April 3, 2006
Two advocacy groups last week said Schering-Plough is discriminating against black people by excluding them from the Phase II clinical trial of its new hepatitis C therapy, the Newark Star-Ledger reports. The trial includes 300 patients around the world and is seeking to establish dosage ranges for the company's new 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, the Star-Ledger reports. According to the Community HIV/AIDS Mobilization Project and the Hepatitis C Action and Advocacy Coalition, 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. Brian Klein of HAAC in a statement said that during a March 16 conference call with Schering-Plough officials, the company "offered no valid safety reason for the exclusion," adding, "It is clear to us that Schering-Plough chose to exclude an entire racial group from the study to achieve the best efficacy results possible on the road to marketing the drug." Judith Dillard of CHAMP said, "The bottom line is that African Americans have been left out of this study to make the drug look good." However, Bob Consalvo, a Schering-Plough spokesperson, said the advocacy groups' criticism "doesn't make sense." He added that black people were left out of the Phase II trial for scientific reasons and would be involved in another part of the Phase II trial, which will study increased dosages. Consalvo also said that public perception was among the company's initial concerns about excluding black patients from the trial, but said that after discussing the move with peer review boards and other researchers, the company decided it was "more prudent and scientific[ally] valid" to restrict the group's involvement until the efficacy of the range of dosages established in the Phase II trial can be tested (Jordan, Newark Star-Ledger, 3/30).
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