Psychiatry & Psychotherapy Podcast - Schizophrenia Treatment: Clozapine, LAIs, Technology and Equity with John Kane, MD and Lauren Hanna, MD

Episode Date: August 25, 2023

John M. Kane, MD. is Professor of Psychiatry and Molecular Medicine at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. Dr. Kane earned his medical degree from New York University in New York, New York, and completed his internship and residency in Psychiatry at The Zucker Hillside Hospital. He is a diplomate of the American Board of Psychiatry and Neurology. Dr. Kane is the recipient of many awards, including the Lieber Prize, The APA's Kempf Award and Foundations Prize, the New York State Office of Mental Health Lifetime Achievement Award, and the Dean Award from the American College of Psychiatrists. He has served as President of the American Society of Clinical Psychopharmacology, the Psychiatry Research Society and the Schizophrenia International Research Society. Dr. Kane has been the principal investigator on 23 NIH grants focusing on schizophrenia, psychobiology and treatment, recovery, and improving the quality and cost of care. He is the author of over 900 peer-reviewed papers and serves on the editorial boards of numerous journals.  By listening to this episode, you can earn 1.75 Psychiatry CME Credits. Link to blog. Link to YouTube video.

Welcome to the Psychiatry and Psychotherapy Podcast. I'm your host, David Puter. This is your gateway to the intriguing world of mental health. As one listener put it, this is the podcast that your psychiatrist listens to. And we're incredibly proud of that endorsement. Whether you're a loyal, active listener who's been kind enough to reach out, maybe send an email at DM or put in a review, or you're new to this community. We have an exceptional opportunity for you, not only to learn, but to also, earn continued medical education credits with each episode. Our credits are meticulously designed to empower you in your field, demystify complex mental health topics, and transform your learning journey into a truly rewarding experience. To access this and more, just visit Psychiatrypodcast.com. We're grateful to our valued subscribers who are already reaping the benefits of these credits. Your support is instrumental in allowing us to devote time each week to curate. this podcast, sharing cutting-edge insights, featuring top professionals, and exploring the latest

research. Whether you're here to learn, earn credits, or both, we're thrilled to have you with us. Get ready to deepen your understanding of psychiatry and psychotherapy, one enlightening episode at a time. All right, welcome back to the podcast. I am very excited to introduce this episode today. It will be called schizophrenia treatment, clozapine, long-acting injectables, technology, and equity. It is with Dr. John Kane and Lauren Hanna and two psychiatry residents, a fourth year Dr. Tartalia, and Dr. Flaxer. You may remember from the Closepine episode I did with Dr. Cummings that we talked about Dr. Kane and his monumental historical work in bringing Closepine to the U.S. Dr. Kane was monumental in influencing. Another person we're bringing on, Dr. Hanna,

she supervises residents in the early treatment program, and On Track NY as part of the multidisciplinary specialized team with expertise in treating early episode psychosis. And we're going to talk a lot about early episodes psychosis, how to talk to these patients, long-acting injectables. She is also the associate program director and the Director of Anti-Racism and Social Justice at the Zucker Hillside Hospital Psychiatry Residency Program. It is fantastic to meet her today as well. Also, you're going to hear from a

fourth-year psychiatry resident, Dr. Tartalia. She has conducted some research on mental health mobile app interventions, social media use, mental health. And this is cutting-edge stuff on how we can potentially have early markers of psychosis from just how people are using their media. And a special thanks to Dr. Flaxer. He is also a fourth-year psychiatry resident. He plans to pursue a child fellowship and is a leader in the program. And he reached out to me after hearing me talk about Dr. Kane on the Closopine episode with Cummings and thought, hey, why don't we get a bunch of us together and talk about what happened, the historical event that led to Clozapine being approved for treatment resistance schizophrenia. So this is a historical

moment where we get to, you know, remember the people that change the face of psychiatry. there is no better treatment for treatment resistance schizophrenia than chlozapine and it will be great to do another dive into this before we start any episode we have to give any potential conflicts of interest myself dr hana dr tartalia and dr flaxer do not have any conflicts dr kane has a number of potential conflicts of interest i have looked at them and this is recorded after the episode i have thought through what we talked about the episode i do not i do not believe these created a conflict of interest. There are about 20 companies that he is involved in on an advisory board, grant support, shareholder, consultant, and he received some royalties. I will provide a full list on our website, psychiatrypodcast.com and in the show notes,

and now we will begin the episode. I wanted to launch in with Dr. Kane. Tell me about the story was banned in the U.S. And to my understanding, you had to take over a group of closamine patients at Hillside Hospital in New York, and you had to wean them off of closepine. Tell me that story. Sure. Yeah. Thanks very much.

Thanks for having us on. So as you said, there were some problems with clozapine. In the mid-1970s, there were a series of deaths in Finland from agranolocytosis, and that was a major adverse effect associated with closopine. So there was certainly concern on the part of the FDA in the United States that this was not a drug that could be safely utilized. They did, however, have three INDs. So that's a permission from the FDA to use an investigational new drug. One of the holders of those INDs was a gentleman named Nathan Klein, who was a pioneer. year in psychopharmacology and he had a number of his private patients receiving closeapine.

And he was really not keeping up with the paperwork that was necessary to sustain an I&D. And ultimately, the FDA and the company, Sandos at that time, took away his I&D. That meant that the patients who had been receiving closeapine needed to have someone else to manage their illness. And I was asked to do that because I had expressed interest in clozapine and although I was quite young at the time, had begun to do research and schizophrenia. So I was asked to pick up those patients. And since the likelihood was that the drug was not going to be available in the U.S., they asked that whenever possible I try to have these patients taken off clozapine.

So I began to see about 25 or 30 of these patients. And in some cases, I thought closopine could easily be discontinued. In other cases, some of these patients did not have schizophrenia. But for those who did, we did make some attempt to discontinue the closepine, but with not very good results. and some of them were hospitalized at Hillside. We tried to treat them with other medications and they failed, and ultimately we put them back on Closopin.

And I think the responses were quite dramatic so that even the staff on the units, the nursing staff and the mental health aides were quite impressed with the ability of this drug to reduce some signs and symptoms in some very, very ill patients. And after that, I continue these patients on Closopin. I was very impressed. I joined Sandos in having conversations with the FDA about the potential of this drug. And the FDA, Paul Lieber at that point, was the head of the psychopharmacology division.

And their attitude was, you know, if we are going to consider approving this drug, you really need to do a study to demonstrate that it is superior to conventional medication in the treatment of treatment-resistant schizophrenia. And there had been some early work, particularly in Germany, that had suggested that this drug, you know, would be helpful in treatment-resistant patients. And so we designed a study in conjunction with the FDA and with Sandos. And I was the principal investigator of that study. It came to be known as study 30. It was published in the Archives of General Psychiatry in 1988. And that's what led to the approval of Closopina in the United States in 1990. But with some very strict requirements for monitoring to determine if patients were developing.

neutropenia and agranocytosis. And in those days, I think the risk of agronocytosis was both higher and potentially more lethal. What we've seen over the last three decades is the incidence of agronocytosis is lower than it was, and the rate of fatality is extremely low. It's very rare these days. So I think Clozapine can be given much more safely than what had been anticipated, you know, in the late 1980s, early 1990s. So since then, I think sadly, in a way, several factors. One is that Clozapine is still the only drug approved by the Food and Drug Administration for treatment resistance schizophrenia many, many years later. We still don't really know how Clozapine works and how it distinguishes itself from other antipsychotic drugs.

It does bind to a variety of neuroreceptors in the central nervous system. We used to say it was a dirty drug. Now we like to say it's a drug with a rich pharmacology. But the reality is we still don't know how it really works. And the pharmaceutical industry has tried very hard to replicate clozapine. In fact, alanzapine is very, very similar to Closopene. but doesn't quite have the same efficacy. And the third factor is that clozapine is still grossly underutilized, in my opinion.

I mean, we know, for example, that 20% of first episode patients are treatment resistant from the get-go. They really don't derive adequate benefit from antipsychotic drugs. Yet the utilization of closopin in that population is very, very low. But the general population of treatment-resistant schizophrenia patients, the utilization of clozapine is much lower than it should be. So we would estimate that about 30 percent of patients with schizophrenia would qualify as treatment-resistant.

The utilization rate of chlizepine in the U.S. now is still well under 10 percent. And I think, you know, there are a number of factors that contribute to the underutilization. It's something that we've been working hard on to. try to better understand those obstacles and to work with people to improve their ability to use clozapine. We could talk about that more in a minute. But I think the sad fact in early phase patients is the extent to which we can get the illness under control in the first couple of years is really critical in terms of prognosis. And if we have patients with significant residual positive symptoms, that puts them at risk for many things, also diminishes their opportunity for recovery,

etc., etc. A study that was published in Europe called Optimize, actually a large-scale study treating early-phase patients after analyzing their data, which included initially being treated with amisulpride and then those patients who didn't respond were randomly assigned to a Lanzapine in order to continue on amisulpride, and then if that failed, they went to chlopine. Those investigators concluded in their paper that clozapine should be used in early-phase patients after only one failure, whereas traditionally we expect failure on at least two medications. So that was an interesting conclusion.

I personally would be satisfied if people went to clozepine after two failures, and that would be consistent with the regulatory indications. but that doesn't happen. First episode patients rarely receive Clozapine. And I think, you know, that's a challenge for us as clinicians. And I think so that's a kind of brief summary of the Closepine story. It still is a drug of great interest. We've seen through many reports that Closepine is associated with a lower rate of re-hospitalization.

than other medications and even a lower rate of long-term mortality. I mean, that's true of antipsychotic drugs in general. They reduce rates of mortality in people with schizophrenia. Long-acting injectable medicines, which we can also talk about, have been associated with a significant reduction in the risk of hospitalization as well as the risk of long-term mortality. So, yeah, can you speak a little bit more on that? because I think that when people are afraid of like, oh,

clozapine side effects and risk of mortality, but they don't realize, no, the risk of untreated schizophrenia has high mortality. Like, how do those compare the risks? Absolutely. No, the risks are significantly higher among people who don't receive medication. And I guess another debate in the field has been, you know, how long do we need to continue medicine in somebody who's only had one episode or two episodes? and the data, particularly from Scandinavia, where they have large registration databases

so that every patient with a diagnosis of schizophrenia can be tracked to some extent in the medical records, you know, they've looked at rates of mortality and rates of hospitalization over periods of many years and shown that it's difficult to identify a point in time where it's safe to discontinue antipsychotic drugs. And that suggests, in fact, their data suggests that the risks may even go up over time rather than down. So, but we are talking about schizophrenia here. Sometimes there's confusion in the literature because people publish papers on the outcome

of psychosis, and psychosis is not necessarily schizophrenia. So we do need to be careful that people understand. We're specifically talking about schizophrenia. Obviously, that's a diagnosis that's not easily made. So one should be confident in that diagnosis, and that can take time. But in those patients, I think the advantages of drugs like Clozapine and long-acting formulations are very important. And similar to Clozapine, the long-acting formulations are also grossly untutilized,

despite the fact that they've been available for many years. and even the second generation or atypical antipsychotic drugs, you know, several have been available for many years in long-acting formulations, yet they're still underutilized. And I guess I would say that the reasons, to some extent, are similar in that they're both kind of a hassle to use, that it's more work for the clinician. It's more work in terms of explaining the benefits and also discussing the risks with patients who initially may be reluctant. But that takes, in my opinion, training and time and practice. And, you know, we've done studies where we've been able to train clinicians on the use of these

medications and help them also do a better job in having the shared decision-making conversation with the patient about these medicines. And often, you know, we as physicians like to think that we're very good at communicating with our patients, but often in talking about these two treatments, the communication is far from ideal. And often clinicians start off with the risks rather than discussing the benefits initially, and then obviously including the risks as well. But conversation needs to be balanced. It needs to be well informed. People need to be aware of the data. and very importantly to be able to answer frequently asked questions, some of which can be difficult,

but we have to be prepared to answer them. I would love to hear how you have that initial conversation and discussion. Imagine, I mean, with my audience, you're teaching providers, so teach it as if you're teaching a provider, like how you would teach them, you know, like, what would you say? What questions come up? how do you answer those questions? And I know, Dr. Hannah, you as well probably have been trained in this model, teach residents now in this model, right? Yeah, definitely. So I actually, an interesting history.

So very early in my career, one of my first post-resident, I went to residency at Zuckerer Healthside Hospital, and one of my first post-residency jobs was working with Dr. Kane on like a four-year grant-funded Obama Care Project, where essentially my role was to travel and evangelize, you know, smaller community-based organizations around New York State on best practices for the use of close opinion in LAIs. So I saw very fond memories of those many years ago. But I think, like, I think in terms of the conversation with patients in families about Closapine specifically. My strategy is kind of, you know, dropping a little pearl of information, like, early in the conversation, knowing that it later will be a later

conversation. So I try to set patients and families up for success, but also, I also keep in mind that there are some really common, I guess, concerns, questions, things that people will go to. I think a lot of the things that we try to learn and teach residents at our program is like the evidence-based paths to like not make too many mistakes. Like, you know, not take too long to make too many mistakes than getting people healthy. You know, one of those mistakes would be like maybe not introducing to patients the options of a long-acted injectable early, like waiting, waiting until they've proven that they're not taking their medications. I want to touch on LAIs a little bit just because we're talking about clozapine but I really think it's like a really first step

before we're talking about close apine so I want to talk a little bit about them. So I think one of the really common misconceptions with LAIs, which is patients, families, but also like in the mental health field is that there's like a stigma related to them like these are medications that are only for quote unquote

bad patients, whatever that means, you know, or quote unquote, you know, non-compliant patients, right? When I, you know, non-compliant versus not adherent. I think that the terms we use now is more like inconsistent, right? Because how can a patient or a person, you know, be non-compliant or non-conherent with a medication that they choose to take? So this is like for a bad patient or a or a AOT patient or an inconsistent of medication patients, like this is or.

or an aggressive patient, all of these kind of loaded terms, these are what LAIs are for. And really, LAI is just a really great treatment option to help you stay well, right? I think what we know about people who take medications for chronic conditions, and this is like all chronic conditions, right? We know that it's about 50% of people will take medications as they're intended.

And we're not talking about people who have psychosis, who are disorganized. We're talking about, like, this is even, like, information from the American Heart Association for people taking chronic heart medications. These are all people who are humans, right? And so we just happen for this particular problem

to have certain tools that not all other fields have to treat. And so for LAIs, we counsel our residents to really introduce them early as a treatment option. And it's an option, right? You know, hey, you know, are you and your mom like getting to arguments about am I taking medications, am I not? You know, come in once a month and get a shot. The arguments go away.

You know, hey, are you, you know, wanting to go live your life freely, go to college, do whatever. You don't want people to know you're taking medications. You don't want it to think about it. Come get an LAI, you know. Hey, are you having some side effects that are kind of bothering you? Try an LAI, right? You know, it's more consistent in your bloodstream, so the side effects might be a little bit less. So we try to offer that early as an early option.

Because if 50%, I think LIAs are maybe highly underutilized, maybe like 13 to 20 percent, 15 percent utilized. But if 50, I'm getting head nods from Dr. Kane, so yes, I'll get back. I'll get a good track. So if 50 percent of people don't take medications as prescribed, 50 percent of people could benefit from LIAs. only 50% get offered to them or use them. But then how do you decide which 50% to give your LIA, you know, offer LIAs too? You just offer to 100% at the beginning and then, you know,

hopefully they're more utilized. So one, that's like a first strategy. Now, say we get to the point of talking about clozapine, right? So I usually try to highlight, like, the really great things about Closopine. And when I talk to residents, we speak about kind of like studies and like numbers and all kinds of things. In my experience, I tried that very often with patients and families, and I realized it wasn't super effective. Like, I think patients and families really want to hear about like, you know, like, oh, positive stories, anecdotes. That's why I've moved towards now.

I'll tell a story about a young woman, like, for example, that I remember from early in treatment, I'll try to make it very vague because I'm very conscious about, you know, like PHI stuff, but, you know, who had a Truman show like delusion, a very common, the referential delusion that can happen. And over a period of, I would say, a year and a half after starting Closopine, and Closopin really being kind of really the main agent, she may have had like maybe a benzodiazepine as well or something. You know, it went from believing that everything going on in the environment was like a reality TV show directed at her to, and she's really bothered by it, to it's happening less, it's still happening, but I don't think about it, I don't worry about it, to, oh my goodness, I couldn't believe that

I was thinking that that was happening. And it literally took like a year and a half. So sometimes when I tell that story for patients, it like kind of gives them, like, oh, okay, this could be me as well. When I tell that story to teach residents, I tell it to say that, you know, you have to have a little bit of faith in Closopine, because I think part of the challenge in, part of the challenge that Dr. Kane mentioned in terms of how it's underutilized is, like, the rules are a little bit different. People are afraid to use it, and like they use it too late. And then like if there's, sometimes if there's any kind of side effect that scares them, they pull away from it. So just giving people some confidence that it may take a very, very long time to see good results, even on monotherapy. But the good results can and do come, I think is really reassuring for people to hear. Love it. Love it. If I could just add a couple of things to what Lauren said. So I think with the long-acting formulations, she really emphasized how common it is for people to have difficulty taking their medicine.

And in fact, if you look at some of the drugs that are used to lower cholesterol, et cetera, people don't even get the prescription filled, not alone take the medicine. So it really is, as she said, it's really human nature. and I think we have to destigmatize non-adherence. We have to convey to patients. This doesn't mean you're a bad patient or a bad person. It's just human nature to have trouble taking your medicine. One of the problems is we don't know when somebody is taking their medicine or not. If they're on oral medicine, most of the studies show that doctors are not very good at knowing when their patients are taking medicine.

because we all like to think that our patients are, you know, are very compliant. And in fact, when we've done surveys asking physicians to compare the literature on noncompliance to their own patients, they always say their patients are more adherent than everyone else's patients, which is just not the case. So I think the use of long-acting formulations obviously is one strategy to address this human nature challenge of taking medicine. But it does have other advantages as well in that we know for sure when someone's getting their medicine. So if they relapse, it's not a question of, you know, was the person taking their medicine or not? If they relapse on a long acting, which can happen,

it happens less often than on oral medicine, but it can happen. We know that they've broken through the medicine and we know that we have to, you know, think about other strategies such as Chlosopine. Another factor is, as Lauren mentioned, you know, some doctors sort of say, well, I'll wait until somebody demonstrates non-adherence resulting in a relapse or a hospitalization, and then I'll introduce the LAI. The sad reality is they don't usually do it after the first relapse. It's often several. And data from the University of Toronto, for example, shows that if we let somebody relapse, that their response to medication is not going to be as good as it was in the previous episode. And this study was done in 130 first episode patients who were treated in the second

relapse with the same drug that they received in the first episode, but yet it was less effective. And so we, you know, we think that relapse can be sort of part of that trajectory towards treatment resistance, not to mention the fact that in a young person early in the course of illness, a relapse or a hospitalization can have a tremendous impact on their pathway to recovery. You think about a young person who's, you know, been in university and they have to drop out because of a psychotic episode, but they respond well and they go back to school. What happens if they have another episode and or the same thing with employment or with social relationship? So we really want to try to prevent every relapse possible during the early

phase of illness. And I think the long-acting formulations are just more convenient as well for patients. You know, you don't have to take pills every day. Every time you open the pill bottle, you're reminded, you know, I have schizophrenia. When you go to the clinic once a month, you know, that's not a daily thought necessarily. And also some young people are they might be at university and have roommates and people don't necessarily want their, you know, roommates to know what medicine they're taking and why, et cetera, et cetera. And Lauren mentioned the reduction in family tension that can be a result of using an LAI.

We also, I think, can use lower doses because we know exactly what the patient is getting. We don't have to worry about them missing a dose or two. I also think it can be helpful in patients with comorbid substance abuse. And in our data and some of the national data, between 40 and 50% of patients with schizophrenia, have a lifetime diagnosis.

of substance misuse. So, you know, there too, if someone's on a long-acting formulation, we have more confidence that at least they're getting the antipsychotic drug. They're not going to stop it for the weekend because they want to, you know, use a certain kind of drug or what have you. And then in the case of clozapine, I think, you know, what Lauren said is absolutely true. And the way I try to present it to patients is this gets back to, you know, the data that she mentioned. And so we know that about half the patients are likely to derive clinically meaningful benefit from Closopin. Not everybody, but at least half the patients. But there's a subgroup of patients, and this gets back to the storytelling that she was referring to,

there's a subgroup of patients for whom it's really life-changing. I mean, really life-changing. And we have no predictors at this point. We don't have good biomarkers to identify who's going to benefit from Closepine to what extent, et cetera, et cetera. So I think the patient and the family need to know, yes, this is a medication that is the only drug that's approved by the FDA. There's a good chance it's going to help you. There's also a chance it's going to change your life. It would be a shame to miss that opportunity. And what we can do, if you agree, is institute a three or four month trial of the drug.

And then you can see how it affects you personally. And then you can make an informed decision about whether the side effects, et cetera, the risks associated with Gloosopine are worth it in terms of the benefit that you see for yourself. Otherwise, it's very abstract. I mean, how does somebody, you know, sort of think, well, what do you mean life-changing? What are you talking about? So it's basically, in my opinion, it's basically trying to get an agreement on a three or four months trial. That's long enough for us to get a sense of whether close of peen is going to work. It's not going to tell us the full extent of the benefit, because that can take longer, but it will at least give us a sense of, okay, is this person

going to be a responder to close apine? And then they can make, I think, a more informed decision. So a lot of this is, I think, is how we present it to the patient and to the family. Families are very important in these conversations. I mean, as Lauren mentioned, in the case of long-acting formulations, there's a lot of family tension about medication taking. So if the, and we've had families who've said, you know, gee, no one ever told me that there was a long-acting formulation. That would have been really helpful if I'd known that. So it's a, it's also a matter of sharing that information. And I think back to the storytelling issue, it can be very helpful to have patients with lived experience, you know, sharing their stories

about, we've had patients say, you know, initially I was extremely reluctant to take a long-acting formulation. But eventually I did try it. it was really very good for me. I mean, I've been very happy with it. And same thing with Closopine, to get, you know, have a patient with lived experience who can really explain their own, you know, trajectory, et cetera. I think it can be very powerful. Excellent, excellent points. Yeah. So it sounds like from the very first session with the first episode, psychosis patient, you're already having this conversation about long acting injectables and Closene.

I think particularly for long-acting injectables, I think what the kind of conversation we can have with a first episode patient, not obviously, you know, once we've had established a relationship, et cetera, is to explain that initially, you know, we're going to treat you with oral medicine. We're going to see how you react. We're going to get the dose right. We're going to monitor for side effects, et cetera, et cetera. We're going to make sure we have the right drug. And then, then we're going to switch to a long-acting formulation because that's the way we treat your illness and make it, you know, almost. an expectation, rather than somebody introducing it, you know, months or years later as an option. I think if we can, you know, when someone's admitted to a cancer hospital, they're usually told

that we have a protocol. This is the protocol we use for treating your cancer. And that provides the patient with some expectation. So with the long-acting formulation, even though we may not be using it, you know, the next week or the next, even the next month. month, at least, you know, the patient is informed that this is the expectation. It doesn't come out of the blue. And interestingly, there is a relationship between long-active formulations and clozapine that we should talk about. So patients are often identified as treatment resistant when, in fact, they're not taking the medicine as prescribed. There was a study done in London where they had about almost 100 patients who were referred to a specialty clinic for treatment resistance.

with the expectation that they would get clozapine. And the investigators did blood levels, and about a third of them did not have therapeutic blood levels. So the trip guidelines, which we published in the American Journal of Psychiatry several years ago, which is a focus on treatment-resistant schizophrenia, recommended that before we start chlosephine, we use a long-acting formulation to ensure that the patient is actually getting the medicine. And if we do that for four months and the patient is still, still meets criteria for treatment

resistant, we know that we've eliminated the possibility of pseudo treatment resistance. So I think, you know, there is this, in a sense, relationship between long acting formulations and chlizapine. We've been working recently with a large series of clinics across the U.S. treating first episode patients. And we've seen that the rate of re-hospital. in first episode patients is higher than we'd like. And in a study that we did several years ago,

it was one out of every three patients following a first episode were re-hospitalized within the next two years. And that's consistent with some international studies as well that we meta-analyzed. So if one out of three patients with the first episode are being re-hospitalized within two years, we have to do better than that. And I think long-acting formulations are a way to really,

address that challenge. And we published a paper in JAMA psychiatry a couple of years ago, showing that if we went into clinics and we trained the staff on the utilization of long-acting formulations and even did role-playing with the staff on how to have the conversation with the patient, we got the acceptance rate of long-acting formulations in first episode and early-phase patients up to 86%. And when people saw that, they said that's extraordinary. How did you do that? Well, it really, really has to do with the way, well, the staff should be trained on the utilization of long active formulations, but then it boils down to, you know, how do you have a conversation with the patient? How do you explain this? Unfortunately, a lot of doctors do it in a more pejorative fashion. You know, you're not, you haven't been taking your medicine, so I'm going to, we're going to use injections. And some patients also confound that when we talk about injections, they think back to a, you know,

horrific experience they had in the emergency room where, you know, someone held them down and they were given an intramuscular injection of an antipsychotic drug or or another drug. And that's, you know, that's a traumatic experience. And this is completely different from that. In fact, we're doing this to try to prevent that from happening. So that's part, you know, part of the educational process. But, you know, what we did show in this study with over 400 first episode in early phase patients is that when the conversation, is done in the right way, the acceptance rate can be very, very high. Yeah, I'm curious, like, let's say the patients in their 20s, they have very low insight

into that they have any problem at all. You are the problem. I don't want to be here. I don't want to be at this place. You want to give me poison. The parents may be enthusiastic about you giving the injection, because they see what's happened to their child who's living at home now, who's disorganized, hearing things up all night, destroying property, you know, maybe thinks one of the members

of the family is racist, is yelling at times to themselves. Like, okay, so let's say you have that patient. Walk me through your approach to getting them on an injectable. Well, you know, I think one part of the message is that there's no difference between the injectable medicine and the oral medicine. It's the same medicine. So, you know, the challenge we have with the kind of patient that you're describing is getting them to accept medicine altogether. But if we can get them to accept any medicine, the long active formulation has many advantages in that, you know, they're not forced to try to remember to make that daily decision, you know, because that it doesn't. does boil down to a daily decision to take the medicine and the once a month injection. And there are there are formulations now that are available once every two months,

once every three months, once every six months. I'm not saying we should start, you know, with that in the very beginning. But those are options ultimately. You know, I think we have this challenge, patients who lack insight. We have this challenge about how do we keep them in treatment. And that's, you know, it's not an easy, it's not an easy scenario. I think sometimes it helps to focus on what their goals are in life, not to get into a debate about, you know, the illness they have or don't have, but, you know, you don't have a job. What can we do to help you get a job?

And if these symptoms that you're having are interfering, you know, with your work, let's see if we can get these symptoms under control. and that try to approach this through really a discussion with the patient about what, you know, what do they want? What do they want out of life? What can we help them achieve? But again, it's not easy. We're not going to succeed with all of our patients in this conversation. It's a difficult illness to treat.

There's no question. Dr. Hannah, anything that you've learned for being in the working with these clients for a while now? I think, well, to a certain extent, as a mental health practitioner, everyone has to learn how to, you know, sail their own boat in a sense. I guess what I mean by that is, you know, we come to the job with, like, you know, our own past history, our own unique social locations. And so I think it really will be individualized to the practitioner. Now, for me, I have, I would say, an objectively unique experience, right, as being from an underrepresented in medicine and in psychiatry group as a black, West Indian woman physician. And so I think for me, especially knowing that the population that we treat,

So Joey and I, Joey is a supervisee of mine in early treatment program in the OnTrack, New York program. Our residency program has a continuity clinic experience that introduces residents early into outpatient treatment. So Joey is now a fourth year chief resident, but he and I have been working together in continuity clinic weekly since his second year, right, in our clinic. Wonderful. The population that we treat, you know, first episode psychosis, young people, experiencing psychotic illnesses for the first time, it's a population that is overrepresented by three to four times by black patients and overrepresented by three times for Latinx patients compared to the white population. And so given the, my kind of unique social location that's, you know, unique in medicine

in psychiatry and given the overrepresentation of the patient population for the condition that we treat, for me, my style is kind of very casual style. That works for me. That works for me for kind of who I am and for the patients I treat. And so when they come and see me, like, you know, it's kind of like an unassuming experience. And I think that regardless of the patient population you're treating, regardless of your own unique social location. as a clinician, I think that what we know is that the relationship is like a very huge important driver of help, right? Before we had any medications, what was it like 1950 chloropermazine? I think before medications existed, like the relationship was the main, only thing that we have,

and it's still one of the most important things. So I think that for me, kind of just like, a very casual, like, style can be really helpful in, like, building that relationship. And sometimes in that way, you know, with those difficult conversations, sometimes it helps. Very often it doesn't. We work in a difficult population. I think the other, the other, like, really important pearl of wisdom that I try to relay to residents, I treat also to family members, right? because this is a difficult population, difficult illness, you know, and you're really trying to think about the long game.

So you're trying to do what you can to help. You know, you're trying to inspire hope. You're also trying to be realistic, right? Like, be realistic and kind of in the messages that you're sending, and you're also trying to preserve your own psychological safety, right? because I think that it's really important to focus on kind of wellness, focus on like boundaries, to have a long career when you're working specifically with a very difficult population. Because the, as the clinician, like yourself is like the main driver of that relationship,

and you really need to be coming to the relationship on your A game. And so I think kind of just making sure that you're taking care of, like, wellness, your own wellness is like a crucial thing that I really install in my supervision. Excellent. Yeah. And I want to bring in Dr. Tartalia. Tell me, like, what's going on with how you're looking at digital technology and how it can play a role in treating some of the gaps of early episodes psychosis? Sure. So, you know, technology has a lot of potential to really disrupt the way we're treating psychosis. So, you know, as we've been discussing and you've heard a lot from Dr. Kane and Dr. Hannah, there's a lot of interest in being able to find markers of psychosis in order to detect relapse so we can have early intervention to find, you know, markers that can better monitor treatment response. So, you know, is the drug actually helping the patient? And even adherence. to medication. So is the patient actually taking their medicine? And, you know, we know that there's a lot of limitations of our current care delivery model, which still predominantly relies on, you know, 30-minute clinical evaluations, maybe once a month or every few months. And, you know, we are still primarily assessing a patient's clinical status through subjective reports by the patient, which can be

subject to recall bias. And, you know, as Dr. Kane mentioned, we aren't always good at telling if people are off their meds. So there is some limitations to a clinician's ability to assess. So, you know, what's happening is in between visits, we're not really able to capture a full clinical picture of what's happening to the patient. And a lot of information is being lost. And there's a lot of missed opportunities for early intervention. So, you know, what people realized is what patients are doing between visits on a daily basis is using technology. So we know that people spend hours on their smartphones and their computers. And these devices are gathering a wealth of information about these individuals.

So if you think about your smartphone, right, most of us are glued to our phones, maybe even sleep with them under our pillows. And what these phones are doing is they're capturing a lot of really important data, like people's steps, their geolocation, are they leaving their homes, their sleep data, what time they're sleeping, how much they're sleeping. even voice and conversations, which can be a metric of social engagement. And paired with wearable devices, they can even accurately capture physiological metrics, like your heart rate, your respiratory rate.

So there's evidence that all of these types of information can be linked to changes when someone is undergoing psychosis. There's even a lot of information about what people are doing online. So what people are searching for, when they're so. searching, what they're posting on social media, what time they're posting. So, you know, the question that what we call digital psychiatrists are asking is, can we take all of this digital information about a person that we obtain from devices and apply machine learning to capture digital signatures of mental illness? So in psychosis, in particular, researchers are looking

at signals for psychotic relapse. So this concept of finding a digital biomarker has been coined digital phenotyping by one of me mentors, John Turus and his folks. And we use this term to really capture the concept of looking at two different types of data. So, you know, one type of data that we can get from technology is active data. So this is the data that users are actually. actually inputting into devices themselves. So, for example, filling out a symptom questionnaire that's pushed to them through an

up on their phone. And then there's also passive data. So this is data that's being collected by technology that doesn't require input. And, you know, we really get excited about this kind of data because it uses the, you know, set it and forget it approach, which can, you know, be really helped. in particular in patients with psychosis who, you know, as you can imagine, as people get sicker, they might become less engaged in technology and stop using apps. So, you know, if we can capture information through, you know, tools that people are using on a daily basis, we might be able to

better get a signal that's going to be consistent and, you know, reliable when people actually do get sick. And so this is the kind of research that. that people are starting to look at and apply to psychosis. Wow, really impressive. It's, yeah, I can, I've started looking at some of this data because I'll have patients open up their smartphone and we'll look at their steps. And so one thing I've noticed is that when they'll describe like,

oh, three months ago I started getting depressed, you know, and so I'll have them pull up their phone. And lo and behold, the steps started decreasing like five months, months before and then four months it went down and then three months it went down to like fifteen hundred steps a day right which is super low super low and then go ahead dr kane no i was just going to add to what julia said and to what you just said i think you know this is an enormous opportunity it's really a potential revolution in the way we can help both identify illness and also manage it but you know in the u.s right now and

elsewhere around the world, the duration of untreated illness is staggering. In the case of schizophrenia in the U.S., the median duration of untreated psychosis, meaning the interval between somebody developing actual psychotic symptoms and the first care that they receive is a median of 14 months. So a year and a half, people are ill for over a year before getting any help. And with anxiety disorders, depression, obsessive-compulsive disorder, bipolar illness, it's even longer. So one of the questions, and these, a lot of what Julia referred to is also research that's being done at Zucker Healthside by her and our colleagues. One of our colleagues, for example, in trying to address this challenge of the duration of untreated psychosis, looked at social media

postings. And it turns out that, you know, young people who are developing a psychotic disorder, the nature of their social media posting changes in terms of the words they use, in terms of frequency, et cetera, et cetera. So these are the kinds of things that can be used as aids to us in helping, hopefully, to intervene earlier. And she mentioned internet search histories. That's another thing that she and our colleagues have been looking at is, you know, the internet is an interesting phenomenon because we can see what people are thinking now.

based on what they're searching for. It's really a unique opportunity. And so, you know, these studies have shown that by looking at internet search histories, which are provided to us, you know, voluntarily by the patient, we can seize patterns in illness development or the trajectory of illness, et cetera. And so the duration of untreated illness is one thing. And then when young people are going online, looking for information about mental illness, which is, you know, that's what they do initially.

That's a point where we can also intervene if we're working with national organizations like the Mental Health Association, which provides online tools for self-assessment. So the trick is, you know, many people will do a self-assessment, but if they do score above a threshold, what do they do then? You know, do they really seek help? And many people are very reluctant. So we have to figure out ways, you know, to engage people online and then hopefully, you know, get them the help they need. And if you think about some of the unmet needs, we were talking earlier about first episode of schizophrenia, you know, the things that prevent people from working or going to school are really negative symptoms and cognitive dysfunction, more so than the positive symptoms. We have a hard time assessing negative symptoms because basically somebody comes into our office for half an hour and we're just, trying to make a judgment about their, you know, their level of socialization and of self-care,

of activity, of motivation, et cetera. And they're not necessarily very good at reporting back to us what is actually happening. But if we can monitor someone with their smartphone, as you said, you know, see the change in the number of steps or geolocation or how often are they interacting socially with peers or loved ones, looking at frequency of text messages or phone calls or what have you. These are all very powerful tools to assess things that are extremely important to functioning. Same thing with cognition.

You know, we can monitor cognitive performance with simple tests that can be, you know, done remotely. And even in the case of the differential diagnosis, you know, earlier we were commenting that some of the data we discovered. really was relevant to schizophrenia and not necessarily to other forms of psychosis, well, that differential diagnosis is a challenge, no question. A lot of community mental health centers are understaffed and overburdened. And, you know, I think that the training and time that goes into a differential diagnosis is a challenge.

So if we have methods like speech and voice and facial analysis, those can be extremely powerful in terms of helping us and make a differential diagnosis. So I think this really is a revolution and it's going to provide a lot of opportunities. The obstacle, however, is going to be us. I mean, it's how rapidly will the clinical team actually adopt some of these tools? Because what we know is when we go into a clinic and we offer something new, the initial reaction is often, well, I'm too busy. I can't add anything else to my workload. So all of this has to be done in a fashion that does not increase the workload. But it's also introduced in a way that we can help clinicians understand that this will make their lives easier, ultimately. But that's not an easy message to get across.

I think there's a just for example, the electronic medical record was introduced as a way to make people's life easier. Turned out that not everyone feels that way about the electronic medical record. So I think we have to be careful how we introduce this and to do it well and to understand, you know, how it does impact workflow and how people react to it. So you can have the greatest technology in the world and people are still not going to use it. You know, earlier we were talking about long-acting formulations and clozapine. And we're discussing why these are evidence-based treatments that are underutilized. And, you know, we have to understand the factors that contribute to that. Yeah, I think it's.

one study on internal medicine doctors and EMR is that they spent like, I think it was about 75% of patient care time looking at their EMR compared to 25% looking at the patients. And yeah, so it's like, yeah, at what point is the human connection, you know, decreased by increased technology is probably not a great thing for psychiatry. But I love, I love this idea of, you know, something that populates, into my note, right, with data from what's happened actually in the person's life. It's like different bios, you know, like steps per week, you know, simple things like that. It's like how active someone is. It's a sign of how healthy they are.

I'd be curious, like, what are the other, like how they're writing, you know, we know that people when they're, who have schizophrenia that's very active, they can write very disorganized, right? So it's like now with chat GPT, I'm sure, because I put in, I've asked chat GPD, you know, write me a disorganized conversation from a schizophrenic and a psychiatrist. And it can kind of, it kind of knows what it would look like, right? So I think with these new technologies that are coming out like AI, there's going to be a revolution of the ability to understand where someone is at with symptoms. And I'm just, I'm thinking it's really cool that you guys are at the cutting edge thinking about this stuff. And we could probably dedicate a whole series to this topic, you know, like, or where it's going or what companies are at the forefront, who's thinking about this? It's a fascinating topic.

One thing I would add is that a lot of clinicians are not eager to see all of this data, even though it might be helpful because they're going to view it as a burden. And so I think, and we've done this in some of our. studies is to have a what we called a digital technology health coach. So somebody you can sort of act as an intermediary to do several things. One, to onboard the patient if there is some new app or some new technology to show them how to use it and be in touch with them if they're having any difficulties using it, but also to be the person to initially look at the data and to synthesize it in such a way that it is meaningful to the clinician. Because I think what the clinician ultimately wants to know, you know, the person treating

that patient is, do I need to do something differently? And so a lot of, you know, a lot of the state is going to require attention, analysis, understanding, and then I think translating it into an action plan. And somebody, I think someone is going to need to help the clinician do that, unless it's all done automatically. but, you know, at least in the short term, I think having a real person to serve that role will be very, will be very valuable. And to add to that discussion a little bit, so there's a new term digital psychiatry clinic that is emerging. And at Zucker, we're also, you know, kind of at the forefront of attempting to create something of that sort for our hospital.

So this is, you know, taking all of these concepts and research and actually figuring out ways to, apply it clinically. And we're working with a few different digital phenotyping platforms and, you know, doing research on assessing the efficacy. But to kind of build off of what Dr. King was mentioning, there's a lot of barriers to actual implementation right now. And, you know, one thing I think we haven't mentioned is data safety and also the potential for bias within algorithms. And so So this are two really important topics that are going to require certain changes all the way up at the policy and regulation level to make sure that companies that are managing this data are making sure that the data is kept safe, stored securely.

And also, you know, we do know from research that there's a lot of potential for bias of the saying garbage and garbage out. If you're feeding these algorithms with data sets that don't have diversions. patient populations, for example, you know, we can, we know that there can even be harm done from algorithms, you know, facial detection has shown to have a racial bias, for example. So these are all things that are, you know, very hot topics in the field right now, making sure that we're developing tools that are, you know, equitable, accessible, and safe for our patients.

Wow. That's what you mentioned, Julia, that's one of my main worries or concerns, just knowing that the population we treat specifically for psychosis is so overrepresented with people of color, knowing that things like however, however technology might analyze or machine learning might analyze speech patterns when, you know, we know language can be different and different kind of sociollex, different kind of uses of like slang or different type, you know, language changes and knowing how we know facial recognition is less accurate for brown faces. It's one of my real concerns about kind of the implementation of some of these technology.

Yeah, can you talk a little bit about that? Specifically, I know we cover this topic on the podcast of the over-representation of schizophrenia in the black population. But I wanted to get any feedback you had on that episode, any additions. I think you've listened to it because Dr. Flexter told me. Yeah, so I'm very appreciative. Dr. Flaxer for introducing me to your podcast.

I'm definitely become a more consistent listener, but the episode I did hear was that episode. And I thought it really accurately captured some of the concerns. The one thing that I wanted to add, because I think it was mentioned the

over-representation and the obvious concern about kind of like bias and in diagnosis and contributing to the over-representation. There was an article in American Journal of Psychiatry in 2021 by Anglin and colleagues called From Womb to Neighborhood, a racial analysis of social determinants of psychosis in the U.S. And so one of the things, so there's that article.

There's also an article by Schwartz and Blackenship from, I want to say it was 2014, that did a literature review of studies. of racial disparities in psychosis diagnoses from the past 25 years. So this is like a time period that is subsequent to the time period referenced in protest psychosis, which is I believe in 1940s.

And in Swartz and Blankenship's literature review, what they showed was that black people were overrepresented three to four times, whites for psychosis, Latinx three times, whites for psychosis. This is kind of like the known thing that was referenced in your previous episode. But in terms of what is the, like, what are the contributors to it?

You know, I personally suspect it's multifactorial, right? So I definitely suspect that there are kind of maybe biased, the problem of, you know, maybe lack of relatability. If there's only 3% of psychiatrists are black and, you know, the population of psychosis is overrepresented black, you know, that there might be a relatability issue. But in Anglain's article, they really looked at certain social determinants of health that predisposed or overrepresented in black and brown communities and how that overlapped with like known risk factors for psychosis. And they looked at, they had like three main categories being like birth and obstetric complications, exposure to trauma and also neighborhood factors, kind of like lack of green space. all these other kind of things, and like the overlap, and the theory is that at least some of the answer to why there's this discrepancy, both in the U.S. and also internationally, you know, we know immigration status is a known risk factor for development of psychosis, but we also know

that there's a racial component to that. If you are a racial minority immigrating to a country where you are not the racial majority, that's also a risk factor. So there's a theory that it may not only be bias that's contributing to this over-representation, but I wonder if there's actually, this is a real disparity, right? A real disparity based on the increased social terminal health from structural racism that communities of color are exposed to, and that increased stress, that increased trauma,

just over increasing the risk of development of psychosis. So it's a very complicated issue, and I would encourage everybody to take a look at that article from boom to neighborhood, American Journal of Psychiatry, 2021, Angling and colleagues. Really, really helpful. So, yeah, I think that your passion for this is obvious, and I think your passion for the population

and working with people who are first episodes psychotic patients in New York, right? Where it's like a lot of minorities live. At risk of hijacking your podcast. So Joey and several of our residents are highly involved in a social justice group

at our hospital. And, you know, I would just, I'd be curious to hear his experiences as in being a leadership in that group. Also, his experiences and I think some, I think you have, like, you did an externship or some additional study with the Akhrman Institute for Child and Family

that, like, heavily focuses on bringing kind of the social justice lens to our clinical work. So I guess I would encourage you to ask Joey about some of those topics if there's time. Yeah, no, hijacking. Hijacking is available. Yeah, it sounds like, It's a part of the bigger question on how we treat this difficult population as well.

It's difficult as in like treatment resistance, schizophrenia, first episode psychosis, getting them on the right medication, appropriate follow up. You know, how do we decrease barriers to get help? Minorities can feel a parentalness sometimes with providers. There's a distrust of authority. that is rightfully there at times, you know, especially with like, um, other types of authority that there may be abuses seen more, more visually. Um, yeah, so what, what are some of the things that you guys have been finding, I guess, go ahead and educate my audience. Yeah, I mean, I think to speak to some of the things that Dr. Haddon was alluding to. I mean, no, I mean,

again, this is another one of these topics that we could dedicate a whole bunch of episodes to because there's so much to come into. But I think that, um, you know, one of the things, you know, one of the things I've learned to appreciate as a, you know, as a white person, as a white man, like going through psychiatry training through my experience doing social justice and anti-racism work with people in my program and also at the Akron Institute for the family, which, you know, has been a pioneering organization in helping family therapists, but also more generally through the work of people like Dr. Ken Hardy and helping mental health providers learn and like learn how to speak about social location and race and class and any any form of social

location like within the context of therapy. Not that it's something you have to talk about, but something that you kind of acknowledge internally and often verbally that's present in the room because as Dr. Hannah was talking about earlier, you bring yourself to the work. And so especially, you know, like I've had the privilege of working with Dr. Hannah in the in the on-track New York, like early treatment setting and have, yeah, like, it's been nice to be able to talk about issues around race and social location and supervision and to think of, and to be able to normalize talking about how that influences the patient relationship. I think to tie it, like, more specifically to the, like the clinical work that we do,

like when Dr. Hannah and Dr. Kane earlier, when you had asked them about treating patients, some, you know, with like maybe poor, like poor insight who don't necessarily want to be engaged, don't want to be taking medication. It, you know, it made me think of like the recovery model for treating mental illness. And, you know, when I, when I think about the like the recovery model, it's not something that's just unique to on track New York, but it's into the early treatment program that we use. It's kind of a nationally used model. But I think it's been helpful as a, as a trainee and as a resident, having active supervision with Dr. Hanna and learning to balance kind of the medical model and bringing the best evidence-based treatments that we've been talking

about with the recovery model, which takes an attitude of optimism about the recovery from psychosis and emphasizes empowering people with mental illness. It's a very collaborative model about treatment. And so like in the in on track New York specifically, we're very lucky lucky to have a grant fund from New York State. And so our patients not only like not only we're offering medication, but we're offering to every single person who comes through the door, an individual therapist, education and career specialists, social clubhouse type groups and other like forms of group therapy and peers. And to me, part of like the powerful message for that, like for me through those offerings has been that like for patients who don't want to be on

medication, it's like we're still offering these other things to them because we value them as a whole person who can work and who can go to school and who can engage in treatment in many different ways. And to help and like taking medication doesn't have to be like the first step or anything like that. And obviously because we're grandfunded, we have the privilege of being able to offer those things. Many clinics don't have that privilege in the first place. But I think it really it really helps with that patient relationship because it helps to see people as more, more whole and more human. And I think that helps like the relationship with the patient because they, when they see that you see them as more, more human in that way, you know, and they stay engaged.

And the medication, the medication conversation can always be on the table and can be revisited at different points. Kind of like in the Dr. Michael Garrett episode a few weeks ago when he was talking about how when he does psychotherapy with patients with psychosis, like taking medicine is almost taken off the table at the beginning as a thing that you don't have to do this. And I think, to me, it speaks more broadly to the recovery model. But I think within the recovery model, we're really talking about socio-cultural context and being able to, like, I think to be well-prepared mental health providers, we need to be able to comfortably address race, class, gender, and other, all different

parts of socio-cultural context when we're with patients. Yeah. Yeah. Tell me a little bit more about like when you say recovery model, what, what specifically do you see as the goal of the recovery model in particular? I mean, yeah, and I think like Dr. Cannon, Dr. Cannon, you guys can probably speak to this too. I mean, in my mind, my understanding of the recovery model is that it's like obviously like in all cases we're trying to improve quote unquote treatment outcomes. but the end point is more toward like meaningful and productive roles in society, being able to have, like, live a life by people's, you know, own values in terms of like being able to participate in society and work in their families and in social settings. And it really does require, you know, more than just medication, you know, as Joseph mentioned. And it's a model that is also referred to as coordinated specialty care in the U.S.

And, you know, it's been introduced more broadly. But something that we did a major study funded by NIH a few years ago called Rays. And the idea was to see if we use this kind of model, could we improve quality of life, for example, in a population of first episode patients? And we were able to show that, you know, if you can provide something, the individual therapist, the family psychoeducation and family therapy, also supported education, supported employment, along with appropriate medication, that you have a better chance of producing the kind of outcome that patients are looking for. So a lot of this has to do with, you know,

what is that, what are the goals that that individual has? What do they want to do? And it's not, you know, I think in the past, we often had a way to, to paternalistic attitude. And we've moved towards a shared decision making and a focus on resiliency and focus on strengths rather than weaknesses when we talk to our patients and to really help them understand their goals and how to achieve them. And this is a process. It, you know, it evolves over time.

But sadly, the recovery rates, when we look at the data on recovery and schizophrenia, the rates are low. and we need to do better. Thinking about recovery and medical model stuff, like another way that I think conceptualized recovery is if you're learning as a resident kind of certain things, like, oh, well, this is the BPRS score for response, remission, recovery,

this quote-unquote return to normal, whatever normal means, however many, two years of, like, no symptoms, whatever kind of things are in the textbook, how I think of medical model recovery, whereas, as Dr. Kane and Joey have mentioned, like, more recovery being like, what is your personal goals? Was your goals of treatment, really patient-centered? You know, maybe you might still be having symptoms. But, like, you know, am I living, is that okay for you? Is it, is it, is it okay for you to have this level of symptoms

rather than taking this much medications? Like, it's like redefining the definition on an individual person by person basis of, like, how you want to live your life. what are your values, what are your personal goals, and also giving people, allowing people have the dignity of risk or the dignity of failure. So it's not about kind of, oh, we're trying to prevent, you know, some outcomes we're definitely trying to prevent, like the worst of outcomes. But, you know, sometimes, like, there's a learning process through, like, okay, I went to the hospital a couple times and then I learned from that experience. I tried to live independently in work. I learned from that experience. And just kind of allowing people with mental illness

to have the same decisions that people who don't have serious mental illness have, right? We all as people get advice from people on making decisions, and we all learn from failures in life. And I think that people who have serious mental illness shouldn't feel like they're exempt from that same opportunity to kind of play around in life and make decisions and kind of learn from things that work or don't work for them. That's good. I'm excited to hear, like, as you've instituted this recovery model, psychotherapy, family therapy,

groups, what kind of outcomes are you guys seeing as a whole clinic? Do you have data on that? So those data are being collected by this national study that NIH has funded. We can't comment on the current data because it hasn't been analyzed yet. But I think, you know, overall this model has, has been shown to be more effective than just kind of usual community care. And I think the process is also, you know, as, as Lauren mentioned, of training the staff in this new model so that they, you know, they understand, you know, how to approach this with the patient, with the family. And I think we will see, we will see better outcomes. Yeah. Oh, here's one for Julia. So I was, I recently heard. that a large company, I don't want to name the company, but a large therapy company,

sold the data of people who had signed up. They sold the initial form, which had some initial screening things on how, you know, depressed or anxious they were and their IP addresses to, you know, Facebook and, and so, yeah, I think there is a concern on how companies use patient data, right? And I'm curious if you have any thoughts on that as you kind of go into what you're going into. I think it's very concerning. And, you know, it's a really important topic that a lot of key stakeholders are interested in. And, you know, how can we keep this data safe and what responsibility do companies have to protect this information?

So when we work in hospitalist systems, you know, we fall under HIPAA. But what a lot of people don't realize is a lot of these wellness tools on the market fall under the category of wellness. And they don't label themselves as a medical app. And this company that you're referencing might not even fall under this. But it opens up the umbrella for people to do what they like with the data. And I think one of the problems is when people consent to using apps, they consent by reading terms of agreement, which we all know is written in jargon, difficult to find. And a lot of people don't really know what they're agreeing to when they share their data.

So I'm involved in some committees on the APA. And one of the things we're talking about is how can we advocate for more transparency from companies around how they're using the data and how can we really hold companies responsible to be, you know, safer with this data and, you know, not just selling it without patient consent. So, you know, it's a really challenging topic with no clear solution right now. But I think, you know, we're going to keep reading about it in the headlines because as, you know, as treatment is moving digital, you know, there's just going to be more and more data being collected on people that, has, you know, potential to be exploited. So this one particular company, they faced, you know, lawsuits from the FTC for selling this.

But it's like pennies compared to how much they're making big data is so valuable, right? If a company can target a patient for a new medication, for new treatment, that's an expensive treatment. So, yeah, I'm curious, like, as you're in those conversations, hearing what people are talking about. Like, why isn't there just a broad ban on selling patient data that's like, you know, there's got to be some sacredness to this information, you know? Yeah, I don't know. Any thoughts, Dr. Kane, on this?

This is kind of like... I think it's a challenge, you know, with modern technology in general. You know, we're all doing searches every day on the internet, that information is also being sold. We're getting pop-up ads in response to our previous searches, et cetera, et cetera. So I think it's a social challenge in general. And, you know, these data have to be, we have to protect data from individual personal information, et cetera. And I know in our research, that's an enormous concern.

You know, there's a tremendous amount of care going into the data that we collect. to make sure that there's nothing that would enable anybody to identify a patient based on those data. But this is an ongoing challenge. It's no question. There's always going to be, I think, a benefit risk ratio when we introduce new technology, and this is definitely one of the risks. And I think, you know, something that we've talked about, Dr. Kane, within our digital health program committee is issues with reimbursement.

So I think, you know, there's a lot of excitement for creating digital tools, but right now there aren't a lot of really great ways to monetize them. As we know, there aren't a lot of reimbursement codes for analyzing this data. And, you know, at the end of the day, people are looking for ways to make this solution sustainable and profitable. And, you know, we really need a lot more policy work on that end of things to, you know, be able to create ways to reimburse for, you know, analyzing sleep data. right? What is the compensation structure for that? Absolutely. Perhaps as that end catches up, maybe there will be less incentive to need to,

the desire to sell the data as the revenue stream. Yeah, I think, you know, the policy and the ethical concerns always lag, you know, the actual advancement in technology. So we're, you know, we're seeing that now with AI, and it's going to be a constant challenge, which will probably become more and more critical over time. Dr. Kane, what do you think about, like, is, I almost feel like we need like an ICU level care outpatient for psychiatric practice. And I think Closopene is like one of those things where it's like, if someone's on Closepine, the provider in my mind should be getting paid quite a bit more because this is such an effective medication. It takes so in time intensive. So any thoughts on reimbursement models, potentially.

helping America improve outcomes. Yeah, I mean, I'm not intimately involved in those, in those concerns or discussions, but I think you're absolutely right. I think a lot of behavior is responsive to incentives. And if there is a particular practice that requires extra time, that, you know, it's a disincentive if it's not reimbursed. And I think psychiatry as a whole still has a way to go, in terms of fair reimbursement. And this has led to, I think, many problems in the delivery of care. So we need to, as a field, we need to work for better reimbursement. And then to also break it down into categories of things that are, you know, more cost-effective

than other things. And I think we're way behind on that score. It's really, it's concerning. There's no question. Yeah. It seems to me like an intervention that takes someone out of psychosis, even though it's outpatient, should be reimbursed in a similar way that, you know, a hospital, you know, it's like it's just, it's all flipped around in my mind because in psychiatry, outpatient care is, is ideal. And if it can take, if it can, all the care can take place outpatient, I think it's really ideal because it improves self-efficacy. it decreases chance of something traumatic happening in the patient's experience.

It saves money. It saves. It saves money. Okay, we don't need to go into it, but I just, that's my like perspective that I think we need like an ICU level outpatient care that insurance reimburses to get people out of psychosis who otherwise, you know, like it takes a grant to get them that level of care, right? Right. Well, I think it gets back to the whole notion. of value-based reimbursement. You know, we thought we would be there by now, but we're not.

You know, we think, you know, that payment should be in some way related to the outcome, you know, that we're able to produce. And if a hospital or clinic is seeing a very high readmission rate to the hospital, that's not a good outcome. So they should not be paid as well as a clinic that's doing a better job. So but this is something that just has not happened yet across the United States. It should. And obviously, you know, we don't have national health insurance.

And, you know, there are many other problems in our health care system, which is incredibly fragmented. And I think people with mental illness in particular suffer from that in terms of access and ongoing treatment and reimbursement and so forth and so on. Yeah. I think that Dr. Pooder, you and Dr. Kane are talking about like these really, like, really upstream kind of like, national policy interventions, which we totally need. I think in the interim of having some of those more upstream interventions, like some of the things that we're doing, like I know that at our program, we have a close opine clinic, which is, you know, a program level program that makes it easier for

psychiatrists to prescribe close apine. We have an LAI injection clinic. So some of the things that kind of take away the time that aren't necessarily reimbursed, we have kind of programs make it easier to give these treatments. And within the residency program as well, in the outpatient education, we train residents on efficient billing, because there is a way to efficiently bill for prescribing Closopine within the current system as imperfect as it is. Those are very important points. And I think, you know, earlier we were talking about the obstacles to the use of Clozapine and LAIs. So I think Lauren is addressing an important point that the structure, you know, at the

institution where you work can be very important in that regard. But in addition, I think often residents are not trained in the utilization of LAIs or close opine or lithium for that matter. And I think we should try to, you know, make sure that those in training, you know, those residents around the country are exposed to those treatment options and are comfortable with them. Because if you don't have that experience as a resident, you may not be sufficiently proficient, you know, in offering those evidence-based treatments later on. So we need to work on. We're fortunate at Hillside that we have, you know, these resources and these

opportunities and this, you know, this tradition. A lot of it's grown out of the research that we've done. So that's great, but not every program has that. Yeah, I feel passionate about those topics. We've done two episodes on lithium, one episode on chlozapine, one episode on measuring blood levels of antipsychotics, an episode on long-acting injectables, other episodes on treatment resistance, schizophrenia just as a whole. So it's like, it's, it's a gap that I feel passionate about continuing to educate, continuing to talk about.

Yeah, and I'd be, I'd be open for more episodes in the future, too, if you want to do a deep dive on any of those topics. I think it would be good to hear from a different angle. As we kind of like, I don't know, I want to make sure we're hitting all the things that you want to hit. Dr. Flaxse, tell me, like, are there any questions that you still want to? get to that maybe you could ask. So I guess not necessarily from the outline we went over together, but the conversation we are having did make me think of, I think, a very related topic, which is we talk about LAIs and Clozapine and we're talking about treatment resistance and treatment gaps.

One of the things, especially here at Zucker Hillside that we talk about a lot, is the use of neuromodulation and things like, especially like ECT. We have a really big ECT program here. And I know our inpatient psych type, inpatient attending, is like. to teach us about the studies on like ECT plus Closopine and those kind of treatments that are also like it seemed to be extremely underutilized. And I thought it may be interesting to hear from Dr. Payne or Dr. Hanna or anyone about some of those topics as well if we have the time. Yeah, I think that's a very good point. And I also does have a very large ECT program.

I think the only one that's larger in the country might be the one at Harvard. ECT is still, I think a highly efficacious treatment. And George Petrides at Hillside had published a study a number of years ago, showing that for those patients who failed to respond to Clozapine, that the addition of ECT could bring about further improvement, and that has been replicated. So for those patients who don't respond to Closepine, we really don't have a lot of evidence-based options,

which is always a shame because people feel like that Closepine is the last resort. So the addition of ECT is certainly something to consider in that context. And it's another thing that I think residents need to be trained in and the use of ECT. It still is a very important modality, although it's viewed differently in different geographic areas. I think there's a lot of misinformation and myths about ECT. But we believe that it is an important, very useful modality. How big is your program? I think thousands and thousands of treatments per year.

I think it's probably like 8,000 or do either of you know? So I know that, well, I know this just having recently been working closely with the ECT team. So their clinic operates from Monday through Friday and first treatment is 730. and last treatment is probably somewhere in the afternoon, 4, 430, or a half. And ECT is a very quick, a really quick treatment. I think kind of like the actual treatment stimulus is like a 30 seconds. Like I think all together it might be like a 15 minutes set up. So it really is like a kind of a quick type of in and out treatment.

So it's very, so they do a lot of treatments. they also do, I want to say, we've touched on other aspects of like health equity earlier in this conversation. And so I should mention that they also train people from, you know, around the world pretty much on, I think, a monthly basis. They run trainings. And we, our ECT team has recently also been highly involved in trainings to try to reintroduce ECT service to Guyana. to help address their high suicide rate in partnership with the Ministry of Health with Guyana. So our team hosted a first group of delegates a couple months ago, and then we have a second group coming at the end of this month towards that goal.

Wonderful. You mentioned neuromodulation. So there are obviously other TMS, and we should probably at some point, have you had a podcast, podcasts on on the use of psychedelics and in psychiatry we we've done two on psychedelics and one on microdosing um but i'm i'm curious what your what your brief take is on where the research is and where it needs to go before it becomes mainstream i think it's um i think it's a very exciting area i think there's a lot of potential but there's also a lot of hype um it's very difficult to do double-blind studies when you're using psychedelic medications.

Interestingly, Australia was the first country to have regulatory approval for psilocybin and MDMA. So now psychiatrists in Australia are able to prescribe those drugs under controlled conditions. It has to be reviewed by a committee and et cetera, et cetera. But I think we are approaching a time when these treatments will become available. And right now there are a lot of questions as to, you know, how much therapeutic work is necessary before, during, and after exposure to one of these compounds. And so there's a lot of research that still needs to be done. But I think that some of the early results are very encouraging.

Do you think there's any risks since we're talking about psychosis? I've seen one patient personally who seemed to have a fairly significant psychotic event that I'm still trying to get under control after using mushrooms. Have you seen this? Do you have concern about this? Is this? I think it's similar in some ways to the marijuana story. There's always been a lot of debate as to what impact marijuana has.

And I think my opinion is that, In the case of psychedelics, if one has a diathesis towards a psychotic illness and, you know, psychedelics should be avoided. Obviously, people don't always know that they have that proclivity. So I think we do have to be careful, but I don't think there's a lot of evidence that psychedelics in and of themselves produce persistent psychotic disorder. And, you know, a lot of patients have been exposed to these drugs in the context. of research over the years. So I think they're actually reasonably safe. You want them to be used in appropriate circumstances with appropriate supervision, but I think they actually are pretty safe. One thing in looking at the microdosing data is it seemed like once you

controlled for expectation, the effectiveness of it seemed to not be very present compared to the placebo. I think that's a concern with the even the usual dosing, you know, that we have to understand that it's very hard to do, you know, you can do a placebo controlled trial, but the patient knows that they've had this, they're very conscious of this experience. So it's hard to keep it blind in terms of eliminating expectation bias. Yep. I think the other thing that's interesting in the psychedelic area when it comes to schizophrenia is that I believe, I think, and I think even maybe some of my co-residents here have been looking into kind of the utility and treatment of negative symptoms. So even though we often think about the risk of positive

symptoms, we have such little to offer in terms of treating negative symptoms. And I think there's some, I think, preliminary research, if I'm understanding correctly, that shows potential use in negative symptoms, which we know over the long term is the more impairing part of the illness often. Yes, there's a paper that we wrote with a couple of your resident colleagues, Mitchell Arnavitz and Andrew Spitzberg and Ash Devani, where we review the literature on MDMA as a background to a study that we'd like to do using that compound in negative symptoms.

So, you know, we're just in the early stages of that. But I think, as you said, we don't have any effect. treatment for negative symptoms and an agent that is sort of pro pro social might might help in that context very interesting yeah i think it's um it i think that when you say when it comes to the u.s i um it's like it's already here you know in my mind i think a lot of people are doing it i have patients that come in often that say they've tried it some some it's helped some hasn't. There's huge Reddit communities, huge online communities of people talking about it.

If you tweet at it at all, you know, you get DMs like, hey, do you want to buy some? So, you know, there was a recent psychedelic conference and I know somebody who went there and he said, yeah, pretty much a lot of people were doing it like in the evenings. So it's like, it seems like it's here, you know, more than more than it's not here. It's here. It just hasn't, you know, it hasn't received regulatory approval yet as a treatment. But there's no question that there's widespread use. And, you know, just as with marijuana, we went through a period of years where it was illegal.

Now it's now it's becoming legal in many states. And there are concerns about all of these things. But, you know, the most dangerous drug is still alcohol. in my opinion, the most widely used drug that has serious health sequelae is alcohol. And we haven't been able to manage that. So, you know, we could debate. I don't know if you've done a podcast on the substance use in general and legalization of drugs and how we go about deciding whether they should be legal or not.

A lot of that's political. A lot of it's political, yeah. We went through a period of many, of several, decades where the research on psychedelics was really curtailed in the in the u.s it continued in some other countries but that that was a huge political issue not a scientific issue so we hopefully you know we're living in a culture right now where science is is i think is threatened but we have to we have to try to you know preserve that i mean the beginning research on psychedelics was funded by the government CIA, right? I mean, I've read...

I think using the word research is perhaps a little too positive. Well, there were like medical schools, researchers who were funded. Now, when you said the CIA meant what the CIA was doing, I'm not sure I would want to dignify that as research. But anyways, yes, medical schools. There were medical schools doing very, I think, very appropriate types of research. Okay, let me parse this out because it did sound the way that I phrased it. It sounded like I was excited about that research. It seemed like they were funding multiple projects, some of which were more dubious and unethical than others. But we're talking about how the

government sometimes gets in the way and sometimes how it funds, you know, research. Yes, and I think NIH ultimately will be funding some of the research with psychedelics now, whereas for many years they were not. Yeah. But we have not seen enough research even with marijuana, despite the fact that it's being legalized in so many states. We still, I think, don't have answers to many basic questions about the use of marijuana. And it's health benefits and its health risks.

And that's really a shame because its use is so widespread now. I think ultimately the legalization is a good, move given the kind of my understanding of the historic use of it to disenfranchise people of color and you know continue the new Jim Crow and all of that even like the alcohol as you mentioned my understanding is that you know per none of these being really scientific decisions like prohibition back in the day ended to bring us out of the Great Depression you know so so I think it's definitely good to separate what science tells us and then just like what is happening in the country over time based on the political time?

Absolutely. And I think I think there's these these questions to me are, you know, should be medical questions and not political questions. And, you know, legalization at least provides an opportunity to work with people who can identify themselves as having a problem rather than it being, you know, rather than them being incarcerated inappropriately, it's to me, it shouldn't be criminalized. It needs to be viewed as a health issue. you know, just as smoking, you know, smoking during the course of my lifetime, attitudes towards

smoking changed enormously, which for the better. I would say with the caveat that when Portugal, you know, legalized all drugs, they also funded a lot of chemical dependency programs. Right. So it seems to me that if there is a process of other drugs becoming legal and selling them, I would say those taxes need to go towards psychiatrists treating sequelae and, I don't know, chemical dependency programs and stuff like that. Absolutely.

I don't think will happen, but I can put that out there hopefully. And also maybe giving people a head start when they were kind of criminalized. inappropriately for use of the drugs. Yeah, it's like... It's been a horror show. It's like losing your first... Losing your 10 years in your 20s is just rough. It's absolutely brutal.

Yeah. So, okay, I want to wrap it up. Any final thoughts, Dr. Kane? No, we appreciate your interest in what we're doing in our program. we're pleased to have the opportunity, so thank you. Yeah, it sounds like a really exciting program. Like, I think anyone who's interested in psychosis are just very thoughtful, a good integration of research and clinical practice, a diverse population,

you know, it sounds like a meaningful, a meaningful program. So maybe I'll try to send some of the people who are doing projects with me over to you guys. the good ones. Yeah. Yeah. Any other thoughts from anyone else? Thanks for setting this up. Joey, I'm really excited to have been a part of this.

Thanks so much, Dr. Puder, Julia, always happy to hear of what you're doing. It seems so interesting and important. And for me, it's wonderful to collaborate on another project with you once again, Dr. King. Same here. Julia, any thoughts? Any final closing thoughts? Yeah, I just want to say thank you so much for having us. It's been an honor to engage in this conversation with you all, and I appreciate the opportunity. Dr. Flexer.

I just appreciate so much, you know, Dr. Peter, ever since I reached out to you just via email, not even necessarily about this, just about getting in touch and telling you a little bit about our program and how much I like your podcast. And ever since then, you and everyone else here is just willingness to put this together. And it was so easy. So it was just a very fun and exciting process. So I really appreciate everyone's efforts. Yeah. So I will utilize your help in writing up some of the notes for the episode.

And it'll be on Psychiatrypodcast.com with lots of links to all of the things that we discussed. I like doing that just for the serious carries to be able to go on and dig into specific articles and and learn more about your program as well and about you guys individuals as well. So thank you so much for coming on. We will leave it there for today. Thank you.