Way Out of Reach

By ANDREW PURVIS

For many who suffer from chronic schizophrenia, the drug clozapine seems to work miracles. One woman who thought she was God and could control the weather was in and out of mental institutions 35 times before starting on the antipsychotic drug. After only a few weeks of treatment, she was free from delusions and making plans to go to college. Clozapine, approved by the Food and Drug Administration in February, could benefit an estimated 100,000 people in the U.S.

But the patients who need the drug most face a huge barrier: treatment costs nearly $9,000 a year. The drug is a patented product, available in the U.S. under the brand name Clozaril only from New Jersey-based Sandoz Pharmaceuticals, a subsidiary of Sandoz International of Basel, Switzerland. The company's explanation for the steep price is that clozapine occasionally causes fatal side effects, so patients must be required to have regular blood tests to make sure they are tolerating the drug. The expense of the tests pushes clozapine beyond the reach of the majority of schizophrenics, many of whom are poor and underinsured, and Medicaid programs in most states have not been willing to cover the cost. As a result, only 5,500 Americans have begun the therapy.

That situation has stirred outrage, not only from patients but also from lawmakers, public health-insurance officials and many of the nation's prominent mental-health professionals. Last week in the New England Journal of Medicine, Dr. Carl Salzman, an associate professor of psychiatry at Harvard Medical School, called Sandoz's actions "monopolistic" and demanded that the drug company and health officials come to an agreement that would make the drug more accessible to "the patients for whom it is intended." Earlier this month, Democratic Senator David Pryor of Arkansas introduced legislation that would reduce Sandoz's control of the blood-monitoring system, which he charged had "taken patient care out of the hands of doctors and put it into the hands of drug manufacturers."

No one denies clozapine must be carefully handled. Up to 2% of those who take the drug develop agranulocytosis, an immune-system disorder that is often fatal if left undetected. The FDA was fully aware of this danger: the drug had been released earlier in Europe and withdrawn temporarily for just this reason. But the regulators decided the drug's potential usefulness was too great to keep it off the market. To address the safety question, the FDA ruled that Sandoz must devise a blood-monitoring system that would spot early signs of the fatal complication.

However, critics maintain that the system Sandoz came up with -- in which patients cannot get their weekly dose unless they provide Sandoz, or a company under contract to Sandoz, with a blood sample -- is no more than an elaborate form of gouging. "There are many, many ways to do the same job for a lot less money," said Harvard's Salzman. He and others argue that most hospitals and mental-health clinics could conduct the same testing at a lower cost. They point out that in Europe, where the blood testing is not mandatory, the drug costs only about $1,300 a year. Salzman calls the refusal of some state Medicaid programs to pay the full price of clozapine "outrageous," since they often shell out up to $50,000 a year for procedures like kidney dialysis. In addition, Salzman suggests that U.S. lawmakers could ease Sandoz's liability concerns by providing indemnity.

Several state attorneys general are investigating Sandoz for possible antitrust violations, while a handful of advocacy groups have launched lawsuits to force Medicaid to pick up the clozapine tab. But to patients with schizophrenia, these legal and legislative maneuverings mean little. All that matters to them is an impossible price tag standing between their current mental anguish and a productive life.

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