FDA panel rejects MDMA therapy for PTSD despite its potential benefits. Methodology of clinical trials and concerns about data integrity were major factors in the decision. Guests, including a trial participant and a psychologist, shed light on the topic. The rejection raises questions about the future of psychedelic therapy in treating mental health conditions.
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Joining the Trial
Sarah MacNamee, a trial participant, joined an MDMA therapy trial for PTSD while on medical leave.
A friend told her about the trial, and she signed up, already familiar with MDMA research.
insights INSIGHT
Trial Structure and Concerns
The MDMA therapy trial included preparation, dosing, and talk therapy sessions.
The "therapy" part draws on controversial methods, raising red flags for Sarah in retrospect.
question_answer ANECDOTE
Hope and Hype
Sarah was drawn to the trial by the promise of a faster, more effective treatment, fueled by media hype.
She questioned the claimed efficacy before the trial concluded, highlighting a pre-existing belief among researchers.
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Last month, the first psychedelic therapy treatment came before the Food and Drug Administration for a vote. It entailed using MDMA, also known as ecstasy or molly, to treat PTSD.
MDMA therapy has looked promising as a treatment for PTSD and other mental health conditions in some studies. But the FDA scientific advisory panel that evaluated this treatment voted overwhelmingly against approving it.
Many of the arguments against approval had less to do with MDMA itself than with the methodology of the clinical trials done by Lykos Therapeutics, formerly the Multidisciplinary Association for Psychedelic Studies, or MAPS. The FDA panel was presented with allegations of misconduct and incongruous data, including a letter by trial participant Sarah McNamee.
McNamee, who joined the trial for treatment of PTSD, is also a licensed psychotherapist and researcher of trauma and psychotherapy at McGill University in Montreal. She joins guest host Rachel Feltman alongside Dr. Eiko Fried, a methodologist and psychologist at Leiden University in the Netherlands, to discuss the decision.
If you or someone you know is struggling with PTSD or other mental health conditions, call 988 for the suicide and crisis lifeline.
Transcripts for each segment will be available after the show airs on sciencefriday.com.
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