More bad news for psychedelic drug company: FDA expands probe after rejection

Psychedelic drug company Lykos already slashed staff and overhauled leadership.

See full article...

 

[nathand496]

On top of long-term use being dangerous, other antihistamines like loratadine are much better at being antihistamines! Benadryl is also a bad sleep aid.

All right, I'll bite. What do you have for motion sickness? Because the three I know of are scopolamine (an anticholinergic with dangerous long-term use), H1 antihistamines like Benadryl (anticholinergics with dangerous long term use), and amphetamine.

 

[warfare-guilder]

All right, I'll bite. What do you have for motion sickness? Because the three I know of are scopolamine (an anticholinergic with dangerous long-term use), H1 antihistamines like Benadryl (anticholinergics with dangerous long term use), and amphetamine.

My doctor (who is the one who strongly warned me against using Benadryl) says that he prescribes scopolamine for that and warns against long-term use. But this is besides the point, and I'm sorry for bringing this up because it's been such a distraction.

 

[KChat]

If the FDA approved the drug, the DEA would have to reschedule it at least down to schedule II, because schedule I requires that "[the] drug or other substance has no currently accepted medical treatment use in the U.S." Ergo, the FDA has a major role in banning drugs. I think it is really bad that MDMA is in schedule I along with LSD and psylocibin.

I agree that LSD & psilocybin don't belong on the Schedule I list, though unrelated to their medical use - they do not meet their own definition of addictive drugs & should therefore be Schedule II by default.

FDA approval would end-run their misclassification though, so I hope there are properly-run studies conducted in the future, with absolutely no ties to the psychedelic-proselytizing morons who so horrendously botched this one.

 

[KChat]

My doctor (who is the one who strongly warned me against using Benadryl) says that he prescribes scopolamine for that and warns against long-term use. But this is besides the point, and I'm sorry for bringing this up because it's been such a distraction.

JFC. Scopolamine?!? Like, the amnestic drug from nightshade? Yeah, no problems with that one. Clearly safer than Benadryl. /s

FFS, your "doctor" sounds like someone I wouldn't trust around an unattended drink...

 

[LrdDimwit]

Not at all. There is enough data out there to show that it is very possible that MDMA and similar chemicals can have significant positive effects. However, that data is in small, scattershot, poorly designed trials and just patient reports.

What is definitely needed is some high quality trails 'squeaky clean' trials. Most people in the field think it will show it does work. But you need to walk the walk. Which so far has been a road less traveled.

Furthermore, the birds-eye view makes the hypothesis look pretty sensible. What's the problem with depression, PTSD, and other anxiety disorders? The person's emotional state is pulled too strongly towards the negative feeling end of the spectrum, to a pathological degree that significantly impairs their life. Okay, what if we just... Forcibly pushed it towards the polar opposite?

This, of course, is not proof. The human body is a fiendishly complex machine and many things that seemed promising don't actually pan out when you try them. But the idea certainly merits investigation. Which is probably why the FDA said 'no', they added 'but you should do the study again'.

 

[norton_I]

I read somewhere (maybe here?) that one of the most fundamental problems in constructing a study is that some people have a lot of trauma, and it takes a long time to work through it. If the study has a specific start and end date, some patients will be left in a poorer state when they started, because they're not done unpacking their crap yet. The problems have been surfaced but not processed. IIRC, the comment blamed some of the suicidal ideation on that abrupt cutoff of treatment.

That's true, but it applies to pretty much any psychiatric treatment. Most approved anti-depressents have "suicidal thoughts" listed as a potential side effect. Basically because of a psychoactive drug does anything at all, it's going to affect different people in different conditions differently. Even talk therapy can cause this -- it's not necessarily the presence of drugs, it's trying to deal with previously ignored feelings.

So you do randomized controlled tests. you cant really do blind tests here, but you can do "standard of care" vs "standard of care plus MDMA" and you report how the experimental group did compared to the control, including how many had to have their treatment changed because of side effects. And you do multiple checkpoints over the duration.

It's hard. But it's not uncharted territory.

 

[Eldorito]

I agree that LSD & psilocybin don't belong on the Schedule I list, though unrelated to their medical use - they do not meet their own definition of addictive drugs & should therefore be Schedule II by default.

FDA approval would end-run their misclassification though, so I hope there are properly-run studies conducted in the future, with absolutely no ties to the psychedelic-proselytizing morons who so horrendously botched this one.

Wouldn't that make it Schedule III by default?

Fentanyl is Schedule II, addictive as all hell but because it has a medical use that makes it II. It'd still be misclassified as Sch II.

 

[KChat]

Wouldn't that make it Schedule III by default?

Fentanyl is Schedule II, addictive as all hell but because it has a medical use that makes it II. It'd still be misclassified as Sch II.

Perhaps, but they'd still probably argue that it has a "high potential for abuse," if only because of an overly-puritanical view of what constitutes "abuse."

So while I'd agree they belong even further down in the scheduling, Schedule II is the absolute highest they should be classified. That they are Schedule I is a gross perversion of the law. And don't even get me started on weed ever (& still) being Schedule I...

 

[Fatesrider]

But squeaky clean studies would show that it does not work.

You can't actually say that. The evidence doesn't support its approval now. But given the overall way the studies were done, I don't think that methodology would work to get penicillin approved.

Perhaps you didn't read this:

Notably, when the agency rejected MDMA, it advised Lykos to conduct a new trial.

If there was no evidence of efficacy, the FDA would NOT have recommended a new study. The study simply failed to prove efficacy based on the myriad of issues there were with the methodology and the conduct of the researchers in the first place.

Moreover, the brain is an electro-chemical organ. Emphasis on "chemical". Mind-altering drugs may have a shotgun effect on the brain, but it's likely the chemical imbalances leading to PTSD (and other psychological conditions) have a similar shotgun effect. The treatment for PTSD is often being taken to the moment and reliving it from a "safe place" under guidance. That's pretty traumatic. If some variation on an mind-altering chemical can de-shotgun the brain, that would bring a world of relief to a hell of a lot of men and women, both who have served, and those who just got fucked by life.

You're throwing out a potential baby with that bathwater. Might want to make sure there isn't one in there after all.

 

[waldo22]

I just wish they'd legalize mushrooms.

Username checks out.

 

[scarletjinx]

Aren't head-to-head comparisons an acceptable option for phase 3 trials?

I don't understand why the control group wasn't given the current gold standard medication as an alternative. You'd think they could minimize the ability for participants to know what group they were in if they were given something like Paxil and they filtered out anyone who has previously taken MDMA.

Because there IS NO similar "gold standard " equivalent. How MDMA is being used/studied for therapeutic use is a small number of sessions in a clinical setting/guided by a therapist. It's an intervention treatment not stabilize/maintain. It cannot be used daily, its particular effect needs time between doses.

Placebos wont work as mentioned earlier because it will be immediately obvious who has placebos and who doesn't. Ketamine is the only other substance that I'm aware that is used similarly but I doubt they would use it as a comparison as it's barely ahead of MDMA in being accepted as a treatment. And it seems to be useful for different issues than MDMA

 

[One off]

I read somewhere (maybe here?) that one of the most fundamental problems in constructing a study is that some people have a lot of trauma, and it takes a long time to work through it. If the study has a specific start and end date, some patients will be left in a poorer state when they started, because they're not done unpacking their crap yet. The problems have been surfaced but not processed. IIRC, the comment blamed some of the suicidal ideation on that abrupt cutoff of treatment.

I am no expert in this field (about as far from that as one could possibly be: the only vaguely psychedelic substance I've used is pot, and I'm not sure that even qualifies), and the comment I read was not a primary source, so take this idea with about eighteen grains of salt. It could be absolutely wrongheaded.

I would hope an ethical study including those with trauma or complex trauma would guarantee at minimum number of therapy sessions regardless of how the trial progresses. Expensive, but necessary unless the promise of MDMA / LSD is fully bourne out and such patients require many fewer therapy sessions than currently.

Restricted number of therapy sessions from some healthcare providers is a major problem for those on low incomes who need help with compex experiences for exactly the reason you stated, the therapy ends when they are at a very vulnerable point - often feeling worse than before treatment.

 

[HuntingManatees]

There's a bit of a hype right now re treating some mental health issues with psychedelics & most things that are hyped don't always live up to it. But, for example, I have a close friend who is in an experimental ketamine treatment program & no anti depressants had helped him - and his health had been impacted by them. He has found quite a bit of benefit from this treatment and has stabilized quite a bit.

I think it's worth noting that the current gold standard for treatment-resistant depression is electroconvulsive therapy. And while ECT is unfairly stigmatized, none of the dozen or so shock therapy patients I met during my time in hospitals and group homes ever saw a complete turnaround in mood or had any sort of breakthrough during treatment -- it's a very pragmatic and effective solution that argues, for the most part, "well, at least now you aren't psychotic and suicidal. . . ."

Most of them mentioned that ECT's side effects made it very hard to maintain work and personal routines when administered outside an inpatient setting. Given the choice, I'm sure they'd have much preferred care that was more pleasant, positive and transformative like MDMA has shown the potential for, at least anecdotally.

I just wish that the people who'd benefit from MDMA treatment had a greater voice than this vaguely-lobbyish cabal of weird psychonaut bros who think drugs are all happy magic hippie dream pills.

 

[ChefSalad]

Legal, illegal...there are 100+ species of psychoactive Psilocybe alone--almost anywhere you go will have at least one native species, and most of them aren't difficult to identify with a little study and some help from people with the knowledge. So, do with that what you will.

I have actually seen some of those in the wild. I think. In a Menard's parking lot berm, no less. So, yeah, they're everywhere. I'm just not sure I'd trust my own personal powers of detection enough to try them.

 

[Eldorito]

Perhaps, but they'd still probably argue that it has a "high potential for abuse," if only because of an overly-puritanical view of what constitutes "abuse."

So while I'd agree they belong even further down in the scheduling, Schedule II is the absolute highest they should be classified. That they are Schedule I is a gross perversion of the law. And don't even get me started on weed ever (& still) being Schedule I...

It might seem unimportant, but it comes back to the earlier post - that the FDA can somehow change the legality of drugs.

As you said, going by their own wording, the only difference should be whether there's a medical use. If it's Schedule II that's only acknowledging there's a medical use and changes nothing.

Of course the DEA/government usage and coding of drugs is a joke, but I still don't understand the sudden difference that making it Schedule II adds. Ketamine is Schedule III, wouldn't that be the goal? Or is it simply any movement down is an improvement and we should grab onto it, even though it makes little real world difference?

 

[KChat]

It might seem unimportant, but it comes back to the earlier post - that the FDA can somehow change the legality of drugs.

As you said, going by their own wording, the only difference should be whether there's a medical use. If it's Schedule II that's only acknowledging there's a medical use and changes nothing.

Of course the DEA/government usage and coding of drugs is a joke, but I still don't understand the sudden difference that making it Schedule II adds. Ketamine is Schedule III, wouldn't that be the goal? Or is it simply any movement down is an improvement and we should grab onto it, even though it makes little real world difference?

Schedule II comes with a lot fewer research restrictions. Which means potentially more, & more robust, trials. But yes, the goal should be an even lower scheduling, after the data are in.

 

[zenparadox]

Aren't head-to-head comparisons an acceptable option for phase 3 trials?

I don't understand why the control group wasn't given the current gold standard medication as an alternative. You'd think they could minimize the ability for participants to know what group they were in if they were given something like Paxil and they filtered out anyone who has previously taken MDMA.

Even if you'd never taken MDMA before, the therapeutic dose effect as I understand it is not in any way mistakeable for being in the 'control group' any way you look at it - it's a drug that has a very, very, very noticeable effect on your mood and psyche, the moreso if you don't know whats coming!

I can still remember the first time I ever had it, and staring at the ceiling just thinking completely differently to how my CPTSD up to that point had constrained my brain. The world changed for the better for me that day, although it's not without it's risks.

Almost impossible to have a control group that doesn't know they didn't get the active for this one. At least around the dose that's enough to shift your thinking, which is the desired effect they're trying ti investigate.

You will absolutely fucking know you're in the active group.

ETA - they might be trying to work out how to land in the grey zone just below recreational user goals; there's about 20 mins as it 'comes on' where you are just very happy and chatty and empathic, before the party zone rec users are after kicks in. For rec users if the dose isn't high enough it's considered a fail to stay in this zone lol, however even if you get the dose right and just hit that 'not on a 4 hour high' area, you'd still recognise very much that your mood is being affected.

 

[moriad]

The molecule is un-patentable. The results cannot be double-blind (since tripping break that regimen). Talk-therapy is not conclusively/scientifically(double-blind) verifiable as a "therapy". But the data shows it works. We all know if works. Tens-of-thousands of Vets are dying annually (gun to head), and we all know this works, but..we are left asking what is the FDA for? What do they do other than make for a prohibitive and prohibitively expensive therapy regimen?

The data shows talk-therapy works? The data also shows a lot of other things that work: dozens of currently used anti-depressants and anti-seizure medications, from MAOI's to valproic acid to SSRI's to anti-psychotics, along with therapies ranging from ECT to a 6 week course of online CBT.

Just about anything "works" for some people with mild symptoms. Time being one of the most effective healing agents of them all.

What we're talking about, though, is treatment-resistant depression/PTSD, for which -- by definition -- talk-therapy DOES NOT work. If it did, it wouldn't be treatment-resistant.

Edit: Where talk therapy might work in a way nothing else does (for veterans, specifically) is in dealing with the suffering that comes not just from trauma, but from moral injury. But contemporary psychology (with its efforts to try to demonstrate that it is a scientific field akin to STEM) seems unable to cope with this particular phenomenon. What's needed is probably talk therapy with philosophers.

 

[TimeToTilt]

Because there IS NO similar "gold standard " equivalent. How MDMA is being used/studied for therapeutic use is a small number of sessions in a clinical setting/guided by a therapist. It's an intervention treatment not stabilize/maintain. It cannot be used daily, its particular effect needs time between doses.

Placebos wont work as mentioned earlier because it will be immediately obvious who has placebos and who doesn't. Ketamine is the only other substance that I'm aware that is used similarly but I doubt they would use it as a comparison as it's barely ahead of MDMA in being accepted as a treatment. And it seems to be useful for different issues than MDMA

Eskatamine is also approved for trd I believe, probably the closest thing you could get to a blinding process

 

[blue.lantern]

I find so much of this frustrating.

On the one hand I am so disappointed and enraged at the sexual misconduct at that one trial site and everything surrounding that as well as the FDA and MAPS/lykos overlooking bio data. Many of the criticisms against the trial seem to be about its design which lykos designed with and got FDA approval from.

I am also both unsurprised and disappointed in that quote and the ICER's assessment. The issues of functional unblinding is imo really weird considering lykos worked with the FDA in their DOE and while I agree it is a problem it is also representative of a limitation with blinding and drugs that have significant psychoactive effects.

It also is just representative of engrained bias institutionally against psychedelics drugs and drugs that have "abuse potential"

Overall there is so much blame to go around with this situation and I'm deeply disappointed.

All that being said I'm still massively impressed with MAPS. Some of the issues here imo likely stem from the fact that a non-profit tried to bring a drug through FDA approval. A process with a median cost of 19 million dollars.

Because being critical of rape of trial participants and telling them to be silent about critical harm done is totally "representative of engrained bias institutionally against psychedelics drugs". Or it could be that in no way would any medical trial where such practices were prevalent would this be ok. No a single trial could have been accepted if such practices occurred no matter the type of drug researched. MAPS is incredibly at fault as much as any organization for significantly faulty practices and poor standards, not just Lykos. There are a great many trials of fraud and deception that do make it into prominent journals. What we have to do is uphold the standards and measures, not drop to allowing them to be relaxed because of the perceived feelings of some people wanting to take the drugs who feel they are discriminated against and practitioners who make money off selling services and lifestyle products. That way takes us down the same issues we have with the alternative treatment market and the hot mess of selling toxic substances & practices to those being scammed.

 

[Phubarrh]

If only the FDA review of Oxycontin had been half as scrupulous.

 

[aapis]

VP’s don’t develop drugs/do work, scientists do. If you’re just “overseeing” work done by others, you didn’t “help develop” anything.

Maybe someday a legitimate organization will take over where this weird cult left off, but given the US’ attitude towards drugs in general you have to wonder why they wouldn’t move operations to another country. Could it be, perhaps, that they only knew how to game a broken system?

 

[ColdWetDog]

I agree with your larger points, but the research data does exist. It's in phase 2 studies and moving towards phase 3. If you dig through the literature it's interesting that they've narrowed down on repeated use of a protocol ("correct use"). There might very well be other doses, protocols, and strategies that will prove to be more therapeutic, but it seems the idea is to get one method very well understood and hopefully safe and effective so it can be moved off schedule I.

To your other points it is, in fact, moving at glacial pace*. Which is good, because a year ago there was some wondering why the psilocybin treatment was moving so much more slowly than MAPS. It should be clear now why...



*it occurs to me we might need to retire this turn of phrase as glaciers now rapidly retreat :/

Thanks for that reference. Hadn't seen it. Still, my point pretty much exists. There always has been some research. Just not as much as needed or would be useful - largely due to difficulties of researching a Schedule I drug. Interestingly much of this research (and your reference) has been done in countries other than the US. Although they don't exactly have the DEA, the International Narcotics Control Board exists and has some force of treaty law. Interestingly psilocybin / psilocin isn't on the list (PDF).....

That brings up another part of this discussion - the US isn't the only country on the planet capable of researching things. Thank his noodliness.

 

[Shavano]

I have actually seen some of those in the wild. I think. In a Menard's parking lot berm, no less. So, yeah, they're everywhere. I'm just not sure I'd trust my own personal powers of detection enough to try them.

No kidding. They look a lot like other mushrooms that have no psychoactive substances in them at all, and a lot like other mushrooms that can kill you, and even if you find the right species of mushroom, there's no control on the amount of the drug in wild mushrooms.

 

[Odhejlflishahdjdlcmd]

I find so much of this frustrating.

On the one hand I am so disappointed and enraged at the sexual misconduct at that one trial site and everything surrounding that as well as the FDA and MAPS/lykos overlooking bio data. Many of the criticisms against the trial seem to be about its design which lykos designed with and got FDA approval from.

I am also both unsurprised and disappointed in that quote and the ICER's assessment. The issues of functional unblinding is imo really weird considering lykos worked with the FDA in their DOE and while I agree it is a problem it is also representative of a limitation with blinding and drugs that have significant psychoactive effects.

It also is just representative of engrained bias institutionally against psychedelics drugs and drugs that have "abuse potential"

Overall there is so much blame to go around with this situation and I'm deeply disappointed.

All that being said I'm still massively impressed with MAPS. Some of the issues here imo likely stem from the fact that a non-profit tried to bring a drug through FDA approval. A process with a median cost of 19 million dollars.

I have some overlap with this research and know folks involved in some of the MDMA studies and the psilocybin work and you hit the nail on the head: functional unblinding was a known confound but was accepted since niacin and other attempted placebos could not truly approximate the drug effect. There is now an MDMA-like agent without the psychedelic effects being tested that can be blinded. But importantly, this drug is not a cheap generic, but instead will be on patent by pharma.

In the end, MAPS/Lykos has structural issues and should be overhauled in terms of management. But I promise you there are really creepy people on the academic side of research too. Many of them. I am frustrated that neither Beth Mole nor any other coverage is highlighting that these attacks all came from an industry PAC paid by pharmaceutical companies that make billions from esketamine and other competing products. They launch basically an ad hominem attack on the research group but when psilocybin gets approved with the same blinding problem, we’ll all pretend it’s fine for that one.

 

[Sadre]

I have no problems at all with psychedelics. I'd argue, if you are curious, maybe find other ways like hiking. But if you are an adult in a functioning life? Like the people who post say at Ars? Go for it but be a bit careful.

Or not! Clear yer calendar for the next 2 years and add a chapter to your life!

So it is very true I have no problems with psychedelics. But I have all kinds of problems with psychedelics + a profit motive.

Use your own imagination to speculative all the ways that can go terribly wrong.

 

[Prostetnic]

Timothy Leary? Is dat choo?

 

[Xepherys]

And, yet, here we are 4 years after a pandemic, and we are STILL GRANTING EMERGENCY AUTHORIZATION to 2-3 UNPROVEN drugs.

How can we tell these drugs are unproven RNA Blueprint transferring medications? Because 4 fucking years later and they still can't pass the damn tests for actual authorization.

Yeah. But we need to prosecute the guys growing some mushrooms.

Our FDA should go forth and fuck itself.

You dropped your tin foil hat, bro...

But seriously, I'm not sure how any regular reader of Ars can be so woefully ignorant of actual science and the realities of things as well studied as the COVID vaccines.

 

[42Kodiak42]

If only the FDA review of Oxycontin had been half as scrupulous.

Maybe it's because the controversy of OxyContin's overprescription and off-label uses and general addictive nature and overall destruction of American lives took center-stage whenever the drug was brought up, but I'm unaware of controversies on the study-side of the Sacklers' bane upon our country.

 

[ColdWetDog]

I have some overlap with this research and know folks involved in some of the MDMA studies and the psilocybin work and you hit the nail on the head: functional unblinding was a known confound but was accepted since niacin and other attempted placebos could not truly approximate the drug effect. There is now an MDMA-like agent without the psychedelic effects being tested that can be blinded. But importantly, this drug is not a cheap generic, but instead will be on patent by pharma.

In the end, MAPS/Lykos has structural issues and should be overhauled in terms of management. But I promise you there are really creepy people on the academic side of research too. Many of them. I am frustrated that neither Beth Mole nor any other coverage is highlighting that these attacks all came from an industry PAC paid by pharmaceutical companies that make billions from esketamine and other competing products. They launch basically an ad hominem attack on the research group but when psilocybin gets approved with the same blinding problem, we’ll all pretend it’s fine for that one.

Pics or it didn't happen.

While I'm perfectly happy to believe that industry groups attempted to denigrate MAPS/Lykos, the existing reporting indicates that they didn't need that kind of help.

Do you have anything to back your assertion up other than 'people in general, and Pharma in particular are sleazy assholes'. Which, I will assert, is a ground truth.

 

[ColdWetDog]

Maybe it's because the controversy of OxyContin's overprescription and off-label uses and general addictive nature and overall destruction of American lives took center-stage whenever the drug was brought up, but I'm unaware of controversies on the study-side of the Sacklers' bane upon our country.

The FDA's failure in the prescription drug overuse issue was the lack of ongoing review of drug prescribing after the drug is approved. That is hugely problematic because the FDA is underfunded, there are both institutional and legislative barriers to that (Hi DEA!) and it is difficult and time consuming.

They kinda sorta did that by forcing drug manufacturers to make it less trivial to defeat the slow release formulation. Originally you could just grind up oxycontin (designed as long acting) tablets and get an rapid release (and buzz). It took them way to long to do way too little but hey, welcome to the '20's.

 

[Uncivil Servant]

Not at all. There is enough data out there to show that it is very possible that MDMA and similar chemicals can have significant positive effects. However, that data is in small, scattershot, poorly designed trials and just patient reports.

What is definitely needed is some high quality trails 'squeaky clean' trials. Most people in the field think it will show it does work. But you need to walk the walk. Which so far has been a road less traveled.

IIRC, the primary pharmacodynamic difference between MDMA and SNRIs is that MDMA does the amphetamine-style reversal of DAT/NET and (critically for MDMA) SERT uptake.

On the one hand, increasing synaptic serotonin levels in some regions of the brain can clearly have effects on mood. On the other hand, as someone who takes amphetamine by prescription, I have to say the fast-in, fast-out effect is also the opposite of what would be ideal for most psychiatric uses.

MDMA is in that annoying area where we know it's psychoactive and reasonably well-tolerated, like most recreational drugs, and it has a mechanism eerily similar to drugs we know are therapeutically effective, but the evidence is too piecemeal to be able to make any kind of serious recommendations.

And that's where drugs like thalidomide hang out, hence all the necessary caution.

 

[NetMage]

JFC. Scopolamine?!? Like, the amnestic drug from nightshade? Yeah, no problems with that one. Clearly safer than Benadryl. /s

The dose makes the medicine.

 

[EnPeaSea]

I have actually seen some of those in the wild. I think. In a Menard's parking lot berm, no less. So, yeah, they're everywhere. I'm just not sure I'd trust my own personal powers of detection enough to try them.

Saving big money, fellow midwesterner?

 

[jeremy56]

Well,
If people need to take them for their mental health then it doesn't make sense that it should not be allowed.
Doctors prescribe very poisonous medicines all the time that are FDA-approved, but they do help a few people.
Look at colchicine.. if taken wrong it is deadly and so is methotrexate (the Nazis used it to kill the Jews in the concentration camps, but it's legal).

But both of those drugs do help the ones that need it. That same should apply the MDMA or anything that can relieve suffering.
If they need to take MDMA, THC, or LSD to stop depression then it should be available and they should not have to sacrifice their freedom or their jobs when taking it.
Hell, I'm hooked on Nexuim (PPI) and its slowly destroying my bones. but it does help my acid reflux.
The whole thing is crazy.

 

[ColdWetDog]

The dose makes the medicine.

Actually, the quote is ’the dose makes the poison’, but that works as well..

 

[Oldmanalex]

That's not historically true.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6435835/
Like all psych meds, there has been some positive results, some negative results, and some -no- results. There is not a single med out there that is effective for the majority of patients, and all seem to have significant negative side effects (weight gain, decreased sexual functioning, etc). One reason why there is exploration of alternative therapies like this, or with ketamine, psilocybin et al is that some people's conditions are resistant to all other meds or the side effects are perceived to be worse than what the med is treating.

There's a bit of a hype right now re treating some mental health issues with psychedelics & most things that are hyped don't always live up to it. But, for example, I have a close friend who is in an experimental ketamine treatment program & no anti depressants had helped him - and his health had been impacted by them. He has found quite a bit of benefit from this treatment and has stabilized quite a bit.

Some of this all could be snake oil, some of it could be effective. And, it's subjective. For mental health issues, it is the patient's experience that determines efficacy. Not your bias.

Your bias can greatly affect the outcome; especially if you are the one administering the treatment and tabulating the results. And ignoring side effects is the biggest no-no, because virtually all drugs do something positive for some people, at some dose so the measurement of concomitant harms is almost always the decider, as 1% getting a 10% improvement versus say 10% dying does not an attractive package make.

 

[Tom the Melaniephile]

Some mushrooms do cause very painful deaths

So why aren't the deadly ones illegal instead of the low-health-risk psilocybe mushrooms?

 

[Tom the Melaniephile]

FDA approval would end-run their misclassification though, so I hope there are properly-run studies conducted in the future, with absolutely no ties to the psychedelic-proselytizing morons who so horrendously botched this one.

While I agree there needs to be a lot more robust research, there are at least some properly run studies of psychedelics. Johns Hopkins is one example of a major medical research center which has been doing psychedelic research for decades - and apparently they suggest psilocybin be dropped from Schedule I all the way to Schedule IV.

If you are interested, this website has a database of psychedelic research. If you're interested in something near you, scroll down to the map and zoom in.