists MAPS in petitioning the DEA for a hearing before its Administrative Law Judge to appeal the denial of Prof. Craker's application.

DEA Rejects the Application from Prof. Lyle Craker

DEA finally rejects the application from Prof. Lyle Craker nearly three and a half years after the application was initially filed, stating that to approve Prof. Craker's application would not be in the public interest and that international treaty obligations would prevent it from issuing the license.

Rep. Sam Farr (D-CA) Sends Out a Dear Colleague Letter

Rep. Sam Farr (D-CA) sends out a Dear Colleague letter to all members of the U.S. House of Representatives questioning whether the National Institute on Drug Abuse (NIDA) is unbiased toward marijuana research.


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

The D.C. Court of Appeals Orders DEA to Respond

The D.C. Court of Appeals orders DEA to respond to Prof. Craker's application;

Decision on MAPS' Claim of "unreasonable delay" in MAPS' applications to NIDA

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.

Prof. Craker Files Lawsuit Against the DEA

Prof. Craker files a lawsuit against the DEA in the U.S. Court of Appeals, D.C. Circuit, arguing that the DEA has engaged in unreasonable delay, as defined in the Administrative Procedures Act, for failure to respond to his application to grow research-grade marijuana at the University of Massachusetts, Amherst facility. The lawsuit demanded that DEA respond to Prof. Craker's application.

DEA Claims Application Was Lost

DEA claimed the application was lost. Prof. Craker resubmitted a photocopy but was 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. Prof. Craker resubmitted the original application to DEA on August 20, 2002.

Prof. Craker Files an Application to the DEA

Prof. Craker files an application to the DEA for permission to grow research-grade marijuana for legal, privately funded research into the potential medicinal effects of marijuana.