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The Case Against Race-Based Quotas in Pharmaceutical Trials

Published online by Cambridge University Press:  28 June 2023

Michael Conklin*
Affiliation:
Angelo State University, San Angelo, TX, USA

Abstract

This Article is the first to offer a comprehensive case against using racial quotas in pharmaceutical studies by providing a detailed examination of the arguments for and against the practice. It begins by discussing the current racial classification system, calls for racial quotas in pharmaceutical trials, and the troubling history of combining race and scientific investigation. It next examines the cautionary tale of BiDil, the first drug authorized by the U.S. Food and Drug Administration (FDA) for use in only Black people. The third part of the Article sets forth the arguments against racial quotas. The fourth part provides legal analysis of these arguments, concluding that racial quotas in pharmaceutical trials likely would not satisfy the strict scrutiny standard for two independent reasons. The fifth part evaluates the alleged benefits of racial quotas and demonstrates that when properly understood they are insignificant in comparison to the disadvantages. The final part weighs the evidence to arrive at a conclusion and considers future implications.

Ultimately, this Article provides a valuable framework for assessing the legal and pragmatic implications not just for pharmaceutical trial quotas but also for other racial-classification issues in health care. For example, while it presents a cumulative case against the proposed practice of racial quotas in pharmaceutical trials, many of the same arguments presented are also applicable to the currently mandated practice of acquiring and reporting racial data of pharmaceutical trial participants. It will serve as a valuable resource not only for opponents of racial quotas but also for advocates. For example, this Article provides numerous race-neutral alternatives for consideration. And the strong case against racial quotas helps facilitate a refocus of efforts away from merely ameliorating the end results of health care disparities and instead targeting the root causes. Evidence suggests that this redirected focus on root causes is more effective at producing positive change. In this way, rejecting these quotas is not in conflict with addressing health disparities; rather, it is beneficial to it. This Article will hopefully serve as a catalyst for future research regarding best practices on how pragmatic; legal; and diversity, equity, and inclusion considerations can synergistically exist.

Type
Articles
Copyright
© 2023 The Author(s)

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References

1 Illuminating BiDil, 23 Nature Biotechnology 903, 903 (2005).

2 Meg Tirrell & Leanne Miller, Moderna Slows Coronavirus Vaccine Trial Enrollment to Ensure Minority Representation, CEO Says, CNBC (Sept. 4, 2020, 12:47 PM), https://www.cnbc.com/2020/09/04/moderna-slows-coronavirus-vaccine-trial-t-to-ensure-minority-representation-ceo-says.html [https://perma.cc/L7AQ-3G6T].

3 Id.

4 Under the applicable Directive 15 classifications, “Hispanic/Latino” is defined as the Caucasian race but its own ethnicity. For the purposes of this Article, Hispanics are included in discussions of race, and the term “white” refers only to non-Hispanic whites.

5 David E. Bernstein, Classified: The Untold Story of Racial Classification in America 152 (2022).

6 Planet Money, Moonshot in the Arm, NPR, at 20:40 (Nov. 5, 2021), https://www.npr.org/2021/11/05/1053003777/moonshot-in-the-arm [https://perma.cc/WC4U-4P45].

7 Bernstein, supra note 5, at xi.

8 NAtl Insts. of Health, Racial and Ethnic Categories and Definitions for NIH Diversity Programs and for other Reporting Purposes, NAtl Insts. of Health (Apr. 8, 2015), https://grants.nih.gov/grants/guide/notice-files/not-od-15-089.html [https://perma.cc/4Z6M-MESZ]. Note that under this system, “Hispanic or Latino” is not a racial classification but an ethnic classification within the white racial class.

9 Bernstein, supra note 5, at xi.

10 Directive No. 15, Race and Ethnic Standards for Federal Statistics and Administrative Reporting, 43 Fed. Reg. 19, 269 (1978) (to be codified at 20 C.F.R. 416).

11 Roxanne Melvin, Comment, Open Door to Pharmaceutical Shortcuts: How the FDA Can Regulate Race-Based Personalized Medicine, 6 Health L. & Poly Brief 25, 27 (2012).

12 Id.

13 U.S. Food & Drug Admin., Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry: Draft Guidance (2022), https://www.fda.gov/media/157635/download [https://perma.cc/P5CG-NMS7].

15 Diversity & Inclusion in Clinical Trials, Natl Insts. of Health, https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html [https://perma.cc/26GL-5KQN] (last visited Nov. 5, 2022). It is never explained how a pharmaceutical trial that lacks diversity somehow denies all communities the benefits of scientific advances.

16 Melvin, supra note 11, at 27–28.

17 Leah Rosenbaum, How the U.S. Government’s Billion Dollar Bet on Moderna’s Covid-19 Vaccine Paid Off, Forbes (Dec. 18, 2020, 7:41 PM), https://www.forbes.com/sites/leahrosenbaum/2020/12/18/the-feds-risky-billion-dollar-bet-on-moderna-pays-off-as-fda-authorizes-its-covid-19-vaccine/?sh=65a1d7cc65ad [https://perma.cc/5Y4Z-LD4M].

18 Id.

19 Bernstein, supra note 5, at 152.

20 Planet Money, supra note 6, at 20:40.

21 Farrah J. Mateen, Is it Time for Quotas to Achieve Racial and Ethnic Representation in Multiple Sclerosis Trials?, 12 Frontiers Neurology 1, 3 (2021); see also id. (“Enrollment targets have risks but, at least in the short term, are a singularly clear mechanism to remain accountable and attempt to ensure research progress is collective.”).

22 Caroline Chen & Riley Wong, Black Patients Miss Out on Promising Cancer Drugs, ProPublica (Sept. 19, 2018, 5:00 AM), https://www.propublica.org/article/black-patients-miss-out-on-promising-cancer-drugs [https://perma.cc/9VXC-Z7QF].

23 Chelsea Weidman Burke, The Importance of Diversity in Clinical Trials (Because Right Now, It’s Lacking), BioSpace (Oct. 10, 2018), https://www.biospace.com/article/the-importance-of-diversity-in-clinical-trials-because-right-now-it-s-lacking-/ [https://perma.cc/V6LB-UD26] (“Simply mimicking the U.S. population percentages in trials may not be enough to draw statistically significant conclusions based on race. For example, including only 6 Asian or 1 Native American participant in a trial of 100 people wouldn’t provide enough data to generalize results for the whole race.”).

24 See discussion and accompanying footnotes infra Part III(B).

25 Rene Bowser, Racial Profiling in Health Care: An Institutional Analysis of Medical Treatment Disparities, 7 Mich. J. Race Law. 79, 104–05 (2001).

26 Nancy Krieger, Shades of Difference: Theoretical Underpinnings of the Medical Controversy on Black/White Differences in the United States, 1830-1870, 17 Intl J. Health Servs. 259, 268–69 (1987).

27 Sarah Zhang, The Surgeon Who Experimented on Slaves, Atlantic (Apr. 18, 2018), https://www.theatlantic.com/health/archive/2018/04/j-marion-sims/558248/ [https://perma.cc/TBP3-46C7].

28 John S. Haller, The Physician Versus the Negro: Medical and Anthropological Concepts of Race in the Late Nineteenth Century, 44 Bull. Hist. Med. 154, 156 (1970).

29 Pamela Newkirk, The Man Who Was Caged in a Zoo, Guardian (June 3, 2015, 12:59 AM), https://www.theguardian.com/world/2015/jun/03/the-man-who-was-caged-in-a-zoo [https://perma.cc/7L2U-N7T4].

30 Id.

31 See Buck v. Bell, 274 U.S. 200 (1927).

32 Paul A. Lombardo, Three Generations, No Imbeciles: Eugenics, The Supreme Court, and Buck v. Bell 175 (Johns Hopkins University Press ed., 2d ed. 2022).

33 Kristan Hawkins, Remove Statues of Margaret Sanger, Planned Parenthood Founder Tied to Eugenics and Racism, USA Today (July 23, 2020, 4:00 AM), https://www.usatoday.com/story/opinion/2020/07/23/racism-eugenics-margaret-sanger-deserves-no-honors-column/5480192002/ [https://perma.cc/F5UY-URTX].

34 Caitlin Dickerson, Secret World War II Chemical Experiments Tested Troops Based on Race, NPR (June 22, 2015, 4:59 AM), www.npr.org/2015/06/22/415194765/u-s-troops-tested-by-race-in-secret-world-war-ii-chemical-experiments [https://perma.cc/84BL-32K5].

35 Elizabeth Nix, Tuskegee Experiment: The Infamous Syphilis Study, History (Dec. 15, 2020), https://www.history.com/news/the-infamous-40-year-tuskegee-study [https://perma.cc/AWS4-3AVW].

36 Thomas A. Guglielmo, Desegregating Blood: A Civil Rights Struggle to Remember, PBS (Feb. 4, 2018, 11:17 AM), https://www.pbs.org/newshour/science/desegregating-blood-a-civil-rights-struggle-to-remember [https://perma.cc/63NF-RS63].

37 Ryan Grim, American Mengele: Human Radiation Experiments, Brooklyn Rail (Autumn 2002), https://brooklynrail.org/2002/10/express/american-mengele-human-radiation-experim [https://perma.cc/T953-C92A].

38 Id.

39 Id.

40 1976: Government Admits Unauthorized Sterilization of Indian Women, Natl Libr. of Med., https://www.nlm.nih.gov/nativevoices/timeline/543.html [https://perma.cc/9EAR-DUWW] (last visited Nov. 5, 2022).

41 Mark Schoofs, Half-Truths and Consequences, Vill. Voice (May 5, 1998), https://www.villagevoice.com/1998/05/05/half-truths-and-consequences/ [https://perma.cc/4T5V-2Q4A].

42 Id.

43 Michael J. Malinowski, Dealing with the Realities of Race and Ethnicity: A Bioethics-Centered Argument in Favor of Race-Based Genetics Research, 45 Hous. L. Rev. 1415, 1427 (2009) (quoting Richard Herrnstein & Charles Murray, The Bell Curve: Intelligence and Class Structure in American Life 269 (1994)) (“‘Large human populations differ in many ways, both cultural and biological. It is not surprising that they might differ at least slightly in their cognitive characteristics.’”).

44 Marian E. Gornick et al., Effects of Race and Income on Mortality and Use of Services Among Medicare Beneficiaries, 355 New Eng. J. Med. 791, 791 (1996).

45 Id. at 798.

46 Kevin A. Schulman et al., The Effect of Race and Sex on Physicians’ Recommendations for Cardiac Catheterization, 340 New Eng. J. Med. 618, 618-23 (1999).

47 Knox H. Todd et al., Ethnicity and Analgesic Practice, 35 Annals Emergency Med. 11, 11-12 (2000).

48 Janice A. Sabin, How We Fail Black Patients in Pain, Assn of Am. Med. Colls. (Jan. 6, 2020), https://www.aamc.org/news-insights/how-we-fail-black-patients-pain [https://perma.cc/CZS3-6682].

49 Press Release, Ctrs. for Disease Control, Racial and Ethnic Disparities Continue in Pregnancy-Related Deaths (Sept. 5, 2019, 1:00 PM), https://www.cdc.gov/media/releases/2019/p0905-racial-ethnic-disparities-pregnancy-deaths.html [https://perma.cc/B9FZ-CWNL].

50 Yue-Harn Ng et al., Does Racial Disparity in Kidney Transplant Persist After Accounting for Social Determinants of Health?, 104 Transplantation 1445, 1445 (2020).

51 Melvin, supra note 11, at 26.

52 Id.

53 Id.

54 Id.

55 Id.

56 Id.

57 Id.

58 Malinowski, supra note 43, at 1446.

59 Id.

60 It is also referred to as “data fishing,” “data snooping,” and “p-hacking.” Ragul Awati, Data Dredging (Data Fishing), TechTarget, https://www.techtarget.com/searchdatamanagement/definition/data-dredging [https://perma.cc/794H-75ZT] (last visited Nov. 5, 2022). An analogy helps illustrate this principle: If each student in a class of 100 is asked to flip a coin ten times, the overall average of the class will likely be close to 50% heads and 50% tails. However, if the results are then selectively analyzed, seemingly unlikely results will emerge. Perhaps people with red shirts are more likely to flip heads, the back row is more likely to flip tails, people born in the summer are more likely to flip heads, etc. Then, in hindsight and reported independently, the result can be made to appear skewed from the overall class average.

61 Experimental Treatments and Clinical Trials, Fair Health Consumer, https://www.fairhealthconsumer.org/insurance-basics/your-health-plan/experimental-treatments [https://perma.cc/48MV-5T4M] (last visited Feb. 4, 2023).

62 Taunya Lovell Banks, Funding Race as Biology: The Relevance of “Race” in Medical Research, 12 Minn. J.L. Sci. & Tech. 571, 600 (2011).

63 Francis S. Collins, et. al, Human Molecular Genetics and Genomics—Important Advances and Exciting Possibilities, New Eng. J. Med (Jan. 7, 2021), https://www.nejm.org/doi/full/10.1056/NEJMp2030694 [https://perma.cc/CZ4T-MMNE].

64 Id.

65 Id.

66 Id.

67 Id.

68 Jonathan Kahn, From Disparity to Difference: How Race-Specific Medicines May Undermine Policies to Address Inequalities in Health Care, 15 S. Cal. Interdisc. L.J. 105, 107 (2005).

69 Id. at 116.

70 Id. at 116–17.

71 Id.

72 Id. at 106.

73 Id.

74 Id.

75 Id. at 107.

76 Latoya Hill, Samantha Artiga & Sweta Haldar, Key Facts on Health and Health Care by Race and Ethnicity, Kaiser Family Found. (Jan. 26, 2022), https://www.kff.org/racial-equity-and-health-policy/report/key-facts-on-health-and-health-care-by-race-and-ethnicity/ [https://perma.cc/UJZ2-P6DV].

78 See supra notes 4546 and accompanying text.

79 Michael Conklin, Racial Preferences in COVID-19 Vaccination: Legal and Practical Implications, 5 How. Hum. & C.R.L. Rev. 141, 147–48 (2021).

80 Racial, Ethnic Minorities and Low-Income Groups in U.S. Exposed to Higher Levels of Air Pollution, Harv. Sch. of Pub. Health (Jan. 12, 2022), https://www.hsph.harvard.edu/news/press-releases/racial-ethnic-minorities-low-income-groups-u-s-air-pollution/ [https://perma.cc/4L4U-RKJ8].

81 Dorothy E. Roberts, What’s Wrong with Race-Based Medicine?: Genes, Drugs, and Health Disparities, 12 Minn. J.L. Sci. & Tech. 1, 3 (2011).

82 Id.

83 See supra notes 710 and accompanying text.

84 David E. Bernstein, Two Decades Ago, the FDA and NIH Mandated the Use of Race to Categorize Subjects and Report Results in Medical and Scientific Research They Oversee. It was a Huge Mistake, Yale J. on Reg. (Jan. 12, 2022), https://www.yalejreg.com/nc/two-decades-ago-the-fda-and-nih-mandated-the-use-of-race-to-categorize-subjects-and-report-results-in-medical-and-scientific-research-they-oversee-it-was-a-huge-mistake-by-david-e-bernstein/ [https://perma.cc/8LLB-3YNH].

85 Bernstein, supra note 5, at 130.

86 “Freedmen” are the descendants of Black slaves owned by Native Americans. Harmeet Kaur, The Cherokee Nation Acknowledges That Descendants of People Once Enslaved by the Tribe Should Also Qualify as Cherokee, CNN (Feb. 25, 2021, 8:53 PM), https://www.cnn.com/2021/02/25/us/cherokee-nation-ruling-freedmen-citizenship-trnd/index.html [https://perma.cc/TUJ4-9J54].

87 Rene Bowser, Race as a Proxy for Drug Response: The Dangers and Challenges of Ethnic Drugs, DePaul L. Rev. 1111, 1113 (2004).

88 F. James Davis, Who Is Black? One Nation’s Definition, PBS: Frontline, https://www.pbs.org/wgbh/pages/frontline/shows/jefferson/mixed/onedrop.html (last visited Nov. 5, 2022).

89 Id.

90 See, e.g., Kirk Johnson et al., Rachel Dolezal, in Center of Storm, Is Defiant: ‘I Identify as Black, N.Y. Times (June 16, 2015), https://www.nytimes.com/2015/06/17/us/rachel-dolezal-nbc-today-show.html [https://perma.cc/G5RA-T9YL].

91 For example, should a blond-haired, blue-eyed person from Spain be classified as Caucasian or Hispanic? Should a dark-skinned Muslim from Yemen be classified as Caucasian? Are native people from India and Afghanistan Asian or Caucasian?

92 Janet K. Shim et al., Race and Ancestry in the Age of Inclusion: Technique and Meaning in Post-Genomic Science, 54 J. Health & Soc. Behav. 504, 511 (2014).

93 Bernstein, supra note 5, at 151.

94 David Bernstein, May an Individual Claim Minority Status Based on a DNA Test Showing a Small Amount of African Heritage?, Reason: The Volokh Conspiracy (Jan. 8, 2020, 12:14 PM), https://reason.com/volokh/2020/01/08/may-an-individual-claim-minority-status-based-on-a-dna-test-showing-a-small-amount-of-african-heritage/ [https://perma.cc/M8M9-LSBL].

95 David E. Bernstein, The Modern American Law of Race, 94 S. Cal. L. Rev.171, 173–74 (2021) (providing the example of mixed-race George Zimmerman, who would be classified as different races depending on which entity is doing the classifying). For a detailed explanation of the differences between states and governmental agencies in how race is determined, see id. at 209–14.

96 Id.

97 Id. at 219 (citing a case of erroneous racial classification in Jana-Rock Construction, Inc. v. New York State Department of Economic Development, 438 F.3d 195 (2d Cir. 2006)).

98 Bernstein, supra note 5, at 25.

99 Banks, supra note 62, at 600.

100 Turna Ray, HHS Draft Report Suggests Genetic Test for BiDil; NitroMed Does Not Rule Out Dx, GenomeWeb (Sept. 2, 2011, 5:30 PM), http://www.genomeweb.com/dxpgx/hhs-draft-report-suggests-genetic-test-bidil-nitromed-does-not-rule-out-dx [https://perma.cc/TUL7-9ZKX].

101 For example, some mistakenly believe that sickle cell anemia is limited to the Black community. See Elizabeth Landau, How Medicine is Advancing Beyond Race, CNN: Defining Am. (July 8, 2011, 7:41 AM), http://www.cnn.com/2011/HEALTH/07/08/race.personalized.medicine/index.html.

102 Bowser, supra note 87, at 1115.

103 Malinowski, supra note 43, at 1427.

104 Id. at 1426–1427.

105 Liz Hamel et al., KFF/The Undefeated Survey on Race and Health, Kaiser Family Found. (Oct. 13, 2020), https://www.kff.org/report-section/kff-the-undefeated-survey-on-race-and-health-main-findings/ [https://perma.cc/LYS7-ZGKD].

106 Kahn, supra note 68, at 127.

107 Id.

108 Id.

109 Malinowski, supra note 43, at 1427 (quoting Richard Herrnstein & Charles Murray, The Bell Curve: Intelligence and Class Structure in American Life 269 (1994).

110 See e.g., Malinowski, supra note 43, at 1426-27.

111 Rustin Crutchley, Personalized Medicine and the Future of Pharmacogenomics, Wash. State Univ. (Feb. 11, 2022), https://pharmacy.wsu.edu/2022/02/11/personalized-medicine-and-the-future-of-pharmacogenomics/ [https://perma.cc/4DC5-86MD].

112 Id.

113 Id.

114 See e.g., Gornick et al., supra note 44; Schulman et al., supra note 46; Todd et al., supra note 47; Sabin, supra note 48; Ctrs. For Disease Control, supra note 49; Khuali, supra note 50.

115 See generally Bernstein, supra note 5, at 146.

116 Bowser, supra note 25, at 115.

117 Id.

118 National Health Spending in 2020 Increases due to Impact oof COVID-19 Pandemic, Ctrs. for Medicare & Medicaid Servs. (Dec. 15, 2021), https://www.cms.gov/newsroom/press-releases/national-health-spending-2020-increases-due-impact-covid-19-pandemic [https://perma.cc/RUW2-DFZA].

119 Financial Audit: Bureau of Fiscal Service’s FY 2022 and FY 2021 Schedules of Federal Debt, U.S. Govt Accountability Off. (Nov. 9, 2022), https://www.gao.gov/products/gao-23-105586 [https://perma.cc/4GDS-YSLA].

120 Troy Duster, Race and Reification in Science, 307 Science 1050 (2005).

121 Cindy George, Families Find Sickle Cell Anemia Not Limited to Blacks, Hous. Chron. (Dec. 1, 2010), https://www.chron.com/news/houston-texas/article/Families-find-sickle-cell-anemia-not-limited-to-1702983.php.

122 Conklin, supra note 79, at 168.

123 Id.

124 Olga Khazan, How White Supremacists Use Victimhood to Recruit, Atlantic (Aug. 15, 2017), https://www.theatlantic.com/science/archive/2017/08/the-worlds-worst-support-group/536850/ [https://perma.cc/965L-5L4U].

125 This would be similar to the link between affirmative action in college admissions and white resentment, except the severity of losing a loved one would likely enhance the potential for resentment. See, e.g., Vann R. Newkirk II, The Myth of Reverse Racism: The Idea of White Victimhood is Increasingly Central to the Debate over Affirmative Action, Atlantic (Aug. 5, 2017), https://www.theatlantic.com/education/archive/2017/08/myth-of-reverse-racism/535689/ [https://perma.cc/9WBE-NCH2] (discussing “white resentment that’s surrounded the use of race in job and university application processes since the 1960s”).

126 Bowser, supra note 25, at 111.

127 Id.

128 See e.g., Nondiscrimination in Health Programs and Activities, 87 Fed. Reg. 47824 (proposed Aug. 4, 2022) (to be codified at 42 C.F.R. pt. 438).

129 Id.

130 CFR § 46.111(b) (2023).

131 Barbara A. Noah, The Participation of Underrepresented Minorities in Clinical Research, 29 Am. J.L. & Med. 221, 239 (2003).

132 13 C.F.R. § 124.103(b)(1) (2022).

133 DCS Elec., Inc., SBA No. 399 MSBE-91-10-4-26 (May 8, 1992).

134 Bernstein, supra note 5, at 146.

135 Life Expectancy: Your Race Should Not Determine Your Ability to Live a Long and Healthy Life, Natl Equity Atlas, https://nationalequityatlas.org/indicators/Life_expectancy#/ [https://perma.cc/V3YF-SXXQ] (last visited Feb. 5, 2023) (showing the average life expectancy for Black people, Hispanic people, and Asian people as 75, 81, and 84, respectively).

136 Jail Incarceration Rate of Confined Inmates in the United States in 2020, by Race/Hispanic Origin, Statista, https://www.statista.com/statistics/816699/local-jail-inmates-in-the-united-states-by-race/ [https://perma.cc/UD2W-6SNX] (last visited Feb. 5, 2023) (showing the rate of incarceration per 100,000 individuals for Black people, Hispanic people, and Asian people is 465, 134, and 19, respectively).

137 Labor Force Statistics from the Current Population Survey, U.S. Bureau of Lab. Stat., https://www.bls.gov/web/empsit/cpsee_e16.htm [https://perma.cc/J4VU-BAJL] (last visited Feb. 5, 2023) (showing that the 2022 third quarter unemployment rate for Black people, Hispanic people, and Asian people is 5.5%, 3.9%, and 2.6%, respectively).

138 2018 Crime in the United States, U.S. Dept of Just., https://ucr.fbi.gov/crime-in-the-u.s/2018/crime-in-the-u.s.-2018/tables/expanded-homicide-data-table-6.xls [https://perma.cc/CDH7-HQND] (last visited Feb. 5, 2023) (showing that Black people have a higher homicide victimization rate than Hispanic people, who have a higher rate than Asian people).

139 Gretchen Livingston, The Changing Profile of Unmarried Parents, Pew Rsch. Ctr. (Apr. 25, 2018), https://www.pewresearch.org/social-trends/2018/04/25/the-changing-profile-of-unmarried-parents/ [https://perma.cc/6CPB-GPTV] (showing that Black people have a higher rate of single parent homes than Hispanic people, who have a higher rate than Asian people).

140 Public High School Graduation Rates, Inst. for Educ. Scis., Natl Ctr. for Educ. Stat., https://nces.ed.gov/programs/coe/indicator/coi/high-school-graduation-rates [https://perma.cc/24UC-4R6X] (May 2021) (showing that Black students have a lower high school graduation rate than Hispanic students, who have a lower rate than Asian students).

141 Andrew Daniller, Majorities of Americans See at Least Some Discrimination Against Black, Hispanic and Asian People in the U.S., Pew Rsch. Ctr. (Mar. 18, 2021), https://www.pewresearch.org/fact-tank/2021/03/18/majorities-of-americans-see-at-least-some-discrimination-against-black-hispanic-and-asian-people-in-the-u-s/ [https://perma.cc/BN3H-CAAR].

142 Bernstein, supra note 5, at 148.

143 Id.

144 Travis L. Dixon & Daniel Linz, Overrepresentation and Underrepresentation of Agrican Americans and Latinos as Lawbreakers on Television News, 50 J. Commc n 131, 131 (2000).

145 See Luther T. Clark et al., Increasing Diversity in Clinical Trials: Overcoming Critical Barriers, 44 Current Probs. In Cardiology, no. 5, 2019, at 152-53.

146 See generally id.

147 See generally id.

148 “Black patients account for just 5% of clinical trial participants.” Patrick Boyle, Clinical Trials Seek to Fix Their Lack of Racial Mix, Assn of Am. Med. Colls. (Aug. 20, 2021), https://www.aamc.org/news-insights/clinical-trials-seek-fix-their-lack-racial-mix [https://perma.cc/JP98-5HAG].

149 See e.g., Bernice Roberts Kennedy, et al., African Americans and Their Distrust of the Health Care System: Healthcare for Diverse Populations, 14 J. Cultural Diversity 56 (2007).

150 Sheldon Krimsky, The Profit of Scientific Discovery and Its Normative Implications, 75 Chi.-Kent L. Rev. 15, 34 (1999).

151 See e.g., Bowser, supra note 87.

152 Id. at 1126.

153 Id.

154 Id.

155 Awati, supra note 60.

156 Adrian Erasmus, Bennett Holman, & John P A Ioannidis, Data-dredging bias, 27 BMJ Evidence-Based Med. 209, 209.

157 See Lana Khalil et al., Racial and Ethnic Diversity in SARS-CoV-2 Vaccine Clinical Trials Conducted in the United States, 10 Vaccines 290 (2022).

158 Lindsey Wahlstrom-Edwards, Delivering on Diversity: How Do We Move the Needle?, Antidote, https://www.antidote.me/blog/delivering-on-diversity-how-do-we-move-the-needle (last visited Nov. 5, 2022).

159 Chen & Wong, supra note 22.

160 Id.

161 Id.

162 AMA Code of Medical Ethics, Am. Med. Assn, https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/principles-of-medical-ethics.pdf (last visited Nov. 5, 2022).

163 See infra footnotes Part IV.

164 See supra note 136 (showing the Hispanic life expectancy to be 81 years and the non-Hispanic white life expectancy to be 79 years).

165 Id. (showing the Asian life expectancy to be 84 and the non-Hispanic white life expectancy to be 79).

166 Sandra Crouse Quinn et al., Improving Informed Consent with Minority Participants: Results from Researcher and Community Surveys, 7 J. Empirical Rsch. Hum. Rsch. Ethics 44, 45 (2012).

167 Sigal Samuel, Should People of Color Get Access to the COVID-19 Vaccine Before Others?, Vox (Oct. 28, 2020, 10:55 AM), https://www.vox.com/future-perfect/2020/10/2/21493933/covid-19-vaccine-black-latino-priority-access [https://perma.cc/8L7P-7P2A] (explaining that, when asked about receiving priority for the COVID-19 vaccine, some Black people respond, “In other words, we’re the guinea pigs,” and, “We are not crash test dummies, we’ll go after you.”).

168 Id.

169 Dezimey Kum, Fueled by a History of Mistreatment, Black Americans Distrust the New COVID-19 Vaccines, Time (Dec. 28, 2020, 8:30 AM), https://time.com/5925074/black-americans-covid-19-vaccine-distrust/ [https://perma.cc/H7U2-NB5W] (“Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, predicted at a recent Harvard event that the number will need to be somewhere between 75 to 85%.”).

170 Samuel, supra note 168.

171 See, e.g., Maria Marabito, Life Expectancy Gap Between Black and White Americans Diminishes by 48.9%, Healio (Oct. 11, 2021), https://www.healio.com/news/primary-care/20211011/life-expectancy-gap-between-black-and-white-americans-diminishes-by-489 [perma.cc/98T5-ELH4].

172 This in no way implies that modern-day issues that the Black community face are insignificant, only that they are less severe than past treatment such as slavery and Jim Crow.

173 Hamel et al., supra note 106.

174 See Bernstein, supra note 5, at 162–63.

175 See id.

176 Abdallah S. Daar & Peter A. Singer, Pharmacogenetics and Geographical Ancestry: Implications for Drug Development and Global Health, 6 Nature Revs. Genetics 241, 242 (2005).

177 Fisher v. Univ. of Tex. (Fisher), 570 U.S. 297, 310 (2013) (quoting Fullilove v. Klutznick, 448 U.S. 448, 523 (1980) (“‘[A]ny official action that treats a person differently on account of his race or ethnic origin is inherently suspect.’”).

178 Johnson v. California, 543 U.S. 499, 505 (2005).

179 Fisher, 570 U.S. at 310 (quoting Grutter v. Bollinger, 539 U.S. 306, 326 (2003)).

180 Id. at 310–11.

181 Johnson, 543 U.S. at 512-13 (applying strict scrutiny to assess a prison policy that placed inmates with cellmates of the same race in order to minimize gang-related violence).

182 Mitchell v. Washington, 818 F.3d 436, 444 (9th Cir. 2016).

183 Johnson, 543 U.S. at 505 (“We have insisted on strict scrutiny in every context, even for so-called ‘benign’ racial classifications, such as race-conscious university admissions policies, race-based preferences in government contracts, and race-based districting intended to improve minority representation.” (citations omitted)).

184 Wygant v. Jackson Bd. of Educ., 476 U.S. 267, 271 (1986).

185 Id.

186 Fisher v. Univ. of Tex., 570 U.S. 297, 310 (2013) (quoting Grutter v. Bollinger, 539 U.S. 306, 326 (2003)).

187 Id. at 312.

188 While some advocates may indicate that the goal is to decrease health disparities between different racial groups, the goal here is defined as improving health outcomes of racial minorities. This is because the latter is a far better goal than the former, as health disparities could be reduced by simply decreasing the health outcomes of white people while leaving the poor health outcomes of racial minorities the same, thus benefitting nobody.

189 This is similar to what was done to increase the willingness of those in the Black community to get the COVID-19 vaccine. See Conklin, supra note 79, at 157.

190 For a detailed discussion of race-based outreach in the medical context, see Erik Lillquist & Charles A. Sullivan, The Law and Genetics of Racial Profiling in Medicine, 39 Harv. C.R.-C.L.L. Rev. 391, 456 (2004) (“In general, . . . courts have classified efforts to increase minority participation in employment and housing as race-neutral, and therefore constitutionally permissible.”).

191 See supra notes 15556 and accompanying text. The medical skepticism that the quotas threaten to ignite could produce lower vaccination rates, fewer medical checkups, and a reduced willingness to take prescribed medicine, all outcomes that would result in worse health outcomes.

192 See People Who Care v. Rockford Bd. of Educ., School Dist. No. 205, 111 F.3d 528, 535 (7th Cir. 1997) (“It is true that ‘reverse discrimination’… is not unlawful per se, at least when it is intended to remedy past misconduct by the reverse discriminator.”); Builders Ass’n of Greater Chi. v. Cnty. of Cook, 256 F.3d 642, 643–44 (7th Cir. 2001) (“A law that grants preferential treatment on the basis of race or ethnicity does not deny the equal protection of the laws if it is … committed by the public entity that is according the preferential treatment.”).

193 See, e.g., Brunet v. City of Columbus, 1 F.3d 390, 408–09 (6th Cir. 1993) (citing examples of racial preferences that were allowed to remedy discrimination that occurred eight years before the preferences were instituted but not after fourteen years had passed); Hammon v. Barry, 826 F.2d 73, 76–77 (D.C. Cir. 1987) (holding that a time period of eighteen years between the discriminatory conduct and the institution of the preferences was too remote).

194 City of Richmond v. J.A. Croson Co., 488 U.S. 469, 470 (1989).

195 Vitolo v. Guzman, 999 F.3d 353, 361 (6th Cir. 2021).

196 Id.

197 Id.; see also Richmond, 488 U.S. at 503.

198 See Guzman, 999 F.3d at 360-61

199 “For example, in a 1993 case involving an affirmative action plan in hiring female firefighters, a finding that the city did not intentionally discriminate against women in the past was upheld despite the facts that prior to 1975 women were barred from the position, that only five in 832 firefighters were women, that the director of the training academy was biased against women, and that the city had previously refused to adopt testing methods less discriminatory against women.” Michael Conklin, Legality of Explicit Racial Discrimination in the Distribution of Lifesaving COVID-19 Treatments, 19 Ind. Health L. Rev. 315, 320–21 (2022) (referencing Brunet v. City of Columbus, 1 F.3d 390, 405–06 (6th Cir. 1993)).

200 Vitolo, 999 F.3d at 362.

201 Regents of the Univ. of Cal. v. Bakke, 438 U.S. 265 (1978).

202 Id. at 310.

203 Lillquist & Sullivan, supra note 191, at 444 (“[V]ery few governmental interests have been found by the Supreme Court to be compelling enough to validate a racial classification.”).

204 You Can Quote SCOTUS on Quotas (Regents of the University of California v. Bakke), Am. Bar Assn for Law Students: Student Law. (June 8, 2018), https://abaforlawstudents.com/2018/06/08/quimbee-regents-of-the-university-of-california-v-bakke/ [perma.cc/HBM7-BF6Y].

205 Title VI allows colleges to voluntarily implement an affirmative action plan, even when there is no past discrimination being remedied.

206 Additionally, on October 31, 2022, the Supreme Court heard two cases challenging the constitutionality of affirmative action in college admissions. Given the oral arguments and the current makeup of the Court, many are predicting that the Court will overrule Grutter and ban racial preferences in college admissions. See, e.g., Ann E. Marimow et. al., Supreme Court’s Conservative Majority Questions Race-Conscious Admissions, Wash. Post (Oct. 31, 2022, 4:08 PM), https://www.washingtonpost.com/nation/2022/10/31/supreme-court-affirmative-action-case-harvard-unc/ [perma.cc/A2NN-2FV4].

207 Malinowski, supra note 43, at 1438–39.

208 See Vinay Harpalani, The Supreme Court and the Future of Affirmative Action, Am. Const. Socy: Expert F. (Oct. 28, 2019), https://www.acslaw.org/expertforum/the-supreme-court-and-the-future-of-affirmative-action/ [perma.cc/8ECU-3EZA] (explaining that, even before Amy Coney Barrett replaced Ruth Bader Ginsburg, Justices John Roberts, Samuel Alito, Clarence Thomas, Neil Gorsuch, and Brett Kavanaugh would likely vote to strike down affirmative action in college admissions as currently implemented).

209 Parents Involved in Cmty. Schs. v. Seattle Sch. Dist. No. 1, 551 U.S. 701, 748 (2007).

210 Malinowski, supra note 43, at 1444–45 (“[R]ace and ethnicity should be accepted as possible research variables, especially in light of how environmental factors interact with and influence genetics, the influence of race and ethnicity on how we group ourselves socially, the impact of these groupings on environmental exposures, and the fact that race and ethnicity have influenced social groupings for centuries.”).

211 Id. at 1444–45.

212 Under this classification system, the five races are American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. Natl Insts. Of Health, supra note 8.

213 Chen & Wong, supra note 22.

214 For example, the ProPublica piece emphasizes the potential benefits of participating in a pharmaceutical trial but does not mention any of these potential downsides. Id.

215 Given the disproportionately low average life expectancy of Black people, these two standards could be very different.

216 Root Cause Analysis Principles, Tonex, https://www.tonex.com/root-cause-analysis-principles/ [perma.cc/ZD2D-VCC7] (last visited Nov. 5, 2022) (“The logic behind [root cause analysis] is [that] correcting or completely removing root causes, rather than addressing the surface symptom is the best way to solve problems.”).