The history of clozapine and its emergence in the US market: a review and analysis.
Clozapine is known as the first 'atypical' medication and is effective in people who have treatment-resistant schizophrenia. Its 1990 emergence in the USA was marked by considerable controversy over its high cost, due in large part to having been both the first new antipsychotic medication to come to market in over a decade and the need for comprehensive safety monitoring within a decentralized health system. This paper traces the history of clozapine's discovery and development in Europe, its part in the 1975 Finnish agranulocytosis scare, and its subsequent volatile emergence in the USA. Analyses examine peripheral forces at the time, particularly the influence of political, corporate, medical and societal forces which shaped its market course.
Crilly
John
J
Department of Psychiatry, University of Rochester, School of Medicine and Dentistry, 300 Crittenden Blvd, Rochester, NY 14642, USA. john_crilly@urmc.rochester.edu
D014150:Antipsychotic Agents / Q000009:adverse effects / Q000266:history* / Q000627:therapeutic use; D003024:Clozapine / Q000009:adverse effects / Q000266:history* / Q000627:therapeutic use; D017277:Drug Approval / Q000266:history; D005387:Finland; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D011570:Psychiatry / Q000266:history*; D012559:Schizophrenia / Q000188:drug therapy / Q000266:history*; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history
D014150:Antipsychotic Agents; D003024:Clozapine