Last Friday, the Under Secretary for Health at the Department of Veterans Affairs (VA), Shereef Elnahal, spoke on stage at Horizons’ 16th conference in New York City alongside Healing Breakthrough’s Executive Director Jason Pyle.
“The reason I’m here,” Elnahal said, “is that the data and results, the stories that I have heard from veterans who have gone through these studies, these therapies, speak for themselves.”
He acknowledged that throughout the last forty years, many of those in the audience had been working against the grain to validate the potential of psychedelic therapies. “I was really touched to learn that some of you have been at this in the mid-1980s,” he said, “when I’m sure nobody like me would be on the stage!”
Elnahal is evidently excited about the potential of psychedelics. “The evidence-based therapies that we have,” he said, “while they help, pale in comparison if we are able to replicate the scale seen in the preliminary results we have seen in psychedelics, especially MDMA for PTSD, and increasingly psilocybin for treatment-resistant depression.”
VA Warms Up to Psychedelics
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.
“We’re Going to See Demand for This Go Through the Roof”
“We know that the moment the FDA approves MDMA”, Elnahal said, reminding the audience that he has no insight into that process, “we’re going to see demand for this go through the roof, especially among the veteran population.”
“If it does happen, we have to be prepared”, he continued, “especially for the overwhelming demand that I believe we will have from the veteran community.”
To meet this challenge, the VA has formed what it calls an ‘Integrated Project Team’, which it has done for other initiatives like its Long COVID care program. This multidisciplinary team is tasked with preparing “to administer this therapy as soon as the FDA approves MDMA.”
Given that VA’s studies are only expected to receive funding in the fall, it’s a tight timeline to translate any learnings into the system’s delivery of the new therapy.
What’s more, the scale of the system is enormous, with the VA being the largest integrated healthcare system in the country. Around seventy per cent of physicians graduating in the US will have had some experience in the VA, Elnahal noted, as well as a vast number of mental health clinicians, of which the system boasts more than anyone other in the country.
As was seen in the roll-out of other interventional psychiatry treatments, like esketamine and TMS, the system will likely focus its early efforts on its centres of excellence. This will mean the early delivery of MDMA-assisted therapy will likely skew toward urban sites, but over time the system will aim to overcome the rural-urban divide.
“Indian country is the highest serving demographic in the US military, by far,” Elnahal noted, adding that there is also a much higher representation of veterans that choose to live in rural areas versus the broader population.
The VA’s Closer to Me cancer program sees care teams travel to community-based outpatient clinics or other facilities to allow veterans to receive cancer care closer to home. “I imagine that something like this can also be analogous” to how MDMA roll-out might eventually look, Elnahal said.
But people shouldn’t underestimate the investment that systems and providers will have to make to deliver these therapies, Elnahal emphasised: “You gotta have the space, you gotta have the clinicians”.
Given the fact that any space or resources you assign to one treatment modality are liable to be taken away from another, Elnahal explained that “there may not be enough capacity in our brick and mortar healthcare system for this.” In response to this scenario, he predicts “a proliferation of very unique and specific providers, and I think there’s already investment in that concept across the country.”
“But what I refuse to do”, he continued, “is to completely outsource that work to any party.” “The VA has to be first”, he said.
Just the Beginning
“We’re proving the case that the federal government is no longer unwilling to engage with this”, Elnahal told the crowd. “It took some work to get there…but we’re there”.
The agency’s funding of MDMA and psilocybin studies is ‘just the beginning’, he told the audience. He hopes the VA will look to “expand into the long list of other types of psychedelics” that are under investigation for various ailments, adding that “chances are that, because of the similar mechanisms of action, you can see unique benefits of some of these other compounds.”
In his closing remarks, he encouraged those in the audience to ‘keep going’, and to keep building the case for psychedelic therapies while maintaining healthy scepticism. Most of the crowd stood to applaud Elnahal as he exited the stage.
