Controversy grows over monitoring system for new schizophrenia drug

Article Abstract:

Clozapine, a drug manufactured by Sandoz Pharmaceuticals Corporation under the name Clozaril for treating schizophrenia, helps many patients who are not able to be helped by other medications. It is also, however, associated with a potentially fatal side effect, agranulocytosis (destruction of white blood cells), and Sandoz requires that patients enter its own weekly monitoring program to detect early signs of this disorder. The Clozaril Patient Monitoring System (CPMS) increases the yearly cost of therapy to as much as $9,000, and has been attacked from several standpoints. Patients who receive governmental funds for health care cannot afford Clozaril. Lawsuits against state governments that have sought to restrict disbursement of funds for the drug have been filed; currently, 34 state mental health programs fund it for some patients, and 24 Medicaid programs will pay for it. A representative of the American Medical Association has stated that physicians should have the responsibility for monitoring their own patients, and that they can be trained to do this. Clozapine has been used in England for several years, with monitoring every two weeks, which shifts to monthly monitoring after the patient has used the drug for 18 months. Sandoz has also been criticized by the American Psychiatric Association and the National Alliance for the Mentally Ill. The company, for its part, maintains it can only market the drug in the US with the CPMS, and refers to earlier clinical trials with physician monitoring, where compliance was only 75 percent. At least 6,000 patients now receive clozapine, and no deaths from agranulocytosis have occurred under the CPMS. A proposal by the US Department of Veteran Affairs to allow the organization to monitor its own clozapine patients was not approved by Sandoz. Senator David Pryor has introduced a bill to regulate the purchase of specific services under Medicaid, and believes that Sandoz is gouging the public in the case of Clozaril. Questions concerning the ultimate responsibility for patient monitoring and governmental intervention in the pharmaceutical market remain to be resolved. (Consumer Summary produced by Reliance Medical Information, Inc.)

Finance, Product information, Political activity, Pryor, David

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Public pressure ends ''bundled'' drug program, but how much cost will drop remains unclear

Article Abstract:

Clozapine (Clozaril), a powerful new antischizophrenia drug sold by Sandoz Pharmaceuticals Corporation, may be available to a broader range of patients now that obtaining the drug is no longer linked (''bundled'') to monitoring by Caremark Homecare Inc. Before antitrust suits and acts of Congress forced Sandoz to change its policy, patients taking Clozaril were required to undergo weekly blood testing by Caremark to prevent the development of agranulocytosis, a potentially fatal side effect. Under this plan, the cost of the drug was $9,000 per year; now, its price is $2.85 per tablet, making a yearly total of $4,160, still considerably higher than in Europe ($1,500), where clozapine has been prescribed for 17 years. There may be limits to how low the price can drop, however, since monitoring for less than $1,000 per year may be possible only for the largest provider organizations (states, hospitals). These organizations, in turn, may decide to increase their prices. Although Sandoz denies in newspaper advertisements that it has ''made a single penny of profit'' on Clozaril, that the company will fail to make money is doubted by some experts. Moreover, Sandoz's insistence on a monitoring program seems to imply that physicians cannot be trusted to care for their own patients, and assumes a right to intervene in treatment. For its part, Sandoz held that the Clozapine Patient Monitoring System was an innovative approach to ensure patient safety and prevent litigation. More than 139 adverse blood reactions were found; in contrast, more than 50 clozapine patients in other countries have died. Some Congresspersons objected to the exclusive nature of the Caremark agreement, since Medicaid cannot pay for programs of this sort. Attorneys general from more than two dozen states filed an antitrust suit against Sandoz. With the price reduced, it seems likely that states, through Medicaid, will have funds for the drug. Advocates for the mentally ill will now be able to compare monitoring costs and help their clients obtain this much-needed drug. (Consumer Summary produced by Reliance Medical Information, Inc.)

Safety and security measures, Prices and rates

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Schizophrenia therapy controversy continues

Article Abstract:

Clozapine, marketed by Sandoz Pharmaceutical Co. under the brand name Clozaril, effectively treats schizophrenia in many patients. However, it also produces a potentially life-threatening blood disorder, agranulocytosis, in 1 to 2 percent of patients. Because of the likelihood of product liability suits resulting from this side effect, Sandoz has required that patients could only be prescribed the drug if their blood was monitored weekly by Caremark Homecare Inc. This increased the cost of drug therapy immensely, and has led to charges of antitrust law violations by the attorneys general of 29 states and the District of Columbia. In March 1991 the Antitrust Subcommittee of the US Senate Judiciary Committee heard testimony on Sandoz's continued insistence on controlling physician monitoring. As of April 1, Sandoz agreed to allow health care providers to perform the monitoring, as long as Sandoz approved the system of doing so. This new system is still unacceptable to the states because the company preserves control over distribution. The necessity of the revised system, as well as who benefits from it financially, is still not clear. Other drugs with greater propensity to cause the same side effect are not monitored, but the drug industry is studying other linkage agreements, which are likely to result in higher industry profits. The debate may soon be resolved by recent research on antigens that may identify patients at risk. (Consumer Summary produced by Reliance Medical Information, Inc.)

Investigations, Market share liability, United States. Congress. Senate. Subcommittee on Antitrust, Monopolies and Business Rights, Sandoz Pharmaceutical Co., Caremark Homecare Inc.

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