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For all its superiority, the drug almost didn't make it to the U.S. market. Approved in several European countries in 1969, it was quickly withdrawn six years later, after Finnish doctors reported that eight patients taking the drug had died of agranulocytosis, a sudden loss of infection-fighting white blood cells. In the U.S., the Food and Drug Administration halted even preliminary tests. "We assumed it was a dead product," recalls psychopharmacologist Gilbert Honigfeld, who helped develop the drug for Sandoz and is now in charge of marketing it in the U.S. American and European research eventually showed that agranulocytosis occurred in 1% to 2% of clozapine patients and that it could be detected and nipped in the bud by conducting blood tests on a weekly basis.
In 1989 the FDA approved clozapine for patients who failed to benefit from Thorazine-type drugs, but required the weekly blood testing. Then Sandoz, with the agency's approval, added an unprecedented stipulation: only its representatives could administer the blood tests. Technicians representing Sandoz were prepared to travel hundreds of miles to draw a single patient's blood if necessary. The policy boosted the drug's price tag to an astonishing $8,944 a year and raised a fire storm of protest from families, mental-health advocates and state mental-health-department officials, who argued that local technicians could perform the blood tests at a much lower cost. Finally, the controversy was resolved when Sandoz agreed last summer to sell clozapine without company blood testing.
Now at $4,160 a year, clozapine still looms beyond the reach of most who need it. The stiff price has discouraged many state institutions and agencies, which are responsible for the care of the vast majority of American schizophrenia patients. While a few states have embraced the drug -- Minnesota, for example, has provided clozapine to 1,000 of its 4,300 eligible patients -- most have not made that commitment. California, for instance, with 60,000 potentially eligible patients, has treated only 1,300. Veterans hospitals, which treat as many as 9,000 eligible schizophrenia patients annually, have given clozapine to only 300.
In addition, many private insurance companies resist paying for the drug. "The miracle of clozapine has turned into a mirage," says Laurie Flynn, executive director of the National Alliance for the Mentally Ill. "You can see it. You can read about it. But you can't get it." The Flynn family, in Alexandria, Va., had to pay an extra $6,000 in insurance to obtain coverage that allowed their daughter Shannon, 24, to use clozapine. Once seriously ill, the young woman has recovered sufficiently to graduate from Georgetown University and hold a part-time job at NIMH.
Cases like Shannon's indicate that clozapine is a good investment. In fact, a soon-to-be published study by Case Western Reserve's Meltzer concludes that clozapine can save more than $30,000 a year in medical costs per patient, compared with Thorazine-type drug treatment, by greatly reducing the need for hospitalization and other intervention.