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USING CLOZAPINE FOR TREATMENT OF SCHIZOPHRENIA
In 1973, Gilbert Honigfeld, director of scientific affairs at Sandoz Pharmaceuticals of East Hanover, New Jersey, started researching clozapine. Two years later, reports from Europe told of the drug’s blood problem: it was killing patients. This discovery nearly stymied Sandoz’s introduction of clozapine in the United States. Because a small number of patients had done well with the drug, however, they continued to receive it under a compassionate-need program. Their success eventually led to the resumption in 1987 of full-scale research in the United States.
At that time, with the knowledge of the Food and Drug Administration (FDA), says Mr. Honigfeld, Sandoz developed a weekly blood test to “ensure patient safety.” It also probably afforded protection from lawsuits. Each week, a medical technician visited the patient, took a blood sample, and, if test results were satisfactory, handed out the next week’s pills. Sandoz kept the drug on hold while the FDA studied results of the blood-monitoring program. In 1989, the FDA approved the use of clozapine by schizophrenia patients for whom all other treatments have failed. Cost to the patient: 8,900 dollars a year – probably for a lifetime.
Protests rained down on Sandoz, which markets the drug under the trade name Clozaril. The National Alliance for the Mentally 111 (NAMI), an organization of patients and their families, said the expensive weekly blood-testing program would shut out the poor. State Medicaid officials refused to cover the costs.
In 1991, Sandoz announced that doctors, clinics, and hospitals could arrange for their own blood tests. Patients would be required simply to show their doctor or pharmacist proof of the satisfactory results of the weekly blood test before getting the next supply. The Health Care Financing Administration then ordered all state Medicaid programs to cover the expenses for their patients and said it would pay some of the states’ medical costs.
Roch Thibodeau Jr., of Burlington, Vermont, got his clozapine under Medicaid. Schizophrenia had destroyed his ability to earn a living. When his illness began, Mr. Thibodeau first took older drugs, including Stelazine (trifluoperazine). Stelazine was a major breakthrough in treatment in the 1950s, along with Thorazine (chlorpromazine).
While the medicines kept him going and controlled the symptoms of the disease, young Mr. Thibodeau experienced severe side effects. “He suffered terrible dry mouth, blistering reactions to the sun, slurred speech,” says his father. “He could not sit still. He could not focus.” These side effects led Mr. Thibodeau to stop taking his medications. As a result, his schizophrenia again took hold.
When he started taking Clozaril in 1989, the symptoms all but disappeared. Side effects were not a problem. He began working 20 hours a week at a bus station kiosk, selling newspapers and light snacks. Now he works for a hospital, delivering supplies to various departments.
“Before Clozaril, I could not have done that,” says Mr. Thibodeau. “I had a real struggle. I could not handle stress or function. I have a lot more motivation now.”
Now, more than 60,000 patients have taken clozapine. Laurie Flynn, Shannon’s mother, says, “Clozapine is the closest thing to a miracle that you will ever see. You see an amazing return of a patient’s sense of humor, interest in life, and ability to relate to others.” She adds that the drug probably would help many of the nation’s schizophrenics, “but, for most of the people for whom this medicine would make a remarkable difference, it is unavailable.”
*78/266/5*
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