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

Psychedelic drug company Lykos already slashed staff and overhauled leadership.

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[Gibborim]

You'd think that as professional advocates, they would have known that any studies had to be squeaky clean.

 

[Steve austin]

Not if they were tripping at the time?

 

[original_mds]

Not if they were tripping at the time?

There is precedent for that.

 

[ChefSalad]

I just wish they'd legalize mushrooms. I mean, they kind of are legal in the US, in that if your religion uses them as part of its sacraments then you're technically fine. Having said that, of still rather not have to deal with the cops who aren't as up on the law as you'd like them to be.

For those who don't remember, in the early nineties SCOTUS said that religion didn't matter, mushrooms are definitely illegal. So Congress passed and Clinton signed the Religious Freedom Restoration Act, which changed the test used to determine these kind of religious drug use cases among other things. After that, the issue came up again and SCOTUS said, this time, because of the RFRA, mushrooms and peyote are fine for religious use as long as their use was a bona fide part of your actual religion. This remains the state of the law. I believe there's a permitting system run by the Fed, but don't quote me on that. Don't tell the states though, because they don't want to hear it.

 

[ColdWetDog]

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

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.

 

[Boskone]

So they peed in the bath, and didn't like being handed cleaning supplies?

 

[norton_I]

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

Maybe, maybe not. There definitely seem to be a fair number of legitimate experts who are not cultists who think it's at least promising. And lots of anecdotal evidence of people for whom it has been part of a successful treatment. But it needs well done studies. In particular we need a good understanding of the potential side effects. After all, if a lot of people report that it helps them with a condition like PTSD, that's about as good as you can expect -- it's like you can do a totally double blind study, and the metrics for success aren't as quantifiable as a tumor treatment. But if the side effects are serious or common, it's not reasonable to recommend it's general use.

 

[scarletjinx]

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

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.

 

[ColdWetDog]

I just wish they'd legalize mushrooms. I mean, they kind of are legal in the US, in that if your religion uses them as part of its sacraments then you're technically fine. Having said that, of still rather not have to deal with the cops who aren't as up on the law as you'd like them to be.

For those who don't remember, in the early nineties SCOTUS said that religion didn't matter, mushrooms are definitely illegal. So Congress passed and Clinton signed the Religious Freedom Restoration Act, which changed the test used to determine these kind of religious drug use cases among other things. After that, the issue came up again and SCOTUS said, this time, because of the RFRA, mushrooms and peyote are fine for religious use as long as their use was a bona fide part of your actual religion. This remains the state of the law. I believe there's a permitting system run by the Fed, but don't quote me on that. Don't tell the states though, because they don't want to hear it.

You won't really get anywhere until psilocybin gets off of DEA schedule I. While you can do research on a schedule I drug, it is an unholy pain in the ass with chain of custody paperwork that would make a prosecutor blush, intrusive patient reviews and potential random physical audits.

And getting something off of a DEA schedule is hard because it is in the DEA's best interest to keep stuff there. So they can continue watching over it. For a fee. The Biden administration has managed to get marijuana switched over from schedule I to schedule 3 started. So we have a ways to go yet for psilocybin and related substances.

It is nice that some localities and states have essentially decriminalized psilocybin, but we are missing the actual research data that would allow us to use it correctly.

 

[Gibborim]

A big problem is that MDMA doesn't interact effectively with a number of pretty standard psychiatric medications. I know several people for whom MDMA is ~0% effective by virtue of them being on anti-depressants.

I can see how it would be challenging to assemble a quality trial if you have to get doctors and patients to forego pretty standard and largely effective treatments in-favor of drugs. You are going to have a hell of a time screening out biases. Of course, that isn't a good reason to run a Swiss cheese study that isn't going to get you anywhere.

 

[warfare-guilder]

All of the crap around Lykos/MAPS aside, MDMA has worked really well for me therapeutically to help cope with CPTSD. (I'm not a party person at all.)

 

[Nowicki]

Between agencies holding it back for funding reasons, the GOP being militant against psychedelics, and corporations padding profits with patented drugs these things don't stand a chance in our political climate.

Even if we did get it rescheduled and viable to test how long would a Republican administration wait to ban it if corp and billionare donors said to?

Even if they didn't take the executive or legislative branch how long until a shopped Texas judge throws it out, or passes to SCOTUS to kick?

 

[nathand496]

I just wish they'd legalize mushrooms. I mean, they kind of are legal in the US, in that if your religion uses them as part of its sacraments then you're technically fine. Having said that, of still rather not have to deal with the cops who aren't as up on the law as you'd like them to be.

For those who don't remember, in the early nineties SCOTUS said that religion didn't matter, mushrooms are definitely illegal. So Congress passed and Clinton signed the Religious Freedom Restoration Act, which changed the test used to determine these kind of religious drug use cases among other things. After that, the issue came up again and SCOTUS said, this time, because of the RFRA, mushrooms and peyote are fine for religious use as long as their use was a bona fide part of your actual religion. This remains the state of the law. I believe there's a permitting system run by the Fed, but don't quote me on that. Don't tell the states though, because they don't want to hear it.

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.

 

[warfare-guilder]

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

MDMA has the same issue as, say, gender-affirming care, in that whether you're in the treatment or control group is so obvious so you can't double-blind it at all. You can still systematically study it but you can't do an RCT with it.

The FDA seems to have not approved it due, in large part, to one really horrific case of a Canadian couple sexually abusing a patient. But this statement is ridiculous:

The trials should be scrutinized as if Scientology or NXIVM had submitted a new drug application to the FDA

The difference is that MDMA is real, it has a widely-understood risk profile (I'd rather take MDMA than an SSRI!), and there are tons of patient reports of it helping.

 

[spopepro]

...

It is nice that some localities and states have essentially decriminalized psilocybin, but we are missing the actual research data that would allow us to use it correctly.

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 :/

 

[OtherSystemGuy]

MAPS was founded by Rick Doblin, a longtime psychedelic activist and advocate

This is problem number one and is going to lead to distrust in any research associated with him or his organization. Medical application and access to all for world peace are two totally different ends of the spectrum.

As has been noted by many comments so far, a good, clean trial needs to be performed. I suspect the results will show there is verifiable efficacy for a limited population and I believe that access should be limited to those in that group and for continued research for additional applications. Opening access simply on anecdotal evidence will cause more harm than good.

 

[Janeazy]

completely unrelated, but a funny name for a psychedelics drug company would/should be "Altavista"

 

[raxadian]

legalize mushrooms

Some mushrooms do cause very painful deaths

 

[Mental Gear Reduction]

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.

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.

 

[toxman]

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.

If you are referring to the COVID vaccines, the Pfizer and Moderna vaccines received full letters of approval in Aug 2021 and Jan 2022, respectively. These are probably some of the most studied drugs in modern history.

 

[Emon]

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

That's literally not what this article is about.

Not only are you believing nonsense about vaccines (proven above by another poster), you're literally writing fanfic then assuming it's reality.

Do better.

 

[KChat]

Why should access be limited to a group like that? Why should the government be so paternal about it? You can buy Benadryl over the counter, a drug that honestly no one should take for any reason.

Psychedelics have real risks! But the government's job should be to empower people with knowledge, not just ban stuff.

Show me on the doll where Benadryl touched you...

Saying no one should take Benadryl for any reason is one take, I guess. Not a good one, but the bar for stupid in this thread is "anti-vax nutjob who can't read," so carry on.

 

[chelgrian]

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.

No you should perform that operation.

The original vaccines were granted full approval a few months later after follow-up studies and the EUAs had a far higher bar (phase three trial and 2 months of follow up) than a normal EUA.

The same has been done for reformulated versions for newer variants, an EUA to get it in to use fast enough to make a difference followed by full approval after additional surveillance studies.

 

[graylshaped]

The FDA deserves a share of the displeasure here, for approving a study of dubious design (and admitting they overlooked aspects of that design later), for controversial approvals of drugs like aducanumab that led to medical professionals refusing to prescribe it, and for cumbersome arcane processes overall.

Let's not forget, though, that we are still recovering from four years of a concerted effort of an administration whose clear objective was to drive out experience and expertise from all federal agencies, from the FDA to the State Department, and had had well over 100 former participants in that administration contribute work to the Project 2025 manifesto laying out detailed plans to turn the entire federal government into a theocracy under the personal control of an unfettered con man.

 

[KChat]

Long-term Benadryl use has serious side effects, and there are much better drugs for every possible use of Benadryl.

But even if you disagree, I think the FDA has no business banning any psychedelic.

1.) Benadryl is tolerated pretty well by most of the population, & is even given in hospitals as a sleep aid because it is safe & non-habit-forming. If used occasionally, it's fine.

2.) The FDA is not banning psychedelics - the DEA has drugs scheduled.

3.) The predictable consequences this article is about are because it was a shitty study run by shady people, not whatever uninformed axe you came to grind.

 

[Faustius23]

MDMA has the same issue as, say, gender-affirming care, in that whether you're in the treatment or control group is so obvious so you can't double-blind it at all. You can still systematically study it but you can't do an RCT with it.

The FDA seems to have not approved it due, in large part, to one really horrific case of a Canadian couple sexually abusing a patient. But this statement is ridiculous:



The difference is that MDMA is real, it has a widely-understood risk profile (I'd rather take MDMA than an SSRI!), and there are tons of patient reports of it helping.

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.

 

[nathand496]

1.) Benadryl is tolerated pretty well by most of the population, & is even given in hospitals as a sleep aid because it is safe & non-habit-forming. If used occasionally, it's fine.

2.) The FDA is not banning psychedelics - the DEA has drugs scheduled.

3.) This article is about a shitty study run by shady people, not whatever uninformed axe you came to grind.

I think they're talking about how long term use of anticholinergics like Benadryl might increase risk of dementia/Alzheimer's. Pretty sure the bit about there being better drugs for every use case is nonsense, though.

 

[nathand496]

Some mushrooms do cause very painful deaths

Illegalize Amanita ocreata!

 

[Eldorito]

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.

That is one of the worst logical leaps I've read in quite a while.

The FDA can regulate whether it can be used as a medicine or not. If the DEA changed it to schedule II, it would mean it's legal to use as a highly regulated medicine and... that's it.

It means black market MDMA will likely be more readily available, but legally it doesn't make a scrap of difference for the majority of people.

 

[warfare-guilder]

That is one of the worst logical leaps I've read in quite a while.

The FDA can regulate whether it can be used as a medicine or not. If the DEA changed it to schedule II, it would mean it's legal to use as a highly regulated medicine and... that's it.

It means black market MDMA will likely be more readily available, but legally it doesn't make a scrap of difference for the majority of people.

I think the practical gap between schedules I and II is much bigger than that.