Tomorrow, a Food and Drug Administration advisory committee will meet to discuss whether the United States should approve its first psychedelic drug. The fate of the treatment-MDMA-assisted therapy for post-traumatic stress disorder-will turn on how the FDA interprets data from two clinical trials that, on their face, are promising. Long-suffering patients who took the drug while undergoing intensive talk therapy were about twice as likely to recover from PTSD as patients who got the placebo with therapy.
In clinical trials, participants (and the researchers studying them) generally aren't supposed to know whether they're getting the actual drug or a placebo, to avoid allowing people's expectations about a treatment to shape their response to it. Blinding, as this practice is called, is a key component of a randomized controlled clinical trial, or RCT-medicine's gold standard for demonstrating that a drug actually works. But virtually no one can take a psychedelic drug and not know it.
Some experts believe that unblinding threatens to undermine the entire field of psychedelic research because it means researchers can't know whether the drugs' early promise in clinical trials is real or a mirage, driven by the placebo effect and outsize expectations about the power of these drugs. But others argue that RCTs themselves are at fault. To them, psychedelics are exposing long-ignored cracks in our gold standard, especially for testing drugs that act on our minds.
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