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Research into the chemical found in ecstasy is plagued with allegations of misconduct

LEILA FADEL, HOST:

Later this summer, the Food and Drug Administration is expected to decide whether the chemical found in the drug ecstasy can be used as a treatment for post-traumatic stress disorder. FDA approval of MDMA would be a milestone for the movement to bring psychedelics into the mainstream of mental health care, but now there are questions about the research suggesting MDMA is effective for PTSD. NPR's Will Stone has our report.

WILL STONE, BYLINE: At the heart of the controversy are the clinical trials that have inspired enormous optimism. Those studies have focused on what's known as MDMA-assisted therapy - basically, the drug is given during several sessions, under the supervision of two trained therapists. Some patients have described the treatment as transformational.

CASEY TYLEK: It was amazing. I was blown away.

STONE: That's Casey Tylek, a military veteran who was in one of the PTSD trials.

TYLEK: I don't think I'd be alive today if it wasn't for this trial.

STONE: The data from the randomized control trials is promising. MDMA outperformed a placebo and was generally well tolerated. In fact, the company behind the research, Lykos Therapeutics, has raised more than $100 million ahead of possible FDA approval. Now, though, this foundational research is under scrutiny. It started with a report from a nonprofit called the Institute for Clinical and Economic Review that found substantial concerns about the validity of the results. Dr. David Rind is the institute's Chief Medical Officer.

DAVID RIND: We certainly couldn't convince ourselves that it was safe and effective.

STONE: He says one big issue is that most participants in the trial could tell when they received MDMA. Beyond that, however, the report raises the possibility that strong prior beliefs about the benefits of MDMA influenced the findings.

RIND: Patients may have been pushed to report positive outcomes and pushed away from reporting negative outcomes.

STONE: The report did not name its sources, but Rind says it included people involved in a podcast that featured two patients from the trials who said their condition deteriorated after taking MDMA and they contemplated suicide.

RIND: You have a group of people who are very upset about how these trials went. We couldn't tell, even though we talked with people where this happened, whether that represents a tiny fraction of bad events, or a number of bad events large enough to have rendered the trial just not believable.

STONE: Researchers who worked on the trials, like clinical psychologist Willa Hall, have strongly rejected the claims that bias among therapists influenced their results.

WILLA HALL: I saw nothing like that. I only saw professionalism.

STONE: Hall and more than 70 of her colleagues have published a detailed response to the institute's report, questioning the reliability of its sources and saying it misrepresented aspects of the trial.

HALL: I think a lot of us were just sort of shocked at sort of the gossipy, kind of hearsay nature of the report. We are all therapists that are invested in finding new tools to help our patients, that is true, but we also want to do it safely.

STONE: Hall says therapists meticulously detailed any adverse events. Sessions were recorded to protect against bias. Data from participants about their PTSD symptoms were collected online by people who did not know whether the person had taken MDMA or a placebo. Jennifer Mitchell at the University of California, San Francisco was the lead author of the published findings from the trials.

JENNIFER MITCHELL: I didn't feel any pressure from the sponsor to come up with anything different than what the data was providing. I didn't feel that at all, and wouldn't have continued to work with them if I had felt that.

STONE: Mitchell acknowledges she doesn't know what happened every day at each trial site, but she points out the FDA is closely involved in the trials and has access to all the data.

MITCHELL: So there's no keeping things from the FDA.

STONE: In fact, the FDA is holding a public meeting on MDMA-assisted therapy next month. That's after Nese Devenot and several others petitioned the FDA. Devenot is a lecturer in the writing program at Johns Hopkins who studies psychedelics.

NESE DEVENOT: The possibility that the data might not be representative of what's actually happened in clinical trials I don't think has been publicly reckoned with.

STONE: Their petition alleges trial data may have been manipulated to leave out troubling events. It cites a former employee of the drug company Lykos and implicates the Multiisciplinary Association for Psychedelic Studies, known as MAPS. That nonprofit has led the revival of psychedelic research, including MDMA. A spokesperson for MAPS disputes the claims in the petition and says it stands behind the clinical data. One of those who signed the FDA petition is anesthesiologist Boris Heifets. His lab studies psychedelics at Stanford University.

BORIS HEIFETS: I don't know if the allegations are true. It makes me deeply sad if there was actually trial malfeasance for such an important trial.

STONE: He says MAPS helped inspire him to research psychedelics and has supplied his lab with MDMA.

HEIFETS: I would really like to understand the risk profile of this drug before it's approved, not after.

STONE: The FDA says it plans to make a decision on MDMA by early August.

Will Stone, NPR News.

(SOUNDBITE OF MUSIC) Transcript provided by NPR, Copyright NPR.

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Will Stone
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