FDA Rejects MDMA-Assisted Therapy For PTSD 54
The FDA has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA as a treatment for post-traumatic stress disorder (PTSD), according to drugmaker Lykos Therapeutics. NBC News reports: There had been intense political pressure on the FDA to approve the drug. Friday's decision was the first time the agency had considered a Schedule 1 psychedelic for medical use. If approved, it would have been the first new treatment for PTSD in more than two decades. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. The agency's decision came after an independent advisory committee in June declined to recommend approval of the drug, saying there was not enough evidence that the therapy was safe and effective.
The committee cited a myriad of concerns, including poorly designed studies, allegations of sexual misconduct during a midstage clinical trial and the potential for serious health risks after taking the drug, including heart problems and abuse. A review by FDA scientists, published ahead of the June meeting, also raised concerns about how the trials were carried out, including that a number of patients and therapists likely were able to guess who was given the medication and who got the placebo. Despite the rejection, experts say they expect that psychedelic therapies are still on their way to FDA approval. There are around four dozen MDMA trials in various stages of clinical development, according to ClinicalTrials.gov. "I think it will be a temporary setback," said Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania. "The advisory committee and FDA gave very clear indications of what they're looking for in terms of study design and adverse event reporting, so Lykos and other companies should know pretty clearly how to proceed going forward if they want to get psychedelics approved."
The committee cited a myriad of concerns, including poorly designed studies, allegations of sexual misconduct during a midstage clinical trial and the potential for serious health risks after taking the drug, including heart problems and abuse. A review by FDA scientists, published ahead of the June meeting, also raised concerns about how the trials were carried out, including that a number of patients and therapists likely were able to guess who was given the medication and who got the placebo. Despite the rejection, experts say they expect that psychedelic therapies are still on their way to FDA approval. There are around four dozen MDMA trials in various stages of clinical development, according to ClinicalTrials.gov. "I think it will be a temporary setback," said Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania. "The advisory committee and FDA gave very clear indications of what they're looking for in terms of study design and adverse event reporting, so Lykos and other companies should know pretty clearly how to proceed going forward if they want to get psychedelics approved."
Seriously doubt the political pressure (Score:2)
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was to approve the drug.
Seriously doubt The People have the nerve or the balls to threaten politicians to approve it or else they’ll be out of office.
Citizens should remember they’re still elected officials. Who care greatly about which way you vote. They might not care about much else from you, but they do care a lot about that. Proving it still has power to elect Change. And quickly.
Re: Seriously doubt the political pressure (Score:5, Interesting)
Two of the trial therapists got into bed with a patient. One of the therapists was physically restraining the patient going through a bad trip. One of the therapists later had sexual relations with that patient. Everything about this trial was horribly executed and they deserve to be rejected. Nothing to do with political pressure at all
Re: Seriously doubt the political pressure (Score:5, Funny)
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Two of the trial therapists got into bed with a patient. One of the therapists was physically restraining the patient going through a bad trip. One of the therapists later had sexual relations with that patient. Everything about this trial was horribly executed and they deserve to be rejected. Nothing to do with political pressure at all
In order to prove how “deadly” marijuana was, the Government strapped gas masks to monkeys faces and pumped burning plant matter into their lungs until they were all dead. Nevermind the fact we have decades of data from firefighters that prove inhaling smoke with no oxygen can pretty much kill any living creature. Nope. Must have been that “deadly” weed that did it.
MDMA threatens every other competing profit motive, just like a medically useful plant that’s still illegal. W
Billions at stake (Score:2)
Anything that upsets the current crop of treatment paths for medical or mental conditions has an army of opponents from the medical industry, doctor's lobbying groups, non-profits, local/state/fed officials and more.
Conjecture: Even if the treatment in question is 99% safe, the 3 standard deviations outside the bell curve patients will cause enough deaths, insanity patients, crime, and other socially negatively effects that government, police, moms, etc. will campaign against the medical treatment.
Conjectur
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This is the same FDA that has been approving THC based drugs for more than 5 years, yet did not changed how that drug was scheduled until...oh, they haven't done it after 5 years. They should all be fired.
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Pity (Score:5, Insightful)
Anyone who's tried it will tell you it's got the potential to help people. It's a pity the ones trying to make it happen didn't seem to have their shit together. Hopefully it will happen someday.
Reuptake inhibitors don't work (Score:3)
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They can be useful in treating some specific kinds of mood disorders. The problem is they prescribe them for anything and everything they don't know how to fix. That alone is what makes the majority of written SSRI prescriptions useless. Not that the drugs themselves.
I'm a big advocate for LSD and MDMA, but I'm not sure you can separate the physical (possibly, but not necessarily, sexual) and personal aspects of the MDMA experience from its therapeutic potential.
I'm only 1 data point, but physically touchin
I think I agree on this one. (Score:4, Interesting)
REAL MDMA is an abuse potential Drug. While I do think in the end it will prove useful I do not think it will achieve three sigmas of obvious effectiveness.Maybe two.Other drugs are more likely to be approved in it's place.
Maybe in a couple hundred years we will be better able to prescribe such drugs on a personal effectiveness prescription.
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Yeah, let's wait two hundred years to solve this problem because someone might get addicted
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One word: (Score:1)
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REAL MDMA is an abuse potential Drug.
Yeah, who hasn't encountered one of those nasty junks sucking dicks in an alley for some molly? And what about all those rockstars and other celebrities that overdosed on it and died?
Seriously, though. Of all the shit people do with and to their body, MDMA really is one of the softest fucking things around. Energy drinks and soda drinks in general are arguably more dangerous than MDMA.
Fighting a losing battle. (Score:1)
They can approve bogus alzheimer's drugs... (Score:1)
Don't expect them to approve a drug with a political stigma that actually works and has a potential to be a curative.
Treatment in perpetuity or nothing. Gotta keep that American pharma profit system running.
On MDMA? (Score:2)
also raised concerns about how the trials were carried out, including that a number of patients and therapists likely were able to guess who was given the medication and who got the placebo
I would be concerned if people couldn't tell if they were on MDMA or not... unless the trial was giving people another similarly potent drug as a "placebo". This isn't one of those situations where you can just give someone sugar pills and expect their mind to play tricks on them.
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It would be pretty hard to find another drug that couldn't be mistaken for MDMA if you had educated participants, but if they haven't had it before it shouldn't be too hard to come up with a drug that produces euphoria.
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It would be pretty hard to find another drug that couldn't be mistaken for MDMA if you had educated participants, but if they haven't had it before it shouldn't be too hard to come up with a drug that produces euphoria.
Even possible that that drug might work better than MDMA.
The "sexual misconduct" thing is really not all that surprising. when we go down the list of MDMA's effects https://en.wikipedia.org/wiki/... [wikipedia.org]
While used in treating PTSD, that will have to be considered. The patient might get a bit randy.
Re: On MDMA? (Score:2)
Medical protocols should require all personnel to be ugly and happily married.
The functional unblinding is a huge issue (Score:4, Interesting)
I think of all of the Agency's objections, the functional unblinding is by far the most problematic to address. Everything else--safety, standard of care, measurement of response, assessment of durability of response--can be resolved with further data collection. But the fact that the overwhelming majority of participants can accurately determine whether they received investigational product, combined with the psychiatric nature of the endpoint, presents a huge challenge that should have been properly addressed by the trial sponsor prior to Phase 3 recruitment. That they chose to go ahead anyway really reflects a serious miscalculation, given the cultural bias against MDMA and psychedelics in general, as well as the current standard of care options on the market.
Now, to be clear, I absolutely think such treatment has potential and that there is compelling (if not entirely convincing) evidence for efficacy. And the existing treatments--SSRIs and the like--are nowhere near as safe or effective as their approvals might lead one to believe. I would even go so far as to say that for the moderate to severe PTSD indication, MDMA is probably both safer and more effective. But the sponsor took a gamble and didn't address the functional unblinding. In therapeutic areas where a placebo effect is not significant or applicable (e.g., cancer), open-label trials are acceptable evidence, but we are talking about a condition that, while debilitating and very real, is psychiatric in nature, and the measurement of efficacy must not be biased by knowledge of the treatment.
I read the briefing documents and it strikes me that the ethical objection based on earlier phase studies exploring the dose-response relationship of MDMA showing that low-dose treatment increased anxiety, in itself does not furnish an adequate reason to oppose the Agency's recommendation to use a masking dose in the placebo group. I would have designed such a trial with three arms--placebo, low-dose, and therapeutic dose, with a 1:1:2 allocation, which would allow at least some measurement of placebo effect on response. Or do something else, because the blinding issue cannot be ignored.
The people out there who are experiencing severe PTSD are going to see this news and they're going to find a way to self-medicate. That's the reality that the FDA and the Advisory Committee members have set into motion. It's not that they should have approved it--in a sense, there really was no other choice--but the consequences are quite predictable, and it's going to mean a lot of people who really need help will end up potentially abusing MDMA, taking the wrong dose, not getting the appropriate medical supervision and psychotherapy, and removing themselves from the pool of potential future trial participants. It's a setback for everyone, and it really was the responsibility of the sponsor to get the trial design right.
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Part of the problem (taken from another field) is the test is wrong. If double blind is the standard for something that has obvious affects, there .should alternative methods presented by the FDA that would satisfy their requirement, otherwise you end in an endless chasing of what does the test actually measure rather than efficacy.
Not justifying Lykos and how the trial went, but the FDA is as much to blame.
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Now, I'm quite critical of a lot of the decisions that the FDA has made and the positions they've taken (e.g., oxycodone, aducanumab), but on this issue, I can't "blame" the FDA. They can only play an advisory role in telling the sponsors what is and is not "adequate and well-controlled." And in this case, they DID advise: they even suggested how to reduce bias, and the sponsor disagreed and went ahead anyway. To then say they share an equal part of the blame for not telling the sponsor how to design the
Re: The functional unblinding is a huge issue (Score:2)
How is it standard to reject any study that demonstrates an unequivocal effect? That seems like a systemic bias towards existing drugs. There could be a drug that cures cancer and AIDS, but we won't approve it because it turns your skin purple for a day?
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Well, let's first address your question in the context of efficacy only, and then expand the scope to efficacy and safety (i.e., consider the risk/benefit profile).
The phrase "demonstrating an unequivocal effect" needs further clarification as it applies to the statistical interpretation of a study's outcome. For instance, you could design a massive randomized and well-controlled study, collect data, and compute a highly significant $p$-value, but the effect size is tiny. The treatment effect unequivocall
Bad/evil researchers (Score:5, Informative)
https://slate.com/technology/2... [slate.com]
The FDA Might Reject MDMA Therapyâ"but Not for the Reasons You Think
The drug has the potential to provide unprecedented treatment for issues like PTSD. But sloppy research and abusive practices may end up causing more harm than good.
Further, there are confirmed examples from MAPSâ(TM)s/Lykosâ(TM) MDMA trials in which a therapist explicitly overrode the will of a participant and initiated physical contact while the patient was on MDMA, even after it became clear that such contact was further upsetting them. In an incident from 2015, study facilitators sexually assaulted trial participant Meaghan Buisson during an MDMA dosing session.
A video of the session shows both therapists, Donna Dryer and Richard Yensen, hugging and cuddling Buisson and Yensen lying on top of her while sheâ(TM)s obviously distressed and resisting touch. Notably, her PTSD stemmed from previous sexual assaults. MAPS said it didnâ(TM)t review the videos from Buissonâ(TM)s sessions until 2021â"six years after they were filmed and three years after Buisson filed a complaint with the organization.
Stick to mushrooms. (Score:1)
MDMA is seriously dangerous. The mushrooms are safer, if slightly less fun. The fun part is a big part of the danger of MDMA, but it's also seriously dangerous from a pure toxicity standpoint as well; it's a methamphetamine derivative.
Re:Stick to mushrooms. (Score:5, Interesting)
> MDMA is seriously dangerous
Lemme guess, you're going to cite the study where the lab tech substituted methamphetamine?
This is so debunked as to be embarassing in 2024.
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3,4-Methylenedioxymethamphetamine
Side effects include sweating and jaw clenching.
Still not as dangerous as good ol' meth, but let's not pretend they're not related [nih.gov].
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> MDMA is seriously dangerous
Lemme guess, you're going to cite the study where the lab tech substituted methamphetamine?
This is so debunked as to be embarassing in 2024.
(Weed) ”Oh, YOU think you know embarrassment when it comes to lies and delusions? Hold my bud..”
Blood on their Hands (Score:2)
It's proved beyond reasonable doubt to significantly decrease suicidality.
That's why Congress has been pushing so hard.
FDA is just going along with DEA because blackops are funded by drug smuggling.
FDA is an existential threat at this point. Time for States to buck up and 10a the drug labeling process, same as they did with medical cannabis.
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hmmm... I don't think ecstasy (and mushrooms and LSD) are considered "hard drugs", though your point about it's being obviously different from a pure placebo stands.
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It's proved beyond reasonable doubt to significantly decrease suicidality.
That's why Congress has been pushing so hard.
Pushing for what exactly? Keeping a drug to help mitigate suicide illegal, or keeping the suicidal social media drug legal for children, feeding a suicide problem?
Yet another shining example of how the Government is “here to help.” /s
Surprised no one mentioned Australia (Score:1)
Since 1 July 2023, psychiatrists here in Australia can be authorised to prescribe products containing 3,4methylenedioxymethamphetamine (MDMA) for PTSD.
Also, Psilocybin for treatment-resistant depression (TRD).
Quote "Psychiatrists will need to show they have the necessary training, competency and robust evidence-based treatment protocols that appropriately control the risks to patients."
Have not heard any negative reports coming out about it.
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Have not heard any negative reports coming out about it.
You mean you have not heard of any major competing revenue streams being affected.
Yet.
(Greed has a longstanding and well-known tradition in medicine to shit-talk the competition into submission, prescribed in deadly amounts.)
Re: Surprised no one mentioned Australia (Score:2)
Don't they have single payor healthcare? Probably not a lot of revenue flying around when you only have one customer in your sales region.
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iunderstoodthatreference.jpg
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clarity (Score:2)
Not clear how scrambling your brain is going to help a scrambled brain.
They decided ahead of time... (Score:2)
They took poorly designed studies to claim they 'tried' to investigate legal uses.
Wish we had AI to apply here. To science and medicine. But something that could explain why/how it concluded what it did. That could step us through the process it used, and point to all the evidence it applied or ignored... and why.
People ALWAYS have bias. People in power? They have more reason for bias than most. Authoritarian systems cannot be efficient or effective in the long term. At best I think of them like ran
I think this is a legit rejection. however... (Score:2)