#EndtheClozapineREMS: Activists and Survivors of Psychosis Speak to Lawmakers (ep.68)

Thanks to the Schizophrenia & Psychosis Action Alliance for choosing us to be the first to share this important event.

On May 24th, 2023, The Angry Moms joined the Schizophrenia & Psychosis Action Alliance and other advocacy groups for A Day of Action at the U.S. Capitol, in recognition of World Schizophrenia Awareness Day.

In a briefing dedicated to discussing barriers to clozapine treatment, two courageous survivors of psychosis disorders spoke about their experience with the FDA’s restrictions against clozapine treatment. Hear what they had to say in this moving and important episode.

Links:

Angry moms testimonials:

https://drive.google.com/drive/folders/1px4dkTi_ncNM7hxCj6ODJDDo1CZW1nlm

 Schizophrenia & Psychosis Action Alliance: https://sczaction.org

https://www.facebook.com/sczaction/?locale=ms_MY

https://www.theangrymoms.com/post/in-their-own-words-analisa-and-michael

Mindy and her book: https://mindygreiling.com/

Randye and her book: https://benbehindhisvoices.com/

Miriam (Mimi) and her book: https://www.miriam-feldman.com/

Hosts:

 Randye Kaye - was a morning Radio Personality bringing humor to CT families when her own son was diagnosed with schizophrenia. Now she is still a Broadcaster, Actress, Voice Talent, Speaker, and Author (Ben Behind his Voices, Happier Made Simple)

Miriam Feldman -  is an artist, writer, and the mother of an adult son with schizophrenia. Her book, He Came in With It chronicles her family's story and was released to rave reviews on July 21st, 2020.

Mindy Greiling - Mindy Greiling was a member of the Minnesota House of Representatives for twenty years. She helped found the nation's first state mental health caucus, which successfully lobbied for a significant increase in Minnesota's mental health funding Her acclaimed memoir is Fix What You Can.

Transcript

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SPEAKER_05 0:00

I suffered for five long years. I was in and out of hospitals while my mother tried to get care for me. None of the prescribed medications worked. And many just made me feel worse. Instead of trying two antipsychotics before trial of closopene, which is the standard of care with the American Psychiatric Association, I was forced to try 13 different antipsychotics.

SPEAKER_01 0:22

The use of closopene by patients in desperate need for this drug is being restricted by the FDA's overly stringent mandated requirements to receive medication.

SPEAKER_03 0:34

You have heard today that when we postpone treatment in our patients' six, seven, eight, nine, ten antipsychotics, it actually leads to a lower chance of recovery and a lessened ability to maintain and to live a very meaningful life.

SPEAKER_04 0:50

I was forced to use seven different antipsychotics, each of them having severe side effects such as involuntary movement, self-harm, insomnia, increased psychosis, and confusion, to name a few.

SPEAKER_02 1:03

I'm Randy Kaye, one of the co-hosts of Schizophrenia Three Moms in the Trenches. This episode is a little bit different. The Schizophrenia and Psychosis Action Alliance has graciously allowed Three Moms to be the first to share what these speakers had to say in Washington on World Schizophrenia Awareness Day. It's very, very powerful and very, very important. Welcome to our podcast, Schizophrenia. Three Moms in the Trenches. From the place where schizophrenia and real life collide. East Coast, West Coast, Middle America. With Miriam Feldman, Mindy Gryling, and Randy Kaye.

SPEAKER_01 1:45

I want to welcome you all to the Schizophrenia and Psychosis Action Alliance and the American Association of Psychiatric Pharmacists panel discussion on schizophrenia and related psychosis spectrum disorders. I'm Linda Mims, the Vice Chair of the Schizophrenia and Psychosis Action Alliance, and a former Senate staffer back in the day, way back in the day. Today we will shine the light on the barriers to life-saving treatment people living with these treatable chronic illnesses face. We really appreciate you taking the time out of your busy schedules to attend this important discussion. Hopefully, you will walk away with a better understanding of the barriers to equitable health care that people with psychosis spectrum disorders face and the policy changes needed to improve treatment and give people back their lives. There's a lot of confusion and misperception on what schizophrenia is. To begin with, the very definition of the word itself means split mind. Schizophrenia is a chronic, treatable, no-fault neurological brain disease. It alters how people think, feel, and act. It is most commonly characterized by delusions and hallucinations, impaired thinking, and difficulty socializing with others. Untreated schizophrenia results in psychosis or a disconnection from reality. It starts to appear in adolescents, usually between the ages of 15 and 25. As many as 5.3 million people in the US and 24 million worldwide are living with schizophrenia. Schizophrenia is one of the most disabling, discriminated against, and stigmatized illnesses on our planet. But it doesn't have to be. Our society has marginalized and painted people living with this treatable brain disease as throwaways with no hope for recovery. In fact, with proper medical care and supports, the opposite is true. There are thousands of people in the United States and around the world living their best lives, thriving, and contributing to society. So why are there so many untreated sick people suffering in jails and prison cells, homeless on our streets, or living in the back rooms of family homes? Because our country has decided that unlike people living with other chronic neurological illnesses, people with schizophrenia do not deserve proper health care. Most also experience the cruel symptom of anasygnosia, which renders them unable to recognize that they are sick and prevents them from seeking treatment on their own. As a result of not getting the proper treatment they need at the onset of their illness, we see terrible downstream consequences. Did you know that the longer a person is in untreated psychosis, the more brain damage occurs? With that brain damage comes increased disability and a lower chance of a robust recovery. Our organization did a study that revealed the mind-blowing cost of this discrimination and neglect of $281.6 billion each year from caregiver expenses to health care costs to those stemming from justice system involvement. It takes an average of 10 years, 10 years to get a diagnosis. People's life expectancy is reduced by 28 and a half years. We are not treating these illnesses as the urgent medical conditions that they are. Think about this. If someone in your family has a heart attack or another medical emergency, you call an ambulance, they are rushed to the hospital, diagnosed, and given immediate life-saving care, whether or not they can consent, and they are provided with follow-up supportive services. But when that medical emergency is psychosis, where a person loses touch with reality and in rare cases becomes violent, the police respond and throw that person handcuffed into the back of their squad car. Chances are that the very sick person, instead of getting the life-saving medical care they need, will be thrown in a cell with no treatment. Or, if they get to a hospital, they will be sedated and thrown back onto the street with no essential follow-up care plan to put the person on the path to recovery. Quite a stark contrast, I think you can agree. These gravely ill folks suffer from systemic neglect, discrimination, and stigma. Their human right to health care is being denied in the 21st century. We are working hard to change the status quo and help these folks recover and thrive. Today you will hear a lot about clozepine, the life-saving drug for those with treatment-resistant schizophrenia. The use of clozapine by patients in desperate need for this drug is being restricted by the FDA's overly stringent mandated requirements to receive medication. These requirements are termed REMS, Risk Evaluation and Mitigations Strategy. On that note, I'd like to introduce you to our panel. Annalisa Chase of Tacoma, Washington is a behavioral interventionist who works to improve the quality of life for people on the autism spectrum. In 2016, at age 24, she was diagnosed with schizoaffective disorder, a combination of schizophrenia and bipolar disorder. Doctors prescribed Annalisa six different antipsychotic medicines. None effectively treated her disease, and many caused severe side effects. Her physicians refused to prescribe clazopine, despite its indication for treatment-resistant schizophrenia. Dr. Deanna Kelly is a professor of psychiatry at the University of Maryland School of Medicine and the acting director of the Maryland Psychiatric Research Center, one of the premier schizophrenia research centers worldwide. Dr. Kelly has led and been involved in numerous clinical trials in schizophrenia and severe mental illnesses, and has been active in psychopharmacology research for almost 26 years. Mr. Kurt Decker is a for is the former executive director of the National Disabilities Rights Network, the membership organization of the Protection and Advocacy Systems and Client Assistance Programs, the nation's largest providers of legal advocacy services for people with disabilities. He was instrumental in creating the organization and was responsible for adding its mental health component. Mr. Decker was involved in the passage of the Americans with Disabilities Act and many other mental health policy initiatives, including the Federal Hate Crimes Act and the President's Executive Order on Policing. Michael Brisbane has been in meaningful recovery from schizophrenia for five years. He is a full-time undergraduate at the College of the Ozarks in Branson, Missouri. After he graduates with the Bachelor of Science in Social Work, he plans to earn a master's degree in social work for clinical practices. In 2019, Michael joined NAMI, the National Alliance on Mental Illness. He started a NAMI peers support group for people with mental illness in his hometown. In 2020, he started a weekly virtual support group for young adults living with mental illness with members in attendance from all over the world. Michael also founded NAMI on campus groups at three different colleges in Missouri. We are going to start with Annalisa.

SPEAKER_04 10:24

Good afternoon. My name is Annalisa Chase. I am 30 years old from Tacoma, Washington, a psychology graduate from the University of Washington, and I work as a behavior interventionist, improving the quality of life for people on the autism spectrum. In 2016, at the age of 24, I was diagnosed with schizoaffective disorder, which is a psychosis spectrum illness. It was devastating and debilitating. My illness causes severe hallucinations and thought disorder. The worst part is that when the symptoms occur, I cannot function or even recognize that I am sick. It is a very dangerous illness. The first thing you should know about me is that most people that live with this condition are not like me. Almost everyone with this illness is gravely disabled, unable to travel across the country, unable to stand before an audience, and unable to verbalize or speak about their condition the way that I'm doing here today. In fact, one reason that the FDA's discriminatory and often barbaric restrictions against clozapine have persisted for so long is because those suffering psychosis disorders have no voice. I'm able to speak to you today because of one medication, clozepine. The other thing you should know about me is that I live in constant fear. I live in fear that a technicality, a lab error, or a logistical problem with obtaining frequent blood tests could at any time block my clozapine prescription. This happened once in 2018. I missed a weekly blood draw and my clozapine refill was denied. Within three days, I became severely ill with terrible hallucinations. I became delirious and confused, and my progress was erased to the point that I was forced to start the treatment all over. When my clozepine was reinstated a week later, I did not just bounce back. Sudden episodes of severe psychosis have a lasting effect on the brain. I was institutionalized longer just because I didn't get a blood test in time. I do not want this to happen ever again. In order to prevent interruptions in treatment, I have rationed and stockpiled my clozapine pills so that I have built up a safety buffer. I have had no choice. Patients and caregivers have been forced to do this to avoid dangerous interruptions and treatment. After my diagnosis, many doctors refused to use clozapine, and my mother had to fight for it. According to the American Psychiatric Association, if two antipsychotic medications don't work, then doctors should use clozepine. But this is not what happened to me. I was forced to use seven different antipsychotics, each of them having severe side effects such as involuntary movement, self-harm, insomnia, increased psychosis, and confusion to name a few. Doctors simply refused to follow the standard of care because they had no knowledge or experience with clozapine, and they did not want to manage patients requiring strict weekly blood tests. I recently became aware of some scientific information that is upsetting. I feel betrayed by the FDA and by the medical community. I have learned that there are dozens of medications with higher risks of severe neutropenia than clozapine, but none of them require frequent blood tests or have a REMS that blocks the prescription. I have learned that the risks of severe neutropenia are no different for clozapine than most other antipsychotics. I have learned that severe neutropenia associated with clozapine almost exclusively occurs in elderly patients, not in people my age. I have learned that the condition only affects people in the first few months of starting clozapine. My risk of developing the illness today is probably less than one in a million. Yet I have been subject to years of unnecessary testing, unnecessary suffering, and severe discrimination against clozapine patients. These excessive blood tests that I have been forced to endure as a condition of receiving my medication and the devastating delays and interruptions in treatment have been wrong. The doctors who could not or would not prescribe me clozapine were wrong. The FDA's inappropriate and discriminatory regulations for clozapine patients are wrong. The FDA is directly responsible for insurmountable barriers to treatment that have cost thousands of lives and decades of grave disability. Where are my rights as a patient? If I don't submit to read testing, I will be forced to suffer. This is all just wrong. This is discrimination against a disabled person's right to reasonable treatment services. Clozepine is the only medication FDA approved for treatment-resistant schizophrenia, and is the only medication that works for many individuals with psychosis disorders. It is the only medication that works for me. There is no substitute. On behalf of all patients with psychosis disorders that do not have a voice, please remove the clozapine's REM restrictions and eliminate the unnecessary blood tests. Please stop blocking clozapine prescriptions. Start educating and training doctors to use clozapine when indicated. The sickest among us need your help. Please help them.

SPEAKER_01 15:56

Now, Dr. Kelly.

SPEAKER_03 16:09

I think that's really such a powerful story, and I'm so glad that she got to lead. I'm Deanna Kelly. I'm from the University of Maryland. I'm a professor there and uh in school of medicine and the director of the treatment research program associated with a state hospital on the grounds. I've dedicated my life to the treatment of schizophrenia and finding new treatments. So I have been there. So I'm a clinician and a scientist, and I've been there 26 years. 26 years, majority of time, I've been working to find new treatments and working to advocate for the medication close of pain that we're here to talk about today. So it's my pleasure to be here. So thanks so much for having me. Today, if you haven't heard, is World Schizophrenia Day. So it's really just an honor on this day to come together for a lot of voices to be heard to talk about this illness and the barriers, especially to the medication close of pain I'll be talking about. There's 1.6% of our population, and we heard Linda say this, over five million individuals in our country have schizophrenia, which is a brain disorder causing hallucinations, delusion, and thought disorder, like you've heard. But it's important to note that this is a treatable illness. Many of our patients live very meaningful lives. Remission and recovery is possible, but it does depend on how soon you're treated and what you're treated with. You have heard today that when we postpone treatment in our patients, six, seven, eight, nine, ten antipsychotics, it actually leads to a lower chance of recovery and a lessened ability to maintain and to live a very meaningful life. So it's important that we treat with good medications early. Schizophrenia is in the top 15 leading causes of disability worldwide. The lifespan, as you heard, is cut short by 20 to 25 or more years with this disorder. And people, we didn't hear this yet today, but many people die by suicide. 5% of our family members, of our friends, of the people that we know have schizophrenia will die by suicide, one of the highest rates that we know of among all diseases and disorders. And 50% of our people that have schizophrenia will try to die by suicide. And often many attempts are made. So they're left sometimes with disabling symptoms and issues after trying to die by suicide. These are important because this medication, as you're gonna hear, is actually effective for not only the treatment of schizophrenia, but decreasing suicidal behavior as well. And so there's so also there's a very high economic financial burden. So upward, you can see on the screen here, of $281 billion. This is our to our society for um uh for the for this illness. Up to 50% of people who have schizophrenia have what we call treatment resistant schizophrenia. As you heard, as you heard Annalisa say, we determine treatment-resistant schizophrenia in those people who fail initial treatments. And the guidelines say, in the evidence base, and all of our guidelines say this: after two failed trials, we should go on to clozapine. It's a first line agent for treatment-resistant schizophrenia. But too often we hear people say, oh, this is a last-line agent. It's not, it's a first-line agent, and it's the only FDA approved medication for treatment-resistant illness. If you had a disease in your family where there was one treatment available for this illness, you would be using it. And this is the case here with clozapine. It's also the only FDA approved medication for suicidal behavior, not just in people who have treatment resistance, but all people with schizophrenia. And I want to note also as I'm talking about schizophrenia, I'm talking about schizoaffective disorder like Annalisa has been diagnosed with and the spectrum of illnesses that are very similar. So that so we're looking in our country up to 2.8 million people who have treatment-resistant illness. But but we're only using the medication clozapine in less than 5% of our patients. Other countries around the globe have much, much higher use rates, but in the United States of America, less than 5% of people are able to get this medication. As I mentioned, clozapine saves lives. We prevent suicides, people live meaningful lives, and it's severely underused. And in all of psychiatry, it's probably one of the most underutilized, evidence-based treatments that we have today. So, what's the barriers? There are many barriers. One of the major barriers is the blood work. And you heard Annalisa's story about blood work. So we are and so Annalisa has no choice in this matter. Annalisa, if she wants clozopine, has to comply with this system. So it's mandatory, laboratory blood tests that are done throughout your lifetime, not throughout the risk period of having what we call severe neutropenia or a low absolute neutrophil count. This is a type of white blood cell that we monitor. And if it if it goes too low, we call we call it agranulocytosis. And so it's done weekly for weekly for the first six months. These blood tests are then done bi-weekly after that, and then monthly. Even though the risk for this side effect happens in the first 18 weeks, we continue for a lifetime. The history of it, just so you understand, is in the 1970s, there was a group of people in an area of Finland who all had this severe side effect, which has never happened to date again. You'll hear me talk about this, but it happened. And the FDA, then in our country, pulled the clozapine from the US markets. It was reintroduced in the late 80s and the early 1990s with a surveillance system. And this surveillance system is what we now have today as the Clozapine REMS program. You've heard a little bit about it. I just wanted to make sure you understood it was it was intended as a safety program. The FDA establishes the need for it. And this particular REMS program for Clozapene is called the Clozapine REMS. This surveillance platform requires then these blood tests to be done to get the medication. I want to point out that patients don't have a choice in this. We have a choice in many things in life, but they don't have a choice to participate. They must comply with this. And all of the logistics have to happen. If you go to the website to sign up today as a provider, you will see that you have to review 24 different versions of close of pine. You have to look at a 17-page document, you have to pass a quiz, and then you have to sign a paperwork that says you will comply with close of pine use, or you will not be allowed to prescribe close of pine. And then your pharmacy has to sign up and do several things. And then your blood work has to go and it has to connect all right for you to get that prescription. It's cumbersome. I have been trouble even understanding all the details of it. And I'm studying this and using it all the time. It's very cumbersome. A lot of people won't even sign up. So a lot of physicians, a lot of providers, nurse practitioners don't want to go through that hassle. They're too busy to do that. And so it becomes a barrier just to even use, let alone if something goes wrong in that system to get your treatment. You can understand how cumbersome this treatment is. And because of the closer Pene REMs, then we have many people, and you can see, you can read the screen here, many prescribers that don't enroll, many people's treatment that has been disrupted, people that have been hospitalized because of it. Lots of consequences have occurred. But but I've mentioned and also that the utilization, the use of this medication, 5%, has not gone up since this program. In fact, it has gone down in our country. So it has not, this program has not led to an increase in prescriptions, but arguably potentially a detriment to people getting it. And then with 30 years of clozapene on the market, with all these blood tests, we still have no studies that I'm aware of that suggest that the benefits to the REM system outweigh any of the risks that we have. There's no published literature on this to date. So as a mental health community, there's a consensus growing, and I'm going to talk a little bit about the aspects of the community that are contributing to this consensus. The consensus is that due to no available data or evidence that the REMS program prevents more than it harms, we suggest that the REMS program is overhauled, that we eliminate these mandatory reported blood tests, that pharmacies don't have to be authorized, that the system is overhauled, and that we do better at the education component. So potentially at educational REMs, or eliminate the REMs altogether, as it has contributed to a lot of poor outcomes, as Annalisa has mentioned. So there's all fronts are coming together. This is not just my opinion. I'm here to talk about the science today. I'm here to talk about the data that's available, that's what I know, that's what I do. But there's pressure coming from all fronts from a lot of groups out there. And let me just tell you a few. Professional associations are speaking out. There was an FDA listening session in February of this year, and this included the American Psychiatric Association, the American Psychiatric Nurses Association, the pharmacists, the psychiatric pharmacists, the largest grassroots organization, the National Alliance of Mental Illness, NAMI, National Council. These are just the few that are listed up here, that came together, talked to the FDA, and brought up most of the points that I'm bringing up today about the REMs. Patients and families are speaking out. NAMI themselves held some sessions and put together information on patients and their stories. And these are just a few of them. People can't find doctors. There's pharmacy and lab airs, they are lifelong treatment. This is really challenging. People are stockpiling, as you heard Annalisa, her story's not the only one. People are stockpiling medication because they're afraid they could miss it and listen to the listen to this the detriment that happens when you miss clozapine. The Schizophrenia and Psychosin Action Alliance that's here today also had a drug development meeting on schizophrenia and in November of 2022 also put together many different quotes. I'm just listing a few here. But REM's program has robbed us of a wonderful psychiatrist. We've had to go to Mexico to get our antipsychotic, to get clozopine. And so this is a problem. This is patients, this is families speaking out. Also, the media is speaking out, and many clinicians, many researchers out there know that this has been a problem. The media's picked up on, there's been many stories written. These are just a few that I threw up here. There's also an Angry Moms group that has been created to support their family members. And you and many are here today, and you'll hear more about it. The hashtag and the clozapine REMs has recently started on social media. This is growing, this movement is growing from the grassroots. What about the original people that developed this program? Let me tell you a little bit. Dr. Gilbert Honingfeld is a psychiatrist is a researcher that has been working with clozapine for 50 years. He's actually the oldest surviving member of the US medical team that helped Shepherd clozapine through the regulatory process when it came back to market, okay? He has recently written a letter to the FDA. He shared that with myself and many others. He suggests that this needs to be eliminated right away. What are some of his rationale? He was one of the original people to develop the monitoring system. So what does he have to say? He says that this was meant to be short-lived. We were to protect against some of those, the the the group of people in Finland that originally had this side effect, to protect against this happening again here, to understand it, to make sure, to make sure doctors knew how to monitor the side effects, et cetera. Is short-lived 30 years? I don't think so. Um he meant he also mentions in the letter, and you've heard this from Linda earlier, that there are many, many, many other medications, including other antipsychotics that have severe neutropenia associated with it. If you look on the FDA website, there is a page with 50 medications listed. Not one of them has a REMS program, and a lot of them are associated with higher risks of this severe neutropenia than clozapene itself. Why is this the only one that has it? So in all I as I mentioned, in all these years, we have no data to suggest that it's been helpful. Clinicians are speaking out. In our state of Maryland, in the state of Maryland where I work, we run an educational program for clinicians around the state. It's called the Clozapine Champion Project. We're championing the use of this medication. We do education every other week. We're studying outcomes. We're looking at how to better help people. We have a consultation line where people can call anytime and we can help them with anything. I have a team of 12 people, psychiatrists, psychiatric nurses, et cetera, working to help answer questions. Do you know what calls come into our consultation line? They're not calling about how do I manage severe neutropenia. They're not calling about how do I dose. They're calling about help me with the REMs, I don't know what to do, or I don't think I can do this, I don't have time to do this. Can you help me do this? I don't, I don't know how to find this time, or I don't even understand it. 40% more calls come in about the REMs on how to use it than actually how to use the medication itself. We also have within our system, when patients are discharged from the hospital on clozapine, and our team uses this many, many, most of our patients are if are if they're if they're um eligible are tried on clozapine because it's so important to use. But when we try to uh discharge the outpatient, we have trouble finding prescribers that will register and follow through with clozapine. Also, researchers are speaking out today at the American Associate Associate American Psychiatric Association in San Francisco. There's um a project being presented from people at the University of Maryland who have been working with the FDA funding to look at look at what what are some of the barriers, what should be changed, and and um this is being presented maybe just in the last hour today on the West Coast. So more data is coming out. It's a call to action in the research committee community. Papers are being published. You can read a lot of papers saying it's time, it's really time to revisit this system. And angry parents are speaking out. I don't have to really speak to this, but there was a death that happened. Um raise your hand, everybody in this room. Yeah, yeah, raise this hand. Yeah, there was a death that happened, and the pay in the and this poor young man had been taken off clozapene recently. I don't want to belabor this, but this is another piece. I want to get to some of the scientific aspects. So, three decades of science, and this is really what I'm here, I'm a scientist, I'm a clinician. Three decades of science should speak the final word. Science should lead these changes. I mean, all these other things matter dramatically, but science should help lead this. To date, we now know there's little known published data, if any, that I I'm not aware of any that support the safety of the clozapene REMs. I don't know any of any data. We now know 30 years later, so much more than we knew before. So it's time. It's time to rethink this. Neutropenia is not as dangerous as previously thought. The risk of death is less than 0.05%. In my 26 years, I've never seen anyone die from clozapine, um, from neutropenia, but I have seen people die of suicide that didn't get clozapene or who were taken off clozapine in the outpatient setting after leaving us. The original concerns from the 1970s that I mentioned that really led to the surveillance system have not been replicated since. We have not seen a group of people, um, and this was a more elderly folk that and there were other medications involved. There's lots of reason to suspect that this was um contributed from something else at that time. The blood draw legit, we now know that the logistics of getting a blood draw is the number one reason why people aren't prescribing clozapene. The REMS contributes to that. Patients of African descent, or are black patients among us, are even treated less frequently. And I could spend a whole time, I could spend an hour on that topic alone, and I do, and I did it just recently. But we've completed a large study in 274 people here in our country and in sub-Saharan Africa to look at the rates of severe neutropenia. They are not higher. These people have lower white blood cell counts to begin with. In the REMs, it says it's a condition, it's not a condition, it's the normal fluctuation in their white blood cell count. So the discriminatory language exists in this population, and people have not been treated, especially those of African descent, and we need to change that for sure. We do know that suicide risk associated with not using clozapine is much higher. 5% or more. There's lead out there that say 5 to 13%. I'm being very conservative when I'm saying 5% here. I'm just noting that. The 0.4%, you can see that that's numerically higher. The more lives we could save from people going on to die by suicide is much, much higher than any of those people that are gonna die by severe neutropenia, which I have never seen. The other point is that we now know that other countries around the globe have have less restrictive guidelines than we do here in our country, and they do not have a higher rate of severe neutropenia. It's not happening differently. If this was the case, that this was working here differentially, we would have a much lower rate than around the globe, and it's not different, it's the same. So our monitoring here is much more stringent in other countries and arguably too stringent and should be eliminated. And we do know that, as I mentioned, we also know that clozapene saves lives, and it is FDA-approved treatment for suicidal behavior. So, in conclusion, as in everything that I mentioned today, patients who need clozapine can't often access. People have trouble getting it if something goes wrong. But you know how many? There's a lot of people out there that won't even sign up for it. There's a lot of prescribers out there who just won't go through the cumbersome paperwork. If we could get rid of that, it could make a big difference. The risk of clozapene non-use and the consequences outrage this low risk of death, and I mentioned it a few times. All the stakeholders are calling for action on this. It's not just clinicians, it's not just researchers, it's not just angry moms, it's not just the architect of this program who thought it was going to be short-lived. It's all of us, collectively in the mental health field, say it's time, it's time to change this. And after 30 years, it's time to revisit this rationale for the stringent blood oversight. Something that happens in the first 16 week of treatment is lifelong. So, in conclusion, patients with schizophrenia spectrum disorders deserve access to this only one, there's one, one medication that's out there that's FDA approved for treatment-resistant schizophrenia, for decreasing suicidal behavior, and this opportunity is is out there for life-saving care. Thank you so much for listening.

SPEAKER_01 34:33

Thank you, Dr. Kelly. And now I'd like to introduce again Mr. Kurt Decker.

SPEAKER_00 34:40

Good afternoon. Uh as you heard, I'm Kurt Decker. Um, I've been uh in the ment in the disability advocacy world for over 40 years, and for the last 36 years, I was the executive director of the National Disability Rights Network. NDRN is the voluntary membership association of the 57 protection and advocacy programs that was created by Congress to provide uh legally based advocacy for people with disabilities and be a voice for people with disabilities. Uh in 1986, uh Congress added people with serious mental illness as eligible for PA services. And as a result of these programs out there for the last 36 years, uh the PAs, uh, given their access authority, uh, PAs can go into almost any facility, any place where a person with mental illness resides or is housed or incarcerated, uh, and is able to have first-hand knowledge of the massive discrimination that people with serious mental illness uh fake. We've seen abusive congregate uh use uh of facilities for people with mental illness, we've seen inappropriate use of psychotropics, we've seen strained and seclusion and forced treatment, and we've seen an incredible incarceration of people with serious mental illness in jails and prisons. Uh it's uh and our programs have tried to resolve some of that. We've been able to garner millions of dollars in treatment resources for uh incarceration people in jails and prisons. They shouldn't be there in the first place. Um we also have seen how people with serious mental illness are stigmatized. Um, that our society blames people with mental illness for societal ills not of their own making. Most recently, uh, people with mental illness blamed because of a gun uh epidemic ravaging our country. We've also failed to implement the Mental Health Parity Act, which was designed to make physical health care and mental health care equal, and it hasn't happened. As a result, people with mental illness are not getting the services they need. Um this lack of parity, this unequal treatment discrimination, if you will, um, can be seen in how the FDA has handled its uh work with clozapine. And the fact that, as you've heard now several times, it is the only drug that's available for treatment resistance to people with schizophrenia. Um and the disability community has seen how the FDA and its very cumbersome, onerous processes can stand in the way of really useful good treatment. Um, it is the nation's established organization to look to approve drugs and to guarantee their safety, but we've also learned that once established, they often fail to review the data, uh, review their processes, and things sort of just disappear and we're left with, as you've heard, 30 years of really, really onerous and cumbersome activities. Um and the larger disability communities had experience with the FDA. We tried for years to try to ban devices that did electrical shocks for young children to change their behavior. And finally, after years of advocacy and public hearings, we were able to get the FDA to say, yes, these kinds of treatments were not appropriate, and this device should be banned. So it's really time now for some advocacy with the FDA on to try to change these cumbersome and onerous uh requirements of REMS. Um it's time for them to review the data that's out there, or the lack of data that's out there, to really uh change their approach. We are caught up in a serious political situation right now because this is now being tied up with the whole issue around the abortion drug, which is now going to the court system, and so we're going to have to see how that is maintained before that. But we know that this these cumbersome onerous restrictions are really denying uh care to people. It's making physicians and pharmacists unable to uh deal with this drug, and as a result, many, many people are being left untreated. I think that we should we have to develop a coalition of mental health groups, mental health advocacy groups, not just the professional groups that you've seen today, but add the voice of the mental health advocacy community to in order to really work on this. And as we continue to advocate for quality community mental health systems, removing the police uh from interacting with people with mental illness, uh preventing incarceration of fental people in jails and prisons, we now must also focus on all of us coming together. We won't agree on all these issues, but come together and become a strong voice for advocacy for changing these uh REMs for provisions. And hopefully in the next, uh as this political situation resolves, we'll be able to see the FDA really take seriously their role in reviewing these kinds of um these kinds of requirements. So thank you.

SPEAKER_01 39:36

Thank you, thank you, Mr. Decker. And now we have Michael Brisbane.

SPEAKER_05 39:42

Good afternoon. My name is Michael Brisbane. I'm 26 years old and from Kansas City. I am attending college to obtain a degree in social work to help improve the lives of people with mental illness. Like Annalisa, I'm a walking miracle. I'm one of the very few who has recovered from serious mental illness well enough to speak confidently and coherently in front of members of Congress. At 15, I was an honored student looking forward to a college scholarship in engineering. However, I began having trouble concentrating on my schoolwork and feeling anxious in social studies. These were the first signs that I was developing a brain on us. In 2016, at 18 years old, I developed full-blown schizophrenia. One of the hallucinations I experienced was a tactile hallucination. I felt a disgusting creature crawling all over my body. The sensation felt real. This creature would crawl all over my limbs, head, into my mouth, and down my throat and cause me to gag physically. I was unable to eat, and I became emaciated. I had to be hospitalized, of horse fed. This is torture. Day in, day out, unbearable torture. I did not want to live, and few here will understand. I suffered for five long years. I was in and out of hospitals while my mother tried to care for me. None of the prescribed medications worked, and many just made me feel worse. Instead of trying two antipsychotics before trial of cause pain, which is a standard of care with the American Psychiatric Association, I was forced to try 13 different antipsychotics. I deteriorated and could no longer recognize my family members' faces. I was out of touch with reality and lost in a waking nightmare. The hallucinations and terror were more than I could bear. I tried to end my suffering. Even after a failed suicide attempt in a stay at ICU, I was still denied causal pain. The only FDA medication indicated for suicidal behavior. Despite all this, no doctors wanted to deal with the frequent mandatory blood tests, the risks of interrupted treatment, and the FDA's cumbersome rings program. I still have some mild risk symptoms. Like Annalisa, I live in constant fear that my medication will be interrupted or stopped. If I miss even one day of causopene, the horrible creature might come back and start falling down my throat. I might become too sick to get myself to the hospital, and I can only hope that someone would be available to help me. Yes, even short delays or interruptions in cause of very dangerous for me. I try to keep a stockpile of extraclazepine. However, my refill was delayed because the lab waited to process my blood work last month. I now only have 11 days of extraclozen. This means I am always 11 days from disaster. Like tens of thousands of suffering individuals, I am held hostage by the FDA. Clozepine is not a controlled substance, nor is it addictive. Why does the FDA require blood monitoring? For side effect risk, that is one in a million, while the risk of suicide and violence from a person in psychosis is 10%. Clozapine saves lives. It is like insulin, heart medication, or anti-convulsive. If it is withheld or abruptly stopped, I'm in danger. And in the case of clozapine, so is the community. The FDA is completely out of touch with the nature of my illness. The FDA regulators are comprised of bureaucrats that read scientific papers yet never talk to the patients or families. When was the last time an FDA regulator spent time in the cycling of a prison or on the street with mentally ill homeless? Like Annalisa, I feel betrayed. The FDA's Classine phrase is no blood, no drug. Well, how much blood is enough? My family's blood if I hurt them while I'm in psychosis? My blood if I become one of the thousands who commit suicide because I can't live like that. The FDA has been cherry-picking science. They have lacked compassion and have effectively ignored the flight of patients. They just don't give it. Please, end the pharmacy's dispensing restrictions on cause ofine. Start training doctors and start holding them accountable to use cause of indicated. Instead of mandating strict blood tests for patients, start mandating that doctors follow the standard of care.

SPEAKER_01 44:58

Thank you, Michael. Thank you so much for sharing that with us. We really appreciate it. And Annalisa, too, and everybody on this panel. They've did a great job.

SPEAKER_02 45:12

Hey, thanks for joining us for this episode of Schizophrenia Three Moms in the Trenches with Randy Kay, Mindy Gryling, and Miriam Feldman. To get in touch with us or to learn more about our books, please visit our websites at Miriamfeldman.com, MindyGryling.com, or RandyK.com.