Feb. 4, 2025
The fallout from the F.D.A.’s rejection of MDMA-assisted treatment for PTSD worries researchers and experts who fear other psychedelic drugs in the pipeline could be jeopardized.
After more than three decades of planning and a $250 million investment, Lykos Therapeutics’ application for the first psychedelic drug to reach federal regulators was expected to be a shoo-in.
Lykos, the corporate arm of a nonprofit dedicated to winning mainstream acceptance of psychedelics, had submitted data to the Food and Drug Administration showing that its groundbreaking treatment for post-traumatic stress disorder — MDMA plus talk therapy — was significantly more effective than existing treatments.
At a pivotal public hearing last summer, two dozen scientists, doctors and trauma survivors told an F.D.A. advisory panel how MDMA-assisted therapy had brought marked relief from a mental health condition associated with high rates of suicide, especially among veterans.
Then came skeptics with disturbing accusations: that Lykos was “a therapy cult,” that practitioners in its clinical trials had engaged in widespread abuse of participants and that the company had concealed a litany of adverse events.
“The most significant harms in Lykos’s clinical trials were not caused by MDMA, but by the people who were entrusted to supervise its administration,” Neşe Devenot, one of the speakers opposed to Lykos’s treatment and a senior lecturer in the writing program at Johns Hopkins University, told the committee.
Dr. Devenot and six others presented themselves as experts in the field of psychedelics, but none had expertise in medicine or therapy. Nor had the speakers disclosed their connection to Psymposia, a leftist advocacy group whose members oppose the commercialization of psychedelics and had been campaigning against Lykos and its nonprofit parent, the Multidisciplinary Association for Psychedelic Studies, or MAPS.
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