The U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials , which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted (...) baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act. (shrink)

The famous 1959 Two Cultures essay by C. P. Snow has become a foil for decades of discussions over the relation between science and the humanities. The problem of the “two cultures” is often framed in terms of how the particular epistemological claims or general intellectual orientations of particular individuals on either side of this purported divide obstruct interdisciplinary dialogue or cooperation. This formulation, however, is ultimately unsatisfying, because often it focuses narrowly on the intentions and arguments of individuals, without (...) considering the institutional frameworks within which such debates occur. In this article, I propose to bracket issues of individual epistemological orientation while .. (shrink)

This article endeavors to place into context recent developments surrounding the United States Food and Drug Administration recent approval of BiDil® (isosorbide dinitrate/hydralazine hydrochloride) (NitroMed, Inc., Lexington, MA) as the first ever race-specific drug—in this case to treat heart failure in African Americans. It focuses in particular on both commercial incentives and statistical manipulation of medical data as framing the drive to bring BiDil to market as a race-specific drug. In current discourse about pharmacogenomics, targeting a racial audience is perceived (...) as necessary because at this point the technology and resources do not exist to scan efficiently every individual's genetic profile. The article argues that medical researchers may say they are using race as a surrogate to target biology in drug development, but corporations are using biology as a surrogate to target race in drug marketing. Pharmacogenomics may hold great promise, but on our way to that Promised Land, it is imperative to review such short cuts with a critical eye. (shrink)

This article is concerned about what may be happening to race and medicine in the “meantime” between today's clinical realities and the promised land of pharmacogenomics where the need for using race in medicine is supposed to fade away. It argues that previous debates over the use of race in medicine are being side-stepped as 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. Embracing the trope of “promise” in pharmacogenomics alongside the idea of using race as a useful interim proxy for genetic variation raises concerns that new diagnostic and therapeutic interventions may reflect or be mapped upon existing social categories of race, class, gender, and ethnicity in a harmful or dangerous manner. At the most basic level, the politics of the meantime in pharmacogenomics may be promoting the scientifically unjustified and socially dangerous recasting of race as a social and historical construct into a reified genetic category. (shrink)

In 1878, Friedrich Engels famously wrote that on the road to realizing the communist utopia, “the state is not abolished, it withers away.” In a similar manner, biomedical researchers telling us that come the promised land of individualized genomic medicine, the need for using race will also “wither away” in the face of scientific progress. Such millennial hopes are, no doubt, sincere, but they enable the continued casual proliferation of racial categories throughout biomedical research, product development, marketing, and clinical practice. (...) My contrasting quotation to frame this article is drawn from the 20th century pioneer of rock and roll, Buddy Holly whose 1957 hit “Not Fade Away” begins with the line, “I’m gonna tell you how it's gonna be” — the point being that far from withering away, race is persisting even as genomic milestones are being reached and passed. (shrink)