GENEWATCH
 
BOOK REVIEW: RACE IN A BOTTLE
By Lundy Braun
 

In Race in a Bottle, Jonathan Kahn tracks the contentious history of BiDil, the first drug targeted specifically to African Americans. Ironically, race-based drug treatment emerged in the wake of the sequencing of the human genome, a project that theoretically promised both to scientifically refute the notion of genetically distinct racial groups and to usher in an era of personalized medicine. Though hyped by researchers, the FDA, and the press as an important first step toward personalized medicine, BiDil is a drug administered to patients based on their membership in a group.

This is a complex case that Kahn makes accessible through careful examination of how market forces shaped what counted as "evidence" in BiDil's convoluted path to the market. As Kahn recounts, BiDil is not a "new" drug. Rather it is a combination of two generic vasodilators, long considered effective in the management of heart failure-for all people, regardless of race. Because the new formulation as a single pill did not work any better than the generic drugs, it was unable to win FDA approval. NitroMed, the company that gained the intellectual rights to the combination drug, got creative, drawing on race in their attempt to extend patent protection. With the barest hint of evidence for a differential effect in African Americans (based on only 49 African American subjects) from one of the large but poorly designed clinical trials of treatment for heart failure, NitroMed filed a claim with the U.S. Patent and Trademark Office. As a necessary condition for FDA approval, they conducted a clinical trial that enrolled only African American subjects. Not surprisingly, the drug was effective in African Americans, just as it had been on other groups in earlier trials. On June 23, 2005 the FDA approved BiDil for the treatment of heart failure only in African Americans. Physicians were free to prescribe the drug off label for other patients but the drug was lauded for its unique effects in African Americans. Its exorbitant price compared to the inexpensive generics, however, doomed BiDil, at least for the time being.

Several overarching questions frame Kahn's analysis: How and why did race become an object of pharmacogenomics, such that it could reasonably be used in a patent application? How specifically did race play out in the medical, legal, and regulatory arenas? What are the broader social and political implications of racialized biomedicine? Focusing on BiDil, Kahn argues convincingly that innovations in genomics, the vagaries of U.S. patent law, powerful commercial interests, federal mandates for inclusion, and uncritical advocacy around racial disparities in heart disease converged to create the conditions for NitroMed's successful patent application. He then extends his analysis to biotechnology more broadly, examining how race has been invoked in diagnostic testing for Warfarin metabolism, even when specific genetic mutations that influence its metabolism are known.

Critical to Kahn's argument regarding evidence is the fact that the clinical trials on which the company based its patent application for BiDil were never designed to compare racial difference in response to the drug. Using "care of the data" as an organizing theme, Kahn highlights one of the many troubling aspects of this controversy: the extraordinarily loose, if not sloppy, construction of what passed as evidence in the patent application and FDA hearings. From the use of misleading statistics on mortality from heart failure in African Americans, to the failure to define the central variable of race, to the design of a clinical trial (A-HeFT) that included only African Americans (and therefore could not determine differential efficacy) to the lack of any mechanistic understanding for a differential effect, Kahn shows that attention to the data was consistently problematic when it came to matters of race. The chapter on the FDA hearings is particularly illuminating.

Kahn is a widely acknowledged expert in the history of BiDil. As a historian of science and a lawyer with expertise in patent law, Professor Kahn is ideally positioned to analyze the complex interactions between biomedicine, the law, the market, the state, and an uncritical media in exploiting race in the context of drug development. As he notes, Kahn has been both a participant in these debates and an analyst. Importantly, he places the case studies of BiDil and Warfarin in the larger frame of contemporary debates over race, medicine, and genetics, thus providing the reader with tools for analyzing new cases as they arise. The specifics of each case will differ, as he illustrates in his comparison of BiDil to Warfarin, but the principles for understanding the problems with race-based medicine, and particularly the subtle forms of discrimination race-based medicine engenders, are generalizable.

Race in a Bottle is an important book for anyone interested in sorting through the morass of hype and biomedical evidence in the age of genomics. In probing the complexity of commercial interests in the shaping of the very questions scientists ask, this book will be of interest to scientists, clinicians on the frontline of race-based medicine, and patients. For advocates seriously invested in the social justice project of eliminating racial disparities in disease, Kahn's book should be required reading. At a time when the ties between scientific researchers and the pharmaceutical industry are becoming ever more entangled, Race in a Bottle provides valuable insights into the consequences of these connections for health and health care - and, importantly, for what passes as knowledge.

Lundy Braun, PhD, is a Professor of Africana Studies and Pathology and Laboratory Medicine and a member of the Science and Technology Studies Program at Brown University.

 
 
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