FDA Expands Probe of Ecstasy-Based Drug Studies

ole_timer shares a report from Ars Technica, written by Beth Mole There’s more bad news for the company behind an experimental MDMA therapy for post-traumatic stress disorder, which the Food and Drug Administration roundly rejected earlier this month. According to a report from The Wall Street Journal, the FDA is now expanding an investigation into clinical trials behind the experimental psychedelic therapy — even though the agency has already rejected it. Agency investigators reportedly interviewed four additional people last week, asking questions regarding whether the trials underreported side effects.

People involved in the trial have previously alleged, among other things, that ill effects, such as suicidal thoughts, went undocumented, and trial participants were discouraged from reporting them to bolster the chances of FDA approval. Overall, the MDMA trials faced crushing criticism amid the FDA’s review, with outside experts and agency advisers calling out allegations of sexual misconduct at one trial site, as well as flaws in overall trial designs, multiple sources of biases, and claims that the company behind the therapy, Lykos, fostered a cult-like belief in psychedelics.

According to the Journal, the recent interviews were being conducted by the FDA’s Office of Regulatory Affairs, which oversees inspections, and a subdivision of that office called Biomedical Research Monitoring Program, which works to ensure the quality and integrity of data submitted to FDA. Notably, when the agency rejected MDMA, it advised Lykos to conduct a new trial. While the FDA’s rejection and expanded investigation are bad enough for Lykos, the company announced this month that it’s laying off 75 percent of its staff and overhauling its leadership. The moves were in response to the FDA’s rejections, the company said. Additionally, a scientific journal retracted three of the company’s MDMA studies, citing “protocol violations amounting to unethical conduct” in its trials, echoing claims raised amid the FDA review.