FDA’s review of MDMA for PTSD highlights study bias and safety concerns

Xatolos@reddthat.com to News@lemmy.world – 153 points –
FDA’s review of MDMA for PTSD highlights study bias and safety concerns
arstechnica.com
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Psh. "Cardiovascular concerns." Fucking read the side effects for the drugs you've already approved, FDA. You've allowed an autoimmune treatment drug that has a high chance of giving terminal fucking cancer, you dumb fucks. Fucking Viagra has "cardiovascular concerns."

Biased, bought, dumb-asses.

Bought is it.

Mental health meds are a huge industry. MDMA has the potential to help cure what other medication can only treat.

Nah, that's not the issue (nor do I believe in magic bullets, but that's a different matter). See, the issue is that MDMA can't be patented. Anyone can make it so no one pharmacorp can have a 20 year monopoly

I said potential to help cure. I think MDMA assisted psychotherapy, in particular, has the potential to cure PTSD in a lot of people. Not everyone. But a lot.

And the patent issue on this has been solved by starting a non-profit pharmaceutical company and getting grants and donations to fund these trials. And then patenting the treatment protocols under a public trust corp I believe. I follow MAPS quite a bit, the non-profit that spear headed a lot of this.

I think what the other poster said about the FDA approving drugs with more cardiovascular issues than MDMA is true and points towards corporate bias in the panel (which most of us probably know is true).

Treating mental health with SSRIs etc. is a big business. Some of that panel probably stands to lose money if some of those repeat customers find a cure.

You sound like you'd be interested in David Healy's work. Check out Children of the Cure if you haven't already. That, as well as a plethora of other shady things I learned in university, are responsible for reorienting me toward public policy rather than becoming a practicing psychologist.

I found a TED talk with him I'm listening now. Thanks for the lead I hadn't heard of him before.

Usually first to market work generics enjoys a year of exclusivity. Usually other companies abandon our back burnera project they don't make to market first. There's still money to be made. Just not as much.

I think you don't quite understand the comment.

Current pharmaceuticals are usually a (life)long prescription. It's not like antibiotics, where you get a dose for a few days or weeks and you're done. Antidepressants have to be taken for years. Every day. That means revenue every day. It's a treatment, not a cure.

MDMA on the other hand is a (potential) cure. You take it a few times under supervision and that's it.

Problem is, this takes away customers from the former group. And that means, far less revenue from "traditional" psychopharmacology products. MDMA cannibalizes other drugs.

Well, I guess it's not only that. Psychedelic drugs can really fuck you up, if you aren't prepared. People talk about set and setting a lot.

I suspect that these drugs sure help a lot of people, but can also fuck a lot of people up really badly. It's like, people who don't go along well with these substances, avoid them instinctively.

Now, if someone would prescribe them, I'm pretty sure that a lot of people who are simply not prepared for it mentally (instead blindly trust the medics), would take them and get hurt pretty badly because of that.

That's why its better to take them under medical supervision(at least for the first time). Just giving them someone is probably the dumbest thing you could do.

It's not just supervision IMO.

I prepared myself for years before I took psilocybin for the first time, because I knew that it's going to bring up all of the subconscious shit that I carried around. So I "cleaned" myself enough emotionally beforehand, before taking the fungus.

Now, imagine your typical asshole walks into your medical treatment facility and demands psilocybin. Sure, you can give them psilocybin, but you cannot give them the sense of respect and understanding in front of these drugs.

Edit: by "your typical asshole" i mean, the typical asshole that you would encounter daily. Not you personally or sth.

These drugs are typically used for individual and group therapy sessions and not given as prescriptions to take at home. They're basically just there to augment therapy sessions.

I do think they should be legalized and allowed for recreational use as well but your concerns aren't really justified if you look at what existing therapeutic applications are like and what companies in the psychedelic space are trying to do right now.

It does not have that potential. This should be downvoted to oblivion.

There is no such thing as "curing" a mental disorder/disability. Although it could theoretically help speed up recovery from temporary bouts of depression or post-traumatic stress (which is often labelled "PTSD" when it's not), it cannot cure a lifelong disorder like depressive/mood disorders or PTSD & CPTSD. "Curing" a mental disorder would mean making you a completely different person, it's inseparable from the rest of your brain – especially something that leans more into the "neurodivergence" idea, like ADHD or ASD/Autism, which both have imperfect yet effective treatments (ASD less so than ADHD), but "curing" such a thing would be impossible.

The only solution that helps people with disabilities is to make treatment in the form of pharmaceuticals, counselling, and other methods widely available and accessible over the long term – not to look for a cure. Not to say that MDMA can't be used for that though, it definitely can, it'd just be misleading to call it a cure.

I mean if it has an effect on the heart it should be mentioned...in a study about MDMA's effect on the heart...I don't really know how 2 trials about MDMA's psychiatric effects has much to with cardiovascular health. I mean, if you stretch it you can maybe say something about the cardiovascular effects in relation to anxiety, but that's about it.

Addendum: somehow forgot to add "in relation to anxiety"

Yeah. Every drug has side effects; I'm saying that it's a weak excuse for not approving it, considering all of the other crap FDA's approved, with all of the other crap's side effects. So label it, put a warning on it.

Cigarettes will most likely kill you if you smoke enough of them, and FDA still allows their sale even though they have no medical application. Same with alcohol; despite the alcohol industry's efforts to link health benefits with alcohol consumption, there are as many studies showing there's no verifiable link between any benefit and any amount of alcohol consumption. It's a poison that dehydrates you and shrinks your brain a little every time you drink it. But it's legal.

FDA is the only dyke preventing outright charlatanism by the pharma and medical device industries, but fuck them on this topic. They're there to ensure companies don't outright lie to consumers about benefits and risks; preventing access to risky behavior is not their job.

preventing access to risky behavior is not their job.

I disagree. Lots of people will listen if you tell them about the dangers of a specific medication, but few will understand. Especially if they have no background in medicine or pharmaceutics.

As a species, we're horrible at statistical risk-based decision-making. My opinion is that we - as a society - should better educate and prepare children in statistical evaluation, and then as long as the behavior directly impacts only the individual, let people do what they want. The alternative is a morass of laws dictating personal behavior, with often unintended and arguably worse outcomes for society (c.f. The War on Drugs).

But in any case, FDA's job is to dictate the actions of companies, and prevent as well they can companies lying to and misleading consumers. Its mission is not to dictate individual behavior. And nor should it be.

FDA is there to stop cigarette companies from arguing or advertising to consumers that smoking is healthy, or that it makes you dick bigger, or whatever they think can make sales. FDA does not make rules preventing you from smoking.

What they're doing here is flexing control over a substance that has no giant, well-heeled organization pressuring them to allow companies to sell it.

I will note that I'm not an MDMA advocate; I've consumed a variety of chemicals, some in numerous quantities, but I've never knowingly taken MDMA. So my argument doesn't come from being butt-hurt about targeting my favorite drug; it's about the hypocrisy in the FDA wording of their warning.

Oh, I'll add: FDA doesn't make laws, but they're listened to by, and provide guidance for, lawmakers. And they do make decisions that decide whether a pharmaceutical or medical device company can bring a product to market, so they control legal supply. And this is only in the US, of course; the each country has their own version, and the EU has dozens from which corporations can pick and "give business to" to get approval to sell in that market.

There is this game where you get a million dollars with 99% probability and die a gruesome death with 1% probability if you press a certain button.

What would you do in that case?

IMO, statistics isn't everything, and one cannot only rely on statistics to make meaningful decisions. Lots of people I know wouldn't press that button.

Ah, but I disagree! The "gruesome" part is what changes it; it's an important detail in Pascal's Wager. If it were a sudden, painless death? I'd absolutely press it. If it meant death by being buried alive in a coffin? I wouldn't press it if the odds were 1,000:1, or 10,000:1. The "badness" vs "goodness" factor of each certainly factors into the decision process. The benefit would have to be enormous to outweigh the consequence of a long, terrifying, and/or painful death. Far more than money, for me.

But it if were even 50:1 odds, and the penalty is a sudden and painless death, vs the world being contacted and accepted into Iain Bank's The Culture? Heck yeah, gimme the button. I might take even worse odds.

And yet, I'm human, and humans are terrible at making decisions based on statistical odds; I'm maybe a little better than average for an American, but only because I have a formal process for making decisions like this. But I don't apply it intuitively to every risk, so I'm as bad as anyone else, in general.

Imagine that (hypothetical scenario) MDMA heals 70% of people, doesn't do anything for 10% of people, but throws 20% of people into mental disturbances.

Would you take it?

I don't have any mental illnesses of which I'm aware, but it depends on how bad the illness was if I did. Is it debilitating? Am I regularly having suicide ideation? Am I miserable all the time because of my depression? Is it running my marriage, my friendships? Yeah, I'd take it. 20% is pretty high odds, but if I'm so I'll I'm considering suicide already, 70% of being cured sounds good. Wouldn't you?

Is my illness such that I have sad days a couple of times a month? But 20% chance of getting a permanent psychosis? Probably not worth the risk.

If the perceived goodness value * % chance good outcome is greater than the perceived badness value * % chance of a bad outcome, then "Yes." That's the basis of Pascal's Wager, and it's a good a decision process as any I know.

Oh, heck... if I'm honest, I'd probably take MDMA recreationally at least once just to see what it's like, if it were legal and available.

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Just use magic mushrooms.

Totally safe, effective against PTSD,

Endorsed twice as a "breakthrough drug" by the FDA.

MDMA is better for PTSD.

And I love mushrooms. It's wheelhouse isn't PTSD though.

Both should be useable as medicine.

One perfectly safe dose of psilocybin instantly treats depression, anxiety and PTSD for more than 6 months at 80% efficacy, improving sociability, open-mindedness, resetting traumatic patterns, what are the numbers for MDMA, which is more physiologically dangerous and more difficult to apply in therapy?

https://med.nyu.edu/departments-institutes/population-health/divisions-sections-centers/medical-ethics/education/high-school-bioethics-project/learning-scenarios/ptsd-treatment-psychedelics

I love mushrooms and I have PTSD. It's helpful. But, MDMA deconditions the fear response in most people far more effectively.

I've seen this first hand again and again and again. I grew up in the rave scene. Still in the burner scene. Still in the psychedelic scene.

MDMA promotes a sense of safety that's integral to treating PTSD. Your link is to a class summary? It doesn't support the numbers you just cited, as far as I could see. Unless you're referring to that one linked animal model study.

https://www.ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp

Here's a review of both. While psilocybin is of interest in treating PTSD, studies so far have been minimal.

As I said, MDMA is the gold standard for treating PTSD. That's why MAPS has invested so heavily into it.

Psilocybin is excellent for treating other things. End of life anxiety and depression, for example. John's Hopkins has invested a lot in research here.

I know the landscape. So, do the therapists and researchers who are studying and investing their time into it. MAPS put their money on MDMA for PTSD because they've seen it work better than other psychedelics. Rick Doblin is the protégé of Stanislov Grof, who was a leading LSD researcher before it was criminalized. These aren't shots in the dark or even educated guesses. But a painstaking effort to prove to the Feds that these drugs (both of them) need to be usable legally in psychiatry.

Okay, you can be personally excited about therapeutic MDMA possibilities without making up a "gold standard'.

The study I've linked to above is specifically for psilocybin treating PTSD with an 80% efficacy rate after one entirely safe dose for 6 to 12 months.

The link you've supplied, as far as I can tell, does not report conclusive results for MDMA treating PTSD.

MDMA is not a gold standard, it's one non-standardized psychedelic therapeutic possibility that is physiologically more dangerous with fewer studies, more risks and more time commitment, therapeutic prerequisites and necessary conditions than psilocybin, without the resulting necessary controlled and conclusive clinical trials providing evidence of effective treatment.

I stand by my original point of seeing little reason to focus on more dangerous, less effective therapies when we already have a completely safe, simpler and so far more effective therapy according to conclusive controlled studies and patient testimony.

I went back and carefully read what you linked I suggest you do too.

The number you are citing matches end of life anxiety studies. This is not PTSD and especially not chronic PTSD or complex PTSD such as my own, which I'm telling you from decades of anecdotal experience being in the psychedelic scene as well as research into the pharmacology of these medications, that MDMA is the gold standard for PTSD treatment.

That doesn't mean better treatments won't be developed or better drugs won't be developed in the future. Or that psilocybin and LSD don't have some efficacy in treating PTSD. But MDMA works better for the majority of people because it helps to relax the fear response in a way that classical psychedelics do not.

If I was to invest personal time and money into a classical psychedelic for PTSD treatment it would be mescaline. Which coincidentally is in the same class of chemical as MDMA.

And if I was to use psilocybin to treat PTSD I would do it at the tail end of an MDMA roll. Or as an adjunct to therapy. Depending on the PTSD, I would expect this to take multiple sessions and not be one and good for six months like in anxiety depression treatments.

PTSD, especially CPTSD from child abuse etc, is very difficult to treat. The success rates in anxiety and depression studies aren't necessarily applicable.

I'm glad you read that article closely, although they specifically mentioned that the scientists chose terminally ill cancer patients because the symptoms are identical to the symptoms of post-traumatic stress disorder, and some of the patients in that study had comorbid PTSD.

There are studies going on right now with victims of domestic violence and veterans with PTSD.

https://scholar.google.com/scholar_url?url=https://psyarxiv.com/t6k9b/download%3Fformat%3Dpdf&hl=en&sa=X&ei=0VZbZqyMM5--6rQP8ZCGMA&scisig=AFWwaebv_6yDRogfHBRZDmA5TMvP&oi=scholarr

https://scholar.google.com/scholar_url?url=https://bmjopen.bmj.com/content/bmjopen/13/5/e068884.full.pdf&hl=en&sa=X&ei=0VZbZqyMM5--6rQP8ZCGMA&scisig=AFWwaeYIYvNPeVNtPh_PlbCu_YN_&oi=scholarr

I like all the drugs you're suggesting, and I think people should be able to choose, although I maintain that the logical therapeutic focus should be on the one completely safe, easily administered and controlled drug proven to be effective in treating depression, anxiety, and especially the traumatic symptoms of post-traumatic stress disorder.

People should do whatever drugs they want, but that doesn't make whatever drug they want the best choice for therapy right now.

We have a safe drug for that already. Psilocybin. It has passed every test so far, and it's completely non-toxic.

I'm for research into both. I outlined why MAPS is focusing on it for PTSD. Because they've been using it for this in closed circles for decades and it works well in more cases.

I've died and been reborn on tryptamines a few times. I get how healing they are.

But navigating attachment disorders and trauma triggers in this life is much different, regardless of the symptomatology being similar on the depression/anxiety scale.

I'll read the papers you sent though. I do believe psilocybin can help with cptsd with the right set and setting and integration. I just don't believe the current therapy models and studies support the conclusions you're making about current efficacy.

Personally, I would take the risk with molly if it was available in psychotherapy. I'll save the mushrooms for personal exploration, enjoying nature, and other traditional medicine spaces. Where they work quite well and again we're just showing the feds Nixon was an asshole, ultimately. Because this is stuff psychotherapists have known for a generation.

Again, I'm all for anecdotal advocacy and the use of any drugs people prefer

I still don't see the point of focusing on more dangerous, less effective drugs as therapy when we have a perfectly safe, effective therapy available.

Maybe I'm missing something from what you're saying, because I didn't see any outline for why maps is focusing on Molly specifically for PTSD.

The proposed benefits you're talking about using Molly are already known benefits of taking psilocybin, athough psilocybin has a lower physiological risk and simpler therapy scheduling.

No problem with researching both, this is more a case of diagnosing a problem, having the solution, but making people wait by purposefully diverting our attention elsewhere while there is a more effective, risk-free solution available.

It seems at best a waste of time and at worst cruel to tell people we might decide to help them soon If they wait for unknown years while we look into different solutions instead of helping them directly at no risk with the safe, effective solution we have.

First of all, there's no we here. MAPS is a non-profit entity that survives mostly off private donations. So, it's their decision and the decision of people who support them to invest primarily in MDMA research because they believe it fits best with the Western treatment and insurance model for PTSD.

Your links are to a PTSD research proposal with zero results and positive results from small group (medicine circles) therapy. I do believe the medicine circle model is effective for treating PTSD, and mentioned it specifically in my last response.

That said, it's also a liability nightmare for insurance companies and much different than how talk therapy is usually conducted under the Western modality. Medicine spaces work through shared vulnerability. Allowing someone with trauma to integrate into the community. Raves and Burns and other psychedelic spaces create a similar setting for classical psychedelics to do this. And there's 'men's work' and many other methods that do something similar without drugs by creating ritual spaces for shared vulnerability.

MDMA helps a person lower their fear response. To be vulnerable without feeling vulnerable. This helps a person open up and feel safe in a more traditional talk therapy environment, which is how MAPS is using it.

I hope that helps clarify some things. And btw, Psilocybin comes with cardiovascular warnings too. Though, the danger of this is mostly in microdosing due to chronic use. But there is a danger there with it. And the cardiovascular distress from MDMA is comparable to many drugs the FDA has approved in the past.

I think the FDA board making a fuss about this is drug war bias and protection of antidepressant cash flows, tbh. And not about the cardiovascular issues at all. Though, the critique of the failed double blinding is valid, I know these aren't the only two phase 3 clinical trials that have been submitted either.

Of course you believe there's a "we", you are continually asserting your place within this research landscape to legitimize your anecdotes.

And again, psilocybin conclusively provides the same possible benefits you're proposing MDMA may provide without the physiological risk or burdensome therapeutic balancing and time management.

As for the "cardiovascular risks" of psilocybin, caffeine also comes with cardiovascular warnings and is twice as "toxic" as psilocybin, similar to the also more toxic MDMA.

It's fine if you personally like MDMA more and cool if you believe it helps you more than other therapies, but it doesn't make mdma more simple, safe or effective than psilocybin.

Maybe more research will come out later that legitimizes MDMA, or makes it as simple or as safe a therapy as psilocybin already is.

But not even a therapeutic process, let alone research on mdma is anywhere near conclusively positive yet, so I don't see the point of experimenting with more complicated unsafe medication when psilocybin is available, simple and safe.

Nothing you've linked has really backed up your assertions about psilocybin being great for PTSD so I'm going to stop replying.

Medicine circles personal exploration end of life anxiety etc.

I've explained why MDMA is better at relaxing the amygdala. The pharmacology supports this as does the current research. The papers you have linked don't really. One study in a small group setting, which I absolutely do believe would be beneficial for reasons I've mentioned earlier. And I also explained why the Western therapy modality conflicts with that model. And how that would make access difficult because of insurance issues. I. E. good luck getting insurance on guided group psilocybin journeys anytime soon. The U.S. health industry already struggles with access to group therapy and they're not giving everyone hallucinogens.

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I miss good mdma

I know! I'm past the point in my life where I wanna rave, but I feel sorry for kids these days. Who knows what's stuff actually is anymore what with bath salts and fentanyl. Sucks for the chillen. I had some really good times in barn raves out on the prarie

I don't want anyone to take this as an endorsement of recreational drugs, but it sucks you gotta risk od and brain damage to do some molly.