Panel rejects psychedelic drug MDMA as a PTSD treatment in possible setback for advocates

WASHINGTON (AP) — A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD was roundly criticized Tuesday — a potentially major setback to psychedelic advocates who hope to win a landmark federal approval and bring the banned drugs into the medical mainstream.

A 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. 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 agency’s rationale for rejecting the treatment.

MDMA is the first in a series of psychedelics — including LSD and psilocybin — that are expected to come before the FDA for review in the next few years as part of a resurgence of interest into the drugs’ medical potential, which advocates claim could transform the treatment of mental health disorders.

But FDA advisers spent most of Tuesday’s meeting leveling pointed 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