The FDA has definitely approved Drs. Al Kurland, Richard Yensen and Donna Dryer’s research protocol for the investigation of the use of LSD-assisted psychotherapy in the treatment of substance abusers. Their next steps are to obtain Institutional Review Board approval and then to seek funding.
Drs. Charlie Grob and Gary Bravo, both of the U. of California Irvine, and I are developing a protocol for the investigation of MDMA-assisted psychotherapy in the treatment of physical and emotional pain in terminal cancer patients. We’re currently seeking expert consultants to assist with the design of the experiment. Submission of the completed protocol to the FDA is several months off.
Over the past four months I have been exploring the possibility of serving my two-year Presidential Management Internship (PMI) award within the FDA office that regulates the medical use of MDMA, LSD, marijuana, and other Schedule 1 drugs. Though a job offer was not forthcoming (I was told hiring me would be like letting the camel into the tent), I was able to meet at length with several key FDA officials. Relationships of mutual respect are developing which will make my MAPS work more effective. As a result, I’ve withdrawn from the PMI program and will focus on MAPS.
In mid-August The Journal of Transpersonal Psychology will publish my paper on the follow-up to Walter Pahnke’s Good Friday experiment into psychedelics and mystical experiences. A previous draft of the paper was sent to all MAPS members several months ago. On July 1,The Journal of Clinical Oncology published my paper on the medical use of marijuana.The Economist featured my research in an article dated July 6th (reprinted on page four of this newsletter). The New Republic printed an article on medical marijuana in its July 15-22 issue which I highly recommend. Also recommended is the July issue of Gentleman’s Quarterly, which contains a fascinating article about the use of psychedelic substances by people involved in Silicon Valley’s computer industry.
The June 1991 issue of High Times has a very well written article discussing the February, 1991 conference on psychedelics held at Stanford. MAPS was described as “advocating a strategy of reconciliation with the authorities, based on the assumption that accumulation of scientific evidence favoring the benefits of psychedelics would eventually change the government’s position.” This was contrasted with the position of Timothy Leary, summarized as “Fuck the government.”
On June 24, after a one-year hiatus, official governmental permission was given to four Swiss psychiatrists to resume work with 100 patients previously treated with LSD, MDMA or 2C-B. Switzerland is once again the only country in the world where psychiatrists have legal permission to treat patients with these substances. As you may recall, permission was withdrawn as a result of a tragic situation in France when a woman died after taking the African psychedelic root ibogaine. When the autopsy results were finally released by the Swiss and French authorities there was no evidence that MDMA, LSD, or 2C-B was involved.
Treating new patients will require a rigorous research context and a separate permit. Several Swiss doctors are currently discussing protocol designs with consultants recommended by the Swiss government. Approval for treating new patients is expected by October, 1991. Human pharmocokinetic studies of MDMA are being planned at Bern University to take place in late 1991.
MAPS was contacted by Dr. Yevgeny Krupitsky, a psychiatrist in Leningrad who works as director of a government research team into the treatment of substance abusers. Yevgeny has successfully incorporated Ketamine into the in-patient treatment of alcoholics and is interested in initiating an effort to conduct MDMA research in Leningrad. MAPS arranged a visit for Yevgeny to Baltimore, where he met with Drs. Charlie Grob, Richard Yensen, Donna Dryer, Al Kurland, and myself. We reviewed the LSD and MDMA protocols and discussed research collaboration.
MAPS member Dr. Jim Prescott has begun to collaborate with Drs. Grob, Bravo, and I along with Dr. Fernandez, a Mexican physician, on the design of a protocol to investigate MDMA-assisted psychotherapy in the treatment of young women with breast cancer. This protocol will be submitted for approval to the Mexican health authorities, possibly before the end of 1991.