AP/San Jose Mercury News Examines Implications Of Schering-Plough's Exclusion Of Blacks In Hepatitis C Drug Trial

Main Category: Clinical Trials / Drug Trials
Also Included In: Liver Disease / Hepatitis;  Litigation / Medical Malpractice
Article Date: 04 May 2006 - 16:00 PDT

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The AP/San Jose Mercury News on Sunday examined the implications of Schering-Plough's decision to exclude black people from the Phase II clinical trial of its experimental hepatitis C therapy (Jordan, AP/San Jose Mercury News, 4/30). The Community HIV/AIDS Mobilization Project and the Hepatitis C Action and Advocacy Coalition in March said the pharmaceutical company was discriminating against black people by excluding them from the trial. The trial includes 300 patients around the world and is seeking to establish dosage ranges for the company's experimental protease inhibitor. According to the company, the new treatment is for patients who are nonresponders to traditional combination therapy of interferon and ribavirin. A "statistically significant" percentage of black people do not respond to traditional hepatitis C treatments. According to the two advocacy groups, the drug company is barring black patients -- whom Schering-Plough classifies as "hard to treat" because they may not respond well to traditional hepatitis drugs -- from participating in the trial in order to have a more positive outcome. A spokesperson for Schering-Plough in April said that blacks would be involved in another part of the Phase II trial, which will study increased dosages (Kaiser Daily HIV/AIDS Report, 4/3). The controversy "highlights a collision of scientific research and social realities in the development of life-saving medicines," according to the AP/Mercury News. "Somebody better wake up in Washington to come up with the next generation of rules that tells how to go forward with testing drugs," Arthur Caplan, chair of the department of medical ethics at the University of Pennsylvania and director of its Center for Bioethics, said. Cecil Picket, head of research at Schering-Plough, said that blacks were excluded from the early stages of the trials for safety purposes, adding that Schering-Plough "didn't want to expose a population [it] know[s] are poor responders to existing therapies to an investigational new drug." According to William Gray, an official of the Association of Clinical Research Professionals, Schering-Plough does not have to "fulfill any social obligation very early in the testing of a new drug" (AP/San Jose Mercury News, 4/30).

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