The FDA is expected to decide within a week whether to allow doctors to prescribe the drug ecstasy, or MDMA, to treat post-traumatic stress disorder. An advisory panel already has recommended against approval, citing problems with the study. Now, days before the agency's potentially groundbreaking decision is released, the Wall Street Journal reports further potential trouble—the newspaper talks to three study participants who say their suicidal thoughts during the course of the study were not reflected in the final results. One woman, Montreal's Sarah McNamee, spoke on the record and told the Journal the drug made her feel "cracked open" and dredged up memories of prior traumatic events.
But the study didn't ask about those events—it focused only on one particular event related to her diagnosis, and her symptoms on that one improved. The two other subjects said they didn't report their own suicidal feelings because they felt pressured by therapists conducting the study to report positive outcomes. McNamee spoke of that, too. The pressure "made me feel like I belonged to something bigger than me, and it also made me feel like I had a serious responsibility to make sure that other people could get access."
Lykos Therapeutics, the company sponsoring the studies, said that it did not recruit therapists known to have a bias in favor of MDMA and that the study was designed to capture participants' suicidal feelings, adding that an independent panel monitored their safety. Meanwhile, CNN reports that 80 members of Congress from both parties have signed letters to the FDA and to President Biden urging approval. "Our country has a severe veteran suicide and PTSD crisis where 6,000 veterans die by suicide each year," the letter reads. (More PTSD stories.)
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