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March 27, 1991

Schizophrenia Therapy Controversy Continues

JAMA. 1991;265(12):1503-1507. doi:10.1001/jama.1991.03460120017005

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ENDING an exclusivity arrangement may not ease the threat of antitrust actions against the Sandoz Pharmaceutical Co of East Hanover, NJ.

The Antitrust Subcommittee of the US Senate Judiciary Committee heard testimony this month concerning the company's continued insistence on controlling physician monitoring of patients taking its schizophrenia drug clozapine (Clozaril) because of concerns about product liability suits.

Sandoz sent no representative to the hearing, citing a conflict with ongoing antitrust suits brought by attorneys general of 29 states and the District of Columbia (JAMA. 1991;265:837-838).

David Winter, MD, vice president for scientific and external affairs, says there is "no basis for antitrust" now, or even with the original exclusive linkage arrangement, under which patients could only get the drug by submitting to weekly monitoring by Caremark Home-care Inc of Lincolnshire, Ill. The testing is for agranulocytosis, a blood disorder affecting 1% to 2% of patients that can be fatal