The U.S. Food and Drug Administration’s decision on MDMA-assisted therapy for post traumatic stress disorder.
Psychedelics are now at the center of a global conversation about mental health, mysticism, and even how we experience illness and death. In Altered States, host Arielle Duhaime-Ross explores how people are taking these drugs, who has access to them, how they’re regulated, who stands to profit, and what these substances might offer us as individuals and as a society. Listen to more episodes here.
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ARIELLE DUHAIME-ROSS: Hey, it’s Arielle.
ARIELLE DUHAIME-ROSS: This is Altered States.
ARIELLE DUHAIME-ROSS: We’re working hard to bring you our next episode, a deeply honest and intimate story from the Middle East that we’ll share with you next week.
ARIELLE DUHAIME-ROSS: But in the meantime, we have an update on some big news from the FDA.
ARIELLE DUHAIME-ROSS: You might remember that last week we published an episode about the attempt to get MDMA-assisted therapy approved by federal regulators.
ARIELLE DUHAIME-ROSS: Well, the FDA gave its answer on Friday.
NEWS CLIP: The FDA rejected MDMA therapy as a treatment for PTSD.
ARIELLE DUHAIME-ROSS: So for now, it’s a no.
NEWS CLIP: It’s a setback for the growing movement to use psychedelics for treatment of mental health conditions.
ARIELLE DUHAIME-ROSS: Friday’s decision suggests a change of heart for the FDA, which had designated MDMA-assisted therapy for PTSD, a breakthrough therapy in 2017, and had decided to expedite the drugs’ review.
ARIELLE DUHAIME-ROSS: The FDA said the application couldn’t be approved based on the data provided.
ARIELLE DUHAIME-ROSS: So they asked the company behind the application, Lycos Therapeutics, to run new clinical trials to assess whether the drug is safe and effective, which would likely take years to complete.
ARIELLE DUHAIME-ROSS: The FDA didn’t make the full reasoning for its decision public, but an advisory committee previously raised concerns about a bunch of things, including missing data on adverse events, accusations of misconduct, inadequate data on the drug’s addiction potential, and concerns that the research didn’t make clear what role the therapy part of things may have played in the clinical trial results.
ARIELLE DUHAIME-ROSS: It’s hard to know how this is all going to play out at this point, but the decision constitutes a significant setback for research on psychedelic-assisted therapy.
ARIELLE DUHAIME-ROSS: If you’d like to learn more about the FDA’s decision and what it might mean for the future of psychedelic science, check out The Microdose.
ARIELLE DUHAIME-ROSS: It’s a journalism newsletter supported by the UC Berkeley Center for the Science of Psychedelics.
ARIELLE DUHAIME-ROSS: We’ll be back next week.