Hostname: page-component-848d4c4894-p2v8j Total loading time: 0.001 Render date: 2024-05-20T11:24:29.627Z Has data issue: false hasContentIssue false
  • English
  • Français

Beyond Best Practices: Strict Scrutiny as a Regulatory Model for Race-Specific Medicines

Published online by Cambridge University Press:  01 January 2021

Osagie K. Obasogie
Get access Rights & Permissions [Opens in a new window]

Extract

Race is becoming an increasingly common lens through which biomedical researchers are studying the relevance of genes to group predispositions that may affect disease susceptibility and drug response. These investigations contravene decades of research in the natural and social sciences demonstrating that social categories of race have little genetic significance. Nevertheless, a resounding debate has ensued over the utility of race in biomedical research — particularly as new drugs claiming to serve particular racial populations enter the marketplace. Now that the Food and Drug Administration (FDA) has approved BiDil as the first race-specific treatment despite conflicting evidence and unsettled debates, is there a way for federal regulators to promote research that may address minority health concerns without giving undue credence to the dangerous idea that social understandings of race are genetically relevant? It may be useful for the FDA to turn to an area with experience negotiating such dilemmas — constitutional law — and its approach — strict scrutiny — to help guide when and under which circumstances government should give effect to racial categories in biomedicine.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 3 , Fall 2008 , pp. 491 - 497
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Long, J. C., “Human Genetic Variation: The Mechanisms and Results of Microevolution,” Understanding Race: A Project of the American Anthropological Association,” available at <http://www.understandingrace.org/resources/papers_activity.html> (last visited July 18, 2008); Lopez, I. H., “The Social Construction of Race: Some Observations on Illusion, Fabrication, and Choice,” Harvard Civil Rights and Civil Liberties Law Review 29, no. 1 (1994): 1–62.Google Scholar
Adler, N. et al., “Reaching for a Healthier Life: Facts on Socioeconomic Status and Health in the U.S.,” 2007, The John D. and Catherine T. Macarthur Foundation Research Network on Socioeconomic Status and Health; Smedley, B. D., Smith, A. Y., and Nelson, A. R., eds., Unequal Treatment: Understanding Racial and Ethnic Disparities in Health Care, Institute of Medicine, 2003.Google Scholar
March, R., “Pharmacogenomics: The Genomics of Drug Response,” Yeast 17, no. 1, (2000): 16–21.3.0.CO;2-E>CrossRefGoogle Scholar
See Gonzalez Burchard, E. et al., “The Importance of Race and Ethnic Background in Biomedical Research and Clinical Practice,” New England Journal of Medicine 348, no. 12 (March 20, 2003): 1170–1172; see also Daar, A. S. and Singer, P., “Pharmacogenomics and Geographical Ancestry: Implications for Drug Development and Global Health,” Nature Reviews Genetics 6, no. 3 (October 2005): 241–246.CrossRefGoogle Scholar
See Bowcock, A. et al., “High Resolution of Human Evolutionary Trees with Polymorphic Microsatellites,” Nature 368, no. 6470 (1994): 455–457; Bowcock, A. et al., “Drift, Admixture, and Selection in Human Evolution: A Study with DNA Polymorphisms,” Proceeding of the National Academy of Sciences 88, no. 3 (1991): 839–843.CrossRefGoogle Scholar
Rosenburg, N. et al., “Genetic Structure of Human Populations,” Science 298, no. 5602 (2002): 2381–2385; Bamshad, M. J. et al., “Human Population Genetic Structure and Inference of Group Membership,” American Journal of Human Genetics 72, no. 3 (2003): 578–589; see also Mountain, J. et al., “Multilocus Genotypes: A Tree of Individuals, and Human Evolutionary History,” American Journal of Human Genetics 61, no. 3 (1997): 705–718.CrossRefGoogle Scholar
Risch, N. et al., “Categorization of Humans in Biomedical Research: Genes, Race and Disease,” Genome Biology 3, no. 7 (2002): 1–12.CrossRefGoogle Scholar
See Burchard, Gonzalez et al., supra note 4.Google Scholar
Graves, J. L., “What We Know and What We Don’t Know: Human Genetic Variation and the Social Construction of Race,” June 7, 2006, Social Science Research Council Is Race Real?, available at <http://raceandgenomics.ssrc.org/Graves/> (last visited May 20, 2008).+(last+visited+May+20,+2008).>Google Scholar
Cooper, R. S. et al., “Race and Genomics,” New England Journal of Medicine 348, no. 12 (March 20, 2003): 1166–1170.CrossRefGoogle Scholar
Id.Google Scholar
Watkins, W. S., “Genetic Variation among World Populations: Inferences from 100 Alu Insertion Polymorphisms,” Genome Research 13, no. 7 (2003): 1607–1618.CrossRefGoogle Scholar
Duster, T., “Race and Reification in Science,” Science 307, no. 5712 (2005): 1050–1051.CrossRefGoogle Scholar
Franciosa, J. A. and Taylor, A. L. et al., “African-American Heart Failure Trial (A-HeFT): Rationale, Design, and Methodology,” Journal of Cardiac Failure 8, no. 3 (2002): 128–135.CrossRefGoogle Scholar
Taylor, A. L. et al., “Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure,” New England Journal of Medicine 351, no. 20 (November 11, 2004): 2054–2057.CrossRefGoogle Scholar
Saperstein, A., “Double Checking the Race Box: Examining Inconsistency between Survey Measures of Observed and Self-Reported Race,” Social Forces 85, no. 1 (2006): 57–74; Harris, D. R. and Sim, J. J., “Who is Multiracial? Assessing the Complexity of Lived Race,” American Sociological Review 67, no. 4 (2002): 614–627.CrossRefGoogle Scholar
Puckrein, G., “BiDil from Another Vantage Point,” Health Affairs 25, no. 5 (August 15, 2006): w368–w374; Puckrein, G. and Yancy, C., “BiDil's Impact,” Nature Biotechnology 23, no. 11 (November 2005): 1343.Google Scholar
See Duster, , supra note 15.Google Scholar
See Sankar, P. and Kahn, J., “BiDil Race Medicine or Race Marketing?” Health Affairs 455, no. w5 (web exclusive) (October 11, 2005): 455–463.Google Scholar
Gregg Bloche, M., “Race-Based Therapeutics,” New England Journal of Medicine 351, no. 20 (November 11, 2004): 2035–2037, at 2036.CrossRefGoogle Scholar
Ferdinand, K., “The Isosorbide-Hydralazine Story: Is There a Case for Race-Based Cardiovascular Medicine?” Journal of Clinical Hypertension 8, no. 3 (March 2006): 156–158 .CrossRefGoogle Scholar
“BiDil African-American Subset Is Surrogate for Genomics, Cmte. Chair Says,” The Pink Sheet 67, no. 25 (June 20, 2005).Google Scholar
Collins, F. S., “Foreword,” in Pharmacogenomics: Social, Ethical, and Clinical Dimensions (Hoboken: John Wiley and Sons, 2003).Google Scholar
Meadows, M., “The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective,” FDA Consumer 36, no. 4 (July-August 2002): 19–24.Google Scholar
“Dear Colleague” letter from the Department of Health and Human Services, October 26, 1998, available at <http://www.fda.gov/oc/ohrt/irbs/irbletr.html> (last visited May 20, 2008).+(last+visited+May+20,+2008).>Google Scholar
The Slaughterhouse Cases, 83 U.S. 36, 71 (1873).Google Scholar
Gruetter v. Bollinger, 539 U.S. 306, 326 (2003).Google Scholar
Richmond v. J. A. Croson, 488 U.S. 469, 493 (1989).Google Scholar
Id., at 494.Google Scholar
Lillquist, E. and Sullivan, C., “The Law and Genetics of Racial Profiling in Medicine,” Harvard Civil Rights and Civil Liberties Law Review 39, no. 2 (2004): 391–484.Google Scholar
Kahn, J., “Genes, Race, and Population: Avoiding a Collision of Categories,” American Journal of Public Health 96, no. 11 (2006): 1965–1970.CrossRefGoogle Scholar
Roberts, D., “Legal Constraints on the Use of Biomedical Research: Toward a Social Justice Framework,” Journal of Law, Medicine & Ethics 24, no. 3 (2006): 526–534.CrossRefGoogle Scholar
Winickoff, D. and Obasogie, O., “Race-Specific Drugs: Regulatory Trends and Public Policy,” Trends in Pharmacological Sciences 29, no. 6 (2008): 277–279.CrossRefGoogle Scholar
Rados, C., “Advisory Committees: Critical to the FDA's Product Review Process,” FDA Consumer Magazine 38, no. 1 (January-February 2004), available at <http://www.fda.gov/fdac/features/2004/104_adv.html> (last visited July 17, 2008).Google Scholar
Richmond v. J. A. Croson, 488 U.S.Google Scholar