'Racially-Tailored' Medicine Unraveled

American University Law Review, Vol. 55, No. 2, pp. 395-452, December 2005

Case Legal Studies Research Paper No. 05-32

59 Pages Posted: 8 Sep 2005 Last revised: 2 Jun 2013

See all articles by Sharona Hoffman

Sharona Hoffman

Case Western Reserve University School of Law

Date Written: August 1, 2005


In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical mistakes, stigmatizations, discrimination, exacerbation of health disparities, and violation of anti-discrimination mandates. The author does not argue against the pursuit of attribute-based therapies, but cautions that the attribute or attributes at issue must be carefully determined and will not be equivalent to what is conventionally thought of as "race." The article develops recommendations for safeguards that should be implemented by scientific review boards, IRBs, researchers, health care providers, and journalists involved with attribute-based research and therapeutic practices to ensure that this new approach promotes rather than diminishes public health and welfare.

Keywords: BiDil, Federal Drug Administration, Race, Medicine, Discrimination, Race-based Medicine, Racially-tailored Medicine, Attribute-based Medicine, Racial Profiling, Institutional Review Boards, Scientific Review Boards

JEL Classification: K23, K32

Suggested Citation

Hoffman, Sharona, 'Racially-Tailored' Medicine Unraveled (August 1, 2005). American University Law Review, Vol. 55, No. 2, pp. 395-452, December 2005, Case Legal Studies Research Paper No. 05-32, Available at SSRN: https://ssrn.com/abstract=799931

Sharona Hoffman (Contact Author)

Case Western Reserve University School of Law ( email )

11075 East Boulevard
Cleveland, OH 44106-7148
United States
216-368-3860 (Phone)

HOME PAGE: http://sharonahoffman.com/

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