A Substantive Reply to IRB

MAPS submitted a series of documents today to the IRC-IRB, in response to their initial comments about the protocol which MAPS received on January 6. These documents represent a very substantial amount of staff time on MAPS’ part and include a twenty page primary response letter, a five page protocol summary, a two page plan for external evaluation, a two page phone script for the initial screening calls from potential volunteers, and a sixty page updated review of the MDMA literature published since our initial review was completed.

Dr. Michael Mithoefer and Rick Doblin will meet in person with the IRB review panel on January 28 to discuss the issues under consideration.

History Lesson for the DEA. MAPS submitted a letter to DEA from Rick Doblin concerning Dr. Michael Mithoefer’s July 2002 application for a Schedule I license to possess the MDMA that will be used in the MDMA/PTSD study. DEA has indicated that it has safety concerns that need to be addressed before it will issue the license. However, DEA is only legally charged with diversion control (preventing drugs approved for medical use to be diverted to non-medical uses) and has no legal mandate to review safety concerns, which are the responsibility of the FDA. In 1994, DEA tried to use similar arguments to justify its delay in issuing a Schedule I license to Dr. Donald Abrams for his FDA-approved marijuana/AIDS wasting study. Fortunately, FDA Commissioner Dr. David Kessler protested to Dr. Lee Brown, Director, Office of National Drug Control Policy (the Drug Czar), who wrote a letter to DEA Administrator Tom Constantine reminding him that DEA has no authority to review scientific matters. Dr. Brown told DEA that established lines of responsibility and authority should be respected and that national policy was to permit research with Schedule I drugs. MAPS’ letter reminds DEA of this history and urges it to respect the national interest in facilitating, and not obstructing, important research into new treatments for PTSD.