http://www.maps.org/images/mapslogo-sm.gif http://www.maps.org/ 50 50 Psychedelic Research News http://www.maps.org/ Psychedelic Research News en-us editor@maps.org webmaster@maps.org Fri, 10 Feb 12 13:50:42 -0600 http://www.maps.org/media/view/crakers_legal_team_submits_opening_brief_in_lawsuit_against_dea/ http://www.maps.org/media/view/crakers_legal_team_submits_opening_brief_in_lawsuit_against_dea/#When:23:22:52Z 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. http://www.maps.org/media/view/maps_receives_pro-bono_representation_to_appeal_craker_case_in_first_circui/ http://www.maps.org/media/view/maps_receives_pro-bono_representation_to_appeal_craker_case_in_first_circui/#When:17:59:10Z 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. http://www.maps.org/media/view/nida_phs_rejects_marijuana_ptsd_protocol_blocking_maps_fda-reviewed_st/ http://www.maps.org/media/view/nida_phs_rejects_marijuana_ptsd_protocol_blocking_maps_fda-reviewed_st/#When:18:00:36Z 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. http://www.maps.org/media/view/dea_rejects_judges_recommendation_upholding_federal_marijuana_monopoly1/ http://www.maps.org/media/view/dea_rejects_judges_recommendation_upholding_federal_marijuana_monopoly1/#When:23:51:17Z 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. http://www.maps.org/media/view/nida_phs_completes_review_of_marijuana_for_ptsd_protocol_maps_awaits_r/ http://www.maps.org/media/view/nida_phs_completes_review_of_marijuana_for_ptsd_protocol_maps_awaits_r/#When:17:40:56Z 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. http://www.maps.org/media/view/fda_accepts_marijuana_for_ptsd_protocol/ http://www.maps.org/media/view/fda_accepts_marijuana_for_ptsd_protocol/#When:15:24:51Z 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. http://www.maps.org/media/view/dea_asks_admin_to_reject_judges_rec_in_response_to_final_brief/ http://www.maps.org/media/view/dea_asks_admin_to_reject_judges_rec_in_response_to_final_brief/#When:00:17:36Z 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. http://www.maps.org/media/view/us_government_institution_acknowledges_medicinal_uses_of_cannabis/ http://www.maps.org/media/view/us_government_institution_acknowledges_medicinal_uses_of_cannabis/#When:00:52:09Z 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. http://www.maps.org/media/view/maps_submits_revised_marijuana_ptsd_protocol_to_fda/ http://www.maps.org/media/view/maps_submits_revised_marijuana_ptsd_protocol_to_fda/#When:21:39:56Z 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. http://www.maps.org/media/view/crakers_lawyers_file_final_brief_in_dea_lawsuit_to_grow_mmj_for_resear/ http://www.maps.org/media/view/crakers_lawyers_file_final_brief_in_dea_lawsuit_to_grow_mmj_for_resear/#When:01:16:29Z 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.