FDA rejects promising new therapy for PTSD, veteran advocates sound off: ‘Big gut punch’

A Federal Drug Administration advisory panel has voted against authorizing MDMA-assisted therapy for PTSD.

MDMA, more commonly known as ecstasy, is a Schedule I narcotic that’s illegal, despite the benefits it’s been shown to pose for those struggling with certain mental ailments.

The decision comes months after a company called the MAPS Public Benefit Corporation filed an application with the FDA in December asking it to consider allowing drugs like MDMA to be used to treat post-traumatic stress disorder.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” MAPS CEO Amy Emerson said in a statement at the time, as reported by CNN.

Fast-forward to last week when the decision was made.

“[A]dvisers to the Food and Drug Administration pored over shortcomings and missteps in the research and overwhelmingly rejected the evidence supporting MDMA as an effective treatment for post-traumatic stress disorder,” according to NPR.

Supporters of the plan weren’t pleased.

“It really doesn’t feel like the data was given its proper due,” Ingmar Gorman, who was involved in the MDMA trials that were scrutinized by the panel, told NPR. “The hope was always, if we do the science and we do the science right, the data will speak for itself.”

“We are disappointed in today’s vote, given the urgent unmet need in PTSD, and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” Emerson added.

Blowback has also come from the GOP — namely Rep. Morgan Luttrell, a retired U.S. Navy Seal who himself has used MDMA to treat PTSD.

“I can personally attest to the benefits in treating PTS and other cognitive issues through the use of psychedelic substances,” he wrote in an op-ed this week for Marijuana Moment. “While these treatments still carry a stigma, I believe it stems from a lack of education and experience around the clinical use of psychedelics.”

“I understand that when many of my colleagues in the House of Representatives and researchers in this space hear ‘psychedelics,’ they think about how they were abused decades ago. However, this perception could not be further from the reality of the clinical applications we are discussing. Psychedelic substance trials take place in a medical setting and are administered by trained professionals in the medical field,” he added.

“These rigorous, controlled studies have shown that psychedelics, when administered in a therapeutic setting, can lead to profound and lasting improvements in mental health,” he continued.

Juliana Mercer, a 16-year Marine Corps veteran and leading advocate of MDMA-assisted therapy, said the decision was a “big gut punch.”

“When I heard the verdict, all I could think about was the hopes of those veterans being dashed … and not having a solution for them,” she told Fox News in a statement.

Indeed, approval of MDMA for therapy would have greatly benefitted veterans. The U.S. Department of Veterans Affairs notes that a study conducted last year found that 85 percent of participants achieved a “clinically meaningful benefit” from using MDMA for their PTSD.

Mercer reportedly attended an FDA panel hearing before the decision was made. At the hearing, she said there were “quite a few large veteran organizations that shared the great need for a solution to PTSD.”

“There were also individual veterans who had undergone the therapy and talked about this life-saving treatment they received,” she added.

One Marine who attended the hearing reportedly talked about the phone calls he’s received from other veterans asking, “How do I get this treatment?”

“I get those same calls,” Mercer said. “Veterans have heard that this works. They’ve seen the data and the science, and they’ve been desperately waiting for this approval.”

Vivek Saxena


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