Update: LSD-Assisted Psychotherapy in Persons Suffering from
Anxiety Associated with Advanced-Stage Life-Threatening Illness:
A Phase 2, Double-Blind, Placebo-Controlled Dose-Response Pilot Study
Peter Gasser, MD
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.
"In the end, the committee was convinced
that the potential benefits of LSD-assisted therapy
outweigh the risks.."
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! ¥
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