Here We Go Again: Why is the FDA Reifying Race as Genetic?

In recent years the issue of whether, how and when to use racial categories in biomedicine has been a subject of heated and extended debates that have ranged over wide areas of research and practice. Over the past decade, significant scientific advances sparked by the federally financed Human Genome Project have placed genetics at the center of many of these debates. In no area is this more pronounced than in the field of pharmacogenomics, the study of how individual genetic differences affect drug response.

Ostensibly, pharmacogenomics is all about the individual, not about race. Indeed, part of its promise is its purported ability to move beyond race, to render it irrelevant as a biological category in assessing drugs response. Yet pharmacogenomics remains in its infancy. Some progress has been made, but a recent report from the Royal Society in the United Kingdom asserts that realizing the promise of truly individualized pharmacogenomic therapies remains decades away. Nonetheless, major government, academia, and industry initiatives are drawing huge amounts of material and intellectual capital into the pursuit of this distant promise.

I am concerned about what may be happening to race and medicine in the “meantime” – that is, between today’s clinical realities and the promised land of pharmacogenomics. Previous debates over the use of race in medicine are being side-stepped, and race is being reconfigured from a “crude surrogate” for genetic variation into a purportedly viable placeholder for variable drug response – to be used here and now until the specific genetic underpinnings of drug response are more fully understood.

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