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FDA advisors voted against MDMA therapy – researchers are still fighting for it (www.bbc.com)

submitted 6 months ago by [email protected] to c/news

31 comments fedilink hide all child comments

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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[–] [email protected] 9 points 6 months ago* (last edited 6 months ago)

The government doesn't work for us. The war on drugs continues.

[–] [email protected] -5 points 6 months ago (3 children)

Psilocybin.

Let them use psilocybin, which more effectively treats the same symptoms of PTSD for a longer time with simpler therapy schedules and no physiological risks or side effects, and let the researchers pursue MDMA as long as they want until they can figure out an effective therapy that isn't dangerous.

[+] [email protected] 17 points 6 months ago* (last edited 1 week ago) (1 children)

[deleted]

[+] [email protected] -11 points 6 months ago (1 children)

There's no reason to use a second solution to the exact same symptoms that a safe, simple and effectively solution already resolves.

You can choose your own therapy, but it's silly to tell people not to take the available, simpler, more effective proven solution in hopes that in the future a different solution will be available that might be as effective as psilocybin already is for these symptoms.

[–] Jimmyeatsausage 5 points 6 months ago (1 children)

There is absolutely reason to pursue second, third, and fourth solutions to medical problems. There is 0 reason to assume that if treatment A is effective in 70% of patients and treatment B is effective in 70% that it's the same 70%.

Braindead take.

[–] [email protected] 1 points 6 months ago

I agree, especially if the 70% is a hypothetical future therapy that isn't ready to be applied yet.

Use the thing that already works while you try to develop a different therapy.

Helping people now with psilocybin doesn't mean you can't do research into molly and other methods simultaneously.

[–] Fondots 15 points 6 months ago (2 children)

As a child on a taco commercial once said

¿Por qué no los dos?

Both show promise though need further research to determine how they should be used most effectively and safely, they have similar legal hurdles, and different patients may respond better to one, the other, or possibly even a combination of both,

[–] [email protected] -2 points 6 months ago

As much as I hate to say this, MDMA being used for treatment of mental illnesses might not be viable option because of it's negative effects. I do not know if short term severe depression and long term memory loss is worth a reduction in PTSD. Maybe as a last resort medication similar to how methamphetamine is prescribed for drug resistant ADHD.

[–] [email protected] -5 points 6 months ago (1 children)

As I said, there's no reason why not two.

Similarly, there's no reason to make people wait for a potential mdma medication while psilocybin is available, effective against the exact same symptoms, perfectly safe and has a simpler therapy regimen.

[–] [email protected] 7 points 6 months ago (1 children)

Because not everyone is exactly the same. Different experiences, different histories, different types of injuries/traumas means different methods of treatment.

Yes psilocybin is good. But it may not be for everyone.

[–] [email protected] -4 points 6 months ago (1 children)

Nobody argued everyone's the same.

All of the arguments that are put forth for using MDMA to treat PTSD symptoms already work for over 80% of patients using a single treatment of psilocybin that is already available.

Go ahead and research MDMA, but don't deny people an available, effective, safe and simple treatment while we wait for the development of experimental therapies.

[+] [email protected] 6 points 6 months ago* (last edited 1 week ago) (1 children)

[deleted]

[+] [email protected] -7 points 6 months ago (2 children)

It's fine if you didn't read or don't like that study.

Those symptoms resolved by psilocybin are the same as the PTSD symptoms that MDMA hopes to treat one day.

You not liking a particular medication doesn't make it less effective or safe for people.

You might want to check out the news recently though,, MDMA is specifically not being approved last weekend this week because a safe therapy has not been found, unlike with psilocybin.

Psilocybin is safe, simple and effective.

Controlled studies have born this out.

[–] [email protected] 7 points 6 months ago (1 children)

You do know the hope is not to treat symptoms but underlying disorders, right?

[–] [email protected] -4 points 6 months ago

That's close.

Ptsd is much more effectively treated when you deal with the symptoms and the disorder itself instead of just focusing on The disorder and ignoring the symptoms.

Luckily, psilocybin therapies work on both symptoms and disorders.

I mentioned symptoms specifically because MDMA therapies are specifically focused on the symptoms right now that psilocybin already effectively treats.

So you can take the effective and perfectly safe psilocybin therapy regimen to alleviate symptoms and the disorder itself while focusing on supplementing that treatment with more traditional therapies to dig deeper into the disorder.

[+] [email protected] 4 points 6 months ago* (last edited 1 week ago) (1 children)

[deleted]

[–] [email protected] -5 points 6 months ago (1 children)

I remember you had those blinders about MDMA.

It's easier for you to believe whatever it is you believe than to accept the scientific and therapeutic conclusions that disagree with your beliefs.

Ask for slanting the narrative. However you feel like it, yeah go for broke.

The numbers and consistent facts make it pretty easy for me to fix your mistakes anyway.

[+] [email protected] 4 points 6 months ago* (last edited 1 week ago) (1 children)

[deleted]

[–] [email protected] -5 points 6 months ago (1 children)

You claim to identify external projection by critiquing your own misunderstandings and assumptions about others.

I'm glad you personally like Molly and find it helpful.

It doesn't change how effective and safe psilocybin is.

You can like Molly 20% or 100% or a million percent personally, but that doesn't have any bearing on how safe and effective other therapies are at treating the same symptoms.

[+] [email protected] 4 points 6 months ago* (last edited 1 week ago) (1 children)

[deleted]

[–] [email protected] -3 points 6 months ago (2 children)

I understand it's easier for you to pretend I said something different than I said, but make-believe is not as convincing as you think it is.

MDMA is not ready as a therapy yet.

It isn't effective yet against the symptoms or disorder, and it isn't safe yet.

https://www.technologyreview.com/2024/06/06/1093327/fda-advisors-just-said-no-to-the-use-of-mdma-as-a-therapy/amp/

You should do all the drugs you want, drugs are great, but you shouldn't tell people not to take effective and safe therapies because you personally enjoy a drug that may have benefits in the future.

Psilocybin is here.

It helps with these problems.

MDMA does not yet have an effective therapy regimen.

9 out of 11 FDA researchers say:

Hold your horses

[–] [email protected] 3 points 6 months ago (1 children)

One has to wonder how many drugs you may have ingested that would make you think saying the same thing over and over again, without verifiable scientific proof (that is not simply a copy-pasta of an article in a tech mag) somehow proves your point.

[–] [email protected] -2 points 6 months ago (1 children)

You don't believe scientific articles or studies.

Convincing rebuttal.

[–] [email protected] 2 points 6 months ago (1 children)

You haven't posted any. Do that and I will read them.

[–] [email protected] 0 points 6 months ago (1 children)

I've posted a few, this is a longer conversation than you might be assuming.

Which type of articles are you specifically looking for?

[–] [email protected] 1 points 6 months ago (1 children)

The ones that scientifically support your statements.

[–] [email protected] 0 points 6 months ago (1 children)

I'm going to go ahead and let you scroll back to my earlier conversations on this topic if you don't have any specifics you're curious about.

It's all in the post history.

If you want something new or specific that wasn't covered, let me know.

[–] [email protected] 1 points 6 months ago (1 children)

You have exactly zero studies in any of your prior posts and you're telling me to go back and look anyway?

Either support what you say or sit down.

[–] [email protected] 0 points 6 months ago (1 children)

I can't help you if you don't know how to scroll.

But that's not on me.

I'm sure there's some YouTube tutorial you could watch.

I support what I say. You apparently don't know what you're looking for.

[–] [email protected] 1 points 6 months ago (1 children)

You apparently don't understand what facts are or how to find them ... preferring to blame others for your own failures.

[–] [email protected] 0 points 6 months ago (1 children)

If it makes you more comfortable to ascribe your ineptitude to others, I'm happy to help.

There's got to be a video tutorial somewhere out there that can teach you how to scroll, though.

Might be easier than you having to make all this stuff up.

[–] [email protected] 1 points 6 months ago (1 children)

Might be easier if you find proof for your statements.

[–] [email protected] 1 points 6 months ago

It was pretty easy the first time.

[–] quinkin 4 points 6 months ago (1 children)

Make it legal for cluster headache treatment too.

[–] [email protected] 0 points 6 months ago

Oh man, a thousand and 10%.

I did a deep dive into cluster headaches and that jaw nerve disorder that drives a lot of people to suicide, I really hope they do what psilocybin trial to relieve people of that.

Trigeminal neuralgia.

Yes 100%, people who have tried geminal neuralgia or any nerve damage and cluster headaches should probably try magic mushrooms.

Physiologically safe, rewires your brain in good ways in every study so far and a thousand anecdotal stories, why not try it?