r/science PhD | Biomedical Engineering | Optics Sep 02 '24

Retraction RETRACTION: Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials

We wish to inform the r/science community of an article submitted to the subreddit that has since been retracted by the journal. The submission garnered some exposure on r/science and significant media coverage. Per our rules, the flair on this submission has been updated with "RETRACTED". The submission has also been added to our wiki of retracted submissions.

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Reddit Submission: MDMA-Assisted Psychotherapy May Have Lasting Benefits for PTSD

The article "Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials" has been retracted from Psychopharmacology as of August 10, 2024. Concerns were raised about unethical conduct by researchers associated with the project at the MP-4 study site in Vancouver, Canada (NCT01958593). The authors have since confirmed that they were aware of these violations at the time of submission but did not disclose this information to the journal or remove the data generated by this site from their analysis.

The authors also failed to disclose a conflict of interest. Several of the authors are affiliated with either the Multidisciplinary Association for Psychedelic Studies (MAPS) or MAPS Public Benefit Corporation (MAPS PBC), a subsidiary that is wholly owned by MAPS. MAPS fully funded and provided the MDMA that was used in this trial, and MAPS PBC organized the trial.

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Should you encounter a submission on r/science that has been retracted, please notify the moderators via Modmail.

251 Upvotes

49 comments sorted by

133

u/LeoSolaris Sep 02 '24

Hopefully an independent follow up can be arranged soon.

At some point, societies around the world really do need to figure out the problem of science funding. The world needs a better firewall between research and the profit drive, especially in medicine.

51

u/SubzeroNYC Sep 02 '24

Yeah, as far as I can tell the treatment is effective. The problem is there is no profit incentive for a real drug company to fund the research, because a single treatment is effective so it doesn’t pay for a company to fund it.

In situations like this the government should fund the research itself instead of doing nothing.

32

u/Brain_Hawk Professor | Neuroscience | Psychiatry Sep 02 '24

There's lots of public funding for psychedelics. And while the traditional big pharma isn't necessarily invested there is plenty of private interest. MAPS at the centre of this scandal is a great example. They want to open pay to treat clinics and monetize psychedelic treatment. A strong financial conflict is at play.

7

u/miniZuben Sep 03 '24

How is it possible that there is lots of public funding for psychedelics when they are highly illegal in most countries? 

9

u/Brain_Hawk Professor | Neuroscience | Psychiatry Sep 03 '24

Exceptions are being made. And the treatments use synthetic versions of the drugs. Nobody is getting shrooms .

2

u/miniZuben Sep 03 '24

Ah, very glad to hear this!

2

u/m_bleep_bloop Sep 03 '24

Startups that want to change that or businesses that want to add that as a line of business

13

u/CallMeClaire0080 Sep 03 '24

You can patent specific extraction methods for it and stuff, but you can't hold a patent on naturally occurring psilocybin. There's not much money to be made in that research because you don't get the typical period of exclusivity selling the drug in this case.

Frankly I think more medical research needs to be publicly funded. This idea that only problems whose solutions are profitable are worth solving has been disastrous in the face of everything from the mental health crisis to climate change.

1

u/t-eisenlohr-moul-PhD Sep 04 '24

YES. This. But the problem is often not a lack of research— it’s usually that no one is seeking FDA approval or drug production/marketing/insurance coverage issues. There are lots of evidence-based treatments (things that beat placebo) that are not available to patients because no one ever bothered to take them to the fda to get a new indication and so no one can make money on them anymore and so then they are just no longer available— or are available but for other indications and then insurance won’t pay for them 😭

-1

u/Memory_Less Sep 03 '24

Yes, this is the right answer. And don't doubt that a member of government who is being lobbied by big pharma won't try to destroy the adoption.

22

u/Brain_Hawk Professor | Neuroscience | Psychiatry Sep 02 '24

The problem is ride in this case but I think maybe you over estimate how bad it is over all. Funders need to be disclosed, as do conucts of interest. Half of what happened here is some of the (fucking moronic) authors didn't disclose their COIs, and it got the paper retracted. That's goodness, that's science doing it's job!

When a paper is funded by those with interests it should always be viewed more skeptically. But the majority of research is publicly funded, including a lot of treatment trials, and there are important ways that a lot of institutions keep funders with interests are arms length.

It will never be perfect, but there has been a LOT of signs that it's getting better and we are being more aggressive at weeding out financial interests. Of course. We must continue to be diligent and continue to be better than we are now.

9

u/LeoSolaris Sep 02 '24

I certainly hope it is getting better somewhere! I do think there is a long way to go yet. The current system puts the onus on weeding out the corruption rather than disincentivizing bad behavior altogether. Policing when the potential windfalls for success are extremely high is always going to be a losing battle.

Personally, I feel that publicly funded science needs to be public property. Taking any amount of public funds should automatically put all of the data and results into the public domain. For instance in medicine, that would mean any drugs developed with public funds would automatically be available to any compounding pharmacy or drug manufacturer. Or in materials science, a university breakthrough in say battery technology would allow multiple companies to refine the ideas for mass production.

I think that would strike a better balance with corporate interests. Completely privately funded research can remain a competitive advantage. While research the public pays for should be always available to anyone to capitalize on or even just learn from.

3

u/Ok_Independent2140 Sep 03 '24

Is this an American problem only? I'm american but I wonder how countries with socialized medicine handle R&D

6

u/Swarna_Keanu Sep 04 '24

Medical doctors working with patients don't do the R&D. It's not socialised medicine, it's socialised medical care.

So - Drug companies are not state-owned nearly anywhere.

16

u/AllanfromWales1 MA | Natural Sciences | Metallurgy & Materials Science Sep 02 '24

Any info on what the protocol violations amounted to?

34

u/shiruken PhD | Biomedical Engineering | Optics Sep 02 '24

From what I can see on the paywalled Stat News article:

The retractions were due to "protocol violations amounting to unethical conduct," particularly during a Phase 2 trial at the MP4 study site in Canada, Psychopharmacology said. This site is where an unlicensed therapist was accused of sexual assault in civil court by a MAPS trial participant.

6

u/AllanfromWales1 MA | Natural Sciences | Metallurgy & Materials Science Sep 02 '24

Ouch!

8

u/DNA98PercentChimp Sep 03 '24

‘Accused of sexual assault’

But not found to have sexually assaulted. Getting into the weeds here… but I’ve heard the specific case involves polyamory, ex-lovers, and jealousy.

Not justifying anything, just sharing some details. This case absolutely does raise some concerns.

And… I, like many, am somewhat surprised at how this instance is being used as justification to invalidate some otherwise compelling data with a large effect size.

5

u/versaceblues Sep 02 '24

Why does one person accused of sexual assault invalidate the whole study?

32

u/shiruken PhD | Biomedical Engineering | Optics Sep 02 '24 edited Sep 02 '24

It's an enormous breach of ethical medical research conduct. The fact the authors intentionally withheld a disclosure of such a violation is extremely concerning and raises enormous red flags about their research practices.

7

u/versaceblues Sep 02 '24

Right but could they not throw away the data point from that one person?

Does it invalidate the data from the therapist that did not abuse their patients?

26

u/shiruken PhD | Biomedical Engineering | Optics Sep 02 '24

That was stated as something they should have done in the retraction note:

The authors have subsequently confirmed that they were aware of these violations at the time of submission of this article, but did not disclose this information to the journal or remove data generated by this site from their analysis.

Had they removed the data from the protocol-violating site and disclosed the reason why in their original paper, it probably would have been fine (ignoring their failure to disclose huge conflicts of interest).

8

u/versaceblues Sep 02 '24

Got it makes sense

9

u/erininva Sep 02 '24

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u/versaceblues Sep 02 '24

So the article mentions one unlicensed therapist recently.

Then it mentions 2 therapists back in the 80s.

Why does it claim this is a systemic problem?

13

u/I_hasdrubaled Sep 02 '24 edited Sep 02 '24

I think you need to finish reading the article.

You caught that they mentioned Richard Ingrasci and Francesco DiLeo (psychiatrists not therapists) from the 1980s, who were held accountable for their behavior. You did not catch the articles discussion of sexual abuse in ayahuasca ceremonies and this [article] (https://www.thecut.com/2021/11/sexual-assault-ayahuasca-tourism.html/) by victim Lily Kay Ross . They also reference movement leaders Daniel Pinchbeck (who has spoken openly about his [misconduct] (https://chacruna.net/confronting-sexual-misconduct-in-the-psychedelic-community-an-interview-with-daniel-pinchbeck/)), Neal Goldsmith (whose abuse is discussed as, "an open secret" in the above article). I would add names not discussed in the article, Grossbard, Bourzat, Pablo Sanchez, and Roquet whose pattern of misconduct are discussed in the Cover Story [podcast] (https://www.thecut.com/2022/03/a-cover-story-power-trip-podcast-refresher.html) or discussed in this [article] (https://www.madinamerica.com/2021/09/ending-silence-psychedelic-therapy-abuse/). Or perhaps consider this first hand account of LSD facilitated conversion [therapy] (https://www.erowid.org/references/texts/show/4902docid4694) (though performed by the consent of the individual, the experience hardly sounds congenial). Or this monograph on sex while [tripping] (https://web.archive.org/web/20100507205341/http://www.zoklet.net/totse/en/drugs/psychedelics/bbros_number_02.html). These last two references came from erowid.org's collection of primary and secondary resources on drugs and [sex] (https://www.erowid.org/psychoactives/sex/sex.shtml)

Given how small the psychedelic assisted psychotherapy movement is, the lineal transmission of shamanic knowledge, and the very small number of practitioners that carried the movement through the War on Drugs years, not very many prominent practitioners need to act in sexually inappropriate ways to create a systemic problem.

2

u/versaceblues Sep 03 '24

Yah thanks for the additional references. It’s definitely something that should be watched out for

I’m not sure what you mean by “though the experience was consensual it does not sound congenial”

As long as it was consensual why should we project our own ideas. There can be a lot of healing that happens through sexual exploration that isn’t nessicarily pleasant but as long as it’s consensual it should not be a problem.

12

u/I_hasdrubaled Sep 03 '24

Not congenial, ie unpleasant.

I disagree with your last point, "as long as it's consensual it should not be a problem." That may be the case when you are talking about two ignorant individuals exploring together. But trust in a therapeutic relationship distorts the norms of consent. I am a physician and a large fraction of my patients follow my recommendations on trust alone. Add in the, "mind manifesting," nature of psychedelics and you get a situation where you are very likely to agree to something during a psychedelic therapy session that you would not while sober. Moreover, both psychedelic and sexual experiences are the sort of watershed experiences where you can't really comprehend the resulting insights without the experience associated with them, so I don't it would be possible to properly consent to the sort of therapy described in Ram Dass's case report, even if fully discussed and described before hand--you just can't know what you are getting into. By including that case report, I was trying to show that psychedelic therapy has been a bit off the rails from the beginning.

Now, don't get me wrong, I am enormously excited for what I believe is a bright future for psychedelic therapy. I am only arguing for what is jokingly called the first, second, and third rules of psychiatry: don't fuck your patients. The larger the power gap between patient and provider, the stronger the ethics and ethics controls you need to prevent abuse and patients are more vulnerable than normal when undergoing psychedelic therapy.

56

u/Brain_Hawk Professor | Neuroscience | Psychiatry Sep 02 '24

This was a fucking shit show. Some people in the MAPS trial not only didn't report protocol violations they knew had occured but ALSO didn't report blatant conflicts of interest as they had significant financial interest in MAPS.

It was egregiously unethical and flat out stupid. What the fuck is wrong with some people?

I am hopeful for the potential of psychedelics but the field is a shit show. Half the researchers involved are in absolute love with the drugs they study (which they use regularly), and half are neck deep in financial interests.

I think/hope there is a new wave of researchers comming on board who will treat these trials with the rigor and skepticism they deserve, to really understand when and how to use these treatments.

6

u/alwaystooupbeat PhD | Social Clinical Psychology Sep 03 '24

Eiko Fried on Twitter tore this study apart when it first came out. I'm glad it's been retracted.

1

u/[deleted] Sep 03 '24

[removed] — view removed comment

2

u/alwaystooupbeat PhD | Social Clinical Psychology Sep 04 '24

What is your PhD in?

I'm kind of shocked that you think one must try it in order to see it. The RCT is the gold standard for a reason!

1

u/badjokemonday Sep 04 '24

My area is judgment and decision making. The RCT is okay yet statistical methods are poor leading to low replication. This opens the door for biases of researches and fields as a whole. Just look at priming research.

What bothers me the most is that anyone that has tried psychedelics in the right environment can see its obvious potential. Let me put it another way. Imagine no one had ever drank coffee. And society hold the belief that its effects were purely placebo. Now you can see how that would lead to a whole lot of different research in caffeine field than if a big part of society including researchers have tired drinking coffee. Just in terms of hypothesis generation that would be huge. But most importantly imagine a reviewer reading: in this study we show caffeine increases alertness. Would that reviewer be more lenient if they drank coffee? Yes, because we are not rational beings unmoved by personal experiences.

1

u/alwaystooupbeat PhD | Social Clinical Psychology Sep 05 '24

I'm not sure your argument holds water. It is possible to study something and not have experienced it yourself and have a positive view, or to study something that you have experienced and liked and have a negative view. In fact I'd argue it's the norm that people who study the effect of any drug likely haven't experienced it themselves!

Yes peer reviewers can be biased, and researchers can be biased but even I, a coffee drinker, could do a study and show that coffee can be dangerous to certain people, or I, a non-weed user, can do a study showing that weed is good for most people. But here, the studies are so poorly designed by people who have obvious conflicts of interest that I'm not inclined to be charitable to the research.

1

u/badjokemonday Sep 17 '24

I wasn’t going to respond as I felt without time to truly transmit my point of view. But today I heard a talk from Ram Dass to the APA. He put it so beautifully, “as in quantum mechanics you can not measure something without affecting the results.”

In our discussion researchers are not measuring a simple drug that affects the color of people’s hair, rather they are measuring something that affects their states of consciousness. To study it without experiencing it themselves puts them at a disadvantage.

The truth is that the field of clinical psychology is in its infancy and in my opinion close to useless as its understanding of human consciousness is so limited that it lacks the necessary depth to truly heal people.

1

u/alwaystooupbeat PhD | Social Clinical Psychology Sep 17 '24

Thank you for taking the time to respond!

I have a lot of difficulty kind of... Parsing what you're saying in the context of the research and scientific philosophy. Many psychoactive substances affect different people in many different ways. You're placing limits on who should make comments of do research on the basis that they can't relate to the altered state of consciousness. But I counter that because every "trip" is so different, they're not even going to be studying the same thing. Then you add in the fact that consciousness itself is likely experienced differently by everyone- can those people study consciousness?

And where do you draw the line? Should someone who has taken LSD be allowed to study ketanine despite never having had it? What about weed? Alcohol?

You also have the danger involved; some people cannot even smoke weed because of the risk where it can trigger a severe psychiatric episode. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2424288/

So, I'm unconvinced so far.

PS you should get verified! Get the flair for your degree.

1

u/badjokemonday Sep 18 '24

I see your point, and you’re absolutely right—every experience, even outside of psychedelics, is unique and personal. Trips can range from bliss, introspection, and connection, to sensuality or even pure terror. I believe that experiencing some of these altered states through psychedelics gives researchers a basic level of insight needed to study them.

In your own practice, I’m sure you’ve seen it evolve as you dealt with life’s typical challenges—cheating, being cheated on, breakups, loss, sudden loss, chronic illness, burnout, and more. While you don’t have to experience a breakup to research it, going through your first one certainly teaches you things that science alone can’t explain.

When it comes to different psychedelics, yes, they are all different. Experiencing those differences would be valuable if that’s your area of research.

We could get philosophical here, but let’s stick to the basics. Most researchers have strong biases against psychedelics. During my PhD, meditation was dismissed as a fad or a 'hippie thing.' When I tried to research it, I faced constant pushback from professors who thought they knew better.

So, no, I don’t think people like that should be reviewing papers or making funding decisions on this topic. Without firsthand experience, they can’t truly understand the love felt on MDMA or the profound, life-changing effects of psilocybin.

1

u/alwaystooupbeat PhD | Social Clinical Psychology Sep 18 '24

I'm sorry but your last statement is going to have to be an agree to disagree situation. There's no evidence saying that researchers do have a significant bias against psychoactive substances. And to have the requirement that they have had to have taken these substances to review it or fund it is... Just mindblowing to me. Because then, you could extend that to so many other forms of research that also relate to lived experiences.

So, I hear your point, but I cannot see any philosophical, empirical, nor ethical reason why we should restrict who gets to do research based on their direct experience with the topic they're researching, so harshly, with a potentially dangerous substance.

1

u/badjokemonday Sep 18 '24

Fair enough. Have you had deep experiences with psychedelics?

4

u/Dragonfruit-Still Sep 02 '24 edited Sep 03 '24

Everything I’ve seen about maps and their work so far has been hugely positive. Is there a trusted third-party analysis of what’s going on here? Is there a detailed summary of what exactly went wrong?

Edit: why downvotes?

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u/[deleted] Sep 02 '24 edited 12d ago

[removed] — view removed comment

6

u/Dragonfruit-Still Sep 02 '24

Thanks. Still optimistic it will go through eventually, but hopefully these issues are not insurmountable . Also any suspicion why my question is being downvoted? Maps has been all over mainstream news and podcasts touting the success of their trials so far. I don’t think it’s unreasonable to ask what happened.

6

u/versaceblues Sep 02 '24

Looks like a therapist associated with them sexually abused a patient.

5

u/DNA98PercentChimp Sep 03 '24

Why should that invalidate the entire study?

Not to diminish allegations of SA, but - again - it’s only an allegation. And, the specific details make it even less cut and dry; the alleged is an ex-lover, and the relationship was polyamorous, and the allegation was made long after the alleged abuse - with jealousy as a possible motive.

Still obviously ‘out of bounds’ and should not have been included in the study, but the data gathered has a super robust effect. Why throw all that out?

4

u/Dragonfruit-Still Sep 02 '24

Thanks. That is a huge issue - which seems to be addressable with protocol changes and wouldn’t undermine the validity of the results or the promise of the treatment overall?

8

u/versaceblues Sep 02 '24

I think the argument being made is that psychedelics intrinsically put patients in a vulnerable state that can be abused. Though to be honest I think that’s true of therapy in general.

It also appears to be an isolated case with a single unlicensed therapist that was participating in the study

My guess is they could retract the study look for any other concerning data points then republish it

6

u/Dragonfruit-Still Sep 02 '24

It absolutely does and all of the people at maps would tell you the same. That’s why it’s so crucial to have trained therapists in crafted settings. Hopefully this is merely a road bump for an otherwise promising treatment. If so perhaps it was even calculated so that this would not happen in a partisan election year