A recent panel of US health experts convened by the Food and Drug Administration has voted overwhelmingly against the use of MDMA, also known as ecstasy, to treat post-traumatic stress disorder (PTSD). This decision comes despite the fact that PTSD is a debilitating mental health condition that affects an estimated five percent of Americans each year, with limited pharmaceutical treatment options available. The experts based their decision on the fact that pharmaceutical treatment options are limited to two antidepressants which require three months of dosing to take effect, and even then, response rates to these medications have shown to be inconsistent.
California-based Lykos Therapeutics has sought regulatory approval for the use of MDMA in treating PTSD based on two clinical studies. These studies, each enrolling around 100 participants, evaluated the effectiveness of MDMA when used in conjunction with other psychological interventions such as talk therapy, as compared to a placebo with talk therapy. While these studies, published in the prestigious journal Nature Medicine, indicated that MDMA was both safe and highly effective in treating PTSD, the panel of experts still had concerns.
Despite the positive results from the clinical studies, nine out of 11 experts on the panel believed that the available data was insufficient to demonstrate the effectiveness of the treatment. Additionally, 10 out of 11 experts felt that the potential benefits of using MDMA did not outweigh the associated risks. The vote by the expert panel is non-binding, but the FDA generally follows their recommendations. Approving MDMA for medical use would represent a major shift as it is currently classified as a Schedule 1 drug under the Controlled Substances Act.
Prior to the meeting, FDA staff raised concerns about the integrity of the clinical studies conducted by Lykos Therapeutics. They pointed out that there was “functional unblinding” in the studies, which means that participants and healthcare workers were able to accurately guess who had received the treatment and who had received the placebo. This could introduce bias and uncertainty into the outcomes of the studies. FDA staff also criticized the lack of sufficient data on potential side effects of MDMA, such as impacts on heart and liver health.
Allegations of Research Impropriety
Troubling allegations of research impropriety surfaced in a draft report by the nonprofit Institute for Clinical and Economic Review. These allegations included claims that the trials selectively recruited participants from the psychedelic community, potentially skewing the results. Some patients also reported being prevented from entering the long-term follow-up study, leading to concerns about data manipulation. The FDA has stated that they are taking these allegations seriously and are investigating the matter.
Final Decision and Potential Stipulations
Lykos Therapeutics is awaiting a final decision from the FDA, which is expected by mid-August. If the FDA were to authorize the use of MDMA for PTSD treatment despite the expert panel’s objections, there could be strict stipulations attached. For example, the drug may only be dispensed in healthcare settings, with participants carefully monitored and enrolled in a registry to document any side effects that may arise.
While MDMA shows promise in the treatment of PTSD, there are still significant concerns and challenges that need to be addressed before it can be considered a viable treatment option. The controversy surrounding its use underscores the importance of thorough research and strict regulatory oversight in the field of mental health treatment.
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