In June, an independent FDA advisory committee overwhelmingly voted against approving the treatment. The committee raised concerns about the integrity of the trial data, particularly around safety and potential bias in efficacy results. The committee also noted the difficulty in determining how much of the treatment’s success was due to the accompanying talk therapy, which the FDA does not regulate.
The FDA and its advisors identified flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials, including an alleged cult-like support of psychedelics.
[…]
FDA advisors also noted the public allegations of a sexual assault of a trial participant during a Phase II trial by an unlicensed therapist providing the MDMA-assisted psychotherapy.
[…]
For the conflicts of interest, the journal claims the authors did not fully disclose their affiliations with MAPS and its subsidiary—the MAPS Public Benefit Corporation—despite the fact that MAPS funded the studies.
Did Lykos Therapeutics cheat in the trials?
From the article:
In June, an independent FDA advisory committee overwhelmingly voted against approving the treatment. The committee raised concerns about the integrity of the trial data, particularly around safety and potential bias in efficacy results. The committee also noted the difficulty in determining how much of the treatment’s success was due to the accompanying talk therapy, which the FDA does not regulate.
There were apparently a lot of problems with Lykos. Ars goes into a bit more detail: https://arstechnica.com/science/2024/08/mdma-for-ptsd-three-studies-retracted-on-heels-of-fda-rejection/
Those are some pretty big red flags.
Holy crap…