Prior to initiating a serious drug development research program that would require an estimated $10 million and 10 years, MAPS first needs to obtain access to an independent source of supply of marijuana that is legal for medical research. MAPS, in association with Prof. Lyle Craker, UMass Amherst Dept. of Plant and Soil Sciences, is in the midst of an ongoing struggle since June 25, 2001 seeking DEA permission to establish a medical marijuana production facility to grow high-potency marijuana for FDA-approved research (See MAPS Planned Marijuana Production Facility And Legal Challenges).

Craker’s applications for regulatory approval, legal struggles, and proposed facility are sponsored by MAPS, which plans to design, fund, and obtain government approval for the clinical research necessary to develop marijuana into an FDA-approved prescription medicine. If successful, MAPS would bring smoked and/or vaporized marijuana to market under a nonprofit pharmaceutical model similar to the Population Council’s development and distribution of RU-486.

At present, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can be used in research, provides low-potency material, and only makes it available to projects it approves. MAPS needs its own independent source of marijuana since NIDA’s arbitrary and lengthy review process for providing marijuana essential to research can derail any drug development plan. NIDA has refused to supply marijuana to two MAPS-sponsored protocols that the FDA had already approved.

Despite NIDA obstructionism, MAPS has been able to provide some analytical data about the constituents of the marijuana vapors produced by vaporizers to Dr. Donald Abrams, UC San Francisco. Dr. Abrams has used this data as part of his successful application to FDA to conduct a study evaluating subjective effects, cannabinoid blood levels, and carbon monoxide levels in subjects who smoke marijuana and then at a different time inhale marijuana vapors from a vaporizer.

The initiation of FDA-approved clinical research with a marijuana vaporizer was MAPS’ second prerequisite to starting a serious drug development research program, so that clinical research could be conducted both with smoked and vaporized marijuana. That way, we’d be able to produce data that would compare the risks of smoking versus vaporization and could address the Institute of Medicine’s recommendation for a non-smoking delivery system with a system that uses the organic plant rather than chemical extractions or synthetic chemicals. At present, only the ending of NIDA’s monopoly on supply (which it doesn’t have for MDMA, LSD, psilocybin or any other Schedule 1 drug) stands in the way of an active effort to develop marijuana into an FDA-approved prescription medicine.

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

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

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

More about our DEA lawsuit can be found on the DEA lawsuit page.

June 5, 2009. 

Craker’s lawyers filed an impressive list of potential witnesses and documents regarding our pending Motion to Reconsider. DEA has until July 1 to decide whether or not to grant our Motion.

May 14, 2009. 

On June 5, Crakers Lawyers Filed Witness and Document Lists, DEA has until July 1 to respond.

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

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

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

May 13, 2009. Rick Doblin, Mike Corral Visit Israel to Help Medical Marijuana Program.

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

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

May 11, 2009. May 1 Comes and Goes Without DEA Action - Craker's Marijuana Production Application Still Pending

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

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

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

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

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

May 1, 2009. 

May 1 Comes & Goes Without DEA Action - Craker's Marijuana Production Application in Limbo.

The effective date of DEA's final ruling rejecting Prof. Craker's license was supposed to be May 1. However, we have heard nothing so far directly from DEA regarding a response to our pending Motion to Reconsider. Based on conversations between our attorneys and the Department of Justice, and Senator Durbin's staff and DEA, we have learned that DEA review of our Motion to Reconsider is still pending, and that it is not rare for such matters to take place after final orders have become effective. As a result on May 11, 2009, we asked the First Circuit, US Court of Appeals (where in a defensive maneuver we have filed a new lawsuit against DEA) to delay consideration of our case until after we learn how DEA responds to our pending Motion.

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

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

March 16, 2009. Productive Planning Produces Productive Pot Production in Israel:

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

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

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

March 10, 2009. The Los Angeles Times editorialized in favor of DEA licensing of Prof. Craker's medical marijuana production facility, citing as support President Obama's March 9, 2009 statement about scientific integrity. The LA Times editorial said, "DEA is one of the many federal agencies ready for enlightenment."

February 6, 2009. Congress and Professor Craker Respond to Bush Administration and DEA’s Obstruction of Scientific Freedom:

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

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

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

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

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

  Health and Human Services and National Institute on Drug Abuse Place Another Hurdle in Front of Marijuana Vaporizer Research:

On January 23, 2009, Gregory Goldstein, Health and Human Services (HHS) Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic Laboratories. The letter requires Chemic to do a validation study showing that Chemic could reliably measure various cannabinoids. HHS is suddenly requiring this validation study before it will even review Chemic's November 6, 2008 reply to the June 18, 2008 Public Health Service’s (PHS) and National Institute on Drug Abuse’s (NIDA) critique of Chemic's January 16, 2008 protocol. In this way, HHS/NIDA avoided responding to the substance of Chemic Labs’ reply by insisting on a preliminary validation study. This latest message is part of a five and half year tactic of blocking MAPS-sponsored vaporizer research, since a validation study had not been mentioned before in the previous communications and critiques.

In the January 23, 2009 message, HHS provided a list of questions for Chemic Labs to use as guidance for the validation study, but in their own words the questions are “not inclusive of all aspects of method validation.” Therefore, we could spend $50,000 or more on this validation study and HHS could claim that we did not meet all of the requirements and could request additional expensive validation data, all before reviewing the vaporizer protocol itself, which would only cost an estimated $25,000.

What makes this especially frustrating is that a validation study isn't truly necessary for the sort of academic study we're seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as an FDA-approved medical device, which MAPS isn’t seeking to do. We're exploring collaborating with Dutch scientists from the University of Leiden, who are already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less than half the cost of the validation study.

We are wary of conducting a validation study, or even a cross-validation study, without HHS/NIDA having reviewed and approved the vaporizer protocol itself. We’ll get back to HHS after we determine if we can make a case for a cross-validation study, then we’ll ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.

January 30, 2009. On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the DEAs final ruling, which was the Bush Adminstration's final blow to medical marijuana research.

January 26, 2009. Mimi Peleg Provides Guidance to Medical Marijuana Facility in Israel:

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

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

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

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

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

January 14, 2009. The Bush administration struck a parting shot to legitimate science on January 14th, as the Drug Enforcement Administration (DEA) refused to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research. DEA's final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. The prior recommendation on February 12, 2007, stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEAs contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA's monopoly fundamentally obstructs MAPS research aimed at developing smoked or vaporized marijuana into a prescription medicine.

January 9, 2009. Medical Marijuana Donation Leveraged in Israel 

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

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

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

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

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

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

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

  Bush Administration Last Minute Blow to Scientific Freedom

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

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

December 1, 2008. Israel Medical Marijuana Production Facility Receives $15,000 in Matching Funds: MAPS sent $15,000 to an Israeli medical marijuana production facility directed by Yohai Golan, who produces medical marijuana with a license from the Israeli Ministry of Health. This was a matching grant, which required Yohai to first raise $15,000, which he was able to do. The production facility has legal permission to grow and distribute marijuana to Ministry of Health-approved patients. However, the facility must give away the medicine for free and cannot sell it until marijuana has been approved as a prescription medicine by the Ministry of Health -which will require substantial clinical research. In the long run, this policy requiring the free distribution of medicine is an unsustainable model because the facility can only operate on donations while the patient base is steadily increasing. Meanwhile, some useful data is being gathered from the patients provided medicine by the facility and more doctors and patients are becoming comfortable with medical marijuana use.

November 6, 2008. Chemic Labs submitted a response to a June 16, 2008, critique of our vaporizer protocol (PDF) by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). We submitted the protocol to NIDA/PHS on January 16, 2008, along with three letters of support from peer reviewers.

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

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

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

  Slate Magazine contributor Amanda Schaffer wrote an excellent article on the promise of, and obstacles to, medical marijuana research. The article discusses a variety of successful research applications of marijuana and marijuana derivatives.

October 15, 2008. Were requesting that MAPS supporters actively help us recruit subjects for Dr. Abrams National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are already using opioid medications for pain. This is one of only two medical marijuana studies in patients currently taking place in the US. Dr. Abrams investigation was scheduled to conclude in Fall 2008, but the study completion date has been extended to January 9th, 2009, in order to provide more time to recruit subjects. The study (PDF) was designed for 24 subjects, 16 of which have completed the study and an additional 8 more are needed. MAPS is supporting this study by paying for travel and lodging for participants who live outside of the San Francisco Bay area, with funding donated to MAPS by California medical marijuana dispensaries Capital Wellness Collective, Harborside Health Center, and Green Door, as well as from Oaksterdam University.

It is urgent that the study, finds the remaining subjects. Preliminary results are positive and the study will be more persuasive if the initially intended number of 24 subjects is actually enrolled. Supporters can help us by downloading flyers (PDF) and posting them at facilities such as medical marijuana dispensaries, and pain management centers. We would also appreciate it if people would post the text found in this link on appropriate web pages, blogs, and online forums. Subjects cannot have used marijuana within the previous 30 days, so pain patients on opiates from states without medical marijuana laws may be especially interested in volunteering for the study. If you would like more information about how you can help us recruit patients for this study, please contact: randolph@maps.org

October 10, 2008. David Bronner, of Bronner’s Magic Soaps, has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachi’s facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years

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

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

April 24, 2008. 

February 12, 2008. On January 16, 2008, MAPS Volcano vaporizer research protocol was resubmitted to HHS for the required scientific review by the National Institute of Drug Abuse--Public Health Service (NIDA-PHS). The submission included three supportive letters from peer-reviewers (see 1, 2, 3), confirming the scientific merit of the study and urging NIDA-PHS to approve it. The goal of this study is to gather further information about the chemical constituents that are contained in the cannabis vapor stream.

November 29, 2007. This press release discusses the North Dakota Supreme Court's rejection of the 8 year bid of North Dakota farmers to grow industrial hemp as well as the signing of a Memorandum of Understanding between North Dakota State University (NDSU) and the ND Supreme Court.

November 27, 2007. 

SYNOPSIS OF DEA RESCHEDULING DRONABINOL

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

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

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

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

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

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

November 9, 2007. The American Psychiatric Association has passed a unanimous resolution supporting medical marijuana.

November 4, 2007. According to a new study by Swiss researchers, teenagers who smoke marijuana but not tobacco appear to be more likely to get good grades, play sports and live with both parents than those who also use tobacco. Moreover, the study found that teens who smoke pot were more likely to have a good relationship with their friends than teens who smoked neither tobacco nor pot, found the study published in the November issue of Archives of Pediatrics & Adolescent Medicine. Click here to read a report.

October 10, 2007. 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.

August 26, 2007. MAPS President Rick Doblin gave a comprensive interview about MAPS' medical marijuana efforts on Health Radio with Dr. Meg Jordan. Click here to listen to the full interview.

August 9, 2007. Orange County Register Senior Editor Alan Bock published an insightful editorial about the implementation of California's medical marijuana law. Bock connects the challenges of implementation to the federal government's obstruction of scientific research. He descibes MAPS' effort to establish the nation's first privately-funded research-grade marijuana production facility at UMass-Amherst, which would pave the way for an FDA drug development effort with marijuana.

July 3, 2007. MAPS President Rick Doblin, PhD, appeared as a special guest and gave a lengthy interview on the Deborah Ray Healthy Talk Show. (The interview comes on about halfway into the show.)

June 29, 2007. Nature published an excellent article ("Scientists stir the pot for right to grow marijuana") about MAPS' campaign to break the federal government's illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA's standards for safety and efficacy.

June 16, 2007. An anonymous donor has pledged $10,000 to MAPS to enable MAPS to provide technical assistance to a small, legal medical marijuana production facility in Israel. The facility will be directed by an Israeli medical marijuana advocate, and has been authorized by the Israeli Ministry of Health to provide marijuana only to medical marijuana patients formally approved by the Ministry. MAPS is working to provide technical assistance to create an organic, hydroponic, standardized production facility, which will start small and give marijuana away for the next several months. Once a successful track record has been established, the Ministry will determine whether to permit the facility to produce medical marijuana on a commercial basis.

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

May 31, 2007. The Los Angeles Times published a strongly supportive editorial in favor of MAPS and Prof. Craker in their struggle with the DEA to break the federal government's monopoly on medical marijuana research by establishing an independent research-grade marijuana production facility at University of Massachusetts.

May 21, 2007. The Economist published a great editorial in favor of MAPS and Professor Lyle Craker's application to establish the nation's first privately funded medical marijuana production facility.

May 15, 2007. 

Today MAPS recieved a copy of the "Transmittal Letter" sent by ALJ Judge Mary Ellen Bittner to the DEA, transferring the record in the Craker matter to the DEA's Deputy Administrator, Michelle Leonhart on May 15, 2007. The letter was accompanied by this note:

1316.67 Final order
As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the Federal Register his final order in the proceeding, which shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based. This order shall specify the date on which it shall take effect, which date shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that the public interest in the matter necessitates an earlier effective date, in which event the Administrator shall specify in the order his findings as to the conditions which led him to conclude that an earlier effective date was required.
So let the "practicable" clock begin . . .

April 15, 2007.  This op-ed published in the Sacramento Bee is an excellent summary of the political and legal implications of MAPS' recent legal victory over the DEA in MAPS' quest to put marijuana through FDA clinical trials.

March 26, 2007. DEA Attorney Submits 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.

March 14, 2007. In light of our recent hard-won victory in Prof. Craker's lawsuit against the DEA, we're ramping up for a lobbying campaign of unprecedented significance and scale. MAPS must show DEA that there is substantial public support for scientific freedom in marijuana research. Thats why MAPS is coordinating a lobbying campaign aimed at pressuring DEA to actually accept Judge Bittner's recommended ruling.

On March 26, DEA's lawyers will submit their critique to DEA Administrative Law Judge (ALJ) Mary Ellen Bittner's recommended ruling that DEA grant a Schedule I license to Prof. Lyle Craker for his proposed MAPS-sponsored marijuana production facility. On May 4, our lawyers will submit a reply to the DEA lawyers' critique, and then within a few weeks the ALJ will formally submit her recommendation and the dueling comments from the two legal teams to DEA. The DEA has an unlimited amount of time to make a final ruling.

MAPS has already utilized over $250,000 in resources to help Prof. Craker win his lawsuit against DEA, mostly in the form of pro bono legal services. Now, we must harness the momentum from this victory to demonstrate to DEA that the public wants to see the safety and efficacy of marijuana determined by rigorous scientific research, not by the vested political interests of NIDA and DEA. The opportunity to resolve the controversy over medical marijuana through FDA-approved clinical trials hangs in the balance.

We estimate that the odds of prevailing over DEA are 2-1 against us -- in other words, more favorable than many of MAPS' long-shot efforts. Even if we lose, we win in some important ways. If the DEA rejects the ALJ's recommendation, it will highlight DEA obstruction of FDA-approved research and will help build support for state-level medical marijuana reform efforts.

Last week, our lobbying campaign received a big boost with news that MAPS has been awarded a grant of $45,000 from the Marijuana Policy Project (MPP). Over the next few weeks, we'll be formulating a strategy. Then, well ask MAPS members and many others to contact their Congressional legislators to request that they write to DEA urging the agency to accept the ALJ's recommendation.

February 13, 2007. The Washington Post reported in "Research Supports Medicinal Marijuana" on Dr. Donald Abrams' double-blind study of smoked marijuana for HIV-related peripheral neuropathy that was published in the respected journal Neurology. The findings showed that marijuana can be a safe and effective medication for many people with this condition, and is evidence of marijuana's therapeutic potential. Yet, no researchers are continuing Dr. Abrams' promising research, because NIDA's monopoly and arbitrary review process deters any private sponsor from investing in a medical marijuana drug development effort. The article finished by mentioning MAPS' victory in our lawsuit against DEA/NIDA, although it unfortunately doesn't explicitly connect the two issues.

January 31, 2007. Reuters reported in "Smokable Pain Drugs Promise Faster Action" on Alexza's development of smokeable drugs for migraine, pain, panic and agitation. This development could have implications for research with medical marijuana, since one of the government's main arguments has been that no legitimate medicine is smoked.

December 4, 2006. "Safer Deals: the Pastor" was published in Crawford, Texas' Lone Star Iconoclast this week, describing some of the unusual alliances that have been formed between religious groups and secular activists in order to help medical marijuana research gain credibility. MAPS isn't mentioned explicitly but Professor Lyle Craker's DEA lawsuit for a MAPS-sponsored marijuana production facility is mentioned.

November 29, 2006. Of particular applicability to MAPS' medical marijuana drug development efforts is Brian Vastag's new article, "US marijuana laws clamping the lid on pot research," published in Nature Medicine, which speaks to the difficulties faced by marijuana researchers.

September 8, 2006. It has now been four months since lawyers representing MAPS and DEA filed final legal briefs in Prof. Lyle Craker's lawsuit against the DEA for refusing to license a proposed MAPS-sponsored marijuana production facility at the University of Massachusetts-Amherst. MAPS and medical marijuana reform advocates nationwide are eagerly awaiting a recommendation from DEA Administrative Law Judge (ALJ) Mary Ellen Bittner within the next two months.

In the meantime, we are focusing our attention on preparing to pressure the DEA to accept Judge Bittner's recommendation if she actually recommends that the DEA should issue a Schedule I license to Prof. Craker. Towards this end, MAPS is working with David Ostrow, M.D., who is funded by the Marijuana Policy Project (MPP), to lobby the American Medical Association (AMA) to pass a two-fold resolution at this November's annual meeting. The first part of the resolution says that privately-funded, FDA-approved research into marijuana's potential therapeutic uses should be encouraged, and that privately-funded production facilities that meet all regulatory requirements should be licensed by DEA to produce pharmaceutical-grade marijuana for use exclusively in FDA- and DEA-approved research. The second part of the resolution says that in states where patients are permitted to use medical marijuana for serious and/or chronic illnesses and the patient's physician has recommended its use in accordance with that state's medical practice standards, that patients should not be subject to federal criminal penalties for such appropriate medical use.

May 28, 2006. The Boston Sunday Globe published "Weed Control," an article describing the proposed medical marijuana growing facility at the University of Massachusetts-Amherst, the current government monopoly on marijuana grown for research and the MAPS-supported lawsuit filed against the DEA to end this monopoly. The piece describes MAPS' involvement in developing the proposed facility and features quotes from MAPS' president Rick Doblin. The article, with multiple graphics, was the lead article in the Ideas section which most everyone reads since it contains the editorials, the op-eds and other feature articles.

May 21, 2006. The New York Times published a letter to the editor from Jerry Epstein of the Drug Policy Forum of Texas, in which he cites the federal governement's obstruction of Dr. Lyle Craker's proposed MAPS-sponsored medical marijuana production facility as an example of its "insane policy against the medical use of marijuana". Click here to read the full text of Epstein's letter.

May 8, 2006. Prof. Lyle Craker, assisted by lead lawyer Julie Carpenter, Jenner & Block, Allen Hopper, ACLU and Emanuel Jacobowitz, Steptoe & Johnson, filed the final brief (PDF) in his lawsuit against DEA. DEA also filed a final brief (PDF) for this lawsuit. We anticipate that DEA ALJ Judge Bittner will issue her recommendation to DEA Karen Tandy within the next two to four months.

May 5, 2006. The LA Times published "Puffing is the Best Medicine", an opinion piece by Lester Grinspoon supporting smoking as an effective means of taking medical marijuana in response to a recent statement on this topic from the FDA.

May 1, 2006. Two Texas researchers found that the ONDCP's anti-marijuana public service announcements may actually have made their attitudes toward pot less negative. The study, by M Czyzewska and HJ Ginsburg, was published electronically in the journal "Addictive Behaviors" (PDF).

April 28, 2006. On this date, a letter to FDA was sent by 24 Members of Congress asking for the scientific basis of the recent statement by FDA on the medicinal potential of marijuana first published on April 20, 2006.

April 27, 2006. The critical backlash against the FDA's transparent politicization of science continued with a thorough and well-documented article in The Economist entitled "Reefer Madness: Marijuana is medically useful, whether politicians like it or not." The article discusses Prof. Lyle Craker's proposed MAPS-sponsored medical marijuana production facility and his ongoing MAPS-supported DEA lawsuit.

April 26, 2006. The San Diego Union-Tribune published an Op Ed piece by Stephen Sidney and Bruce Mirken on the FDA statement on medical marijuana.

April 23, 2006. The Chicago Tribune responded to the FDA's recent statement concerning the medicinal potential of cannabis with an editorial, "Dissembling on Medical Pot" that quotes Prof. Lyle Craker of the University of Massachusetts at Amherst, saying "The reason there's no good evidence is that they don't want an honest trial."

April 22, 2006. The New York Times published an editorial, "The Politics of Pot" that refers to the FDA statement on the medicinal value of marijuana as "disingenuous," and ending with this statement, "It's obviously easier and safer to issue a brief, dismissive statement than to back research that might undermine the administration's inflexible opposition to the medical use of marijuana."

April 21, 2006.  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.

April 11, 2006. DEA lawyers have formally petitioned DEA Administrative Law Judge Mary Ellen Bittner to extend the deadline for filing our final legal briefs to May 8, 2006. Lawyers for Prof. Craker have agreed to DEA's request, as a matter of professional courtesy. We expect that once the final briefs are filed, DEA ALJ Bittner will take 2-4 months to issue her recommendation to DEA Administrator Karen Tandy

April 7, 2006. The Daily Nexus published Activists Assemble for Cannabis Conference, announcing The Fourth National Clinical Conference on Cannabis Therapeutics at Santa Barbara City College, which features lectures from doctors, health care researchers and patients, as well as talk show-host and medical marijuana advocate Montel Williams.

March 7, 2006. Lawyers from both sides of the case have filed motions to extend the deadline to April 27 for the submission of final legal briefs in Prof. Lyle Craker's MAPS-supported lawsuit against the DEA for obstructing a MAPS-sponsored medical marijuana production facility. DEA Administrative Law Judge Mary Ellen Bittner is now expected to make a decision three to six months after the briefs have been submitted.

January 31, 2006. Click here to listen to a podcast news update produced by MAPS about Prof. Lyle Craker's MAPS-supported lawsuit against the DEA for obstructing a MAPS-sponsored medical marijuana production facility.

January 6, 2006. Our lawyers learned today that DEA has decided not to hold the final hearing that had been scheduled for January 17, solely in order to cross-examine under oath our rebuttal witness, Al Byrne. Perhaps DEA lawyers read my commentary posted on the MAPS website on December 20, 2005, in which I suggested that it would be wise for them not to call Al as a witness since he would have persuasively testified to the low quality of NIDA marijuana and to the veracity of the picture of the seeds and stems in three NIDA marijuana cigarettes that Prof. ElSohly had foolishly challenged as being somehow not accurate. Probably, DEA lawyers were just trying to intimidate Al into withdrawing his affidavit in order to avoid having to testify under oath inside DEA headquarters. When that failed, they decided to cancel the hearings regardless of my suggestions, which they haven't taken in other instances anyway. In any case, there will now be no more courtroom drama, only dueling legal briefs. At this point, I guess that the final briefs will be due in several months and that DEA Administrative Law Judge Mary Ellen Bittner will issue her recommendation to DEA Administrator Karen Tandy in late Spring or early Summer 2006.

December 27, 2005. The New York Daily News Washington Bureau published a succint and informative article about the DEA Lawsuit.

December 19, 2005.  The Daily Journal published Ole Miss marijuana monopoly under fire, reporting on the University of Mississippi's insistence that their marijuana is of an acceptable grade.

December 15, 2005. Join Together published Researchers Seek New Source of Marijuana.

December 13, 2005. The Associated Press published Prof. questions gov't monopoly on marijuana, a positive article about the DEA Lawsuit.

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

December 12, 2005. The Washington Post published Federal Marijuana Monopoly Challenged, an article that comprehensively summarizes the MAPS/Craker DEA Lawsuit, quoting Lyle Craker, Rick Doblin, and Grover Norquist.

December 6, 2005. 38 Members of Congress (36 Democrats and 2 Republicans) sent a letter to DEA urging the approval of Prof. Lyle Craker's application to DEA for a license for a marijuana production facility. Republican political activist Grover Norquist also sent a letter to DEA. These should get DEA's attention!

December 5, 2005. A press release was issued today, "DEA to Argue Against U. Mass Growing of Medicinal Cannabis at Administrative Hearing December 12-16: Grover Norquist, Medical Groups and 35 Members of Congress Tell DEA They Support Expanded Research." We've also posted background information including transcripts of the hearing.

November 30, 2005. MAPS and MPP file an amicus curiae brief in the on-going Raich v. Gonzales case. On June 6, 2005, the US Supreme Court rejected the decision of the 9th Circuit Court of Appeals that there was no interstate commerce, and thus affirmed federal jurisdiction over state medical marijuana laws. However, a new lawsuit making other legal arguments has been filed. The amicus curiae brief describes the federal obstruction of MAPS' efforts to conduct federally-approved medical marijuana research.

November 29, 2005. NORML.org published NIDA's Pot Monopoly To Resume Next Month.

November 16, 2005. The ALJ denies Craker's attempt to admit Scherer's testimony

November 14, 2005. The DEA files an opposition to the motion to have Dr. Scherer testify

November 8, 2005. The ALJ rules on the DEA witnesses

November 2, 2005. Prof. Lyle Craker files a motion to have Dr. Scherer testify. [Also see: Scherer motion in word format]

October 20, 2005. The DEA responds to our motion to exclude

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

September 27, 2005. The cannabis based medicine, Sativex, is effective in reducing central neuropathic pain and sleep disturbance in people with Multiple Sclerosis (MS) in a UK study published today in the medical journal, Neurology.

September 22, 2005. Click to contact your local congressional representative, urging them to sign-on to the letter to DEA Administrator Karen Tandy expressing support for the proposed UMASS-Amherst medical marijuana production facility. You can view the congressional members that have signed on so far.

September 19, 2005. An article from Salon.com marks the The Return of Reefer Madness, as the US Drug Czar's marketing implies a connection between marijuana and insanity.

September 16, 2005. The DEA requests to postpone hearings to December dates.

September 10, 2005. At the International Association for Cannabis as Medicine 3rd Conference, held in Leiden, Holland, Mr. Hector Vizoso, study coordinator for Dr. Donald Abrams' study of smoking v. vaporizing, discussed the results of their clinical trial in humans comparing cannabinoid blood levels, carbon monoxide levels, and subjective effects in subjects who smoke and at other times vaporize marijuana (with the Volcano vaporizer). When subjects used vaporizers, the study found reductions in blood carbon monoxide levels as compared to smoking. In addition, the study showed that the vaporizer produced reliable levels of cannabinoids. The study also found that more subjects preferred vaporizing over smoking. This study was funded by a grant of about $136,000 from the Center for Medicinal Cannabis Research (CMCR). MAPS and CaNORML contributed an additional $100,000 on preliminary laboratory data analyzing the content of the vapors produced by the Volcano vaporizer.

Results of a second paper on vaporization (with the Volcano vaporizer) were presented by Arno Hazekamp, Ph.D, of Leiden University. This study "confirms that the pulmonary administration of cannabinoids by evaporation certainly has a clinical potential. With the Volcano a safe and effective cannabinoid delivery system seems to be available to patients."

September 9, 2005. Chemic Laboratories sends a letter to Assistant Secretary for Health Joel Egertson, responding to his July 27, 2005 letter (received August 15, 2005) rejecting Chemic's June 2003 application to NIDA to purchase 10 grams of marijuana for further vaporizer research. Chemic's letter rebuts every critique of the protocol used by Mr. Egertson and urges him to reconsider. After taking over two years to reply, HHS/NIDA's protocol reviewers didn't take the time to read the protocol carefully and made some rather basis mistakes in the review. HHS/NIDA's refusal to sell Chemic 10 grams of marijuana for MAPS-sponsored vaporizer research is yet another example of the need to break NIDA's monopoly on the supply of marijuana that can be used in legal research.

September 1, 2005. A summary of recent press coverage of the MAPS/Craker/DEA hearing is available here.

August 27, 2005. The New York Times published op-ed column "Marijuana Pipe Dreams" by John Tierney, reporting on the current Craker-DEA lawsuit. In a subsequent letter to the editor responding to the mention of a Marinol patient choking to death on his own vomit, Michael Simmons informed the New York Times of the vomit-choking myth.

August 25, 2005. The Sacramento Bee Washington Bureau published Clash over pot research gets personal, an article about the DEA-Craker lawsuit proceedings including a quote from Rick Doblin.

August 22, 2005. The ACLU issues a press release on the MAPS DEA Lawsuit proceedings.

  August 22-26, 2005: The DEA Administrative Law Judge hearings took place, starting with witnesses for Prof. Lyle Craker and including one DEA witness. Transcripts are available of each day's hearing. For various legal motions since the hearing, see Timeline section below. The second round of DEA hearings will take place December 12-16, with additional DEA witnesses. For further details, see our page related to our Congressional sign-on letter campaign, in which over 34 members of the U.S. House of Representatives have signed on to a letter to DEA Administrator Karen Tandy urging her to issue a license to Prof. Craker.

August 18, 2005. The Perspective Section of the New England Journal of Medicine published an article, "Medical Marijuana and the Supreme Court," by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.

August 17, 2005. Commentary in the Journal of the American Medical Association (JAMA), by Dean Lawrence Gostin, Georgetown Law School, criticizes NIDA for blocking medical marijuana research. The article is entitled, "Medical Marijuana, American Federalism, and the Supreme Court."

August 16, 2005. DEA Administrative Law Judge Mary Ellen Bittner issued a ruling granting the government's motion to exclude several of our witnesses, Angel Raich and Valerie Corral, and limited the testimony of Dr. Lester Grinspoon, on the grounds that they would have testified about the medical uses of marijuana which was irrelevant to the issue of whether Prof. Craker's facility would be in the public interest since both sides have stipulated that research is ongoing and can be conducted under current regulations. This seems reasonable to us and in some senses favorable since we don't need to argue about the scientific research. Judge Bittner rejected the government's request to exclude our witness, Dr. Irwin Martin, who will testify about how the pharmaceutical drug development process normally takes place, with the sponsor of research selecting and producing the drug to be tested. This also is a reasonable ruling.

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

August 15, 2005. Chemic Laboratories receives a response letter from the Department of Health and Human Services (view as html), rejecting the vaporizer protocol and recommending that NIDA not sell Chemic 10 grams of laboratory-grade marijuana for the vaporizer studies. This response took more than two years and arrived, coincidentally and conveniently, just one week before the start of the DEA Administrative Law Judge hearings over DEA refusal to grant a license to Prof. Craker, UMass Amherst, for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Chemic's reply to the critiques was sent to HHS/NIDA on September 9, 2005.

August 12, 2005. DEA Administrative Law Judge Mary Ellen Bittner issued a ruling granting the government's motion to exclude several of our witnesses, Angel Raich and Valerie Corral, and limited the testimony of Dr. Lester Grinspoon, on the grounds that they would have testified about the medical uses of marijuana which was irrelevant to the issue of whether Prof. Craker's facility would be in the public interest since both sides have stipulated that research is ongoing and can be conducted under current regulations. This seems reasonable to us and in some senses favorable since we don't need to argue about the scientific research. Judge Bittner rejected the government's request to exclude our witness, Dr. Irwin Martin, who will testify about how the pharmaceutical drug development process normally takes place, with the sponsor of research selecting and producing the drug to be tested. This also is a reasonable ruling.

August 11, 2005. The DEA filed a supplemental prehearing statement, indicating that under DEA law and policy, a researcher (though not Prof. Craker) might be allowed to grow various strains of marijuana for medical marijuana research. DEA seems to have abandoned the argument that international treaty obligations prevent it from issuing a license to anyone other than a NIDA-sponsored grower.

August 8, 2005. MAPS filed objections to the governments motion to exclude four of our witnesses.

   Prof. Lyle Craker filed a motion to exclude some DEA witnesses. [Also see: exclusion objection in word format]

July 26, 2005. U.S. Congressional Representatives John Olver (D-MA) and Michael Capuano (D-MA) have sent a letter to DEA Administrator Karen Tandy urging DEA to issue a license to Prof. Craker for his MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. This letter will be sent to other members of Congress seeking additional signatures.

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

July 22, 2005. DEA files a motion seeking to disqualify four of our proposed witnesses. We'll prepare a reply within the next several weeks.

June 20, 2005. San Francisco Chronicle writer Joe Garofoli reports on the completion of the nation's first clinical human study on vaporization at UCSF. He gives an overview of vaporizer benefits and use, and informs readers how to obtain affordable vaporizers.

  A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American Prospect, The Nation, Reason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy.

June 13, 2005. The Boston Globe runs an article by Cathy Young entitled, "The Medical Pot Hysteria," that includes a mention of Sally Satel's terrific New York Times op-ed piece talking about federal obstruction of research.

June 8, 2005. Sally Satel pens an Op-Ed in the New York Times today about medical marijuana, focusing on Lyle Craker, UMass Amherst and Federal obstruction of medical marijuana research.

  Wired Magazine writes Legal Pot's No Pipe Dream, discussing the recent Supreme Court decision on medical marijuana and MAPS efforts to estabish a medical marijuana pilot production facility at the University of Massachussets at Amherst with Professer Lyle Craker.

  DesMoines Register Columnist Rekha Basu delivers a compassionate and practical article on the benefits of marijuana and the "Catch-22" of the present medical marijuana struggle. She dicusses the treatment limitations that patients with serious illnesses face and urges Americans to "push their representatives for legalization of medicinal marijuana and for more unbiased research."

June 7, 2005. Eric Bailey of the LA Times writes: Marijuana Patients Remain Defiant

  Ryan Grim, Salon Magazine, publishes his article A guide to Gonzales vs. Raich, What the medical marijuana ruling means for patients, the commerce clause, marital sex, Antonin Scalia's career and more. Ryan writes "But if the Supreme Court told us nothing else on Monday, it was that if this drug quagmire is ever going to end, it'll have to be stopped by the ones who started it: members of Congress. Until then, we'll gradually build our way to a society where half the population is locked in prison and the other half is guarding the prisoners."

  Nature.com offers an article by Mark Peplow discussing the U.S. Supreme Court ruling against medical marijuana, mistakeningly stating that over the past two years MAPS has spent over $2 million on marijuana research when in fact, MAPS has spent that figure on all psychedelic research projects.

June 6, 2005. The Washington Post reports on today's Supreme Court decision supporting Federal power over State's rights in medical marijuana law: A Defeat For Users Of Medical Marijuana. The article quotes John Walters, President Bush's director of national drug control policy, who said: "Our nation has the highest standards and most sophisticated institutions in the world for determining the safety and effectiveness of medication. Our national medical system relies on proven scientific research, not popular opinion."

However, the WP article fails to adequately address Federal obstruction of all attempts to engage in research to demonstrate the medical efficacy of marijuana, exemplified by the difficulty MAPS has in obtaining Federal approval for The Amherst MMJ production facility project.

May 18, 2005. A prehearing conference took place today between the DEA Administrative Law Judge, our lead lawyer Julie Carpenter of Jenner and Block, and DEA's lawyer. The Judge set the dates for the hearing as August 22-26, 2005, with two additional weeks if needed, those being September 26-30 and December 12-16. We have the burden of proof and have to go first. Supplemental pre-hearing statements are due July 26, with any new exhibits.

May 11, 2005. Cannabis Culture offers an article on medical marijuana patient Angel Raich's struggle in the Supreme Court

April 25, 2005. "Science, not politics, should govern medical research," says ACLU in challenge to the DEA's marijuana policy. The American Civil Liberties Union (ACLU) issued a press release about the filing of the prehearing statement in the lawsuit against the U.S. Drug Enforcement Agency (DEA) filed by University of Massachutes-Amherst Professor Lyle Craker, objecting to DEA's refusal to issue him a license for a MAPS-sponsored facility to produce marijuana for federally-approved research. For more information, see the ACLU statement by Allen Hopper and the MPP statement by Steve Fox.

April 22, 2005. ACLU enters marijuana research dispute.
Washington, DC, Apr. 22 (UPI) -- The American Civil Liberties Union Friday challenged the Drug Enforcement Administration's refusal to allow an alternative source of research marijuana.The ACLU said it filed a statement with a federal administrative law judge opposing the DEA's refusal to allow University of Massachusetts Professor Lyle Craker to grow the alternative source of research-grade marijuana.A hearing before the judge is slated to begin this summer.

April 18, 2005. Fox News Online recently published "Red Tape, Big Pharm Muscle Strangling Medical Marijuana," a piece discussing the difficulties of conducting medical marijuana research with current restrictions on the supply of cannabis for research, with quotes from Lyle Craker and John Halpern.

March 29, 2005. The New York Times published "Medicinal Marijuana On Trial", discussing medical marijuana research and Ashcroft v. Raich.

February 28, 2005. DEA files its prehearing statement in the DEA Administrative Law Judge (ALJ) hearing. The ALJ hearing is taking place because of a lawsuit that Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant and Soil Sciences, has filed against DEA for refusing to grant him a license for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. In DEA's initial "Order to Show Cause" explaining its rationale for rejecting Prof. Craker's application (see entry for Dec. 10, 2004), DEA claimed that it would be against the public interest for it to approve the license and that, in any case, US international treaty obligations prevented DEA from issuing the license. Surprisingly, the prehearing statement speaks only to the issue of public interest and says nothing about DEA's international treaty claims. Could it be that DEA realizes it has a weak case on that point? Prof. Craker has until April 22 to file his prehearing statement. Then the ALJ will schedule a conference to meet with lawyers for both parties to discuss the case and set the date for the formal hearing itself.

February 8, 2005. A new medical marijuana DEA Administrative Law Judge hearing was formally launched on Monday, February 7. Prof. Lyle Craker, UMass Amherst, filed a request for a hearing about DEA's proposed rejection of his application for a license to establish a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Our goal is to break the government's monopoly on the supply of marijuana that can be used in FDA-approved research, thereby creating the proper conditions for a $5 million, 5 year drug development effort designed to transform smoked and/or vaporized marijuana into an FDA-approved prescription medicine.

MAPS has arranged for a consortium of lawyers to represent Prof. Craker on a pro-bono basis. These lawyers include lead counsel Julie Carpenter of Jenner and Block (DC law firm), Allen Hopper, ACLU Drug Law Reform Project, and Emanuel Jacobowitz of Steptoe & Johnson (DC law firm). The estimated value of this pro-bono support is more than $100,000.

Within about a week, the DEA ALJ office will issue a timetable for the submission of prehearing statements, with DEA being given 3 weeks and Prof. Craker being given 6 weeks, ending about March 28 or so. The ALJ will then review the prehearing statements and schedule a meeting with the lawyers to discuss the scope of the case, probably taking place sometime in April. At that meeting, the date for the hearing itself will be set. Most likely, the hearing will take two days and take place in DC in late spring/early summer.

The two main issues to be argued are 1) whether it is in the public interest for there to be a facility at UMass Amherst producing marijuana for federally-approved research and 2) whether US international treaty obligations permit DEA to issue a license to a privately-funded production facility.

It took suing the DEA for "unreasonable delay" in the DC Circuit Court of Appeals to get DEA to finally reject Prof. Craker's application, after 3 1/2 years of delay. We're delighted to have finally gotten the opportunity to argue this issue on the merits.

February 5, 2005.  The New Scientist publishes "Cannabis: Prescribing the Miracle Weed" by Clare Wilson. The initial MAPS-sponsored medical marijuana research efforts of Dr. Donald Abrams are discussed though MAPS is not mentioned.

January 25, 2005. Common Sense for Drug Policy just placed an ad in 6 or 7 major political magazines (Nation, New Republic, Weekly Standard, etc) about MAPS' lawsuits v. DEA/HHS.NIDA.

January 20, 2005. The Drug-Free America Foundation, Inc. reports on its website on the DEA rejection of the UMass Amherst application for a license to establish a facility to produce marijuana for federally-approved research.

January 7, 2005. An editorial published by The Oregonian, "Stop Blocking Marijuana Research", supports the UMass Amherst project.

January 6, 2005. Dr. Lyle Craker has received a 30-day extension on the deadline for submitting a request for a DEA Administrative Law Judge hearing concerning DEA's decision to deny his application for a license to establish a MAPS-sponsored marijuana production facility at UMass Amherst. The new deadline is February 8, 2005. While we were extremely reluctant to be responsible in any way for further delays in this process, which DEA has successfully managed to delay already for 3 1/2 years, we do not as of yet have our complete legal team assembled. We are seeking pro-bono representation which takes time to obtain. We have been assured that Dr. Craker's request for a hearing will definitely be granted once we submit it, so it's all the more important that we have our legal team ready to work on the case before we submit the request for the hearing.

January 5, 2005. The San Diego City Beat published a discussion and analysis of a recent legal challenge to the HHS to change how marijuana is scheduled, with the legal challenge relying on a 2002 law, the Data Quality Act, originally crafted to benefit the tobacco industry and other corporate interests.

December 19, 2004. The Providence (RI) Journal published an excellent op-ed about the financial reasons why drug warriors don't want to see the licensing of the UMass Amherst production facility.

December 10, 2004. DEA finally rejected (see MAPS comments) the application from Prof. Lyle Craker, UMass Amherst, seeking a license to establish a MAPS-sponsored facility to produce marijuana for federally-approved research, 3 and 1/2 years after the application was initially filed. DEA acted under pressure from MAPS' July 21 lawsuit arguing "unreasonable delay" and the DC Circuit Court of Appeals Nov. 22 decision which gave DEA until Dec. 22 to reply. Just as we'd hoped, the lawsuit forced DEA to issue its ruling, which we can now challenge in the context of Administrative Law Judge hearings.

December 7, 2004. Rep. Sam Farr (D-CA) has sent out a Dear Colleague letter to all member of the US House of Representatives, in response to a bill filed by U.S. Rep. Mark Souder that seeks to have the National Institute on Drug Abuse (NIDA) write a report about the "medical" uses of marijuana for FDA to distribute. Rep. Souder is the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources and the author of the much criticized bill that denies federal student loans to anyone convicted of a drug-related crime. Rep. Farr's letter questions whether NIDA is unbiased and cites NIDA's refusal in over 17 and 1/2 months to provide 10 grams of marijuana for vaporizer research (sponsored by MAPS and CaNORML). Federal obstruction of medical marijuana research is starting to get more attention. This may help generate pressure to break NIDA's monopoly on supply, which it uses to obstruct research.

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

November 29, 2004. We have a decision regarding MAPS' lawsuits against DEA and against HHS/NIH/NIDA regarding our claim of "unreasonable delay" in responding to MAPS-sponsored applications to NIDA to purchase 10 grams of marijuana for vaporizer research (submitted June 24, 2003), to DEA to import 10 grams of marijuana for vaporizer research from the Dutch Office of Medicinal Cannabis (submitted June 24, 2003), and to DEA for a license to grow marijuana for research at UMass Amherst (submitted June 2001).

MAPS's lawyer's assessment: The decision is very particular about the applications delayed, so they obviously read & at least partially understood what was what. Unfortunately, 17 months delay to the court (unlike patients needing pain relief) is no biggie, so we lose on compelling action on the application to HHS/NIDA to purchase 10 grams for research and on the application to DEA to import 10 grams. The 3 1/2 year delay in DEA non-response to the UMass Amherst application for a license to grow marijuana for research trips the further inquiry wire at DEA, however, so there apparantly is a chance for some oversite. Reconsideration (of the outright denials) must be filed within 14 days [5pm Dec. 6], which we will file.

  Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.

November 22, 2004. The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as "absurd."

November 11, 2004. MAPS initiates work on a legal motion for expedited scheduling of our lawsuits against DEA and against HHS/NIH/NIDA. It's now been more than 3 1/2 months since July 21, 2004, when MAPS, Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana (WAMM) in Santa Cruz, California, and Prof. Lyle Craker, UMass Amherst, filed a lawsuit against DEA, and MAPS and Valerie Corral filed a lawsuit against HHS/NIH/NIDA.

The lawsuits claimed that the agencies were engaging in unreasonable delay in not responding to MAPS-sponsored requests to grow, import and purchase marijuana for a program of scientific research designed to develop marijuana into an FDA-approved prescription medicine. We hope the motion for expedited scheduling will get this case before the judge sooner than if we were to do nothing. The lawsuits have been filed in the United States Court of Appeals for the District of Columbia Circuit.

October 13, 2004. MAPS and MPP filed our amicus curiae brief today in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research. The goal of the brief is to educate the Supreme Court judges so that they don't rule against medical marijuana patients under the false assumption that the FDA drug development approach is a viable alternative to state medical marijuana initiatives and legislative actions. As long as the obstruction of MAPS' medical marijuana research efforts continues, the only way that patients can obtain legal access to the medical use of marijuana is through the decision of the 9th Circuit Court of Appeals, which decided that there was no interstate commerce involved when patients or caregivers grow marijuana for patients' personal medical use. That decision prohibited the federal authorities (DEA) from enforcing the Controlled Substances Act prohibitions against the use of marijuana, which the 9th Circuit judges declared unconstitutional when applied against patients or caregivers growing marijuana in states that had approved such use. MAPS and MPP's brief transforms our failure to obtain the necessary permissions and supply of marijuana for MAPS' research efforts into a weapon against the forces of repression (DEA and the Drug Czar ).

October 10, 2004. The San Francisco Chronicle reports that "Medical Marijuana Advocates Likely to Get Break Under Kerry". MAPS' UMass Amherst project is mentioned in the article

October 8, 2004. The October 8-14 Boston Phoenix features an interview with MAPS' president Rick Doblin Ph.D. that discusses, among other things, ongoing research into the therapeutic effects of MDMA, psilocybin, and marijuana.

September 30, 2004. Reuters News Service published a story stating "British, French Drug Firms Lead in Marijuana Tests", noting that US drug development is hampered by marijuana's schedule 1 status and government control over the supply of marijuana researchers must use for their studies.

September 29, 2004. The second subject is enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The first subject was enrolled on September 21, 2004 (see that entry for more details about study design). This study is now well underway!

September 21, 2004. The first subject was enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The study requires subjects to live on an in-patient ward for 6 days, with each day involving either smoking marijuana or using the vaporizer. The research involves the use of 3 different marijuana cigarettes, one with 1.7 % THC, one with 3.5% THC and one with 7% THC. The cigarettes are cut in half and used in a randomized, double-blind manner, with half of each cigarette being smoked and the other half unrolled and the marijuana placed in the vaporizer.

August 10, 2004. In response to an inquiry to DEA from Prof. Lyle Craker, Mr. Wayne Raabe, DOJ Criminal and Dangerous Drug Division, called Prof. Craker and said that DOJ is making a decision this week on which division will be handling the case. He promised to call and let Prof. Craker know as soon as the decision on handling the case was made. Taxpayer money would be much better spent if, instead of working on responding to the lawsuit from MAPS and Prof. Craker, DEA and DOJ would just make a decision on the application for a license to establish a facility to grow marijuana exclusively for federally-approved research, which Prof. Craker submitted over three years ago! Yet more evidence that the Bush Administration is actively working to obstruct medical marijuana research.

July 29, 2004. MAPS files a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.

July 28, 2004. Scientific Journal Nature publishes an article about MAPS's lawsuit against DEA, HHS, NIH, and NIDA for obstructing Marijuana research. Dr. Stanley Watson of the University of Michigan, Ann Arbor, who co-authored a 1999 Institute of Medicine report agrees that political factors are obstructing medical marijuana research.

July 22, 2004. Newspapers around the country have carried an AP wire story on MAPS' lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research. An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.

  The Springfield Republican publishes an article about MAPS recent medical marijuana research lawsuits.

July 21, 2004. MAPS, Prof. Lyle Craker and Valerie Corral, file lawsuits against DEA and against HHS/NIH/NIDA for obstructing medical marijuana research. MPP sends out a press release..

June 9, 2004. NIDA Director Dr. Nora Volkow responds to MAPS' letter of May 19, as well as MAPS' May 24, 2004 letters to HHS Secretary Tommy Thompson and Director of the National Institutes of Health Dr. Elias Zerhouni. Dr. Volkow writes, "As you know, NIDA is just one of the participants on the HHS review panel...It is not NIDA's role to set policy in this area...Moreover, it is not NIDA's mission to study the medicinal uses of marijuana or to advocate for the establishment of facilities to support this research. Therefore, I am sorry but I do not believe that we can be of help to you in resolving these concerns."

Conspicuosly missing from Dr. Volkow's letter was any information whatsoever about where in the process is the review of the vaporizer protocol. As a result, MAPS is now considering a lawsuit against HHS/NIDA claiming "unreasonable delay" under the Administrative Procedures Act.

May 19, 2004. MAPS has sent a letter to NIDA Director Dr. Nora Volkow, and all members of NIDA's National Advisory Council on Drug Abuse (NACDA), asking them to expedite the NIDA/HHS review of Chemic's vaporizer research protocol. Chemic initially submitted the protocol to NIDA on June 24, 2003, as part of a request to purchase 10 grams of NIDA's marijuana needed for the study. MAPS' letter explains that there has so far been an eleven month delay in MAPS' research agenda, while MAPS waits to see if NIDA/HHS considers the protocol to be "scientifically meritorious" and therefore worthy of the privilege of purchasing NIDA's low-potency marijuana. The letter protests that this is an unreasonable delay of MAPS' efforts to conduct research to evaluate marijuana's potential use as an FDA-approved prescription medicine. The letter informs Dr. Volkow and the members of the NACDA that NIDA/HHS is doing its best to provide clear and persuasive evidence that NIDA's monopoly on the supply of marijuana for research is a fundamental obstruction that must end, preferably with DEA licensing of the UMass Amherst production facility.

April 1, 2004. Congressman Mark Souder, Chairman of the U.S. House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources, held a hearing about "Marijuana and Medicine: The Need for a Science-Based Approach." MPP Executive Director Rob Kampia testified (video and transcript) and answered questions (video and transcript). During his comments, he discussed the importance of MAPS' vaporizer research efforts as well as the UMass Amherst project.

   Statement of ROBERT J. MEYER, M.D., FDA, on Medical Marijuana.

  Testimony of Nora Volkow, Director of NIDA, to Cong. Souder.

October 1, 2001. Penthouse Magazine publishes "The Gang That Couldn't Grow Straight"by Michael Simmons.

March 28, 2004. Ex-Surgeon General Joycelyn Elders publishes a great op-ed, Myths about Medical Marijuana.

February 27, 2004. The Ninth Circuit federal appeals court has refused to reconsider its Raich-Monson decision that allows Californians to grow and use marijuana to treat their illnesses. Not a single judge on the circuit voted to accept the government’s request for reconsideration. The government’s only recourse to reverse the Raich-Monson decision is to appeal to the Supreme Court. The government has 90 days to file a petition for certiorari. An article about this decision by Dean Murphy appeared in the New York Times.

February 17, 2004. Pot Proponent Just Says No, by Bill Breen, Fast Company Online.
Medical marijuana’s elder statesman is not convinced that the therapeutic benefits of cannabis can be separated from the psychoactive effects -- or that cannabis should be "pharmaceuticalized."

The Cannabis Conundrum by Bill Breen, Fast Company Online.
As the founder of a British Pharmaceutical company put it, if it weren’t called Marijuana there would be an entire biotech business built around this plant. And that’s just what is starting to happen (but not for the US drug industry or the patients these medicines might help).

February 10, 2004. Pipe Dream? Rick Doblin has a prescription for fixing NIDA’s ailing medical-marijuana program: establish an alternative. By Bill Breen, Fast Company. An excellent article about MAPS’ UMass Amherst project.

January 27, 2004. A NY Times article about medical marijuana discusses the implications for US drug policy of the impending approval of a medical marijuana extract in England, with quotes from and illustrated by photos of Lester Grinspoon and Rick Doblin.

 Read Dr. Grinspoon’s comments on this article.

December 16, 2003. Medical marijuana patient Angel McClary Raich and her caregivers and Diane Monson won in an historic Ninth Circuit decision in their injunction against Ashcroft, the DEA Chief, and the Federal Government. The Court declared the Controlled Substances Act unconstitutional for violating rights under the Commerce Clause if the marijuana isn’t sold, transported across state lines or used for non-medicinal purposes.

MAPS, MPP and Dr. Ethan Russo filed an amicus curiae brief in this case, which can be found here. We testified about Executive branch obstructionism of medical marijuana research and concluded, "The Court should not rule against patients’ constitutional rights to use cannabis based on the illusion of a well-functioning FDA-approval process. Executive branch obstructionism has made it necessary for patients to assert their constitutional rights to use cannabis as a legal ’safety net’ for a limited number of patients."

In its decision, the Court noted, "The appellees also contend that granting the appellants’ requested injunction would create a slippery slope as other plaintiffs seeking use of other schedule I controlled substances would bypass the statutory process established by Congress. The appellees claim that the appellants’ proposed injunction therefore has the potential to significantly undermine the FDA drug approval process. Our holding is sufficiently narrow to avoid such concerns." Though the Court didn’t point this out, it’s totally hypocritical for the Bush Administration to accuse Angel Raich of undermining the FDA drug approval process when DEA, with ONDCP support, is obstructing privately-funded medical marijuana research by not granting a license to grow marijuana for research to Prof. Craker at UMass Amherst (Read this for more details).

Fortunately, the Court’s decision will increase pressure on the Bush Administration to approve the UMass Amherst marijuana production facility by making it more obvious that a denial just increases the need for patients like Angel to grow their own medicine free from federal persecution.

 The Court’s decision is here. Click on "opinions" at the upper left. Then select Raich vs.. Ashcroft
 Download the major pleadings from the litigation (Raich v. Ashcroft) here and here.
 Also read the Dec. 16, 2003, Associated Press article, " Federal Appeals Court OKs Medical Marijuana in Some Cases"

November 26, 2003. MAPS sent a letter today to NIDA Director Nora Volkow, Ph.D., responding to a November 18, 2003 letter from Dr. Volkow to Rick Doblin. This exchange of letters was part of a package of material that MAPS sent today to members of NIDA’s National Advisory Council on Drug Abuse (NACDA) requesting that NACDA recommend to NIDA that it write to DEA expressing support for Prof. Craker’s application for a license for a marijuana production facility at UMass Amherst.

Dr. Volkow indicated in her thoughtful but careful letter that since NIDA’s mission doesn’t include the medical use of marijuana, that it wasn’t appropriate for NIDA to recommend that DEA license the UMass Amherst facility. In reply, Rick Doblin noted that, "it is precisely because NIDA’s mission doesn’t include the study of the medicinal uses of marijuana that NIDA’s monopoly on the supply of marijuana for FDA-approved medical research is so inappropriate. I request you reconsider your decision not to recommend a change in the status quo."

November 21, 2003. MAPS responds to Dr. ElSohly’s letter to DEA. Several days ago, as a result of its Freedom of Information Act (FOIA) request, MAPS received a copy from DEA of the one public comment about Prof. Craker’s application for a license to produce marijuana that was filed with DEA during the public comment period that ended September 22, 2003. The comment was submitted by Professor Mahmoud ElSohly, Director of NIDA’s marijuana farm at the University of Mississippi, who strongly opposed DEA licensing of Prof. Craker’s facility. MAPS’ reply to Prof. ElSohly’s letter was sent today to DEA. Basically, Prof. ElSohly wants to retain his monopoly.

Rather hilariously, he explains that he and NIDA didn’t consider it a significant issue that the marijuana cigarettes made available to researchers for the last twenty years or so contained seeds and stems. Nevertheless, they have installed "custom-manufactured deseeding equipment that rids the plant material of any seeds and small stems prior to the manufacturing of the cigarettes." One day, we can perhaps look forward to NIDA’s coming to understand the value of growing female plants that aren’t permitted to go to seed.

November 18, 2003. WBUR, the Boston NPR station, broadcast a long, positive story about medical marijuana and the UMass Amherst project, with interviews with Rick Doblin, UMass Amherst Prof. Lyle Craker, and ONDCP’s Dr. Andrea Barthwell. The story, "Massachusetts Considers Medical Marijuana," is by Rachel Gotbaum and begins by stating, "Governor Mitt Romney is expected to decide later this month whether he will join Senators Kennedy and Kerry and urge the federal drug enforcement administration to allow a Massachusetts professor to grow marijuana for medical research."

 Letter from Dr. Volkow to Rick Doblin

November 10, 2003. Gov. Romney’s senior policy advisor meets in the State House about the UMass Amherst project with Rick Doblin and Scott Mortimer of the Drug Policy Forum of Massachusetts. The meeting was arranged by Romney supporter Leo Kahn, who also attended the meeting along with Joe Rosen.

October 28, 2003. A New York Times article on doctors and the law discusses the legal situation faced by physicians who recommend marijuana to their patients.

October 27, 2003. MAPS sends a short memo to David Murray, special assistant to ONDCP Director John Walters, outlining the reasons why ONDCP and DEA should support the licensing of Prof. Craker’s UMass Amherst marijuana production facility, sponsored by MAPS. This report was requested by David Murray.

October 23, 2003. Both US Senators from Massachusetts support UMass Amherst project!

Today, MAPS received a copy of an Oct. 20, 2003, letter that Senators Kennedy and Kerry signed and sent to DEA Administrator Karen Tandy, expressing their strong support for the UMass Amherst marijuana production facility. The letter was fantastic and will make it significantly more difficult for DEA to reject the application.

The Senators’ wrote:

"We are writing to express our strong support for the application by the University of Massachusetts Amherst for registration as a bulk manufacturer of marijuana for distribution to researchers in clinical investigations authorized by the Food and Drug Administration and non-clinical investigations at DEA-licensed laboratories.... We believe that the National Institute on Drug Abuse facility at the University of Mississippi has an unjustifiable monopoly on the production of marijuana for legitimate medical and research purposes in the United States...The current lack of such competition may well result in the production of lower-quality research-grade marijuana, which in turn jeopardizes important research into the therapeutic effects of marijuana for patients undergoing chemotherapy or suffering from AIDS, glaucoma, or other diseases."

This is a major step forward in MAPS’ efforts to create the conditions necessary for a serious medical marijuana drug development effort aimed with FDA-approval of the prescription use of marijuana, with the two essential elements being an independent source of supply of high-potency marijuana and FDA-approval of the use of vaporizer in clinical research.

To show what an incredible accomplishment it was to obtain support from Senator Kerry for medical marijuana research, see the text of a letter he sent on October 21, 2003 to a constituent in which he expresses his reasons for supporting the current criminalization of the non-medical use of marijuana.

October 20, 2003. MAPS sends a letter to all members of the National Institute on Drug Abuse’s National Advisory Council on Drug Abuse, requesting that it recommend that NIDA support Prof. Craker’s application to DEA for a privately-funded medical marijuana production facility as an alternative source of supply to NIDA. (also available in Word format)

October 19, 2003. Dr. Ethan Russo writes A Requiem for the Journal of Cannabis Therapeutics. (also available in Word format)

October 17, 2003. Snake-oil salesmen
Why does the Bush administration seem so intent on denying medical marijuana to adults in extreme discomfort?, Kristen Lombardi, Boston Phoenix
(MAPS comments on this article are here.)

October 7, 2003. MAPS files FOIA request with DEA. MAPS learned through a phone call to DEA that only one public comment about Prof. Craker’s application for a license to produce marijuana was filed with DEA during the public comment period that ended September 22, 2003. However, we also learned that we could see that comment only by filing a formal Freedom of Information Act (FOIA) request, which we did today.

October 1, 2003. Nature publishes an excellent article on medical marijuana research (also available in pdf format).

September 16, 2003. MAPS sends a letter to NIDA director Nora Volkow requesting that NIDA submit a comment to DEA supporting Dr. Craker’s application.

August 18, 2003. Dr. Abrams and team publish an article in the Annals of Internal Medicine, claiming "Short-Term Medical Cannabis Does Not Harm HIV+ Patients"! For more details, see MAPS’ Comments and UCSF Press Release.

April 30, 2003. MAPS, MPP and Dr. Ethan Russo filed an updated version of this amicus curiae brief in the US Court of Appeals for the Ninth Circuit case of Angel Raich et al. v. John Ashcroft as Attorney General and Asa Hutchinson, Administrator of the DEA. (PDF Format)

November 9, 2002. Dr. Donald Abrams and Dr. Ethan Russo report on their medical marijuana research at the Marijuana Policy Project (MPP)/Students for a Sensible Drug Policy (SSDP) conference in Anaheim, California.

View Dr. Abrams’ powerpoint presentation, "Clinical Trials of Cannabis in California." (IE4+ required to view this presentation)

View Dr. Russo’s powerpoint presentation, "Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of the Benefits and Adverse Effects of Legal Clinical Cannabis" (IE4+ required to view this presentation)

In addition to supporting Dr. Abrams’ protocol investigating the effects of marijuana in HIV+ subjects, the first study in 15 years to investigate the therapeutic application of cannabis, MAPS has supported the efforts of Dr. Ethan Russo, University of Montana, for expenses involved in preparing NIH grant applications for the study of the use of marijuana in the treatment of people whose migraines fail to respond to conventional medications. This study continues to face difficulties in getting started. In 1997, MAPS submitted an application to the Food and Drug Administration’s Office of Orphan Drug Products requesting that cannabis be designated an Orphan Drug for the treatment of AIDS wasting syndrome. This effort recently came to fruition. MAPS has also co-funded studies of medical marijuana potency and water pipes and vaporizers.

On February 20, 2001, MAPS, MPP and Dr. Ethan Russo filed an Amicus Curiae brief in the medical marijuana case, US v. Oakland Cannabis Buyers’ Cooperative. Even though FDA approved Dr. Russo’s MAPS-supported protocol to study the use of smoked marijuana in treating patients suffering from migraines, NIDA refused to supply the marijuana. As a result, Dr. Russo’s study never took place. We have tried to turn our frustrating experience with NIDA to the advantage of medical marijuana patients by letting the U.S. Supreme Court know that the FDA drug development process is politically obstructed. Our brief’s basic point is that these obstructions create more of a need for the medical necessity defense for patients who run into conflict with the police over their use of marijuana as medicine.

On April 30, 2003, MAPS, MPP and Dr. Ethan Russo filed an updated version of this amicus curiae brief in the US Court of Appeals for the Ninth Circuit case of Angel Raich et al. v. John Ashcroft as Attorney General and Asa Hutchinson, Administrator of the DEA. (PDF Format)

Dr. Russo has abandoned his struggle to conduct FDA-approved research. Instead, he has designed a basic safety study of the few patients remaining alive who legally receive marijuana from NIDA as part of the Compassionate IND program that was closed by HHS in 1992. MAPS donated $10,000 to this study, which started in May 2001. Preliminary results of the study show therapeutic benefits, with no significant adverse effects. The final paper about the study, reference below, reports on the study in detail.

[ Russo E, Mathre ML, Bryne A, Velin R, Bach P, Sanchez-Ramos J, Kirlin K. Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis. Journal of Cannabis Therapeutics Vol. 2 (1) (2002): 3-57. ]

View Dr. Russo’s powerpoint presentation, "Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of the Benefits and Adverse Effects of Legal Clinical Cannabis" (IE4+ required to view this presentation)

Read about the struggle to begin medical marijuana research in the 90’s.

 

Table of Contents

June 5, 2009: Craker’s lawyers filed potential witness and document lists regarding our pending Motion to Reconsider May 18, 2009: DEA filed an Interim Order requesting that Craker submit list of potential witness by June 5, 2009 May 11, 2009: Craker’s Lawyers file update in First Circuit, U.S. Court of Appeals May 1, 2009: Final Order goes into effect, but DEA review of Motions to Reconsider still Pending April 29, 2009: Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden April 15, 2009: Congressmen John Olver and Sam Farr send letter requesting that Ogden intervene on behalf of Prof. Craker April 13, 2009: DEA lawyers file their final document post motions March 25, 2009: DEA Lawyers Extend to April 13 their reply to Prof. Craker's Supplemental Motion to Reconsider March 11, 2009: Lawyers for Prof. Craker Submit Supplemental Motion to Reconsider to the DEA March 9, 2009: LA Times Editorial Supports Craker, Says DEA Needs Enlightenment February 10, 2009: Request to DEA to Vacate Final Order of January 14, 2009 February 9, 2009: DEA Extends Deadline to March 11 for Response to Final Order Rejecting Craker Marijuana License February 6, 2009: ASA gets 16 Members of the United States Congress to Sign a Letter to the Attorney General January 30, 2009: A Motion of Reconsideration was Filed in Response to the DEA’s Final Ruling January 18, 2009: ACLU Collection of Legal Submissions January 14, 2009: DEA refuses to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research October 10, 2007: Massachusetts Senators Kerry and Kennedy Commit to Send New Letter to DEA in Support of Prof. Craker September 18, 2007: Forty-Five U.S. Representatives Send Letter to DEA in Support of Medical Marijuana Research July 12, 2007: ONDCP and DEA Officials Grilled on MAPS/Craker Case at Congressional Hearing on "DEA's Regulation of Medicine" May 12, 2007: Organizations Writing to DEA Supporting Prof. Craker May 4, 2007: Final Legal Brief filed in the Craker vs. DEA case April 15, 2007. The Sacramento Bee published an excellent op-ed about MAPS DEA Lawsuit March 26, 2007 DEA Attorney Submits "Exceptions" to ALJ Opinion February 22, 2007: DEA Lawyers to File Objections March 26 February 21, 2007: Media Coverage of Judge's Decision in Favor of Prof. Craker February 13, 2007: MAPS Press Release Following Favorable Recommendation from Judge Bittner May 8, 2006: MAPS and DEA file final briefs for DEA Lawsuit April 28, 2006: Letter from Members of Congress to FDA April 22 - May 25, 2006: The FDA's statement on the medicinal marijuana generates op-ed criticisms April 21, 2006: FDA statement on medical marijuana, New York Times reports on responses to statement April 6, 2006. The Drugs and the Law Committee of the Association of the Bar of the City of New York sends a tremendous letter to DEA Administrator Karen Tandy. March 22, 2006 Report by Rick Doblin, Ph.D., MAPS January 6, 2006: DEA Hearing Report, by Rick Doblin, Ph.D., MAPS December 20, 2005: DEA Hearing Report, by Rick Doblin Sign-on Letter with list of signatories December 12, 2005: The Washington Post publishes an article about the DEA Lawsuit. November 22, 2005: Grover Norquist letter to DEA Case For A Sign-On Letter to DEA Administrator Karen Tandy supporting Proposed UMASS Amherst Marijuana Production Facility Background on the University of Massachusetts Amherst Marijuana Production Facility Project Statement Of Frederic M. Scherer, professor emeritus at the John F. Kennedy School of Government, Harvard University. August 27, 2005:  New York Times Op-Ed, "Marijuana Pipe Dreams," by John Tierney. MAPS/Craker/DEA hearing transcripts

June 5, 2009: Craker’s lawyers filed potential witness and document lists regarding our pending Motion to Reconsider

On June 5, Craker’s lawyers filed an impressive list of potential witnesses and documents regarding our pending Motion to Reconsider. DEA has until July 1 to decide whether or not to grant our Motion.

May 18, 2009: DEA filed an Interim Order requesting that Craker submit list of potential witness by June 5, 2009

On May 18, DEA filed an Interim Order requesting that Craker submit by June 5, 2009, potential witness and document lists regarding our pending Motion to Reconsider. DEA also extended the effective date of its final ruling to July 1, 2009, leaving it three weeks to consider whether or not to grant our Motion to Reconsider.

May 11, 2009: Craker’s 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.

May 1, 2009: 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.

April 29, 2009: 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.

April 15, 2009: Congressmen John Olver and Sam Farr send letter requesting that Ogden intervene on behalf of Prof. Craker

On April 15 Congressmen John Olver and Sam Farr sent a letter to DEA requesting that Ogden intervene on behalf of Prof. Craker by asking the DEA to cease going forward on its May 1 deadline.

April 15, 2009: Congressmen John Olver and Sam Farr send letter requesting that Ogden intervene on behalf of Prof. Craker

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.

March 25, 2009: DEA Lawyers Extend to April 13 their reply to Prof. Craker's 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.

March 11, 2009: 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.

March 9, 2009: LA Times Editorial Supports Craker, Says DEA Needs Enlightenment

The Los Angeles Times editorialized in favor of DEA licensing of Prof. Craker's medical marijuana production facility, citing as support President Obama's March 9, 2009 statement about scientific integrity. The LA Times editorial said, "DEA is one of the many federal agencies ready for enlightenment."

February 10, 2009: Request to DEA to Vacate Final Order of January 14, 2009

Attorney Julie Carpenter, Jenner & Block, wrote a letter to DEA on February 10, 2009, requesting that DEA vacate the final order published in the Federal Register on January 14, 2009. Unless the order is vacated, we'll go ahead this Friday and file an appeal with the DC Circuit Federal Court of Appeals

February 9, 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.

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

January 30, 2009: A Motion of Reconsideration was Filed in Response to the DEA’s Final Ruling

Lawyers for MAPS and Professor Lyle Craker filed a motion of reconsideration in response to theDrug Enforcement Administration’s (DEA) final ruling. MAPS and Professor Craker rebutted DEA’s final order with the support of theAmerican Civil Liberties Union (ACLU)on grounds that new evidence was introduced in the final ruling that was not included during testimony in the case.

January 18, 2009: ACLU Collection of Legal Submissions

ACLU has created a webpage with a comprehensive set of the legal documents in the Craker case and other commentary.

January 14, 2009: DEA refuses to end the government monopoly over the supply of marijuana available for Food and Drug Administration (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.

October 10, 2007: 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.

September 18, 2007: Forty-Five 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.

July 12, 2007: ONDCP and DEA Officials Grilled on MAPS/Craker Case at Congressional Hearing on "DEA's 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: "Not Enough Marijuana" 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"

May 12, 2007: 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 American Medical Students Association 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

May 4, 2007. 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.

April 15, 2007. 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.

March 26, 2007 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.

February 22, 2007: DEA Lawyers to File Objections March 26

The DEA's lawyers have 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 Judge¹s decision is non-binding, MAPS must coordinate another Congressional lobbying campaign after the DEA¹s lawyers file their objections on March 26. Our aim will be to generate sufficient pressure on the DEA to accept the Judge¹s 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.

February 21, 2007: Media Coverage of Judge's Decision in Favor of Prof. Craker

The top media outlets across the country are taking notice of MAPS' historic legal triumph over the DEA. MAPS produced this podcast to spread news of the case, its implications, and MAPS' plans to pressure DEA to follow the Judge's recommendation. Chicago Tribune Truth and Medical Marijuana Boston Globe: Judge: Let prof grow medicinal marijuana San Francisco Chronicle: Judge sides with botanist on pot supply McClatchey News' newswire article, which was carried in The Miami Herald, San Jose Mercury-News, Seattle Post-Intelligencer and others: Judge rules government supply of marijuana is inadequate St. Petersburg Times: DEA stymies science Northeast Mississippi Daily Journal: Ole Miss may get competition in growing marijuana Austin Chronicle Reefer Madness: Judge Supports Bid to Grow Research Pot

February 13, 2007: MAPS Press Release Following Favorable Recommendation from Judge Bittner

Contact Jag Davies, MAPS Director of Communications (831) 336-4325 or jag@maps.org 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.

May 8, 2006: 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 (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 (PDF). 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.

April 28, 2006: Letter from Members of Congress to FDA Acting Commissioner von Eschenbach.

On April 28, 2006, a letter to FDA was sent by 24 Members of Congress asking for the scientific basis of the recent statement by FDA on the medicinal potential of marijuana.

April 22, 2006 - May 25, 2006: The FDA's statement on the medicinal potential of marijuana generates a number of op-ed criticisms

The FDA's statement on the medicinal potential of marijuana, issued April 20, 2006, generated a number of editorial criticisms: April 22, 2006: The New York Times April 23, 2006: The Chicago Tribune April 26, 2006: The San Diego Union-Tribune April 27, 2006: The Economist May 17, 2006: Medscape General Medicine May 19, 2006: In These Times May 25, 2006: Cancer Monthly

April 21, 2006: 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.

April 6, 2006: The Drugs and the Law Committee of the Association of the Bar of the City of New York sends a tremendous letter to DEA Administrator Karen Tandy.

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.

March 22, 2006: 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.

January 6, 2006: 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.

December 20, 2005: DEA Hearing Report by Rick Doblin, Ph.D., MAPS

I'm back home after a week in DC for the DEA hearings. Our lawyers and I are convinced that the DEA witnesses ended up helping our case substantially more than the DEA's case. The hearings are now almost all over except for one additional witness who is scheduled to testify on January 17. The story of this final witness will help explain the DEA's self-destructing case (though whether the DEA Administrative Law Judge Mary Ellen Bittner will recommend that Prof. Craker receive his license is too difficult to predict). The DEA called Mahmoud ElSohly, NIDA's grower at UMiss, as a witness on both Monday and Tuesday. He claimed that he could provide marijuana of any potency and CBD content and thus no alternative source of supply was needed. At one point, he was looking at a document that contained information on the marijuana in NIDA's inventory. We managed to ask to see it and then get it introduced into evidence. There is nothing in the inventory with a CBD content more than about half of what the Dutch government is offering, and only small amounts of high-THC content marijuana, which have even lower amounts of CBD. There is nothing comparable to a strain offered by the Dutch government, containing 18% THC and 0.8% CBD. ElSohly consistently defended the quality of NIDA's marijuana. He was quite sensitive about the quality of his product and explained proudly about the new equipment that can take the seeds and the stems out of NIDA's marijuana cigarettes. One of his mistakes was to get defensive about the picture of the seeds and stems from 3 of NIDA's cigarettes that was published in Dr. Ethan Russo's article about the study of the Compassionate Use patients. He got so defensive that he ended up stating that the picture couldn't have been from NIDA's cigarettes but could have been from the raw material, prior to the seeds and stems being taken out. He even said that the seeds looked larger than they should have compared to the size of the stems and came as close as you could to claiming the photo was fraudulently doctored without actually saying the word fraud. After ElSohly's testimony, I contacted Al Byrne, who was in the room when the picture was taken, and ask Al if he would testify. After ACLU lawyer Allen Hopper had a conversation with Al's lawyer, Al agreed to submit a signed affidavit that we tried to introduce into evidence on Friday. The affidavit was submitted to DEA lawyer Brian Bayly and the Judge. The Judge then asked Mr. Bayly whether he had any objections to introducing the affidavit as rebuttal evidence. At this point, one of the most telling moments in the entire hearing took place, the classic pregnant pause. Mr. Bayly was silent and stared at the letter for an extended period of time. Nobody in the courtroom said a word for more than a minute, a long, slow period of time. We could tell that Mr. Bayly was struggling to figure out how to object to this affidavit, and was perhaps also cursing ElSohly for making such foolish and unnecessary statements. He remained still for so long that Judge Bittner felt it necessary to speak again, asking him once more if he had any objections. He then shook off his paralysis and went over the letter paragraph for paragraph, line for line, trying to exclude whatever background information that wasn't directly about the photograph itself. Our attorney, Julie Carpenter, did a great job of arguing that the background information was helpful to provide context. The Judge then ruled to admit the letter in its entirety! We now have ElSohly claiming that NIDA marijuana can't possibly be as bad as it really is, and we have photos and witnesses to prove that it is indeed that bad. Then, in what seems like an example of pulling an even greater defeat out of the jaws of a significant defeat, Mr. Bayly said that he wanted to cross-examine Al Byrne! All the other testimony is over, but the Judge was compelled to schedule another hearing date on January 17 just to bring in Al to be placed under oath on the witness stand. Al is eager to have his day in court in order to be able to tell the Judge all he knows about the low quality of NIDA's pot. What I think Bayly was hoping is that Al wouldn't want to be called to testify, and we'd withdraw the affidavit. Once Bayly learns that Al can't be intimidated into withdrawing his testimony, we suspect that Bayly will decide to cancel his testimony. ElSohly also was forced to explain his personal commercial interests in marijuana-based products, such as his THC suppository and his new DEA license permitting him to grow marijuana to extract THC for sale to the pharmaceutical company, Mallincrodt, to manufacture generic Marinol, which is now off-patent. We established that ElSohly has a major conflict of interest if he were to be the sole supplier of marijuana to MAPS for prescription use, if such use were permitted by FDA. ElSohly also claimed that if marijuana were to be approved by FDA using marijuana provided by NIDA, that we would have no trouble just switching to another product with similar THC levels. Testimony on Friday by DEA's expert on pharmaceutical drug development blew this apart, as I'll explain below. In the DEA hearing on Wednesday, we got several very important admissions out of Steve Gust, Assistant Director of NIDA. First off, he said that the PHS/NIDA review of protocols, after FDA review, takes between 3-6 months. This is incredibly damning since time delays in pharmaceutical drug development are very expensive and substantially impede the process. Alternatively, FDA has just 30 days to respond to protocol submissions. Then Steve Gust said that there is no formal appeal process but that if an appeal is made, it might take another 3-6 months! He couldn't explain why the PHS/NIDA review of Chemic's vaporizer protocol and request for 10 grams took more than two years. Furthermore, he admitted that unlike normal peer-review processes, the PHS/NIDA peer review process is composed entirely of government employees, with no outside experts. He also claimed that there were FDA staff on the Chemic review committee but couldn't name anyone from FDA and had to back off that claim. He then said there is no clear way to obtain a list of the reviewers. These sorts of delays, on top of the arbitrary nature of the review process, are more than enough to persuade any funders of marijuana research that it isn't worth investing millions of dollars in a serious drug development effort. The problems with the NIDA review process provide a strong argument for the research-restricting nature of NIDA's monopoly on the supply of marijuana legal for FDA-approved research. Steve Gust said that the purpose of NIDA's review was to make sure that the protocols were scientifically meritorious, and that FDA just reviewed for safety. Unfortunately for him, the official HHS statement of policy about the provision of marijuana to privately-funded studies says in no uncertain terms that FDA reviews Phase I studies primarily for safety but reviews Phase II and Phase III protocols for scientific merit! We directed Steve Gust to that portion of the guidelines and got him to admit, reluctantly, that FDA doesn't just review for safety but also for scientific merit. He wouldn't say it but this makes the NIDA review clearly duplicative and unnecessary. We also got Gust to acknowledge that the priorities of the HHS guidelines for providing marijuana to researchers are clearly skewed away from research aimed at developing marijuana into a medicine in its plant form, with the guidelines even using the word "must" be aimed at developing marijuana extracts. He tried to dodge saying that it wouldn't make any difference to NIDA if protocols were aimed at developing the marijuana plant itself into a prescription medicine, but he couldn't explain away the clear language of the guidelines. Also on Wednesday, we were able to enter into the official exhibits the updated Congressional sign-on letter to DEA urging approval of Prof. Craker's license, which 38 Reps. have now signed. In order to try to minimize and discredit it, DEA attorney Brian Bayly remarked first off that if we got another several hundred or so, the hearings wouldn't be necessary. Then he said that all the signatories were probably Democrats, as if their support didn't indicate a significant public interest in ending NIDA's monopoly on supply but were only indicative of partisan sniping. We replied that we had two Republicans and also a letter of support from Grover Norquist. Thursday, the DEA had no witnesses and there were no hearings Friday, the first DEA witness was Dr. Eric Voth, prominent and long-time prohibitionist. Even though he was supposed to talk about the risks of diversion, and not directly about the risks and/or benefits of marijuana, he couldn't help but talk about the risks of marijuana and compared marijuana smoke to tobacco smoke. That gave us an opportunity to get something into evidence that we'd been looking to do ever since my testimony in August, when I'd failed to find a way to mention Dr. Donald Tashkin's new study showing that marijuana wasn't linked to lung cancer, and actually had a slight protective effect. We asked Dr.Voth about the comparison he made between marijuana and tobacco smoke and he discussed Tashkin's results in a rather accurate manner, getting on the record that there is no scientific evidence linking marijuana to lung cancer! We also got him to admit that the cannabinoids have anti-tumor properties while nicotine does not. Voth then made claims about the dangers of high-potency marijuana and stated that there was no evidence that people self-titrated high-potency marijuana in a way that enabled them to inhale less smoke. He made other claims about the addictive nature of marijuana, the link to mental illness, etc. This enabled us to ask that a chapter from Lester Grinspoon's Marijuana-The Forbidden Medicine, "Measuring the Risks," be entered into evidence as rebuttal, even though the DEA had previously requested, and the Judge had agreed, to block us from entering Lester's book since the risks and benefits of marijuana wasn't at issue in this case. The Judge now agreed to let us provide this information as rebuttal evidence, and Lester's excellent chapter is now officially in evidence in this case, contradicting Voth's testimony in numerous ways. Voth's main point was that marijuana has so many ingredients that it can't possibly be made into a medicine. He testified that it was extremely difficult to standardize marijuana since different plant strains could be so different from each other, implying that blocking us from doing marijuana research doesn't matter since there is no way that the FDA would accept the marijuana plant as a prescription medicine. This is the sort of argument that was more persuasive up until about 10 years ago, before the FDA developed guidelines for the investigation of botanical medicines. Later in the day, over strenuous DEA objections, we were able to enter into evidence FDA statements saying that FDA welcomes research protocols aimed at evaluating whether the marijuana plant is safe and efficacious and deserved to be available as a legal prescription drug. Once again, FDA's willingness to place science over politics was of major assistance to our efforts. DEA's final witness, Dr. Auslander, was an expert in pharmaceutical drug development. His entire testimony ended up substantially helping our case. He started by reinforcing the view expressed by Dr.Voth that it was extremely difficult to standardize a plant and that different strains might look similar but had significantly different "fingerprints" of the chemical composition. He admitted that cloned plants had identical genetic fingerprints. Most importantly, at the end of his testimony, we asked him if the difference in fingerprints of different strains was something that FDA would be concerned about. He said yes, definitely. We then asked him if it would be problematic for a pharmaceutical company if it did research with one strain of a plant, got FDA approval to market it, but then tried to market a different strain with a different fingerprint. He said this would matter quite a bit to FDA and could require replication of some clinical studies which are very expensive. What he didn't realize was that this is the exact opposite of what ElSohly testified to, saying we could conduct research with NIDA marijuana and then just switch to another plant strain if we didn't want to get marijuana for prescription use from him, of the same strain he grew for NIDA. ElSohly was not presented to the Court as an expert in pharmaceutical drug development, but Dr. Auslander was. His testimony therefore is more important on these points. Dr. Auslander thus supported one of our main points, that conducting research with NIDA marijuana from ElSohly isn't reasonable since NIDA's mission doesn't include providing marijuana for prescription sales, just research. Therefore, if we use NIDA marijuana in research and prescription use is approved, we either have to obtain the same strain from ElSohly, who has major conflicts of interest since he has other products for which smoked or vaporized marijuana would compete plus since he would lack competition could charge anything he wanted, or we could try to obtain FDA approval to market a different strain from a new manufacturer. However, switching to a new manufacturer would present new difficulties due to the different fingerprints of the different strains, even if we matched THC levels (though in our opinion we should also have to match CBD levels since this is a pharmacologically active cannabinoid). In any case, there is no alternative supplier with a DEA license and starting a new facility would take a substantial amount of time, easily a year or more, with these time lags being very costly after investing millions in research. In response to our final questions, Dr. Auslander testified very helpfully that pharmaceutical companies would want to be assured of a reliable and consistent supply of a drug that could be used in research and also be available for prescription sales. This is what we have been saying all along and is something that isn't guaranteed as long as NIDA retains its monopoly. We ended the week thankful for DEA's witnesses, eagerly looking forward to the final testimony on January 17, though we would not be surprised if DEA decides to cancel the cross-examination of Al Byrne.

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)

December 12, 2005: The Washington Post publishes an article about the DEA Lawsuit.

Lyle Craker from the University of Massachusetts at Amherst would like to grow marijuana for pharmaceutical research. He is challenging the government's control of the substance. (By Bob Stern -- (Springfield, Mass.) Republican) Federal Marijuana Monopoly Challenged Researchers Want to Grow More Plants and Find More Medicinal Uses By Marc Kaufman Washington Post Staff Writer Monday, December 12, 2005; A02 For decades, the federal government has been the nation's only legal producer of marijuana for medical research. Working with growers at the University of Mississippi, the National Institute on Drug Abuse has controlled both the quality and distribution of the drug for the past 36 years. But for the first time the government's monopoly on research marijuana is under serious legal challenge. The effort is being spearheaded by a group that wants to produce medicines from currently illegal psychedelic drugs and by a professor at the University of Massachusetts who has agreed to grow marijuana for the group if the government lets him. In a hearing due to start today before an administrative law judge at the Drug Enforcement Administration, professor Lyle Craker and his supporters will argue for a DEA license to grow the research drugs. It is the climax of a decades-long effort to expand research into marijuana and controlled drugs and of Craker's almost five-year effort to become a competing marijuana grower. "Our work is focused on finding medicinal uses of plants, and marijuana is one with clear potential," said Craker, director of the medicinal plant program of the university's Department of Plant, Soil and Insect Sciences in Amherst, Mass., and editor of the Journal of Herbs, Spices and Medicinal Plants. "There's only one government-approved source of marijuana for scientific research in this country, and that just isn't adequate." The DEA, which has to license anyone who wants to grow marijuana, disagrees. The agency, as well as the National Institute on Drug Abuse, which formally runs the marijuana research program, argues that it is not in the public interest to have more than one source of marijuana, in part because it could lead to greater illicit use. What's more, they said in legal briefs, the Mississippi program supplies all the marijuana that researchers need. Agency officials declined to comment further. In his suit against the DEA for a license to grow marijuana, Craker has backing from 38 members of Congress, the two senators from Massachusetts, numerous medical societies and even Grover Norquist, the president of the conservative Americans for Tax Reform. The effort has been organized by Richard Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS) and a longtime advocate of medical research into controlled drugs. It was Doblin who recruited Craker after the association concluded it would never get a dependable supply of government marijuana. "Dr. Craker has no goal here except to advance scientific research into marijuana, and our goals are the same," said Doblin, whose group is also sponsoring research into other controlled drugs, including MDMA (better known as "ecstasy") and the psychedelic mushroom psilocybin. "By controlling who can research marijuana and how they can do it, the DEA has greatly limited promising research that could lead to [government] approved medications," Doblin said. The problems, he said, are not limited to winning approval to buy the Mississippi marijuana. Doblin and other researchers contend that the government marijuana is low in quality and potency and could never be a stable source of basic ingredients if the Food and Drug Administration ever did approve a marijuana-based medication. Marijuana, or cannabis, is now listed as a Schedule I drug -- with no medicinal use -- under the Controlled Substances Act. Its use was initially restricted in 1937 and eliminated from medicinal practice in 1942. On its Web site, the DEA lists marijuana as the most frequently abused illicit drug in America. Since the 1970s, however, researchers have found potential uses for marijuana, or its active ingredient THC, in relieving nausea and vomiting associated with chemotherapy and to help with appetite loss in AIDS patients. A synthetic form of marijuana's active ingredient has been made into a prescription drug, Marinol. Doblin said there are potentially many other medicinal uses of marijuana, including the treatment of multiple sclerosis and AIDS-related neuropathy. He also said researchers believe that if they can perfect a method of "vaporizing" marijuana -- allowing it to be inhaled rather than smoked -- it would be easier to administer as medicine. But because of fears of illicit use, he said, the agency has essentially blocked the research. "I believe the DEA policy is one of delay, and they've succeeded in essentially blocking marijuana development for 30 years," Doblin said. In its filings with Administrative Law Judge Mary Ellen Bittner, the DEA disputes the charge that it is standing in the way of marijuana research. It says that medical marijuana research is underway in California using its Mississippi supply, and that the drugmaker Mallinckrodt Inc. has a contract with the Mississippi supplier to produce extracts of cannabis for its drug development program. In addition, DEA lawyer Brian Bayly told the law judge in August, when the first five days of testimony were heard, that the quality and potency of the government's marijuana was acceptable to the researchers his agency surveyed. The hearing is expected to continue through the week, with a decision several months later. If Craker and his team prevail, however, the DEA is not obliged to give him a license or change its policies. And as a result, Craker and his team plan to continue lining up political support, such as the Nov. 22 letter sent by Norquist to the DEA. "The use of controlled substances for legitimate research purposes is well-established, and has yielded a number of miracle medicines widely available to patients and doctors," Norquist wrote. "This case should be no different. It's in the public interest to end the government monopoly on marijuana legal for research."

November 22, 2005: 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

CASE FOR A SIGN-ON LETTER TO DEA ADMINISTRATOR KAREN TANDY SUPPORTING PROPOSED UMASS-AMHERST MARIJUANA PRODUCTION FACILITY GENERAL POLICY ISSUE: Should the controversy over the medical use of marijuana be resolved through FDA-approved scientific research or through legal and political struggles? Should the federal government facilitate or obstruct scientific research? SPECIFIC POLICY ISSUE: Is it in the public interest for DEA to license Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant, Soil and Insect Sciences, University of Massachusetts Amherst, to establish a privately-funded facility to produce marijuana exclusively for federally-approved and privately-funded research, or should the federal government, through the National Institute on Drug Abuse (NIDA), retain its unique monopoly on the supply of marijuana that can legally be used in research? CONTEXT: On June 6, 2005, the US Supreme Court ruled, in Gonzales v. Raich, that the federal government can arrest patients who use marijuana with their doctor’s recommendation even if it is legal under state law. On June 29, 2005, the US House of Representatives defeated the Hinchey Amendment, 161-264, which would have prohibited the use of federal funds for the prosecution of medical marijuana users in states that have passed laws allowing medical marijuana programs. Currently, the only process that could result in marijuana becoming legal as a medicine under federal law is for privately-funded sponsors to conduct scientific research with the aim of obtaining FDA approval for its use as a prescription medicine. Unfortunately, NIDA’s monopoly on the supply of legal marijuana is a fundamental obstruction to privately-funded research, none of which is currently taking place despite strong interest. The DEA wants to have it both ways, denying that marijuana is a medicine because the FDA has not approved it while simultaneously blocking research by refusing to allow the University of Massachusetts Amherst to manufacture marijuana for medical research. NIDA’s monopoly is against the public interest and may be contrary to federal law, which clearly requires adequate competition in the manufacture of Schedule I and II substances for research purposes. [See 21 U.S.C. § 823(a)(1); see also 21 C.F.R. § 1301.33(b).] Researchers have unobstructed access to other Schedule I and II drugs and marijuana should be no exception. Professor Craker is suing the DEA in a DEA Administrative Law Judge hearing, but the DEA can approve the project at any time. MONOPOLY PROBLEMS: NIDA’s monopoly results in arbitrary and lengthy delays or refusals in providing research material. Chemic Labs, a DEA-licensed analytical lab, was made to wait over two years for a reply to its request to purchase 10 grams for research into vaporizers, a non-smoking delivery system which the Institute of Medicine report recommended be developed. On July 27, 2005, NIDA refused to sell Chemic Labs the 10 grams, preventing the study from taking place. NIDA has also refused to provide marijuana to two FDA-approved protocols (Dr. Abrams, UC San Francisco, marijuana for AIDS wasting syndrome-IND #43-542; Dr. Russo, U. Montana, marijuana for migraines –IND #58,177). NIDA’s monopoly prevents sponsors from conducting research with the strain of marijuana they believe has the most potential. Furthermore, NIDA can legally provide marijuana for research but is not authorized to provide it for prescription use, should FDA approve such use. As a result, the strain of marijuana NIDA provides for research might not even be available for prescription use, an unacceptable uncertainty to sponsors. RECOMMENDATION: The FDA cannot consider approving marijuana for medical use until the federal government’s unique monopoly on the production of marijuana for medical research is broken. Members of Congress should sign onto a letter to DEA Administrator Karen Tandy urging the DEA to approve Professor Craker’s application in order to facilitate medical marijuana research.

Background

The University of Massachusetts-Amherst (Dr.Lyle Craker, Director, Medicinal Plant Program, UMass Amherst Department of Plant and Soil Sciences) in association with Multidisciplinary Association for Psychedelic Studies (MAPS) is in the midst of the process of seeking DEA permission to establish a medical marijuana production facility to grow high-potency marijuana for FDA-approved research. At present, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can be used in research, seriously hindering medical marijuana research. NIDA provides inferior, low-potency marijuana to researchers whose protocols it approves and denies marijuana even to FDA-approved protocols it doesn't approve, preventing those studies from taking place. No privately-funded sponsor (such as MAPS or alternatively a for-profit pharmaceutical company) will invest significant sums in a realistic drug development research program aimed at obtaining FDA-approval for the prescription use of marijuana without first obtaining its own independent source of supply of a drug whose quality, price and availability it determines. There have been no US-based privately-funded marijuana production facilities since 1942, when marijuana was removed from the US Pharmacopoeia and its medical use was prohibited. Dr. Lyle Craker originally submitted the application for a license to DEA in June 2001. In December 2001, DEA claimed it was lost. Subsequently a photocopy was resubmitted but UMASS/MAPS were told in February 2002 that the photocopied application was invalid since it didn't have an original signature. In July 2002, the original application was returned, unprocessed, with a DEA date stamp showing it had been received in June 2001. Dr. Craker resubmitted the original application to DEA on August 20, 2002, which DEA finally acknowledged receiving. UMASS/MAPS worked with the Marijuana Policy Project on a Congressional sign-on letter to the DEA expressing support for the UMass Amherst license. The letter was submitted to DEA Administrator Asa Hutchinson on June 6, 2002 (attached). DEA Administrator Asa Hutchinson responded in a letter to Rep. Barney Frank on July 1, 2002 (attached). DEA questioned whether this new facility would be in the public interest, since NIDA currently grows marijuana for research. In response, MAPS drafted a document explaining why it would be in the public interest for DEA to grant a license for the UMass Amherst facility, and submitted the document to DEA, the Office of National Drug Control Policy (ONDCP) and NIDA. The DEA has also indicated that granting such a license might conflict with US international treaty obligations, specifically the Single Convention on Narcotic Drugs. In response, UMASS/MAPS worked with Graham Boyd of the ACLU Drug Policy Litigation Project and Peter Barton Hutt and Alexei Silverman, of the DC law firm Covington & Burling, on the development of a legal document detailing why US international treaty obligations do not prevent the licensing of the UMass Amherst facility. On July 24, 2003, DEA finally filed a notice in the Federal Register about Prof. Craker's application, with a public comment period ending on September 23, 2003. On October 23, 2003, Senators Kennedy and Kerry wrote a letter to the Administrator of the DEA expressing their strong support for DEA licensing of the facility. UMASS/MAPS expected DEA’s approval or rejection of Dr. Craker's application sometime before the end of 2003 but that did not occur as DEA delayed any decision as long as possible. On July 21, 2004, MAPS, Prof. Craker and Valerie Corral filed lawsuits against DEA and also against HHS/NIH/NIDA for obstructing medical marijuana research. On July 29, 2004, MAPS filed a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA. Shortly thereafter, on November 22, 2004, the Court required DEA to respond by December 22, 2004 to the portion of the lawsuit against DEA about the UMass Amherst marijuana production facility. On December 3, 2004, MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 ½ months to their applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research. On December 10, 2004, DEA finally rejected the application from Dr. Lyle Craker, UMass Amherst, seeking a license to establish a MAPS-sponsored facility to produce marijuana for federally-approved research, 3 and 1/2 years after the application was initially filed. On February 28, 2005, DEA filed its pre-hearing statement in the DEA Administrative Law Judge (ALJ) hearing. In DEA's initial "Order to Show Cause" explaining its rationale for rejecting Prof. Craker's application, DEA claimed that it would be against the public interest for it to approve the license, and that, in any case, US international treaty obligations prevented DEA from issuing the license. On April 22, 2005, UMass (Prof. Lyle Craker) filed his pre-hearing statement to the DEA Administrative Law Judge for the hearing with assistance from lead lawyer Julie Carpenter of Jenner & Block, Allen Hopper of the ACLU Drug Law Reform Project, and Emanuel Jacobowitz, Steptoe & Johnson, all working on a pro-bono basis. On August 15, 2005, Chemic Laboratories received an official letter indicating that NIDA refused to sell it10 grams of marijuana for MAPS-sponsored research into the use of marijuana vaporizers. Chemic Labs had applied to purchase the 10 grams more than two years before. The initial round of hearings took place August 22-26, 2005, with an additional week December 12-16, 2005, for DEA to present its witnesses During the August hearings, DEA seemingly abandoned the claim that US international treaty obligations prevent it from licensing Prof. Craker’s facility, with a DEA official testifying on the stand that there is nothing in DEA law or policy that prevents it from licensing individual researchers from growing different strains of marijuana. The central issue remaining is whether it is in the public interest for DEA to license the UMass Amherst facility or whether NIDA should retain its monopoly on supply, a monopoly that clearly obstructs research.

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

August 27, 2005,  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

Transcript of court hearing, Monday, December 12, 2005 Witness is Prof. Mahmoud ElSohly, NIDA's marijuana grower. Transcript of court hearing, Tuesday, December 13, 2005 Witness is Prof. Mahmoud ElSohly, NIDA's marijuana grower. Transcript of court hearing, Wednesday, December 14, 2005 Witness is Steve Gust, Assistant to the Director of NIDA (Hearing was not held on Thursday, December 15, 2005) Transcript of court hearing, Friday, December 16, 2005 Witnesses are Dr. Eric Voth and Dr. Auslander. Transcript of court hearing, Monday, August 22, 2005 Craker opening statement by Julie Carpenter, Witnesses are Lyle E. Craker and Irwin G. Martin Transcript of court hearing, Tuesday, August 23, 2005 Witnesses are Lyle E. Craker, Barbara Roberts, John Vasconcellos, Dale Gieringer Transcript of court hearing, Wednesday, August 24, 2005 Witness is Rick Doblin Transcript of court hearing, Thursday, August 25, 2005 DEA opening statement by Brian Bayly, Witness is Matthew Strait Transcript of court hearing, Friday, August 26, 2005 Witness is Matthew Strait

MAPS Medical Marijuana Production Facility: A Progress Report by Rick Doblin, Ph.D. Fall 2001. Volume XI, Number 2. Page 6.

MAPS’ Medical Marijuana Production Facility: Following Up on Orphan Drug Designation. Spring 2000. Volume X, Number 1. Page 5. 

In a prolonged triumph of drug-war politics over science, our vaporizer research has been blocked since June 2003 by the National Institute on Drug Abuse (NIDA), which has a monopoly on the supply of marijuana that can be used in research. Since 2003, NIDA has rejected and/or ignored our repeated requests (including one lawsuit for “unreasonable delay”) seeking to purchase 10 grams of marijuana to continue our studies. NIDA uses its monopoly to obstruct studies into both the beneficial medical uses of marijuana as well as into drug delivery devices that might increase the chances of FDA approval of marijuana as a prescription medicine, and might decrease the harms associated with the non-medical uses of marijuana.

In our initial studies, when NIDA wasn’t so politicized about medical marijuana, we learned early on that water-pipes don’t help filter out undesirable particulate matter, although water-pipes may help reduce certain water-soluble gases. In contrast, vaporizers do eliminate combustion products and address the Institute of Medicine’s 1999 recommendation for the development of non-smoking delivery systems for the medicinal use of marijuana. Vaporizers are the only non-smoking delivery system that use the marijuana plant itself, rather than patented and for-profit, pharmaceutical-company-marketed marijuana extracts in spray, lozenge, drops, or pill form. In contrast, vaporizers could conceivably be used in conjunction with material that patients grow themselves or obtain in other ways, at substantially reduced cost as compared to patented products, and, as our preliminary research suggests, at virtually no increased health risk or reduced efficacy.

While the use of vaporizers in medical marijuana research is the most politically desirable route, since they don’t involve smoking, we plan to include groups that smoke as well as vaporize marijuana in future clinical studies. We would be surprised if there are significant differences in safety and efficacy for most patients, due to the lack of evidence linking marijuana smoking and cancer and the increasing body of evidence about the anti-tumor properties of marijuana.

Unlike NIDA, MAPS and CaNORML believe that the medical use of marijuana is an issue that needs to be resolved scientifically rather than politically. MAPS has identified two essential prerequisites before we can justify starting a serious ($10 million) drug development effort conducting studies under FDA’s Investigational New Drug (IND) program. The first prerequisite was that a vaporizer device needed to be accepted by FDA for use in clinical research. This objective has been met, since our initial vaporization research was used by Dr. Donald Abrams to obtain a $137,000 grant in 2004 from California’s Center for Medicinal Cannabis Research (CMCR) for a Phase I vaporizer research protocol. The study compared subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath and used the Volcano vaporizer. The study concluded that vaporization produced similar cannabinoid blood levels and subjective effects as smoking but with reduced carbon monoxide.

MAPS second prerequisite is obtaining DEA permission for our own independent supply of marijuana, thereby breaking the NIDA monopoly so we can work directly with FDA without the obstruction, delays and outright refusal of NIDA to provide the necessary marijuana. We’ve been working since 2001 with Prof. Lyle Craker, UMass Amherst, seeking a DEA license for a MAPS-sponsored medical marijuana production facility. On February 12, 2007, Prof. Craker won a DEA Administrative Law Judge (ALJ) hearing when DEA ALJ Mary Ellen Bittner found that it would be in the public interest for DEA to issue a license to Prof. Craker and recommended that DEA issue Prof. Craker a license, thereby ending the federal monopoly on supply. DEA has not yet issued its required final ruling, following its highly successful strategy of delay which has prevented marijuana from becoming an FDA-approved prescription medicine for almost 40 years, since 1970 when the use of marijuana to control nausea associated with cancer chemotherapy was reported. MAPS is working with the Americans for Safe Access and other drug policy reform organizations seeking to persuade the Obama Administration to issue Prof. Craker his license.

• 1993: http://www.maps.org/news-letters/v04n3/04310pip.html
• 1994: http://www.maps.org/news-letters/v05n1/05119wps.html
• 1995: http://www.maps.org/news-letters/v06n2/06209pip.html
• 1996: http://www.maps.org/news-letters/v06n3/06359mj1.html
• 2001: http://www.maps.org/news-letters/v11n1/11120gie.html
• 2003: http://www.maps.org/news-letters/v13n1/13111gie.html
• 2004: http://www.maps.org/news-letters/v14n1-html/medical_marijuana_research.html

Results from a MAPS-supported study in 2003 found that inhaling vaporized marijuana can drastically reduce toxins found in marijuana smoke

Results from a MAPS- and California NORML-supported study in 1996 found that water pipes are ineffective at removing harmful tars from marijuana smoke

February 6, 2009. Health and Human Services and National Institute on Drug Abuse Place Another Hurdle in Front of Marijuana Vaporizer Research:

On January 23, 2009, Gregory Goldstein, Health and Human Services (HHS) Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic Laboratories. The letter requires Chemic to do a validation study showing that Chemic could reliably measure various cannabinoids. HHS is suddenly requiring this validation study before it will even review Chemic's November 6, 2008 reply to the June 18, 2008 Public Health Service’s (PHS) and National Institute on Drug Abuse’s (NIDA) critique of Chemic's January 16, 2008 protocol. In this way, HHS/NIDA avoided responding to the substance of Chemic Labs’ reply by insisting on a preliminary validation study. This latest message is part of a five and half year tactic of blocking MAPS-sponsored vaporizer research, since a validation study had not been mentioned before in the previous communications and critiques.

In the January 23, 2009 message, HHS provided a list of questions for Chemic Labs to use as guidance for the validation study, but in their own words the questions are “not inclusive of all aspects of method validation.” Therefore, we could spend $50,000 or more on this validation study and HHS could claim that we did not meet all of the requirements and could request additional expensive validation data, all before reviewing the vaporizer protocol itself, which would only cost an estimated $25,000.

What makes this especially frustrating is that a validation study isn't truly necessary for the sort of academic study we're seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as an FDA-approved medical device, which MAPS isn’t seeking to do. We're exploring collaborating with Dutch scientists from the University of Leiden, who are already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less than half the cost of the validation study.

We are wary of conducting a validation study, or even a cross-validation study, without HHS/NIDA having reviewed and approved the vaporizer protocol itself. We’ll get back to HHS after we determine if we can make a case for a cross-validation study, then we’ll ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.

January 30, 2009. On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the DEAs final ruling, which was the Bush Adminstration's final blow to medical marijuana research.

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

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

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

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

January 14, 2009. The Bush administration struck a parting shot to legitimate science on January 14th, as the Drug Enforcement Administration (DEA) refused to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research. DEA's final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. The prior recommendation on February 12, 2007, stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEAs contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA's monopoly fundamentally obstructs MAPS research aimed at developing smoked or vaporized marijuana into a prescription medicine.

January 9, 2009. Bush Administration Last Minute Blow to Scientific Freedom

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

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

January 5, 2009. Dutch and US Marijuana Vaporizer Researchers Collaborate

MAPS President Rick Doblin and Dutch PhD student Justin Fischedick of Leiden University, met with Joseph St. Laurent and Scott Goodrich at Chemic Labs, outside of Boston LINK to CHEMIC.  Justin and his associates have been conducting marijuana vaporizer research at Leiden University using the Volcano vaporizer. They have decided to share data and procedures with Joseph St. Laurent and Scott Goodrich, who have been trying without success for over 5 1/2 years to purchase 10 grams of marijuana from NIDA for MAPS and CaNORML-sponsored vaporizer research.  

Justin and his associates have been looking mostly at what is in the marijuana vapors, such as cannabinoids and terpinoids. In order to determine whether vaporization is an effective harm reduction device, the Chemic researchers intend to mostly investigate what isn't likely to be in the marijuana vapors, but is in marijuana that is burned. This research will focus on various tars and products of combustion such as carbon monoxide.

Chemic is waiting on reviewers from NIDA and the Public Health Service to review their latest reply to questions about their proposed protocol, submitted on November 6, 2008. Once permission is eventually obtained for their research, they will check with Justin to see what his team has learned and then move forward.

November 6, 2008.  Chemic Labs submitted a response to a June 16, 2008, critique of our vaporizer protocol (PDF) by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). We submitted the protocol to NIDA/PHS on January 16, 2008, along with three letters of support from peer reviewers.

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

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

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

June 18, 2008. NIDA Delays Vaporizer Research, Averts MAPS Lawsuit:

On June 18th, after a five month review process, the National Institute of Drug Abuse-Public Health Service (NIDA-PHS) finally responded to our revised vaporizer research protocol, submitted for review January 16, 2008. The submission included three supportive letters from peer-reviewers, confirming the scientific merit of the study and urging NIDA-PHS to approve it. By responding, NIDA/PHS avoided MAPS filing another lawsuit for unreasonable delay, which wed intended to file in the middle of August.

MAPS has still been waiting two years and nine months for NIDA/PHS to respond to our September 2005 reply (PDF) to their rejection of our previous vaporizer protocol (PDF), which we initially submitted in June 2003, after which it took them more than two years to evaluate! We submitted the revised protocol in January 2008 to see if that might motivate NIDA to respond, which it has.

According to Rick, The review is filled with issues designed to delay and exhaust us, that have little importance to the safety or relevance of the intended research, but I don't think it will deter us for too long. We'll respond thoroughly and quickly before the end of July, and then wait yet again for a reply. Now that NIDA/PHS are familiar with the issues and have articulated their concerns, their response to our comments should be faster. We're already making progress in that the strategy of delay has been overcome and a review was issued.

If this situation werent so genuinely tragic for all the sick people who might benefit from this research, then it would simply appear ridiculous. All MAPS is requesting to do is purchase ten grams of marijuana--something virtually any high school student in the US could obtain--so that we can move forward with a study of a non-smoking delivery system for marijuana that might benefit people suffering from a wide range of debilitating, difficult-to-treat illnesses.

The FDA has thirty days to review complicated human protocols. With NIDA/PHSs dysfunctional review process, they have provided us with powerful evidence for why we need to break the NIDA monopoly on the supply of marijuana that can be used in research, said Doblin.

MAPS has been waiting since February 12, 2007 for the DEA to issue a final ruling in response to DEA Administrative Law Judge Bittners recommendation (PDF) that the NIDA monopoly on the production of marijuana legal for research be ended, and that Professor Lyle Craker be issued a DEA license for a MAPS-sponsored medical marijuana production facility.

February 12, 2008. On January 16, 2008, MAPS Volcano vaporizer research protocol was resubmitted to HHS for the required scientific review by the National Institute of Drug Abuse--Public Health Service (NIDA-PHS). The submission included three supportive letters from peer-reviewers (see 1, 2, 3), confirming the scientific merit of the study and urging NIDA-PHS to approve it. The goal of this study is to gather further information about the chemical constituents that are contained in the cannabis vapor stream.

November 27, 2007. 

SYNOPSIS OF DEA RESCHEDULING DRONABINOL

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

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

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

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

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

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

June 29, 2007. Nature published an excellent article ("Scientists stir the pot for right to grow marijuana") about MAPS' campaign to break the federal government's illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA's standards for safety and efficacy.

May 16, 2007. Two new studies, one from University of California-San Francisco, and the other from SUNY-Albany, provide strong evidence that vaporization has promising potential as a method of medical marijuana delivery. The first study, published online by the journal Clinical Pharmacology and Therapeutics, was conducted at UCSF by a team led by Donald Abrams, MD, and compared a commercially available vaporizer to smoking in 18 volunteers. The researchers found that, "vaporization of marijuana does not result in exposure to combustion gases, and therefore is expected to be much safer than smoking marijuana cigarettes." Dr. Abrams was able to obtain permission from FDA to conduct his study based in part on data on the composition of the ingredients in marijuana vapor gathered in research sponsored by MAPS and CaNORML. That line of MAPS-sponsored research is currently blocked since NIDA has refused to sell marijuana for additional studies. Click here to read Dr. Abrams' full report.

The second study, conducted by Mitch Earleywine, PhD, at SUNY-Albany, and published in Harm Reduction Journal, was based on an extensive survey of over 7,000 marijuana users. After adjusting for variables such as age and cigarette use, Earleywine found that vaporizer users were 60 percent less likely than smokers to report respiratory symptoms such as cough, chest tightness or phlegm, and that the effect of vaporizer use was more pronounced the larger the amount of marijuana used. Click here to read Dr. Earleywine's full report.

MAPS hopes to eventually put vaporized marijuana through FDA clinical trials, but has been stalled since June 2003 because of NIDA's monopoly on the supply of research-grade marijuana. Research into alternative delivery methods such as vaporization was one of the primary recommendations of the Institute of Medicine's landmark 1999 report on medical marijuana.

Marijuana vaporization is an effective delivery method because it has the rapid action and easy dose adjustment of inhalation, but without the respiratory hazards associated with smoking. Unlike smoking, a vaporizer does not burn the plant material, but heats it just to the point at which THC and cannabinoids vaporize into steam.

May 15, 2007. 

Today MAPS recieved a copy of the "Transmittal Letter" sent by ALJ Judge Mary Ellen Bittner to the DEA, transferring the record in the Craker matter to the DEA's Deputy Administrator, Michelle Leonhart on May 15, 2007. The letter was accompanied by this note:

1316.67 Final order
As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the Federal Register his final order in the proceeding, which shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based. This order shall specify the date on which it shall take effect, which date shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that the public interest in the matter necessitates an earlier effective date, in which event the Administrator shall specify in the order his findings as to the conditions which led him to conclude that an earlier effective date was required.
So let the "practicable" clock begin . . .

  The Walrus published a fascinating article entitled "Peaking on the Prairies" that describes Dr. Humphrey Osmond's extensive psychedelic therapy research program in the 1950's.

March 17, 2007. On February 16, MAPS President Rick Doblin met with Joe St. Laurent and Scott Goodrich, the founders of Chemic Labs, the analytical laboratory that has conducted prior MAPS/CaNORML-funded vaporizer research. They discussed the development of a new vaporizer research protocol to submit to NIDA for review, once again seeking to purchase 10 grams from NIDA and seeking DEA permission to import 10 grams of high THC/high CBD marijuana from the Netherlands, with a cannabinoid content that NIDA doesn't have available. The design work and the study itself, should we eventually obtain approval from NIDA, will be co-funded by MAPS and CaNORML, as have all our previous vaporizer research projects.

This new protocol seeks to analyze the constituents of the vapor produced in the Volcano vaporizer, from samples of NIDA marijuana that contain THC and samples of imported marijuana that contain both THC and CBD. During the meeting at Chemic, we reviewed in detail the critiques of the original vaporizer research protocol that the PHS/NIDA reviewers offered back in August 2005. We will make a few changes in the protocol so that this will be a new submission and we will respond in detail to each critique. The proposed methodology will call for testing at various temperatures, and will measure for carbon monoxide levels, cannabinoids and certain particulates.

PHS/NIDA's handling of the original version of this protocol was another classic case of the dysfunctional nature of NIDA's monopoly on research-grade marijuana. After waiting for more than two years for PHS/NIDA to review the protocol, during which time we unsuccessfully sued NIDA for unreasonable delay in the DC Circuit Court of Appeals, the critique that was finally issued contained several important misunderstandings and seemed to come from people who had barely even read the protocol. Chemic filed a response to the critiques in September 2005, which PHS/NIDA has totally ignored for more than 17 months. There seems to be no appeal process at all in the PHS/NIDA review of medical marijuana research proposals and there are certainly no deadlines that compel PHS/NIDA to respond within any reasonable period of time. This is in contrast to FDA, which must reply to protocol submissions within 30 days and has a clearly defined and prompt appeal process.

The new vaporizer protocol will be submitted to NIDA in April. Then, we anticipate a long wait. NIDA has successfully ignored Chemic's response to its critiques but it will be more difficult for NIDA to ignore a new protocol submission.

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

September 10, 2005. At the International Association for Cannabis as Medicine 3rd Conference, held in Leiden, Holland, Mr. Hector Vizoso, study coordinator for Dr. Donald Abrams' study of smoking v. vaporizing, discussed the results of their clinical trial in humans comparing cannabinoid blood levels, carbon monoxide levels, and subjective effects in subjects who smoke and at other times vaporize marijuana (with the Volcano vaporizer). When subjects used vaporizers, the study found reductions in blood carbon monoxide levels as compared to smoking. In addition, the study showed that the vaporizer produced reliable levels of cannabinoids. The study also found that more subjects preferred vaporizing over smoking. This study was funded by a grant of about $136,000 from the Center for Medicinal Cannabis Research (CMCR). MAPS and CaNORML contributed an additional $100,000 on preliminary laboratory data analyzing the content of the vapors produced by the Volcano vaporizer.

Results of a second paper on vaporization (with the Volcano vaporizer) were presented by Arno Hazekamp, Ph.D, of Leiden University. This study "confirms that the pulmonary administration of cannabinoids by evaporation certainly has a clinical potential. With the Volcano a safe and effective cannabinoid delivery system seems to be available to patients."

September 9, 2005. Chemic Laboratories sends a letter to Assistant Secretary for Health Joel Egertson, responding to his July 27, 2005 letter (received August 15, 2005) rejecting Chemic's June 2003 application to NIDA to purchase 10 grams of marijuana for further vaporizer research. Chemic's letter rebuts every critique of the protocol used by Mr. Egertson and urges him to reconsider. After taking over two years to reply, HHS/NIDA's protocol reviewers didn't take the time to read the protocol carefully and made some rather basis mistakes in the review. HHS/NIDA's refusal to sell Chemic 10 grams of marijuana for MAPS-sponsored vaporizer research is yet another example of the need to break NIDA's monopoly on the supply of marijuana that can be used in legal research.

August 18, 2005. The Perspective Section of the New England Journal of Medicine published an article, "Medical Marijuana and the Supreme Court," by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.

August 15, 2005. Chemic Laboratories receives a response letter from the Department of Health and Human Services (view as html), rejecting the vaporizer protocol and recommending that NIDA not sell Chemic 10 grams of laboratory-grade marijuana for the vaporizer studies. This response took more than two years and arrived, coincidentally and conveniently, just one week before the start of the DEA Administrative Law Judge hearings over DEA refusal to grant a license to Prof. Craker, UMass Amherst, for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Chemic's reply to the critiques was sent to HHS/NIDA on September 9, 2005.

July 26, 2005. U.S. Congressional Representatives John Olver (D-MA) and Michael Capuano (D-MA) have sent a letter to DEA Administrator Karen Tandy urging DEA to issue a license to Prof. Craker for his MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. This letter will be sent to other members of Congress seeking additional signatures.

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

July 22, 2005. DEA files a motion seeking to disqualify four of our proposed witnesses. We'll prepare a reply within the next several weeks.

June 20, 2005. San Francisco Chronicle writer Joe Garofoli reports on the completion of the nation's first clinical human study on vaporization at UCSF. He gives an overview of vaporizer benefits and use, and informs readers how to obtain affordable vaporizers.

  A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American Prospect, The Nation, Reason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy.

December 10, 2004. After almost 18 months, DEA finally responds to the applications from Chemic Laboratories to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis, and to purchase 10 grams of marijuana from NIDA, for further vaporizer research. DEA claims that Chemic actually needs a "Research" license instead of an "Analytical Laboratory" license, which may take another 4-6 months to obtain. DEA's rationale is not stated but it seems that they now consider the research to be publicly funded, which requires a "Research" license. However, this research is not publicly funded. DEA's theory seems to be that since the analytical data has been used by Dr. Donald Abrams to obtain FDA permission for a clinical study comparing smoked v. vaporized marijuana, in a study funded by the State of California, that Chemic's privately-funded research is actually publicly funded. Chemic will immediately file for a "Research" license and we will seek more information about DEA's rationale.

December 7, 2004. Rep. Sam Farr (D-CA) has sent out a Dear Colleague letter to all member of the US House of Representatives, in response to a bill filed by U.S. Rep. Mark Souder that seeks to have the National Institute on Drug Abuse (NIDA) write a report about the "medical" uses of marijuana for FDA to distribute. Rep. Souder is the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources and the author of the much criticized bill that denies federal student loans to anyone convicted of a drug-related crime. Rep. Farr's letter questions whether NIDA is unbiased and cites NIDA's refusal in over 17 and 1/2 months to provide 10 grams of marijuana for vaporizer research (sponsored by MAPS and CaNORML). Federal obstruction of medical marijuana research is starting to get more attention. This may help generate pressure to break NIDA's monopoly on supply, which it uses to obstruct research.

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

November 29, 2004. We have a decision regarding MAPS' lawsuits against DEA and against HHS/NIH/NIDA regarding our claim of "unreasonable delay" in responding to MAPS-sponsored applications to NIDA to purchase 10 grams of marijuana for vaporizer research (submitted June 24, 2003), to DEA to import 10 grams of marijuana for vaporizer research from the Dutch Office of Medicinal Cannabis (submitted June 24, 2003), and to DEA for a license to grow marijuana for research at UMass Amherst (submitted June 2001).

MAPS's lawyer's assessment: The decision is very particular about the applications delayed, so they obviously read & at least partially understood what was what. Unfortunately, 17 months delay to the court (unlike patients needing pain relief) is no biggie, so we lose on compelling action on the application to HHS/NIDA to purchase 10 grams for research and on the application to DEA to import 10 grams. The 3 1/2 year delay in DEA non-response to the UMass Amherst application for a license to grow marijuana for research trips the further inquiry wire at DEA, however, so there apparantly is a chance for some oversite. Reconsideration (of the outright denials) must be filed within 14 days [5pm Dec. 6], which we will file.

  Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.

November 22, 2004. The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as "absurd."

  The Court required DEA to respond by December 22, 2004 to the portion of our lawsuit against DEA about the UMass Amherst marijuana production facility. This is a positive development in that DEA can no longer just delay and not have to explain why.

November 11, 2004. MAPS initiates work on a legal motion for expedited scheduling of our lawsuits against DEA and against HHS/NIH/NIDA. It's now been more than 3 1/2 months since July 21, 2004, when MAPS, Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana (WAMM) in Santa Cruz, California, and Prof. Lyle Craker, UMass Amherst, filed a lawsuit against DEA, and MAPS and Valerie Corral filed a lawsuit against HHS/NIH/NIDA.

The lawsuits claimed that the agencies were engaging in unreasonable delay in not responding to MAPS-sponsored requests to grow, import and purchase marijuana for a program of scientific research designed to develop marijuana into an FDA-approved prescription medicine. We hope the motion for expedited scheduling will get this case before the judge sooner than if we were to do nothing. The lawsuits have been filed in the United States Court of Appeals for the District of Columbia Circuit.

October 13, 2004. MAPS and MPP filed our amicus curiae brief today in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research. The goal of the brief is to educate the Supreme Court judges so that they don't rule against medical marijuana patients under the false assumption that the FDA drug development approach is a viable alternative to state medical marijuana initiatives and legislative actions. As long as the obstruction of MAPS' medical marijuana research efforts continues, the only way that patients can obtain legal access to the medical use of marijuana is through the decision of the 9th Circuit Court of Appeals, which decided that there was no interstate commerce involved when patients or caregivers grow marijuana for patients' personal medical use. That decision prohibited the federal authorities (DEA) from enforcing the Controlled Substances Act prohibitions against the use of marijuana, which the 9th Circuit judges declared unconstitutional when applied against patients or caregivers growing marijuana in states that had approved such use. MAPS and MPP's brief transforms our failure to obtain the necessary permissions and supply of marijuana for MAPS' research efforts into a weapon against the forces of repression (DEA and the Drug Czar ).

September 29, 2004. The second subject is enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The first subject was enrolled on September 21, 2004 (see that entry for more details about study design). This study is now well underway!

September 21, 2004. The first subject was enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The study requires subjects to live on an in-patient ward for 6 days, with each day involving either smoking marijuana or using the vaporizer. The research involves the use of 3 different marijuana cigarettes, one with 1.7 % THC, one with 3.5% THC and one with 7% THC. The cigarettes are cut in half and used in a randomized, double-blind manner, with half of each cigarette being smoked and the other half unrolled and the marijuana placed in the vaporizer.

July 29, 2004. MAPS files a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.

July 22, 2004. Newspapers around the country have carried an AP wire story on MAPS' lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research. An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.

July 21, 2004. MAPS, Prof. Lyle Craker and Valerie Corral, file lawsuits against DEA and against HHS/NIH/NIDA for obstructing medical marijuana research. MPP sends out a press release..

June 9, 2004. NIDA Director Dr. Nora Volkow responds to MAPS' letter of May 19, as well as MAPS' May 24, 2004 letters to HHS Secretary Tommy Thompson and Director of the National Institutes of Health Dr. Elias Zerhouni. Dr. Volkow writes, "As you know, NIDA is just one of the participants on the HHS review panel...It is not NIDA's role to set policy in this area...Moreover, it is not NIDA's mission to study the medicinal uses of marijuana or to advocate for the establishment of facilities to support this research. Therefore, I am sorry but I do not believe that we can be of help to you in resolving these concerns."

Conspicuosly missing from Dr. Volkow's letter was any information whatsoever about where in the process is the review of the vaporizer protocol. As a result, MAPS is now considering a lawsuit against HHS/NIDA claiming "unreasonable delay" under the Administrative Procedures Act.

May 19, 2004. MAPS has sent a letter to NIDA Director Dr. Nora Volkow, and all members of NIDA's National Advisory Council on Drug Abuse (NACDA), asking them to expedite the NIDA/HHS review of Chemic's vaporizer research protocol. Chemic initially submitted the protocol to NIDA on June 24, 2003, as part of a request to purchase 10 grams of NIDA's marijuana needed for the study. MAPS' letter explains that there has so far been an eleven month delay in MAPS' research agenda, while MAPS waits to see if NIDA/HHS considers the protocol to be "scientifically meritorious" and therefore worthy of the privilege of purchasing NIDA's low-potency marijuana. The letter protests that this is an unreasonable delay of MAPS' efforts to conduct research to evaluate marijuana's potential use as an FDA-approved prescription medicine. The letter informs Dr. Volkow and the members of the NACDA that NIDA/HHS is doing its best to provide clear and persuasive evidence that NIDA's monopoly on the supply of marijuana for research is a fundamental obstruction that must end, preferably with DEA licensing of the UMass Amherst production facility.

April 1, 2004. Congressman Mark Souder, Chairman of the U.S. House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources, held a hearing about "Marijuana and Medicine: The Need for a Science-Based Approach." MPP Executive Director Rob Kampia testified (video and transcript) and answered questions (video and transcript). During his comments, he discussed the importance of MAPS’ vaporizer research efforts as well as the UMass Amherst project.

March 19, 2004. Dr. Donald Abrams receives word that his FDA-approved Phase I vaporizer study is now ready to enroll subjects. He will be comparing cannabinoid and carbon monoxide levels and subjective effects in subjects who at different times inhale either marijuana smoke from a burning cigarette or marijuana vapors from the Volcano vaporizer. Being able to use a vaporizer in FDA-approved clinical trials is one of MAPS’ two prerequisites to justifying the expense of a $5 million effort to develop marijuana into an FDA-approved prescription medicine, the other prerequisite being an independent source of supply of marijuana for research other than using material from the National Institute on Drug Abuse (NIDA).

March 17, 2004. In an effort to find out what is going on with the Health and Human Services (HHS) review of the scientific merit of the vaporizer protocol, an exchange of email took place today between Willem Scholten, Head of the Dutch Office of Medicinal Cannabis and Rear Admiral, Assistant Surgeon General and Deputy Assistant Secretary for Health (Operations) Arthur J. Lawrence. Willem Scholten inquired about the status of the review.

Dr. Lawrence replied that the responsibility for the review was being shifted from his office and at the moment he didn’t know exactly to where or what was going on. He was, however, sure that, " this protocol will, as all proposed protocols for this sort of research are, be given fullest consideration and deliberation in the scientific review."

Somewhat dissatisfied with the review seemingly being on the slow track to nowhere, MAPS President Rick Doblin replied to Dr. Lawrence. He requested whatever help Dr. Lawrence could offer in expediting the review, noting that the protocol was first submitted for review on June 24, 2003 and that all we were asking for was to purchase 10 grams of NIDA marijuana and import 10 grams from the Dutch. He concluded by stating, "The vaporizer research project is part of MAPS’ efforts to work through the rigorous FDA drug review process to conduct exactly the sort of studies that DEA, ONDCP, NIDA, IOM, all claim to want to see conducted. Given the difficulties in purchasing a tiny amount of marijuana for this simple vaporizer research protocol, it should not be surprising why so many States have gone ahead and legalized the medical use of marijuana in one form or another without waiting for the FDA to approve its medical use on the basis of double-blind, randomized, placebo-controlled research."

Also, Dr. Scholten informed MAPS that some vaporizer research with the same Volcano device was being conducted in the Netherlands. We’ve sent a message to the researcher and look forward to collaborating and sharing information.

January 29, 2004. The scientific review of the vaporizer protocol being conduced by the federal Dept. of Health and Human Services is now being supervised by Assistant Surgeon General Arthur J. Lawrence Ph.D. Mr. Joel Egertson, senior drug policy advisor to the Secretary of HHS, has retired and the responsibility for the review has been reassigned. A revised and updated package of information has been submitted today by Chemic Labs to Assistant Surgeon General Lawrence. If HHS determines that the vaporizer protocol is scientifically meritorious, NIDA will agree to sell us 10 grams of marijuana and DEA will be required to address our request to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis. The protocol is a rigorous investigation and, if reviewed in an unbiased manner, will be determined to be scientifically meritorious. MAPS initially requested permission in June 2003 to purchase marijuana from NIDA and import marijuana from the Dutch. This delay is clear evidence why NIDA’s monopoly on supply of research marijuana serves more to obstruct than to facilitate marijuana research.

December 16, 2003. MAPS received a grant of $13,000 for further vaporizer research from the Marijuana Policy Project. The grant includes $5,000 for the writing of a scientific paper about the results of the research for submission to a journal indexed in Medline. Also included is $8,000 for a study of the cannabinoid content of each of the 1st, 2nd, and 3rd balloons created by the Volcano vaporizer from the same sample of marijuana. We want to see if we can eliminate the use of the 3rd balloon in clinical research if only minimal amounts of cannabinoids are released the third time the same sample is heated and vaporized. This study can be conducted only after we have been able to obtain approval from HHS to purchase 10 grams of marijuana from NIDA, a time-consuming hurdle that wouldn’t be necessary if MAPS had its own independent source of supply of marijuana that could be used in federally-approved research (as we have with MDMA and psilocybin, for example).

December 4, 2003. The manufacturers of the Volcano vaporizer that MAPS and CaNORML are using in our vaporizer research, STORZ & BICKEL GMBH & CO. KG, announce that they have received the Dr. Rudolf Eberle Prize, the prize for innovation of the State of Baden-Wurttemberg. This prize has been awarded on an annual basis since 1985 to small and medium-sized industrial and craft firms who have successfully implemented outstanding technical innovations. The prize committee uses the criteria of technical progress, special entrepreneurial achievement and the economic success of the innovation to make its decision.

November 14, 2003. Vaporizer protocol likely to start early in 2004. According to Dr. Donald Abrams, "As far as I know we are awaiting our award from CMCR. All approvals are granted and we plan to commence the vaporizer protocol in January 2004."

October 10, 2003. The analytical lab conducting the vaporizer research has received replies from NIDA and the DEA regarding its requests to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis and to purchase 10 grams from the National Institute on Drug Abuse (see entry below for June 24, 2003). The reply from NIDA came from Joel Egertson, Senior Drug Policy Advisor to the Secretary of Health and Human Services (HHS). Mr. Egertson wrote, "It has been determined that there is insufficient information in the application to judge the merits of the proposal. " Mr. Egerston had been submitted the protocol for which the 10 grams was requested but asked for additional information that has already been generated from previous research protocols and has already been submitted to the FDA. This additional information will be submitted to Mr. Egerston very soon for HHS review.

The reply from DEA indicated that it would not proceed with the import permit until the scientific merits of the protocol had been accepted by HHS.

While a decision on these requests has been delayed, we believe we can adequately address all the issues raised by HHS and DEA. Yet again, this prolonged process to purchase tiny quantities of marijuana for important privately-funded research demonstrates the need for MAPS to sponsor a privately-funded facility to produce marijuana for federally-approved research, as we are attempted to do in partnership with Prof. Craker at UMass Amherst.

June 24, 2003. Grant for Vaporizer Study with Humans Approved Contingent upon Regulatory Approval. California’s Center for Medicinal Cannabis Research (CMCR) preliminarily approved Dr. Donald Abrams’ Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000, contingent upon the protocol obtaining all the necessary regulatory approvals. The study will compare subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath in subjects on six different days, three days smoking 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC, and three days vaporizing 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC.

The protocol now goes to FDA for its review, finally. The big question is whether the FDA will want more data than MAPS and California NORML have already gathered on the Volcano (www.vapormed.de) or will accept the data we have already submitted, which is more than FDA has about what is in marijuana smoke post-combustion. We should hear from FDA within 4-6 weeks or so.

Also reviewing the protocol will be NIDA (since NIDA pot is being requested), DEA (supposedly to see what it can do to prevent the diversion of research supplies), and the Research Advisory Panel of California (which reviews all Schedule I research in California). The key review will be by FDA, since it will decide whether or not MAPS and California NORML need to raise more funds for additional vaporizer research.

June 24, 2003. Maps Working to Import Dutch Cannabis for Research. MAPS has completed negotiations with the head of the Dutch Office of Medicinal Cannabis for the importation of ten grams of high THC, high CBD marijuana for use in the next phase of the vaporizer research project. Chemic Laboratories, where the project will be conducted, has submitted an application to the DEA for an import license. This request to the DEA is, to our knowledge, the first attempt to import the marijuana plant from the Netherlands, through the newly established Office of Medicinal Cannabis. Chemic Laboratories has also submitted a request to NIDA for ten grams of its best quality product for the vaporizer project.

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"Study Shows Vaporizer Can Drastically Reduce Toxins in Marijuana Smoke"
California NORML/ MAPS Press Release — May 2, 2003

"Vaporizer Research: An Update"   (PDF Format)  
Dale Gieringer, Ph.D. (canorml@igc.apc.org)
MAPS Bulletin, Spring 2003; Volume XIII, Number 1

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April 15, 2003. Vaporizer Study Report. The Vaporizer report is now available. The findings show substantial reduction (about 99%) in certain toxins in the vapor as compared to marijuana smoke, and substantial amounts of cannabinoids produced by the vaporizer. The results could hardly have been better. This report has been submitted to FDA as part of Dr. Donald Abrams’ IND application to study subjective effects and cannabinoid blood levels in subjects who both smoke marijuana and then at a later time inhale marijuana vapors. We should hear from FDA in early May about what additional information, if any, it needs to have before deciding if the vaporizer can be used in a clinical trial.

January 21, 2003. MAPS and CANorml sign a contract for a $25,000 protocol study to evaluate the contents of the vapor stream from the Volcano Vaporizer (http://www.vapormed.de). The purpose of the study is stated in the contract as follows: This protocol is intended to provide guidance on the completion of an extraction evaluation of emissions produced when marijuana is vaporized using the Volcano; to provide evidence of product efficiency to MAPS, which would subsequently design and seek agency (FDA) approval for the protocol development and initiation of a Phase I clinical investigation comparing cannabinoid blood levels in subjects smoking (i.e. pyrolysis) marijuana versus marijuana vaporized with the Volcano, and to meet the requirements of cGMP: 21 CFR Part 160.

We expect the study to be completed by the end of March 2003.

 

• www.vapormed.de
• www.volatizer.com
• www.air-2.com
• www.de-verdamper.nl/vaporeizere.html
• www.aromed.com

SUMMARY: Published in MAPS Bulletin Volume IX Number 3
MAPS Succeeds in Securing an Orphan Drug Designation for Marijuana (1999)

• May 1999: Letter of Approval from FDA for MAPS’ ODD application
• February 1999: MAPS’ fifth amendment in response to the December 1998 rejection
• December 1998: Third letter from FDA rejecting the application/amendments 2-4
• November 1998: Fourth amendment from MAPS to the FDA
• August 1998: Third amendment from MAPS to the FDA
• June 1998: MAPS’ 2nd amendment in reponse to the 2nd FDA rejection
• March 1998: Supporting letter from Dr. Alice Tang
• November 1997: Second letter from FDA rejecting the application
• October 1997: Supporting letter from Dr. Alice Tang
• September 1997: MAPS’ first amendment in reponse to the first rejection
• September 1997: Supporting letter from Dr. Kathleen Mulligan
• September 1997: Supporting letter from Dr. Donald Abrams
• June 1997: First letter from FDA rejecting the application
• April 1997: Letter from FDA acknowledging the application was received
• April 1997: MAPS’ original application to FDA

January 26, 2009. Mimi Peleg Provides Guidance to Medical Marijuana Facility in Israel:

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

January 9, 2009. Medical Marijuana Donation Leveraged in Israel 

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

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

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

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

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

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

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

December 1, 2008. Israel Medical Marijuana Production Facility Receives $15,000 in Matching Funds: MAPS sent $15,000 to an Israeli medical marijuana production facility directed by Yohai Golan, who produces medical marijuana with a license from the Israeli Ministry of Health. This was a matching grant, which required Yohai to first raise $15,000, which he was able to do. The production facility has legal permission to grow and distribute marijuana to Ministry of Health-approved patients. However, the facility must give away the medicine for free and cannot sell it until marijuana has been approved as a prescription medicine by the Ministry of Health -which will require substantial clinical research. In the long run, this policy requiring the free distribution of medicine is an unsustainable model because the facility can only operate on donations while the patient base is steadily increasing. Meanwhile, some useful data is being gathered from the patients provided medicine by the facility and more doctors and patients are becoming comfortable with medical marijuana use.

October 15, 2008. We are requesting that MAPS supporters actively help us recruit subjects for Dr. Abrams National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are already using opioid medications for pain. This is one of only two medical marijuana studies in patients currently taking place in the US. Dr. Abrams investigation was scheduled to conclude in Fall 2008, but the study completion date has been extended to January 9th, 2009, in order to provide more time to recruit subjects. The study (PDF) was designed for 24 subjects, 16 of which have completed the study and an additional 8 more are needed. MAPS is supporting this study by paying for travel and lodging for participants who live outside of the San Francisco Bay area, with funding donated to MAPS by California medical marijuana dispensaries Capital Wellness Collective, Harborside Health Center, and Green Door, as well as from Oaksterdam University. It is urgent that the study, finds the remaining subjects. Preliminary results are positive and the study will be more persuasive if the initially intended number of 24 subjects is actually enrolled. Supporters can help us by downloading flyers (PDF) and posting them at facilities such as medical marijuana dispensaries, and pain management centers. We would also appreciate it if people would post the text found in this link on appropriate web pages, blogs, and online forums. Subjects cannot have used marijuana within the previous 30 days, so pain patients on opiates from states without medical marijuana laws may be especially interested in volunteering for the study. If you would like more information about how you can help us recruit patients for this study, please contact: randolph@maps.org

October 10, 2008. David Bronner, of Bronner’s Magic Soaps, has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachi’s facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years David has also donated $15,000 as a matching grant to a second Israeli medical marijuana production facility, led by Yohai Golan. Current Israeli medical marijuana regulations require that marijuana providers not charge for medicine. Providers must give the medicine away for free to Ministry of Health-approved patients, which is why the project needs subsidies. Yohai has raised $25,000 in matching funds from Israelis in response to David’s $15,000 matching grant, so we are now seeking an additional $10,000 to match the additional Israeli matching funds. If any MAPS supporters are able to or know someone who would be interested in helping match the other $10,000, please contact us. David has also donated $5000 to Philippe Lucas of Vancouver Island Compassion Society (VICS) for research with patients who have been provided marijuana from VICS over the last several years. David had previously donated $8000 to this project. The goal of this research is to see if we can match demographics of patients with particular strains of marijuana, in order to see if particular strains are best for particular illnesses and medical needs.

November 27, 2007. 

SYNOPSIS OF DEA RESCHEDULING DRONABINOL

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

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

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

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

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

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

November 9, 2007. The American Psychiatric Association has passed a unanimous resolution supporting medical marijuana.

November 4, 2007. According to a new study by Swiss researchers, teenagers who smoke marijuana but not tobacco appear to be more likely to get good grades, play sports and live with both parents than those who also use tobacco. Moreover, the study found that teens who smoke pot were more likely to have a good relationship with their friends than teens who smoked neither tobacco nor pot, found the study published in the November issue of Archives of Pediatrics & Adolescent Medicine. Click here to read a report.

June 16, 2007. An anonymous donor has pledged $10,000 to MAPS to enable MAPS to provide technical assistance to a small, legal medical marijuana production facility in Israel. The facility will be directed by an Israeli medical marijuana advocate, and has been authorized by the Israeli Ministry of Health to provide marijuana only to medical marijuana patients formally approved by the Ministry. MAPS is working to provide technical assistance to create an organic, hydroponic, standardized production facility, which will start small and give marijuana away for the next several months. Once a successful track record has been established, the Ministry will determine whether to permit the facility to produce medical marijuana on a commercial basis.

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

May 1, 2006. Two Texas researchers found that the ONDCP’s anti-marijuana public service announcements may actually have made their attitudes toward pot less negative. The study, by M Czyzewska and HJ Ginsburg, was published electronically in the journal "Addictive Behaviors" (PDF).

April 28, 2006. A letter to FDA was sent by 24 Members of Congress asking for the scientific basis of the recent statement by FDA on the medicinal potential of marijuana first published on April 20, 2006.

April 27, 2006. The critical backlash against the FDA’s transparent politicization of science continued with a thorough and well-documented article in The Economist entitled "Reefer Madness: Marijuana is medically useful, whether politicians like it or not." The article discusses Prof. Lyle Craker’s proposed MAPS-sponsored medical marijuana production facility and his ongoing MAPS-supported DEA lawsuit.

April 21, 2006.  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.

November 30, 2005. MAPS and MPP file an amicus curiae brief in the on-going Raich v. Gonzales case. On June 6, 2005, the US Supreme Court rejected the decision of the 9th Circuit Court of Appeals that there was no interstate commerce, and thus affirmed federal jurisdiction over state medical marijuana laws. However, a new lawsuit making other legal arguments has been filed. The amicus curiae brief describes the federal obstruction of MAPS’ efforts to conduct federally-approved medical marijuana research.

December 7, 2004. Rep. Sam Farr (D-CA) has sent out a Dear Colleague letter to all member of the US House of Representatives, in response to a bill filed by U.S. Rep. Mark Souder that seeks to have the National Institute on Drug Abuse (NIDA) write a report about the "medical" uses of marijuana for FDA to distribute. Rep. Souder is the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources and the author of the much criticized bill that denies federal student loans to anyone convicted of a drug-related crime. Rep. Farr’s letter questions whether NIDA is unbiased and cites NIDA’s refusal in over 17 and 1/2 months to provide 10 grams of marijuana for vaporizer research (sponsored by MAPS and CaNORML). Federal obstruction of medical marijuana research is starting to get more attention. This may help generate pressure to break NIDA’s monopoly on supply, which it uses to obstruct research.

April 1, 2004. Congressman Mark Souder, Chairman of the U.S. House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources, held a hearing about "Marijuana and Medicine: The Need for a Science-Based Approach." MPP Executive Director Rob Kampia testified (video and transcript) and answered questions (video and transcript). During his comments, he discussed the importance of MAPS’ vaporizer research efforts as well as the UMass Amherst project.

• Statement of ROBERT J. MEYER, M.D., FDA, on Medical Marijuana.
• Testimony of Nora Volkow, Director of NIDA, to Cong. Souder.

February 16, 2004. John Gilmore donates $100,000 to MAPS for the creation of a start-up fund to assist new research projects in getting off the ground, with the first project being the UMass Amherst medical marijuana production facility. John’s intention is for the start-up fund to be used as a catalyst to start the UMass Amherst project, with the money to be replenished if the UMass Amherst project becomes fully funded so that the funds can then be used again to help catalyze another research project.

December 16, 2003. Medical marijuana patient Angel McClary Raich and her caregivers and Diane Monson won in an historic Ninth Circuit decision in their injunction against Ashcroft, the DEA Chief, and the Federal Government. The Court declared the Controlled Substances Act unconstitutional for violating rights under the Commerce Clause if the marijuana isn’t sold, transported across state lines or used for non-medicinal purposes.

MAPS, MPP and Dr. Ethan Russo filed an amicus curiae brief in this case, which can be found here. We testified about Executive branch obstructionism of medical marijuana research and concluded, "The Court should not rule against patients’ constitutional rights to use cannabis based on the illusion of a well-functioning FDA-approval process. Executive branch obstructionism has made it necessary for patients to assert their constitutional rights to use cannabis as a legal ’safety net’ for a limited number of patients."

In its decision, the Court noted, "The appellees also contend that granting the appellants’ requested injunction would create a slippery slope as other plaintiffs seeking use of other schedule I controlled substances would bypass the statutory process established by Congress. The appellees claim that the appellants’ proposed injunction therefore has the potential to significantly undermine the FDA drug approval process. Our holding is sufficiently narrow to avoid such concerns." Though the Court didn’t point this out, it’s totally hypocritical for the Bush Administration to accuse Angel Raich of undermining the FDA drug approval process when DEA, with ONDCP support, is obstructing privately-funded medical marijuana research by not granting a license to grow marijuana for research to Prof. Craker at UMass Amherst (Read this for more details).

Fortunately, the Court’s decision will increase pressure on the Bush Administration to approve the UMass Amherst marijuana production facility by making it more obvious that a denial just increases the need for patients like Angel to grow their own medicine free from federal persecution.

The Court’s decision is here. Click on "opinions" at the upper left. Then select Raich vs.. Ashcroft Download the major pleadings from the litigation (Raich v. Ashcroft) here and here.  Also read the Dec. 16, 2003, Associated Press article, " Federal Appeals Court OKs Medical Marijuana in Some Cases"

April 30, 2003. MAPS, MPP and Dr. Ethan Russo filed an updated version of this amicus curiae brief in the US Court of Appeals for the Ninth Circuit case of Angel Raich et al. v. John Ashcroft as Attorney General and Asa Hutchinson, Administrator of the DEA. (PDF Format)

Dr. Russo has abandoned his struggle to conduct FDA-approved research. Instead, he has designed a basic safety study of the few patients remaining alive who legally receive marijuana from NIDA as part of the Compassionate IND program that was closed by HHS in 1992. MAPS donated $10,000 to this study, which started in May 2001. Preliminary results of the study show therapeutic benefits, with no significant adverse effects. The final paper about the study, reference below, reports on the study in detail.

[ Russo E, Mathre ML, Bryne A, Velin R, Bach P, Sanchez-Ramos J, Kirlin K. Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis. Journal of Cannabis Therapeutics Vol. 2 (1) (2002): 3-57. ]

View Dr. Russo’s powerpoint presentation, "Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of the Benefits and Adverse Effects of Legal Clinical Cannabis" (IE4+ required to view this presentation)

Read about the struggle to begin medical marijuana research in the 90’s.

November 9, 2002. Dr. Donald Abrams and Dr. Ethan Russo report on their medical marijuana research at the Marijuana Policy Project (MPP)/Students for a Sensible Drug Policy (SSDP) conference in Anaheim, California.

View Dr. Abrams’ powerpoint presentation, "Clinical Trials of Cannabis in California." (IE4+ required to view this presentation)

View Dr. Russo’s powerpoint presentation, "Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of the Benefits and Adverse Effects of Legal Clinical Cannabis" (IE4+ required to view this presentation)

In addition to supporting Dr. Abrams’ protocol investigating the effects of marijuana in HIV+ subjects, the first study in 15 years to investigate the therapeutic application of cannabis, MAPS has supported the efforts of Dr. Ethan Russo, University of Montana, for expenses involved in preparing NIH grant applications for the study of the use of marijuana in the treatment of people whose migraines fail to respond to conventional medications. This study continues to face difficulties in getting started. In 1997, MAPS submitted an application to the Food and Drug Administration’s Office of Orphan Drug Products requesting that cannabis be designated an Orphan Drug for the treatment of AIDS wasting syndrome. This effort recently came to fruition. MAPS has also co-funded studies of medical marijuana potency and water pipes and vaporizers.

March 2, 2002. "Netherlands to run trials of marijuana in patients with multiple sclerosis" Tony Sheldon British Medical Journal () 324:504.

The Dutch government has announced a small scale cross over trial into the effect of three sorts of medical marijuana, plus a placebo, on 16 patients with multiple sclerosis.

Two foundations in Rotterdam, the Institute for Medical Marijuana and Maripharm, have been contracted by the government to produce the drug to a standard quality and provide metal pipes for inhalation.

A Bureau for Medical Cannabis, set up by the ministry and the Amsterdam’s Free University medical centre, will run the year’s trial.

The bureau also intends to make medicinal cannabis available through pharmacists on prescription by spring 2003. The Dutch cabinet recently agreed to change the law to permit this.

Four trials of cannabis are taking place in the United Kingdom. The cannabis in multiple sclerosis (CAMS) study, which is sponsored by the Medical Research Council, started at Derriford Hospital, Plymouth, last year and aims to take in 660 participants in 40 centres.

Three smaller phase II trials - in Guernsey, Oxford, and Norfolk - have been under way since autumn 2000, examining a sublingual spray developed from plants grown by G W Pharmaceuticals in Kent. The researchers expect to extend these trials to 2000 patients over two years and to enroll not only people with multiple sclerosis but also patients with various chronic pain syndromes, such as neuralgia and lower back pain.

February 20, 2001, MAPS, MPP and Dr. Ethan Russo filed an Amicus Curiae brief in the medical marijuana case, US v. Oakland Cannabis Buyers’ Cooperative. Even though FDA approved Dr. Russo’s MAPS-supported protocol to study the use of smoked marijuana in treating patients suffering from migraines, NIDA refused to supply the marijuana. As a result, Dr. Russo’s study never took place. We have tried to turn our frustrating experience with NIDA to the advantage of medical marijuana patients by letting the U.S. Supreme Court know that the FDA drug development process is politically obstructed. Our brief’s basic point is that these obstructions create more of a need for the medical necessity defense for patients who run into conflict with the police over their use of marijuana as medicine.

November 28, 2001. "University of California at San Diego Gets Approval for Medical Marijuana Study"

A California university has received final approval from the federal government for a study on medical marijuana.

Two professors of neurology at the University of California at San Diego Medical Center plan to study the effects of marijuana on patients with multiple sclerosis and those who suffer neuropathy, or nerve pain, associated with AIDS.

The studies will be the first to emerge out of the university’s Center for Medicinal Cannabis Research (CMCR), a program created by the state Legislature in 1999.

Since California became the first state to approve medical marijuana in 1996, six other states have followed suit. Federal law, however, prohibits the sale of marijuana for medical uses.

The Drug Enforcement Administration granted the final approval Wednesday, saying it hoped to introduce some science into what has been an emotionally charged debate. The agency maintains that past studies have shown no medical benefit to smoking marijuana.

"The question of whether marijuana has any legitimate medical purpose should be determined by sound science and medicine," DEA Administrator Asa Hutchinson said in a statement.

July 2001. San Mateo County health officials received their first shipment of government grown medical marijuana last week. The federally-provided pot will be dispensed imminently to local AIDS patients as part of a groundbreaking local study to better determine the herb’s therapeutic value.

"I see this as a milestone -- a first step -- toward the day when this drug will be available for doctors to prescribe for people who are suffering in great pain," said Michael Nevin, President of the San Mateo County Board of Supervisors. Nevin first began lobbying for the program in 1997 and received federal permission to implement the plan last November.

In April, local health officials requested 300 marijuana cigarettes from the federal National Institute on Drug Abuse (NIDA). The shipment -- approximately a two-month supply, according to health officials -- arrived at San Francisco International Airport last Wednesday. Federal researchers cultivate marijuana for research purposes at the University of Mississippi at Oxford. NIDA is the only legal supplier of marijuana in the United States.

Sixty local AIDS patients will have access to the government-grown pot as part of an 18-month study to evaluate the drug’s ability to mitigate symptoms of the AIDS wasting syndrome. Only patients who have prior experience using marijuana are eligible to participate in the program, which will be led by Dr. Dennis Israelski, chief of infectious diseases and AIDS medicine at San Mateo County Hospital and Clinics.

Although there exists a large body of anecdotal evidence indicating that marijuana provides symptomatic relief for patients with AIDS, almost no scientific research has been conducted on humans. Preliminary results announced last year from an ongoing University of California-San Francisco study found that patients who smoked marijuana gained significantly more weight on average than those receiving a placebo, and had slightly lower viral levels.

Patients interested in participating in the trial may contact Mark Traves, Project Coordinator, at (650) 573-2748.

Articles Related to the San Mateo County Study

• "New Life Breathed into Marijuana Study"(June 12, 2003)
• "Doctors Want Better Marijuana for Study" (January 24, 2003)
• "Lone Patient Quits Marijuana Study" (October 3, 2001)
• "Medicinal Pot Study Under Way: San Mateo County Says the Project Is a Preliminary Step Toward Large-Scale Research into the Subject" (August 5, 2001)
• "Marijuana Study Finds 1 Patient Joint-worthy" (July 25, 2001)

May 21, 1999. HHS Policy Statement about Access to NIDA’s Marijuana. Announcement of the Department of Health and Human Services’ Guidance on Procedures for the Provision of Marijuana for Medical Research.

February 25, 1997 NIH Workshop on the Medical Utility of Marijuana. MAPS report (Turning Protests into Protocols: Dr. Harter´s Legacy) to NIDA’s Expert Panel on Medical Marijuana Research - submitted February 25, 1997 following the February 19-20, 1997 NIH Workshop on the Medical Utility of Marijuana held at the NIH Campus in Bethesda, MD. Five recommendations to proactively expedite medical marijuana research.

1997 S made available a document at the NIH Workshop on the Medical Utility of Marijuana: Private And State-Funded Medical Marijuana Research Should Be Encouraged, Not Prohibited

December 2, 1996. After Proposition 200 and 215
December 2, 1996 Senate Judiciary Committee Hearing on Medical Marijuana - A message to new visitors of the MAPS website.
MAPS Policy in Response to Prop. 200 and Prop. 215

August 22, 1996: NIH Grant Application Process
NIH August 1996 Rejection and Critique of "Smoked Marijuana for HIV-Associated Anorexia and Wasting Protocol"

Summer, 1996. Water Pipe Study by Dale H. Gieringer, Ph.D. (Summer 1996)
Why Marijuana Harm Reduction? by Dale H. Gieringer, Ph.D. (Summer 1996)

April 1996. Smoked Marijuana for HIV-Associated Anorexia and Wasting Protocol, (IND#43,542) submitted to the NIH May 1, 1996 by Dr. Donald Abrams.

1995: FDA-approved research and the effort to begin it Dr. Donald Abrams’ FDA-approved research protocol, (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.

• NIDA rejection letter (April 1995) regarding request for marijuana for Dr. Donald Abrams´ FDA-approved study.
• Reply to NIDA by Dr. Donald Abrams
• Comment by Rick Doblin on the NIDA decision.
• Letter to the New England Journal of Medicine.

1994 A comprehensive clinical plan developed by MAPS in consultation with the FDA for the investigation of marijuana’s medical use in the treatment of the HIV-related wasting syndrome. This Clinical Plan was submitted with Dr. Donald Abrams’ research protocol (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.It is designed to also be adapted for indications other than the wasting syndrome. Originally printed in the Summer 1994 MAPS Newsletter.

Minimum Informational Requirements for Establishing an FDA Drug Master File for Cannabis - Questions To Be Answered by Potential Manufacturers.

1990 Doblin/Kleiman Survey of Oncologists

• Doblin RE, Kleiman MA. Marijuana as antiemetic medicine: a survey of oncologists’ experiences and attitudes. J Clin Oncol 1991 Jul;9(7):1314-9.
• 2002 New York Times Mention of Survey
• Reed Irvine, Letter to the Editor
• Doblin/Kleiman Response
• All Scientific Papers and Media Mentions of the Survey

Follow these links for information about MAPS’ sponsored Medical Marijuana studies

• Dr. Abrams’ short term effects of cannabinoids in HIV infection study
• Dr. Russo’s cannabis in migraine treatment study
• Medical marijuana potency testing project

• Visit Marijuana Policy Project, a lobbying organization which has assisted in putting pressure on NIDA on behalf of research
• Website of Dr. Lester Grinspoon and James. B. Bakalar of Harvard Medical School, authors of Marihuana: The Forbidden Medicine
• For information about California State-funded medical marijuana research projects, coordinated by the Center for Medicinal Cannabis Research (CMCR), look here.
• For information about GW Pharmaceutical Company research into the medical uses of marijuana extracts, see their website

November 6, 2008. Slate Magazine contributor Amanda Schaffer wrote an excellent article on the promise of, and obstacles to, medical marijuana research. The article discusses a variety of successful research applications of marijuana and marijuana derivatives.

November 29, 2007. This press release discusses the North Dakota Supreme Court’s rejection of the 8 year bid of North Dakota farmers to grow industrial hemp as well as the signing of a Memorandum of Understanding between North Dakota State University (NDSU) and the ND Supreme Court.

August 26, 2007. MAPS President Rick Doblin gave a comprensive interview about MAPS’ medical marijuana efforts on Health Radio with Dr. Meg Jordan. Click here to listen to the full interview.

August 9, 2007. Orange County Register Senior Editor Alan Bock published an insightful editorial about the implementation of California’s medical marijuana law. Bock connects the challenges of implementation to the federal government’s obstruction of scientific research. He descibes MAPS’ effort to establish the nation’s first privately-funded research-grade marijuana production facility at UMass-Amherst, which would pave the way for an FDA drug development effort with marijuana.

July 3, 2007. MAPS President Rick Doblin, PhD, appeared as a special guest and gave a lengthy interview on the Deborah Ray Healthy Talk Show. (The interview comes on about halfway into the show.)

June 29, 2007. Nature published an excellent article ("Scientists stir the pot for right to grow marijuana") about MAPS’ campaign to break the federal government’s illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA’s standards for safety and efficacy.

May 31, 2007. The Los Angeles Times published a strongly supportive editorial in favor of MAPS and Prof. Craker in their struggle with the DEA to break the federal government’s monopoly on medical marijuana research by establishing an independent research-grade marijuana production facility at University of Massachusetts.

May 21, 2007. The Economist published a great editorial in favor of MAPS and Professor Lyle Craker’s application to establish the nation’s first privately funded medical marijuana production facility.

April 15, 2007.  This op-ed published in the Sacramento Bee is an excellent summary of the political and legal implications of MAPS’ recent legal victory over the DEA in MAPS’ quest to put marijuana through FDA clinical trials.

February 13, 2007. The Washington Post reported in "Research Supports Medicinal Marijuana" on Dr. Donald Abrams’ double-blind study of smoked marijuana for HIV-related peripheral neuropathy that was published in the respected journal Neurology. The findings showed that marijuana can be a safe and effective medication for many people with this condition, and is evidence of marijuana’s therapeutic potential. Yet, no researchers are continuing Dr. Abrams’ promising research, because NIDA’s monopoly and arbitrary review process deters any private sponsor from investing in a medical marijuana drug development effort. The article finished by mentioning MAPS’ victory in our lawsuit against DEA/NIDA, although it unfortunately doesn’t explicitly connect the two issues.

January 31, 2007. Reuters reported in "Smokable Pain Drugs Promise Faster Action" on Alexza’s development of smokeable drugs for migraine, pain, panic and agitation. This development could have implications for research with medical marijuana, since one of the government’s main arguments has been that no legitimate medicine is smoked.

December 4, 2006. "Safer Deals: the Pastor" was published in Crawford, Texas’ Lone Star Iconoclast this week, describing some of the unusual alliances that have been formed between religious groups and secular activists in order to help medical marijuana research gain credibility. MAPS isn’t mentioned explicitly but Professor Lyle Craker’s DEA lawsuit for a MAPS-sponsored marijuana production facility is mentioned.

November 29, 2006. Of particular applicability to MAPS’ medical marijuana drug development efforts is Brian Vastag’s new article, "US marijuana laws clamping the lid on pot research," published in Nature Medicine, which speaks to the difficulties faced by marijuana researchers.

May 28, 2006. The Boston Sunday Globe published "Weed Control," an article describing the proposed medical marijuana growing facility at the University of Massachusetts-Amherst, the current government monopoly on marijuana grown for research and the MAPS-supported lawsuit filed against the DEA to end this monopoly. The piece describes MAPS’ involvement in developing the proposed facility and features quotes from MAPS’ president Rick Doblin. The article, with multiple graphics, was the lead article in the Ideas section which most everyone reads since it contains the editorials, the op-eds and other feature articles.

May 21, 2006. The New York Times published a letter to the editor from Jerry Epstein of the Drug Policy Forum of Texas, in which he cites the federal governement’s obstruction of Dr. Lyle Craker’s proposed MAPS-sponsored medical marijuana production facility as an example of its "insane policy against the medical use of marijuana". Click here to read the full text of Epstein’s letter.

May 5, 2006. The LA Times published "Puffing is the Best Medicine", an opinion piece by Lester Grinspoon supporting smoking as an effective means of taking medical marijuana in response to a recent statement on this topic from the FDA.

April 26, 2006. The San Diego Union-Tribune published an Op Ed piece by Stephen Sidney and Bruce Mirken on the FDA statement on medical marijuana.

April 23, 2006. The Chicago Tribune responded to the FDA’s recent statement concerning the medicinal potential of cannabis with an editorial, "Dissembling on Medical Pot" that quotes Prof. Lyle Craker of the University of Massachusetts at Amherst, saying "The reason there’s no good evidence is that they don’t want an honest trial."

April 22, 2006. The New York Times published an editorial, "The Politics of Pot" that refers to the FDA statement on the medicinal value of marijuana as "disingenuous," and ending with this statement, "It’s obviously easier and safer to issue a brief, dismissive statement than to back research that might undermine the administration’s inflexible opposition to the medical use of marijuana."

April 21, 2006.  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.

April 7, 2006. The Daily Nexus published Activists Assemble for Cannabis Conference, announcing The Fourth National Clinical Conference on Cannabis Therapeutics at Santa Barbara City College, which features lectures from doctors, health care researchers and patients, as well as talk show-host and medical marijuana advocate Montel Williams.

January 31, 2006. Click here to listen to a podcast news update produced by MAPS about Prof. Lyle Craker’s MAPS-supported lawsuit against the DEA for obstructing a MAPS-sponsored medical marijuana production facility.

December 27, 2005. The New York Daily News Washington Bureau published a succint and informative article about the DEA Lawsuit.

December 19, 2005.  The Daily Journal published Ole Miss marijuana monopoly under fire, reporting on the University of Mississippi’s insistence that their marijuana is of an acceptable grade.

December 15, 2005. Join Together published Researchers Seek New Source of Marijuana.

December 13, 2005. The Associated Press published Prof. questions gov’t monopoly on marijuana, a positive article about the DEA Lawsuit.

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

December 12, 2005. The Washington Post published Federal Marijuana Monopoly Challenged, an article that comprehensively summarizes the MAPS/Craker DEA Lawsuit, quoting Lyle Craker, Rick Doblin, and Grover Norquist.

November 29, 2005. NORML.org published NIDA’s Pot Monopoly To Resume Next Month.

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

September 27, 2005. The cannabis based medicine, Sativex, is effective in reducing central neuropathic pain and sleep disturbance in people with Multiple Sclerosis (MS) in a UK study published today in the medical journal, Neurology.

September 19, 2005. An article from Salon.com marks the The Return of Reefer Madness, as the US Drug Czar’s marketing implies a connection between marijuana and insanity.

September 1, 2005. A summary of recent press coverage of the MAPS/Craker/DEA hearing is available here.

August 27, 2005. The New York Times published op-ed column "Marijuana Pipe Dreams" by John Tierney, reporting on the current Craker-DEA lawsuit. In a subsequent letter to the editor responding to the mention of a Marinol patient choking to death on his own vomit, Michael Simmons informed the New York Times of the vomit-choking myth.

August 25, 2005. The Sacramento Bee Washington Bureau published Clash over pot research gets personal, an article about the DEA-Craker lawsuit proceedings including a quote from Rick Doblin.

August 18, 2005. The Perspective Section of the New England Journal of Medicine published an article, "Medical Marijuana and the Supreme Court," by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.

August 17, 2005. Commentary in the Journal of the American Medical Association (JAMA), by Dean Lawrence Gostin, Georgetown Law School, criticizes NIDA for blocking medical marijuana research. The article is entitled, "Medical Marijuana, American Federalism, and the Supreme Court."

June 20, 2005. San Francisco Chronicle writer Joe Garofoli reports on the completion of the nation’s first clinical human study on vaporization at UCSF. He gives an overview of vaporizer benefits and use, and informs readers how to obtain affordable vaporizers.

June 20, 2005. A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American Prospect, The Nation, Reason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy.

June 13, 2005. The Boston Globe runs an article by Cathy Young entitled, "The Medical Pot Hysteria," that includes a mention of Sally Satel’s terrific New York Times op-ed piece talking about federal obstruction of research.

June 8, 2005. Sally Satel pens an Op-Ed in the New York Times today about medical marijuana, focusing on Lyle Craker, UMass Amherst and Federal obstruction of medical marijuana research.

Wired Magazine writes Legal Pot’s No Pipe Dream, discussing the recent Supreme Court decision on medical marijuana and MAPS efforts to estabish a medical marijuana pilot production facility at the University of Massachussets at Amherst with Professer Lyle Craker.

DesMoines Register Columnist Rekha Basu delivers a compassionate and practical article on the benefits of marijuana and the "Catch-22" of the present medical marijuana struggle. She dicusses the treatment limitations that patients with serious illnesses face and urges Americans to "push their representatives for legalization of medicinal marijuana and for more unbiased research."

June 7, 2005. Eric Bailey of the LA Times writes: Marijuana Patients Remain Defiant

Ryan Grim, Salon Magazine, publishes his article A guide to Gonzales vs. Raich, What the medical marijuana ruling means for patients, the commerce clause, marital sex, Antonin Scalia’s career and more. Ryan writes "But if the Supreme Court told us nothing else on Monday, it was that if this drug quagmire is ever going to end, it’ll have to be stopped by the ones who started it: members of Congress. Until then, we’ll gradually build our way to a society where half the population is locked in prison and the other half is guarding the prisoners."

Nature.com offers an article by Mark Peplow discussing the U.S. Supreme Court ruling against medical marijuana, mistakeningly stating that over the past two years MAPS has spent over $2 million on marijuana research when in fact, MAPS has spent that figure on all psychedelic research projects.

June 6, 2005. The Washington Post reports on today’s Supreme Court decision supporting Federal power over State’s rights in medical marijuana law: A Defeat For Users Of Medical Marijuana. The article quotes John Walters, President Bush’s director of national drug control policy, who said: "Our nation has the highest standards and most sophisticated institutions in the world for determining the safety and effectiveness of medication. Our national medical system relies on proven scientific research, not popular opinion."

However, the WP article fails to adequately address Federal obstruction of all attempts to engage in research to demonstrate the medical efficacy of marijuana, exemplified by the difficulty MAPS has in obtaining Federal approval for The Amherst MMJ production facility project.

May 11, 2005. Cannabis Culture offers an article on medical marijuana patient Angel Raich’s struggle in the Supreme Court.

April 18, 2005. Fox News Online recently published "Red Tape, Big Pharm Muscle Strangling Medical Marijuana," a piece discussing the difficulties of conducting medical marijuana research with current restrictions on the supply of cannabis for research, with quotes from Lyle Craker and John Halpern.

March 29, 2005. The New York Times published "Medicinal Marijuana On Trial", discussing medical marijuana research and Ashcroft v. Raich.

February 5, 2005.  The New Scientist publishes "Cannabis: Prescribing the Miracle Weed" by Clare Wilson. The initial MAPS-sponsored medical marijuana research efforts of Dr. Donald Abrams are discussed though MAPS is not mentioned.

January 25, 2005. Common Sense for Drug Policy just placed an ad in 6 or 7 major political magazines (Nation, New Republic, Weekly Standard, etc) about MAPS’ lawsuits v. DEA/HHS.NIDA.

January 20, 2005. The Drug-Free America Foundation, Inc. reports on its website on the DEA rejection of the UMass Amherst application for a license to establish a facility to produce marijuana for federally-approved research.

January 18, 2005. A Newsweek article about DEA’s rejection of Prof. Craker’s UMass Amherst application does a good job of explaining the issues but takes some pot shots at MAPS.

January 16, 2005. The Boston Globe published an article contrasting FDA approval of MAPS’ study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer with DEA rejection of Prof. Lyle Craker’s MAPS-sponsored application for a license to establish a facility to produce marijuana for federally-approved research.

January 7, 2005. An editorial published by The Oregonian, "Stop Blocking Marijuana Research", supports the UMass Amherst project.

January 5, 2005. The San Diego City Beat published a discussion and analysis of a recent legal challenge to the HHS to change how marijuana is scheduled, with the legal challenge relying on a 2002 law, the Data Quality Act, originally crafted to benefit the tobacco industry and other corporate interests.

December 19, 2004. An op-ed by Steve Chapman of the Chicago Tribune criticizes the DEA for blocking the UMass Amherst marijuana production facility

The Providence (RI) Journal published an excellent op-ed about the financial reasons why drug warriors don’t want to see the licensing of the UMass Amherst production facility.

December 18, 2004. An expanded article by Fred Gardner appears on counterpunch.org, "DEA Upholds Grower’s Marijuana Monopoly." This is the most detailed critique yet published of DEA’s rationale for rejecting the UMass Amherst application.

December 16, 2004. An excellent article in the Boston Phoenix dissects the DEA’s rejection of the UMass Amherst application.

December 15, 2004. An article in the Boston Globe gives background to the DEA rejection of the UMass Amherst project and explains the legal pressure that forced DEA to act, the DEA’s obstruction of research, and political support for the license.

An article in the Anderson Valley Advertiser, "DEA Upholds Grower’s Monopoly," by Fred Gardner, discusses in detail the DEA’s rejection of the UMass Amherst application. The Anderson Valley Advertiser has followed the details of the medical marijuana issue more closely than any other paper.

Howie Carr of the Boston Herald writes IN AT LEAST ONE WAY, ZOOMASS ISN’T GOING TO POT.

December 14, 2004. The New York Times reports that the DEA has rejected the application from UMass Amherst for a license to grow marijuana. The article notes that there is a 30 days period within which an appeal can be filed, which we will do.

November 22, 2004. The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as "absurd."

October 10, 2004. The San Francisco Chronicle reports that "Medical Marijuana Advocates Likely to Get Break Under Kerry". MAPS’ UMass Amherst project is mentioned in the article

October 8, 2004. The October 8-14 Boston Phoenix features an interview with MAPS’ president Rick Doblin Ph.D. that discusses, among other things, ongoing research into the therapeutic effects of MDMA, psilocybin, and marijuana.

September 30, 2004. Reuters News Service published a story stating "British, French Drug Firms Lead in Marijuana Tests", noting that US drug development is hampered by marijuana’s schedule 1 status and government control over the supply of marijuana researchers must use for their studies.

October 1, 2001. Penthouse Magazine publishes "The Gang That Couldn’t Grow Straight"by Michael Simmons.

July 28, 2004. Scientific Journal Nature publishes an article about MAPS’s lawsuit against DEA, HHS, NIH, and NIDA for obstructing Marijuana research. Dr. Stanley Watson of the University of Michigan, Ann Arbor, who co-authored a 1999 Institute of Medicine report agrees that political factors are obstructing medical marijuana research.

July 22, 2004. Newspapers around the country have carried an AP wire story on MAPS’ lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research. An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.

The Springfield Republican publishes an article about MAPS recent medical marijuana research lawsuits.

March 28, 2004. Ex-Surgeon General Joycelyn Elders publishes a great op-ed, Myths about Medical Marijuana.

February 27, 2004. The Ninth Circuit federal appeals court has refused to reconsider its Raich-Monson decision that allows Californians to grow and use marijuana to treat their illnesses. Not a single judge on the circuit voted to accept the government’s request for reconsideration. The government’s only recourse to reverse the Raich-Monson decision is to appeal to the Supreme Court. The government has 90 days to file a petition for certiorari. An article about this decision by Dean Murphy appeared in the New York Times.

February 17, 2004. Pot Proponent Just Says No, by Bill Breen, Fast Company Online. Medical marijuana’s elder statesman is not convinced that the therapeutic benefits of cannabis can be separated from the psychoactive effects -- or that cannabis should be "pharmaceuticalized."

February 17, 2004 The Cannabis Conundrum by Bill Breen, Fast Company Online. As the founder of a British Pharmaceutical company put it, if it weren’t called Marijuana there would be an entire biotech business built around this plant. And that’s just what is starting to happen (but not for the US drug industry or the patients these medicines might help).

February 10, 2004. Pipe Dream? Rick Doblin has a prescription for fixing NIDA’s ailing medical-marijuana program: establish an alternative. By Bill Breen, Fast Company. An excellent article about MAPS’ UMass Amherst project.

January 27, 2004. A NY Times article about medical marijuana discusses the implications for US drug policy of the impending approval of a medical marijuana extract in England, with quotes from and illustrated by photos of Lester Grinspoon and Rick Doblin.

Read Dr. Grinspoon’s comments on this article.

January 18, 2004. The Demonized Seed. Reporter Lee Green wrote an article for the LA Times Sunday magazine about the DEA crackdown on hemp products and on the growing of hemp. The article helps put in context MAPS’ struggle to sponsor a growing facility at UMass Amherst to produce high-potency marijuana for federally-approved research.

November 18, 2003. WBUR, the Boston NPR station, broadcast a long, positive story about medical marijuana and the UMass Amherst project, with interviews with Rick Doblin, UMass Amherst Prof. Lyle Craker, and ONDCP’s Dr. Andrea Barthwell. The story, "Massachusetts Considers Medical Marijuana," is by Rachel Gotbaum and begins by stating, "Governor Mitt Romney is expected to decide later this month whether he will join Senators Kennedy and Kerry and urge the federal drug enforcement administration to allow a Massachusetts professor to grow marijuana for medical research."

 Letter from Dr. Volkow to Rick Doblin

November 10, 2003. Gov. Romney’s senior policy advisor meets in the State House about the UMass Amherst project with Rick Doblin and Scott Mortimer of the Drug Policy Forum of Massachusetts. The meeting was arranged by Romney supporter Leo Kahn, who also attended the meeting along with Joe Rosen.

October 28, 2003. A New York Times article on doctors and the law discusses the legal situation faced by physicians who recommend marijuana to their patients.

October 19, 2003. Dr. Ethan Russo writes A Requiem for the Journal of Cannabis Therapeutics. (also available in Word format)

October 17, 2003. Snake-oil salesmen Why does the Bush administration seem so intent on denying medical marijuana to adults in extreme discomfort?, Kristen Lombardi, Boston Phoenix (MAPS comments on this article are here.)

October 1, 2003. Nature publishes an excellent article on medical marijuana research (also available in pdf format).

August 29, 2003. An article entitled "UMass professor seeks OK to grow marijuana legally" written by Marcella Bombardieri was published in the Boston Globe Note: several news stations have reported this story, including NBC San Diego, FOX-Texas, ABC and NBC-Boston, and a TV station in Jacksonville, FL.

August 28, 2003. An article was published in GazetteNet in which Rep. Olver (D-MA) (from the Amherst area) issues a statement supporting the MAPS/UMass Amherst application.

August 20, 2003. JAMA article about CMCR. The JAMA article on CMCR showed how important it is to obtain alternative sources of funding for medical marijuana research, since Center Co-director Andrew Mattison makes it clear that the ultimate goal is not FDA approval of marijuana but the development of "new molecules that interact with the body’s built-in cannabinoid receptors." Even Stage #2, which is the development by CMCR of non-smoking delivery systems, was described in the article as focusing primarily on products like the GW Pharmaceutical mucosal spray, which requires a marijuana extract, rather than the vaporizer, which can be used with the marijuana plant itself.

August 18, 2003. Dr. Abrams and team publish an article in the Annals of Internal Medicine, claiming "Short-Term Medical Cannabis Does Not Harm HIV+ Patients"! For more details, see MAPS’ Comments and UCSF Press Release.

July 25, 2003. An excellent and detailed interview with Dr. Geoffrey Guy, founder of GW Pharmaceuticals from the Anderson Valley Advertiser

July 19, 2003. Several excellent questions about strategy. MAPS received a series of questions via email from a reader of Jacob Sullum’s Jully 11 Reason article about MAPS’ effort to break NIDA’s monopoly on the supply of marijuana available for research. The questions and answers concern the possible importation of marijuana from the Netherlands as another way to break the NIDA monopoly (which we are trying in the context of the vaporizer research), the basis for a potential MAPS lawsuit against DEA, and the potential safety advantages of using hash rather than bud.

July 11, 2003.An article entitled "Privatizing Pot - Can the marijuana monopoly be broken?" written by Jacob Sullum was published in Reason.

April 25, 2003. MAPS publishes "DEA and the UMass Amherst Medical Marijuana Production Facility: An Update" by Rick Doblin, Ph.D. (pdf format) in the MAPS Bulletin, Spring 2003; Volume XIII, Number 1

December 15, 2001. "After Two-Decade Halt, Marijuana Research Is Set" - Philip J. Hilts, The New York Times