New drug combo intensifies race-based medicine debate

A recent study shows positive outcomes for African-American patients treated with a new therapy for heart failure.

By Susan J. Landers, AMNews staff. Dec. 6, 2004.

Washington -- When it comes to health care access, outcomes and even treatment issues, it is clear that race matters. A new heart drug therapy is now further complicating this reality and raising some awkward questions.

The African-American Heart Failure Trial found a drug combination of isosorbide dinitrate and hydralazine, known as BiDil, to be effective in reducing mortality and hospitalizations among black patients with heart failure, raising the possibility of medications that treat a single racial group.

If the Food and Drug Administration approves BiDil specifically for treating black patients, it would be the first time a race-specific drug is given the nod. But it also would follow years of troubling negative associations with race, based on well-documented disparities in quality and access to health care.

"Are we moving into a new era of race-based therapeutics?" asks M. Gregg Bloche, MD, co-director of Georgetown-Johns Hopkins Joint Program in Law and Public Health, in his Nov. 11 New England Journal of Medicine editorial. The BiDil trial findings were published in the same issue.

Whether the study represents an attempt to gain rapid approval from the FDA for a medication that is essentially a combination of two older drugs, or a marketing ploy, or a genuine effort to find effective treatments for blacks with heart failure is a matter of dialogue. Part of the debate centers on whether race and ethnicity might, in this light, prove to be positive variables, rather than factors that historically have made the field uneven. In other words, does a drug like BiDil function to close the treatment gap for minorities, or will it ultimately widen it further?