Race and Medicine

Should "race" be a criterion for inclusion in a clinical trial -- and, by extension, is it appropriate for drug labeling to mention it specifically? For instance, should a drug's label say that only "white people" should take it? Those are complicated questions, but the simple answer is that you go where the data take you, says Henry Miller, the Robert Wesson Fellow in Scientific Philosophy and Public Policy at the Hoover Institution.

Dr. Abigail Zuger, a professor of medicine at Columbia University in New York, has strong opinions about the subject: "It has been clear for decades that race has minimal relevance to the body's inner workings. Research has repeatedly shown that the biologic variations among individuals of the same race are reliably great enough for race to retain little utility as a biologic predictor. You might as well sort people by height."

This may not be so true in the context of reviewing a book about a cardiac drug called BiDil, which was approved in the United States in 2005 specifically for black patients (although it can be prescribed off-label for anyone).

• Due to the lack of evidence of usefulness in early clinical trials, the drug had been rejected by the U.S. Food and Drug Administration nine years previously for approval for patients of all races.
• But because analysis of the data in various subgroups revealed a suggestion of benefit to black patients, another trial was performed on 1,050 self-identified black patients with severe heart failure who had already been treated with -- but had not responded to -- the best available therapy.
• The results were so striking -- 43 percent reduction in mortality and 39 percent decrease in hospital visits among patients who received BiDil -- that the study was stopped early and the drug was approved.

Commentators have expressed a wide spectrum of views about the appropriateness of a therapy designated for one racial group. Francis Collins, then director of the U.S. National Human Genome Research Institute, said at the time BiDil was approved that "we should move without delay from blurry and potentially misleading surrogates for drug response, such as race, to the more specific causes."

He was correct, of course. But you go to war against illness with the data you have, not the data you wish to have. Political correctness notwithstanding, drug testing, approvals and labeling must go wherever the evidence leads.

Source: Henry I. Miller, "Race, Medicine, and Political Correctness," Hoover Institution, October 9, 2013.