ON MARCH 19, 2007, during a long phone call with the president of the Ethics Committee (EC) (the Swiss equivalent to an institutional review board), which is responsible for the approval of my proposed MAPS-sponsored study, she announced that the committee had granted conditional approval.
So we have reached a milestone. I am convinced that the approval by the EC is the most difficult step in the entire approval process. Ethical decisions are judgments. Four years ago I was a member of a group of researchers from the Swiss Medical Society for Psycholytic Therapy (SaePT) that had a frustrating experience with a psilocybin/ depression project that was not allowed to proceed following rejection by the EC.
During the recent EC meeting, although the committee was critical and posed detailed questions, in general they were not overcome by prejudice. In the end, the committee was convinced that the potential benefits of LSD-assisted therapy outweigh the risks. Now, how to continue? First, before receiving unconditional approval, I have to wait for the written report of the EC and fulfill their requirements. Then, I will submit my papers to Swissmedic (Swiss Food and Drug Administration equivalent) and finally to the BAG (Swiss Drug Enforcement Administration equivalent). After all three of these groups grant approval, I will have full regulatory approval for the study.
I am happy and relieved to have reached this step. I’d like to thank everybody who supported me until now. As a researcher in private practice I depend on a network of people who are able to support this work. I’d like to thank Rick Doblin for his enthusiasm and financial support; Ilsa Jerome for busy and patient support in scientific literature research; Valerie Mojeiko, Amy Emerson, and Josh Sonstroem for their methodological support; John Halpern and Matt Bagott for permission to use their protocols; Rudolf Brenneisen for his support in accessing and handling the LSD; and, finally, I thank Albert Hofmann for the opportunity to consult with him about this study.
This was a big step in the right direction, although it’s still a long climb to the mountain top. I’ll keep you up to date!