Exploiting race in drug development: BiDil's interim model of pharmacogenomics.
This paper explores events surrounding the US Food and Drug Administration's formal approval of the heart failure drug BiDil in 2005. BiDil is the first drug ever to be approved with a race-specific indication, in this case to treat heart failure in 'self-identified black patients'. BiDil has been cast by many as a step toward the promised land of individualized pharmacogenomic therapies. This paper argues, however, that when examined in context, the approval of BiDil emerges as a new model of how a pharmaceutical company may exploit race in the marketplace by literally capitalizing on the racial identity of minority populations and leveraging the disproportionate risk of adverse health outcomes they suffer into a cheaper, more efficient way to gain the US Food and Drug Administration's approval for drugs. Discussions of BiDil in both popular media and professional journals have repeatedly elided the difference between pharmacogenomic and race-based medicine. In fact, broad-based true pharmacogenomic therapies remain years-perhaps decades-in the future. The story of BiDil's development elucidates an alternative model to developing tailored therapies that promises to fill in the gap between the promise and reality of pharmacogenomic medicine. It is a model that exploits race to gain regulatory and commercial advantage, while ignoring its power to promote a regeneticization of racial categories in society at large.
Kahn
Jonathan
J
Hamline University School of Law, St Paul, MN 554104-1237, USA. jkahn01@hamline.edu
D002317:Cardiovascular Agents / Q000266:history*; D004338:Drug Combinations; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D006830:Hydralazine / Q000266:history*; D018973:Intellectual Property; D007548:Isosorbide Dinitrate / Q000266:history*; D010597:Pharmacogenetics / Q000266:history*; D044469:Racial Groups / Q000266:history*; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history*
D002317:Cardiovascular Agents; D004338:Drug Combinations; C431665:isosorbide-hydralazine combination; D006830:Hydralazine; D007548:Isosorbide Dinitrate