Why’s the FDA letting PTSD patients suffer? MDMA therapy REJECTED

Last week, FDA rejected an application for MDMA-assisted therapy, a potentially game-changing treatment for PTSD, despite successful phase 3 results that a peer-reviewed study in Nature Medicine described as "highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities." The therapy looks more compelling in PTSD than ketamine did for depression, yet FDA approved JNJ's application for esketamine while rejecting little-known Lykos' application for PTSD. Ask yourself why.

One of FDA's reasons for rejecting the Lykos product is supposedly "functional unblinding" of the phase 3 studies - that is, patients on the drug arm experienced euphoria while patients on the placebo arm didn't - which means the trial wasn't really "blinded" to the patients or physicians, which could theoretically introduce bias in recording study results.

But that's bogus for at least two reasons: (i) that side effect is inextricably linked to MDMA's mechanism of action and may even account for its therapeutic effect, and (ii) FDA knew about that side effect and signed off on the phase 3 plan regardless...which caused a company to waste exorbitant resources only to be denied at the end. Meanwhile, PTSD patients suffer & are deprived of therapy as a consequence.

This is a strong case for federal court appeal in a post-Chevron world. But here's the problem: no biotech or pharma has the stones to even try it, because they know FDA will retaliate against them on their future products. "FDA never forgets," as the age-old adage goes in pharma. Everyone in the industry knows it, but they also know better than to say it too loudly.

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