Bid To Approve MDMA As PTSD Treatment Overwhelmingly Rejected By FDA Advisors

WASHINGTON (AP) — Federal health advisers voted Tuesday against a first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD, handing 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 panel of advisers to the Food and Drug Administration sided 10-1 against the overall benefits of MDMA when used to treat post-traumatic stress disorder. They cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse.

“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.

The FDA is not required to follow the group’s advice and is expected to make its final decision by August, but the negative opinion could strengthen FDA’s rationale for rejecting the treatment.

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.

“The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth