The panel of advisers to the Food and Drug Administration voted 10-1 against the overall benefits of MDMA when used to treat post-traumatic stress disorder
The panel of advisers to the Food and Drug Administration voted 10-1 against the overall benefits of MDMA when used to treat post-traumatic stress disorder— a potentially major setback to psychedelic advocates who hope to win a landmark federal approval and bring the banned drugs into the medical mainstream.
The vote followed hours of pointed questions and criticisms about the research submitted on MDMA — 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.
MDMA’s main effect is triggering feelings of intimacy, connection and euphoria. When used to enhance talk therapy, the drug appears to help patients process their trauma and let go of disturbing thoughts and memories. “I’m not convinced at all that this drug is effective based on the data I saw,” said Dr. Rajesh Narendran, a University of Pittsburgh psychiatrist who chaired the panel.
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