Bipartisan Congressional Lawmakers Push FDA To Approve MDMA Therapy For PTSD

Bipartisan congressional lawmakers staged an event at the U.S. Capitol on Wednesday, calling for the approval of MDMA as a therapeutic option for those suffering from post-traumatic stress disorder (PTSD) and joining activists who launched an art installation memorializing military veterans who die by suicide.

About a month after a Food and Drug Administration (FDA) advisory panel rejected an application to authorize MDMA-assisted therapy, four members of Congress along with veterans advocates organized the event to raise awareness about the need for alternative treatment options, including psychedelics.

Reps. Lou Correa (D-CA), Jack Bergman (R-MI), Morgan Luttrell (R-TX) and Jimmy Panetta (D-CA) took part in the ceremony, where 150,000 military dog tags were displayed to symbolize the number of veterans who’ve been lost to suicide since 9/11. Each of the veteran participants individually hung 17 dog tags to mark the 17+ veterans who die by suicide per day on average.

The art installation was meant to draw attention to the PTSD and suicide crisis among veterans, but the lawmakers and advocates also stressed that this epidemic underscores the need for lawmakers and the administration to act boldly when it comes to exploring the therapeutic potential of psychedelics.

“What we’re asking for the FDA to recognize is the science,” said Luttrell, who last month criticized the FDA Psychopharmacologic Drugs Advisory Committee for recommending against against MDMA-assisted therapy in an op-ed for Marijuana Moment. The agency itself is expected to make a decision on approving the application next month.

“The word ‘psychedelics’ scares everyone. I get it. It terrified me when I first got into the research on this,” he continued. “The treatments we have in place, some are exceptional, but the human body is very different for every single person. The brain is different, cognitive instabilities are different for every single human being, and we need tools in our proverbial toolbox to effect change, to decrease symptomatic issues, to increase quality of life. And MDMA is so perfectly positioned to do that.”

Luttrell also discussed his own personal experience using psychedelic medicines to treat mental health conditions following his service-related trauma.

“I have gone through psychedelic treatments, and I did have to go overseas in order to do that,” he noted.

Today, 150,000 dog tags will be arranged on the U.S. Capitol grounds representing veterans who have died by suicide since 9/11 to serve as a reminder to @US_FDA why approving MDMA-AT for PTSD is so urgent.

Thankful for my colleagues @RepJackBergman , @RepLouCorrea, and… pic.twitter.com/XcTBu0JAhN

— Congressman Morgan Luttrell (@RepLuttrell) July 10, 2024

Bergman, a veteran of the Vietnam War, also said the issue is close to his heart.

“Our nation is facing an ongoing PTSD, mental health and suicide epidemic,” he said, “one that especially impacts those who served in uniform. Fortunately, there are new, groundbreaking treatments, as you’ve heard, that have offered hope to those afflicted by the invisible wounds of war.”

“Psychedelic-assisted therapies have the potential to be the first genuine advancement in the treatment of veterans’ mental health in decades—in decades,” Bergman went on. “I have had the opportunity to personally meet with many of the researchers studying these treatments, and the veterans whose lives have been forever changed for the better by receiving them.”

Correa, who co-founded of the Congressional Psychedelic Advancing Therapy Caucus alongside Bergman, said the group had a simple message: “FDA, do your job.”

“We have a proven cure for PTSD,” he said. “What’s the problem? What is going on here? We owe it to our veterans to give them the medicines that they need, and the FDA is essentially stalling.”

He asked for a show of hands for how many veterans in the audience had to travel to another country to obtain psychedelic-assisted treatment.

“These veterans had to leave the United States to get therapy because it was not available, and it was essentially illegal to do so in the United States,” Correa said. “Something’s wrong here, ladies and gentlemen.”

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Fellow Californian Panetta said that for all the work the country has done so far to address PTSD and suicide among veterans, “we all acknowledge that we have a major health problem in our society when it comes to suicides. And sadly, a quarter of all suicides that are in the United States are from veterans. So we’re here today not just to highlight this disturbing dilemma. We are here today to say that something has to change.”

Juliana Mercer, a Marine Corps veteran and the director of veteran advocacy and public policy for the nonprofit Healing Breakthrough, was a speaker and the emcee at the event.

“I’ve lost more veteran brothers and sisters than I care to count to PTSD and suicide,” she said. “I’m here today because I have committed my life to bringing the veteran PTSD and suicide epidemic to an end.”

“The lack of innovation in PTSD treatment over the past 20 years has contributed to rising veteran suicide rates, with estimates ranging between 17 and 44 veterans taking their own lives each day,” continued Mercer. “Let that sink in for a minute. Since 9/11, we’ve lost 21 times more veterans at home to suicide than we’ve lost to combat. That’s not a statistic, it’s a national tragedy.”

Today, on the steps of the US Capitol alongside many other advocates, Juliana Mercer spoke about the importance of the FDA following the science and approving MDMA-AT for PTSD #veterans.@WeHeroicHearts pic.twitter.com/dD42Cmcu1B

— Healing Breakthrough (@HBveterans) July 10, 2024

Dakota Meyer, a fellow Marine Corps veteran and a recipient of the Medal of Honor, said that upon returning home from service, “I frequently experienced nightmares, anxiety attacks so intense that sometimes they made life feel unbearable,” causing pain not only to himself but those he cared about most. He said he spent years of his children’s lives avoiding letting them see him sleep “because of the fear of them seeing the other side of who I was.”

“The good news,” he continued, “is that the innovations in PTSD treatment continue to advance. MDMA-assisted therapy in particular has shown great promise in addressing the root cause of PTSD symptoms. It is rare in life to find something that has the potential to help everyone, and MDMA-assisted therapy is one of those things.”

“Treating the trauma of PTSD helps veterans reconnect with their loved ones and support systems,” Meyer said. “When you heal a veteran, you heal a family, and where there is healing, there is hope.”

While he was clear to say that MDMA-assisted therapy “is not a cure-all,” he insisted that for some people, it can help transform them “from the chaos in a Downtown New York City rush hour into the calmness of a quiet country road.”

Dr. Barbara Rothbaum, a PTSD expert, director of the Emory Healthcare Veterans Program and past president of the International Society of Traumatic Stress Studies, said that as a “mainstream PTSD researcher,” MDMA has long felt outside her realm, “but I have embraced it.”

I joined @WeHeroicHearts to underscore the necessity of psychedelic therapies to treat combat-related cognitive injuries.

I’m proud to be a voice effecting change in this space.

We have to continue to push forward to get our veterans & service members the help they deserve. pic.twitter.com/mKK7qRHPMZ

— Congressman Morgan Luttrell (@RepLuttrell) July 11, 2024

“I stand before you not only as someone who’s been developing and studying treatments for PTSD almost as long as PTSD has been an official diagnosis, but as a witness to a national crisis that demands our attention.”

The few available FDA-approved medications for PTSD are “weak coffee,” Rothbaum said. “Nobody thinks that those are the answer to PTSD.”

Prolonged exposure therapy appears more effective, she continued, but combining therapy with MDMA appears to be a promising innovation.

“Randomized clinical trials with MDMA-assisted therapy have shown impressive results,” she said, noting that “71 percent of participants no longer met PTSD criteria” and “86 percent experienced significant symptom reduction with almost no dropout from the studies, which is unheard of with PTSD.”

“Most of the research with medications occurs after FDA approval,” Rothbaum concluded. “We have to do better. Our veterans deserve the best care that we can provide. We need more effective treatment options for PTSD to save lives. We think MDMA-assisted therapy can help. We need your help to make it an option.”

Jesse Gould, served as an Army Ranger before founding the organization Heroic Hearts Project, which he heads. The group has helped more than 1,500 veterans obtain psychedelic-assisted therapy, Gould said, “but there are millions more out there yearning for just a glimmer of hope.”

MDMA-assisted therapy is twice as effective as other treatments available to veterans, he said. “This is why we stand shoulder-to-shoulder with all the veterans of this great nation demanding access to effective treatements. This is why we stand here today at the forefront of change, demanding an end to the status quo and advocating for FDA approval for MDMA-assisted therapy. Enough is enough.”

The @US_FDA has the opportunity to follow the science and support veterans by approving MDMA-assisted therapy for PTSD. This week, Medal of Honor recipient @Dakota_Meyer, bipartisan members of Congress, and veterans gathered to remind this country what is at stake in this… pic.twitter.com/HOXPCN2Lrd

— Heroic Hearts Project (@WeHeroicHearts) July 12, 2024

Amid growing calls among veterans advocacy groups and lawmakers, especially Republicans, to speed research and access to psychedelic-assisted therapy, House lawmakers last month approved amendments to a large-scale spending bill that would authorize U.S. Department of Veterans Affairs (VA) doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.

The psychedelics-focused provision would encourage VA to support research into the benefits of psychedelics in treating medical conditions commonly affecting military veterans.

“As we saw last year, demonstrating clear congressional approval for these innovative efforts can motivate real action within the federal bureaucracy,” Bergman said on the floor ahead of the vote. “We owe it to our veterans to do everything we can in support of these breakthrough therapies.”

Correa said at the time that “we’ve seen our nation’s veterans continue to needlessly suffer suicides, mental health, opioid overdoses—and it’s crucial that the VA do everything in its power to ensure that they have safe and scientifically sound and potentially life-saving therapies as soon as they are available and approved in the United States.”

The House also accepted separate amendment from the most of the same lawmakers that urges VA to report to Congress on possible incorporation of MDMA-assisted therapy into the department’s formulary following federal approval of the drug.

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