A recent panel of US health experts, convened by the Food and Drug Administration, has voted against the use of MDMA, commonly known as ecstasy, to treat post-traumatic stress disorder (PTSD). The decision comes after California-based Lykos Therapeutics submitted two clinical studies, published in Nature Medicine, showing the effectiveness of MDMA in treating PTSD when combined with talk therapy.
Despite the promising results from the clinical studies, the panel of experts expressed skepticism about the treatment. The majority of experts on the panel believed that the available data was insufficient to prove the efficacy of MDMA for treating PTSD. Additionally, concerns were raised about the safety of the treatment, with 10 out of 11 experts voting that the benefits did not outweigh the risks.
One of the main concerns raised by the FDA staff was the potential bias introduced by the “functional unblinding” in the studies. This bias could affect the accuracy of the study outcomes and calls into question the reliability of the results. Furthermore, there were criticisms regarding the lack of sufficient data on side effects, such as the impact of MDMA on heart and liver health.
Troubling allegations of research impropriety surfaced in a draft report by the nonprofit Institute for Clinical and Economic Review. The report claimed that the trials may have drawn participants from a biased pool, potentially skewing the results. Some patients also alleged that they were prevented from entering the long-term follow-up study, raising concerns about the integrity of the data set.
Lykos Therapeutics is awaiting a final decision from the FDA on the authorization of MDMA for PTSD treatment, expected by mid-August. If the FDA were to approve the treatment despite the panel’s objections, there may be strict stipulations attached, such as limited dispensing in healthcare settings and close monitoring of subjects for side effects.
The debate over the use of MDMA for treating PTSD continues to spark controversy and skepticism among health experts. While the clinical studies presented by Lykos Therapeutics show promising results, concerns about bias, safety, and research integrity cast doubt on the efficacy of MDMA as a treatment for PTSD. The final decision by the FDA will be critical in determining the future of MDMA as a potential therapy for individuals suffering from this debilitating mental health condition.
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