Corona Clinical Trials

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The Role of Racial Diversity in Clinical Trials

Adolph Reed:

"We have already noted the history of medical and political mischief generated by treating race as a legitimate biological category. That mischief can derive from ostensibly benign intentions no less than from ignoble or evil ones. Jonathan Kahn, in Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age (New York: Columbia University Press, 2014), examines the alliance between Big Pharma, the Association of Black Cardiologists, and the Federal Drug Administration in the early 2000s that led to the first patent in history for a supposedly race-specific drug, a blood thinner that hadn’t proven effective for general use but was approved, after dubious testing, as effective for African-American men. Of course, it wasn’t.

The confusion about what race is and isn’t, combined with the dominance of the disparities frame, has already led to a misplaced focus on calls for racial diversity in selecting subjects for clinical trials testing possible COVID-19 vaccines. Washington Post science writer Carolyn Y. Johnson displays the problem clearly

- The unprecedented scientific quest to end the pandemic with a vaccine now faces one of its most crucial tests, and nothing less than the success of the entire endeavor is at stake. A vaccine must work for everyone—young and old; black, brown, and white. To prove that it does, many of the 30,000 volunteers for each trial must come from diverse communities. It’s a scientific necessity, but also a moral imperative, as younger people of color die of coronavirus at twice the rates of white people, and black, Hispanic and Native Americans are hospitalized at four to five times the rate of white people in the same age groups. (Carolyn Y. Johnson, “A Trial for Coronavirus Vaccine Researchers: Making Sure Black and Hispanic Communities are Included in Studies,” Washington Post [July 26, 2020]: n.p.)

We have no quibble with the contention that researchers should select clinical trial participants from a diverse population. However, Johnson’s claim presumes that racial classification can map onto biologically meaningful differences. Once again, it cannot, because race is an ideological contrivance imposed arbitrarily on a human species that certainly varies biologically, though not only not very much compared to other primate species, but in ways that have nothing to do with abstract racial taxonomy. Regarding medical practice in particular, Darshali Vyas and co-authors recently published an article in the New England Journal of Medicine sounding the alarm about ways that unjustified “race correction” in clinical algorithms can reinforce existing inequalities. They note

- despite mounting evidence that race is not a reliable proxy for genetic difference, the belief that it is has become embedded, sometimes insidiously, within medical practice. One subtle insertion of race into medicine involves diagnostic algorithms and practice guidelines that adjust or “correct” their outputs on the basis of a patient’s race of ethnicity. Physicians use these algorithms to individualize risk assessment and guide clinical decisions. By embedding race into the basic data and decisions of health care, these algorithms propagate race-based medicine. Many of these race-adjusted algorithms guide decisions in ways that direct more attention and resources to white patients than to members of racial and ethnic minorities. (Darshali A. Vyas, Leo G. Eisenstein, and David S. Jones, “Hidden in Plain Sight—Reconsidering the Use of Race Correction in Clinical Algorithms,” New England Journal of Medicine 383, no. 9 [August 27, 2020]: 874-82; this quotation is from 874.)

Vyas et al. report that often “algorithm developers offer no explanation of why raical or ethnic differences might exist. Others offer rationales, but when these are traced to their origins, they lead to outdated, suspect racial science or to biased data.” Moreover, they observe that “racial differences found in large data sets most likely often reflect effects of racism—that is the experience of being black in America rather than being black itself—such as toxic stress and its physiological consequences. In such cases, race adjustment would do nothing to address the cause of the disparity. Instead, if adjustments deter clinicians from offering clinical services to certain patients, they risk baking inequity into the system” (879).

In such instances, race is hardly intended as a proxy for class. Rather, it does the work that race has always done as a contrivance that makes class invisible and reads inequality into nature. And, unsurprisingly, market considerations also figure into the race corrections to the extent that cost effectiveness is an element in calculating the algorithms. Vyas et al. also report

A widely used used clinical tool took past health care costs into consideration in predicting clinical risk. Since the health care system has spent more money, on average, on white patients than on black patients, the tool returned higher risk scores for white patients than for black patients. Those scores may well have led to more referrals for white patients to specialty services, perpetuating both spending disparities and race bias in health care. (879)" (