The company behind the therapy says it will appeal the FDA’s decision.

I understand the purpose of appeals and that we rarely hear about things that are not appealed. But I don’t think either the FDA or court system are functioning when people and companies go in front of a decision-making body knowing they’re going to lose and viewing the ruling as the real starting gun.

  • fracture [he/him] @beehaw.org
    35·
    3 months ago

    idk dawg this seems pretty sound according to the article

    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. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).

    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.

    …

    On Saturday, using the existing data and scientific literature to support MDMA therapy got a little more difficult for Lykos. The journal Psychopharmacology posted retraction notices for three studies that involved Phase II clinical data of the therapy. The studies included a 2019 rationale for a Phase III trial design, a 2020 pooled analysis, and a 2020 study on how antidepressant use may affect the response to MDMA therapy.

    The retraction notice cited two reasons for the retractions, including “protocol violations amounting to unethical conduct” at one of the clinical trial sites—a reference to the sexual assault allegations—and undisclosed conflicts of interest by the authors.

    like. these are pretty good reasons for not going ahead. it’s on lykos and the scientists running the trials for not keeping their paperwork straight and, you know, not warning people about the risks of the study

    from an article cited within (https://qz.com/1809184/psychedelic-therapy-has-a-sexual-abuse-problem-3):

    A few years ago, a therapist working in a MAPS MDMA study publicly spoke about his challenges dealing with a patient’s sexuality. Early in his career, Richard Yensen was working with a “lovely young lady who became very sexualized in her relationship around the [MDMA] sessions,” he told an audience at California Institute of Integral Studies in 2016. “It got so intense,” said Yensen, that the chair of his department saw him mid-therapy session and told him to leave the room, warning him to always have another therapist alongside him during sessions. “And thank god, because she became more and more and more activated sexually,” said Yensen. “I don’t think I could have handled it.”

    Not long after, Yensen was accused of sexually assaulting a PTSD patient, Meaghan Buisson, during a MAPS clinical trial on MDMA

    like. even GENEROUSLY assuming that nothing truly unethical happened. this is a huge issue that will only get worse if it’s made publicly available

    i’m not taking a position on whether or not it should be made available as a treatment. i don’t know and i’m not qualified to determine that. but given what’s been said, it feels reasonable to want more data and perhaps go “hey think you could run a trial without getting accused of assaulting people?”

    • HappyRedditRefugee@lemm.ee
      10·
      3 months ago

      Love mdma, I belive that it could help PTSD, but I agree with you, is no benefit for anyone to rush such a thing.

      The whole vive is "they stopted it cause is “drugs”, but like, those are good reasons to stop any trials.

    • Pete Hahnloser@beehaw.orgOP
      2·
      3 months ago

      I’m baffled. At no point did I say the denial was the wrong decision. The best MAPS can do here is start over again at Phase III but this time figure out solutions to the fatal flaws that sank the application – and maybe not let anyone get sexually assaulted in the process.

      The biggest hurdle I see is blinding. There’s simply no way to know you’re not rolling, whether you’ve done MDMA in the past or not, so placebo is pointless.

      • fracture [he/him] @beehaw.org
        2·
        3 months ago

        oh okay, sorry, i took away a different impression from your OP talking about how the FDA process is flawed due to appeals being the starting point (which very well may be true) - but including that with this article made it seem like you felt that way about this particular incident (e.g. the link was supporting evidence), not that the commentary on the FDA process was it’s own, unrelated thing

        glad to hear that we’re in agreement about the denial, though

        i can’t really comment on the process, i’ve never taken mdma myself. that said, you say there’s no way you wouldn’t know you’re on it, but there’s a number of substances out there where you’d think that would be the case, but it isn’t (think like, the stereotype of people acting drunk with little / no alcohol, just thinking they had it). also, the dosages may be lower / less obvious, although i have no idea what the dosages used for recreational use vs for therapeutic use are here

        • Pete Hahnloser@beehaw.orgOP
          1·
          3 months ago

          I recall seeing that the therapeutic dose was pretty close to if not the same as recreational, which would be 100 mg.