- Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age by Jonathan Kahn
When BiDil was approved by the U.S. Food and Drug Administration in 2005 for heart failure in black patients, it became the first ever drug to receive a racial indication. Race in a Bottle is likely to be the most in-depth book that will ever be written about BiDil’s controversial regulatory approval. Its author, Jonathan Kahn, has followed the case of BiDil’s approval at least as closely as anyone else, probably including those most directly involved (the clinicians, the pharmaceutical company, the FDA). Ever since he first heard about BiDil in 2002 (p. 4), Kahn has pursued the story doggedly. He became part of BiDil’s story through the articles he wrote about it, starting with a 2003 piece in Perspectives in Biology and Medicine, which debunked the statistic that blacks were twice as likely as whites to die of heart failure. These articles were read by regulators, among others, and in 2005 Kahn testified against BiDil’s race-specific indication at the FDA hearings on the drug (p. 94). Kahn notes that material in this book has previously been published in sixteen different journal articles and book chapters (pp. ix–x); Race in a Bottle is the definitive compilation of that body of work.
Regulatory processes are at the center of Kahn’s account. According to Kahn, “Race enters biomedicine through many pathways. Foremost among these are federal initiatives that shape the production and use of racial categories in biomedical research” (p. 25). Kahn carefully traces the ways in which the terrain of BiDil was laid by mandates at the FDA and NIH to use OMB categories and, especially, by patent law. This regulatory focus is not inevitable as a way to approach how race enters biomedicine: we might start with lived experience in a structurally racist society, or with clinical encounters, or with social movements mobilized against health disparities, or elsewhere. But Kahn’s passion is for regulation, and this is where his expertise is on display.
Race in a Bottle is at its most effective in debunking two things: BiDil’s racialized indication and racialized medicine as a path toward pharmacogenomics. As Kahn fastidiously shows, the vasodilating drug combination that would become BiDil (isosorbide dinitrate and hydralazine) was originally conceived of as a treatment for anyone with heart failure, not just blacks, and it was commercial imperatives—specifically circumventing the fact that the patent on the drug without the racial indication was about to expire—rather than persuasive scientific evidence that led the pharmaceutical company to seek approval for it as a drug for blacks. Kahn also persuasively debunks the notion that racialized medicine is a step toward pharmacogenomics. Although many BiDil proponents argued that race was a “crude surrogate” but nevertheless useful “in the meantime” until more was known about the genetics of drug response (p. 157), Kahn shows that even when there are genetic tests available to indicate drug response (as in warfarin, the “poster child for pharmacogenomics” [p. 165]), “far from withering away, race is persisting and even proliferating as genetic information increases” (p. 168). [End Page 708]
Race in a Bottle is less convincing as a window into “racialized medicine in a post-genomic age.” Situating BiDil in a “post-genomic age” is misleading. In Kahn’s own account, BiDil emerged from statistical signals in clinical trial data, not from genetic research. Related claims of racial differences in heart failure foregrounded pathophysiology, not genetics. BiDil’s FDA indication is for “self-identified black patients,” an explicitly social category rather than a genetic one. Yet the book opens by describing the White House ceremony on the occasion of the completion of the Human Genome Project (p. 1). This narrative choice is emblematic of a preoccupation with genetics in the account as a whole, and shows the intractable appeal of analyzing race in...