this post was submitted on 13 Aug 2024
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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.

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[–] fracture@beehaw.org 36 points 1 month ago (4 children)

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 points 1 month 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.

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