Panel rejects psychedelic drug MDMA as treatment for PTSD, in potential setback for advocates

The FDA is not required to follow the group's advice and is due to make a final decision by August, but a negative opinion could strengthen the agency's case for rejecting the treatment.

MDMA is the first in a series of psychedelic drugs, including LSD and psilocybin, that are expected to come under FDA review within the next few years amid renewed interest in the drug's medical potential as it could revolutionize the treatment of mental illness.

But FDA advisers spent much of Tuesday's meeting issuing harsh criticism of the reported studies on MDMA, also known as ecstasy or Molly. Panelists pointed to flawed studies that could have biased the results, a lack of follow-up data on patient outcomes and a lack of diversity among participants. The vast majority of patients were white, with only five Black patients given MDMA, raising questions about the generalizability of the results.

“The fact that this study has so many white participants is a problem because we don't want to develop a study that is only going to help this particular group,” said Elizabeth Joniak Grant, a patient representative for the group.

FDA advisers also noted recent news reports of allegations of clinical trial misconduct. A report by the nonprofit Institute for Clinical and Economic ReviewThe National Institute for Clinical Trials and Clinical Oncology (NICU), which evaluates drug treatments, said in a 2018 report that these cases included: Sexual Misconduct A photo of a therapist and her husband taken while treating a patient.

Lycos Therapeutics, which led the study, said it had already reported the incident to the FDA and to regulators in Canada, where the therapists are based.

Lycos is essentially an offshoot of the leading US psychedelic drug advocacy group, the Multidisciplinary Association for Psychedelic Drug Studies (MAPS), which funded the research. The group was founded in 1986 to promote the benefits of MDMA and other mind-altering substances.

In a statement after the meeting, Lycos said it would work with regulators to address the committee's concerns.

“While we are disappointed with the outcome of the vote, we are committed to continuing to cooperate with the FDA as it continues its review of our drug application over the coming weeks,” the company said. The FDA is expected to make a decision by Aug. 11.

The panel's overwhelmingly negative decision could further discourage investment in the nascent psychedelic drug industry, which has been funded primarily by a few wealthy backers. Dozens of startups have been founded in recent years to study drugs like psilocybin, ketamine and others for conditions including depression and addiction, but many of them have struggled to raise capital.

MDMA does not produce the visual hallucinations common to psychedelics. Instead, its primary effect is to induce feelings of intimacy, connection, and euphoria. When used to enhance talk therapy, the drug appears to help patients process trauma and let go of unpleasant thoughts and memories.

But given the difficulty of objectively testing hallucinogens, the committee struggled with the reliability of the results reported by Lycos.

Because MDMA induces such intense psychological experiences, nearly all patients in two key studies of the drug were able to guess whether they had received MDMA or a placebo. This is the opposite of the approach typically required for quality drug research, which minimizes bias by “masking” patients and researchers whether they received the drug under investigation.

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

Panelists also noted the difficulty in determining whether the patients' improvements were due to MDMA or simply the long-term treatment, which for many patients lasted more than 80 hours. Results were further marred by other complicating factors, including the fact that many of the patients had previously used MDMA or other hallucinogens recreationally.

During the comment period, nearly 30 public speakers addressed the committee, including military veterans who claim to have benefited from MDMA therapy, medical professionals who recommend against MDMA use, and journalists and independent researchers who detailed allegations of misconduct in the clinical trials.

At the end of the meeting, several experts encouraged Lycos and the FDA to continue researching psychedelics for PTSD, given the field's potential to help patients.

“We think this is a really great treatment and are encouraged by the results so far,” said Dr. Paul Holzheimer of the VA's National Center for PTSD, “but we feel it's still early in terms of safety and effectiveness.”

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science Education Media Group. The AP is solely responsible for all content.

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