“Racially-Tailored” Medicine Unraveled

“Racially-Tailored” Medicine Unraveled

American University Law Review
Volume 55, Number 2 (December 2005)
pages 395-452

Sharona Hoffman, Professor of Law, Professor of Bioethics, and Associate Director of the Law-Medicine Center
Case Western Reserve University School of Law

Table of Contents

  • Introduction
  • I. “Race-Based” Research and Therapeutic Practices
    • A. The Story of BiDil
    • B. “Race-Based” Research
    • C. A Growing Interest in “Race-Based” Medicine: Why Now?
  • II. Does “Race” Mean Anything?
    • A. “Race” in the Medical and Social Sciences
    • B. “Race” and the Law
    • C. Shifting the Focus Away from “Race”
  • III. The Dangers of “Racial Profiling” in Medicine
    • A. Medical Mistakes
    • B. Stigmatization and Discrimination
    • C. Exacerbation of Health Disparities
  • IV. Violation of Anti-Discrimination Provisions
    • A. Constitution and Federal Civil Rights Laws
    • B. State Laws Prohibiting Discrimination in the Medical Arena
      • 1. Civil rights statutes
      • 2. Hospital and medical facility licensing requirements
      • 3. Patients’ bill of rights laws
      • 4. Public services regulation
      • 5. Insurance codes
    • C. Violation of Research Regulations and Guidelines
      • 1. NIH policy and guidelines
      • 2. Federal research regulations
    • D. Discrimination Theory
  • V. Recommendations
    • A. Review of Research Studies by Scientific Review Boards and IRBs
      • 1. Scientific reviews
      • 2. Institutional review boards
    • B. Investigators and Health Care Providers
    • C. Public Discourse Concerning Attribute-Based Medicine:The Responsibilities of Investigators, Institutions, and the Media
  • Conclusion


F.D.A. Approves a Heart Drug for African-Americans. This June 2005 headline announced the arrival of BiDil, a heart failure edication that is approved for African-Americans only. BiDil is the first drug in pharmaceutical history that will constitute standard therapy for only one particular “race.”Health care professionals are becoming increasingly interested in “racebased” medicine in the research and therapeutic contexts. Many researchers are attempting to discern “racial” differences in disease manifestation, biological functioning, and therapeutic response rates. As this approach develops, physicians may prescribe different dosages of medication for people of separate “races” or may provide them with entirely different drugs. In light of the success of BiDil, investigators are also likely to pursue the development of additional “racially-tailored” medications. In fact, several academic and professional conferences have already devoted significant time to the discussion of “race-based” medicine. On April 18, 2005, the University of Minnesota hosted aconference entitled Proposals for the Responsible Use of Racial & Ethnic Categories in Biomedical Research: Where Do We Go From Here? Likewise, the Eighth World Congress on Clinical Pharmacology and Therapeutics, held in 2004 in Brisbane, Australia, devoted an afternoon to ethnopharmacology.While “racial profiling” in medicine has generated significant discussion in medical and bioethics circles, it has thus far gained relatively little attention in legal literature. This Article aims to develop the discourse concerning this important topic. It argues that “race-based” medicine is an inappropriate and perilous approach. The argument is rooted partly in the fact that the concept of “race” is elusive and has no reliable definition in medical science, the social sciences, and the law.  Does “race” mean color, national origin, continent of origin, culture, or something else? What about the millions of Americans who are of mixed ancestral origins—to what “race” do they belong? To the extent that “race” means “color” in colloquial parlance, should physicians decide what testing to conduct or treatment to provide based simply on their visual judgment of the patient’s skin tone? “Race,” consequently, does not constitute a valid and sensible foundation for research or therapeutic decision-making.

Further, this Article contends that “racial profiling” in medicine can be dangerous to public health and welfare. A focus on “race,” whatever its meaning in the physician’s eye, can lead to medical mistakes if the doctor misjudges the patient’s ancestral identity or fails to recall that a particular condition affects several vulnerable groups and not just one “race.” The phenomenon can also lead to stigmatization and discrimination in the workplace and elsewhere if the public perceives certain “races” as more diseased or more difficult to treat than others. In addition, “racial profiling” could exacerbate health disparities by creating opportunities for health professionals to specialize in treating only one “race” or to provide different and inferior treatment to certain minorities. It could also intensify African-Americans’ distrust of the medical profession. Finally, “race-based” medicine might violate numerous anti-discrimination provisions contained in federal law, state law, and federal research regulations and guidelines…

…The Article will proceed as follows. Part I of the Article will describe “race-based” research and therapeutic practices and will examine the growing interest in “race-based” medicine and the reasons for it. Part II will argue that “race” is a concept that has no coherent meaning and that is potentially pernicious. Part III will focus on the dangers of “raciallytailored” medicine, and Part IV will analyze a variety of anti-discrimination mandates that could potentially be violated by the practice. Finally, Part V will detail recommendations for the development of attribute-based medicine in a manner that will promote the health and welfare of all population groups…

…This Article argues against substantial use of the concept of “race” in medical settings. A primary reason for this restriction is that “race” has no coherent meaning, and therefore, reliance upon it for research or treatment purposes can be confusing at best and can lead to significant adverse consequences at worst. This section will build the argument that based on medical science, the social sciences, and the law, “race” has no reliable definition or real meaning. Moreover, it is a pernicious concept that has been used to suggest that human beings can be divided into subspecies, some of which are morally, intellectually, and physically inferior to others. Thus, medical professionals should focus on more precise and meaningful aspects of human identity rather than on the amorphous concept of “race.”…

Read the entire article here.

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