The first major drug for treating schizophrenia introduced in the United States in the last two decades is currently too expensive to be administered by Camarillo State Hospital or other Ventura County mental health facilities, officials said Monday.
The drug Clozapine costs $9,000 a year per person--even more than the anti-AIDS drug AZT, which costs up to about $8,000 a year--and the county facilities cannot now afford it, the officials said.
Stephen Wilson, Ventura County's medical director for mental health services, said the county would have to cut other programs to afford to use Clozapine on a handful of about 2,000 schizophrenic patients undergoing treatment in the county.
"We would have to lay off staff just to free up money," Wilson said. "We just don't have the funds this year."
Ventura County is not alone in its funding dilemma.
The state will pay for treatment in its hospitals only if counties agree to pick up the tab after patients are released, said Steven Shon, acting director of the state Department of Mental Health.
So far, no county has agreed to help with the expense. Making matters worse, a Medi-Cal offer to pay for a portion of the medication was rejected by Sandoz Pharmaceuticals, the manufacturer of the drug.
Sandoz officials said they are cautious about how the drug is distributed because it has a deadly side effect. Tests show that about 1% of people who take Clozapine contract agranulocytosis, a blood disorder that cripples the immune system and could kill the patient if untreated.
Because of this side effect, company officials said, they are forced to monitor patients closely, which has driven up the price of treatment.
Sandoz has set up a system requiring patients to receive Clozapine during weekly home health care visits. A patient receives a week's supply of Clozapine pills only after a nurse or technologist working for the home health care firm Caremark Inc. draws blood and tests for agranulocytosis. The patient's doctor is notified of results, and treatment will be stopped if the blood disorder is found.
Of 112 cases of agranulocytosis occurring worldwide through 1986, 35% resulted in death, health officials said. During U.S. testing, 15 cases occurred. All were caught early and reversed after the drug was stopped. Clozapine was first developed by Swiss-based Sandoz Ltd. in 1961, but early enthusiasm for it faded by the mid-1970s because of the European deaths, officials said.
Sandoz unsuccessfully sought FDA approval to sell the drug in 1984. But after the company fine-tuned its distribution plan, it gained FDA permission in October. The drug went on the market in January.
The American medical community at first greated the drug with enthusiasm. Some officials hoped that more than half of an estimated 200,000 schizophrenics in the United States who are not helped by conventional drugs, such as Haldol and Thorazine, would find Clozapine a lifeline.
Blamed on abnormal brain chemistry, schizophrenia usually strikes without warning in the late teen-age or early adult years, throwing victims into an hallucinatory world. The drug can aid 60% of the patients tested, according to health officials.
But increasingly, the medication is being called a "rich man's drug for a poor man's disease" because few states can afford it, Shon said.
"There is no other treatment that comes close to the cost of this," Shon said. He said the state has asked if it can purchase the pills and allow state and local nurses to test for agranulocytosis, which would sharply reduce the cost of treatment. But the pharmaceutical company has refused.
"Despite the heat we're getting, we're confident we're doing what's best for the safety of the patients," said Gilbert Honigfeld, a company official.
According to Carl Elder, chief counsel with the state Department of Mental Health, antitrust lawyers with the California attorney general's office are deciding whether to legally challenge Sandoz's position.