HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Sunday, March 30, 2014

Guest Blogger Professor Jonathan Kahn: Race in a Bottle

KahnIn my recent book, Race in a Bottle:  The Story of BiDil and Racialized Medicine in a Post-Genomic Age (Columbia U. Press), I examine how law, science, and commerce converge in the field of biomedicine to produce distinctive understandings and uses of race as a central organizing concept in the development of pharmaceuticals and related medical practice in a post-genomic age. I take an interdisciplinary approach that builds out from a case study of BiDil, the first drug ever approved by the FDA with a race-specific label – for the treatment of heart failure in a “black patient”.  It extends this case study to illuminate the larger phenomenon of the emergence of race-based medicine and the continuing, indeed increasing, use of racial categories in biotechnological research and product development. It examines how the use of race in biomedicine is shaped by a complex interplay among commercial, legal, political and scientific forces.  The book argues that many people using race in biomedical research and product development are doing so with good intentions but without taking sufficient care to understand the potential of such use to reify race as genetic and/or reinforce stigmatizing racial stereotypes.  It considers, in particular, how commercial and legal imperatives have driven the rising use of race is a manner that distorts framing and presentation of underlying scientific information about the place of race in biomedical research and practice.

On June 23, 2005, the U.S. Food and Drug Administration formally approved the heart failure drug BiDil to treat heart failure in “self-identified black patients.”  Widely hailed throughout the media and professional journals as the first “ethnic” drug, it has also has been touted by the FDA and others as a significant step toward the promised era of personalized pharmacogenomic therapies.  Upon closer examination, however, BiDil’s story is far more complex. Race in a Bottle explores how its emergence as a racially marked drug reveals a multifaceted interplay of legal, commercial, and technoscientific interventions driving its framing as a racial drug. The book uses this story to provide a gateway to exploring much broader phenomena involving the strategic use of race as a genetic category to obtain patent protection and drug approval and a fuller consideration its implications for the politics of addressing race-based health disparities.

BiDil is not an anomaly.  Similar race-specific trials for the hypertension drug Bystolic and the statin Crestor, among others, indicate that BiDil has ushered in a new era of race-based medicine. Targeting a racial audience is perceived as necessary because at this point the technology and resources do not exist to scan efficiently every individual’s genetic profile.  Instead businesses must market the product to a particular social group that is hypothesized to have a higher prevalence of a relevant genetic variation.  It is in this “meantime” on the road to the promise of truly personalized genomic medicine that race is flourishing and becoming reified as genetic through the interventions of law and commerce as much as through medical consideration.

The book also considers how, since the completion of the first draft of the human genome in 2000, a dramatic rise in the use of race in biotechnology and related patents indicates that researchers and affiliated commercial enterprises are coming to see social categories of race as presenting opportunities for gaining, extending, or protecting monopoly market protection for an array of biotechnological products and services.  Racialized patents are also providing the basis for similarly race-based clinical trial designs, drug development, capital raising and marketing strategies that carry the construction of race as genetic out to ever widening and consequential segments of society.

-Guest Blogger Professor Jonathan Kahn

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