FDA Stalls Momentum on MDMA-Assisted Therapy for PTSD, Advocates Remain Hopeful

By Brendan Scanland

It’s estimated that roughly two dozen veterans die by suicide each day as a result of mental health challenges, like post-traumatic stress disorder (PTSD). 

Psychedelic assisted therapy, including MDMA assisted therapy (MDMA-AT) has shown promise in clinical trials for those living with PTSD. 

Despite a recent setback, advocates and lawmakers are pressing forward.  

Last week, the Food and Drug Administration declined to approve the application for MDMA-AT to be used as a potential treatment for post-traumatic stress disorder. As many as 10% of all male veterans, and 19% of all female veterans, suffer from PTSD.  

“It can take many different forms, but either way, it is life destroying, it is family destroying. It can affect people for generations,” said Jesse Gould, a former Army Ranger and founder of the non-profit Heroic Hearts Project

After experiencing psychedelic assisted therapy, Gould set out on a mission to help fellow veterans. 

“It helped it phenomenally for my own, and I wanted to bring this education and connect veterans,” said Gould. 

Gould says MDMA-AT is unlike traditional medications that tend to mask symptoms. 

 “These can actually help resolve some of these traumas. And we really have seen people get their life back,” he said. 

“If what you’re doing, which is a pill society, doesn’t work, stop doing it and get some new breakthrough therapies,” said Rep. Jack Bergman (R- MI), the highest-ranking combat veteran elected to Congress. 

Bergman says he feels a duty to work with colleagues on both sides of the aisle to save lives. 

“It kind of puts the mantle on my shoulders,” said Bergman. “This is not Democrat or Republican. This is about better mental health outcomes, especially for veterans,” said Bergman. “If we get it right for our veterans with breakthrough therapies, that’s going to translate to the population in general.” 

With the support of dozens of Democrats and Republicans in the House and Senate, Bergman is leading the charge on Capitol Hill, pressuring the FDA to take action, and quickly. 

“There’s a difference between a month from now and two years from now, because you can count the number of suicides that will occur within that time,” said Bergman. 

Last week, the FDA declined to approve MDMA as a therapy to treat PTSD and requested third stage trials be repeated. 

“Which could take years and cost millions of dollars. In the meantime, more veterans are suffering,” said Gould. 

Gould says with an estimated 150,000 veteran suicides since 9/11, “it’s just shocking that this isn’t more front and center of political discourse.”  

Despite the setback, advocates, veterans and lawmakers are not giving up on the mission. 

“But veterans will get knocked down. We’ll pick ourselves right back up and keep advocating,” said Gould. 

“While the US falls behind again, other countries are moving forward with government-supported research and programs like those in Israel, the Netherlands, Australia, and Canada to address life-threatening mental health conditions. In the US, science hasn’t yet won out over decades of drug war propaganda and stigma, but we are heartened by the growing support for psychedelic-assisted therapies among voters and elected officials,” said Betty Aldworth, Director of Communications & Post-Prohibition Strategy at the Multidisciplinary Association for Psychedelic Studies (MAPS). 

Gould encourages more people to get involved- both veterans and civilians. 

“Because this is not just for veterans. There’s a mental health crisis across the U.S. and these treatments will change how we approach mental health,” said Gould. “This is a pivotal moment, even though it was a denial by the FDA, the fight is certainly not over. We need people’s support. We need more voices to come together,” said Gould.