FILE - In this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off Cape Neddick in Maine on Dec. 11, 2017. Federal health advisers are considering the first request to approve the mind-altering club drug MDMA as a treatment for PTSD. The advisers to the Food and Drug Administration are scheduled to vote on the drug's safety and effectiveness Tuesday, June 4, 2024, potentially setting the stage for federal approval later this year. (AP Photo/Robert F. Bukaty, File)
A groundbreaking proposal to introduce MDMA as a treatment for PTSD faced severe criticism Tuesday, potentially stalling the efforts of psychedelic advocates aiming for federal approval and mainstream medical acceptance of banned drugs.
A panel of experts advising the FDA voted 10-1 against endorsing the overall efficacy of MDMA in treating post-traumatic stress disorder (PTSD). They highlighted flaws in the study data, concerns about research integrity, and significant health risks associated with the drug, including heart issues, harm, and misuse.
Dr. Melissa Decker Barone, a psychologist at the Department of Veterans Affairs, expressed skepticism about the treatment's effectiveness, citing multiple issues with the research data. The FDA, though not bound by the panel's decision, is expected to finalize its stance by August, potentially influenced by the negative feedback.
MDMA, also known as ecstasy or molly, represents the forefront of a wave of psychedelics, including LSD and psilocybin, seeking FDA evaluation for medical purposes. Advocates believe these drugs could revolutionize mental health care, but Tuesday's meeting cast doubt on MDMA's potential.
The FDA panel scrutinized the research on MDMA, pointing out shortcomings such as biased studies, missing patient follow-up data, and a lack of diversity among participants. Concerns were raised about the limited representation of Black patients, with questions about the treatment's applicability beyond white populations.
Elizabeth Joniak-Grant, the patient representative on the panel, emphasized the importance of inclusivity in medical research and expressed concern about the study's predominantly white participants.
Allegations of misconduct during the trials further tarnished MDMA's prospects. Reports of sexual misconduct involving a therapist raised questions about the integrity of the research. The incident was reported to the FDA and Canadian regulators, given the therapist's involvement.
Lykos Therapeutics, the company overseeing the study, pledged to address the panel's concerns. However, the negative outcome could hamper financial investments in the emerging psychedelic industry, which has attracted funding from a limited number of affluent supporters.
Unlike traditional psychedelics, MDMA doesn't induce visual hallucinations but fosters feelings of intimacy and euphoria. Coupled with therapy, it purportedly helps patients process trauma and alleviate distressing thoughts. However, the panel doubted the reliability of the reported results, citing challenges in objectively assessing psychedelic effects.
Dr. Rajesh Narendran, the panel chair, expressed skepticism about MDMA's efficacy based on the available data, highlighting the need for rigorous research standards. Concerns were raised about distinguishing MDMA's therapeutic effects from the impact of extensive therapy sessions.
Despite the setbacks, experts urged continued exploration of psychedelics for PTSD treatment, underscoring their potential to address mental health challenges. Dr. Paul Holtzheimer of the VA's National Center for PTSD acknowledged the treatment's promise but cautioned against premature conclusions regarding safety and effectiveness.
