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Hepatitis C clinical trial unfairly excludes blacks

Hepatitis C clinical trial unfairly excludes blacks

Advocacy groups say blacks are being excluded from clinical trial to skew study data.

Two advocacy groups are blasting the decision by pharmaceutical company Schering-Plough to exclude African-Americans from a clinical trial of its experimental hepatitis C treatment, a decision the company says was needed to better gauge the efficacy of the medications, The [Newark] Star-Ledger reports.

Schering-Plough officials say that because African-Americans are traditionally harder to treat than members of other ethnic groups, they were excluded from the Phase II clinical trial of the company's HCV protease inhibitor in order to have a clearer picture of how well varying doses of the medication work. But the Community HIV/AIDS Mobilization Project and the Hepatitis C Action and Advocacy Coalition say blacks are being unfairly excluded because the company is deliberately trying to skew the study toward favorable results. "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," says Brian Klein of HAAC in a press statement.

Bob Consalvo, a Schering-Plough spokesman, told the Star-Ledger that the advocacy groups' concern "doesn't make any sense." He also says African-Americans will be involved in another phase of the clinical trial that will be launched after optimum doses of the medication are identified in the current study. (The Advocate)

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