A scientific journal has retracted three studies underpinning the clinical development of MDMA—aka ecstasy—as a psychedelic treatment for post-traumatic stress disorder. The move came just a day after news broke that the Food and Drug Administration rejected the treatment, despite positive results reported from two Phase III clinical trials.
On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a rejection letter from the FDA. Lykos said the letter echoed the numerous concerns raised previously by the agency and its expert advisory committee, which, in June, voted overwhelmingly against approving the therapy. The FDA and its advisers 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. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).
FDA advisers 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.
(Score: 1, Troll) by JoeMerchant on Wednesday August 14 2024, @03:18PM
Try this, if it flies we'll be on the cutting edge!
When it fails, deny that it ever happened.
🌻🌻🌻 [google.com]
(Score: 2, Interesting) by VLM on Wednesday August 14 2024, @03:30PM (7 children)
They make vegans look calm rational and logical, yet even then they STILL could not ram it through, which makes me think the FDA is almost certainly correct. The odds of it being scientifically useful seem very low if even rabid supporters can't sell it.
On the other hand, we're in a post-scientific method post-truth era of medical treatment, if you look at the last couple decades of government/corporation enforced dietary advice, various preventative treatments, and certain viral pandemic issues. So if most psych medicines are no more effective than placebo for most of the diseases they're prescribed for, whats one more even if its mostly a recreational drug? Consider that statins don't really do anything other than make certain people very rich. Or massive over-prescription of opioids. Or the outcomes of certain recent vaccinations.
The industry can coast for a couple more decades based on the extremely high effectiveness of pharma mid-last century. But eventually, the more modern scam-industry that doesn't actually provide positive outcomes will collapse. That will be interesting to watch.
(Score: 4, Insightful) by JoeMerchant on Wednesday August 14 2024, @04:19PM (4 children)
>The odds of it being scientifically useful seem very low if even rabid supporters can't sell it.
Rabid supporters can't help themselves... they are true believers and must do anything to further their cause.
Doesn't necessarily mean they are wrong, just that you can count on them to always support their cause even while ignoring the associated negatives...
I continue to be disappointed in the current implementation of the peer review process in that "experts" will let papers with "flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials" go to publication, without even disparaging notes, and only retract them when others point out the flaws.
However, having been a party to a few of these FDA "expert review panels" - the "experts" they bring in to help decide the approval process have been... very far out of their depth in terms of the things they are judging. My favorite expert question regarding an implantable neurostimulator: "what about the negative consequences of having this thing inside your body, what happens when it rusts?" Answer: "The case is made of titanium, it does not rust."
I will continue to repeat: placebo is a very powerful treatment option. It's better than most of the advanced drugs currently in development and testing, and it has the best side-effect profile of all interventions. If the recreational high is otherwise harmless, X would make a great placebo for all kinds of problems.
Optimistic, are we? I think a lot of other societal cancers will have to be excised first before snake-oil lobbyists get shut down.
🌻🌻🌻 [google.com]
(Score: 2) by VLM on Wednesday August 14 2024, @06:22PM (3 children)
I don't think they ever get shut down they just rotate into new scams.
Not sure what the next scam-bubble will be. Possibly infertility treatments for older folks who waited too long. Possibly solar-electric everything even stuff that makes no sense (The solar powered flashlight, perhaps). I was thinking maybe water treatment as municipal structures collapse people will still want safe(r) water, and scammers will sell them all kinds of nonsense instead.
(Score: 2) by JoeMerchant on Wednesday August 14 2024, @07:20PM
>Possibly infertility treatments for older folks who waited too long.
We had out kids at 38 & 40, the natural way... 60 year olds don't have any business raising children under the age of 20 - not with the physical / mental condition that most 60 year olds are in today.
>The solar powered flashlight, perhaps
Hey, I am very seriously considering one of these for use in my new carport! Panel on the roof, some batteries, LED lights...
>maybe water treatment
IDK where you live, around every place I have EVER lived, water treatment scammers are some of the most successful... people get sold a charcoal filter and their water "tastes great" compared to untreated, for a week or two, then the charcoal needs replacement, but they don't like the cost of the replacement cartridges, so they continue to use the old charcoal until the stuff growing in it is actually worse for them than a PVC pipe would be... Oh, you know about the charcoal scam, do you? Well, let me introduce you to seventeen other kinds of water treatment options available for anything from your drinking pitcher to the whole house and every level in-between....
I am actually considering a mini treatment system for our washing machine, because we have very calcium-carbonate rich water - sourced from a lime-rock aquifer - and it tends to get crusty on things like the solenoid valves, especially the hot side for some reason. What I can't decide is: who to trust regarding a cost-effective system that would prevent the scale buildup on the washing machine internals... everybody's proposed solution is so very very effective, to hear them tell it, and the industry is so broad that meaningful reviews are about as easy to come by as they are for matresses.
🌻🌻🌻 [google.com]
(Score: 1, Informative) by Anonymous Coward on Wednesday August 14 2024, @08:45PM
> The solar powered flashlight, perhaps
Already available (more or less), sold as solar lights to accent your sidewalk or other path. Here's some little ones, a buck for a dozen! https://www.aliexpress.us/item/3256806830833735.html [aliexpress.us]
(not quite a dime-a-dozen, there's been some inflation...grin)
(Score: 3, Informative) by Tork on Wednesday August 14 2024, @11:27PM
Solar powered flashlights make a lot of sense and can even save lives. Are you aware of .. um... more than two decades of improvements to battery tech and LEDs...?
🏳️🌈 Proud Ally 🏳️🌈
(Score: 4, Insightful) by Thexalon on Thursday August 15 2024, @10:33AM
So I think it's worth mentioning a couple of points here:
- There was a period when these drugs weren't illegal. That's when people like Timothy Leary started doing experiments with them - not just because they were fun, but also because they thought they had real promise as psychiatric tools. There were papers published back then about the benefits.
- These all got shut down by the Nixon administration pushing to make all these drugs very very illegal, and the reason the Nixon administration did that is that he was looking for an excuse to lock up the hippies [cnn.com]. It had nothing to do with science or risk to the public, and everything to do with those long-hairs not falling in line behind the Vietnam War.
The people who share both of these views are still very much around. As for the recreational trippers: I've been in environments where some people like to trip (not me, not my thing, but the scene is generally friendly). I haven't seen any indications that those people pose any danger to anybody other than themselves, and if they're being remotely responsible they generally have somebody tasked with keeping an eye on them so they don't, say, walk into a lake and drown.
"Think of how stupid the average person is. Then realize half of 'em are stupider than that." - George Carlin
(Score: 2, Interesting) by Spamalope on Wednesday August 14 2024, @06:21PM (1 child)
I wonder if they'll come for Ket therapy too? MDMA has benefits for nearly the same reason Ket does.
I'm suspicious about the reasons. I know safety and efficacy aren't the only reasons meds are denied.
I've got an immune disorder. There is 1 and only 1 drug specifically for it permitted in the US. There is a cheap alternative available worldwide. It's not banned or illegal in the US, as it's got too much of a safety record for the FDA to ban it to protect the US drug. So... pharmacies are prohibited from dispensing it. And I have a severe allergic reaction to the US drug (the intended result works too - the med is fine for most - I just can't tolerate that particular drug).
(Score: 3, Insightful) by JoeMerchant on Wednesday August 14 2024, @10:57PM
Our son greatly benefits from a particular drug, recently patented combination of dextromethorphan and quinidine. Approved drug: $20 per pill, covered by Medicare and most insurance at 2 pills per day. Generic equivalent: only available from compounding pharmacies, not covered by insurance, used to be $0.50 per pill but recently increased to just over $1 per pill.
We could save over $700 per year by switching to the patented version... But for how long? And when you get stuck with the "actual" bill of over $14,000 per year, then what?
🌻🌻🌻 [google.com]