Each was touted as a "wonder drug" for crippling mental illness. But in the past year, Prozac, the nation's best-selling antidepressant, and clozapine, a powerful anti-psychotic drug used to treat the most intractable cases of schizophrenia, have been the focus of controversy.
The debate over Prozac centers on safety, while the major concern about clozapine is its cost. Both drugs also raise broader issues, such as the right of patients to receive state-of-the-art treatment, the right of a drug company to control the sale of a lucrative new drug, and media hype about a medication that may be dangerous or overprescribed.
Publicity about Prozac, generically known as fluoxetine, began with a barrage of magazine cover stories about its lack of side effects and its extraordinary success in treating people for whom other antidepressants had proved ineffective.
That was followed, six months later, by another barrage -- of lawsuits filed by people who claim that Prozac caused their suicide attempts or homicidal actions. Central to the lawsuits is a report published last year in a psychiatric journal that six hospitalized patients who took Prozac developed obsessive suicidal thoughts.
Eli Lilly & Co., the manufacturer of Prozac, last year changed the package insert to list "suicidal ideation" among possible side effects; Lilly officials say there is no evidence that Prozac causes more suicidal thoughts than other antidepressants and the Food and Drug Administration says it has not received an unusual number of complaints about adverse reactions to the drug. A Manhattan lawyer who is handling many of the Prozac lawsuits estimates that about 50 have been filed so far; none has come to trial.
In the case of clozapine, there is no dispute that the drug, initially marketed in Europe in the 1970s but first sold in the U.S. last year, can have potentially lethal side effects. If it is not monitored properly, clozapine can cause agranulocytosis, a potentially fatal blood disorder. The question is whether Sandoz, the Swiss pharmaceutical company that holds the exclusive patent on the drug, sometimes known by its trade name Clozaril, can make its sale contingent on a costly monitoring system to detect agranulocytosis. At $9,000 a year, clozapine is one of the world's most expensive prescription drugs.
It also has proven to be unusually promising. Mental health officials say they believe that at least 100,000 Americans who have "treatment resistant" schizophrenia and have not responded to other drugs could be helped by it.
The problem, according to advocates for the mentally ill and state and federal officials, is that most of them simply can't afford it. Many are indigent and rely on underfunded public hospitals for care. In Pennsylvania, officials set up a lottery last summer in state mental hospitals to determine which of the 800 patients considered eligible would get clozapine.
Last month, after a spate of Congressional inquiries and several lawsuits, Sandoz announced it would cut the price of clozapine and permit alternatives to the current monitoring system. How much the price will be reduced is not known. A company official said last week it expects to announce those details next month.
Two weeks ago 23 states, including Maryland and Virginia, filed suit in federal court in New York, charging Sandoz with price-fixing and anti-trust violations. They claim that the company's promises are "vague" and that the drug remains unavailable to those who need it most.