Can a whites-only drug trial really be prudent and scientifically valid?

By Anjana Ahuja. This is an extract of ‘Science Notebook’ (THE TIMES, 10/04/06):

THE HIGHLY charged discussion about what role, if any, race plays in medicine has taken a quiet but significant turn. The pharmaceutical company Schering-Plough has begun testing a hepatitis C drug, codenamed SCH 503034, and has specifically excluded African-American patients from the Phase 2 trial — the stage that attempts to find the right dosage. The exclusion has led two patient groups to accuse the company of racism.

For reasons unknown, black patients have a lower response rate than whites to standard therapies for hepatitis C. Schering-Plough says the exclusion will make the drug trials “more prudent and scientifically valid”, and that African-Americans can come on board as the study advances (and as the law requires). Patient groups respond that, since the exclusions cannot be justified on safety grounds, they cannot be justified at all. “The bottom line is that African-Americans have been left out of this study to make the drug look good,” says Judith Dillard, of the Community HIV/Aids Mobilisation Project. The Hepatitis C Action and Advocacy Coalition has joined the chorus of condemnation, saying that the exclusion is based on expediency.

The company is baffled by the criticisms, but it shouldn’t be. It seems perverse that a drug targeted at “non-responders” should initially not be tested on the very patients who are being failed by current medication. If there are valid scientific reasons for this approach, these should have been discussed frankly with patient groups at the outset.