this post was submitted on 21 Jun 2024
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135
FDA advisors voted against MDMA therapy – researchers are still fighting for it (www.bbc.com)
submitted 4 months ago by girlfreddy@lemmy.ca to c/news@lemmy.world
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Some 13 million Americans struggle with post-traumatic stress disorder (PTSD). Existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. So, there was distinct disappointment when an advisory committee at the US Food and Drug Administration (FDA) voted earlier this month against a therapy that many had hoped could offer the first new treatment for PTSD in 25 years.

A number of experts who study psychedelics have since spoken out in support of MDMA-assisted therapy for PTSD and have sharply criticised the recommendations of the FDA's Psychopharmacological Drugs Advisory Committee. But some are still optimistic that the treatment might be approved when the FDA delivers its final decision in August.

Ahead of the meeting, FDA approval of MDMA-assisted therapy for PTSD seemed likely, says Sandeep Nayak, an assistant professor of psychiatry at Johns Hopkins University, who investigates psychedelics as treatments for substance use and mood disorders. About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase 3 clinical trials.

It's an outcome that is "almost double that of existing medications", says Gül Dölen, a neuroscientist at the University of California, Berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "What's more, [the treatment] led to durable improvements in these patients lasting at least six months."

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[–] treefrog@lemm.ee 3 points 4 months ago* (last edited 4 months ago) (1 children)

I'm not telling anyone not to take psilocybin. Don't put words in my mouth.

I'm questioning the bias in that FDA advisory board. A reasonable question considering decades of prohibition and that historically FDA advisory boards have owned stocks in pharmaceutical companies that stand to lose profits if MDMA is approved as a medication.

In other words, the 9 out of 11 statistic that you just cited is a statistic that I don't trust because these individuals have historically been biased and are not specialists in psychedelic medicine.

And your whole argument hinges on this idea that because we have a treatment that could be effective we should not look into more effective treatments. In which case, meditation works just fine for all of this and is much safer than any medication we can put in our body. So, should we not use any mental health medications? And put all of our research money just into meditation? After all it is safe and effective, and much safer than either of these drugs.

[–] Varyk@sh.itjust.works -1 points 4 months ago

Question and enjoy whatever you like.

Meditation is not much safer than psilocybin.

Magic mushrooms are twice as safe as coffee.

Just because MdmA doesn't work, it doesn't mean that you don't have to use any therapies at all that do work.

This is the problem with your approach and conclusions.

You're so devoted to your personal experience with MDMA that when MDMA has been rejected, your next question is so then there's nothing?

That is not the logical conclusion.

The treatment you prefer is not yet safe or effective.

That's fine. There is a safe and effective treatment already.

Whatever else you are reading into this conclusion is your own.

There's nothing wrong with having effective solutions that don't jive with your personal preferences.