Jonathan Kahn

BiDil was the first drug to be approved by the FDA with a race-specific indication, but it won’t be the last. Kahn explores the troubling implications of this race-medicine-commerce intersection. BiDil was approved with a race-specific indication based on a trial only on African-Americans, even though “like BiDil, most drugs on the market today were also approved based on data from single-race clinical trials—in white people.” But we call those drugs for people, because the assumption has been that whiteness is the norm. Moreover, the discourse surrounding BiDil conflates race with biology. African-Americans have high hypertension rates, but Nigerian Africans have the world’s lowest rates, far lower than Germany’s overwhelmingly white population.

Kahn argues that biologizing race in the way that BiDil’s approval did both pathologizes black bodies and redefines disparity as difference, nobody’s fault and nobody’s responsibility but the individual’s. Some researchers have argued that, holding other factors constant, race still matters to health outcomes, but they’ve considered a remarkably thin set of “other factors”—mainly income and education. Concluding that what remains after those are factored out must be biological ignores things like the effects of racial discrimination, and the resulting stress, on human bodies, and on the treatments that get offered. Racial difference is social and invites social responses; genetic difference is individual and invites technical responses, so there is a political bias inherent in defining differences as genetically determined even if it seems neutral in the case of medicine.

In fact, the motivation for BiDil’s race-specific indication was not neutral: it was propounded in order to garner extra years of patent protection. At the same time, its makers hoped to have significant off-label use in other patients, as a larger market available once approval for African-Americans had been secured and the drug could be legally marketed. The strategic, commercial use of race risks turning social status into “genetic” fact as a side effect on the way to profit.

Kahn also criticizes the casual way researchers and patent examiners treat race, as if it were a natural category that could be divined either by self-reports or by observation (not mattering much either way who did the categorizing)—Kahn notes the huge contrast between the care researchers take with other technical aspects of data collection compared to how they see race as “easy and obvious.” This casualness with respect to race should create a conflict with patent law, but no one has noticed. In “unpredictable arts,” courts are usually particularly attentive to whether a patent properly describes the claimed invention (known as enablement), because small changes can lead to big differences in results. Only by treating race as easily knowable and definable can applicants claim enablement; Kahn argues that courts and the Patent & Trademark Office should instead require a rigorous definition of the “race” that matters in race-based patents.

Kahn also discusses the role the “politics of the meantime” plays in race-based medicine. The theory is always that someday there will be individualized genomic medicine, and the need to use race will thus “wither away.” Kahn argues, however, that race is evolving into a residual category “that is being used to explain any variation in drug response not captured by specifcally identified genetic or social factors.” Thus race will never disappear from this model: it will always be used to explain variation. It will also continue to have commercial value—it’s more profitable to promote a product for “African-Americans” than for some subgroup (including people of many races) that will most likely have to be identified by expensive tests.… (mehr)