Researchers Still Fighting For MDMA Therapy After FDA Advisors Vote Against It (bbc.com) 56
An anonymous reader quotes a report from the BBC: A vote against using MDMA as part of therapy for PTSD has provoked a powerful backlash among researchers who study psychedelic drugs. 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 criticized 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.
While MDMA, also commonly known as ecstasy or molly, is listed as a Schedule 1 controlled substance in the US and so is illegal to use outside research, there has been a growing number of studies suggesting that when used with psychotherapy it could have potential for treating PTSD and some other mental health conditions. 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 Gul Dolen, 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."
About half of people who enroll in current gold standard PTSD treatments drop out, which is "absurd," says Loree Sutton, a psychiatrist and retired Brigadier General in the US Army. She says new treatments are essential. "We have to do better." "Even if there are risks, we've got to figure this out, because we cannot not let this treatment be available," adds Rachel Yehuda, a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai who has conducted studies on the effects of MDMA-assisted therapy for PTSD. "Without it, we're just leaving too many people in suffering that they don't need to be in, and that is not right." The FDA is currently considering an application from California-based drug company Lykos Therapeutics for using MDMA capsules taken in conjunction with therapy in the treatment of PTSD. In the recent FDA advisory meeting, committee members cited apparent flaws in study design and data collection. The nine-hour hearing concluded with committee members voting 9-2 that the available data do not show "that the drug is effective" for PTSD, and voting 10-1 that the benefits of MDMA do not outweigh the risks.
While MDMA, also commonly known as ecstasy or molly, is listed as a Schedule 1 controlled substance in the US and so is illegal to use outside research, there has been a growing number of studies suggesting that when used with psychotherapy it could have potential for treating PTSD and some other mental health conditions. 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 Gul Dolen, 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."
About half of people who enroll in current gold standard PTSD treatments drop out, which is "absurd," says Loree Sutton, a psychiatrist and retired Brigadier General in the US Army. She says new treatments are essential. "We have to do better." "Even if there are risks, we've got to figure this out, because we cannot not let this treatment be available," adds Rachel Yehuda, a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai who has conducted studies on the effects of MDMA-assisted therapy for PTSD. "Without it, we're just leaving too many people in suffering that they don't need to be in, and that is not right." The FDA is currently considering an application from California-based drug company Lykos Therapeutics for using MDMA capsules taken in conjunction with therapy in the treatment of PTSD. In the recent FDA advisory meeting, committee members cited apparent flaws in study design and data collection. The nine-hour hearing concluded with committee members voting 9-2 that the available data do not show "that the drug is effective" for PTSD, and voting 10-1 that the benefits of MDMA do not outweigh the risks.
I'm too nervous about giving up reality to try it (Score:3)
It absolutely infuriates me how we fight this stupid and pointless drug war and it all goes back to Richard Nixon wanting to use it to go after some of his political opponents. It's one of those things that's so insane that even if you know for a fact it's true because the people who did it have admitted that it happened and that was why they started the drug war it's damn near impossible to accept it
Re: I'm too nervous about giving up reality to try (Score:2)
Not sure what you mean with "giving up reality" but I don't think it's a good description of the effects, generally speaking (the effects are described on Wikipedia, for curious readers). It involves a shift in your subjectivity, as all psychedelics do I suppose, but your subjectivity was never "reality".
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I once heard a neuroscientist remark, "I believe in the outside, objective world. I just think nobody's ever been there."
Your perception and understanding of reality is not the same thing a reality. PTSD is a great example. People with it perceive a persistant state of endangerment that doesn't actually exist in reality. If there is a drug that corrects that, it's not going to do that by plugging people into some kind of direct and perfectly accurate perception of reality; that's a philosophical implaus
Re:I'm too nervous about giving up reality to try (Score:5, Informative)
You don't "lose yourself" on MDMA. That's part of the reason ravers love it: raves frankly aren't the best place for full blown psychedelics, and I don't understand why people go to them shitfaced on acid, or pass out on ketamine in the corner. Neither one pairs well with that environment, but MDMA does. You might end up making out with a random stranger just because you both thought the other was cute in the moment, and you'd probably fall for a scam, so don't make any irreversible decisions that aren't absolutely necessary -- but you're still you. You're just a shiny, happy you in a shiny, happy world.
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There are good reasons to be nervous, but giving up reality isn't one of them. This is based on my experience with a very large number of doses in 1999-2001. I'd tell you how many, but I don't actually know. Hundreds, anyway. You certainly aren't going to disconnect with a therapeutic dose. I doubt they'd hand you some pills, turn on the black lights, and put some Lisa Lashes on a turntable...
Re:I'm too nervous about giving up reality to try (Score:5, Insightful)
It absolutely infuriates me how we fight this stupid and pointless drug war and it all goes back to Richard Nixon wanting to use it to go after some of his political opponents. It's one of those things that's so insane that even if you know for a fact it's true because the people who did it have admitted that it happened and that was why they started the drug war it's damn near impossible to accept it
Don't blame Nixon. This predilection of the US government for butting into people's relationships with consciousness-altering substances goes back at least as far as Prohibition in the 1920's.
I find it utterly amazing that a country which so loudly proclaims its love for freedom, has a government which throws so many people in prison for indulging in a little artificial joy.
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I find it utterly amazing that a country which so loudly proclaims its love for freedom, has a government which throws so many people in prison for indulging in a little artificial joy.
There is a big difference between people who love the principles of their country and those who wrap themselves in the flag. The latter will use patriotism to excuse almost anything, plus they are a lot noisier.
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Just don't hug the flag. Nobody has ever been able to hug a flag without looking like a complete doofus.
What the actual fuck? (Score:3)
You damn well bet I'm gonna blame Nixon. He was He was president of the United States and in charge of the Department of Justice.
We backed off Prohibition already, so that's a lame excuse and a bit of whataboutism.
Now, Americans do have a history of using drug policy in nasty ways, Pot was illegal because it was used by Mexican farm workers and that was an easy way to chase them out of
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We backed off Prohibition already, so that's a lame excuse and a bit of whataboutism.
That was hardly the end of that. I figured as a big fan and avid user of recreational drugs yourself, surely you'd have heard of the original reason for banning cannabis by now? That was well after prohibition and well before Nixon.
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We have freedom to enjoy a simple puritanical lifestyle; anything outside of that bubble is highly suspect and should be scrutinized by a panel of wizened crones and geezers.
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Don't blame Nixon. This predilection of the US government for butting into people's relationships with consciousness-altering substances goes back at least as far as Prohibition in the 1920's.
Actually goes back to the start of the temperance movement. Self-identified progressives who wanted to change the world for the better, according to themselves. The road to hell and all that being what it is.
MDMA is fine and all, but (Score:2)
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It might be interesting to cultivate the mushrooms right on site too, if you want the spiritual connection. You don't have to use them immediately, and it's probably easier not to since they're kinda slimy and astringent when prepared fresh, as well as being 90% water. As a side benefit, this makes you scout the area personally, and probably under pleasant conditions, before taking it on in an altered state.
Re: MDMA is fine and all, but (Score:2)
but MDMA mixed with some mushrooms coupled with an all night hike in the wilderness with a bunch of friends is what will really do the trick
Sounds like an excellent recipe for a snipe hunt.
What really happened (Score:5, Informative)
Even one of the person who voted for allowing it use said its benefit did not outweigh the risks.
So the 9-2 vote was that according to the science it was not effective in treating PTSD, and then 10-1 that it did not outweight the risks.
this was just one of the a couple of different research investigation.
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I'd say try psilocybin, which is just as promising while being less risky.
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People with PTSD should be welcome to try it on their own accord, but that's a different issue than it being endorsed by medical institutions. Make it fully Caveat Emptor. A compromise may be to make sure a patient can buy regulated doses instead of having to seek dodgy street-shit.
Re: What really happened (Score:2)
No. Guided therapy is critical. Sitting alone and getting high is probably marginally worse than having a stoner practical joker sitting with you, trying to talk you into doing something stupid. Even a well meaning friend runs the risk of aggravating your PTSD instead of helping you through it.
And please don't get on an airplane [cnn.com] when you are hight.
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I think what they're concerned about is the increased potential for psychological dependence compared to psilocybin, which so far seems equally effective for this purpose. Also the chemical name, MethyleneDioxyMethAmphetamine, offers a few hints.
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Commenter points out why the study was flawed and why the resulting vote went the way it did, and your response is that the person stating such just wants people to commit suicide? You have some serious problems.
Re:What really happened (Score:4, Informative)
The 10-1 against was because of insufficient science studying it, which the US doesn't allow (headslap).
MDMA, LSD, and even Methamphetamine were successfully used as "shell shock" (now known as PTSD) treatment before the drug schedules even existed. Since Nixon created it, the DEA gets the final vote for what schedule any drug gets put on, and tend to put so-called party drugs on schedule 1 (no medical use and high chance of abuse). Even the DEA court said cannabis shouldn't be on schedule 1 and should be schedule 3 and the DEA itself blocked their own court's ruling.
How the **** can you study a drug's effectiveness against something like PTSD when it is a felony for researchers to even possess it? So yeah, I agree with the researchers, but the real villain is the DEA, which ****ing bans any research.
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The 10-1 against was because of insufficient science studying it, which the US doesn't allow (headslap).
This is incorrect. MDMA is available for trials under the BTD programme. Studies exist and all of them indicated positive outcomes.
The actual weasel BS cop-out is that the cohorts were too small and they felt the studies were compromised. So in other words, they're demanding MORE PTSD suffererers be created so that we can increase the cohort sizes to a level they feell will hit the mark.
Some folks just have a hate boner for their fellow humans and there's not much that can be done about it.
Re:What really happened (Score:4, Insightful)
I suspect a lack of PTSD sufferers isn't going to be a limiting factor in further research. But, more interestingly to me, are you saying you have examined the studies, the complaints against them, and found that the conclusion is incorrect? That they were, in fact, not compromised?
Because, if the studies were indeed compromised, generally I'd think it's reasonable to demand higher quality ones. The goal, after all, is to ensure the efficacy of the treatment, high quality studies is how we accomplish that.
Everything I've heard previously has led me to believe that there's been consistently good results from using MDMA in this form of treatment, and I see zero reason to not use it if that is the case, but if that's actually wishful thinking based on poor quality studies, then I'm all for doing more of them. Preferably as quickly as humanly possible, because PTSD can be debilitating and we need better treatments.
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if the studies were indeed compromised, generally I'd think it's reasonable to demand higher quality ones.
The "compromise", according to the argument, is that it was immediately, irreovcobaly and unavoidably obvious as to who was on the placebo and who was not.
Maybe they should swap the placebo for heroine?
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Because, if the studies were indeed compromised, generally I'd think it's reasonable to demand higher quality ones. The goal, after all, is to ensure the efficacy of the treatment, high quality studies is how we accomplish that.
Ah. You think the goal is to find something efficacious. Sadly, no.
The goal, whether consciously realized or not, is to ensure that nobody feels any joy that is not authorized explicitly. "Why should you feel happy when I feel absolutely miserable?" "I can't let you have something that I am unable to have. It's not fair to me."
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This one study just was poorly run and even when they did not follow their own procedures it did not show value.
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Since Nixon created it, the DEA gets the final vote for what schedule any drug gets put on
Another example of unelected people with too much power.
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A major issue with psychedelic research seems to be a lack of unbiased researchers. People are either extreme advocates or extreme critics of psychedelics. Finding good scientific research is difficult.
All that $$$ (Score:1)
Moving a drug to a lower schedule means less arrests, less need for DEA agents, less people in private prisons, less private prisons buying less items from the suppliers that charge insane amounts. We certainly can't have any of that.
Same with cannabis. Another year goes by and exactly zero people have died from cannabis. Meanwhile how many thousands drank themselves to death?
FDA is in critical need of de-corruption. (Score:2, Interesting)
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Do you mean baking powder? Can't find any info on anything called 'backing powder'.
Um, yeah, ok (Score:1)
You'll have to forgive those of us who literally just watched the whole "medical" marijuana scam play out, if we are just a tiny tad skeptical about this stuff. (These claims about the vast medical wonders that we are missing out on by keeping the popular party drugs illegal.)
Re:Um, yeah, ok (Score:5, Insightful)
Medical marijuana was the only thing that kept my mother in law pain free during her cancer treatments. She was too frail and in constant pain. Opioids are too restricted and the suggest of over the counter pain meds a joke. A 5mg edible managed her pain for 4-6 hours.
The fact anyone can't seem medical benefits to marijuana is more on how they were raised to hate it than reality.
Re: Um, yeah, ok (Score:2)
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WeÃ(TM)re finally seeing the gubbermint drop its stupid opposition to cannabis.
They kept it illegal, it's just now possible to do research. Maybe in another 20-30 years they will legalize it. Maybe. But it competes with pharma AND with alcohol so, probably not.
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Medical marijuana was the only thing that kept my mother in law pain free during her cancer treatments. She was too frail and in constant pain. Opioids are too restricted and the suggest of over the counter pain meds a joke. A 5mg edible managed her pain for 4-6 hours.
The fact anyone can't seem medical benefits to marijuana is more on how they were raised to hate it than reality.
The scam is that it didn't stay medical. And everyone knew it wouldn't. The main driving force behind it wasn't medical uses, and everybody knew it.
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For every grandma that is relieved of her pain, there are a hundred youngsters freeing their minds from the economic slavery. Completely unacceptable. grandma will get NO RELIEF.
The FDA needs new minds (Score:2)
Shell shock (Score:3)
I find it concerning that the side effects of physical trauma, eg: concussive shocks, to the brain regularly gets lumped in with general PTSD. I'm not sure if this is just a media reporting problem or if there is medical tendency to do the same.
Lumping the two together reminds me of the way mental patients were historical poorly treated. It can only result in bad outcomes.
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Lumping the two together reminds me of the way mental patients were historical poorly treated. It can only result in bad outcomes.
"That is a sacrifice I am willing to make"
As long as such things happen to other people, it is easy to lump everything together. There is no motivation to look deeper and it takes energy to do so. All sorts of horrors can be endured by the Observer in the "name of solving the issue with the least amount of energy possible".
This is beyond awful (Score:1)
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You really have no idea what you're talking about. This is not an allergen that you can be gradually exposed to higher and higher doses, it's not a survival mechanism like learning to avoid injuring yourself, it requires changing the way that the circuitry of the brain functions. Talk therapy is effective for some people, mostly those with less severe cases, and can take years with many suffering relapses. For those who don't respond to talk therapy chemical intervention can be the difference between (li
Perhaps funding is an issue (Score:2)
It appears the researchers haven't given the FDA enough money in the form of " User Fees ".
Trivia: Nearly one HALF of the agencies operating budget comes from said fees which are paid to the FDA by companies who request approval for a drug or medical device. It's unamusing to note the very companies the FDA is supposed to be regulating are paying the FDA to regulate them in the first place :|
( Google " where does FDA funding come from " to see for yourself )
Data point (Score:2)
I'm not following this research closely, but was disappointed to hear this decision.
The quote that sticks out in my mind from what I consider a reliable source....
https://www.military.com/daily... [military.com] :/
Can Help - Must Never Be Taken Alone! (Score:2)
MDMA Can Help with PTSD (Score:2)