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This chapter focuses on the components and implications of pharmacogenetics, which refers to the relationship between heritable variations and individual differences in drug response. Pharmacogenetics aims to alter pharmaceutical patterns in cancer treatment and other branches of medicine in accordance to the patient’s individual genome. Some commentators believe that investment in pharmacogenetics is the most effective way to deliver the public health welfare originally pledged by the Human Genome Project. The chapter aims to devise a balanced judgment about pharmacogenetics, taking into consideration not only the medical evidence but also issues about justice, patenting, and drug rationing—including issues surrounding BiDil, a controversial personalized drug.

This chapter explores the origins of BiDil as a drug for everyone and considers how it became racialized primarily in response to a FDA ruling that placed in jeopardy the value of its owner's original nonracial patent. Obtaining a second, race-specific patent was driven primarily by concerns to extend the commercial life of the product. Its development depended upon the strategic appropriation of the social category of race to justify patenting and regulatory approval of a drug that purports to act on a “true” biological basis of heart failure. In the story of BiDil, race played the role of a valuable surrogate—i.e. it was presented as having no medical value in its own right but took on significance to the extent that researchers tie it to a “real” biological group through statistical correlations.

This chapter unfolds around the story of an inaccurate statistic claiming that African-Americans suffered mortality from heart failure at a rate twice that of whites. The origins and circulation of this statistic provides a sustained analysis of the power of race to take on a life of its own once introduced into a conceptual system for making sense of health disparities. BiDil's proponents used this statistic, in conjunction with equally problematic assertions that angiotensin-converting enzyme (ACE) inhibitors (another class of drugs to treat heart failure) do not work well in blacks, to create a racial frame for BiDil that played a central role in driving the drug toward its race-specific approval by the FDA.

This chapter provides a close reading of the FDA hearing that approved the race-specific indication for BiDil, in which the racial frame played a critical role in shaping how the committee reviewed the data. The story of BiDil had presented a new model for development of targeted therapeutics that exploited race to cast the drug as an advance toward individualized pharmacogenomics. Specifically, BiDil's proponents used race to first resurrect the fortunes of an apparently failed drug; then to gain faster and cheaper FDA approval; and finally, to expand its potential market by informally promoting off-label use of the product to the general population. BiDil is situated at the forefront of a drive to bring the long-established corporate practice of “ethnic niche marketing” into the world of pharmaceuticals.

This chapter situates BiDil in the larger context of the rising use of racial categories in biotechnology patents. A central theme here is the interplay among commercial interests, regulatory structures, and scientific practice in generating distinctively racialized conceptions of biomedicine in the field of intellectual property. This chapter provides an introduction to some of the core concepts and rationales of patent law and then presents the results of a study showing the steady rise of racial biotechnology patents over the past decade. The use of race in these patents is often premised on an unstated white norm implying some sort of racial difference at the genetic level. Yet while race may be used as a surrogate for statistical correlations and genetics frequencies in the body of the patent, it often becomes solidified into a static and bounded genetic category in the legally operative claims section of the patent.

This introductory chapter explores the intersections of race, science, law, and commerce and shows how a larger scheme of institutional, legal, and commercial imperatives is shaping the use of race in biomedicine. The drug BiDil is used as an entry point into this study. BiDil is a combination of two generic drugs used to dilate blood vessels—hence “Bi” (two) and “Dil” (dilators). Its development into a racialized drug is worth taking into account—this study does so by unearthing five themes in BiDil's history and the overall issue of racialized medicine: the institutional mandates that promote the introduction of race into biomedical research and practice.

This chapter discusses the use of racialized medicine, specifically BiDil, and the concerns that emerge over the dangers of reifying race in a manner that could lead to new forms of discrimination. Approved by the Food and Drug Administration (FDA) in 2005, BiDil was offered as a drug to treat heart failure for only African Americans. NitroMed, the biotech company that produced the drug, requested race-specific approval based on the results of their African-American Heart Failure Trial (A-HeFT), where the trial population happened to be all “self-identified” African American. The chapter explains how BiDil is part of much larger dynamic of reification in which the purported “reality of race” as genetic may be used to obscure the social reality of “racism.” This matter should be addressed as it reductively reconfigures health and other types of disparity in terms of genetic difference.