The New Political Sociology of Science: Institutions, Networks, and Power

12. Institutionalizing the New Politics of Difference in U.S. Biomedical Research: Thinking across the Science/State/Society Divides

In this chapter I describe a recent wave of reforms in biomedical knowledge production and pharmaceutical drug development in the United States. The reforms affect how researchers go about designing clinical studies, with downstream consequences for the medical care that all of us receive. More abstractly, they influence how matters such as citizenship , identity, and difference are understood in the United States, as well as how the politics of race and gender are played out. Given their implications, it would be worthwhile for me to specify these changes in detail, account for their origins, assess their significance, and explore their ramifications, but that is not my agenda here (see Epstein 2003a, 2003b, 2004a, 2004b, 2004c). Instead, in these pages, my use of the case study is somewhat more opportunistic. I provide a brief sketch of the case, describing the reform coalition and tracing the pathways of change. But my goal is to extract a series of conceptual points that, though grounded in the specific example, hold the potential for wider applicability . In particular, I pay attention to the politics of categorization and their role in the institutionalizing of what I call a biopolitical paradigm. 327 12 Institutionalizing the New Politics of Difference in U.S. Biomedical Research Thinking across the Science/State/Society Divides   The concepts that I develop here have a hybrid character: they are meant to demonstrate the potential convergence of analyses in political sociology, science and technology studies, and social theory.1 My goal is to suggest (and in these pages I cannot do more than suggest) that this cross-disciplinary fusion is useful for understanding the nexus of science/state/society relations. Because my empirical case is situated on the terrains of “the state,” “medical science,” and “social movements” and yet confounds attempts to distinguish clear borders between these theoretical entities, it is especially well suited for the task.2 The New Biomedical Politics of Inclusion Since the mid-1980s, an eclectic assortment of reformers has argued that expert knowledge about human health is dangerously flawed. According to this critique, biomedical research has presumed a “standard human” and has been conducted without adequate regard for human variation. Those leveling the charge (including health activists, clinicians , scientists, and political leaders in the United States3) have pointed to numerous culprits in the general failure to attend to biomedical difference , but to the extent that advocates have brought about change, they have done so primarily by targeting the state. Reformers have trained their attention on the U.S. Department of Health and Human Services (DHHS) and especially two of its component agencies: the National Institutes of Health (NIH), the world’s largest funder of biomedical research; and the Food and Drug Administration (FDA), the gatekeeper for the licensing of new therapies for sale. Under pressure from within and without, these federal agencies have ratified a new consensus that biomedical research must become routinely sensitive to human differences of various sorts, especially sex and gender, race and ethnicity, and age.4 Academic researchers receiving federal funds and pharmaceutical manufacturers hoping to win regulatory approval for their company’s products are now enjoined to include women, racial and ethnic minorities, children, and the elderly as research subjects in many forms of clinical research; measure whether research findings apply equally well to research subjects regardless of their categorical identities; and question the presumption that findings derived from the study of any single group, such as middle-aged white men, might be generalized to other populations (see Table 1). Surprisingly, 328   despite attention to the move to include greater numbers of women in biomedical research (Auerbach and Figert 1995; Narrigan et al. 1997; Weisman 1998; Baird 1999; Eckenwiler 1999; Weisman 2000; Corrigan 2002), social scientists have had little to say about the more broad-scale, identity-centered redefinition of U.S. biomedical research practice that encompasses multiple social categories.5 How were these changes propelled? Advocates of reform made a series of interlinked arguments—or, to use a helpful concept from the scholarship on social movements, they put forth into the public arena a series of collective action frames (Snow et al. 1986; Benford and Snow 2000). Much like those promoting affirmative action in the workplace and in higher education, reformers sought to demonstrate that women, people of color, and other groups had been numerically Institutionalizing the New Politics of Difference 329 Table 1...