Grassroots marketing in a global era: more lessons from BiDil.

Since the first phase of the formal effort to sequence the human genome, geneticists, social scientists and other scholars of race and ethnicity have warned that new genetic technologies and knowledges could have negative social effects, from biologizing racial and ethnic categories to the emergence of dangerous forms of genetic discrimination.i Early on in the Human Genome Project (HGP), population geneticists like Luigi Luca Cavalli-Sforza enthusiastically advocated for the collection of DNA samples from global indigenous populations in order to track the history of human ancestry, migration, and languages, while social scientists like Troy Duster insisted that the new genetics was in danger of ushering in insidious practices of eugenics.ii The Human Genome Diversity Project’s 1991 proposal to archive human genetic variation around the world quickly came under intense scrutiny by indigenous peoples and advocacy groups who worried that such measures could exploit indigenous groups as research populations and even resurrect racist taxonomies from the nineteenth century.iii Ongoing sensitivity to genetic discrimination has been evidenced more recently in the May 2008 passage of the Genetic Information Nondiscrimination Act (GINA), which prohibits employers and health insurance companies from collecting and using genetic information for discriminatory purposes.iv While such measures have been, in many ways, effective in raising awareness about such issues and preventing some forms of genetic discrimination before they become a serious problem, the use and reinforcement of identity categories in genomics research continues to be contested terrain in legal, ethical, and public policy debates.v Over the past few years, issues related to race, ethnicity, and genetics have appeared in more subtle and surprising areas, including the domains of intellectual property and pharmacogenomics.vi Today, the reification of race and ethnicity as genetic is occurring in the development and marketing of racially and ethnically targeted drugs, which are supported by patents that contain identity-based claims.vii The recent case of BiDil, a treatment for heart failure that emerged in 2005 as the first FDA approved drug with a race-specific indication, reveals the complex ways that questions about race and genomics persist into the twenty-first century. After BiDil was initially rejected by the FDA in 1997, researchers sought to resuscitate the drug as a racial medicine by seizing on data from the original clinical trials to make a case to the FDA that black patients responded better to the drug than white patients.viii Many epidemiologists and other critics remain unconvinced by this data.ix Moreover, the underlying mechanism for the purported difference in drug response remains unknown and has not been linked to a population-based genetic polymorphism.x Stories in the popular media have, nonetheless, continued to suggest that the purported differential response to the drug is rooted in a genetic difference.xi In their survey of the popular news coverage of BiDil, Timothy Caulfield and Simrat Harry show that while news coverage explicitly focused on the racial dimensions of BiDil tended to offer a surprisingly nuanced view on the complex relationship between race and genetics, articles that simply mentioned that BiDil was a new “race-based drug” presumed the link between race and biology and in so doing, naturalized racial difference as genetic.xii Other news sources have erroneously argued that BiDil is ushering in the era of so-called personalized medicine, in which drugs are tailored to each individual’s genetic profile.xiii While scholars have meticulously shown how the BiDil case exploited race as a marketable commodity and transformed race from a socially constructed category into a marker of innate biological difference, another side of the story complicates this line of argument: black interest groups, including the NAACP, the Association of Black Cardiologists (ABC), and the Congressional Black Caucus (CBC), were solicited for their support of BiDil by the drugmaker, NitroMed, and lobbied for the drug’s approval by the FDA.xiv Representatives from the ABC, NAACP, CBC, and members of the black community regarded BiDil as an appropriate response to race-based health disparities in the U.S. and even as, according to Susan Reverby, “reparations for racial wrongs” like the Public Health Service Syphilis Study at Tuskegee.xv This essay seeks to reevaluate the case of BiDil by showing how the community support shown of BiDil was central for drugmakers in promoting and targeting the drug to African Americans. After FDA approval, NitroMed used the support it had gained from black interest groups and community members to market BiDil as a unique “grassroots” pharmaceutical to African Americans. Furthermore, we seek to complicate the domestic understanding of race in the discourse surrounding BiDil in order to highlight the global nature of racial and ethnic categories as well as health disparities.xvi Finally, we highlight red flags that BiDil raises for the future of personalized medicine.xvii While BiDil has ultimately performed poorly on the market, it is imperative that we better understand the complex factors that brought BiDil to market in the first place. The BiDil case was covered widely in both specialized journals and the popular media and we should expect that scientists and pharmaceutical companies have learned important lessons from its successes and failures, including how to repackage a failing drug through race-based indications, how to use the tools of ethnic niche marketing to target pharmaceutical consumers, and perhaps even how to mobilize grassroots organizations and interest groups in advocating and marketing new drugs.xviii By better understanding the BiDil story, including how race was mobilized from the clinical phase through the patenting process, FDA approval, marketing and final dissemination to patients, we might be better poised to respond once the next BiDil story hits the headlines, as it inevitably will.