MDMA for PTSD not recommended by US Federal Drug Administration scientific advisory panel - FDA approval still possible, but unlikely

By: PerplexityAI and Tom Cloyd - 3 min. read (Published: 2024-06-04; reviewed: 2024-06-04:2335 Pacific Time (USA))

 

The recent decision by the FDA advisory panel to reject MDMA as a treatment for PTSD has generated significant discussion and controversy. The decision, which was nearly unanimous, has been a major setback for advocates of psychedelic therapy.

Page contents…

• FDA Advisory Panel Decision ^
• Key Concerns Raised ^
• Public and Expert Opinions ^
• Implications and Future Steps ^
• Conclusion ^
• Notes ^

 

NOTE: To produce a quick and reliable summary of this breaking news, I used Perplexity AI to summarize the sources listed in Notes, which I reviewed and lightly edited. ~T. Cloyd

 

FDA Advisory Panel Decision ^{^}

On June 4, 2024, a panel of federal health advisers overwhelmingly rejected a proposal to approve MDMA (commonly known as ecstasy or molly) as a treatment for PTSD. The panel, consisting of 11 experts, voted 10-1 against the approval, citing numerous concerns about the safety and efficacy of the treatment¹².

Key Concerns Raised ^{^}

1. Study Flaws and Bias:
   • The FDA’s review highlighted significant flaws in the studies conducted by Lykos Therapeutics, the company behind the MDMA trials. One major issue was the potential for bias, as both participants and therapists could distinguish between those receiving MDMA and those on a placebo³².
   • The studies were criticized for missing follow-up data, a lack of diversity among participants, and allegations of misconduct during the trials¹³.
2. Health Risks:
   • The FDA expressed concerns about the potential cardiovascular risks associated with MDMA, including significant increases in blood pressure and pulse rates, which could trigger cardiovascular events³².
   • Other risks mentioned included potential heart problems, injury, and abuse of the drug¹.
3. Effectiveness of Treatment:
   • Panelists questioned the overall effectiveness of MDMA in treating PTSD, noting the difficulty in determining how much of the patients’ improvement was due to the drug versus the extensive therapy, which totaled over 80 hours for many patients¹.
   • The FDA’s staff analysis also pointed out that no new therapy for PTSD had been approved in over two decades, emphasizing the need for effective treatments but also the importance of rigorous evaluation³².

Public and Expert Opinions ^{^}

• Support for MDMA Therapy:
  • Despite the panel’s decision, there was significant public support for MDMA therapy. Thirty-five public speakers, including veterans who reported benefits from MDMA therapy, addressed the panel¹.
  • David Olson, director of the U.C. Davis Institute for Psychedelics and Neurotherapeutics, emphasized the importance of this development for psychiatry, calling it a “paradigm shift” and highlighting the lack of effective treatments for PTSD³.
• Opposition and Caution:
  • Medical professionals advising against the use of MDMA cited the same concerns raised by the FDA, stressing the need for more reliable and unbiased research¹.
  • Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, expressed her reservations, stating that the combination of data issues and safety concerns made it difficult to support the treatment¹.

Implications and Future Steps ^{^}

• Regulatory Challenges:
  • The FDA is not obligated to follow the advisory panel’s recommendation but is expected to make its final decision by August. The negative opinion from the panel could bolster the FDA’s rationale for denying the treatment¹³.
  • Approval of MDMA therapy would represent a significant shift in the nation’s approach to psychedelic compounds, most of which remain illegal and classified by the DEA as having “no currently accepted medical use and a high potential for abuse”³².
• Impact on Psychedelic Research:
  • The decision is a setback for the burgeoning multibillion-dollar psychedelics industry, which has been advocating for the medical use of psychedelic compounds to treat mental illnesses².
  • The rejection underscores the challenges faced by researchers and advocates in bringing psychedelic therapies into the medical mainstream, highlighting the need for more rigorous and comprehensive studies¹³².

Conclusion ^{^}

The FDA advisory panel’s decision to reject MDMA as a treatment for PTSD has sparked a significant debate within the medical and scientific communities. While the potential benefits of MDMA therapy have garnered substantial support, the concerns over study flaws, health risks, and the overall effectiveness of the treatment have led to a cautious approach by regulators. The final decision by the FDA, expected in August, will be a critical moment for the future of psychedelic therapy and its role in treating mental health disorders.

Notes ^{^}

 

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