Schering-Plough has been accused of racism for excluding African-Americans from a Phase II clinical trial of a new drug for hepatitis C, by a patient advocacy group representing people with hepatitis C.

This is believed to be the first time a drugmaker has been accused of racial bias in the design of a clinical trial.

The accusation has been levelled the USA-based Hepatitis C Action & Advocacy Coalition, which claims that Schering-Plough has deliberately excluded African Americans from its Phase II trial of SCH 503034, a hepatitis C virus protease inhibitor, “in an egregious and cynical tactic to make a drug in development look as good as possible.”

“Compelling safety concerns would justify such an exclusion, but the company provided only vague comments that this was an ‘efficient’ way to develop the drug,” according to HAAC spokesman Brian Klein.

At the heart of the debate is that the African American population has three times the prevalence of hepatitis C virus infection than Caucasians.

Schering-Plough maintains that there are good reasons for excluding African Americans, particularly that the company did not want to expose a population who are known to be poor responders to existing therapy based on interferon alpha and ribavirin to an investigational drug. The plan has been to open the Phase III trials to a broader study population, including African Americans.

Cecil Pickett, senior vice president in charge of research at Schering-Plough and himself a black man, dismissed the allegations as ‘absurd’. He noted that African Americans had been excluded from the studies because some arms included a low dose of interferon alpha and ribavirin in combination with SCH 503034, and the fear was that the patients may develop resistance mutations in the hepatitis C virus that could compromise their future treatment.

One arm of the study, which uses higher doses of the drugs, has enrolled black patients, he noted.

SCH 503034 has been granted fast-track status by the US Food and Drug Administration, and could start Phase III testing next year.