In the clinical setting, psychedelic medicine has promise as a safe and efficacious treatment for PTSD, TBIs, and other mental health issues.
Pharmacy Times interviewed Marcus Capone and Amber Capone, the co-founders of Veterans Exploring Treatment Solutions (VETS), on the current opportunities available for US veterans to seek psychedelic-assisted therapies for post-traumatic stress disorder (PTSD) and traumatic brain injuries (TBIs). The co-founders highlight a severe lack of mental health resources for these neurologic and mental health disorders, and explain how VETS is helping to fly veterans to countries where psychedelic-assisted therapies are available to access these treatments. The Capones highlight the importance of legislation in the United States that can propel initiatives to make access available to veterans in the United States, explaining how the stakes for these individuals are significant, as veterans experience higher rates of severe mental health disorders and suicidality.
Pharmacy Times: What is Veterans Exploring Treatment Solutions (VETS), and why was it founded?
Amber Capone: VETS is a 501(c)(3) charitable organization providing grant funding for veterans who are leaving the United States to travel abroad for access to psychedelic assisted therapies. When veterans come back from their international retreats, we also provide them with a robust menu of services, everything from 1-on-1 coaching to group integration, coaching workshops, spouse support, community platform, etc… and that goes on for life. We also support research happening in the United States around veterans and psychedelic therapies. And we pair the voices in our program alongside the data that we are supporting. We [also] advocate for change policy, [and] change at the state and federal levels. So we've done work in a handful of states. [We] had success legislatively in Texas, but we have our eyes focus mostly right now on Washington D.C. and unlocking more federal funding to further the research for veterans and psychedelic therapies, mainly by our foundational healing grants. So, we provide fundings, more or less just covering the subsidy for veterans to seek these therapies on their own.
We do have, I'd say, have a long-standing vetted retreat (and they're not partnerships) but we certainly have a resource list for veterans who are doing their due diligence on which retreats are operating safely around the globe. Most of our grant recipients have chosen to pursue the same protocol that Marcus did in 2017, which led us into this work, which was Ibogaine [a compound in the roots of the iboga plant], and 5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine). So we exist primarily for 2 reasons; to provide the subsidy and then all the support necessary for successful long term change—but we realize that it's a lot of work to keep a nonprofit going when you're donor dependent and so many veterans reached out to us that we can't help. So how do we really scale and meet the true demand that exists through policy change is the only way?
Pharmacy Times: How is VETS helping veterans of the US Special Forces receive psychedelic-assisted therapy treatment outside the United States?
Marcus Capone: No, so this provides educational resources for the military community, also for the private sector, about the risks and benefits of psychedelic therapy. We do have an e-course and we send we send to everyone to the e-course. It's built for veterans and their families who want to understand the current scientific research on psychedelic science and how it applies to veterans and non-veterans. And for anyone else really interested in learning about psychedelics, or veteran mental health.
Pharmacy Times: Have you been involved in advocacy on behalf of legislation for veterans and others to have access to these treatments for post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI), as well as other disorders?
Amber Capone: Absolutely, so we've spent the last 2 years on Capitol Hill educating and trying to change the narrative on psychedelic therapies overall. So reducing the stigma, putting a friendly face to a very scary and unknown word. I think that the promise that existed around psychedelic therapies dating back like a half century is reemerging in the current day, but the studies were there, before the Controlled Substances Act (CSA) was introduced and all research was more or less halted. So the resurgence is the psychedelic movement, if you will, has been philanthropically funded. And Johns Hopkins has been a big player and the reemergence of psychedelic science. So what many people don't understand or don't realize is that veterans are a population that could potentially benefit most from these [and] the effectiveness of these therapies. Yet the research being done in the United States is so difficult to go about with exemptions and all the red tape that exists with doing psychedelic research, and then the funding component. So being philanthropically-dependent is very limiting. Veterans are largely ruled out of these studies because they have multiple diagnoses or a history of suicidality. So once a researcher has gone through all the hoops of Drug Enforcement Administration (DEA) exemption [and] securing their own funding, [and then] when they get to the recruitment phase, veterans are largely excluded from this promising research. So we have advocated successfully at the state and federal levels for the government to step in and step up for a generation of American soldiers who have gone to combat for sustained 20 years, which is unprecedented. The current treatments are not working for many of these veterans. And the veteran suicide epidemic and rates are indicative of that. So we are simply advocating successfully for the government to provide funding to further their research, we had legislative victory with HB 1802. In Texas, we've worked with elected officials in several other states to get similar legislation up and going, we haven't had any victories since HB 1802 but we have several things in the works. Our focus is mostly at the federal level.
Pharmacy Times: What are you most excited about in terms of the future of psychedelic medicine and the possibilities for treatment of previously untreatable or difficult-to-treat psychiatric and neurological disorders?
Marcus Capone:Veterans believe that psychedelic therapy can lay the foundation of healing for everyone. And as Amber mentioned before, we feel that veterans are leading the charge and that people are listening—both sides of the aisle with Democrats and Republicans, which is nice to see. The foundational healing will enable to continue progress across a range of other therapeutic modalities, and it's supported by robust coaching programs and holistic treatment for veterans and non-veterans alike. Aside from that, psychedelic medicine is not just for veterans. We have a global mental health crisis. One in every 5 Americans that are just reporting have a mental health issue, that number is actually probably close to 30% of individuals, [and] many of these individuals are considered treatment-resistant, meaning the current treatments that are being offered are just not helping.
So treatment-resistant means an individual's given at least 2 of the modern selective serotonin re-uptake inhibitors (SSRIs) or antidepressants and they're not working. But that's where we're seeing psychedelic therapy stepping in and it's helping those individuals. And we're seeing a much broader population outside of the veteran community that are seeking out these treatments. And we have other initiatives that are trying to expand affordable access to psychedelic therapies through self-funded self-funded employer plans, and eventually insurance companies will be stepping in, hopefully in 2 to 3 years, to subsidize these treatments for individuals. I have a venture capital (VC)-backed startup called TARA Mind, which is expanding safe and affordable access to psychedelic therapies.
We're starting with what's legal or FDA approved here in the US right now; ketamine-assisted therapy is proving that it's the fastest-acting antidepressant that we have. Within 15 to 45 minutes, an individual who is treatment-resistant is getting some real relief, especially if there's any suicidality in there. And what we're doing is we're basically packaging what we're calling a Centers of Excellence Network that we've built in the United States with over 100 prescribers, therapists, and now integrative clinics. We're standardizing care and taking that to self-funded employers. Basically, this is going to be offered up as a health benefit. So if you work for “XYZ” corporation, this would just be another benefit that you can use, just like dental or anything else. But we need to figure out a way to subsidize this because these treatments are expensive.
What we'll be doing is collecting data on every individual that is going through these treatments, [taking] that data and then going back to the United States and the cities of the world who are really in charge of paying for these for all populations, Medicaid populations, and all the other populations. And we really see that this will be the future of mental health care— this will be a powerful tool that individuals will be able to access and so not just on the on the charitable side but on the greater side where it's going to reach just a much larger percentage of individuals that need this.
Pharmacy Times: How can health care professionals, such as pharmacists, help to refer patients who qualify for VETS aid to VETS?
Amber Capone: That's tough because we already have a waitlist that is hundreds of individuals long that are waiting for the opportunity to be admitted to our program. I would encourage anyone to reference a course that Marcus mentioned earlier, which can be found on our website, totally free. Vetsolutions.org will give a lot of information about psychedelic-assisted therapies and as they pertain specifically to veteran issues. And our website is where anyone would apply for funding, which is on a link titled Healing Grants (on the vetsolutions.org website). We are only able to serve roughly 20 to 30% of the Special Operations veteran applications that we receive, so to continue to expand the aperture to all veterans that have ever served the country is really, really challenging, which is why we're so focused on policy initiatives. So I would really encourage pharmacists or medical professionals to educate themselves on the benefits of psychedelic therapies, and then check out what Marcus is doing at TARA mind. And of course, always feel free to send veterans to our website, but knowing that our ability to support is rather limited.
Marcus Capone:I’ll add that I think it's very important to follow the science that is happening before you call legalization, and we'd like to call it FDA approved. Right now ([for] MDMA) they will be filing an investigational new drug (IND) application near the end of the year, and we're thinking and hoping that FDA approval happens in the middle to Q3 of next year for PTSD, and in the following [year] 2025, psilocybin will hopefully be going through FDA approval. Both have received FDA Breakthrough status in 2017 and 2018, which is exciting. And I think the clinical trials are showing that they are (these drugs) are safe and efficacious and they're really going to help individuals. And so, I would say just also follow the science and the trials that are continuing.
Pharmacy Times: Closing thoughts?
Amber Capone: Well, it's a shame that we must send any veteran who is willing to die for this nation outside of it to receive access to meaningful care. I would say that our number 1 goal in that regard is to expand access here in the United States through safe, medically guided clinical use of psychedelic-assisted therapies which involve professionals. There are a lot of bottlenecks in bringing that to life, so I think that the first and most important component of that is to receive some sort of assistance from the government, whether the Veterans Affairs (VA) get involved in psychedelic therapies or real federal funding is unlocked for more research. The crisis is happening now, and 20 or more veterans are dying by suicide—Now. So when you talk about these massive changes that need to take place over a number of years, how many more people will have to die before significant change comes about? I think that every veteran deserves access to these therapies, they're incredibly efficacious, far more efficacious in our experience than anything else that was currently available to us. So continuing the research and unlocking federal funding to do that seems like the best place to start.
Marcus Capone: I think it's interesting what's going on in Oregon and Colorado. Even though these are state run initiatives, there will be retreat centers that are going up. And I think everybody the world is watching to make sure that the treatments going on there are safe, clinically guided, and individuals aren't getting hurt. And so I think that [there is] access for individuals who live in the state or can travel to the state, but we also hope that they don't go too far—that individuals come out of those treatments with bad experiences. I think it's going to be very interesting to see what goes on in Oregon and in Colorado.
Amber Capone: And on that note, I don't want to ever evangelize or over proselytize psychedelic therapies, they are incredibly powerful and hold incredible promise. But on the note of being incredibly powerful, if someone's not properly supported before during and after such an experience, it could actually be further traumatizing. And so there are a lot of considerations to take into account when you're talking about the delivery and scale of safe therapeutic use of psychedelic therapies, which is everything from sourcing dosing to therapeutic support before, during, and after treatment…getting someone prepared for such an experience and then really integrating and fully maximizing the benefits following.
Marcus Capone: And I would also add to follow-up on monitoring after an individual goes through multiple integration sessions with the therapists. Specifically, if it's trauma related, I think there needs to be more integration post-treatment. We also need to continue to monitor that individual to make sure that that person continues their healing, and if they fall off or slip, we can take that person and bring them back into the cycle again. Make sure they're properly prepared, they're treated correctly, and they have the right integration, and then monitor them again. I just think it's really important for individuals to educate themselves. We live in this bubble. For the last number of years of what we've been doing, we just assumed that everybody knows about psychedelic science and psychedelic therapy, but really I still feel like half the country needs to understand that these are medicines that were intended for use for individuals that were struggling with their mental health. And they might have gone off track a little bit in the 60s. But let's get back to what they were intended for, and we really can heal a lot of individuals globally who are struggling and that are not getting the treatment that's being offered today.