recent study It found that two-thirds of homeless people have a mental illness, and more than three-quarters of them have experienced a mental illness in their lifetime. between 10 percent and 20 percent Many homeless people suffer from schizophrenia, one of the most debilitating mental illnesses. Easy access to effective antipsychotic medications is critical for people with these serious conditions.
Unfortunately, FDA policies, particularly the Risk Evaluation and Mitigation Strategies (REMS) program, are a major contributor to the underprescription and underuse of clozapine. The only FDA-approved drug for treatment-resistant schizophreniathe most severe form of this disorder.
FDA established REMS. 2007 To ensure safety measures against certain drugs with potentially dangerous side effects. Ensuring drug safety is essential, but REMS programs unintentionally create barriers that disproportionately impact individuals with severe mental illnesses such as schizophrenia, leading to increased risk of unemployment, substance abuse, and suicide. This is exacerbating the significant challenges they already face, such as increased poverty and homelessness.
tragic story abundant Number of stable patients who lost access to clozapine and developed fatal relapses. After Kevin Keith Langemeyer missed his Remus window to refill his clozapine prescription, he became paranoid and brandished a toy rifle at police. shot him dead. Andrew M.delusions and threatening voice He returned when clozapine was discontinued because he did not have regular blood tests. he I took out my right eye He was even able to sever the optic nerve with his fingers.
The FDA approved clozapine, classified as an “atypical” antipsychotic, in 1990 to treat treatment-resistant schizophrenia. In 2002, the FDA announced that clozapine is effective in reducing the risk of schizophrenia. suicide People with schizophrenia and related disorders. Atypical antipsychotics are preferred over so-called “typical” antipsychotics because they have fewer movement-related side effects, such as tremors, stiffness, and uncontrollable muscle movements.tardive dyskinesia) and restlessness. a Brazil Survey 2024 It was found that patients taking non-clozapine atypical antipsychotics were 21 percent more likely to die than those taking clozapine. The World Health Organization has included clozapine in its regulations. List of essential medicines.
clozapine is Included in REMS The program was discontinued in 2015 due to rare side effects (less than 3 percent This is called agranulocytosis, a reversible but life-threatening decrease in white blood cell counts. We believe this policy is too cautious as the risk of agranulocytosis decreases rapidly within a few months It is extremely risky to begin treatment when an untreated patient is unable or unwilling to undergo REMS-mandated weekly blood tests and the risk of failure is significant. Furthermore, research show Within a year, the risk of blood abnormalities caused by clozapine is similar to that of other antipsychotic drugs that do not require weekly blood tests.
It's been 34 years since the FDA approved this essential antipsychotic. However, the agency still requires all prescribers to enroll in and become certified in the Clozapine REMS program, all dispensing pharmacists to be Clozapine REMS certified, and all patients to enroll in the program.
Clozapine REMS requires periodic laboratory tests for people taking this drug, the results of which are reviewed by the prescriber and pharmacy before the patient receives a seven-day supply. These requirements are burdensome even for healthy people; Doctors were discouraged from prescribingbecause pharmacies obtain clozapine from compounding and patients obtain clozapine. With quote 30 percent It is a travesty that clozapine is simply prescribed to patients with schizophrenia who do not respond to first-line antipsychotics. 4 percent Number of people with schizophrenia in the United States.
There is no need for a government-imposed REMS program. After the FDA approves a drug for sale, it requires drug companies to monitor it for unanticipated long-term risks. Reputation and liability concerns are also motivating factors. In addition, doctors also monitor patients if they prescribe drugs that can cause serious side effects. Not doing so is medical malpractice.
For example, widely prescribed statin drugs can cause liver abnormalities in some patients. Doctors regularly check for this, especially in patients who are not taking statins, and reduce monitoring as appropriate. Doctors often prescribe Drugs that can cause severe blood abnormalities Compatible with various conditions. These include other antipsychotics such as: seroquelUnlike clozapine, it is not constrained by a systematic and complex top-down program overseen by a federal bureaucracy.
Although unusual, the F.D.A. Removed REMS requirement Regarding certain drugs in the past. But in this case, there is no incentive for manufacturers of off-patent generic clozapine to petition the FDA. Remove clozapine REMSEspecially when doctors benefit from patented alternatives that are easier to prescribe. Also, without the cost of weekly blood monitoring, the cost of clozapine treatment would be lower.
The FDA's clozapine REMS program is a great example of how overemphasizing safety can do more harm than good. By imposing a one-size-fits-all surveillance regime on drug companies, doctors, and pharmacists, governments are preventing them from using more customized and innovative surveillance methods on their own that they would otherwise adopt. . FDA barriers to access to clozapine prevent thousands of people with schizophrenia from receiving appropriate treatment.
I have an estimate 653,000 homeless people In today's America. Of these, approximately 60,000 to 120,000 people will benefit from easier access to effective medicines that have been used for many years, further straining already depleted resources for homeless people. There is a possibility. The clozapine REMS program gets in the way. it should be eliminated.
Dr. Jeffrey A. Singer practices general surgery in Phoenix and is a senior fellow at the Cato Institute. Dr. Josh Bloom is Director of Chemistry and Pharmacy at the National Council on Science and Health.
