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Panel rejects psychedelic drug MDMA as PTSD treatment

A unique proposal to use the mind-altering drug MDMA as a treatment for PTSD was roundly criticized Tuesday — a potentially major setback for psychedelics advocates hoping to win landmark federal approval and bring the banned drugs to market. medical mainstream.

The Food and Drug Administration’s panel of advisors voted 10-1 against the overall benefits of MDMA in treating post-traumatic stress disorder. They cited flawed research data, questionable research practices and significant drug risks, including the potential for heart problems, injury and abuse.

What you need to know

  • Federal health advisers have rejected the first-ever proposal to use MDMA as a treatment for PTSD
  • The non-binding vote is a potential setback for psychedelics advocates hoping to bring the banned drugs into the mainstream
  • The experts cited flawed research data and potential safety risks of MDMA, including heart problems
  • The FDA is expected to make a final decision on the drug in August

“It seems like there are so many problems with the data. Each problem on its own can be fine, but if you stack them on top of each other… I would have a lot of questions about how effective the treatment is,” says Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.

The FDA is not required to follow the group’s advice and is expected to make its final decision in August, but the negative advice could strengthen the FDA’s rationale for rejecting the treatment.

The vote followed hours of pointed questions and criticism of the submitted research into MDMA, also known as ecstasy or molly. Panelists pointed to flawed studies that could have skewed results, missing follow-up data on patient outcomes and a lack of diversity among participants. The vast majority of patients studied were white, while only five black patients received MDMA, raising questions about the generalizability of the results.

“The fact that this study has so many white participants is problematic because I don’t want something to be rolled out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative.

The FDA advisers also drew attention to allegations of misconduct in the studies that have surfaced recently in news stories and a report from the nonprofit Institute for Clinical and Economic Review, which evaluates experimental drug treatments. The incidents include a 2018 report of apparent sexual misconduct by a therapist who interacted with a patient.

Lykos Therapeutics, the company behind the study, said it had previously reported the incident to the FDA and regulators in Canada, where the therapist is based. Lykos is essentially a spinoff of the country’s largest psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies (MAPS), which funded the studies. The group was founded in 1986 to promote the benefits of MDMA and other mind-altering substances.

MDMA is the first in a series of psychedelics – including LSD and psilocybin – expected to appear before the FDA in the coming years. The panel’s negative ruling could further derail financial investment in the fledgling industry, which is mainly funded by a small number of wealthy backers.

The main effect of MDMA is to induce feelings of intimacy, connection and euphoria. When the drug is used to enhance talk therapy, it appears to help patients process their trauma and release troubling thoughts and memories.

But the panel took issue with the reliability of those results, given the difficulties in objectively testing psychedelic drugs.

Because MDMA produces intense, psychological experiences, almost all patients in two major studies of the drug were able to guess whether they had been given the MDMA or a fake pill. That’s the opposite of the approach typically required for high-quality drug research, which minimizes bias by ‘blinding’ patients and researchers to whether they received the drug under investigation.

“Based on the data I’ve seen, I’m not at all convinced that this drug is effective,” says Dr. Rajesh Narendran, a University of Pittsburgh psychiatrist who chaired the panel.

Panelists also noted that it is difficult to know how much of the improvement in patients is due to MDMA, compared to simply undergoing the extended therapy, which for many patients lasted more than 80 hours in total. The results were further marred by other complicating factors, including a large number of patients who had previously used MDMA or other psychedelics recreationally.

Nearly three dozen public speakers also addressed the panel, including veterans who said they benefited from MDMA therapy, medical professionals who advised against its use and journalists and independent researchers who repeated allegations of misconduct in the trials.

The meeting concluded with several experts encouraging Lykos and the FDA to continue studying psychedelics, citing the field’s potential to help patients.

“I think this is a very exciting treatment and I am encouraged by the results so far,” said Dr. Paul E. Holtzheimer of the VA’s National Center for PTSD, “but from a safety and efficacy perspective, I think it’s premature. ”

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