Psychedelic Therapy and Veterans: What Pharmacists Need to Know About the Right to Try Pathway for Ibogaine

In an interview with Pharmacy Times, Neil Markey, CEO of Beckley Retreats, a network of psychedelic centers that provides integrated health programs utilizing psychedelics, explained that the recent executive order directing the FDA and Drug Enforcement Administration to fast-track investigational psychedelic therapies for veterans changes the federal government's posture and priorities more than it changes what is currently legally available, because substances like ibogaine remain Schedule I. Markey noted that the Right to Try pathway cannot yet be used for ibogaine because the compound has not completed the required phase 1 safety data testing in the United States, a process he expects will take years, particularly given documented cardiac risks and deaths associated with its use. He explained that rescheduling cannot occur until phase 3 trials are complete, noting that psilocybin is further along in this process than ibogaine and could see movement within the next year. Markey also described Beckley Retreats' role in generating observational safety and outcome data through a partnership with Harvard's T.H. Chan School of Public Health, emphasizing that although the field holds extraordinary potential, it must proceed with care, given the real risks involved.

Pharmacy Times: Can you please introduce yourself?

Neil Markey: My name is Neil Markey, and I'm the CEO and cofounder of Beckley Retreats. I got out of the service in 2012, and I actually went to grad school at Columbia University.

Pharmacy Times: You completed 3 combat deployments and later dealt with posttraumatic stress disorder and depression. How did that personal experience shape the way you think about the treatment gap that exists for veterans today?

Markey: So, by some measures, I was doing OK, but emotionally and spiritually, I was in pretty bad shape. I tried SSRIs [selective serotonin reuptake inhibitors], I tried antianxiety medications, and I tried different sleeping pills, and what I've learned about them is they all have their place, but at best, they're just doing symptom reduction, and you really need to get to the root. You need to get to the underlying causes of the traumas to make real progress. It wasn't until a few years later that I was actually introduced to meditation and then had some professionally facilitated psychedelic experiences. While I don't think these experiences are necessarily magic pills, and they're not for everyone, they have pretty extraordinary potential benefit if they're used in the right way, and they're just not available right now, really anywhere outside of ketamine, and this is why you have veterans going to other countries to use them. So I'm very encouraged that it finally looks like we're making some progress.

Pharmacy Times: The executive order directs the FDA and DEA to fast-track access to investigational psychedelic therapies, including ibogaine, for veterans. From your perspective, what does this order actually change in practical terms, and what does it leave unresolved?

Markey: There's a lot that we don't know. It really kind of changes the posture of the federal government more than what's legally available. The substances that are named, including ibogaine, are still Schedule I, but what is new is formally the federal government is saying this is a priority, and that is likely to compress the FDA timelines. There's also a matching grant for $50 million for research, which is meaningful. The directive says the FDA, the VA, and HHS need to collaborate and run trials together, and I think that these organizations are going to listen to this administration, so that momentum is real. But it doesn't answer a lot of the questions. It doesn't say any organization is going to pay for it or how these are going to be delivered. It also points to the right to try for ibogaine specifically, but it's a little bit funky because ibogaine hasn't passed the basic safety data that are required for the right to try. So in some ways, it kind of opens the door, but there's not anything formal on the other side yet. I do think it's generally positive, but there's a lot that we don't know.

Pharmacy Times: The Right to Try pathway is one mechanism mentioned in the order. For pharmacists who may be unfamiliar with how that pathway works, can you walk through what it means for a veteran trying to access ibogaine under the current framework?

Markey: I think the thing is, this is going to take some time. The Right to Try is a federal law, I think it was from 2018, and it's applicable under pretty narrow conditions. But the No. 1 thing is it has to have passed phase 1 safety data testing, and that has not happened with ibogaine in the United States. Most of the work has been happening outside of the country. So, as far as I'm aware, ibogaine still has quite a way to go, and there is real risk. There have been deaths that have been attributed to the use of ibogaine. There's a cardiac risk, so the safety data for ibogaine is going to be really important, and that's going to take some time. So, for pharmacists who are fielding questions around this, I would let people know that this is probably a multiyear process because it hasn't met the kind of basic requirements to allow it under the Right to Try effort.

Pharmacy Times: The order calls for rescheduling reviews following phase 3 trials. What does that timeline realistically look like, and what should clinicians and pharmacists expect in the interim?

Markey: Again, I think this is multiyear, so rescheduling doesn't happen until phase 3s are complete, and ibogaine hasn't even begun. Now, psilocybin, for instance, is a little bit further along, and there's potential for that to complete the process here in the next year, and then there could be a rescheduling. That's exciting for veterans who are considering these compounds. They do need to do their own research. I would say that the risk for these compounds is quite different when you compare psilocybin vs ibogaine, and that's worth noting. There are also contraindications with some of the components of what is in ayahuasca. There's also real risk there, depending on the type of medications that individuals are on. So there are a lot of people who are going outside the country right now to explore these experiences, and they need to do their own research because there is real risk.

Pharmacy Times: How does the real-world data your organization generates factor into the broader regulatory and research process?

Markey: So we're completing our updated IRB [institutional review board] here soon, and we're also in partnership with a leading psychiatric epidemiologist at the Harvard T.H. Chan School of Public Health, Karestan Koenen. We'll be doing an IRB with the Chan School, and we're going to be gathering safety data and outcome data, but what we're doing is observational research. We're not doing clinical trials in our programs. Our programs at Beckley are mostly for well people who are looking to develop professionally and personally, learn new habits, and deal with loss. But we can still get really good data because we have such significant throughput; we put 500 to 750 people through a year, and we're excited to contribute to the field and do really good research with good partners.

Pharmacy Times: Is there anything you would like to add?

Markey: No, I just think it's an exciting time for the field. When we started doing programs in the Netherlands 4 years ago, 5 years ago, it was almost exclusively Europeans. That's changed now. If we do a program in the Netherlands, it'll have 8 to 10 different countries represented, including South Korea, Pakistan, and Saudi Arabia. So the entire world is opening up to the potential, but we do need to do this with care because, like I said, there's extraordinary potential here, but it's not without risk.