Recently, a panel of US health experts gathered by the Food and Drug Administration voted against the use of MDMA, commonly known as ecstasy, to treat post-traumatic stress disorder (PTSD). Despite the fact that PTSD affects an estimated five percent of Americans in any given year, the panel experts were not convinced by the data presented to them regarding the effectiveness of MDMA in treating this debilitating mental health condition.
California-based Lykos Therapeutics based its request for regulatory approval of MDMA on two clinical studies published in the prestigious journal Nature Medicine. These studies included around 100 participants each and evaluated the use of MDMA in conjunction with other psychological interventions like talk therapy compared to a placebo with talk therapy. The results of these studies indicated that MDMA was both safe and highly effective at treating PTSD.
Despite the positive results presented by the studies, nine out of 11 experts on the panel voiced their concerns regarding the lack of sufficient data to prove the efficacy of the treatment. Additionally, 10 out of 11 experts felt that the benefits of MDMA treatment did not outweigh the potential risks. The panel also noted that the available data did not provide a clear picture of the long-term effects and safety of using MDMA to treat PTSD.
FDA staff raised additional concerns regarding the studies conducted by Lykos Therapeutics. They criticized the company for not gathering enough data on side effects such as impacts on heart and liver health. FDA staff also questioned the methodology used in the studies, pointing out instances of “functional unblinding” where participants and healthcare workers were able to accurately guess who received the treatment and who received the placebo.
Troubling allegations of research impropriety surfaced in a draft report by the nonprofit Institute for Clinical and Economic Review. Claims were made that the trials selectively included participants from the community interested in psychedelics, potentially skewing the results. Some participants also alleged that they were prevented from entering the long-term follow-up study, raising concerns about data manipulation.
Despite the panel’s vote against the use of MDMA to treat PTSD, Lykos Therapeutics awaits a final decision from the FDA on authorization by mid-August. If the treatment is authorized, there may be stringent stipulations attached, such as only dispensing the drug in healthcare settings, closely monitoring subjects, and documenting side effects in a registry.
The controversy surrounding the use of MDMA to treat PTSD highlights the complexities of drug approval and the importance of thorough research and data collection in evaluating new treatments for mental health conditions. While the potential benefits of MDMA treatment are promising, further research and scrutiny are necessary to ensure the safety and efficacy of this approach.
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