After MDMA therapy, she considered suicide. The trial data tell a different story Olivia Goldhill By Olivia Goldhill May 24, 2024

After MDMA therapy, she considered suicide. The trial data tell a different story Olivia Goldhill By Olivia Goldhill May 24, 2024 https://www.statnews.com/2024/05/24/mdma-treatment-ptsd-fda-asked-to-probe-adverse-events/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9xjaYJnG14CU2pVec0LpK8d5esUn2rRqkWgbqDH5yd93wZsJ15BuH8zCyhRW7DWFN9R1IXl2dLXcMZqaq6cw-tP3X-DQ&_hsmi=308523819&utm_content=308523819&utm_source=hs_email The psychedelic MDMA has the potential to treat post-traumatic stress disorder, and the FDA is currently reviewing results from two Phase 3 trials of the drug from the Multidisciplinary Association for Psychedelic Studies. But the promising data behind the treatment may overlook significant adverse effects: My colleague Olivia Goldhill reports the case of a Phase 2 trial participant who developed suicidal ideation and whose PTSD worsened during the study — events that don’t seem to be reported in the data. Now the Institute for Clinical and Economic Review, a non-profit that evaluates the cost-effectiveness of drugs, is asking the FDA to look into potential data omissions. Meanwhile, a citizen petition signed by prominent psychedelic researchers is asking the FDA to hold an extended public hearing to discuss concerns. “There’s a pattern when something goes wrong, it’s anything but the MDMA or psychedelics,” said Neşe Devenot, a former MAPS volunteer and co-author of the petition. Read more about the debate.