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FlyingSquid , to news in FDA declines to approve novel MDMA therapy to treat PTSD
@FlyingSquid@lemmy.world avatar

I’d love it if it works.

I’d love it even more if the therapy included also dancing to 90s electronica.

WheelcharArtist , to news in FDA declines to approve novel MDMA therapy to treat PTSD

funny mdma started as medicine

seth , to news in FDA declines to approve novel MDMA therapy to treat PTSD

The military ran experiments with MDMA for treating PTSD at least as far back as 2007, I remember reading about it at the time. Wonder whatever happened to that data. It’s been nearly an entire generation since then. In 40 more years, they will admit efficacy and accept a greatly reduced cost to reimburse the 10% of affected veterans from the “war on terror” who are still alive, like they finally did with Agent Orange. No one who is actually responsible will be around anymore, so it will just be a day’s worth of “good news” in whatever the successor of newspapers is.

venusaur , to news in FDA declines to approve novel MDMA therapy to treat PTSD
@venusaur@lemmy.world avatar

Let’s start with non-hormonal birth control for women that’s not a contraption shoved inside your vagina and birth control for men.

Chozo ,

I don't think those will treat PTSD.

gdog05 ,

No but having been around kids before, these things might prevent PTSD.

mindlight , to news in FDA declines to approve novel MDMA therapy to treat PTSD

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.

Chozo ,

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/

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.

Those are some pretty big red flags.

mindlight ,

Holy crap…

Ab_intra , to news in FDA declines to approve novel MDMA therapy to treat PTSD
@Ab_intra@lemmy.world avatar

Makes sense if they want to study it further… It’s not like a great idea to just start providing this treatment if they are not sure it’s beneficial or even dangerous. But I have high hopes for it.

Nurse_Robot ,

But it’s already evidence based…

bustAsh ,

Exactly. Up until the early 80’s it was used to treat patients in psychiatric wards. Then Reagan squashed it.

John Hopkins is one of the few research hospitals still allowed to experiment with it, along with psilocybin, and LSD. They have for many years declared positive results with patients who suffered from PTSD, depression, anxiety, etc.

yeahiknow3 ,

Pffft. Next up, FDA declines to approve aspirin for headaches. Give me a break. The whole rent-seeking bureaucracy around American medicine is ridiculous.

FundMECFSResearch ,

As someone with a chronic disease.

Bodies like the FDA are needed. Otherwise you get spammed with a million treatments from your doctor whose payed off by pharmaceuticals to sell treatments even if they don’t work.

Cosmonauticus ,

While I agree the FDA has a history of caving to outside business interests.

Otherwise you get spammed with a million treatments from your doctor whose payed off by pharmaceuticals to sell treatments even if they don’t work.

That already happens.

MediaBiasFactChecker Bot , to news in FDA declines to approve novel MDMA therapy to treat PTSD

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