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. Their statements to lawmakers are reprinted here, with their permission.
Analisa Chase, age 30:
My name is Analisa Chase, I am 30 years old, and I am 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 am 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 am able to speak to you today, because of one medication: clozapine.
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 3 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 clozapine 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 in 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 clozapine. 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 individuals 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 routine testing, I will be forced to suffer. This is all just WRONG. This is discrimination against a disabled persons rights to reasonable treatment services.
Clozapine 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 REMS 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.
Michael B., age 26:
My name is Michael. I am 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 Analisa, I am a walking miracle. I am one of very few who has recovered from serious mental illness well enough to speak confidently and coherently in front of members of congress.
At fifteen, I was an honor student looking forward to a college scholarship in engineering. However, I began having trouble concentrating on my schoolwork and feeling anxious in social settings. These were the first signs I was developing a brain illness. In 2016 at eighteen 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 and force-fed. This was torture. Day in, and day out, unbearable torture. I did not want to live. 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 my prescribed medications worked, and many just made me worse. Instead of trying TWO antipsychotics before a trial of clozapine, which is the standard of care the American Psychiatric Association suggests, I was forced to try THIRTEEN 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 and a stay in ICU, I was denied clozapine, the ONLY FDA medication indicated for suicidal behavior. Despite all this, no doctors wanted to deal with frequent mandatory blood tests, risks of interrupted treatment, and the FDA's cumbersome REMS program.
I still have some mild residual symptoms. Like Analisa, I live in constant fear that my medication will be interrupted or stopped. If I miss even ONE day of clozapine, the horrible creature might come back and start crawling down my throat. I could 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 clozapine are dangerous for me.
I try to keep a stockpile of extra clozapine. However, my refill was delayed because the lab waited to process my bloodwork last month. I now have only 11 days of extra clozapine on hand. This means I am always 11 days from disaster.
Like tens of thousands of suffering individuals, I am held hostage by the FDA. Clozapine is not a controlled substance, nor is it addictive. Why does the FDA require blood monitoring for a 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 an anticonvulsant. If it is withheld or abruptly stopped, I am 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 patients or families. When was the last time an FDA regulator spent time in the psych wing of a prison or on the street with mentally ill homeless? Like Analisa, I feel betrayed.
The FDA's clozapine 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 thousands who commit suicide because I can't live like that anymore?
The FDA has been cherry-picking science. They have lacked compassion and have effectively ignored the plight of patients. They just don't get it.
Please end the pharmacies’ dispensing restrictions on clozapine. Start training doctors and start holding them accountable to use clozapine when indicated. Instead of mandating strict blood tests for patients, start mandating that doctors follow the standard of care.