FDA rejects MDMA as treatment for PTSD
WASHINGTON (NEXSTAR) - The FDA rejected a psychedelic treatment for post-traumatic stress disorder Friday. Supporters say it would save veterans' lives, but others say the science isn't there.
"To think that the FDA has said no to this revolutionary treatment is sad news," Rep. Lou Correa (D-Calif.) said.
Correa says the psychedelic drug MDMA, which is also known as ecstasy, shows real promise in easing veterans' PTSD.
"They've told me: 'I'll never do it again. But I've confronted my demons so to speak, I've gotten cured, and I'm ready to move on,'" he said.
Correa and 60 of his colleagues in the House — including Rhode Island Representatives Seth Magaziner and Gabe Amo — signed a bipartisan letter to President Biden earlier this month highlighting the benefits of the treatment.
The FDA's decision comes after its advisory panel in June recommended against approval, calling the treatment's effectiveness unproven.
"If you actually look at the science, this isn't surprising at all," said Kevin Sabet, president and CEO of the Foundation for Drug Policy Solutions.
Sabet says the FDA made the right move.
"These are very powerful, mind-altering, consciousness-altering substances, and we need to really take a lot of care with them," he said.
Sabet says MDMA may be helpful for some, but the broader data doesn't show it's safe and effective long-term. He says it's also hard to study.
"These placebos often fail because you kind of know whether you're taking MDMA or mushrooms, so it's very difficult to even establish placebos," Sabet said.
The FDA has asked for more clinical trials, which could take years.
"We need to go slower," Sabet cautioned.
But Correa says every day without treatment "is another 20 American veterans that take their own lives."
If you or someone you know is in crisis, seek immediate help:
Crisis Text Line: Text HOME to 741741988 Suicide and Crisis Lifeline: Call, text or chat 988BH Link: Rhode Islanders can call 401-414-LINK (5465)Kids' Link RI: Parents can call 1-855-543-5465
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