The article "Race in a Bottle," by Jonathan Kahn, portrays the development of BiDil, the first "ethnic" drug. The controversy surrounding the medicine relates not only to scientific reasons for classifying the heart failure drug as a medicine for African-Americans but to possible commercial motivations for seeking this designation.
NitroMed, the company that makes BiDil, and the Association of Black Cardiologists, a group attempting to eliminate disparities in cardiovascular disease for African-Americans, have taken issue with one aspect of Kahn's critique—the use of race as a biological variable for assessing a drug's effectiveness. Absent better criteria, which may emerge from the work of genomics researchers, both groups assert that race may provide a valid measure of how a drug works in a segment of the population that is underserved by the healthcare system.
The responses of both Nitromed and the Association of Black Cardiologists are presented here along with references to academic papers that they cite in support of their arguments. Their statements are followed by a reply from Kahn.
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To provide insight into why the Food and Drug Administration decided to proceed with what was certain to be a contentious drug endorsement, we are also supplying a link to an article by two agency officials that appeared in the January 2, 2007, Archives of Internal Medicine and which outlines the rationale for moving ahead. Two physicians from the University of California at San Francisco wrote an accompanying article in the same issue that takes a differing view, concluding that the FDA's approval of BiDil represents a "setback in the scientific and policy discourse on medical therapeutics and race and specifically hinders the efforts at eliminating health and health care disparities."
Scientific American commissioned the article from Kahn because of the author's breadth of perspective, which extends beyond technical arguments on the validity of race as a biomarker to an examination of the commercial, legal and sociological ramifications of a drug prescribed based on race. Kahn has published similar analyses in reputable journals, such as the Yale Journal of Health, Policy, Law and Ethics. Moreover, the legal scholar from Hamline University is not the only academic making these types of arguments. Among numerous critiques of BiDil in the health policy sphere, M. Gregg Bloche, a lawyer and physician from Georgetown University, has written a commentary in the New England Journal of Medicine that runs along the same lines.
The fate of racial medicine is highly uncertain. Advances in technology may already be driving toward obsolescence an indicator of drug responsiveness that even NitroMed and the Association of Black Cardiologists acknowledge is less than ideal. The availability of technologies that allow rapid surveys of whole genomes will likely make the segmentation of drug therapy by race a mercifully short chapter in the evolution of personalized medicine.—The Editors