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 Thu, 24 May 12 21:28:43 -0500 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:19:48:06Z 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). 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). http://www.maps.org/media/view/medical_marijuana_new_arizona_law_and_study_for_u.s._veterans_with_ptsd/ http://www.maps.org/media/view/medical_marijuana_new_arizona_law_and_study_for_u.s._veterans_with_ptsd/#When:15:39:57Z On April 3, 2012, Arizona governor Jan Brewer signed into law a bill prohibiting the use of medical marijuana on the campuses of schools, colleges, and universities in the state. The new law is an example of the current backlash against medical marijuana that is taking place at both the state and federal level across the United States. While the bill was intended to regulate state medical marijuana patients, some administrators at the University of Arizona have suggested that the bill could also apply to federally regulated medical marijuana research. This could prevent MAPS from being able to conduct our FDA-approved study of marijuana for PTSD on the campus of the University of Arizona in Phoenix, where Principal Investigator Sue Sisley, M.D., is planning to conduct the study. In the study protocol, we propose to explore the safety and effectiveness of smoked and/or vaporized marijuana in 50 U.S. veterans with chronic, treatment-resistant PTSD. We are now seeking clarification on the extent of the new law, which is on shaky legal ground if used to ban federally regulated research. Meanwhile NIDA, which has a monopoly on the supply of marijuana for use in FDA-regulated research, continues to block the study by refusing to sell us the marijuana required for the study. http://www.maps.org/media/view/dea_files_opposition/ http://www.maps.org/media/view/dea_files_opposition/#When:19:10:38Z On March 22, 2012, the Drug Enforcement Administration (DEA) filed its first response brief (81-page PDF) to Prof. Lyle Craker’s lawsuit in the First Circuit Court of Appeals, which he filed on December 15, 2011. Prof. Craker is objecting to the DEA’s rejection of DEA Administrative Law Judge Bittner’s recommendation that it would be in the public interest to license Prof. Craker to grow marijuana for federally-regulated research. Granting Prof. Craker this license would end the federal monopoly on marijuana for research and open the door for non-profit medical marijuana research. In their response brief, DEA lawyers (1) argue that the First Circuit Court of Appeals lacks jurisdiction in the case, (2) move to strike parts of our argument based on NIDA’s September 2011 refusal to sell us marijuana for our FDA-approved protocol for veterans with PTSD, and (3) reiterate previous arguments claiming that international treaty obligations forbid granting Prof. Craker a license. Prof. Craker’s lawyers are now developing what we believe will be an effective response to the jurisdictional issues as well as the substantive issues. The reply from Prof. Craker’s legal team will be submitted in early May. http://www.maps.org/media/view/dea_requests_yet_another_extension_for_filing_federal_lawsuit_oppositi/ http://www.maps.org/media/view/dea_requests_yet_another_extension_for_filing_federal_lawsuit_oppositi/#When:22:52:12Z On March 14, 2012, Drug Enforcement Administration lawyers requested yet another extension—their third—on the deadline for filing their opposition brief in Prof. Lyle Craker’s lawsuit against the agency. The government’s brief is now due on March 21. http://www.maps.org/media/view/dea_requests_second_extension_for_filing_opposition_brief_in_federal_l/ http://www.maps.org/media/view/dea_requests_second_extension_for_filing_opposition_brief_in_federal_l/#When:17:52:27Z 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. http://www.maps.org/media/view/dea_requests_extension_for_filing_opposition_brief_in_federal_lawsuit/ http://www.maps.org/media/view/dea_requests_extension_for_filing_opposition_brief_in_federal_lawsuit/#When:22:56:41Z 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. 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:23:22:11Z 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.