Federal health advisory panel rejects psychedelic drug MDMA as a PTSD treatment

This photo provided by the Center for Psychedelic Therapy Research shows a Yehuda Lab MDMA-assisted therapy treatment room at the James J. Peters Department of Veterans Affairs Medical Center in the Bronx borough of New York.

“It seems like there are so many problems with the data — each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is,” said Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.

But FDA advisers spent most of Tuesday’s meeting leveling pointed questions and criticisms at the research submitted on MDMA, which is sometimes called ecstasy or molly. Panelists pointed to flawed studies that could have skewed the results, missing follow-up data on patient outcomes and a lack of diversity among participants. The vast majority of patients studied were white, with only five Black patients receiving MDMA, raising questions about the generalizability of the results.

But the panel struggled with the reliability of those results, given the difficulties of objectively testing psychedelic drugs. Panelists also noted the difficulty of knowing how much of patients’ improvement came from MDMA versus simply undergoing the extensive therapy, which totaled more than 80 hours for many patients. Results were further marred by other complicating factors, including a large number of patients who had previously used MDMA or other psychedelics drugs recreationally.

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