FDA Grants Quick Review For 3 Psychedelic Drug Trials
- Reference: 0183047234
- News link: https://science.slashdot.org/story/26/04/29/0340243/fda-grants-quick-review-for-3-psychedelic-drug-trials
- Source link:
> The Food and Drug Administration on Friday [1]granted a quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder. It's the latest move by the Trump administration signaling a shift in policy toward treatments that also give users a high -- coming a day after the Justice Department said it would ease restrictions on state-licensed medical marijuana.
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> UK-based biotech company Compass Pathways said Friday it has received an expedited review for its experimental form of synthetic psilocybin for treatment-resistant depression. In a press release the company cited two large, phase 3 studies that had "generated positive data." Usona Institute, headquartered in Wisconsin, also said it's received a voucher for its work with psilocybin to treat major depressive disorder. In an email, a Usona spokesperson said the company expects the review process to last one to two months after it submits its application. "The voucher expedites the timeline only; it does not alter scientific or regulatory standards," the spokesperson wrote. New York-based Transcend Therapeutics has also been granted a priority review voucher for its experimental drug methylone for PTSD, Blake Mandell, the company's chief executive officer, said.
"There's a battle still raging in their mind that we don't fully understand biochemically," FDA Commissioner Marty Makary said. "When you see something that looks promising for a community that is suffering with mental health illness, despair and suicidal ideation, you can't help but recognize that."
Makary told NBC News that with the priority voucher program, the agency could potentially approve the first psychedelic drug by the end of summer.
[1] https://www.nbcnews.com/health/health-news/fda-psychedelic-drugs-psilocybin-methylone-review-depression-ptsd-rcna341677
Re: (Score:1)
I am sorry I must have missed where people have been using mRNA vaccines recreationally for centuries and all the experience we collectively had with them anecdotally and in terms of actual data.
but go on COVID-vax skeptics are the idiots...
Re:Echoes of COVID vaccine (Score:5, Informative)
> COVID-vax skeptics are the idiots...
Correct, because as you demonstrated here you don't actually have good reason to be other than vibes and what your media diet feeds you. When should all our bad side effects kick in? Any day now we'll all start dropping dead!
"Well your honor, we've got plenty of hearsay and conjecture. Those are KINDS of evidence."
Meanwhile in the real world
[1]A massive, 4 year old study of nearly 30 million people in France found that individuals who received a COVID-19 mRNA vaccine had a 74% lowerrisk of death from severe COVID-19 compared to unvaccinated individuals and zero increased risk of all-cause mortality. [jamanetwork.com]
[2]Pancreatic cancer mRNA vaccine shows lasting results in an early trial [nbcnews.com]
[3]HHS nixes publication of study showing effectiveness of COVID vaccines /a [thehill.com]
[1] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2842305
[2] https://www.nbcnews.com/health/cancer/pancreatic-cancer-mrna-vaccine-shows-lasting-results-early-trial-rcna331969
[3] https://thehill.com/policy/healthcare/5845817-cdc-blocks-covid-vaccine-study/
Re:Echoes of COVID vaccine (Score:5, Insightful)
There was the entire Phase I, II, and III trials available at the time, the phase III trial alone was almost 44,000 people.
There has been information available since it started. If you wanted to be skeptical in 2021 I'd call you silly but sure, whatever, just shut up about it if you dont want to take it.
But in 2024, 2025, 2026? You're either a liar, a grifter, profoundly ignorant or just so lost that you simply cannot, ever, ever admit you were wrong about this.
[1]"I won't change my mind on anything, regardless of the facts that are set out before me. I'm dug in, and I'll never change." [youtube.com]
[1] https://www.youtube.com/watch?v=ndsME9Vd4es
Re: (Score:2)
Unfortunately you are wasting your breath. They will believe ANYTHING that is anti government
Re: (Score:2)
Where are my karma points when I need them
Pre- qualify for the screening (Score:2)
1. When were you born?
2. What music magazines were on the newsstands when there was a new album out?
3. You didn't listen to music? At all? Go to #5.
4. Who was the president then?
5. Just go, man.
"Give users a high" (Score:2)
I dunno, that seems like a clueless thing to say. We're talking about psychedelics, here. They certainly do interesting things to your mind but, doing acid just doesn't seem remotely similar to smoking a joint or shooting up in search of the warm fuzzy-buzzies that constitute a "high". Psychedelics are not recreational in the same sense.
Re: (Score:2)
As a former connoisseur, I disagree.
Re: (Score:2)
You are so don't take psychedelics like that when you're in treatment. I think there are some super low dose things that people might do on their own but otherwise if you're taking a dose enough to really affect you you are doing it under direct and immediate doctor supervision. Has in the doctor is right there watching you trip and guiding you through it.
That seems to be what really works. You have the doctor there guiding you through the psychedelic experience and the two combined, the doctors psychol
Oh, good. (Score:5, Interesting)
My nephew has pretty severe PTSD from his time as a sniper in Afghanistan. The results that have come from experimental treatments with psylocibin and other psychedelics are impressive. This could save his life.
good (Score:2)
I think RFK and Trump are deranged incompetent lunatics, but it is pretty clear FDA staff have an emotional and cultural resistance to psychedlics as treatment.
Re: (Score:2)
Emotion and culture have nothing to do with it. The government studied psychedelics extensively in MK-ULTRA, and when they found out they usually do very much the opposite of what they wanted, they decided that we couldn't have them without a huge fuss and making sure dosage is controlled to have as subtle an effect as possible. You either get barely half of a nothing or you get blackout, no talking to aliens allowed.
Somewhat related (Score:2)
A very good animated series was made about this topic. [1]https://www.imdb.com/title/tt2... [imdb.com]
[1] https://www.imdb.com/title/tt28093628/
Ibogaine... (Score:2)
Was kepts off the market for a total of 18 Deaths during trials that lasted years. 9 of those had pre existing heart conditions, and should have been exempted from the study... So 9 people over the course of YEARS. While one person approximately every 10 minutes, dies from Opiate OD in the USA. Make it make sense.
This is the problem (Score:2, Insightful)
> "There's a battle still raging in their mind that we don't fully understand biochemically," FDA Commissioner Marty Makary said.
You never will understand it biochemically because it's not all biochemical, except in the sense that they are physical beings and we can describe the physical changes with chemistry. We cannot identify any biomarkers for most mental illnesses. We treat them chemically anyway, often with drugs with severe side effects. How many of the people whose symptoms we manage in this fashion (if they have to use the drug for the rest of their life, it's not a cure) are just reacting to their environment, which we del
Re: (Score:2)
NMDA receptor antagonists are safe, fun when used correctly, and pretty much the only psychoactive drug people should be bothering with. It's unfortunate that we have let Big Pharma do bullshit to it to finally get them in the Overton window, but we've known this for a long time.
Gatekeeper: "Oh you mean THIS expedited process?" (Score:2)
> "The voucher expedites the timeline only; it does not alter scientific or regulatory standards,"
If you can expedite the process without lowering the scientific or regulatory standards, that should immediately raise the question of why your process was so slow in the first place.
The quote carries the exact same meaning as: "Our normal timeline contains bureaucratic delays that do not improve scientific or safety outcomes".
Re: (Score:2)
> without lowering the scientific or regulatory standards
Wrong. TFS states: "it does not alter scientific or regulatory standards."
I realize that all you stoners are waiting for the law to allow Dr. Feelgood to dash off prescriptions for all you "study participants". But let's just hold our horses until some real science is done on this stuff.
Hmmmm. (Score:3)
I don't criticise the concept, but the concern is whether it has long-term adverse neurological effects, and a "quick study" doesn't sound like it'll tell us that.
It's essential we have more ways of dealing with treatment-resistant depression. We just need to make sure that they're less harmful than the depression itself. You willl, of course, recall that each and every single bad decision by medical boards to approve a treatment has been because they wanted to rush through a "medical cure" that turned into a medical hell.
I'm not stupid enough to say that mushrooms would cause long-term damage, but equally I'm not stupid enough to say that we should only look to see if it has short-term benefits.
The correct approach would seem to be to make sure there aren't any immediate hazards and, if there aren't, then to continue the study to check for consequences of long-term use whilst authorising short-term prescription use, on the understanding that the prescription use permission will be extended outwards to whatever the data cansafely tolerate. In other words, don't deprive people of necessary treatment but equally don't claim greater confidence than the data supports.
This tightrope has only got to be walked because nobody has been seriously studying depression for a very long time and now we've got a hunge backlog of cases that are refusing to shut up, making it hard to ignore. This research should have been done years ago, but politicians were far too ignorant and far too swayed by religious money. But that doesn't mean we should rush.
I'm sure the scientists know how to keep a level head, but the CEOs and the politicians clearly can't and they're the ones who will be making the demands.
Re: (Score:2)
1) "quickly authorized study" is not "quick study"
2) generally speaking, this entire class of drugs does not have lingering effects unless you make a regular habit of taking too much and traumatizing yourself with it
This is already a solved problem. (Score:2)
Dextromethorphan is available over the counter, and at the dose that's supposedly for suppressing a cough, (which it is clinically proven it does not do) it is a very effective antidepressant with practically no side effects after the first couple weeks. Because it's so weak compared to other NMDA receptor antagonists, you can dial in a very precise macrodose for anything from "I just think music is great" to "time loops" to "talking to the god in your head" to "kissing the void." It lasts six hours and has
Of course the psilocybin is synthetic (Score:2)
They couldn't get a patent on it and make it cost hundreds of dollars unless it is.
Where growing mushrooms, anyone can do.
Re: (Score:2)
Maybe they can produce it faster that way? It could also be due to concerns about contamination - if another fungal spore gets in the mix, it can kill people.
If it makes you feel better, industrial production of vitamin-C is done entirely with mold.
Re: (Score:3)
It's 2026. Given the option of a mega dollar patented synthetic drug or something that grows for free in cow shit, I know what they'll pick.
The grocery store sells mushrooms without the fear or anyone dying.
Re: Of course the psilocybin is synthetic (Score:2)
Also guarantee the dosage, for example I see jimpson weed growing all over the place which contains scopolamine but I don't dare try to use it because I have no idea how much is a moderate dosage, taken in small amounts it is good for calming the nerves and relieves nausia but too much of a dose causes nausia and a puts a person into a hypnotic trance like state, so it is not any good if you can not find the correct dose to use