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.
FILE - In this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off Cape Neddick in Maine on Dec. 11, 2017. Federal health advisers are considering the first request to approve the mind-altering club drug MDMA as a treatment for PTSD . The advisers to the Food and Drug Administration are scheduled to vote on the drug's safety and effectiveness Tuesday, June 4, 2024, potentially setting the stage for federal approval later this year.
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 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 Joniak-Grant, the group’s patient representative.
MDMA is the first in a series of psychedelics — including LSD and psilocybin — that are expected to come before the FDA in the next few years. The panel’s negative ruling could further derail financial investments in the fledgling industry, which has mainly been funded by a small number of wealthy backers.
Because MDMA causes intense, psychological experiences, almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a dummy pill. That’s the opposite of the approach generally required for high-quality drug research, in which bias is minimized by “blinding” patients and researchers to whether they received the drug under investigation.
PTSD FDA Psychedelic Treatment Advisers Research Panel
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