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BiDil Controversy Continues as FDA Approves First “Race-Specific” Drug

Is American health care ready for the first-ever drug targeted specifically to African Americans? On June 23, the U.S. Food and Drug Administration (FDA) approved BiDil® (isosorbide dinitrate/hydralazine hydrochloride), manufactured by NitroMed, Inc., for the treatment of heart failure in black patients. The approval was based primarily on the dramatic results of the 2001-2004 African American Heart Failure Trial (A-HeFT), an all-black clinical trial which found that patients taking BiDil experienced a 39% reduction in the rate of first hospitalization for heart failure and a 43% increase in survival rates.

 

“In BiDil, we now have a new treatment that has been shown to save the lives of black heart failure patients,” says the A-HeFT study’s lead investigator, Anne Taylor, MD, associate dean and professor of medicine at the University of Minnesota Medical School. “African Americans between the ages of 45 and 64 are 2.5 times more likely to die prematurely from heart failure than their non-black counterparts, and they also present with and die from the disease at an earlier age. FDA approval of BiDil represents an important leap forward in addressing this health disparity.”

 

However, as previously reported in MN (“What Color Is Your Treatment?” Winter 2004), some members of the medical and scientific communities continue to be uncomfortable with the idea of a “race-specific” drug. At a joint press conference on June 15, several key physician, research and civil rights groups, including the National Minority Health Month Foundation and the Association of Black Cardiologists, endorsed FDA approval of BiDil but expressed concern that characterizing BiDil as a “drug for blacks” could unfairly exclude other patients who could also benefit from the treatment.

“It would be ‘bad science’ to label or market this drug as a ‘black’ drug,” argued Dr. Gail Christopher of the Joint Center for Political and Economic Studies. “Race-based claims are not credible in the face of modern genetic science.” Dr. Randall Maxey, president of the Alliance of Minority Medical Associations, cited the need for further testing of BiDil across a broader range of ethnicities, because “the A-HeFT researchers do not assert that all black heart failure patients will benefit from BiDil, or that it is not effective in other population groups that can be categorized by social race.”