Thoughts on the Advisory Committee's Vote. The FDA is Doing its Job.
Dr. Signi Goldman at the Living Medicine Institute's training program takes 25 minutes to address the nuances, challenges and hopes going forward. Recorded the morning after the decision came out on June 5, 2024. Real talk without the hype....
Psychedelic psychotherapy is a paradigm shift, and the FDA understandably doesn’t have a pathway for evaluating this kind of model. They are scrambling and doing their best to look at all the potential downsides. And as a society, we do want them to do that.
The headlines in the media that MDMA was determined to be “not effective” are a misunderstanding of a more complex evaluation. Committee members voting “no” on effectiveness doesn’t actually mean the treatment is not effective. It means the available data can’t PROVE that it’s effective- especially with the confusing issue (this is a big one!) of “are the effects from the drug or the therapy part?” and the confusing issue of “if the participants know they are taking the psychedelic, will they be biased towards reporting positive outcomes?” ( in other words, does the fact that we can't blind the studies bias the data?). The press has a hard time understanding these nuances, so here are our broader thoughts.
Thanks for watching. The Living Medicine Institute Team.
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Негізгі бет A Psychedelic Psychotherapist's Thoughts on the FDA Advisory Committee's MDMA Recommendations.
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