A vote against using MDMA as part of therapy for PTSD has provoked a powerful backlash among researchers who study psychedelic drugs.
Some 13 million Americans struggle with post-traumatic stress disorder (PTSD). Existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. So, there was distinct disappointment when an advisory committee at the US Food and Drug Administration (FDA) voted earlier this month against a therapy that many had hoped could offer the first new treatment for PTSD in 25 years.
A number of experts who study psychedelics have since spoken out in support of MDMA-assisted therapy for PTSD and have sharply criticised the recommendations of the FDA's Psychopharmacological Drugs Advisory Committee. But they are still optimistic that the treatment might be approved when the FDA delivers its final decision in August.
While MDMA, also commonly known as ecstasy or molly, is listed as a Schedule 1 controlled substance in the US and so is illegal to use outside research, there has been a growing number of studies suggesting that when used with psychotherapy it could have potential for treating PTSD and some other mental health conditions.
Ahead of the meeting, FDA approval of MDMA-assisted therapy for PTSD seemed likely, says Sandeep Nayak, an assistant professor of psychiatry at Johns Hopkins University, who investigates psychedelics as treatments for substance use and mood disorders. About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase 3 clinical trials.
It's an outcome that is "almost double that of existing medications", says Gül Dölen, a neuroscientist at the University of California, Berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "What's more, [the treatment] led to durable improvements in these patients lasting at least six months."
About half of people who enroll in current gold standard PTSD treatments drop out, which is "absurd", says Loree Sutton, a psychiatrist and retired Brigadier General in the US Army. She says new treatments are essential. "We have to do better."
"Even if there are risks, we've got to figure this out, because we cannot not let this treatment be available," adds Rachel Yehuda, a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai who has conducted studies on the effects of MDMA-assisted therapy for PTSD. "Without it, we're just leaving too many people in suffering that they don't need to be in, and that is not right."
The FDA is currently considering an application from California-based drug company Lykos Therapeutics for using MDMA capsules taken in conjunction with therapy in the treatment of PTSD. In the recent FDA advisory meeting, committee members cited apparent flaws in study design and data collection.
The nine-hour hearing concluded with committee members voting 9-2 that the available data do not show "that the drug is effective" for PTSD, and voting 10-1 that the benefits of MDMA do not outweigh the risks.
The vote has highlighted some of the complexities that regulators face when evaluating psychedelic therapies.
Critics point out that just one member of the FDA advisory committee had expertise in psychedelics, and argue that the committee may have misunderstood aspects of the treatment.
"There are so many different issues and angles to this dumpster fire, which indeed I would say it is," says Franklin King, a psychiatrist at Mass General Hospital and Harvard Medical School, who is overseeing a study of psilocybin-assisted therapy for irritable bowel syndrome and another of MDMA-assisted therapy for fibromyalgia. "The biggest issue is that the advisory committee members really showed a kind of astounding lack of knowledge about the subject matter."
The panel spent some time, for example, debating whether it should be voting on efficacy and safety of "the drug" or the drug-assisted therapy model that the clinical trials investigated. Excluding the therapy from the efficacy evaluation "doesn't make sense, scientifically speaking", says Eduardo Schenberg, director of the Instituto Phaneros, a psychedelic research and therapy group in São Paolo, who has conducted research into MDMA-assisted psychotherapy for victims of sexual abuse with severe PTSD.
The BBC contacted the 11 committee members asking if they had any response to the criticisms raised by researchers quoted in this article. One member, Kim Witczak, a drug safety advocate and the........