FDA advisory panel votes against psychedelic therapy to treat PTSD

A panel of experts tasked with advising the U.S. Food and Drug Administration voted against the use of MDMA with talk therapy to treat post-traumatic stress disorder on Tuesday, despite pleas from veterans and advocacy organizations.

The Psychopharmacologic Drugs Advisory Committee voted 9-2 against the effectiveness of MDMA in the treatment of PTSD. In a second vote, 10 out of 11 panelists said they believe the benefits of MDMA-assisted therapy do not outweigh its risks.

Panelists had concerns about what they called gaps in the data, possibilities for abuse or misconduct of the therapy and a lack of racial diversity among participants. A number of the panelists noted that they believe MDMA-assisted therapy is effective, but outstanding questions gave them pause in providing a full recommendation.

“There’s not enough data on diverse populations or people with severe PTSD,” said Melissa Barone, a psychologist with the VA Maryland Health Care System who voted down the recommendation. “There’s a lot of questions still that I would have about how effective the treatment is and how durable it is.”

Another panelist pointed out that roughly 40% of participants in the Lykos Therapeutics study had already used MDMA outside of the clinical trial. That statistic “stacks the deck” that participants in the trial won’t have adverse reactions, said panelist and sociologist Elizabeth Joniak-Grant.

“I struggle with the fact that 40% of the people in the MDMA-assisted therapy were previous users,” Joniak-Grant said. “We can kind of assume that, if you had a terrible experience or it didn’t do anything worthwhile for you, are you going to go through the effort of being in the clinical trial?”

The committee only advises the agency commissioner, but its vote against MDMA-assisted therapy potentially puts the drug’s approval in doubt. In just 25% of cases the FDA delivers a less restrictive ruling on considered drugs following recommendations from an advisory committee, according to a 2019 study of FDA decisions .

A second phase III trial by Lykos Therapeutics found more than 86% of participants who received the MDMA-assisted therapy for PTSD experienced “clinically meaningful” improvement 18 weeks after starting the trial. More than 71% of participants no longer met the diagnostic criteria for PTSD at the end study, compared to just over 46% of participants who had just therapy.

Speaking in support of MDMA-assisted therapy, retired Brig. Gen. Loree Sutton , who served as the Army’s highest ranking psychologist from 2007 to 2010, called it a pivotal milestone while stressing the urgency of providing “hope for many who are suffering from the ravages of PTSD.”

“Time is not our friend,” Sutton added.

According to the Department of Veterans Affairs, one in 10 male veterans and nearly two in 10 female veterans suffer from PTSD . Veterans of the wars in Iraq and Afghanistan suffer from near-epidemic levels of PTSD, with nearly 30% reporting PTSD symptoms at some point in their lives.

Official VA data says 17 veterans die each day by suicide, but other research suggests the number could be as high as 44.

“[The committee has] missed the forest for the trees,” Julianna Mercer , director of veteran advocacy for Healing Breakthrough, an MDMA therapy advocacy organization, said in a statement. “Six thousand veterans have died from suicide every single year since 9/11 ... despite billions of taxpayer dollars and myriad treatments that have proven ineffective in bringing the veteran suicide epidemic to an end.”

Representatives of numerous veterans organizations — such as the Wounded Warrior Project, Disabled American Veterans and Veterans of Foreign Wars — testified to the panel in support of the treatment.

“The VFW does support MDMA-psycho therapy and its approval, which will allow the expansion of VA research on psychedelics to address veteran mental health,” said Katherine Castle, the VFW’s assistant director of veterans health policy. “We are encouraged by the results that we have seen in our members and veteran counterparts who have experienced this treatment.”

The FDA will make its decision regarding MDMA-assisted therapy’s approval by August 11.