The high price of yet another breakthrough drug came under scrutiny in Congress on Tuesday as a Senate subcommittee heard testimony that Clozaril, used in treating schizophrenia, is priced beyond the reach of 95 percent of patients whom no other drug will help. About 2.5-million Americans suffer from schizophrenia, a brain disease whose symptoms range from hallucinations to catatonia, but not split personalities.
Clozaril is the first new medication for the disease in 20 years, and could help as many as one third, or 200,000, of people who do not respond to other anti-psychotic drugs. But since most are young, poor and institutionalized, its cost is usually picked up by the public.
That cost is currently $9,000 a year, making it "one of the most expensive drug therapies ever," in the words of one regulator. That's a lot less than keeping someone in an institution, but more than many states' budgets for drugs _ and much more than the $1,000 to $2,000 Clozaril costs in Europe.
As a result, only about 9,000 patients have received the treatment since the federal Food and Drug Administration (FDA) approved it a year ago.
A spokesman for Sandoz Pharmaceuticals, the manufacturer, blamed the high price on two things: the company's need to recoup the cost of developing the drug, and a dangerous side effect.
The side effect occurs in 1 to 2 percent of patients whose white blood cell count Clozaril causes to plummet, opening the way to sometimes fatal infections. The risk prompted the FDA to approve the drug only on the condition that recipients also get regular blood tests.
Sandoz agreed, then named the company that would do the tests _ exclusively. The exclusive arrangement doubled the cost of a prescription while providing a service that government clinics and institutions either provide already, or could for less money.
"I believe the marketing scheme has generated obscene profits," said Paul Van Dam, attorney general for Utah, one of 29 states, including Florida, that have sued Sandoz alleging the arrangement violates antitrust law.
Last week, after the antitrust committee scheduled Tuesday's hearing, Sandoz announced it was relenting. Within six months, it said, it will permit doctors to arrange the blood tests, reducing the annual cost of the medication to about $4,000.
But committee chairman Howard Metzenbaum, D-Ohio, said Sandoz made a similar announcement when a hearing was set for December, only to delay the reform when the hearing was canceled.
"It appears they are stalling while patients are being charged exorbitant fees," Metzenbaum said.