Pharmaceutical patenting ontologizes the Black body via flawed clinical trials and equating Blackness as biological. Targeting of the Black body through biomedical patents pathologizes Blackness and abstracts it from materiality.

Race drugs: BiDil and customizing health ‘‘for blacks only’’

On 24 June 2005, the New York Times announced that: ‘‘the Food and Drug Administration took a controversial step toward a new frontier of personalized medicine yesterday, approving the first drug ever intended for one racial group, African Americans’’ (Saul, 2005). This new pharmaceutical, marketed as BiDil, targeted racial health and promised to both revolutionize biomedical attention to racial disparities and pave the way toward pharmacogenomics—where drugs and drug combinations will be optimized for each individual’s unique genetic makeup.7 According to the pharmaceutical company NitroMed (then owner of the patented drug), BiDil is ‘‘for use in addition to routine medicines to treat heart failure in African American patients, to extend life, improve heart failure symptoms, and help heart failure patients stay out of the hospital longer’’ (NitroMed BiDil, n.d.).

BiDil did not begin as a race-specific drug but, rather, became one through what Jonathan Kahn (2004: 11) has called ‘‘a complex array of legal, commercial, and medical circumstances that transformed the drug’s identity.’’ The clinical trial that finally led to BiDil’s approval, the African-American Heart Failure Trial (A-HeFT), was conducted after many years of trying to get the drug off the ground: This trial enrolled only black patients, and NitroMed sought a race-specific approval because that indication had a longer remaining patent life (Kahn, 2012). A-HeFT compared standard-of-care treatment plus placebo with standard-of-care treatment plus BiDil, a new combination of two existing generic drugs, hydralazine hydrochloride and isosorbide dinitrate. While the A-HeFT trial ended early—having convincingly proved that BiDil was beneficial for lowering the risk of death—it did not compare different racial groups, and, thus, the trial did not actually prove race-specific efficacy. The FDA, however, cleared BiDil as only for use in black patients (Ellison et al., 2008: 449).

Essentially, BiDil identifies African Americans as a distinct group—that can be clearly demarcated—in order to make that group into an accessible ‘‘object’’ for the drug’s development, approval, marketing, and consumption. Organizations such as the Association of Black Cardiologists recognized BiDil as a means to address the specific health needs of African Americans and a remedy for enduring health disparities in order to save black lives. The NAACP, too, backed the race-based drug by prioritizing the immediate needs of black individuals having access to medicines that would work—rather than focus on the risks of the drug’s racialized designation. At the same time, however, many were wary of racial profiling in medicine and its associated risks, and the way BiDil might further pathologize risk within the black body.

This latter line of thought directs attention to one of the key problematics of BiDil as an example of race-based biomedical targeting in neoliberal times: It reaffirms and ontologizes racial difference in the space of the black body as a biological truth—at the genetic level. Kahn (2008: 135) has argued: ‘‘Underlying the [BiDil] trial design is a race-specific patent that is premised on a genetic conception of race.’’ The FDA approval for BiDil was also ultimately predicated on this idea, as the organization gave its (and thus the state’s) imprimatur to the claim that African Americans had a different—and implicitly substandard8 —physiology of the heart, attributable to some unknown but inherent biological factor.9 While the participants in the A-HeFT trial (that led to the FDA approval) were not genetically tested, ‘‘race’’ was used as a marker and a descriptor—a proxy—for genetics in the case of BiDil.10 Such a move problematically means that people with radically varying genetic realities are homogenized under the racial descriptor ‘‘African American.’’ It assumes that racial groups are biologically distinct (that there are clear lines between different races) and that African Americans represent a unitary racial group; it suggests that race itself is biological rather than a social category.11 As Troy Duster (2003b: B7) has poignantly argued, however, the issue of black heart failure ‘‘was not biological or genetic in origin, but biological in effect due to stress-related outcomes of reduced access to valued social goods, such as employment, promotion, housing stock, etc. The effect was biological, not the origins.’’

There is no denying that BiDil reduces heart failure. It is not clear, however, that it operates in a racially specific way. The deployment of BiDil as a ‘‘solution’’ to black illhealth elides how the workings of anti-black racism register at the level of biology, as Duster suggests, and directs resources—a pill—at the effects of anti-black racism. This directing of resources at effects rather than causes reaffirms the correlation between biological-based notions of blackness and risk. Biomedical targeting, as in the case of BiDil, then abstracts bodies from material space (and history) and naturalizes the historical conditioning of the black body as separate from template (white) ‘‘Human embodiment.’’ Indeed, BiDil might be viewed as a reinstantiation of the epistemology of anti-blackness in that the black body itself is viewed as the ‘‘problem’’ that needs a separate form of biopolitical administration. Ironically, then, while the pill might be seen as a way to decondition the historical accumulation of antiblackness, it actually augments its operation.