Utah Attorney General Paul Van Dam told Congress Tuesday that Clozaril could be a wonder drug for schizophrenia - except for what he says is an illegal marketing scheme that makes it too expensive and provides "obscene" profits.
But Sen. Orrin Hatch, R-Utah, defended Sandoz - the drug's maker - saying it requires drug-users to buy expensive monitoring services with the drug to prevent deadly side effects and avoid lawsuits from possible deaths.Democrat Van Dam, Republican Hatch and others squared off in a hearing before the Senate Judiciary Subcommittee on Antitrust, Monopolies and Business Rights.
Van Dam, chairman of the National Association of Attorneys General Antitrust Committee, said Sandoz violates monopoly laws by selling its drug through only one distributor, Caremark, and requiring "expensive non-drug services (to monitor white blood cells) that are readily available elsewhere at much lower cost."
He said the package sells for "$8,944 a year for each patient, regardless of the dose or the treatment setting."
Van Dam added, "Were it not for the excessive cost and the intrusive distribution scheme, Clozaril could be widely used. About 200,000 schizophrenia patients, those who suffer psychosis even when on other medications, could benefit from Clozaril treatment."
Utah and 29 other states - which are large purchasers of the drug through Medicaid and other programs - have filed suit against Sandoz to break its monopoly and charge triple damages.
"This marketing scheme has generated obscene profits. Sandoz and Caremark sell for almost $9,000 a year a drug and services that should cost them only about $1,000 a year," Van Dam said. "The lure of these profits has made Sandoz and Caremark willing to prey upon the vulnerability of the victims of schizophrenia to reap corporate profits."
The company refused to testify at the hearing because of the pending lawsuits. But it has pledged to make its drug available through more distributors.
But Howard Metzenbaum, D-Ohio, the subcommittee chairman complained the company made similar promises last December when he originally scheduled his hearings. He canceled them then, but rescheduled them when no action had been taken by Feb. 1.
Metzenbaum said, "It appears they are stalling while patients are being charged exorbitant fees."
But Hatch defended the company. Because 50 people overseas have died from a side effect of the drug called agranulocytosis - a fatal drop in white blood cells - he said the company is justified in requiring monitoring to catch the problem in time to treat it.
"Distribution began in 1990. More than 10,000 patients have received the drug; 250 have developed serious blood disorders. But because of rapid detection, no patient has died."
Hatch said he worries that if the company separates sales of the drug from monitoring, it "could lead to death for some Americans. It could also lead to very serious product liability concerns for the company that may cause it to withdraw this therapy from the marketplace."
But Van Dam rejected such arguments. He said they essentially claim that "mental health professionals cannot be trusted to monitor their patients and must be compelled to buy the exorbitantly priced monitoring system provided by Sandoz and Caremark.
"The states emphatically reject that assumption. Patients should be treated by doctors, not drug manufacturers," Van Dam said.
Hatch also defended Sandoz for not testifying. He said it would have been "the equivalent of giving an open deposition before an audience that includes many of the plaintiffs" in cases against it.