Politico June 5, 2024
THE LAB
An FDA advisory committee on Tuesday dealt a severe blow to drugmaker Lykos Therapeutics, finding that its proposed treatment for post-traumatic stress disorder, the psychedelic drug MDMA combined with therapy, is not effective.
The decision also underscored a big problem for psychedelic medicine going forward: It’s basically impossible to conduct a double-blind trial involving the drugs.
That’s the gold standard clinical trial in which half of patients receive the drug and the other half get a placebo and neither the participants nor the trial researchers are supposed to know who gets what.
Why’s that? The mind-altering effects of psychedelic drugs are so pronounced that participants can usually figure out whether they received one.
And, as the FDA advisers...
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