The VA has been warming up to psychedelic research and the potential roll-out of psychedelic therapies, if approved by the FDA, for the past few years.
Given that it relies on Congress to authorise and fund its activities, political buy-in has been essential. This hasn’t always been easy, Elnahal admitted.
“Everything on our agenda relies on congressional support,” he told the audience, adding that he has been surprised by the strong bipartisan support for research in this area.
A big part of this changing mood and support across the aisle is the testimony of veterans. Veteran stories are “an unstoppable narrative”, Elnahal said.
A prime example is Jonathan Lubecky, a veteran whose PTSD was not responding to treatment as much as he and his VA clinicians had hoped. One day, an ‘intern’—a medical resident—slipped Lubecky a piece of paper and told him to read it only after he left the VA facility. The note encouraged him to look into one of MAPS’ MDMA for PTSD trials.
Since then, Lubecky has become one of the most prominent veteran voices in favour of MDMA therapy for PTSD, sharing his own story of healing with fellow veterans, the media and policymakers alike.
In a sign of this increasingly open attitude to psychedelic therapy, the VA has hosted or engaged with various events over the past year.
In February, Deputy Executive Director of Veterans Health Administration’s Office of Mental Health and Suicide Prevention, Ilse Wiechers, told an FDA-adjacent workshop audience that the VA health system was envisaging rolling-out psychedelic therapies, if approved, in a step-wise fashion, like they did with esketamine (Spravato).
Prior to that, in November 2023, the Veterans’ Affairs Subcommittee on Health convened a hearing on psychedelics, marking the first time the House has substantially discussed psychedelic therapies (see Veterans’ Affairs Subcommittee on Health Discusses Psychedelics). There, speakers encouraged the VA to begin preparing for a potential roll-out of MDMA-AT as soon as possible.
This increased appetite to engage with psychedelics was punctuated In January, when the agency committed to funding psychedelic clinical trials for the first time. Elnahal reminded the audience of this during his talk, which was met with cheers and applause from the crowd.
“We have about 13 studies happening right now, and we want to expand that further,” he said.
These studies won’t simply seek to confirm the efficacy seen in Lykos Therapeutics’ trials, Elnahal explained. Rather, they’ll aim to tackle some of the more practical considerations that might contour the large-scale roll-out of MDMA and, later, psilocybin therapies.
Those questions include:
- Do patients need to spend eight hours in each of the three MDMA sessions? (“Can you do it in four hours?”)
- Is the 2:1 clinician:patient ratio necessary? (“Veterans love being around other veterans”, Elnahal said, adding that this may be ‘inherently therapeutic’—so group MDMA therapy is especially worth exploring in this population.)
- Could a short course of MDMA therapy prove safe and efficacious?
Given that MDMA therapy is resource-intensive, when compared to the standard of care, the answers to these questions could have significant implications for accessibility. Elnahal hopes that those answers could improve the scalability and success of psychedelic therapies, if approved, outside of the VA, too.
The agency hopes to start dispersing that money in August, which is when FDA is expected to make a decision on Lykos Therapeutics’ New Drug Application.