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The Case for MDMA’s Approval Is Riddled With Problems
The FDA is considering approving MDMA alongside psychotherapy as a treatment for PTSD. But evidence of the drug’s effectiveness isn’t clear cut.
The results sounds promising, but Michael Ostacher, professor of psychiatry and behavioral sciences at Stanford University who’s not involved with Lykos and wasn’t on the FDA panel, says there’s a big problem: “It's unclear whether or not the participation in the study and anticipation of the effect is what makes people better, rather than the impact of the drug itself.” Many of the points raised at Tuesday’s meeting were echoed in a report released earlier this year by the Institute for Clinical and Economic Review, a nonprofit that evaluates drug efficacy and prices, which said it had “substantial concerns about the validity of the results” of the Lykos trials. In a statement after Tuesday's meeting, Lykos CEO Amy Emerson said the company remains committed to finding a path forward for MDMA-assisted therapy and is working with the FDA to address outstanding questions.
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