In a groundbreaking move that’s incited critical backlash, consideration is underway for the use of the psychedelic drug MDMA as a therapeutic treatment for post-traumatic stress disorder. This proposal, the first of its kind, suffered a crushing hit on Tuesday with the striking rejection by an advisory panel to the Food and Drug Administration (FDA), thwarting the advocates of psychedelic therapy who anticipate eventual federal approval and thus allowing for previously outlawed substances to secure a spot in conventional medicine.
The advisory group to the FDA, with a nearly unanimous vote of 10-1, negated the perceived general advantages of MDMA in treating PTSD. The panel referred to poor quality study data, dubious research methods, and significant dangers associated with the substance, involving possible heart complications, injury, and potential misuse.
“This data has layers of issues that when accumulated draws my confidence in the treatment’s effectiveness into question,” expressed Dr. Melissa Decker Barone, a psychologist associated with the Department of Veterans Affairs.
Though the FDA isn’t bound by the advice of the advisory panel, the adverse commentary stands to fortify its stance should it choose to dismiss the treatment. The final decision, expected by August, still hangs in the balance.
MDMA, also known as ecstasy or molly, is the pioneer psychedelic under investigation with the FDA, trailed by LSD and psilocybin. In the psychedelic revival, these chemicals are anticipated for review in the forthcoming years. Advocates argue they could revolutionize mental health treatment approaches.
Nonetheless, the FDA advisors took Tuesday’s meeting to cast a fair amount of criticism on the submitted MDMA research. Their concerns included skewed study results, lack of patient follow-up data, and the participant diversity misrepresentation. The majority demographic of the participants was white, with only five Black patients receiving MDMA, thereby casting doubts on the applicability of the results.
Elizabeth Joniak-Grant, representing the group’s patients, voiced, “The fact that this study’s participants are predominantly white is problematic. We certainly don’t want something that benefits only one specific group.”
Additionally, the advisors drew focus to recently publicized allegations of research misconduct. This includes a reported incident in 2018 involving sexual misconduct by a therapist and her husband during patient treatment.
The research was undertaken by Lykos Therapeutics, a company with close ties to the Multidisciplinary Association for Psychedelic Studies (MAPS), a leading advocacy group for psychedelics and primary financial backer of these studies.
In response to the meeting’s outcome, Lykos pledged to work with regulators to address the panel’s concerns, stating their commitment to cooperate with the FDA throughout their ongoing assessment. They also expressed disappointment at the advisory panel’s mostly negative judgment, viewing it as a possible hindrance to financial investments in the emerging psychedelic industry.
Unlike other hallucinogenics, MDMA doesn’t induce vision distortion but instead incites feelings of intimacy, connection, and euphoria. Its integration with talk therapy seems to assist patients in addressing their trauma and freeing themselves from daunting thoughts and memories.
Yet, its effectiveness was questioned by panelists due to the challenges in objectively testing psychedelic substances and complications like patients with a history of recreational psychedelic use. The chair of the panel, Dr. Rajesh Narendran, an eminent psychiatrist, voiced, “I’m not convinced at all that this drug is effective based on the data I saw.”
The advisory panel also heard from nearly three dozen public speakers, ranging from veterans who claimed PTSD relief from MDMA therapy to medical professionals, journalists, and researchers who advised against its usage or highlighted misconduct in its trials.
Despite the concerning disclosures, some experts in the meeting urged Lykos and the FDA to persist in studying psychedelics for PTSD, citing the potential benefit for patients. Dr. Paul Holtzheimer from the VA’s National Center for PTSD chimed in by saying, “I think this is a really exciting treatment and I’m encouraged by the results to date but from a safety and efficacy standpoint, I feel it’s still premature.” The future of MDMA’s role in mental health treatment remains uncertain and doubtlessly a conversation to be continued.
