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, 24 May 13 08:51:35 -0500 http://www.maps.org/media/view/u.s._first_circuit_court_upholds_nida_monopoly_on_marijuana_for_resear/ http://www.maps.org/media/view/u.s._first_circuit_court_upholds_nida_monopoly_on_marijuana_for_resear/#When:05:15:46Z On April 15, 2013, the United States Court of Appeals for the First Circuit rejected University of Massachusetts-Amherst Prof. Lyle Craker’s lawsuit against the Drug Enforcement Administration for denying him a license to grow marijuana for privately funded medical research. With its decision, the Court has ensured that the debate over the medical use of marijuana will continue to take place through political battles rather than through scientific research. The decision brings to an end Craker’s 12-year effort to end the National Institute on Drug Abuse’s monopoly on the supply of marijuana for research. A laboratory at the University of Mississippi under contract to the National Institute on Drug Abuse is currently the only facility in the U.S. permitted to grow marijuana for research. Prior to Craker’s application, NIDA had refused to sell marijuana to two FDA- and Institutional Review Board-approved protocols sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), preventing them from taking place. In September 2011, NIDA refused to sell marijuana to a third FDA-approved MAPS-sponsored protocol in 50 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD). Download the Court’s decision Download the full press release View the complete timeline http://www.maps.org/media/view/dea_notifies_court_of_marijuana_rescheduling_case_crakers_legal_team_respon/ http://www.maps.org/media/view/dea_notifies_court_of_marijuana_rescheduling_case_crakers_legal_team_respon/#When:13:40:15Z On January 22, 2013, the U.S. Drug Enforcement Administration filed a Notice of Supplemental Authority with the First Circuit Court of Appeals in Boston, Mass., in Prof. Lyle Craker’s ongoing federal lawsuit against the DEA for denying him a license to grow marijuana for medical research. The filing was intended to bring to the Court’s attention the outcome of a lawsuit against the DEA by Americans for Safe Access challenging the DEA’s denial of a petition to reschedule marijuana, acknowledging its medical uses. In the ASA case, the Court protected the DEA’s refusal to reschedule marijuana. On January 30, 2013, Craker’s legal team filed a response to inform the Court that the ASA case is not legally relevant to Craker’s lawsuit. The First Circuit Court’s decision in Lyle E. Craker v. Drug Enforcement Administration is still pending. http://www.maps.org/media/view/marijuana_for_ptsd_institutional_review_board_approves_study_protocol/ http://www.maps.org/media/view/marijuana_for_ptsd_institutional_review_board_approves_study_protocol/#When:19:59:51Z On October 25, 2012, the Institutional Review Board (IRB) at the University of Arizona notified Principal Investigator Sue Sisley, M.D., that they had approved the protocol for our planned study of marijuana for symptoms of PTSD in 50 U.S. veterans. The third and final IRB review took place on October 23. The Food and Drug Administration approved the protocol in April 2011, though the study has been blocked by the National Institute on Drug Abuse since September 2011. We are now preparing to resubmit the protocol and study documents, hoping that approval from both the IRB and the FDA will persuade NIDA to sell us the marijuana needed for the study. http://www.maps.org/media/view/marijuana_for_ptsd_protocol_submitted_for_third_time_to_irb/ http://www.maps.org/media/view/marijuana_for_ptsd_protocol_submitted_for_third_time_to_irb/#When:19:06:49Z On October 12, 2012, MAPS and Principal Investigator Sue Sisley, M.D., resubmitted to the Institutional Review Board (IRB) at the University of Arizona the revised protocol, informed consent, and other documents for our study of marijuana for veterans with PTSD. The study aims to explore the safety and effectiveness of smoked or vaporized marijuana for symptoms of PTSD in 50 veterans with chronic, treatment-resistant PTSD. The FDA cleared the study on April 28, 2011, which has since been blocked by the National Institute on Drug Abuse/Public Health Service’s September 16, 2011, refusal to sell researchers the marijuana needed for the study. We are hopeful that approval from the IRB will increase pressure on the NIDA/PHS reviewers to evaluate the protocol on the basis of science rather than politics. NIDA/PHS approval would allow us to submit the protocol to the DEA for final approval, and allow us to continue working to develop more effective treatments for veterans with PTSD. In their August 31 letter, the IRB indicated that they were satisfied with the overall study design, but required several minor changes regarding subject safety. The revised protocol addresses these requested changes, including a detailed safety plan for subjects participating in the study and revised informed consent forms. http://www.maps.org/media/view/marijuana_for_ptsd_irb_requests_changes_to_study_protocol_researchers_respo/ http://www.maps.org/media/view/marijuana_for_ptsd_irb_requests_changes_to_study_protocol_researchers_respo/#When:17:17:37Z On August 31, 2012, the Institutional Review Board at the University of Arizona responded to our July 30 submission of the protocol for our planned study of smoked or vaporized marijuana for 50 U.S. veterans with chronic PTSD. After a meticulous review, the IRB committee sent Principal Investigator Sue Sisley, M.D., a list of nine issues to address, requiring relatively minor changes to the protocol and informed consent documents. The IRB’s letter indicated that they were satisfied with the key protocol design elements. MAPS and Dr. Sisley responded to the IRB’s comments on September 14, and we are hopeful that the protocol will be approved at the upcoming meeting of the IRB on September 25. Thousands of U.S. veterans are using marijuana to treat their PTSD symptoms despite the lack of any controlled research into its safety and effectiveness. Several medical marijuana states use this lack of research as justification for refusing to allow physicians to recommend marijuana for PTSD. Our protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to the National Institute on Drug Abuse/Public Health Service’s refusal to sell researchers the marijuana needed for the study. One of the issues raised by the NIDA/PHS reviewers in their rejection was that the protocol had not yet received IRB approval, although IRB approval is not required for NIDA/PHS to accept a protocol. If NIDA/PHS still refuses to allow us to conduct the study once both the FDA and the IRB have cleared it, the political motivations behind the federal marijuana research blockade will be even more apparent, as will the need for state-level reform. http://www.maps.org/media/view/marijuana_for_ptsd_protocol_submitted_to_institutional_review_board/ http://www.maps.org/media/view/marijuana_for_ptsd_protocol_submitted_to_institutional_review_board/#When:17:59:54Z On July 30, 2012, MAPS and Sue Sisley, M.D., submitted the protocol for our FDA-approved study of marijuana for veterans with PTSD for review by the University of Arizona Institutional Review Board (IRB). The IRB review is scheduled for August 28. MAPS also submitted a detailed cover letter explaining our rationale for various elements of the protocol design. The protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to NIDA’s refusal to sell researchers the marijuana needed for the study. We will respond to the NIDA/Public Health Service reviewers’ comments if the IRB also approves the study protocol. http://www.maps.org/media/view/arizona_medical_association_challenges_nida_blockade_of_medical_marijuana_r/ http://www.maps.org/media/view/arizona_medical_association_challenges_nida_blockade_of_medical_marijuana_r/#When:20:31:41Z On June 2, 2012, the Arizona Medical Association (ArMA) House of Delegates unanimously adopted a resolution (pdf) challenging the National Institute on Drug Abuse’s blockade of medical marijuana research. ArMA’s resolution is yet another pressure point on the federal government’s obstruction of medical marijuana research. ArMA resolved that “once the protocol for privately-funded marijuana research has been reviewed and approved by the Food and Drug Administration and relevant Independent Review Board and the practitioner has obtained registration from the Drug Enforcement Administration, the National Institute of Drug Abuse shall, without further evaluation of the research protocol, supply marijuana for the research, at cost, upon the practitioner’s proper application.” http://www.maps.org/media/view/u.s._first_circuit_court_hears_oral_arguments_in_lyle_e._craker_v._dru/ http://www.maps.org/media/view/u.s._first_circuit_court_hears_oral_arguments_in_lyle_e._craker_v._dru/#When:19:48:13Z On May 11, 2012, the U.S. First Circuit Court of Appeals in Boston, Mass., heard oral arguments (audio, mp3) in the case of Lyle E. Craker v. Drug Enforcement Administration. The arguments are the culmination of 11 years of administrative and legal proceedings in response to the DEA’s denial of a license to Craker to start a production facility under contract to MAPS to grow marijuana exclusively for privately funded, federally regulated medical research. Craker’s attorney from Washington, D.C., law firm Covington & Burling LLP, which is representing Craker pro bono, clarified the issues facing the court and urged the judges to require the DEA to issue Craker’s license. The DEA attempted to get the case thrown out before a ruling by claiming that the court has no jurisdiction over the issue, an argument that the court seems likely to reject. The court’s ruling should come in about three months. Meanwhile, the DEA is succeeding in preventing our medical marijuana research from moving forward. Download the official press release (PDF). Read the complete annotated transcript (PDF). http://www.maps.org/media/view/dea_lawsuit_reply_brief_submitted_oral_arguments_scheduled_for_may_11_/ http://www.maps.org/media/view/dea_lawsuit_reply_brief_submitted_oral_arguments_scheduled_for_may_11_/#When:22:07:00Z On May 4, 2012, the legal team representing Prof. Lyle Craker submitted their reply brief (PDF) in his federal lawsuit against the Drug Enforcement Administration for rejecting a DEA administrative law judge’s 2007 recommendation that it would be in the public interest to grant Prof. Craker a license to grow marijuana under contract to MAPS for federally-regulated research. Oral arguments in the case of Lyle E. Craker v. Drug Enforcement Administration will be presented on Friday, May 11, 2012 at around 9:30 A.M. at the U.S. First Circuit Court of Appeals in Boston, Mass. For more information, download our official press release (PDF). http://www.maps.org/media/view/israeli_study_results_presented_at_clinical_cannabis_conference/ http://www.maps.org/media/view/israeli_study_results_presented_at_clinical_cannabis_conference/#When:22:11:27Z On April 28, 2012, the results of a recently completed exploratory study of medical marijuana in veterans with PTSD were presented (slides available here in PDF format) by Dr. Mordechai Mashiah, Deputy Director of the Abarbanel Mental Health Center in Israel, at the 7th National Clinical Conference on Cannabis Therapeutics, hosted by Patients Out of Time in Tucson, Ariz. The study was sponsored by the Israeli Ministry of Health. MAPS Israeli Clinical Research Associate Mimi Peleg, Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., Clinical Research Assistant Linnae Ponté, and Executive Director Rick Doblin, Ph.D., assisted Dr. Mashiah with data analysis and preparation of his presentation and abstract. MAPS also allocated about $6,000 to assist Dr. Mashiah in analyzing and presenting his results, and will further support him in preparing of a paper for publication in a peer-reviewed scientific journal. To date, there are still no published, placebo-controlled studies of the use of marijuana by people with PTSD. MAPS’ protocol for a study of the safety and effectiveness of marijuana for 50 veterans with PTSD has been approved by the FDA, but the National Institute on Drug Abuse has blocked the study, preventing it from proceeding (see MAPS’ point-by-point annotated response (PDF) to the NIDA review).