Federal Officials Say Psychedelic-Assisted Therapy Shows Promise For PTSD, But More Research Is Needed

Representatives of a number of federal agencies convened last week to discuss new treatments for PTSD, including therapies involving psychedelics, MDMA, ketamine and other drugs. While the officials acknowledged the substances’ potential to help treat PTSD and underlying symptoms, they also emphasized the need for further research to ensure efficacy and patient safety.

The discussion, hosted by the Reagan-Udall Foundation for the Food and Drug Administration, a nonprofit formed by Congress to support FDA, didn’t focus specifically on psychedelic-assisted therapies, but the topic nevertheless featured prominently—especially during a stakeholder comment session where most spoke in favor of wider access to MDMA and other emerging treatments.

Betty Aldworth, director of communications and post-prohibition strategy for the Multidisciplinary Association for Psychedelic Studies (MAPS)—which has helped lead the push to qualify MDMA as a federally approved treatment for PTSD—said the meeting “illustrated the growing public interest in psychedelic-assisted therapies, with nearly every speaker discussing their potential in a meeting that wasn’t specifically about psychedelics.”

“Eighty members of Congress, the Veterans Affairs Administration, trauma experts, patient advocates, and 14 of 23 stakeholder who gave oral testimony agree the existing evidence base for psychedelic-assisted therapies merit widespread, and growing, support,” Aldworth said in a statement after the event. “It’s time to close the 25-year gap on new pharmacotherapies for the treatment of PTSD by approving this most promising treatment for PTSD and bringing psychedelic-assisted therapies into the healthcare system.”

Speakers at the Reagan-Udall event on Friday included representatives from the Department of Defense, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and Department of Veterans Affairs (VA).

The talk comes on the heels of FDA last month declining to approve MDMA-assisted therapy for the treatment of PTSD. Separate research, published in the Journal of Psychedelic Studies, found that while results of clinical trials have been “encouraging,” more robust research is needed before MDMA-assisted therapy (MDMA-AT) sees widespread adoption over currently available forms of treatment

“We all feel some type of way about the decision that came out some time ago, and that’s OK,” said Leith J. States, chief medical officer at the Office of the Assistant Secretary for Health. “It’s indicative of a fact that we’re moving forward and we’re stressing the system, and we’re doing things in a way that marches us forward in an incremental way.”

“At the end of the day, we’re moving forward,” States continued, “and although we may want to see different speeds happen, I’ve been very encouraged in my role, at least.”

FDA several years ago granted MDMA status as a “breakthrough therapy,” a move that can help speed the approval process.

VA, meanwhile, recently began accepting funding requests to study MDMA- and psilocybin-assisted therapies for treatment of a variety of mental health conditions, including PTSD, said Miriam J. Smyth, acting director of the agency’s Clinical Science, Research and Development Service.

“We received the first wave of applications in response to our funding announcement early this summer.” Smyth said. “Decisions related to funding will be made this fall.”

Once those studies are initiated, she added, local medical centers will announce opportunities for veterans to enroll.

“In the meantime,” the official emphasized, “we remind our veterans for their safety that they should not use psychedelics as part of a self-treatment program.”

Neeraj “Jim” Gandotra, SAMHSA’s chief medical officer, said that “certainly we want to provide resources for evidence-based interventions that balance not only the therapeutic efficacy but also the risks that are associated.”

In the follow-up webinar hosted by MAPS after the Reagan-Udall FDA event, advocates emphasized that there’s already a body of research demonstrating MDMA’s efficacy in treating PTSD.

“In the MAPS Phase 3 data, about two-thirds of people lost the diagnosis of PTSD,” said Michael Mithoefer, formerly a senior medical director at MAPS Public Benefit Corporation, now known as Lykos Therapeutics. “If these treatments can get approved, it would be a huge leap forward.”

Regarding criticism that the MDMA for PTSD trials didn’t compare the efficacy of MDMA to that of conventional treatments, Mithoefer said: “The FDA process doesn’t require demonstrating superiority to existing treatments. It requires superiority to placebo and safety. Yes, it would be good to do studies to compare with other treatments, but drug approval normally does not wait for that.”

Aldworth, who directs communications and post-prohibition strategy at MAPS, argued that many people are currently using psychedelics themselves “in unregulated settings because they see them as their last chance to heal.”

“The delay in FDA approval of MDMA-assisted therapy has been heartbreaking, not just for MAPS, but for the thousands of people still suffering from PTSD who have reached out to us, desperate for effective treatment,” she said. “Despite support from 80 members of Congress, Veterans groups, and trauma experts, the FDA continues to delay.”

Separately last month, another VA official said the agency has seen “stunning and robust results” in a first-ever clinical trial into MDMA therapy.

“This first randomized clinical trial at VA seems to have produced stunning and robust results, which I cannot wait to share,” Rachel Yehuda, director of mental health at VA’s James J. Peters Veterans Affairs Medical Center, said in a LinkedIn post. “Some of our veteran research participants shared their moving stories of healing and transformation.”

“The VA continues to take leadership in the psychedelic arena, and it is coming from the top!” added Yehuda, who also serves as director of the Center for Psychedelic Psychotherapy and Trauma Research at Mount Sinai. “The VA will fund psychedelic research, and when the time is right, move to ensure safe clinical implementation.”

Asked about how to proceed after FDA’s decision not to approve the new drug application for MDMA-assisted therapy, Yehuda replied: “Double down on the research. Keep generating the data and the cases. The nature of challenge is, well, that it is challenging. But I am optimistic.”

Bipartisan lawmakers separately staged an event at the U.S. Capitol calling for the MDMA approval by FDA and also launched an art installation memorializing military veterans who died by suicide.

Meanwhile, the U.S. House of Representatives recently approved amendments to a large-scale spending bill that would authorize VA doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.

The Senate Appropriations Committee also last month passed report language for appropriations legislation conveying concerns about restrictions on marijuana and psychedelics research imposed by current prohibition.

FDA also recently withdrew a request for White House permission to conduct a study about the risks of using kratom and psychedelics amid a “rapid resurgence” of public interest in the substances. Advocates are celebrating the news after criticizing the initial request as another example of FDA “bias” against harm reduction options.

A national nonprofit drug policy reform group is separately mounting a challenge to the Drug Enforcement Administration’s (DEA) proposal to ban two psychedelic substances. Experts say the new federal restriction would be detrimental to ongoing research initiatives.

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Photo courtesy of Pretty Drugthings on Unsplash.