Beyond BiDil: the Expanding Embrace of Race in Biomedical Research and Product Development
St. Louis University Journal of Health Law & Policy, Vol. 3, pp. 61-92, 2009
32 Pages Posted: 21 May 2010 Last revised: 9 Nov 2012
Date Written: May 20, 2010
In 2005 the FDA approved BiDil, the first drug ever to include a race-specific indication on its label - to treat heart failure in a “black” patient. In the aftermath of this controversial approval and subsequent marketing of the drug, many have wondered whether BiDil was an anomaly or a harbinger of things to come. This article moves beyond BiDil to explore how similar yet distinct models are developing for the continuing exploitation of race in biomedical practice and product development. It will explore the tensions embedded in the persistent use of racial categories even as specific genetic variations linked to particular drug responses are identified. It will first consider an emerging phenomenon of the rapidly rising use of racial categories in biotech patent applications. It will then consider more specifically several cases of new drugs and diagnostic genetic tests that present direct examples of some of the new strategies being employed to exploit race under the guise of pharmacogenomic advancement. Here race is used to distinguish products and obtain market share in the increasingly competitive arena of biotechnology. The article argues that the promise of leaving race “behind” as more refined “personalized” genetic medicine develops is at present a fantasy that has enabled the continued, indeed, expanding use of race as a quasi genetic category in biomedical research and product development. Race, indeed, has continued to be used because it serves commercial purposes independent of any biomedical utility it is purported to have.
Keywords: race, ethnicity, pharamcogneomics, genomics, discrimination, intellectual property, patents, regulation, FDA, health
JEL Classification: A10, D21, D80, G28, I10, I18, J7, K10, K11, K20, M30
Suggested Citation: Suggested Citation