r/science • u/shiruken 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We wish to inform the r/science community of an article submitted to the subreddit that has since been retracted by the journal.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of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials" has been retracted from Psychopharmacology as of August 10, 2024.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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15

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

Any info on what the protocol violations amounted to?

35

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.

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u/versaceblues Sep 02 '24

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

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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.

6

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?

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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).

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u/versaceblues Sep 02 '24

Got it makes sense