Showing 25 of 315 total entries. View the full timeline of all MAPS marijuana projects.

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February 22, 2012

On February 22, 2012, the Drug Enforcement Administration requested a second extension on the deadline for filing its response brief in Prof. Lyle Craker’s federal lawsuit against the agency. The government’s brief is now due March 16.

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January 13, 2012

DEA Requests Extension for Filing Opposition Brief in Federal Lawsuit

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

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December 15, 2011

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

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

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September 21, 2011

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

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

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

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September 16, 2011

NIDA/PHS Rejects Marijuana/PTSD Protocol, Blocking MAPS’ FDA-Reviewed Study

On September 16, after a delay of four and a half months, the US Department of Health and Human Services informed MAPS that the five NIDA/PHS reviewers had unanimously rejected our planned study of marijuana for veterans with PTSD as currently designed. According to MAPS Executive Director Rick Doblin, Ph.D., the reviewers offered contradictory critiques, misunderstood key protocol design elements, requested expensive and tangential additions to the protocol, and made unfounded assumptions about the study design, revealing their focus on basic science research and lack of familiarity with drug development research. The reviewers also treated the submission as if MAPS were requesting a government grant for the study rather than using private funds. Even if NIDA does eventually agree to sell MAPS the marijuana, getting to that point will take extensive, time-consuming, and costly negotiations—while veterans continue to suffer.

For a concise summary of the HHS review, see the September 16 HHS cover letter. For MAPS’ detailed, point-by-point response to the HHS review, see the annotated reviewer comments.

Download MAPS’ official press release announcing the HHS rejection.

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August 15, 2011

DEA Rejects Judge’s Recommendation, Upholding Federal Marijuana Monopoly

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

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

For more information, see our Medical Marijuana Research page.

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July 15, 2011

NIDA/PHS Completes Review of Marijuana for PTSD Protocol; MAPS Awaits Response

On April 28, 2011, the revised protocol for our planned study of marijuana for symptoms of PTSD in US veterans was accepted by the FDA, and submitted to the Department of Health and Human Services (HHS) to be reviewed by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). On July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon.

The HHS notice came only days before an article about the study in The New York Times (July 18, 2011) made MAPS’ marijuana research national news.

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April 28, 2011

FDA Accepts Marijuana for PTSD Protocol

On April 28, 2011, the U.S. Food and Drug Administration accepted MAPS’ protocol design for our study of marijuana for symptoms of PTSD in war veterans, stating that our revised protocol successfully addresses their previous concerns. Once again, the FDA has demonstrated its willingness to evaluate studies on the basis of scientific merit rather than political partisanship.

Although both MAPS and the FDA are satisfied with the protocol design, we cannot begin the study until passes yet another review process with the National Institute on Drug Abuse/Public Health Service (NIDA/PHS). This redundant review, which may take another year or more, is required solely because NIDA has a monopoly on the supply of marijuana for research, and NIDA/PHS must review the protocol before allowing us to purchase marijuana from the agency. NIDA’s mission does not include exploring the potential beneficial uses of marijuana.

MAPS has been pressuring the federal government through hearings, lawsuits, and appeals for over a decade to allow us to grow our own marijuana. The DEA has refused to accept the recommendation of its own Administrative Law Judge that it would be in the public interest for Professor Lyle Craker of the University of Massachusetts, Amherst, to receive a license to grow marijuana for research regulated by the FDA.

Many U.S. veterans already use medical marijuana to deal with their symptoms of PTSD. MAPS is seeking to conduct the first clinical trial testing the use of the smoked or vaporized marijuana plant in PTSD patients. Now the PHS/NIDA will decide if MAPS can obtain marijuana for 50 suffering veterans.

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April 1, 2011

DEA Asks Administrator to Reject Judge’s Recommendation in Response to Final Brief

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

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March 17, 2011

US Government Institution Acknowledges Medicinal Uses of Cannabis

The National Cancer Institute is the latest addition to a growing list of government agencies and professional medical associations—including the Institute of Medicine, the American Medical Association, and the National Institutes of Health—that have acknowledged the known and possible medical uses of marijuana. The announcement came when the NCI added several sections to its website about the use of marijuana in supportive care for cancer patients. In this article, the American Botanical Council summarizes the NCI’s perspective on medical marijuana, highlights its strengths and shortcomings, and explores its broader implications for research and public policy.

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March 15, 2011

MAPS Submits Revised Marijuana/PTSD Protocol to FDA

On March 15, 2011, MAPS submitted to the FDA the revised protocol for its planned study of smoked and/or vaporized marijuana for PTSD in war veterans. In a February 9 conference call, the FDA acknowledged that we had successfully addressed their concerns about subjects diverting unused marijuana, and requested that we submit this revised protocol. If after reviewing the revised protocol the FDA decides to allow the study to proceed, the next step will be to move the protocol through a complicated review process with the National Institute on Drug Abuse and the Public Health Service.

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March 7, 2011

Craker’s Lawyers File Final Brief in DEA Lawsuit to Grow Marijuana for Research

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

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

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

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

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February 9, 2011

MAPS Addresses FDA Concerns about Planned Marijuana/PTSD Study

On February 3, 2011, the U.S. FDA asked MAPS to provide additional information regarding the protocol for our planned study of the safety and effectiveness of smoked and/or vaporized marijuana for the treatment of PTSD symptoms in war veterans. The agency’s principal concerns involved the possibility of subjects giving or selling (“diverting”) unused marijuana during or after the study. This is an important point for the FDA given that this study would be the first outpatient marijuana study to be conducted in approximately 30 years.

On February 9, 2011, MAPS and the FDA had a teleconference to discuss these concerns. It was a major success. Prior to the meeting, MAPS prepared responses to each of the seven points raised in the February 3 letter and developed a chart listing of the advantages and disadvantages of several strategies for preventing diversion. We proposed a two-part solution: First, each subject will be given a handheld video camera (the Flip) with which they will record themselves removing the marijuana from its canister (containing one week’s supply), using it, and replacing unused material. Study staff will review these videos on a weekly basis prior to giving subjects their next week’s marijuana. Second, subjects will be asked to give us the name of a significant other who we can call weekly for independent verification that subjects used the marijuana themselves. If it cannot be verified that subjects used the marijuana themselves, they will be removed from the study.

During the teleconference, the FDA said our approach was reasonable. They indicated that we should submit the revised version incorporating the new safeguards for FDA review. The FDA saw that we were sincere in trying to address the issue of diversion control, and we saw that the FDA was willing to move forward with our study. However, if the FDA approves the protocol, we still need to run the gauntlet of the redundant Public Health Service/National Institute on Drug Abuse review process, which is likely to be much more difficult and much less reasonable than that of the FDA. At the very least, we are one crucial step closer.

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January 14, 2011

NIDA Claims to Have Marijuana Required for Marijuana/PTSD Study

On December 15, 2010, the FDA notified MAPS that our planned study of smoked or vaporized marijuana for veterans with chronic, treatment-resistant PTSD had been placed on full clinical hold until we are able to provide specific information about the source, composition, concentration, and manufacturing method of the active and placebo marijuana cigarettes we plan to use. We have requested that the National Institute on Drug Abuse (NIDA) provide the marijuana as a result of the agency’s monopoly on the legal supply of marijuana for use in FDA-approved studies. Despite having submitted the study protocol to NIDA and the Public Health Service (PHS) nearly two months ago, we still have not heard a word about the likely time frame for the NIDA/PHS protocol review.

Fortunately, the FDA has a set a precedent of reviewing and even approving protocol designs before having complete information on the source of the drug. We expect to receive FDA’s protocol critiques very soon. Even if we obtain FDA approval, the protocol must also be approved through the NIDA/PHS review process. In the 1990s, MAPS had two medical marijuana protocols approved by the FDA but rejected by NIDA, preventing the studies from taking place.

On January 14, 2011, an official from NIDA sent an e-mail to MAPS Executive Director Rick Doblin, Ph.D., indicating that the agency does in fact have the various levels of marijuana with delta-9-tetrahydrocannabinol (THC) that we need for our study. The study protocol calls for marijuana with five different concentrations of THC and cannabidiol (CBD): 0% THC (placebo), 2% THC, 6% THC, 12% THC, and 6% THC/6% CBD. NIDA claims that it has marijuana cigarettes of 0.004% (placebo), 2.1%, 5.6%, or 6.7% THC. They also claim that their facility at the University of Mississippi has in stock bulk marijuana containing 12% THC that can be manufactured into cigarettes, and that they can blend different batches to produce cigarettes containing marijuana with 6% THC and between 4% and 6% CBD (despite their initial insistence that they did not have any marijuana with CBD).

NIDA appears to be doing its best to provide what we need for the study, perhaps due to the pressure we have been putting on them through Professor Lyle Craker’s ongoing lawsuit against the DEA seeking a license to grow marijuana for federally regulated research under contract to MAPS.

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December 15, 2010

On December 15, 2010, FDA placed MAPS’ study of marijuana for people with PTSD on full clinical hold. (Letter describing study placement on clinical hold.)

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December 6, 2010

DEA Administrator Explains Denial of Request to Reopen Craker Case

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

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November 24, 2010

Marijuana for PTSD Protocol Submitted to FDA and NIDA

On Nov. 11, 2010, MAPS’ clinical research team submitted our newest marijuana protocol to the FDA. If approved, the study will gather preliminary information about whether medical marijuana is a safe and efficacious way to manage symptoms of PTSD. The FDA has already requested more information about where we would obtain the marijuana for the study. On Nov. 23, MAPS Executive Director Rick Doblin, Ph.D., wrote to the Chemistry and Physiological Systems Research Branch at the National Institute of Health (NIH)/National Institute on Drug Abuse (NIDA) to inquire about the cost and THC content of NIDA-supplied marijuana. On Dec. 2, we received an email from the agency informing us that NIDA could provide us with three out of the five potencies of marijuana we wish to test. According to the agency, NIDA has placebo marijuana cigarettes (containing just 0.004% THC) and marijuana cigarettes containing 2.1%, 5.6%, and 6.7% THC. It does not, however, have marijuana cigarettes containing 12% THC or the combination of 6% THC/6% CBD, which our protocol requires. NIDA also cautioned us that the THC content of its marijuana deteriorates over time, and that we should ask for updated potency information prior to ordering. On Dec. 3, Rick wrote back to NIDA asking how much it would cost and how long it would take for NIDA to develop marijuana that contained 6% THC/6% CBD and 12% THC. A NIDA representative replied to Rick’s inquiry on Dec. 8, informing him that Mahmoud Elsohy, Ph.D., the director of NIDA’s marijuana project at the University of Mississippi, was out of town and that NIDA would respond in several weeks.

Meanwhile, on Nov. 24, a representative from the FDA wrote to MAPS requesting information on behalf of the FDA’s Chemistry, Manufacturing, and Controls (CMC) team. They requested information regarding: (1) the source of the active and placebo marijuana cigarettes, including the name and address of the manufacturer, (2) the complete composition of each strength and technical grade of each excipient (the non-marijuana components of each cigarette), (3) how the specific concentration of THC and CBD in the marijuana plant is achieved, (4) the method of manufacture of the cigarettes, (5) the specifications for each strength and description of the analytical procedures, (6) the certificate of analysis for each strength to be used in the clinical study and the date of manufacture,  and (7) a letter of authorization to NIDA’s Drug Master File for marijuana cigarettes. Rick responded to the FDA letting them know that the organization has set a precedent of reviewing and approving protocols before having all the required information for the source of the drug to be used in the study. In such cases, the protocol can be approved, but the study is on clinical hold until the FDA CMC review team is satisfied with the information regarding the drug to be used in the study.

The Public Health Service (PHS)/NIDA protocol review process, which is required for all studies seeking NIDA marijuana (but which isn’t required for any of our psychedelic research since we have our own independent source), can take about six months, and it’s likely that the reviewers will have questions about the protocol. After we respond to those questions, it could take another six months for PHS/NIDA to comment on our replies—a process which will repeat until our protocol is either rejected or approved. Until those reviews are completed and NIDA approves the protocol, NIDA will not give MAPS permission to purchase its marijuana and cross-reference its Drug Master File. Therefore, while it is currently impossible for MAPS to provide the information requested by the FDA CMC review team, the FDA should be able to continue with its review.

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November 19, 2010

Marijuana/PTSD Study Gains Julie Holland, M.D., as Medical Monitor

Julie Holland, M.D., has reviewed the protocol and agreed to be the medical monitor for our newest study of marijuana as a treatment for PTSD. The protocol was submitted to the FDA on Nov. 12, 2010, and on Nov. 17, 2010, MAPS
received a new Investigational New Drug number for marijuana: #110513.

Dr. Holland recently edited and published The Pot Book, which is a magnificent resource about marijuana. The book is available in the MAPS store and proceeds directly fund MAPS’ medical marijuana research mission.

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November 17, 2010

MAPS Receives IND # for Marijuana

MAPS received an Investigational New Drug identification number for marijuana from the FDA. This is part of our study of marijuana for PTSD.

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November 6, 2010

MAPS Hosts Mile High Marijuana Summit

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

Video and audio of the conference is available here.

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October 3, 2010

MAPS’ New Marijuana/PTSD Study Design Finalized

On Oct. 3, Research and Information Specialist Ilsa Jerome, Ph.D., Clinical Research Associate Berra Yazar-Klosinski, Ph.D., and Executive Director Rick Doblin, Ph.D., finalized the study design for our investigation of marijuana as a treatment for Posttraumatic Stress Disorder (PTSD). We are preparing to submit the protocol and informed consent forms to the FDA by the end of this month. We currently consider marijuana usage to be more useful in treating symptoms of PTSD and requiring regular administration, while MDMA-assisted psychotherapy is aimed at achieving a cure by getting to the core of the problem.

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September 22, 2010

MAPS Hires Lobbyist for Marijuana Production Facility/Professor Craker Campaign

MAPS signed a contract with The Raben Group, a Washington, D.C., lobbying group. The Raben Group will initially review and analyze the political situation relating to the Craker case, then provide MAPS with recommendations on next steps for MAPS to consider. If MAPS and The Raben Group agree that securing the license is possible, The Raben Group will develop supporting materials; assist with outreach to other organizations or people willing to support MAPS’ efforts; schedule and staff meetings with the Department of Justice; and provide any necessary follow-up to Department of Justice staff as well as strategic counsel to MAPS.

According to IRS rules, technically none of this work counts as lobbying since we are not trying to change any laws. Instead, we are working with a regulatory and enforcement agency, the DEA, to encourage it to follow the recommendations of DEA Administrative Law Judge Bittner. The judge determined that it would be in the public interest for DEA to issue a license to Prof. Craker to grow marijuana for MAPS for federally-regulated research.

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August 9, 2010

New Marijuana-for-PTSD Protocol Close to Complete

MAPS is preparing a marijuana/PTSD pilot study in veterans of war to be conducted by Principal Investigator Sue Sisley, M.D. in Arizona.  The protocol is close to being submitted to the FDA after having been reviewed, critiqued, and revised by several outside experts. The study is being developed in response to anecdotal reports of marijuana being used to alleviate PTSD symptoms. At present, there is no published data from a randomized,
placebo-controlled, double-blind study of the risks and benefits of marijuana for chronic PTSD sufferers.

Forty subjects will be randomly allocated to one of four treatment groups. Each subject will be provided with two rolled cigarettes daily, each weighing 0.9 grams, the standard-size marijuana cigarette provided by the National Institute on Drug Abuse (NIDA). The cigarettes will contain either (1) 2% D9-tetrahydrocannabinol (THC), (2) 6% THC, (3) 6% THC and 6% cannabidiol (CBD), or (4) 12% THC. The subjects who receive 2% THC will serve as the low-dose/active placebo group; while an ideal placebo would not contain any potentially therapeutic action, previous research has shown completely inactive marijuana is rarely effective at producing an effective double-blind. Marijuana will be self-administered daily on an outpatient basis for four weeks, followed by two weeks of none. Within each treatment group, five of 10 subjects will smoke marijuana cigarettes; the other five are assigned to use a vaporizer.

In this groundbreaking study, marijuana will be used as a pharmacological medicine without associated psychotherapy. The primary outcome variable measuring the severity of PTSD will be the Clinician Administered PTSD Scale (CAPS), required by FDA and the European Medicines Agency (EMEA).

At present, the NIDA does not produce any marijuana with significant levels of CBD. We are specifically requesting NIDA produce such a strain for this study. NIDA has previously indicated that it could provide any marijuana strains requested by researchers. Should NIDA be unable to provide marijuana with CBD—due to NIDA’s monopoly on the supply of marijuana for FDA-regulated research—we would have no other sources of supply and we would be forced to eliminate the 6% THC/6% CBD group from the protocol.

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Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 50 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Clinical Investigator: Sue Sisley, M.D.

This study will look at whether smoking or vaporizing marijuana can help reduce PTSD symptoms in fifty veterans with posttraumatic stress disorder (PTSD). Participants can be men or women aged 18 or older with a diagnosis of PTSD that has not improved after they have tried either medication or psychotherapy.

Study Protocol: MJP-1 Protocol (3/9/2011)

On November 17, 2010, MAPS received an Investigational New Drug identification number for marijuana from the FDA.

On December 15, 2010, the FDA placed the study on full clinical hold.

On February 3, 2011, the FDA sent MAPS a letter outlining several issues relating to protocol design.

On February 9, 2011, the FDA and MAPS held a teleconference during which MAPS successfully addressed the FDA’s concerns, including the potential for diversion of marijuana used in the study.

On March 15, 2011, MAPS submitted the revised protocol incorporating the changes discussed on February 9 to the FDA.

On April 28, 2011, the revised protocol was accepted by the FDA, and submitted to the Department of Health and Human Services (HHS) to be reviewed by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS).

On July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon.

On September 16, 2011, HHS informed MAPS that the NIDA/PHS reviewers had unanimously rejected the protocol as currently designed. For a concise summary of the HHS review, see the September 16 HHS cover letter. For MAPS’ detailed, point-by-point response to the HHS review, see the annotated reviewer comments.

MAPS is now preparing a detailed response to the NIDA/PHS reviewers’ comments.

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MAPS is interested in developing the plant form of marijuana into a prescription medicine for the purpose of making medical marijuana legally available on a federal level. If marijuana were a U.S. FDA-approved prescription medicine, it would no longer be up to individual states to legislate the legality of medical marijuana. Nation wide, any person with a doctors prescription would be legally allowed to use the medicine.

To date, the FDA has not evaluated marijuana as part of a prescription drug-development process. The National Institute on Drug Abuse’s monopoly on the supply of marijuana for federally approved research is in the way.

Prior to initiating a drug-development research program that would require an estimated $10 million and 10 years, MAPS must obtain an independent source of marijuana that is legal for clinical research, since NIDA’s arbitrary and lengthy review process has derailed two MAPS-sponsored protocols the FDA had already approved.

NIDA does not have a monopoly on any other Schedule 1 drug, such as MDMA, LSD, or psilocybin. NIDA provides low-potency marijuana and only makes it available to projects it approves.

MAPS, in association with Professor Lyle Craker of the University of Massachusetts at Amherst Department of Plant and Soil Sciences has been locked in a decade long struggle seeking the DEA’s permission to establish a marijuana-growing facility to produce quality marijuana for FDA-approved research, and to end NIDA’s monopoly.

On June 25, 2001, Craker applied for a license to grow marijuana for research at Umass. Three and half years later on December 10, 2004, the DEA rejected Craker’s application.

On February 12, 2007, Administrative Law Judge Mary Ellen Bittner issued an 87-page ruling recommending Craker should receive a license and NIDA’s monopoly should be dismantled.

On January 14, 2009, the DEA overturned the recommended ruling.

On December 2, 2010, the DEA denied Craker’s Motion to Reconsider.

On March 7, 2011, Craker’s lawyers submitted their final brief in the case.

On August 15, 2011, the DEA issued its final order rejecting ALJ Bittner’s 2007 recommendation.

MAPS is now engaged in efforts to have the DEA’s final order rescinded. We have received pro-bono legal representation by major Washington, D.C., law firm Covington & Burling, LLP, to bring the case to the First Circuit U.S. Court of Appeals to challenge the DEA’s rejection of the 2007 ALJ recommendation.

On September 15, 2011, the DEA sent a Certified List of all documents, exhibits, and other material for the case to the U.S. Court of Appeals for the First Circuit.

On December 15, 2011, Craker’s legal team (Covington & Burling LLP and the American Civil Liberties Union) filed their opening brief (232-page PDF) in their federal lawsuit against the DEA in the U.S. Court of Appeals for the First Circuit.

When Craker receives a DEA license, MAPS will finance clinical research 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, a drug used to end early pregnancies.

Despite NIDA’s obstructionism, MAPS has been able to provide some analytical data about marijuana fumes produced by vaporizers to Donald Abrams M.D. of UC San Francisco. He has used this data as part of his successful application to the FDA to conduct a study evaluating the effects of marijuana on human subjects, cannabinoid blood levels, and carbon monoxide levels in subjects who smoke marijuana and those who use a vaporizer.

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Showing 25 of 74 total entries. View the full timeline of MAPS DEA Lawsuit.

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Table of Contents

December 15, 2011: Craker’s Legal Team Submits Opening Brief in Federal Lawsuit against the DEA September 21, 2011: MAPS Receives Pro-Bono Representation to Appeal Craker Case in First Circuit Court of Appeals August 15, 2011: DEA Rejects Judge's Recommendation, Upholding Federal Marijuana Monopoly August 5, 2011: Craker's Lawyers File Fifteenth Update with U.S. Court of Appeals, First Circuit June 8, 2011: Craker's Lawyers File Fourteenth Update with U.S. Court of Appeals, First Circuit April 11, 2011: Craker's Lawyers File Thirteenth Update with U.S. Court of Appeals, First Circuit April 1, 2011: DEA Asks Administrator to Reject Judge's Recommendation in Response to Final Brief March 7, 2011: Craker's Lawyers File Final Brief in DEA Lawsuit to Grow Marijuana for Research February 10, 2011: Craker's Lawyers File Twelfth Update with U.S. Court of Appeals, First Circuit December 22, 2010: The U.S. Senate unanimously confirmed Michele Leonhart as new DEA Administrator December 13, 2010: Craker’s lawyers file eleventh update with U.S. Court of Appeals, First Circuit December 6, 2010: DEA Administrator Explains Denial of Request to Reopen Craker Case December 2, 2010: DEA responds to Motion to Reconsider, denies re-opening trial, requests brief in support of Motion by March 7, 2011 October 15, 2010: Craker’s lawyers file tenth update with U.S. Court of Appeals, First Circuit August 16, 2010: Craker’s lawyers file ninth update with U.S. Court of Appeals, First Circuit June 18, 2010: Craker’s lawyers file eighth update with U.S. Court of Appeals, First Circuit April 22, 2010: Craker’s lawyers file seventh update with U.S. Court of Appeals, First Circuit February 25, 2010: Craker’s lawyers file sixth update with U.S. Court of Appeals, First Circuit December 28, 2009: Craker’s lawyers file fifth update with U.S. Court of Appeals, First Circuit November 2, 2009: Craker’s lawyers file fourth update with U.S. Court of Appeals, First Circuit September 4, 2009: Craker’s lawyers file third update with U.S. Court of Appeals, First Circuit July 2, 2009: Craker’s lawyers file second update with U.S. Court of Appeals, First Circuit 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

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December 15, 2011

Craker’s Legal Team Submits Opening Brief in Federal Lawsuit Against the DEA

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

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September 21, 2011

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

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

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

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August 15, 2011

DEA Rejects Judge’s Recommendation, Upholding Federal Marijuana Monopoly

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

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

For more information, see our Medical Marijuana Research page.

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August 5, 2011

Craker’s Lawyers File Fifteenth Update with U.S. Court of Appeals, First Circuit

On August 5, 2011, Prof. Craker’s lawyers filed their fifteenth update with the U.S. Court of Appeals, First Circuit.

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June 8, 2011

Craker’s Lawyers File Fourteenth Update with U.S. Court of Appeals, First Circuit

On June 8, 2011, Prof. Craker’s lawyers filed their fourteenth update with the U.S. Court of Appeals, First Circuit.

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April 11, 2011

Craker’s Lawyers File Thirteenth Update with U.S. Court of Appeals, First Circuit

 On April 11, 2011, Prof. Craker’s lawyers filed their thirteenth update with the U.S. Court of Appeals, First Circuit.

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April 1, 2011

DEA Asks Administrator to Reject Judge’s Recommendation in Response to Final Brief

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

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March 9, 2011

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.”

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March 7, 2011

Craker’s Lawyers File Final Brief in DEA Lawsuit to Grow Marijuana for Research

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

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

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

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

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February 10, 2011

Craker’s Lawyers File Twelfth Update with U.S. Court of Appeals, First Circuit

On February 10, 2011, Prof. Craker’s lawyers filed their twelfth update with the U.S. Court of Appeals, First Circuit.

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December 22, 2010

The US Senate unanimously confirmed Michele Leonhart as new DEA Administrator

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

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

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December 13, 2010

Craker’s lawyers file eleventh update with U.S. Court of Appeals, First Circuit

 

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

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December 6, 2010

DEA Administrator Explains Denial of Request to Reopen Craker Case

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

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December 2, 2010

DEA responds to Motion to Reconsider, denies re-opening trial, requests brief in support of Motion

On December 2, 2010, DEA Acting Deputy Administrator Michelle Leonhart responded to our Jan. 30 2009 Motion to Reconsider. Leonhart rejected re-opening the trial, but she requested the submission of a brief by March 7, 2011, to address some of the issues contested in her Final Order.

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November 15, 2010

Craker’s lawyers file tenth update with U.S. Court of Appeals, First Circuit

 

On October 15, 2010, Prof. Craker’s lawyers filed a tenth update with the U.S. Court of Appeals, First Circuit.

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August 16, 2010

Craker’s lawyers file ninth update with U.S. Court of Appeals, First Circuit

 On August 16, 2010, Prof. Craker’s lawyers filed a ninth update with the U.S. Court of Appeals, First Circuit.  We never imagined that the DEA would postpone a decision more than 18 months! We hope it won’t be another 18 months before we here about the Motion to Reconsider.

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June 18, 2010

Craker’s lawyers file eighth update with U.S. Court of Appeals, First Circuit

 On June 18, 2010, Prof. Craker’s lawyers filed an eighth update with the U.S. Court of Appeals, First Circuit.  It has now been 16 months since our lawyers filed the Motion to Reconsider.

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April 22, 2010

Craker’s lawyers file seventh update with U.S. Court of Appeals, First Circuit

 On April 22, 2010, Prof. Craker’s lawyers filed a seventh update with the U.S. Court of Appeals, First Circuit.  It has now been 14 months since our lawyers filed our Motion to Reconsider. The DEA’s tactic of delay is once again in full effect.

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February 25, 2010

Craker’s lawyers file sixth update with U.S. Court of Appeals, First Circuit

 On February 25, 2010, Prof. Craker’s lawyers filed a sixth update with the U.S. Court of Appeals, First Circuit.  It has now been over one year since our lawyers filed our Motion to Reconsider and we still have not heard from the DEA in this matter.

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December 28, 2009

Craker’s lawyers file fifth update with U.S. Court of Appeals, First Circuit

 On December 28, 2009, Prof. Craker’s lawyers filed a fifth update with the U.S. Court of Appeals, First Circuit.  The filing with the Court of Appeals is part of a conintuing defensive action in case the DEA rejects our Motion to Reconsider and DEA’s Final Ruling goes into effect.

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November 2, 2009

Craker’s lawyers file fourth update with U.S. Court of Appeals, First Circuit

 On November 2, 2009, Prof. Craker’s lawyers filed a fourth update with the U.S. Court of Appeals, First Circuit. The filing with the Court of Appeals is a part of our continuing defensive action in case the DEA rejects our Motion to Reconsider and DEA’s Final Ruling goes into effect.

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September 30, 2009

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

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

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

Dear Judge Bittner:

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

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

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

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

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

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

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

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

Sincerely,

Jim Winkler

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• 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

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On May 25, 1999, MAPS successfully secured Orphan Drug Designation for Marijuana in the treatment of AIDS wasting syndrome. Since it is not possible to obtain a patent on marijuana for use as a prescription medicine, an Orphan Drug Designation makes marijuana available for research and development into a prescription medicine. The Orphan Drug Designation program was developed by congress to facilitate the development of rare drugs. In the years since MAPS obtained permission to study this treatment, the advent of protease inhibitors has largely eliminated AIDS wasting syndrome in the US. As a result, we have not pursued this research.

Articles from the MAPS' Bulletin

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

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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

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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 Services (PHS) and National Institute on Drug Abuses (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 isnt 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. Well get back to HHS after we determine if we can make a case for a cross-validation study, then well ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.

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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.

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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.

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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.

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June 29, 2007
  Nature Medicine "Scientists Stir the Pot for Right to Grow Marijuana" by Arran Frood.

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.

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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.

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May 15, 2007
  The Walrus "Peaking on the Prairies" by Jake MacDonald.

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.

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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.

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October 19, 2005
  Mother Jones Magazine "Respectable Reefer" by Gary Greenberg.

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.

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August 18, 2005
  New England Journal of Medicine "Medical Marijuana and the Supreme Court" by Susan Oakie.

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.

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June 20, 2005
   "PDF Article" by .
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.

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November 29, 2004
  Slate "Dude, Where’s My Integrity? Medical marijuana tests the Supreme Court’s true love of federalism" by .

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.

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November 22, 2004
  Scientific American "Current Restrictions on Marijuana Research are Absurd" by The Editors.

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."

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November 22, 2004

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.

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July 22, 2004
   "Newspapers around the country have carried an AP wire story on MAPS’ lawsuits" by .

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.

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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. (.(JavaScript must be enabled to view this email address))
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.

 

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• 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

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