4 Beyond Inclusion, Beyond Difference:
The Biopolitics of Health
In recent years, scholars have devoted significant energy to understanding the ways in which physicians, biomedical scientists, and medical institutions adopt and use racial identifiers. Conversely, and perhaps more importantly, these analysts have called attention to the prominent role of biomedical actors within the broader cultural processes by which concepts of race are given meaning in society—and in particular, the processes by which race becomes treated as a meaningful construct at the level of biology (Marks 1995; Haraway 1997, chap. 6; Graves 2001; Lee, Mountain, and Koenig 2001; Sankar and Cho 2002; Cooper, Kaufman, and Ward 2003; Duster 2003, 2005; Templeton 2003; Wailoo 2003; Fausto-Sterling 2004, 2008; Kahn 2004; Reardon 2005; Shields et al. 2005; Shim 2005; Montoya 2007; Fujimura, Duster, and Rajagopalan 2008; Fullwiley 2008; Nelson 2008; Pollock 2008; Whitmarsh 2008). The goal of this chapter is to argue that, at least with reference to the United States, we should view these developments—what we might call the biomedical remaking of race, or the racial remaking of biomedicine—against the backdrop of a sweeping set of changes at the level of biomedical research policy and practice. This broad wave of reform, which combines new ways of understanding human differences with new emphases on social, political, and medical inclusion, has concerned the politics of race, but it does not concern race alone. In particular, studying the effects of reform helps to pinpoint the intersecting (and also divergent) trajectories of race and sex1 as objects of biomedical and political attention and helps reveal the commonalities in how they are frequently naturalized and reified.
A New Regime
In the early to mid-1980s, in the United States, an eclectic group began to demand new ways of attending to identity and difference in the domain of biomedical research. Reform was promoted by an assortment of health advocates, politicians, biomedical researchers, drug company scientists, and federal health officials; this effort encompassed women’s health and minority health advocacy groups, AIDS and breast cancer activists, mainstream political organizations such as the Congressional Caucus for Women’s Issues, and professional groups such as the American Academy of Pediatrics, among others.2 Reformers championed the goal of equity in biomedical research, insisting that every group in society is deserving of biomedical attention. At the same time, reformers declared war on the biomedical “standard human.” They argued that while this standard human was being used as a stand-in for all humanity, in practice, he was typically white, male, and middle-aged. And they insisted that a variety of social differences are medically meaningful—that it is simply not appropriate to take findings derived from the study of one sort of person and extrapolate them to other sorts.
In fact, the claim that medical researchers were only studying middle-aged white males and had never focused on others was an exaggeration, and in some respects, it was importantly wrong (Epstein 2007, chap. 2). It left out the long history of researchers taking advantage of those people with less power in society (a practice that has continued to some degree in recent decades), and it overestimated the extent to which groups, such as men, actually were predominant in research populations. But the critique did capture something about standard operating procedures in certain domains of medical research and pharmaceutical drug development—for example, cardiovascular disease, where women were significantly underrepresented. Moreover, this charge quickly became the conventional wisdom that united a diverse group of proponents of social and biomedical change. As Bernadine Healy, the first female director of the National Institutes of Health (NIH), recalled of the status quo ante, when looking backward from the perspective of the year 2003 (Office of Research on Women’s Health 2003),
the orthodoxy of sameness and the orthodoxy of the mean, which has dominated much of the thinking in medical science… often impaired our attitude toward clinical research in those days—we tended to want to reduce the human to that 60 kilogram white male, 35 years of age, and make that the normative standard—and have everything extrapolated from that tidy, neat mean, “the average American male.”
Critics suggested that this narrow conception of the standard human had thoroughly penetrated medical theory, practice, education, and training, and that its signs ranged from the composition of clinical trials, to the anatomical images used in medical textbooks, to the presumptions about which sorts of people could best work as doctors or scientists.
Reformers opposed this false universalism and argued for the inclusion of more women, people of color, children, and the elderly as research subjects. These were the categories of political mobilization, but these were also the categories deemed to hold biological relevance. Drawing, in particular, on scientific findings of differential responses to medications according to sex, race, or age, advocates of measuring differences portrayed social groups as bodily distinct and medically incommensurable: they suggested that knowledge simply failed to travel across these categories. Thus reformers joined together ethical and political arguments about equity and inclusion with scientific arguments about embodied difference. The presumption—one which merits scrutiny—was that the relevant categories of identity politics were also the relevant categories of medical differentiation. On the basis of this presumption, reformers called for the measurement of medical differences by categorical identity.
At the broadest level, the result in the United States has been a distinctive fusion of biomedical and governmental goals, terminology, and procedures that I call the inclusion-and-difference paradigm. The name is meant to reference the dual mandate of this new approach. First, advocates have demanded that various groups considered to be underrepresented in medical research—in particular, women, racial and ethnic minorities, children, and the elderly—be included in greater numbers in clinical studies and in pharmaceutical drug development. Second, they have insisted that researchers test for differences across these populations, rather than assuming that findings from any one group, such as adult white men, can be extrapolated to others.
In the United States, this paradigm takes particular forms. First, it includes a political and scientific process of determining which categories are going to matter—or, in the policy lingo used within federal health agencies, who is going to count as a “special population.” And in the policies, guidelines, and laws that I track, the categories that have most explicitly been made to matter are sex and gender, race or ethnicity, and age (at both extremes—pediatric and geriatric). Second, we can perceive the outlines of the paradigm in the new expectations codified in a series of federal laws, policies, and guidelines issued between 1986 and the present that require or encourage research inclusiveness and the measurement of difference. For example, the NIH Revitalization Act, signed into law by President Clinton in 1993, requires not only that women and minorities be included in NIH-funded clinical research, but also that clinical trials be “designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial” (National Institutes of Health Revitalization Act 1993). The NIH Revitalization Act of 1993 has received attention from scholars because of its specifications about sexual and racial/ethnic inclusion, but in fact, it is only one of many such policies. Finally, the paradigm takes visible form in the creation of bureaucratic offices within the U.S. Department of Health and Human Services (DHHS) and within its component agencies such as the NIH, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). These particularly include offices of women’s health and offices of minority health.
Looking farther downstream, the paradigm institutionalizes new standard operating procedures for biomedical research and pharmaceutical drug development (Epstein 2007, chap. 6). For example, researchers with federal funding and drug companies seeking marketing approval are obliged to document the numbers of people from various social groups who participate in studies and, in some cases, to describe differences in outcomes between these groups. The NIH standard grant application form, called the “PHS 398,” was revised to include a chart on which investigators must enter their study recruitment targets by “sex/gender” and by race and ethnicity. If the proposal is then funded, the investigator is also required to submit annual reports on accrual of subjects, demonstrating that the actual demographics of the study are consistent with the inclusion plan that was proposed originally. The adoption of census categories for this purpose has led to predictable difficulties and a certain measure of force-fitting of bodies to categories—particularly in the growing number of cases in which clinical trial subjects are recruited from outside the United States.3 The NIH then aggregates these figures in a database and uses the information to prepare reports for Congress. If investigators do not intend to include both women and men, a range of racial and ethnic groups, and children as well as adults in a proposed study, then they must explain the rationale for exclusion as part of their grant application text. When received by the NIH, all applications are coded by peer review panels to indicate whether women, minorities, and children are included, and whether the inclusion or exclusion is considered acceptable or unacceptable. In addition, if the applicant is proposing a large, phase III clinical trial, then reviewers are expected to comment on whether the investigator is planning to conduct subgroup analysis (either a full-fledged analysis capable of showing statistical significance, for those cases in which prior evidence suggests that results may vary by sex/gender, race, ethnicity, or age, or a simpler, “valid analysis of differences,” for those cases in which there is no reason to expect variation by subgroup; U.S. Public Health Service 1998; National Institutes of Health 2001).
Similarly, in the late 1980s, the FDA began calling for each “new drug application” to “give the number, age range, and sex distribution of subjects” as part of a table showing all studies conducted on the drug being considered for licensing. In addition to providing figures on clinical trial participants, pharmaceutical companies are required to give specific information by subset for any differences in response to a drug revealed by the clinical trials. The “subsets of interest,” the FDA noted, might well vary with the drug and condition being studied, but usually would include sex, race, age, and size, along with such diverse potential factors as the severity of the disease, whether patients suffer from other (“concomitant”) illnesses, the patients’ histories of therapy with other medications for the condition, and smoking and alcohol use. However, the subsets that pharmaceutical companies are specifically requested to tabulate are what they describe as the major ones of age, sex, and race (U.S. Department of Health and Human Services 1988; see also Epstein 2007, chap. 6).
While some experts, policy makers, and health advocates have embraced these new understandings about bodies, groups, and health as obviously valuable, and others have dismissed them as pernicious or silly, my goal is to do neither of these things. In my book Inclusion, where I discuss these developments at length, I seek to understand, first, how a particular way of thinking about medical difference in the United States helped give rise to a strategy to improve medical research by making it more inclusive. Second, I show how this strategy gained supporters, took institutional form, and became converted into common sense. Third, I try to shed light on its various consequences for government agencies, biomedical researchers, and pharmaceutical companies as well as for the social groups targeted by new policies. And finally, by comparing this approach to other ways of imagining the meanings of identities, differences, and inequalities in biomedical contexts, I examine the extent to which the new common sense might lead to better health and a more just society as well as the extent to which I believe it falls short or takes a wrong turn.4
In this chapter, my goals are more restricted. I will bypass the story of how the inclusion-and-difference paradigm came into being and will instead consider specific issues relating to the significance of these developments. I argue that the recent debates concerning the scientific meaning of race (and particularly, the biomedical significance of race) ought to be analyzed in relation to these broader biopolitics of inclusion and difference. To make this point, I focus on three topics. First, I emphasize the biopolitical significance of group-specific medical research within present-day practices of governance. Second, I argue for the importance of race, sex, and age as attributes that permit new forms of standardization for political and biomedical purposes. Finally, I draw out what I take to be the important implication that scholars interested in these historical developments should not be studying the race-science-medicine nexus alone, separately from other social categorizations.
Biopolitics
Michel Foucault (1980) used the term biopolitics to describe the increasing concern by modern states with managing and measuring human populations as well as the treatment of such populations as a resource and object of administrative rule. Building on this influential concept, I suggest that the inclusion-and-difference paradigm can be understood as an example of a biopolitical paradigm, a term meant to suggest how practices of governance and scientific investigation have become interwoven. By biopolitical paradigm, I mean a framework of ideas, standards, formal procedures, and unarticulated understandings that specifies how concerns about health, medicine, and the body are made the simultaneous focus of biomedicine and state policy.5 The inclusion-and-difference paradigm is one such biopolitical paradigm both because it reflects the presumption that health research is an appropriate and important site for state intervention and regulation and because it infuses the life sciences with new political import.
While some might see the inclusion-and-difference paradigm as an example of how biomedicine (for better or for worse) gets politicized, it might just as well be taken as evidence of the converse—how, in the present period, governing gets “biomedicalized.” Medical research thereby becomes reconceived as a domain in which a host of political problems can get worked out—the nature of social justice, the limits and possibilities of citizenship, and the meanings of equality and difference at the biological as well as social levels.
The label “inclusion-and-difference paradigm” is my own invention, and no one within the DHHS, the pharmaceutical industry, or the academic world of clinical research uses the term. But this general approach to health research policy can be seen as built into the standard operating procedures, discourse, and organizational structure of the DHHS as well as a wide range of other biomedical contexts. What work is it doing? As a biopolitical paradigm, the inclusion-and-difference approach hybridizes scientific and state policies and categories. Specifically, it takes two different areas of concern—the meaning of biological difference and the status of socially subordinated groups—and weaves them together by articulating a distinctive way of asking and answering questions about the demarcating of subpopulations of patients and citizens.
This is not an outcome that we should simply take for granted. Although the domains of scientific work and governance are constantly and increasingly crisscrossing, it is hard to anticipate the specific ways in which they can become woven together through words and deeds. Who would have expected that technical questions about the methodologies used by medical researchers and political struggles about group rights would come to be seen as inextricably linked? A contingent set of historical circumstances in the United States prompted an eclectic set of reformers to bring these issues into joint focus—and to assume not only that political pressure should be brought to bear to make science function better, but also that clinical research was an appropriate arena in which goals of social equality and social justice could be worked on. Yet the bridging of concerns made cultural sense, given the existing relations among biomedical institutions, state administration, and social movement activism in countries like the United States in recent decades.
The point here is not that the pristine domain of science was invaded by political concerns; rather, the inclusion-and-difference paradigm is biopolitical because it promotes ways of defining, knowing, and governing populations that are derived from, and serve to shape, both governmental and scientific practices simultaneously. Biomedical science is linked to governance, in this case, not simply because the health of the people has become conceived of as a matter of crucial public concern, but because academic medical researchers, pharmaceutical company scientists, federal health bureaucrats, and lay health advocates have collaborated in deciding on the basic population subunits for biomedical purposes. The effect, as I have already suggested, is to presume that the axes of differentiation and categories of personhood used in the worlds of political organizing and bureaucratic rule are also the best categories to use for biomedical purposes.
In that sense, the inclusion-and-difference paradigm reflects three broad, long-term, and convergent historical trends that have been on the rise, particularly over the past century. First, the agencies of modern democratic states have become increasingly more involved in naming and singling out subgroups of people for policy purposes, assigning social rewards (or punishments) according to administrative categories, and thereby placing phenomena such as race and gender at the heart of the state’s maintenance of social order (Omi and Winant 1986; Connell 1990; Brown 1992; Espiritu 1992; Starr 1992, 160–161; Nagel 1995; Porter 1995; Luker 1998; Benhabib 1999; Goldberg 2002; Skrentny 2002, 85–142; De Zwart 2005). Second, social movements have become ever more likely both to assert demands on the basis of claimed social identities and to elaborate new collective identities through their very activism (Melucci 1989; Morris and Mueller 1992; Johnston, Laraña, and Gusfield 1994). Third, scientific experts progressively have developed new technologies and understandings that result in the segmenting or classifying of the human species, with the result of sometimes shoring up familiar forms of social differentiation, and sometimes (e.g., by the identification of shared genetic characteristics) creating new demarcations or bases of solidarity (Rabinow 1996).
The inclusion-and-difference paradigm unites and harmonizes the categorical work being done in these different worlds of state administration, identity politics, and biomedical science. The various opponents of the so-called standard human were adept practitioners of what I term categorical alignment. Reformers proceeded as if it were self-evident that the mobilization categories of identity politics, the biological categories of medical research, and the social classifications of state bureaucrats were all one and the same system of categorization. In effect, they assumed that the differences defined politically in our society between various haves and have-nots mapped onto the differences that emerged out of biomedical research—for example, the differences in the distribution of genetic variants of the cytochrome p450 enzymes responsible for drug metabolism. By bridging manifestly scientific and political arguments, proponents of inclusion were able to act as if the social movement identity labels, the biomedical terms, and the state-sanctioned categories were all one and the same set of classifications—that is, that the politically salient categories were simultaneously the scientifically relevant categories. It followed from this presumption that political and biomedical remedies could be pursued simultaneously through a single project of reform.
The marker of successful categorical alignment work is that it becomes invisible in hindsight: the superimposition of political classifications with scientific ones seems natural and inevitable. But it is worth noting that there are many bases by which claims of inequality could plausibly be put forward in the domain of health research, including by social class and geographic region, or in relation to social practices and social structures, rather than categorical membership. And, likewise, there are many ways of representing the dispersion of biological or genetic differences within the human population. So it was not foreordained that medical and political categories would come to be aligned in this case.
Standardization: Beyond the Standard Human
Let me now take up a second question about the significance of these biomedical reforms, one that concerns the way that biomedical researchers and policy makers seek to standardize their practices. Or to put it another way, what has come to replace the much-maligned standard human?
Advocates of the inclusion-and-difference paradigm repudiated one-size-fits-all medicine along with the notion that humanity could be standardized at the level of the species—that is, they rejected the presumption that biomedical knowledge could be derived from the study of, or be broadly applicable to, the standard human. But at the same time, these skeptics of universalism did not veer fully to the opposite extreme of embracing total particularity. Though they frequently invoked the rhetoric of “individualized therapy,” their response, in fact, was not to insist on the medical uniqueness of each individual; rather, advocates proposed that the working units of biomedical knowledge making could be social groups: women, children, the elderly, Asian Americans, and so on. The inclusion-and-difference paradigm therefore enshrines what I call niche standardization: a general way of transforming human populations into standardized objects available for scientific scrutiny, political administration, marketing, or other purposes that rejects both universalism and individualism and instead standardizes at the level of the categorical social group—one standard for men, another for women; one standard for blacks, another for whites, another for Asians; one standard for children, another for adults; and so on. In place of a standard human, we find an intersecting set of standard subtypes.
Niche standardization has perhaps not gotten the attention it deserves because many analysts of state bureaucratic practices have emphasized the tendency of modern states to homogenize populations—what Max Weber once called the “leveling of the governed” by the bureaucratic machine (Gerth and Wright Mills 1946, 226). Or alternatively, analysts of practices of governance have considered the contrary tendency to administer through individuation. These analysts have emphasized how states control populations through technologies of identification, such as passports, fingerprints, and biometrics, which seek to precisely distinguish one citizen from another (Torpey 2000; Caplan and Torpey 2001; Cole 2001), or how states make use of the practices, emphasized by Foucault and his followers, of surveillance and comparison of persons against norms (Foucault 1979). What all these discussions share is the presumption of a polar opposition between leveling and individuation, or between universalism and particularity. This binary focus diverts attention from niche standardization: the management (and redefinition) of population subgroups via a specification of standards at the intermediate level of the categorical group.
Within the world of modern biomedicine, as well, niche standardization has been overlooked because of the presumption of a fundamental tension between the universal and the individual. A familiar and continuing debate in biomedicine juxtaposes two ways of conceiving the patient. On one hand, modern medical practice is associated with more or less universal, homogeneous, and standardized approaches to patient care. This standardization reflects a number of historical developments, including the rise of “scientific medicine” in the late nineteenth century and the advent of the randomized clinical trial and modern methods of pharmaceutical drug regulation in the twentieth century. However, it is most often preached by adherents of evidence-based medicine, which prescribes standardized treatment protocols that are well supported by research (Timmermans and Berg 2003). On the other hand, when treating individual patients, physicians frequently reject these standardized formulas (which they sometimes dismiss contemptuously as mere “cookbook medicine”) in favor of more particularistic approaches that depend less on data than on experience and seasoned judgment—the art, as opposed to the science, of medicine. New scientific developments like pharmacogenomics that aim, eventually, at so-called personalized medicine through access to the patient’s genetic profile represent a different individualizing approach, one that would be particularistic but also scientific. But if these are the usual polar alternatives, then what is missing is the important intermediate solution, targeted at the middle level of the collective actor: medicine that is not personalized, but rather, group-specific.
To be sure, niche standardization is broadly familiar in the domain of consumer production and consumption. If the existence of a single standard human was the presumption of fordism (the old-fashioned system of producing mass commodities as predictably invariant as the Model T, to be sold to a universal consumer), then niche standardization is consistent with postfordist production—the niche marketing of diverse products to well-defined subgroups. It is in this context that we may consider recent and familiar examples of pharmaceutical industry marketing practices in relation to distinct racial or ethnic groups.
In 2005, the compound called BiDil, which treats heart failure, became the first drug ever approved by the FDA for use only in a single ethnic group. The drug had initially failed in tests with a diverse population, but analysis of racial subsets had suggested a reduced mortality for African Americans. A subsequent trial with 1,050 African Americans, conducted by the manufacturer, NitroMed, appeared to bear out the claim of benefit. In this way, niche standardization in medical research went hand in hand with niche marketing by industry (Kahn 2004).
Here is a less familiar example: in 2002, Zelnorm, a drug made by Novartis to treat irritable bowel syndrome, became the first of a few drugs so far approved by the FDA for use only in women for a condition that affects both sexes.6 The drug’s advantages over a placebo in a mixed-sex population could not be demonstrated with statistical significance. In this case, as well, the presumption is that the effects of medications correlate in a more or less standard way with categories of group belonging—that is, niche standardization provides the justification for niche marketing.
It is noteworthy, however, that proponents of niche standardization in medicine often adopt a discourse of individualism, but then develop policies that are aimed at social groups. To give one of many examples, an article by FDA officials published in Science in 1995 observes, “Since the early 1980s, [the FDA] has been interested in the individualization of therapy, that is, determining whether and how treatment should be modified for various demographic groups within the population” (Sherman, Temple, and Merkatz 1995, 793). This slippage between referencing individuals and groups is a common feature of discourse surrounding niche standardization; it endows the practice with legitimacy by associating it with individualism, one of the cherished values of U.S. political culture.
One additional biomedical domain where we see niche standardization playing an interesting role is in the renewed attention to group-specific differences at the level of recruitment of subjects into medical experiments. As a consequence of the policies that make up the inclusion-and-difference paradigm, researchers and pharmaceutical companies are now much more attentive to the practical challenges involved in recruiting people from so-called hard-to-recruit populations to participate in clinical research (Epstein 2008). Not only must researchers find willing subjects, and not only must those subjects be diverse, but the groups that researchers now feel pressure to represent include groups, such as children or African Americans, that are routinely considered among the most difficult of all to find and convince to participate.
In fact, I would argue that there has recently emerged a new science—one that has not named itself, but that I call recruitmentology—that has sought to develop an empirical body of studies scientifically evaluating the efficacy of various social, psychological, technological, and economic means of locating members of hard-to-recruit populations and convincing them that they want to become human subjects (Epstein 2008). Recruitmentology has promoted hybrid ways of thinking about race via the filtering of social scientific frameworks into the clinical research domain—awkward encounters in which depictions of race as a bounded, quasibiological, medical, and administrative category sit uneasily alongside an evolving interest in understanding racial identities and communities as sociocultural phenomena. In addressing the mandate to recruit racially diverse subject populations, recruitmentologists try to make sense of race, while simultaneously grappling with problems of community mistrust and collective memory of abuse. At the same time, the increasingly transnational character of biomedical research is intensifying the exploitative dimensions of recruitment, while further transforming the racialized character of human experimentation (Petryna 2006).
Connecting Inequalities
A central implication of this analysis is that attempts to study the modern biomedical and bioscientific remaking of race—at least in the United States7—should do so in a way that places race in relation to the other forms of difference and inequality that are encompassed within the biopolitical regime that I have been describing. I would like to deepen this argument with some closer attention to the relation between race and sex in debates about biology and health. My goal here is to hang on to two intuitions simultaneously.
On one hand, race differences and sex differences are different differences, and they cannot be conflated. They operate according to different logics; they have different histories; they have different groundings in the body and in the body politic. Therefore it is important to question the manner in which the inclusion-and-difference paradigm functions to construct rough equivalences among the various forms of difference that are recognized within it. From the standpoint of DHHS policies and procedures, sex/gender, race/ethnicity, and age are all treated as formally equivalent modes of difference to be handled administratively in similar ways. Because of contingent factors relevant to their histories, the policies and standards that make up the inclusion-and-difference paradigm do vary somewhat from one type of difference to another. (For example, the NIH does not compile statistics on the age distribution of subjects in its research portfolio, for the simple reason that Congress never required it to do so.) There are also some differences between agencies in the definitions of terms. (For example, the NIH considers anyone under the age of twenty-one to be a child for research purposes, while at the FDA, the definition is sixteen years or younger.) Nevertheless, in a more overarching sense, the paradigm tends to flatten differences—to conceptualize sex/gender, race/ethnicity, and age as ways of differing that are all analogous or commensurate from a policy standpoint.8 Formally, the policies also tend to treat sex/gender, race/ethnicity, and age as discrete characteristics of individuals, rather than as complexly intersecting relational properties of groups (Shim 2000, 180). Hence, out of “different differences,” the policies of the inclusion-and-difference paradigm have created a sort of generalized difference. This flattening may facilitate bureaucratic administration, but it also may problematically presume equivalences and analogies across very different sorts of categorizing systems.
But on the other hand, even while asserting the incommensurability of differences, we should also pay careful attention to the broadly similar processes by which scientific and political actors seek to naturalize differences of whatever sort and to ground them in human biology. In particular, by juxtaposing the question of race differences with that of sex differences, not only can we better understand how race and sex are jointly naturalized within the inclusion-and-difference paradigm, but we can also raise questions about why the naturalization of race has received so much more critical scrutiny than the naturalization of sex.
One of the consequences of the policies and regulations that make up the inclusion-and-difference paradigm is that they have promoted a whole host of findings of apparent race differences and apparent sex differences in drug response, health outcomes, and biological processes. But there is a noteworthy distinction to be drawn between the cases of race differences and sex differences: reports of biological difference by race have sparked a heated medical and public controversy about “racial profiling” (Jamerson 1993, 979; Schwartz 2001; Burchard et al. 2003; Cooper, Kaufman, and Ward 2003; Phimister 2003), but no corresponding debate seems to have arisen as yet with regard to biological differences by sex. For the most part, there has been little public discussion of the merits or risks of sex profiling in medicine—indeed, the phrase does not even exist.
Emphasis on sex differences in medicine is part of a larger trend toward claiming or assuming the overriding significance of biology and genetics in understanding the behavior of males and females, in domains ranging from brain functioning to mating behavior.9 As with race, arguments about sex differences drawn from genetics can cut both ways, and occasionally, reports of fundamental genetic similarities make their way into public view. For example, in 2001, The Scientist magazine reported, “Genetic studies are revealing that men and women are more similar than distinct. So far, of the approximately 31,000 genes in the human genome, men and women differ only in the two sex chromosomes, X and Y, and only a few dozen genes seem to be involved” (Beale 2001, 18). However, the notion that our usual distinction between “pink and blue” might be replaced with “a blurred rainbow of confusion”—as the article’s author put it—runs up against the vast wave of commentary that assumes or reports on stark differences between the sexes.
Nowhere is the attention to biological sex differences more pronounced at present than in biomedicine, and the concern with the effects of pharmaceutical drugs is an especially important example. Over the course of the 1990s, a range of reports in the medical literature described differences in drug effects involving both the metabolizing of drugs and their effects on bodily tissues, building on earlier research dating back to the early 1970s. A review in 2001 by pharmacologist Mary Berg noted a wide variety of sex- or gender-related differences, significantly including the effect of oral contraceptives in increasing or decreasing the speed of clearance of drugs such as aspirin, caffeine, and morphine. Berg also described research in “chronopharmacology”—the effect of bodily rhythms, such as the menstrual cycle, on how drugs are processed (Berg 2001). Another review essay—by Monica Gandhi and coauthors, published in 2004—attributed pharmacokinetic differences by sex not only to variation in the cytochrome P450 enzymes, but also to a number of other factors, including body weight and gastric emptying time (Gandhi et al. 2004). Gandhi and coauthors also discussed the burgeoning literature on sex differences in response to pain medications (believed to reflect differences in how men and women actually experience pain) as well as the evidence on differences in the effects and side effects of antipsychotic and antidepressant medications. Antiviral drugs targeting HIV have provided yet another important example: women appear to have more frequent and more severe side effects with several classes of anti-HIV medications, though some research also indicates that such drugs may also be more efficacious for women in terms of keeping the virus in check (Gandhi et al. 2004, 512–513).
“We now know that gender is one of the most important factors that influences and predicts response to all kinds of treatments,” FDA commissioner Mark McClellan said in 2003 in a public speech. “The FDA is working to better define the genetic differences between men and women that influence how they are going to respond to a particular medication” (Sexx Matters 2003, 1). Indeed, research on these various differences in the effects of medications has been a priority at the various women’s health offices, which have organized conferences and developed research agendas. A particular concern has been the issue of adverse drug reactions, estimated by the FDA to affect women at least one and half times as often as men (Anderson 2005, 25). In April 2004, the Agency for Healthcare Research and Quality (a DHHS agency) held a two-day meeting of experts to consider the problem of adverse drug reactions and to focus on the goal of “Improving the Use and Safety of Medications in Women through Sex/Gender and Race/Ethnicity Analysis” (Correa-de-Araujo 2005, 12).
The growing literature on biological sex differences in medicine extends beyond the important issue of pharmacology to include attention to many other kinds of differences in biological processes with health implications. According to the “statement of editorial purpose” of an electronic journal devoted to women’s health research, “it is increasingly evident that sex-based differences exist in a range of conditions, including heart disease, cancer, stroke, depression, HIV/AIDS, autoimmune disorders, neurologic diseases, bone and joint disorders, as well as in reactions to drugs” (Medscape 2003). Heart function and cardiovascular disease provide an excellent example. According to an editorial published in Cardiovascular Research in 2004 (titled “A Radical Idea: Men and Women Are Different”), “gender has a pronounced influence on the type and severity of cardiovascular disease that will likely ensue during one’s lifetime. Sex differences have been noted in most major cardiovascular diseases including coronary heart disease, stroke, and hypertension” (Bowles 2004, 5). Women also tend to develop heart disease at a later age than do men, and women and men are reported to have different symptoms prior to heart attacks—indeed, the canonical symptom of chest pain “was notably absent or was described differently by the women,” according to research reported by Gardner in 2004. Women are more likely than men to have a hidden form of coronary disease (Grady 2006), and women with coronary artery disease and implantable cardioverter-defibrillators also have been reported to develop a form of arrhythmia more often than do men with the device (Medscape 2004). As described in a recent article in Science on the “Molecular and Cellular Basis of Cardiovascular Gender Differences,” many of these differences may be linked to hormones, and some may be traced to developmental pathways laid down in utero (Mendelsohn and Karas 2005).
On April 25, 2001, the Institute of Medicine (IOM) of the National Academy of Sciences announced the forthcoming publication of a book-length report titled Exploring the Biological Contributions to Human Health: Does Sex Matter? This 288-page volume was the product of a lengthy review by a sixteen-member panel of experts, and it was sponsored by a range of government agencies, advocacy groups, and pharmaceutical companies. The report answered the rhetorical question, does sex matter? emphatically in the affirmative: “Sex does matter. It matters in ways that we did not expect. Undoubtedly, it also matters in ways that we have not begun to imagine” (Wizemann and Pardue 2001, x). Calling for medical researchers to study sex differences “from womb to tomb,” the panel reviewed the literature on sex differences in the efficacy of pharmaceutical drugs, sex differences in the etiology and pathogenesis of autoimmune conditions, sex differences in the experiencing of pain, sex differences in coronary heart disease, and so on. The panel also offered a raft of recommendations, including the quite radical one that researchers should “determine and disclose the sex of origin of biological research materials” and that “journal editors should encourage researchers… to specify the extent to which analyses of the data by sex were included in the study” (Wizemann and Pardue 2001, 178–179).
By coincidence, the announcement of the IOM report preceded by only about a week the publication, in the New England Journal of Medicine, of an editorial by a journal editor that blasted the practice of “racial profiling” in medicine (Schwartz 2001). But where reports of medically relevant, biological differences by race provoked controversy, the IOM report seemed almost universally to be praised. For example, in a fifteen-minute segment on NewsHour with Jim Lehrer, the story was presented straightforwardly as an episode in the forward march of medical knowledge (“Sex Matters” 2001). Particularly keen to promote the IOM’s conclusions was the Society for Women’s Health Research (SWHR), one of the groups that had sponsored the report. In the early 1990s, the SWHR had coalesced around the goal of inclusion of women in research and had campaigned for the NIH Revitalization Act. By the late 1990s, the society’s raison d’être was the furtherance of research on differences between men and women that bore medical significance. “This report substantiates everything we’ve been saying for six years,” Phyllis Greenberger, the president of SWHR, told the press. “Many scientists see the emphasis on sex and gender differences as a passing fad, reflecting some kind of political agenda. But the Institute of Medicine has validated this as an important field of research” (Pear 2001, A14). Some time later, at a conference sponsored by the NIH’s Office of Research on Women’s Health, Sherry Marts, the SWHR’s scientific director, repeated the rhetorical question in the report’s subtitle and suggested that the most pithy executive summary to the report might be the single word yes.10
The SWHR has been a key proponent of a social movement within biomedicine, on which the IOM report conferred crucial legitimacy. Along with academic medical researchers, NIH scientists, and scientists at pharmaceutical companies invested in women’s health, the SWHR has sought to establish a new field of study known as gender-based biology or (more recently, in an attempt to clarify their interest in what they understand to be biological, and not social, processes) sex-based biology. Others, such as cardiologist Marianne Legato at Columbia University, have used the term gender-specific medicine. As distinct from more generic proposals for the development of a women’s health specialty in medicine, advocates of sex-based biology emphasize fundamental, thoroughgoing, biological differences between men’s and women’s bodies, from the heart, to the brain, to the immune system. Those who subscribe to this movement believe that women—and men—deserve separate medical scrutiny because they are biologically different at the level of the cell, the organ, the system, and the organism (Haseltine 1997, 331–336).
To what extent, if any, is the case of biological differences by sex or gender analogous to that of biological differences by race and ethnicity? What does it mean that racial profiling in medicine has become an intellectual battleground, while sex profiling has not? These questions have received little direct discussion. To the very limited extent that analysts (in academia and elsewhere) have addressed the comparison, it has been to contrast the “tricky” case of race with the “easy” case of sex: obviously men and women are biologically different, it is claimed, while racial difference at the biological level—and even the determination of which racial categories to work with, or whether race exists at all—is contested terrain. Thus (the argument goes), while choosing a medication on the basis of the patient’s sex may be sensible and commendable, making such determinations according to race is deeply problematic. Even those who differ on the merits of racial profiling, such as the philosophers of science Ian Hacking (2005, 106) and Michael Root (2003, 1181), are in agreement when it comes to this point.
It appears that many critics of racial profiling in medicine have engaged in boundary work, erecting a wall between sex and race to designate the study of sex differences as good science and the study of race differences as bad science. Certainly the biological significance of sex and race are different cases to consider. However, it immediately bears saying that biological sex is not an either-or—not at the anatomic, the hormonal, or the chromosomal level. There are no truly dichotomous variables in nature, and as many scholars have shown, there is no precise or fully satisfactory biological means of demarcating all males from all females. Moreover, most sex differences reported in the medical literature, like most race differences, are statistical differences between means, not absolute differences between groups. (Furthermore, many of the published findings of sex differences may be less robust than claimed or may simply be incorrect.11) And if so, then the problems associated with profiling—such as the risk of treating individuals improperly on the basis of their group affiliations—may apply to medical research on sex differences, too, and not just to research on differences by race.
It is noteworthy that so many claims in the sex-based biology literature are framed, at least rhetorically, as universal observations about all women and all men. Florence Haseltine (1997, 333) has written that “the female body has more fat and less water”; Marianne Legato and Carol Colman’s (1991) book is called The Female Heart. Representations of medically relevant sex differences in the popular press likewise use the language of blanket differences. According to USA Today Magazine (2003, 8), “women are less active and consume less oxygen than men. Rib cages are smaller in women, resulting in lower lung capacity.” Also, “Women say ‘ouch!’ to pain before men do, but tolerate the pain better.” At least at the level of rhetoric, such claims appear to divide the universe of human experience into two utterly separate camps, while thoroughly homogenizing all that which lies within each one. Because of the binary and either-or nature of the discourse on sex differences, such claims seem even more all encompassing and less nuanced than those about racial and ethnic differences in medicine.
Certain sex differences, such as sex-linked traits linked to genes on the X chromosome, may indeed function to demarcate half of humanity from the other half—leaving aside, just for the moment, those individuals whose chromosomal sex is nonstandard. But most of the claims about sex differences are, once again, statements about differences between averages. Clearly it is not the case that all women have smaller rib cages than all men, or that all women say ouch first. Just as the science of statistics has constructed diseases as racial, so statistical processes also result in the sexing of diseases. Stefan Hirschauer and Annemarie Mol (1995, 377) have described how this process works using the example of anemia:
There is nothing inherently sexed about this disease.… A normal hemoglobin level differs from one person to the next and has no sex.… Statistical practice turns anemia into a sexed disease. Statistical practice builds on the anatomical differentiation between the sexes and clusters hemoglobin levels of hundreds of people identified anatomically as either males or females. Two curves emerge. The median and cut-off point of the first are a little higher than those of the second. Thus “men” have a higher normal hemoglobin level than do “women.”
As Hirschauer and Mol (1995, 377) observed, “the sex generated in this way is not one of bodies but is one of populations.”
Particularly in the case of the pharmacokinetics and pharmacodynamics of medications, usually the best that can be claimed is a statement about probabilities. Raymond Woosley, a pharmacology expert who has researched the harmful effects of drugs that prolong the “QT interval” in the heartbeat, noted that certain of those drugs affect men and women in strikingly different ways, while with other drugs, “the most sensitive male [is] equal to the average female, so there is considerable overlap;… it’s a mean difference” (pers. comm., August 9, 2000). Thus sex profiling in the clinic—drawing a decision about treatment based on knowledge of the patient’s sex—may function quite reliably in certain circumstances, while in other circumstances, it might raise the familiar problem of taking statistical generalities about a group and applying them to individual cases. In other words, Hacking’s claim that “many medical differences between males and females are uniform, but medical differences between races are almost always only statistical” fails to ask the crucial question of just how many medical differences between males and females are statistical as well.
As Judith Lorber (1993) has argued, the overriding mistake of so many “epistemologically spurious” studies of sex differences in both the biological and social sciences is that they begin simply by assuming that “men” and “women” are the relevant groups to compare; they then look for differences between them, and then attribute whatever they find to the underlying sex difference. Lorber (1993, 571) observed, “These designs rarely question the categorization of their subjects into two and only two groups, even though they often find more significant within-group differences than between-group differences.”
People and groups differ in an unlimited variety of ways. The problem here—as with race—is when we assume that the ways of differing that are most socially salient and obvious are necessarily the ones that carry the most explanatory weight (Hanson 1997). In the context of clinical care, this becomes dangerous. The unavoidable risk is that some individuals might receive the wrong diagnosis or treatment if they are approached as representative members of their social group. The hard-and-fast language of binary sex difference makes it particularly difficult to catch sight of this limitation, while the reliance on the group stereotype then serves to reinforce that hardness and fastness.
Conclusion
Once again, it is important to insist on the irreducibility of forms of difference and inequality. There can be no simple parallels drawn from the stories of race differences and sex differences in biomedicine. However, as we increasingly recognize the flaws and limits in biological conceptions of racial difference in health, this should lead us to recognize the similar flaws that may exist in notions of sex differences. In both cases, an overeagerness to assume and naturalize difference may actually get in the way of addressing the serious racial and gender disparities in health outcomes.
This recognition itself calls attention to the importance of considering race jointly with the other forms of identity, difference, and disparity that are all handled administratively by the inclusion-and-difference paradigm. (Of course, that includes attending to the intersections of these categories.) For each of these categories that have been fully or partially integrated within this same biopolitical framework, we should be asking a common set of questions: What are the consequences of assuming that a category of political mobilization is also, automatically, inevitably, and uniformly, a relevant category for biomedical purposes? When does this work? When does it not? What categories does it leave out? What happens to our ability to address social inequalities when we assume that differential health outcomes are simply a consequence of biological differences between groups? How can we make sure that we are being appropriately attentive to all the health risks that are shaped less immediately by membership in a group than by the practices in which one engages, the networks within which one moves, or the material and social resources one has at one’s disposal? These are the critical questions across the board.
Notes
1. The categorical terms used in this article are meant to represent the terms employed by the actors I studied, in all the ambiguity of everyday usage. On the history of the biomedical reliance on age, sex, and race categories, see also Hanson (1997).
2. I analyze these developments at greater length in Epstein (2007).
3. On one hand, NIH investigators are encouraged to collect identifying data from their participants around the globe in ways that allow participants to use meaningful, indigenous identifying terms. On the other hand, investigators nonetheless must take these culturally specific responses and aggregate them into the categories sanctioned by the Office of Management and Budget (the FDA guidance on racial categories takes a similar approach to this question; Food and Drug Administration 2005, 5). Exactly how this aggregating work is to be performed is not explained in NIH guidelines (National Institutes of Health 2000; the instructions changed slightly in 2004; see also Epstein 2007, 148–154).
4. Data for the larger project of which this article is a part were obtained in accordance with a strategy to juxtapose perceptions and trace actions across multiple “social worlds” (Clarke 1990), including those of clinical researchers concerned with recruiting underrepresented groups, pharmaceutical companies, federal health officials promoting the health of so-called special populations, politicians, and health advocacy organizations. Data have been obtained from seventy-two semistructured, in-person interviews in and around Boston, New Haven, New York, Baltimore, Washington, D.C., Atlanta, Ann Arbor, Chicago, Denver, Boulder, San Francisco, Los Angeles, and San Diego. Those interviewed included past and present NIH, FDA, and DHHS officials; clinical researchers; pharmacology researchers; biostatisticians; medical journal editors; drug company scientists; women’s health advocates and activists; bioethicists; members of Congress; congressional aides; lawyers; representatives of pharmaceutical company trade associations; experts in public health; and social scientists. Additional primary data sources included documents and reports from the NIH, the FDA, the CDC, the DHHS, and the U.S. Congress; archival materials from health advocacy organizations; materials from pharmaceutical companies and their trade organizations; articles, letters, editorials, and news reports published in medical, scientific, and public health journals; and articles, editorials, letters, and reports appearing in the mass media.
5. In using the term paradigm, my goal is not to resurrect historian and philosopher of science Thomas Kuhn’s familiar (but often criticized) account of decisive shifts over time in how communities of scientific practitioners look at the world (Kuhn 1970). I explain my usage in greater detail in Epstein (2007, chap. 1).
6. Subsequently, the drug was withdrawn from the market.
7. On the extent to which aspects of the inclusion-and-difference paradigm can be found in the policies and practices of other countries, see Epstein (2007, 273–276).
8. This construction of equivalences bears similarities to the “commensuration” practices described by Wendy Espeland and Mitchell Stevens (1998, 316), and it serves a similar function: it “offers standardized ways of constructing proxies for uncertain and elusive qualities [and] condenses and reduces the amount of information people have to process, [thereby] simplifying decision-making.”
9. For a characteristic example, see Marano (2003). For critiques of biological reductionism in the understanding of male-female differences, see Tavris (1992), Fausto-Sterling (1993, 2000a, 2000b, 2005), van den Wijngaard (1997), Lancaster (2003), and Harding and O’Barr ([1975] 1987).
10. Author’s field notes, “Science Meets Reality: Recruitment and Retention of Women in Clinical Studies, and the Clinical Role of Relevance,” scientific workshop sponsored by the NIH Office of Research on Women’s Health, Washington, D.C., January 6–9, 2003.
11. A telling moment came in August 2007, with the publication of an article in the Journal of the American Medical Association reanalyzing reported sex differences in the effects of genes on disease. Nikolaos Patsopoulos et al. (2007) scoured the published literature for articles so certain about having found such differences that the claims appeared in the articles’ titles. But when they reviewed 432 sex-difference claims made in seventy-seven articles, these researchers found a vast tendency to overstate or misinterpret. Most of the claims to have found sex differences were poorly documented. Many were spurious due to faulty statistical analyses. Hardly any had been corroborated in later studies. When the researchers reanalyzed the original data from the studies, half of the supposed sex differences were not statistically significant.
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