[00:00] Bryan Hyde: Welcome to the Health Policy Podcast. I'm Brian Hyde, and today I'm joined by Jen Cutler. She is, she is with the DCI Group, and you're a partner there. Jen, tell us a little bit about who you are and the work you do, and then we have a fascinating topic to explore. [00:15] Jennifer Cutler: Great, thanks, Brian. Thank you so much for having me on your show today. As you mentioned, I work at a firm called DCI Group, which is a public affairs firm, which is based in Washington, DC. We also have offices in New York, Brussels, and Florida. Essentially, we work primarily with corporate clients to help them solve their largest problems. I've been at DCI for a little over 20 years, been a partner for, geez, I think around 16 or 17. I'm losing track of time a bit. And I spend most of my time working on grassroots and coalition building for several of our clients and do a lot of work in the states on a variety of issues, including healthcare, which I think we're talking about today. [00:58] Bryan Hyde: Yeah. In fact, specifically, we're going to be talking about mental health policy. And Jen, I think the first thing I want want to ask you about is there's a lot of attention that's being focused on mental health today. But I understand the treatments themselves are still trying to catch up. Can you help me understand why the treatments are struggling to keep up with mental health care? [01:20] Jennifer Cutler: Yeah, sure. I would start off by saying that mental health continues to be a serious issue in this country. And over 14 million Americans live with a serious mental illness. You know, it's really been about 25 years since there's been new medications on the markets. So it's about 25 years of patients having essentially the same treatment options, though, you know, there's finally a serious wave of innovative new psychiatric medicines using psychedelics moving through the FDA, going through clinical trials, which is really, really exciting. [01:54] Bryan Hyde: I think it was probably not quite 10 years ago, I started to hear about psychedelics being used in mental healthcare. And since then, it seems like I'm hearing more and more about it. But I'm curious, where are the advances coming in terms of psychedelic use in mental health care? And how does the FDA fit into this equation? [02:16] Jennifer Cutler: Yeah, sure. So it is really exciting that there's burgeoning kind of conversation around psychedelics. And, you know, that there's been a lot of kind of use of psychedelics to kind of look to solve these mental health and really brain health, you know, issues for our patients. I think right now there are between 8 or 9 different psychedelic products moving through the FDA pipeline, which is really exciting. And they'll cover everything from PTSD to major mental depressive disorder to general anxiety disorder, treatment-resistant depression, really a gamut of different issues within the mental health space. And as you mentioned, the FDA really has a very serious role here. The FDA is really sort of the scientific body that looks at medicines and determining whether or not they are safe and effective for patients. The FDA process takes several years, and it's really rigorous clinical trials, rigorous science, really looking under the hood at all of these different medicines. And again, having these different psychedelics in the pipeline is really exciting. A couple of them have even gotten designated breakthrough therapy, which means the FDA puts a lot of ergs around them and makes sure they're kind of moving at a And the FDA, you know, once approval, which again takes years and goes through rigorous clinical trials, multiple rounds of trials for each of these different drugs, you know, blind patient, you know, blind multiple patients, you know, blind studies, really everything that any other type of medication would go through is what these psychedelics are going through. And once the FDA actually approves the medicine, you know, the next step for these drugs is going through the DEA process because anything that's a psychedelic is a Schedule I drug. And the DEA has oversight over the schedules of drugs. And so once the FDA approves a medicine, it goes to the DEA to look at for scheduling. And then the DEA will then put it on a federal schedule, which then sort of indicates what it's gonna look like as it moves through the pipeline out to the states. [04:27] Bryan Hyde: And for the sake of folks who are wondering, okay, you guys are talking about psychedelics, can we name some of the different psychedelics that are being explored for their therapeutic value? [04:35] Jennifer Cutler: Yeah, absolutely. I mean, there's several that are kind of really, that are being explored, some of them that are really on the forefront moved through clinical trials to a place where they may even get approval in the next couple of years. That's psilocybin, which is a variety of what you might— a mushroom. Then, you've got LSD, which is another one that's really being looked at pretty seriously. I would say those 2 are probably at the forefront as it relates to where they are in their clinical trials process. [05:08] Bryan Hyde: Just because the FDA is taking a serious look— in fact, I'll make a little leap ahead. Let's assume that the FDA says, yes, this does actually prove out that this is worthwhile and can be safely administered, so they're going to approve it. That doesn't necessarily translate into, well, then patients should be able to easily access it. Why is that? [05:29] Jennifer Cutler: No, that's absolutely a great question and a good point. And it's definitely something that most Americans don't realize. FDA approval is a huge milestone, but by itself, it does not put a medication in patients' hands, especially not for controlled substance, which is obviously what we're talking about here today. You know, FDA approval isn't the finish line for regulators. It's really the starting line for patient access and the starting line for, you know, states to really get engaged. So after the FDA approves the drug, which is talked about as a very rigorous scientific process, and then the DEA schedules it, as I mentioned, you know, it then has to go to the states. And every single state has its own controlled substances law. And no surprise, they all look very different, right? So in some states, federal rescheduling happens automatically. So as soon as the FDA and the DEA act, the state will allow it to, you know, be scheduled in its state. But in most states, it actually takes an act of the legislature or state regulatory board to, you know, bring the law into alignment so then patients can begin to access this. And so I think one of the points I really wanted to make today is that if a state hasn't done any of this groundwork in advance, here's what's going to happen. The FDA is going to approve a drug. Patients are going to start hearing about it. There are doctors who want to prescribe it. But if the legislature isn't meeting for another 6 months, and then it takes a year or 2 for a bill to go through, or maybe the state pharmacy board or HHS or whoever has jurisdiction to write the rules takes a long time, these patients aren't going to have access. access to these drugs. So, you know, you're a veteran with PTSD, or you're a mother with, you know, depression, just waits and waits because these states haven't acted in order to align themselves with the FDA and DEA process. [07:19] Bryan Hyde: I'm looking at an article that, that you had written. This was for Patient Daily. And, and there's a phrase in there that you use about how prepared states will lead and unprepared states will watch. Could you unpack that for me? [07:33] Jennifer Cutler: Yeah, sure. I mean, I think what it really comes down to is ensuring that states are prepared so that when the FDA and DEA have acted, they are able to quickly move their drug on— a drug or whatever's been again approved onto the state schedule so that then there can be a way for patients to access it. If that groundwork has not been laid, as I just mentioned previously, that will not be able to happen. And then again, patients are waiting. It's also possible that your neighboring state has already done so, right? And so, you know, you don't really want to have a patient who's living, having to travel across state lines in order to access medication. You know, you want your patients to be covered and treated in your own state. And so, you know, you don't want to create a system of have and have-nots because you haven't been able to really have the foresight to create a regulatory framework that's going to allow for this patient access. [08:28] Bryan Hyde: I'm curious, what are some of the bigger misconceptions people have about psychedelic-assisted therapy? [08:35] Jennifer Cutler: Yeah, and I think that's a really good question and something that we really deal with quite a bit as we're having these conversations, only because there's been so much conversation about psychedelics over X amount of years, especially conversations about legalization and decriminalization. It all really gets gets conflated when you're having conversations about these issues with state legislators and regulatory bodies, and even as your average American citizen, right? Because when people hear the word psychedelic, you're thinking we're going to go to Woodstock or a festival. Right. Or you find something online and go into your parents' basement, right? Which makes sense because that's really how cultural TV, movies, et cetera, have associated with that word for the past 50 years, right? But that has literally nothing to do with what an FDA-approved psychedelic medicine would actually look like. And what we're talking about here is a pharmaceutical-grade compound that's standardized, dosed, and the purity has been verified. It's manufactured to the same standards as any other prescription drug in America. A patient has to be carefully screened because obviously these treatments aren't right for everybody. This dose happens in a licensed clinical setting. A physician or trained provider is present throughout the entire session. defined protocols before and after. This is a true medicine. And being given this is going to look more like an outpatient medical procedure than I think anything people would actually associate with the word psychedelic. And it really fits under the same regulatory policy that we use for any other prescription drug. I think kind of along the same lines, another misconception is that these treatments are sort of, quote, experimental. [10:24] Bryan Hyde: Right. [10:25] Jennifer Cutler: But as we talked about previously, these medicines are going through extremely rigorous clinical trials— hundreds of patients, double-blind, standardized, everything I mentioned previously. And people who are running these programs, these pharmaceutical companies, are running these programs like they would any other pharmaceutical with insane oversight from the FDA. And the results have been really strong, to the point where some of the largest single pharmaceutical companies in the world, AbbVie and Eli Lilly, have in the past year written billions of dollars of checks just to get into this space. And I'd probably say that the— well, probably a couple other misconceptions would be that people think maybe the goal of the treatment is really the psychedelic experience itself, when it isn't, right? The goal is to have a durable clinical benefit that's measurable and sustained. The patient's looking to have a long-term improvement and not just have the trip. You know, the whole point is to actually see meaningful, lasting results. So it's not the experience, it's about the outcome. And I think probably the last thing that's worth mentioning is I think patients kind of think when they hear about psychedelic medications that they're going to take this at home and it'd be like a pill you swallow every morning, kind of like the traditional, you know, SSRI medications, which are a lot of the current antidepressants. presence on the market, you know, that there could be an opportunity for drug diversion, meaning that you put it in your— you can sell them on the street, right? But that is absolutely not how this model works. You know, all the drugs going through the FDA pathway right now really look— will all be provided and administered in a supervised clinical setting with the provider present throughout. You know, it is safe. You know, I think overall, You know, I think we sort of make sure people understand that we're talking about FDA-approved therapy, we're talking about medicine, we're not talking about legalization or decriminalization. Those are totally different debates and a totally different framework, and it's important we keep them separate so we can have an honest conversation about all this. [12:32] Bryan Hyde: I appreciate you making that clear distinction between those things too, because I know when people hear LSD, well, you know, it's— they're thinking, well, someone's just, you know, looking to escape reality. And I'm not gonna ask for a clinical description, but can you dumb this down for a layman like me, um, how have they found that these compounds in these psychedelics help people with, with PTSD or depression or things like that? Um, is there a simple explanation as to, to why they're finding it's, it's a useful tool? [13:01] Jennifer Cutler: Well, actually, um, and I can't remember all the, uh, history here, but, you know, I think, you know, decades and decades ago, um, researchers were actually doing, you know, various studies looking at LSD and kind of how it worked with the brain, the brain chemistry, to really kind of understand that it could be helpful for situations like this. And then I think unfortunately LSD kind of took a turn and became more of what we'd consider more of your Woodstock psychedelic, which then sort of just destroyed any sort of credibility it was going to have as a potential pharmaceutical-grade medicine. And so I think over the past decade or so, people have been really starting to think through where are there new treatments for these problems that haven't been really totally solved yet, right? And how do we really look at brain chemistry to really understand what is true brain health and how does the brain totally work, right? And why are the current drugs that work for some not working for all? And I think that just allowed them to sort of unearth the conversations that were had decades ago, which has really kind of allowed for this. [14:15] Bryan Hyde: Talk to me about how this is being approached by policymakers. Is it— I assume this is a bipartisan but how are the policymakers approaching it? Is it primarily mental health? Is it for, you know, veterans, you know, helping veterans? What are some of the rationale that brings this bipartisan approach? [14:34] Jennifer Cutler: Yeah, and you're absolutely right. This is a very, very bipartisan issue and probably one of the most bipartisan issues that I've really worked with or worked on over my years. And I think just a couple of issues, you know, kind of rationale for that. You know, first, this is a universal problem. Right? Mental illness does not care about your political party, doesn't care about your state. And I think every legislature, you know, legislator, you know, federally and, you know, state legislators have constituents whose families have been touched by depression or anxiety or PTSD or addiction or suicide. You know, over 14 million Americans, adults, live with serious mental illness, as I think I mentioned. You know, we lose 17 veterans a day to suicide. You know, I think when a problem exists, widespread and it's clear that the current system isn't working, ideology kind of takes a backseat. And to your question about vets, I honestly think that has been a really powerful bipartisan bridge. There are an enormous amount of veterans dealing with PTSD, traumatic brain injury, treatment-resistant depression, and some of them have all those things stacked together. 41% of need mental healthcare programs annually. You know, 85% of vets with substance abuse disorder don't even seek treatment, only because standard medications don't work for many of them. And I think there's sort of a kind of a giving up and fed up sort of mentality. And so, you know, again, I think why they're excited about new innovative options. But going back to bipartisanship, I'll start federally. In the Senate, you've got Cory Booker, who's obviously a progressive Democrat, who's working with Rand Paul, having a conversation conversations around these issues. And in the House, there's actually a bipartisan caucus called the PATH Caucus, which is co-chaired by a California Democrat and a Michigan Republican. So there's a lot of rare, unique pairings happening here. And then moving on to the states, you know, you've got legislators in deep red and deep blue states voting the same way as they're looking to tackle these issues. You know, you'll have a Republican-Democrat That's cosponsoring bills together, moving bills almost unanimously through state chambers. And then you're having Democrats, Republicans signing, governors signing these bills. So it's really refreshing in an era where we don't seem to see a lot of bipartisan support that this issue absolutely does. [17:00] Bryan Hyde: And Jen, one final question for you. That is, you mentioned that there are states that actually have stepped up and taken some decisive steps. Who are the states to keep an eye on that are kind of leading out? [17:13] Jennifer Cutler: Yeah, so I think, you know, even over the past year, we've seen, you know, a handful of states really take this on and even look to pass legislation in this space, right? So, you know, again, showing the bipartisan nature of this, you know, you've had everyone from Utah and Colorado to Illinois to Tennessee and Georgia. You know, it's, it's a broad range of states. States you would never really think would align together, but those are the ones who are really taking the lead. And again, I think a lot of this is because they're really having the foresight to understand that this, you know, is a burgeoning problem. They have constituents, especially, you know, in the vet and even public safety space, that are really concerned about this. You know, people are seeing that there's a lot of talk about mental health but not a lot of action. And so I think these legislators are really looking to lead. And I think this— the next session in '27, you're going to see more and more of this because, again, no state wants to be left behind and have people having to cross borders to find treatment. [18:14] Bryan Hyde: Again, this is a fascinating subject. And we've been talking with Jen Cutler, who is a partner at DCI Group. One final question for you, Jen. Where would you direct people who wish to get a little more information on this? Are there some good resources that they can access? [18:30] Jennifer Cutler: Yes. So as I mentioned, there's a thing called the PATH Caucus, which is part of Congress, and actually, it's called the Psychedelic Medical Association. That's one I would look at. And then, you know, there's also a variety of other ones that I'm simply forgetting. [18:47] Bryan Hyde: Actually, you have been a wonderful resource yourself. And again, thank you for opening the door on this so that people can start to understand that those names they've heard and associated with, you know, rock concerts or whatever, may actually have some, some very useful purposes as well. Again, we're talking with Jen Cutler. She is with DCI Group. Jen, thank you so much for joining us today on the Health Policy Podcast. [19:10] Jennifer Cutler: Great. Thank you so much, Brian. Appreciate you having me.