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By August 11, the Food and Drug Administration is expected to decide whether MDMA — the chemical found in ecstasy or molly — can be prescribed as a treatment for post-traumatic stress disorder. And supporters have launched an all-out push to convince the agency to greenlight the therapy, despite the fact that advisors to the agency overwhelmingly rejected the evidence supporting MDMA in combination with psychotherapy in June. The push includes bipartisan support from Congress. As of Friday, more than 60 House Democrats and Republicans had signed onto their own letter addressed to President Biden, voicing support for the treatment and pushing back on some of the recent criticism. Military veteran groups helped rally this Congressional support. Veterans have emerged as some of the most visible advocates, arguing it fills a much-needed gap in effective treatments for PTSD. C in the coming days to meet with lawmakers and lobby with other veterans. Recently, some prominent figures in mental health and psychedelics, plus a few billionaires on social media, have joined the fight, too. The drugmaker, Lykos Therapeutics, is also putting resources into the effort to build public support. The downvote in June — not to mention controversy about the trials that spilled into full view during a public hearing — has put the FDA in a tough spot. Or greenlight the long-awaited decision on psychedelics? Research shows FDA sides with its advisory committee in most circumstances. There are times when the agency has moved ahead in spite of its advisors, particularly when patients have mounted an aggressive advocacy campaign. The agency has a range of options: Lykos could be required to submit additional data, or even run a new clinical trial, which could push back the timeline considerably. Alternatively, approval could come with the requirements to do post-market research, plus tight restrictions on how the drug is administered. We've put decades of time and resources into doing this research. Still, most in the field believe that approval for MDMA is not so much a matter of if , but when. The treatment was granted breakthrough status , and FDA staff signed off on the trial design, although it became clear during the advisory meeting that certain recommendations were not followed. George Greer , who signed a letter with de Wit and a handful of other researchers, was surprised by the unfavorable reception in June. Still, he remains confident the drug will have its day. The argument many U. Earlier this year, a top doctor at the Department of Veterans Affairs signaled his support for the treatment, which his agency plans to study for mental health along with other psychedelic compounds. There were also concerns about missing data related to safety and a lack of evidence supporting the therapy protocol, to name a few. Jeffrey Lieberman , a professor of psychiatry at Columbia University Medical Center who has written critically about the hype surrounding psychedelics. There is a well-documented instance of therapists having inappropriate physical contact with a patient, Meaghan Buisson, while she was under the influence of MDMA during the phase 2 trials. These issues and others were raised in a report from an institute that evaluates clinical research and in a petition to the FDA, calling for a public hearing because of allegations that bias influenced the results and some patients experienced adverse events that were not reported. During the June advisory meeting, FDA staff alluded to an ongoing investigation, but a spokesperson told NPR the agency cannot comment on the details. Since the hearing, online disputes have played out between the factions in favor of and against approval, with both questioning their underlying motives. The form of therapy used in MDMA sessions, which was developed by MAPS, has faced criticism that it can lead to abuses of power when patients are under the influence and vulnerable to suggestion. McGuire, the Baylor College bioethicist, notes people are already seeking out the drug in the context of underground psychedelic retreats. Her research has tallied nearly of them, many of which are advertising in the U. Search Query Show Search. Support KPBS. Watch Live. Public Matters. Show Search Search Query. Give Now. Play Live Radio. Next Up:. Available On Air Stations. Full Schedule. All Streams. By Will Stone. Facebook WhatsApp Email. Healing Breakthrough. Become a KPBS sponsor. Rogers Masson. Travis Dove for The Washington Post. Will Stone. More News. From school funding to climate warnings, what Project could mean for San Diego. Monday is the final day for San Diegans to register to vote to receive a mail-in ballot. Calmer weather helps contain Oakland, California, fire that forced evacuations.

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