Misconduct Allegations Cast Shadow on MDMA Research for PTSD

New York, NY — Medical research into the use of the psychedelic MDMA to treat post-traumatic stress disorder (PTSD) is facing significant challenges following allegations of misconduct and concerns about the validity of the clinical trials. The U.S. Food and Drug Administration (FDA) is currently reviewing MDMA, commonly known as ecstasy, as a potential treatment for PTSD.

Background and Current Status

The treatment, being developed by the Multidisciplinary Association for Psychedelic Studies (MAPS) and its public benefit corporation Lykos, has shown promise in clinical trials. In 2017, the FDA designated MDMA-assisted therapy for PTSD as a breakthrough therapy, signaling its potential to significantly improve existing treatments and paving the way for further research.

The clinical trials involved administering MDMA or a placebo to 94 patients during three therapy sessions spaced one month apart, with integration sessions to help patients process their experiences. Results showed that 71% of participants in the MDMA group no longer met the diagnostic criteria for PTSD, compared to 48% in the placebo group. However, some participants in both groups experienced adverse effects, such as anxiety or heart palpitations.

Concerns Raised About Research Validity

Despite these promising results, an independent investigation by the Institute for Clinical and Economic Review (ICER) has raised substantial concerns about the validity of the clinical trial findings. A recent draft report by ICER highlighted potential misconduct and ethical violations that could undermine the credibility of the MDMA research. A citizen petition filed with the FDA further alleged possible misconduct.

The ICER report acknowledges the potential of MDMA as an important addition to PTSD treatment options but noted several factors that could cloud the study’s results. One major issue is the difficulty of maintaining blinding in psychedelic research, as participants often correctly guess whether they received the active drug or a placebo, potentially biasing the results.

Allegations of Misconduct and Ethical Violations

The report also mentioned that therapists, researchers, and patients’ strong prior beliefs might have influenced the trial outcomes. Concerns have been raised that therapists might have encouraged positive reports and discouraged negative ones, possibly biasing the recording of benefits and harms.

Additionally, a study participant alleged inappropriate physical contact by two therapists—a married couple—while the participant was under the influence of MDMA during a treatment session in Canada. MAPS’ investigation found that the couple had “substantially deviated” from the treatment protocol, leading to their barring from administering MDMA-assisted therapy and notification of health authorities in Canada and the United States.

Responses from Researchers and Legal Experts

Jennifer Mitchell, lead author of the published Phase 3 trial papers, defended the study’s integrity, stating, “I didn’t feel any pressure from the sponsor to come up with anything different than what the data was providing.” The FDA review also raised concerns about MDMA’s safety, including risks of abuse and potential side effects on the cardiovascular system and liver.

Lykos CEO Amy Emerson expressed confidence in the research’s quality and integrity, emphasizing the need for new PTSD treatments. “Given there has not been a new PTSD medication approved in the United States in over two decades for the 13 million people living with PTSD, we are deeply committed to making a difference by bringing a potential new treatment to patients,” she said.

Shawn Hauser, a partner at the cannabis and psychedelics law firm Vicente LLP, acknowledged the challenges and legitimate concerns in the research but stressed the importance of considering these issues in the broader context of unmet treatment needs for PTSD patients.

The FDA’s ongoing review of MDMA-assisted therapy for PTSD highlights the complexities and challenges of evaluating new psychedelic treatments. The controversy underscores the need for modernizing the FDA’s evaluation process to appropriately assess the safety and efficacy of such therapies.