Yesterday, an advisory panel for the Food and Drug Administration (FDA) recommended approval of a drug, BiDil, for heart failure in African-Americans. (The approval was unanimous, although two panel members voted against the racial indication labeling for the drug.) If the FDA follows the panel's advice, BiDil will become the first drug approved for use by patients of a particular race. The drug is a combination of two generic drugs (isosorbide dinitrate-also known as nitroglycerine-and hyrdralazine) that works by increasing the body's concentration of nitric oxide, which widens the arteries and helps the heart function more efficiently. The drug was tested in 1,050 African-Americans last fall. In that study, patients taking BiDil had much better survival rates and were much less likely to be re-hospitalized for congestive heart failure. Dramatic outcomes like this are a good thing, right? Yes. But the idea that a drug be approved for patients of a specific race makes many doctors uncomfortable, and it may also be bad medicine. Jonathan Kahn, a law professor and medical ethicist at Hamline University, said:
"It sends the message that because [the study] was done only in African-Americans that somehow African-Americans are different genetically than everybody else. And that is a very dangerous message to be sending. It's one that doesn't need to be sent in order to bring this drug to market."
Some cardiologists think the reason the drug works so well for many African-Americans may not be a matter of "race" (for which there is no scientific/genetic basis), but is probably related instead to the root cause of their heart failure: African-Americans are more likely to suffer heart failure due to high blood pressure, while whites are more likely to suffer heart failure due to clots caused by heart attacks or atherosclerosis. But some African-American patients do suffer heart failure caused by clots or hardening of the arteries, and some white patients do have heart failure related to high blood pressure. So critics think that the drug should be labeled for use by patients with heart failure caused by hypertension, instead of use by African-American patients. Dr. Gail Christopher, co-chair of the National commission on Health, Genomics and Human Variation, says:
"It would be 'bad science' to label or market this drug as a 'Black' drug. More importantly, race-based claims are not credible in the face of modern genetic medicine."
The New York Times says:
"The drug's maker, NitroMed Inc., says its decision to test and market BiDil as a drug for African-Americans is based on solid science. But BiDil's application [for FDA approval] has engendered controversy, with many scientists convinced that race is too broad and ill-defined a category to be relevant in determining a drug's approval, especially since geneticists have failed to identify a biological divide separating one race from another. Scientists know that different people have different responses to medications, and in some cases these have been linked to race. The FDA, for example, has said that people of Asian ancestry are more likely than others to get serious side effects from the cholesterol-lowering drug Crestor. But research shows that the underlying genetic variations across races are small. [Studies have shown that genetic variation within any racial group exceeds that between two groups.] Scientists believe that genetic markers will someday be found that explain the different reactions to drugs, but for now, race or ethnicity is an imprecise shortcut. By approving BiDil, the FDA would go well beyond where it has in the past in using race as a category to evaluate which patients respond to drugs."
Other doctors feel that failing to take race into account when treating patients is unacceptable. Dr. Jim Kennedy, a spokesman for the Royal College of GPs, told the Times:
"To close one's eyes to colour is tantamount to a neglect of clinical duties. As a practicing professional, I took an oath not to pay any attention to a patient's race, creed, colour or background, and I take this very seriously. But if there is real evidence that because of your genetic inheritance you should be offered a certain drug, I would be negligent in not offering it to you. There may be people of African descent who will benefit from ACE inhibitors, but trying to guess what genes someone has inherited in impossible. So doctors make a reasonable stab at a first-choice drug and if it doesn't work we'll use our second choice. I think it's far worse if, for reasons of political correctness, we chose to ignore real, hard scientific facts."
What do you think about the prospect of race-based medicine? Should drug companies be marketing to specific ethnic groups? How is this harmful or helpful?