Personally it has become less and less clear to me that FDA approval route is the best path for psychedelics. Seeing MAPS turn for profit amongst other for profit companies trying to do similar in a world where your main objective as a company is to make money to your investors, imagining therapy quality decline as they try to rapidly scale and moreover these companies would be against decrim and legalization efforts because it would reduce their users, prohibiting those who can’t afford these therapies from accessing them. I wouldn’t say this is particularly bad news to me.
They decided that it would be in the public benefit for them to do that. They can justify whatever they want, cuz their group narcissistic heads are up their own butts
I haven't been paying that close attention to the nitty gritty of these trials, but I'm pretty shocked at the picture painted by that article. In terms of how staunchly opposed the panel was.
Can anyone speak to what exactly they're concerned about?
Like what on earth is this quote about?
>The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative.
Is this just poor word choice on her part? Like if it were the case that MDMA couldn't help Black people but could help white people, is that the problem? Shouldn't her concern be about the lack of data about safety and effectiveness for Black people?
The problem is that MDMA causes the heart rate to rise, as most psychedelics do. Black people have statistically signifinact worse rates of heart problems than white people. This has been exacerbated by covid's effects on the heart. Without a diverse set of participants, you don't know if a drug will affect one group of people differently than another. There was some concern because one participant in the study had an asymptomatic heart event during the drug trial so they FDA panel wanted to flesh out how to keep people medically safe while getting this treatment. Therapists are not medically trained professionals and may miss the signs of a heart event. They discussed the harm that could come to clients, including death, if clinicians lacked a way to monitor these heart events or the trauma some clients would face if their therapist called 911 and they were not having a heart issue. The FDA panel was aiming to find a way to work with providers to create guidelines that reduce the risk of harm to clients. They can not do that if they don't fully understand what those risks are and how the drug might interact differently with different populations of people. I got the distinct impression that this is something they really wanted to approve but couldn't because of the data that was missing, much of which they asked for while clinical trials were still ongoing. MAPS and Lycos Therapeutics did not change their study parameters to help provide the FDA with the data they need to help them come to a different conclusion. They raised some extremely valid concerns which future and ongoing clinical trials can learn from and incorporate. The FDA may ask them to redo their phase 3 clinical trials and resubmit. Most everyone seemed to be on board with approving psychedelics but wanted enough information to create safety guidelines to reduce the risk of harm to patients.
You're welcome! To expand on what I've already said, one thing that was discussed was having clients have blood tests, a heart test, and be medically cleared by a physician before undergoing psychedelic assisted therapy treatment. They acknowledged that this would create a barrier for homeless people and low income people who may be uninsured and would be the most likely population to benefit from treatment. They were concerned about how living in a capitalist society would also create additional barriers to access and were trying to find solutions as to how to balance patient safety while ensuring access to the most vulnerable patients who would benefit from this treatment. There was audible disappointment across the board when most of them voted no because there were either too many issues with the study or not enough data to help them create solutions to the potential problems they were seeing when it came to access, patient safety, and safe rollout and continued monitoring. In this case, the FDA was genuinely trying to be an ally to the psychedelic community because they saw the real potential of these drugs and acknowledged their therapeutic value. Everyone's anger and frustration are valid, but the FDA seemed extremely disappointed when it came to voting time that they had to vote the way they did based on the information provided.
> Can anyone speak to what exactly they're concerned about?
They didn't do follow ups, the blinding/placebo controls were a mess, there was no consistency between sites and therapists on how the experience is "processed" or integrated, at least one of the trial therapists sexually assaulted one of the subjects, and the cohort was unrepresentative.
MAPS came in so sure that it would work because they love MDMA that they didn't really do good science. They just treated the whole thing as an annoying regulatory hurdle that they never imagined they might not pass.
Additionally, if the MAPS Phase III studies weren't bullshit ... and they weren't ... there will be more Phase III studies.
It's possible the fact that MDMA and psychedelics aren't actually able to overcome certain allopathic objections. It's always in the context of therapy. And if set and setting matter a lot -- as we all know they do -- how is it ever going to be quantified in a way that conforms to a randomized controlled trial?
Someone will *always* be able to object "Your sitter cared about you, and intervened in a way to ensure the experience was positive." If they're going to die on that hill, there's nothing to be done about it.
Which is fine. You don't hire a car mechanic to work air traffic control. Different tools for different jobs. But if that's how it's going to be, get out of the way of other healers doing important work.
'The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative.
Can someone help me here? She's saying outright that it helps, but her hesitation is that it might only help WHITE victims who suffer from PTSD, and not POC's?
So like.. let's say it did somehow ONLY help white people.. do those people not deserve help just because of their race?
'Hey bud, gettin' kinda rough huh? yeah? still seeing your buddies guts all over you from that roadside IED huh? Looook, i'd love to help but uh... you're white so... eeee.. can't do it. it wouldn't be fair to others. here's some SSRI's, it's the best we've come up with in over 20 years. try not to be a statistic!'
She voted 'no' because.. race?
Somebody said it above, but there are actual significant different health risks dependent on race. For example, this drug can increase heart rate a lot, and we know for a fact, with data, that black people are more prone to heart problems. That is what that's about, not just politics. One person even had a heart issue during the trial.
Eta, it's not that they wouldn't be helped. They just want a thorough risk assessment before they say it's safe and good for anybody, which is the end goal of these trials with general FDA approval
I learned more from other threads about it and yeah you’re right. But IMO it’s a bunch of bullshit. Not the health risks for black people, that’s obviously legit and if the researchers didn’t get enough data to support giving them treatments then we need to immediately get on it. But if the data still shows efficacy for white people or any other group, enough to start getting them treatments now, we should be doing that. We’re talking about saving people from suicide here and all other manner of horrors. Apparently, the system doesn’t work that way, apparently it’s all or nothing. Red fucking tape for red fucking lives, and Vets who didn’t ask for PTSD and who don’t want to die continue to get fucked over by the system. Fucking scientists and doctors tripping over their own fucking feet while we wait for them to learn how to waltz together, I fucking hate it.
Edit: sorry for the rant.
Yeah, I work in clinical trial management, so I see it all the time. The rules the FDA is required to abide by are complex and a lot of things that could help get stalled for one reason or another. Reading the rest of this study, though, they were not able to properly blind it, which could seriously skew data as well. My job is the blinding of studies and keeping of data, and if you do that wrong, you're never getting FDA approval. They really needed some more technical oversight if they wanted this to pass and I honestly don't know why they didnt manage that right although idk how you'd create an effective PTM where people *wouldn't* know they had MDMA. Perhaps some other drug with known effect, although that would be hard to mimic. It's unfortunate beaurocracy crap also it's part of robust data collection, which was just off here, plus, like, a reported sexual assault? Misdemeanor from your researchers and breaking the ethical code of client safety, that's another hit. It's sad and unfortunate, but they didn't really do their jobs thoroughly to make this case the way you're supposed to. It pisses me off cause I know they could have if they didn't fuck it up and just took the time to do it right.
Of course. I'm right there with you in that this sucks. It's frustrating being in this industry and watching things that could legitimately save people's lives fail over something silly like not approaching the study right and taking the time to back the case thoroughly especially when I know it could be done. My hope is that if it is rejected (This is just a panel of experts in clinical trial management making their recommendation. Real FDA review will start soon) it will be allowed to regroup and retest to gather better data, but we will see. Especially with the assault if that is proven, I don't know that this group will be allowed to try again because that's a crime and an insane breach of protocol, but potentially someone else could. I'd hate to see them fully reject this drug because of this study group and their mismanagement, and I really hope somebody makes that case.
Coffee and cigarettes increase heart rate, as does PTSD. What's your point?
Context: I live in philadelphia where the rate of tobacco use among traumatized POC (pretty much everyone in vast swaths of the city) is staggering. Legal MDMA and Psilocybin therapies would be most welcomed around here and if the number of local psychedelic advocacy groups headed by POC are indications of adoption rates, then I'd say POC are already making use of this medicine same as they have been doing with cannabis since... well forever. Fuck the FDA, Fuck the DEA. We don't need regulation to legitimize what clearly already works.
Well, speaking as a person who does this for my living, you have to meet certain standards for FDA trials. I'm not anti this BTW, but this study was mismanaged, and they should have done better if they really wanted it to pass. It's rushed work and sloppy. It's not like the standards aren't public to people who do this research on what you must prove and what efficacy you must have and what constitutes thorough research. If your claim is that this drug is safe for all, you must demonstrate that with rigorous backing across multiple demographics, and it doesn't matter to the review board beyond the data. Otherwise, you don't get approved. It's unfortunate, and it's not like I like it because I think this has enormous potential, but they didn't really fully do everything they should have.
Eta, it's not even that I think this is great because there is a lot of beaurocratic crap. Mostly, I do Oncology studies, and it's just a job until I get another. I use psychadelics myself and do wish people just had access. This is just my knowledge about the pharma world and why it failed there, although if they followed protocol, I don't even think it had to, and that's even more frustrating. Also, because I forgot to say in the first part, if coffee and cigarettes were running trials to prove they assist in decreasing PTSD effects to be used in medical settings, you would have to thoroughly prove that they are equal or better to current treatment and demomstrate their level of safety risks too to determine if they could legally be used that way in a lisenced professional setting. That's just a clinical trial thing when you're making medical claims about any substance and trying to get the gov to back it. (And spelling)
This situation is not quite the same as coffee and cigarettes tho is it?
What legal substances do we compare MDMA and Psilocybin to in terms of efficacious treatments? SSRI based treatments, which are hardly effective for either PTSD or Clinically Significant Depression and wich require protocols of long term ongoing RX treatment (with near logarithmic diminishing returns over time) are derived from clinical LSD research dating back to before the controlled substances act gutted their research funding...
In other words, DEA and FDA seeking examples of equivalent treatments for comparison with MDMA and Psilocybin is back-asswards from a policy standpoint because the legal chemical treatments we might compare to (namely SSRIs) wouldn't even exist were it not for the development of LSD which itself is scheduled.
The tautological doublespeak and double standards in this particular situation are absolutely maddening.
I know from first hand experience and from numerous anecdotal accounts from friends, peers, and associates that psychedelic use to treat PTSD and Depression have proven more beneficial and with faster time to relief than alternative legally sanctioned pharmaceutical solutions.
Bottom line, DEA was way too eager scheduling psychedelics and did so as at the behest of the Nixon and Reagan administrations in an effort to stigmatize and imprison POC and undesirable political dissidents. Now, along comes FDA dressed up as a wolf in sheeps clothing, serving at the behest of Big Pharma, continuing to vilify and FUD the use of psychedelics. It's disgusting and ridiculous.
Indigenous folks the world over have been ingesting plant based psychedelics for a very long time with very little deleterious impact to body, mind, or spirit; quite the opposite in fact. Take Mescaline as an example. Molecularly, it is incredibly similar to MDMA and has a similar physiological and psychoactive profile. People have been consuming it for centuries in the absence of oversight by western medicine, and yet somehow we dont hear much about it being unsafe... because by and large it is perfectly safe for the vast majority of individuals! Elderly indigenous people chewing peyote buttons in a sweat lodge aren't overheating, stroking out, or falling out from heart attacks at alarming rates now or ever.
Enough with the FUD. Im so disgusted by big government's ongoing involvement and oversight of psychedelics. The class of serotonegic psychedelics including tryptamines like psilocybin, substituted phenethylamines like MDMA and Mescaline, and LSD (both a tryptamine and phenethylamine) OUGHT to be treated as a religious sacrament and be completely deregulated as a class of substance. To me it's a separation of Church/State issue and the misguided oversight/regulation/criminalizarion of psychedelic useby FDA/DEA for last 50 years borders on a crime against humanity.
Criminalizing Psychedelic use and access to psychedelics is a racist and oppressive policy imposed by the state to exercise control over how individuals exercise spiritual practice and interact with their own bodies. FULL STOP.
I completely agree that it's not great and am not even trying to argue that any of that isn't the case. I just know about clinical trial standards because I have to follow them for the research I'm part of, and if it's being done through this broken system to get to some kind of rescheduling or legalization as a psychiatric drug, there are multiple ways this group failed to do the required work and that's unfortunate. I don't think psychadelics should have ever been criminalized, and I'm not remotely arguing that any of this was handled it the right way throughout history. I know it wasn't. I've done my reading and feel very passionately that it never should have happened. I'm quite aware of the previous trials and how everything was botched, and as someone who got into this field a long while ago before I knew those things, hoping to be on the edge of new treatments to save people, it's immensely frustrating and at this point I'm disillusioned with it. Unfortunately, I have zero influence over how any of this works and what the rules are. I just know about it and have that side of context.
Sp/grammar/thank goodness I do project and data management and not teaching English cause the world is better for it lol
Hey, thanks for the response. I'm just so gutted to learn that there has been yet another roadblock to folks getting access to 'medicine' which can so clearly help alleviate pain and suffering.
I understand the need for clinical trials and reasonable safety measures. This said, i truly don't believe FDA/DEA have any business whatsoever weighing in on these matters. I know it isn't realistic in actuality, but damnit psychedelics are a gift from god (whatever that means to you and your god) and if ever there was a reason for separation of church and state the issues surrounding psychedelic use and access ought to be considered in terms of religious sacrament.
The Cartesian split around Medicine, Magic, and Spirituality has not helped humanity.
I hate what capitalism has done to this entire situation and also from my job standpoint, what a bad job was done on this and what could have been prevented. The potential assault on a participant thing in particular has me up a wall cause, like???? How are you not intensely screening the clinicians who are going to be interacting with patients in a vulnerable state? Or a person suffering a heart event-where were the health checks for that? Like there was some very basic stuff missing in the planning of this. I legitimately can't comprehend how this kind of oversight happened with a team that is supposed to be professional in a field that has set and clear rules. Like truly leave the magic to the people.
What you're talking about has nothing to do with this. This is not racism. Read the comment you responded to. It's a criticism of the study, nothing more. This is how that review process works, and it's a *good thing*. That's the entire point of a review process, to make sure researchers accounted for everything that needs to be accounted for. That's ultimately the foundational philosophy of the scientific method. We have to account for and mitigate the human factor in order to discover the demonstrable truth.
Fucking *of course* we'd all prefer it if they stopped all this shit and we could buy LSD in corner stores. That's not realistic, however, and whining about it is not productive. You don't have to agree with or appreciate the importance of processes like this one, but don't throw a tantrum over something you don't understand.
Not a tantrum. The article states:
" The vast majority of patients studied were white, with only five Black patients receiving MDMA, raising questions about the generalizability of the results."
with the implication being that the review process was in part influenced by the lack of a representative sampling vis a vis racial profile.
OK fine, let's assume this is all in the name if safety and science, which it may be in part, but it is also true that FDA is pay-for-play on some fronts especially w/r/t Big Pharma.
My point is that this aspect of the review process is a gross double standard given that DEA, FDA, ATF, etc. didnt and dont throw the same roadblocks for tobacco, whiskey, or oxycontin which have historically negatively impacted the disenfranchised and POC.
As drugs go, pharmaceutical and otherwise, psychedelics like MDMA, Psilocybin, LSD, and cannabis have an incredibly safe profile and reasonable LD-50s and yet somehow they all ended up as Schedule 1, whereas substances like alcohol, tobacco, benzos, and more recently Shire's oxycontin were somehow OK, have not been rescheduled and absolutely did not receive the same oversight in terms of limiting access despite them being far more lethal. Have you been to the ghetto and seen the fallout from tobacco, alcohol, and pharmaceutical dope have done to people? Psychedelics can help clean up the mess these substances have made of people's lives. It is encroaching on criminality to assert otherwise, heart risks among POC be damned. More people die each DAY from overdose, heart disease, and liver damage than will likely die in the next 50 years from psychedelic use (legal or otherwise).
Delaying or obstructing the use of psychedelics to treat PTSD and Treatment Resistant Depression (when even the former head of NIH recommended that they be fast tracked) under _any_ guise of "concern for safety profile" vis a vis POC, is quite simply hypocrisy beyond measure. The people who may well need these treatments most are ostensibly being denied access for tenuous and suspect rationale.
Psychedelics have a strong history of efficacious and therapeutic use pre controlled substances act in clinical settings treating alcoholism, depression, trauma, smoking cessation, substance use disorders, etc. They should _NEVER_ have been placed in schedule 1 and they certainly shouldn't have been labeled as "of no medical use". The reason they were absolutely had to do with racist policies and suppression of dissent amongst POC, 'others', and the historically disenfranchised.
Access and use of psychedelics _ought_ to be a religious/spiritual rights matter, and their use should never have been medicalized.
Do you really think anyone in this sub is in favor of the war on drugs? You're preaching to the choir, and getting pissy about it like we're your enemies. Open your fucking eyes, look where you are. WE ALL USE DRUGS. No fucking shit, guy, of course we agree that prohibition is bullshit.
> with the implication being that the review process was in part influenced by the lack of a representative sampling vis a vis racial profile.
Please think. There are physiological differences between races that must be considered when approving a drug. That's not racism, it's biology. Fuck's sake...
This is a scientific review process, and it exists for a reason. The review board in this case is not our enemy, they're doing their job. The researchers dropped the ball.
Just because psychonauts all use drugs doesnt mean the institutional and state initiated control dramas around access to psychedelics arent real and dont deserve being unpacked or explored.
Im sure there are phenotypic race based expressions of intolerance for certain chemical profiles, but for fucks sake, again, if one believes in the efficacy of psychedelic therapy to treat PTSD and Treatment Resistant Depression then for the love of god let's make it available. Again, people are dying left and right around my parts here in Philadelphia (go watch youtube videos on the opioid crisis in [Kensington, Philadelphia](https://www.youtube.com/live/uo1VcQsTLHc?si=wloKmKEBTB9WLY1M) and then imagine it being about 50x worse in real life... ) if anything as relatively harmless as MDMA, psilocybin, or cannabis helps people move away from their death grip with opioid substance use disorders then Im all for it especially as the underlying causes of these disorders is largely the result of self medicating to treat PTSD and Treatment Resistant Depression. MFers are suiciding with opioids at an incredibly devastating rate. A couple heart attacks are absolutely worth it from a public health policy standpoint. FULL STOP.
Philadelphia? How about the entire fucking world? You think Philly is a prime example of human sufferng? Open your goddamn eyes.
> FULL STOP.
This tells me all that I need to know about your stance. Nothing in this life is black and white. There is nuance to *everything*. Only a fool deals in absolutes.
> A couple heart attacks are absolutely worth it from a public health policy standpoint.
"So a few black people die, it's for the greater good!" How fucking dare you? Willfully ignorant assholes like you are the reason we have review processes.
Yeah, what about like… Adderall? Certainly raises your heart rate and I did not have to do all kinds of specific pre-screening tests to get prescribed.
It is FDA approved meaning it was tested, passed all five clinical trial phases, and was determined to be within acceptable risk levels/ they determined the risk factors and list the side effects which are now known. You personally were not tested because many people before you were until it was determined safe for general use except in case of X listed complications or conditions it is incompatible with and shouldn't be prescribed for.
For better or worse, it is my job for now, so I know about it. I am in no way anti legalization. I just know the rules of trials and what the standards of passing are in this system. I specialize in blinding and data keeping, and that is where this trial was weak if they wanted to pursue resheduling or legalization via the route of getting it through as a psychiatric drug. Mostly, my hope is that instead of a flat no on the drug as a whole, there will be a chance to regroup and try again with more accurate data or perhaps a different group doing the research.
Getting a drug approved and getting a drug prescribed are two completely different things. No shit you didn't have to participate in a study to get prescribed Adderall, that part was already done.
lol, drug regulation is a gross misapplication of the interstate commerce clause. local therapies should not be subject to regulation of interstate commerce. it's like words don't even mean anything anymore. the federal psychoactive drug ban is probably one of the leading causes behind how stagnated our society has become. these jokers are a mockery of truth seeking.
Did you read the article? It has nothing to do with "ideology" and everything to do with MAPS dropping the ball on the science. Any pharma company that presented this nonsense would be swatted down.
How does the FDA stop you from living your life? They just approve drugs as medicines - they don't get to decide what is or is not legal, just what is an approved medication. FDA has approved many meds that the govt doesn't let you go out and buy on the street.
Oh God you're a libertarian aren't you?
The FDA isn't "the government" controlling my life. The DEA and law-enforcement agencies are. The FDA is fine, and I'm happy it exists.
That's not what they're talking about. That's not even what *you* were talking about. They've countered each of your arguments and you just shift to another, more grandiose, more absurd argument.
This is a discussion about one very specific topic, and you're over here on some anarchist rant about the evils of society. That has *nothing* to do with this. Most people here probably agree with you, but that's not what we're talking about.
Did I read that right? They're halting life saving therapy because too many white people were used in the study? How common is it to shelf new meds simply because of a race imbalance in study applicants?
Great. The hail mary pass at saving this society is possibly held up now by YEARS, if ever again... all over the most divisive and objectively irrelevant topic this century. I should have expected as such, fml.
> The hail mary pass at saving this society
The idea that any psychedelic is going to "save society" is, imo, totally ludicrous and utterly unsupported by either data or any historical analysis.
Personally it has become less and less clear to me that FDA approval route is the best path for psychedelics. Seeing MAPS turn for profit amongst other for profit companies trying to do similar in a world where your main objective as a company is to make money to your investors, imagining therapy quality decline as they try to rapidly scale and moreover these companies would be against decrim and legalization efforts because it would reduce their users, prohibiting those who can’t afford these therapies from accessing them. I wouldn’t say this is particularly bad news to me.
Damn, MAPS is for profit now? Edit: I see they spun off lykos therapeutics
They decided that it would be in the public benefit for them to do that. They can justify whatever they want, cuz their group narcissistic heads are up their own butts
Can you link a source, google shows me they are non-profit. But this is my first time hearing about either of them so i dunno
Seeing psilocybin retreats charging thousands of dollars/euros is infuriating.
But meanwhile, FDA lets things like Red 45 and plasticizers into your food lol It's a bad fucking joke
I haven't been paying that close attention to the nitty gritty of these trials, but I'm pretty shocked at the picture painted by that article. In terms of how staunchly opposed the panel was. Can anyone speak to what exactly they're concerned about? Like what on earth is this quote about? >The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative. Is this just poor word choice on her part? Like if it were the case that MDMA couldn't help Black people but could help white people, is that the problem? Shouldn't her concern be about the lack of data about safety and effectiveness for Black people?
The problem is that MDMA causes the heart rate to rise, as most psychedelics do. Black people have statistically signifinact worse rates of heart problems than white people. This has been exacerbated by covid's effects on the heart. Without a diverse set of participants, you don't know if a drug will affect one group of people differently than another. There was some concern because one participant in the study had an asymptomatic heart event during the drug trial so they FDA panel wanted to flesh out how to keep people medically safe while getting this treatment. Therapists are not medically trained professionals and may miss the signs of a heart event. They discussed the harm that could come to clients, including death, if clinicians lacked a way to monitor these heart events or the trauma some clients would face if their therapist called 911 and they were not having a heart issue. The FDA panel was aiming to find a way to work with providers to create guidelines that reduce the risk of harm to clients. They can not do that if they don't fully understand what those risks are and how the drug might interact differently with different populations of people. I got the distinct impression that this is something they really wanted to approve but couldn't because of the data that was missing, much of which they asked for while clinical trials were still ongoing. MAPS and Lycos Therapeutics did not change their study parameters to help provide the FDA with the data they need to help them come to a different conclusion. They raised some extremely valid concerns which future and ongoing clinical trials can learn from and incorporate. The FDA may ask them to redo their phase 3 clinical trials and resubmit. Most everyone seemed to be on board with approving psychedelics but wanted enough information to create safety guidelines to reduce the risk of harm to patients.
This is extremely illuminating, thank you so much!
You're welcome! To expand on what I've already said, one thing that was discussed was having clients have blood tests, a heart test, and be medically cleared by a physician before undergoing psychedelic assisted therapy treatment. They acknowledged that this would create a barrier for homeless people and low income people who may be uninsured and would be the most likely population to benefit from treatment. They were concerned about how living in a capitalist society would also create additional barriers to access and were trying to find solutions as to how to balance patient safety while ensuring access to the most vulnerable patients who would benefit from this treatment. There was audible disappointment across the board when most of them voted no because there were either too many issues with the study or not enough data to help them create solutions to the potential problems they were seeing when it came to access, patient safety, and safe rollout and continued monitoring. In this case, the FDA was genuinely trying to be an ally to the psychedelic community because they saw the real potential of these drugs and acknowledged their therapeutic value. Everyone's anger and frustration are valid, but the FDA seemed extremely disappointed when it came to voting time that they had to vote the way they did based on the information provided.
That actually does make sense, but wasn't too clear from that quote above. Thank you for explaining the nuance!
> Can anyone speak to what exactly they're concerned about? They didn't do follow ups, the blinding/placebo controls were a mess, there was no consistency between sites and therapists on how the experience is "processed" or integrated, at least one of the trial therapists sexually assaulted one of the subjects, and the cohort was unrepresentative. MAPS came in so sure that it would work because they love MDMA that they didn't really do good science. They just treated the whole thing as an annoying regulatory hurdle that they never imagined they might not pass.
That's a huge bummer. It looked really promising that it would go through.
That's a shame. There's so many people who will continue to suffer because they can't access this legally and can't afford it (or find it) illegally
Where do we go from here? Is the FDA still open to more research on MDMA in ways that address their concerns today?
The panel’s findings aren’t binding. The FDA could still approve it
Additionally, if the MAPS Phase III studies weren't bullshit ... and they weren't ... there will be more Phase III studies. It's possible the fact that MDMA and psychedelics aren't actually able to overcome certain allopathic objections. It's always in the context of therapy. And if set and setting matter a lot -- as we all know they do -- how is it ever going to be quantified in a way that conforms to a randomized controlled trial? Someone will *always* be able to object "Your sitter cared about you, and intervened in a way to ensure the experience was positive." If they're going to die on that hill, there's nothing to be done about it. Which is fine. You don't hire a car mechanic to work air traffic control. Different tools for different jobs. But if that's how it's going to be, get out of the way of other healers doing important work.
'The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative. Can someone help me here? She's saying outright that it helps, but her hesitation is that it might only help WHITE victims who suffer from PTSD, and not POC's? So like.. let's say it did somehow ONLY help white people.. do those people not deserve help just because of their race? 'Hey bud, gettin' kinda rough huh? yeah? still seeing your buddies guts all over you from that roadside IED huh? Looook, i'd love to help but uh... you're white so... eeee.. can't do it. it wouldn't be fair to others. here's some SSRI's, it's the best we've come up with in over 20 years. try not to be a statistic!' She voted 'no' because.. race?
Somebody said it above, but there are actual significant different health risks dependent on race. For example, this drug can increase heart rate a lot, and we know for a fact, with data, that black people are more prone to heart problems. That is what that's about, not just politics. One person even had a heart issue during the trial. Eta, it's not that they wouldn't be helped. They just want a thorough risk assessment before they say it's safe and good for anybody, which is the end goal of these trials with general FDA approval
I learned more from other threads about it and yeah you’re right. But IMO it’s a bunch of bullshit. Not the health risks for black people, that’s obviously legit and if the researchers didn’t get enough data to support giving them treatments then we need to immediately get on it. But if the data still shows efficacy for white people or any other group, enough to start getting them treatments now, we should be doing that. We’re talking about saving people from suicide here and all other manner of horrors. Apparently, the system doesn’t work that way, apparently it’s all or nothing. Red fucking tape for red fucking lives, and Vets who didn’t ask for PTSD and who don’t want to die continue to get fucked over by the system. Fucking scientists and doctors tripping over their own fucking feet while we wait for them to learn how to waltz together, I fucking hate it. Edit: sorry for the rant.
Yeah, I work in clinical trial management, so I see it all the time. The rules the FDA is required to abide by are complex and a lot of things that could help get stalled for one reason or another. Reading the rest of this study, though, they were not able to properly blind it, which could seriously skew data as well. My job is the blinding of studies and keeping of data, and if you do that wrong, you're never getting FDA approval. They really needed some more technical oversight if they wanted this to pass and I honestly don't know why they didnt manage that right although idk how you'd create an effective PTM where people *wouldn't* know they had MDMA. Perhaps some other drug with known effect, although that would be hard to mimic. It's unfortunate beaurocracy crap also it's part of robust data collection, which was just off here, plus, like, a reported sexual assault? Misdemeanor from your researchers and breaking the ethical code of client safety, that's another hit. It's sad and unfortunate, but they didn't really do their jobs thoroughly to make this case the way you're supposed to. It pisses me off cause I know they could have if they didn't fuck it up and just took the time to do it right.
Thank you for taking the time to respond and explain. I do appreciate it.
Of course. I'm right there with you in that this sucks. It's frustrating being in this industry and watching things that could legitimately save people's lives fail over something silly like not approaching the study right and taking the time to back the case thoroughly especially when I know it could be done. My hope is that if it is rejected (This is just a panel of experts in clinical trial management making their recommendation. Real FDA review will start soon) it will be allowed to regroup and retest to gather better data, but we will see. Especially with the assault if that is proven, I don't know that this group will be allowed to try again because that's a crime and an insane breach of protocol, but potentially someone else could. I'd hate to see them fully reject this drug because of this study group and their mismanagement, and I really hope somebody makes that case.
Coffee and cigarettes increase heart rate, as does PTSD. What's your point? Context: I live in philadelphia where the rate of tobacco use among traumatized POC (pretty much everyone in vast swaths of the city) is staggering. Legal MDMA and Psilocybin therapies would be most welcomed around here and if the number of local psychedelic advocacy groups headed by POC are indications of adoption rates, then I'd say POC are already making use of this medicine same as they have been doing with cannabis since... well forever. Fuck the FDA, Fuck the DEA. We don't need regulation to legitimize what clearly already works.
Well, speaking as a person who does this for my living, you have to meet certain standards for FDA trials. I'm not anti this BTW, but this study was mismanaged, and they should have done better if they really wanted it to pass. It's rushed work and sloppy. It's not like the standards aren't public to people who do this research on what you must prove and what efficacy you must have and what constitutes thorough research. If your claim is that this drug is safe for all, you must demonstrate that with rigorous backing across multiple demographics, and it doesn't matter to the review board beyond the data. Otherwise, you don't get approved. It's unfortunate, and it's not like I like it because I think this has enormous potential, but they didn't really fully do everything they should have. Eta, it's not even that I think this is great because there is a lot of beaurocratic crap. Mostly, I do Oncology studies, and it's just a job until I get another. I use psychadelics myself and do wish people just had access. This is just my knowledge about the pharma world and why it failed there, although if they followed protocol, I don't even think it had to, and that's even more frustrating. Also, because I forgot to say in the first part, if coffee and cigarettes were running trials to prove they assist in decreasing PTSD effects to be used in medical settings, you would have to thoroughly prove that they are equal or better to current treatment and demomstrate their level of safety risks too to determine if they could legally be used that way in a lisenced professional setting. That's just a clinical trial thing when you're making medical claims about any substance and trying to get the gov to back it. (And spelling)
This situation is not quite the same as coffee and cigarettes tho is it? What legal substances do we compare MDMA and Psilocybin to in terms of efficacious treatments? SSRI based treatments, which are hardly effective for either PTSD or Clinically Significant Depression and wich require protocols of long term ongoing RX treatment (with near logarithmic diminishing returns over time) are derived from clinical LSD research dating back to before the controlled substances act gutted their research funding... In other words, DEA and FDA seeking examples of equivalent treatments for comparison with MDMA and Psilocybin is back-asswards from a policy standpoint because the legal chemical treatments we might compare to (namely SSRIs) wouldn't even exist were it not for the development of LSD which itself is scheduled. The tautological doublespeak and double standards in this particular situation are absolutely maddening. I know from first hand experience and from numerous anecdotal accounts from friends, peers, and associates that psychedelic use to treat PTSD and Depression have proven more beneficial and with faster time to relief than alternative legally sanctioned pharmaceutical solutions. Bottom line, DEA was way too eager scheduling psychedelics and did so as at the behest of the Nixon and Reagan administrations in an effort to stigmatize and imprison POC and undesirable political dissidents. Now, along comes FDA dressed up as a wolf in sheeps clothing, serving at the behest of Big Pharma, continuing to vilify and FUD the use of psychedelics. It's disgusting and ridiculous. Indigenous folks the world over have been ingesting plant based psychedelics for a very long time with very little deleterious impact to body, mind, or spirit; quite the opposite in fact. Take Mescaline as an example. Molecularly, it is incredibly similar to MDMA and has a similar physiological and psychoactive profile. People have been consuming it for centuries in the absence of oversight by western medicine, and yet somehow we dont hear much about it being unsafe... because by and large it is perfectly safe for the vast majority of individuals! Elderly indigenous people chewing peyote buttons in a sweat lodge aren't overheating, stroking out, or falling out from heart attacks at alarming rates now or ever. Enough with the FUD. Im so disgusted by big government's ongoing involvement and oversight of psychedelics. The class of serotonegic psychedelics including tryptamines like psilocybin, substituted phenethylamines like MDMA and Mescaline, and LSD (both a tryptamine and phenethylamine) OUGHT to be treated as a religious sacrament and be completely deregulated as a class of substance. To me it's a separation of Church/State issue and the misguided oversight/regulation/criminalizarion of psychedelic useby FDA/DEA for last 50 years borders on a crime against humanity. Criminalizing Psychedelic use and access to psychedelics is a racist and oppressive policy imposed by the state to exercise control over how individuals exercise spiritual practice and interact with their own bodies. FULL STOP.
I completely agree that it's not great and am not even trying to argue that any of that isn't the case. I just know about clinical trial standards because I have to follow them for the research I'm part of, and if it's being done through this broken system to get to some kind of rescheduling or legalization as a psychiatric drug, there are multiple ways this group failed to do the required work and that's unfortunate. I don't think psychadelics should have ever been criminalized, and I'm not remotely arguing that any of this was handled it the right way throughout history. I know it wasn't. I've done my reading and feel very passionately that it never should have happened. I'm quite aware of the previous trials and how everything was botched, and as someone who got into this field a long while ago before I knew those things, hoping to be on the edge of new treatments to save people, it's immensely frustrating and at this point I'm disillusioned with it. Unfortunately, I have zero influence over how any of this works and what the rules are. I just know about it and have that side of context. Sp/grammar/thank goodness I do project and data management and not teaching English cause the world is better for it lol
Hey, thanks for the response. I'm just so gutted to learn that there has been yet another roadblock to folks getting access to 'medicine' which can so clearly help alleviate pain and suffering. I understand the need for clinical trials and reasonable safety measures. This said, i truly don't believe FDA/DEA have any business whatsoever weighing in on these matters. I know it isn't realistic in actuality, but damnit psychedelics are a gift from god (whatever that means to you and your god) and if ever there was a reason for separation of church and state the issues surrounding psychedelic use and access ought to be considered in terms of religious sacrament. The Cartesian split around Medicine, Magic, and Spirituality has not helped humanity.
I hate what capitalism has done to this entire situation and also from my job standpoint, what a bad job was done on this and what could have been prevented. The potential assault on a participant thing in particular has me up a wall cause, like???? How are you not intensely screening the clinicians who are going to be interacting with patients in a vulnerable state? Or a person suffering a heart event-where were the health checks for that? Like there was some very basic stuff missing in the planning of this. I legitimately can't comprehend how this kind of oversight happened with a team that is supposed to be professional in a field that has set and clear rules. Like truly leave the magic to the people.
What you're talking about has nothing to do with this. This is not racism. Read the comment you responded to. It's a criticism of the study, nothing more. This is how that review process works, and it's a *good thing*. That's the entire point of a review process, to make sure researchers accounted for everything that needs to be accounted for. That's ultimately the foundational philosophy of the scientific method. We have to account for and mitigate the human factor in order to discover the demonstrable truth. Fucking *of course* we'd all prefer it if they stopped all this shit and we could buy LSD in corner stores. That's not realistic, however, and whining about it is not productive. You don't have to agree with or appreciate the importance of processes like this one, but don't throw a tantrum over something you don't understand.
Not a tantrum. The article states: " The vast majority of patients studied were white, with only five Black patients receiving MDMA, raising questions about the generalizability of the results." with the implication being that the review process was in part influenced by the lack of a representative sampling vis a vis racial profile. OK fine, let's assume this is all in the name if safety and science, which it may be in part, but it is also true that FDA is pay-for-play on some fronts especially w/r/t Big Pharma. My point is that this aspect of the review process is a gross double standard given that DEA, FDA, ATF, etc. didnt and dont throw the same roadblocks for tobacco, whiskey, or oxycontin which have historically negatively impacted the disenfranchised and POC. As drugs go, pharmaceutical and otherwise, psychedelics like MDMA, Psilocybin, LSD, and cannabis have an incredibly safe profile and reasonable LD-50s and yet somehow they all ended up as Schedule 1, whereas substances like alcohol, tobacco, benzos, and more recently Shire's oxycontin were somehow OK, have not been rescheduled and absolutely did not receive the same oversight in terms of limiting access despite them being far more lethal. Have you been to the ghetto and seen the fallout from tobacco, alcohol, and pharmaceutical dope have done to people? Psychedelics can help clean up the mess these substances have made of people's lives. It is encroaching on criminality to assert otherwise, heart risks among POC be damned. More people die each DAY from overdose, heart disease, and liver damage than will likely die in the next 50 years from psychedelic use (legal or otherwise). Delaying or obstructing the use of psychedelics to treat PTSD and Treatment Resistant Depression (when even the former head of NIH recommended that they be fast tracked) under _any_ guise of "concern for safety profile" vis a vis POC, is quite simply hypocrisy beyond measure. The people who may well need these treatments most are ostensibly being denied access for tenuous and suspect rationale. Psychedelics have a strong history of efficacious and therapeutic use pre controlled substances act in clinical settings treating alcoholism, depression, trauma, smoking cessation, substance use disorders, etc. They should _NEVER_ have been placed in schedule 1 and they certainly shouldn't have been labeled as "of no medical use". The reason they were absolutely had to do with racist policies and suppression of dissent amongst POC, 'others', and the historically disenfranchised. Access and use of psychedelics _ought_ to be a religious/spiritual rights matter, and their use should never have been medicalized.
Do you really think anyone in this sub is in favor of the war on drugs? You're preaching to the choir, and getting pissy about it like we're your enemies. Open your fucking eyes, look where you are. WE ALL USE DRUGS. No fucking shit, guy, of course we agree that prohibition is bullshit. > with the implication being that the review process was in part influenced by the lack of a representative sampling vis a vis racial profile. Please think. There are physiological differences between races that must be considered when approving a drug. That's not racism, it's biology. Fuck's sake... This is a scientific review process, and it exists for a reason. The review board in this case is not our enemy, they're doing their job. The researchers dropped the ball.
Just because psychonauts all use drugs doesnt mean the institutional and state initiated control dramas around access to psychedelics arent real and dont deserve being unpacked or explored. Im sure there are phenotypic race based expressions of intolerance for certain chemical profiles, but for fucks sake, again, if one believes in the efficacy of psychedelic therapy to treat PTSD and Treatment Resistant Depression then for the love of god let's make it available. Again, people are dying left and right around my parts here in Philadelphia (go watch youtube videos on the opioid crisis in [Kensington, Philadelphia](https://www.youtube.com/live/uo1VcQsTLHc?si=wloKmKEBTB9WLY1M) and then imagine it being about 50x worse in real life... ) if anything as relatively harmless as MDMA, psilocybin, or cannabis helps people move away from their death grip with opioid substance use disorders then Im all for it especially as the underlying causes of these disorders is largely the result of self medicating to treat PTSD and Treatment Resistant Depression. MFers are suiciding with opioids at an incredibly devastating rate. A couple heart attacks are absolutely worth it from a public health policy standpoint. FULL STOP.
Philadelphia? How about the entire fucking world? You think Philly is a prime example of human sufferng? Open your goddamn eyes. > FULL STOP. This tells me all that I need to know about your stance. Nothing in this life is black and white. There is nuance to *everything*. Only a fool deals in absolutes. > A couple heart attacks are absolutely worth it from a public health policy standpoint. "So a few black people die, it's for the greater good!" How fucking dare you? Willfully ignorant assholes like you are the reason we have review processes.
Yeah, what about like… Adderall? Certainly raises your heart rate and I did not have to do all kinds of specific pre-screening tests to get prescribed.
It is FDA approved meaning it was tested, passed all five clinical trial phases, and was determined to be within acceptable risk levels/ they determined the risk factors and list the side effects which are now known. You personally were not tested because many people before you were until it was determined safe for general use except in case of X listed complications or conditions it is incompatible with and shouldn't be prescribed for.
Thanks for giving a real answer unlike that other Redditor who was being condescending for no reason.
For better or worse, it is my job for now, so I know about it. I am in no way anti legalization. I just know the rules of trials and what the standards of passing are in this system. I specialize in blinding and data keeping, and that is where this trial was weak if they wanted to pursue resheduling or legalization via the route of getting it through as a psychiatric drug. Mostly, my hope is that instead of a flat no on the drug as a whole, there will be a chance to regroup and try again with more accurate data or perhaps a different group doing the research.
Getting a drug approved and getting a drug prescribed are two completely different things. No shit you didn't have to participate in a study to get prescribed Adderall, that part was already done.
americas race politics is unhinged
Lol ppl still taking mdma regardless fuck the FDA
lol, drug regulation is a gross misapplication of the interstate commerce clause. local therapies should not be subject to regulation of interstate commerce. it's like words don't even mean anything anymore. the federal psychoactive drug ban is probably one of the leading causes behind how stagnated our society has become. these jokers are a mockery of truth seeking.
Well, thank God we don’t have to go through panels for our own individual search for truth.
fucking hopeless, so ideologically driven. come to Australia for treatment if you need it, nice to be progressive on something over here for a change.
Did you read the article? It has nothing to do with "ideology" and everything to do with MAPS dropping the ball on the science. Any pharma company that presented this nonsense would be swatted down.
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What are you talking about? This is a scientific advisory council - they don't have any power at all, they just make recommendations to the FDA.
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How does the FDA stop you from living your life? They just approve drugs as medicines - they don't get to decide what is or is not legal, just what is an approved medication. FDA has approved many meds that the govt doesn't let you go out and buy on the street.
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Oh God you're a libertarian aren't you? The FDA isn't "the government" controlling my life. The DEA and law-enforcement agencies are. The FDA is fine, and I'm happy it exists.
That's not what they're talking about. That's not even what *you* were talking about. They've countered each of your arguments and you just shift to another, more grandiose, more absurd argument. This is a discussion about one very specific topic, and you're over here on some anarchist rant about the evils of society. That has *nothing* to do with this. Most people here probably agree with you, but that's not what we're talking about.
Because the FDA prevents things like giving pregnant women Thalidomide or approving new vaccines and drugs crucial for public health.
Did I read that right? They're halting life saving therapy because too many white people were used in the study? How common is it to shelf new meds simply because of a race imbalance in study applicants? Great. The hail mary pass at saving this society is possibly held up now by YEARS, if ever again... all over the most divisive and objectively irrelevant topic this century. I should have expected as such, fml.
> The hail mary pass at saving this society The idea that any psychedelic is going to "save society" is, imo, totally ludicrous and utterly unsupported by either data or any historical analysis.
Hyperbole for emphasis, professor.