A federal panel of independent health advisers convened yesterday to deliberate on a groundbreaking proposal to approve MDMA as a treatment for post-traumatic stress disorder (PTSD). Ultimately, Lykos’ proposal to approve MDMA for PTSD treatment was rejected with a decisive 1-10 vote, casting doubt on the possibility of federal approval later this summer.
The Psychopharmacologic Drugs Advisory Committee, which provides guidance to the Food and Drug Administration (FDA) on such matters, meticulously reviewed the latest research on MDMA. These studies were conducted by Lykos Therapeutics, a spinoff of the Multidisciplinary Association for Psychedelic Studies (MAPS). During the trials, patients who received MDMA as part of an intensive, four-month course of talk therapy showed significantly lower PTSD scores compared to those who did not receive the drug, according to the data presented to the panel.
Concerns Over Data Reliability and Safety
Despite the promising results, the FDA expressed concerns about the reliability of the data and potential safety risks associated with MDMA, including heart problems and the risk of abuse. Additionally, critics of the trials voiced their concerns during the public comment portion of the meeting. Dr. Tiffany R. Farchione, an FDA reviewer, noted the complexity and significance of the application at the start of the meeting.
The Need for More Research
After hearing public comments, the committee deliberated on the available data regarding the effectiveness and safety of MDMA-assisted psychotherapy for PTSD. Several panel members raised issues about functional unblinding, expectation bias, and the limited diversity of study participants, which affected the interpretation of efficacy results. They also highlighted the lack of long-term safety data, the potential for abuse, and the need for comprehensive patient safeguards.
When asked if the available data demonstrated MDMA’s efficacy in treating PTSD, the committee voted 9-2 against it, citing various confounding factors and limitations. Additionally, the committee voted 10-1 that the benefits of MDMA-assisted psychotherapy did not outweigh its risks, despite acknowledging the therapy’s potential and the urgent need for new treatments. Most panel members felt that more research was necessary to address the outstanding questions and concerns regarding safety, efficacy, and the therapeutic approach.
Dr. Walter Dunn, a UCLA researcher who voted yes on risk-benefit, remarked, “I think the greatest strength of the treatment is also its greatest liability. And that’s therapist in the room, the psychotherapy. And unfortunately, that sounds like it’s out of the direct purview of the agency.”
The FDA will consider the advisory committee’s recommendations in its decision-making process regarding the approval of MDMA-assisted psychotherapy for PTSD. Although the agency is not obligated to follow the committee’s votes, the overwhelming lack of support suggests that more data may be required before MDMA can be approved as a legal treatment option for PTSD patients.
Public Statements and Concerns
During the public statements, the panel heard from a diverse array of stakeholders, including veterans, mental health professionals, researchers, and individuals with personal experiences related to PTSD and MDMA therapy.
Supporters, like Brian Dempsey from the Wounded Warrior Project, highlighted the potential benefits of MDMA-assisted psychotherapy for veterans with PTSD, emphasizing the high prevalence of the condition and the need for innovative treatments. Deran Young from Black Therapist Rock also spoke in favor of MDMA-assisted therapy, particularly for addressing racial trauma.
However, serious concerns about Lykos’ leadership and clinical model were also presented. Meghan Poisson, a phase 2 clinical trial participant, shared her traumatic experience during the trial. Through a proxy, Sarah Grosch, Poisson alleged that she endured physical and sexual assaults during MDMA-assisted therapy sessions, despite not consenting to such treatments. Poisson also claimed she became suicidal during the trial, but Lykos failed to document this adverse event.
Independent investigative journalist Sasha Sisko raised concerns about alleged misconduct by Lykos and its founder, Richard Doblin. Sisko highlighted incidents such as the assault of Poisson, proposals to enroll Ukrainian refugees in MDMA-assisted group therapy trials, and the promotion of off-label use of MDMA-assisted couples therapy.
Journalist Russell Hausfeld, who has been following Lykos Therapeutics for years, pointed out the company’s mishandling of clinical trial data and mistreatment of participants. A veteran quoted by Hausfeld said, “I watched as Lykos and its researchers used veterans up and discarded them as soon as they no longer served a useful purpose, regardless of mental health consequences or social implications.”
Therapist Training and Patient Support
Bo Wittka, who experienced severe symptoms following a guided MDMA therapy session, stressed the importance of proper therapist training and patient support. He shared his experience, stating, “The frightening state I am in, and if I learned to cope with to the best of my ability, began immediately following a single guided MDMA assisted therapy session on Feb. 19, 2023.” Wittka emphasized the lack of support and safety net for patients like him.
Former members of the psychedelic research community, including Rev. Joe Welker, alleged that Lykos leadership used the MDMA trials to advance a religious and spiritual agenda, with instances of abuse and misconduct against trial participants. Welker stated, “While Lykos leadership may envision a spiritualized humanity, in this very study, Lykos treated the people who were harmed under their care with a falsely spiritual inhumanity.”
If ultimately approved, MDMA would become the first illegal psychedelic substance to gain mainstream medical acceptance. However, the road to approval remains fraught with challenges and controversies. As the FDA continues to evaluate the data and recommendations, the future of MDMA as a treatment for PTSD hangs in the balance, with many advocating for further research and stringent safety measures to ensure its efficacy and safety for patients in need.
Is MDMA currently approved for the treatment of PTSD? MDMA is not currently approved for the treatment of PTSD. The FDA is still reviewing the data and recommendations from the advisory committee.
What were the main concerns of the advisory committee regarding MDMA for PTSD treatment? The advisory committee’s main concerns included data reliability, potential safety risks such as heart problems and abuse, functional unblinding, expectation bias, and the limited diversity of study participants.
Why did the committee vote against approving MDMA for PTSD treatment? The committee voted against approval due to concerns about the sufficiency of the evidence demonstrating efficacy, various confounding factors, and the limitations in the data presented.
What are the potential benefits of MDMA-assisted psychotherapy for PTSD? Potential benefits of MDMA-assisted psychotherapy for PTSD include significantly lower PTSD scores and improved mental health outcomes for patients undergoing intensive talk therapy in conjunction with MDMA.
What are the risks associated with MDMA therapy? Risks associated with MDMA therapy include potential heart problems, the risk of abuse, and other safety concerns highlighted by the advisory committee and public commenters.
What steps need to be taken before MDMA can be approved for PTSD treatment? Further research is needed to address the outstanding questions and concerns regarding safety, efficacy, and the therapeutic approach. The FDA will consider the advisory committee’s recommendations and may require additional data before making a final decision.
The proposal to approve MDMA for the treatment of PTSD marks a significant and controversial moment in the field of psychopharmacology. While the advisory committee’s vote against approval underscores the need for more research and robust patient safeguards, the promising nature of MDMA-assisted psychotherapy offers hope for innovative treatments for PTSD. As the FDA deliberates, the future of MDMA therapy will depend on addressing safety concerns, ensuring rigorous scientific standards, and prioritizing patient well-being.