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For patients who get the drug, the greatest drawback is the risk of developing agranulocytosis. So far, six of the 20,000 Americans who have been treated with clozapine have died from the condition. Although that is considered a low fatality rate, it is still enough to make mental-health professionals nervous. They worry that the uncertainty and risks might jump in 1994, when Sandoz loses its exclusive license to manufacture clozapine. The appearance of generic versions of the drug may be a boon for cash-strapped families, but it raises the specter of fewer controls -- and more deaths.
The appearance of agranulocytosis -- marked by a drop in white blood cells -- is always tragic. Some patients, when informed that they must immediately go off clozapine, beg to remain on it rather than descend again into madness. Phil, 36, was awakened by clozapine after 13 years of suffering. Thanks to the drug, he was able to work part time in a grocery store and start up a social life. Then agranulocytosis struck, and he had to be taken off the drug. "He has his voices and moods again," his father reports sadly. "We'll just have to wait for something else to come along."
Researchers are working furiously to develop that something else. Janssen Pharmaceutica, a Belgium-based subsidiary of Johnson & Johnson, is in the lead with risperidone, a drug that so far appears to be safer than clozapine and works in the same way. Testing is incomplete, however, and the drug is at least 18 months away from the market. Abbott Labs, Eli Lilly and others are also developing successors to clozapine.
Research into brain chemistry is progressing so quickly that doctors in the frustrating field of schizophrenia finally have reason to be optimistic. "We can do for schizophrenia what we've done for so many major illnesses," insists Dr. Samuel Keith, head of NIMH's National Schizophrenic Plan. "We can dissect and demystify it. Then we can defeat it."