Winter 2012 Vol. 22, No. 3: 2012 Annual Report
Progressive change is in the air. President Obama was re-elected; the US Senate has shifted slightly to the left; gay marriage passed in Maine, Maryland, and Washington; marijuana was legalized in Washington and Colorado; and Massachusetts became the 18th state, along with the District of Columbia, to have approved the medical use of marijuana. The implications for MAPS of a gradual progressive shift could be profound.
We’re in the early stages of working to prepare a grant application for MDMA-assisted psychotherapy for PTSD research to the National Institute of Mental Health (NIMH), which would probably happen in collaboration with a major research university. As far as I know, if such a grant application is eventually accepted, this would be the first time in over 40 years that NIMH, or any other US government agency, has funded psychedelic psychotherapy research.
MAPS is also working to start a study of MDMA-assisted psychotherapy for active duty soldiers with PTSD. For the first time in 15 years of effort, we have the opportunity to submit a protocol to an Institutional Review Board (IRB) at a Dept. of Defense facility. Our current study in veterans with PTSD is generating promising results. However, the VA is not actively referring subjects to our study. Rather, veterans with PTSD who have not been successfully treated by the VA are volunteering on their own, with hundreds on our waiting lists.
MAPS is even making some slow but steady progress with the protocol for our planned study of marijuana for veterans with PTSD, which was approved by the FDA on April 28, 2011. On September 16, 2011, the protocol was rejected (a more accurate word would be “trashed”) by the Public Health Service (PHS) reviewers who evaluated the protocol from the perspective of basic science rather than drug development. As a result, the National Institute on Drug Abuse (NIDA) refused to sell us any of its marijuana. This killed the study since NIDA has a monopoly on the supply of marijuana legal for use in federally regulated clinical research. On October 25, 2012, we managed to obtain approval for the study from an IRB at the University of Arizona, which accepted all our key protocol design elements but added some safety procedures and measures. This IRB approval places us in an excellent position to return to the PHS reviewers to request marijuana for the study as currently designed.
Our 11-year legal struggle with the Drug Enforcement Administration (DEA)—seeking to end the NIDA monopoly by obtaining a DEA license for Prof. Lyle Craker of UMass-Amherst to produce marijuana under contract to MAPS for federally regulated research—is now awaiting a ruling from the First Circuit Court of Appeals. Oral arguments were held on May 11, 2012, with Prof. Craker receiving outstanding pro-bono legal representation from the major Washington, DC, law firm Covington & Burling LLP, and the ACLU. We anticipate a ruling soon.
The importance of MAPS’ research into the healing of PTSD has been highlighted by tragic news taking place as I write this message. I’ve just learned that the start of MAPS’ Israeli MDMA-assisted psychotherapy for PTSD study may be delayed due to the possibility that some of the psychiatrists and therapists conducting the study may be called into the reserves for a potential invasion of Gaza. I was also sent a picture of a rocket coursing through the sky immediately over an Israeli medical marijuana production facility. Sadly and paradoxically, our efforts to treat PTSD in a small number of subjects may be postponed as the result of a war that will create many new cases of PTSD in Israel and Gaza.
We ask for your continued and expanded support so that we can fund our research into the treating of PTSD. May the technology of healing spread faster than the technology of war.
Rick Doblin, Ph.D.
MAPS Founder and Executive Director