Inclusion: The Politics of Difference in Medical Research available in Paperback
With Inclusion, Steven Epstein argues that strategies to achieve diversity in medical research mask deeper problems, ones that might require a different approach and different solutions.
Formal concern with this issue, Epstein shows, is a fairly recent phenomenon. Until the mid-1980s, scientists often studied groups of white, middle-aged men—and assumed that conclusions drawn from studying them would apply to the rest of the population. But struggles involving advocacy groups, experts, and Congress led to reforms that forced researchers to diversify the population from which they drew for clinical research. While the prominence of these inclusive practices has offered hope to traditionally underserved groups, Epstein argues that it has drawn attention away from the tremendous inequalities in health that are rooted not in biology but in society.
“Epstein’s use of theory to demonstrate how public policies in the health profession are shaped makes this book relevant for many academic disciplines. . . . Highly recommended.”—Choice
“A masterful comprehensive overview of a wide terrain.”—Troy Duster, Biosocieties
About the Author
Steven Epstein is professor of sociology and director of the Science Studies Program at the University of California, San Diego. He is the author of Impure Science: AIDS, Activism, and the Politics of Knowledge and coauthor of Learning by Heart: AIDS and Schoolchildren in America's Communities.
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InclusionThe Politics of Difference in Medical Research
By Steven Epstein
University of Chicago PressCopyright © 2007 The University of Chicago
All right reserved.
Chapter OneHealth Research and the Remaking of Common Sense
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." -Dr. Bernadine Healy, former director of the National Institutes of Health
Since the mid-1980s, specific ideas about what it means for humans to differ have refashioned medical research and practice in the United States. Two decades of reform-reflected in policies about who gets studied and how they are studied-have placed group identity and group difference squarely in view within the biomedical arena. Socially significant categories and characteristics such as sex and gender, race and ethnicity, and age, used routinely when people assert their belonging or are classified by others, have taken on a new salience within modern medicine.
That these socially meaningful aspects of personhood divide humanity into medically distinguishable populations has become a commonplace assertion, even a cliché:
"Men and Women Are Different," declared the title of an editorial in a medical journal in 2004. "Sex differences have been noted in most major cardiovascular diseases," the author observed, and "medicine is not exempt from the basic biological fact that men and women are indeed different, and may need to be treated therapeutically as such." According to the New York Times, researchers "have found that men and women sometimes report different symptoms of the same disease, and that certain drugs are more effective in one sex than the other, or produce more severe side effects in one sex." Television news broadcaster Peter Jennings reported in 2002 that hundreds of children die each year from reactions to medications. Because the drugs have not been tested in pediatric populations, these children have become the victims of "guesswork" in the determination of proper dosages. In an article about how medical researchers were seeking members of racial minority groups to participate in clinical trials, the Charleston Post and Courier quoted a registered nurse and oncology research coordinator in 2005: "When you do a randomized trial with an all-white population, you can only extrapolate to the white population.... You don't know if it actually works in African-American or Hispanic populations." In 2005, the U.S. Food and Drug Administration (FDA) licensed a pharmaceutical drug called BiDil for treatment of heart failure in African American patients only. Having failed to demonstrate the drug's efficacy in the overall population, BiDil's manufacturers reinvented it as an "ethnic drug" and tested it only on African Americans.
Characteristic of this way of thinking is the assumption that social identities correspond to relatively distinct kinds of bodies-female bodies, Asian bodies, elderly Hispanic male bodies, and so on-and that these various embodied states are medically incommensurable. Knowledge doesn't travel across categories of identity-at least, we can't presume that it does. We are obliged always to consider the possibility that the validity of a medical knowledge claim stops dead when it run up against the brick wall of difference. While some experts, policymakers, and health advocates have embraced this way of thinking about bodies, groups, and health as obviously valuable, and others have dismissed it as pernicious or silly, my goal is to do neither of the above. I seek to understand, first, how a particular way of thinking about medical difference in the United States helped give rise to an important strategy to improve medical research by making it more inclusive. Second, I intend to show how this strategy gained supporters, took institutional form, and became converted into common sense. Third, I want 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 thinking about the meanings of identities, differences, and inequalities in biomedical contexts, I aim to understand 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 it either falls short or takes a wrong turn.
An evaluation of the merits of this emphasis on bodily difference might begin by considering a second set of recent claims:
According to the U.S. National Center for Health Statistics, out of every 1,000 babies born to U.S. mothers whose race was identified as "White" or "Asian or Pacific Islander" or whose ethnicity was "Hispanic or Latino," fewer than 6 died within the first year of life. By contrast, the infant mortality rate (the number of deaths per 1,000 live births) was 8.6 for "American Indian or Alaska Native" mothers, and 13.8 for "Black or African American" mothers. According to the same source, a white woman born in the United States in the early twenty-first century could expect, on average, to live 11.5 years longer than an African American man. On the basis of a public opinion poll, researchers from Harvard University reported in 2003 that two-thirds of black people in the United States believe that the health care they receive is inferior to that of whites. One in five white respondents agreed with them. Eight out of ten blacks in the study attributed the substandard care to bias, intended or otherwise, on the part of physicians. Only one in five white respondents thought this was the case.
Reports of health disparities-inequalities with regard to health status, access to health care, or experiences within the health care system, measured according to factors such as race, class, gender, geographic location, and sexual identity-have become ubiquitous in recent years. While there is a general sentiment that they constitute a significant social problem, the precise meaning of these disparities has been a matter of some debate. Concern over these disparities also coincides with growing frustration about other problems: the plight of the more than 40 million Americans who lack health insurance (a problem unique to the United States among countries within the so-called developed world), the high price of pharmaceutical drugs, and the quality and character of health care as organized and rationed under the system known as managed care.
Will the new focus on embodied difference lead to the elimination of health disparities? To some extent, the new emphasis that takes categories of human difference as basic units of analysis in medical research and medical treatment has coincided and cooperated with research on these disparities. But in other respects, this way of attending to difference-equating group identities with medically distinct bodily subtypes-has precluded direct attention to reducing inequalities in the domain of health, while encouraging the misleading notion that better health for all can best be pursued through study of the biology of race and sex.
ONE SIZE FITS ALL?
Today's pronouncements about medical differences are often accompanied by self-conscious reflection on social change within biomedical institutions-indeed, by strenuous criticism of past deficiencies. For years, a range of health activists from outside the establishment have issued stinging critiques of neglect by researchers of women, racial and ethnic minorities, and others who have fallen beneath the radar screen.
Well-established biomedical insiders also have had their say. Bernadine Healy, who served as the first (and so far only) female director of the National Institutes of Health (NIH) from 1991 to 1993, commented in 2003 on the worldview that prevailed until relatively recently among medical researchers. When Healy denounced "the orthodoxy of sameness and the orthodoxy of the mean" (see the epigraph at the start of this chapter), she targeted a double whammy of biomedical insensitivity: not only were groups such as women, children, the elderly, and racial and ethnic minorities routinely under-studied in clinical research, but it was assumed that the absence of these groups didn't matter much, because the findings from studying the "normative standard"-middle-aged white men-could simply be generalized to the entire population. Yet the more that researchers have included distinct groups among research subjects, critics have argued, the more it has become apparent that differences do matter and that we cannot just extrapolate medical conclusions from white people to people of color, from men to women, or from middle-aged adults to children or the elderly.
These are not isolated sentiments. Since the mid-1980s, an eclectic assortment of reformers has argued that expert knowledge about human health is dangerously flawed-and health research practices are fundamentally unjust-because of inadequate representation of groups within research populations in studies of a wide range of diseases. The critics have included prominent elected officials, like former member of Congress Patricia Schroeder, who, as cochair of the Congressional Caucus for Women's Issues, asked "Why would NIH ignore half the nation's taxpayers?" Voices calling for change also have come from the ranks of grassroots advocacy groups, clinicians, scientists, professional organizations, and government health officials.
Collectively, reformers have pointed to numerous culprits in the general failure to attend to biomedical difference, but in their bid to change them, they primarily have targeted the state. Reformers have trained their attention on the U.S. cabinet-level Department of Health and Human Services (DHHS) and especially two of its component agencies: the NIH, the world's largest funder of biomedical research, currently providing about $27 billion annually in research grants; 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-now a $94 billion industry in the United States-must become routinely sensitive to human differences, especially sex and gender, race and ethnicity, and age. 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.
These expectations are 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. The new mandate is reflected, as well, in the establishment, from the early 1980s forward, of a series of new offices within the federal health bureaucracy; these include offices of women's health and offices of minority health that support research initiatives focused on specific populations. Versions of the inclusionary policies also have been adopted by the "institutional review boards" (IRBs) located at universities and hospitals across the United States-the committees that review the ethics of proposals to conduct research on human subjects. As a result, these policies affect not just those researchers seeking federal support or those companies seeking to market pharmaceuticals; they may apply, in some fashion or another, to nearly every researcher in the natural or social sciences performing research involving human beings.
In other words, if indeed we are witnessing a repudiation of so-called one-size-fits-all medicine in favor of group specificity, then the shift is apparent not just in the realm of free-floating ideas. It is anchored to institutional changes-new policies, guidelines, laws, procedures, bureaucratic offices, and mechanisms of surveillance and enforcement-that are the products of collective action. These changes matter for those who carry out medical research on humans: researchers are obliged to alter their work practices to comply with new requirements if they want to get funding, and so must pharmaceutical companies, if they seek to get their products on the market. But the changes also matter downstream: they may affect any person who, now or in the future, becomes obliged to claim the status of "patient." More diffusely, but importantly, they also matter insofar as they alter social understandings of what qualities such as race and gender are taken fundamentally to be.
Yet this redefinition of U.S. biomedical research practice has been little remarked upon by social scientists. Several scholars have provided excellent accounts or analyses of recent attempts to include greater numbers of women in biomedical research. In addition, an important and growing body of literature by science studies scholars, while not precisely focused on questions of research inclusion, is analyzing how concepts of race are used in biomedicine-especially, new scientific attempts to take findings from the genetic study of populations and use them to make claims about the medical meaning of race. However, there has been almost no scholarly attention to the broad-scale attempt to dethrone the "standard human" and mandate a group-specific approach to biomedical knowledge production-an identity-centered redefinition of U.S. biomedical research practice that encompasses multiple social categories.
I call this set of changes in research policies, ideologies, and practices, and the accompanying creation of bureaucratic offices, procedures, and monitoring systems, the "inclusion-and-difference paradigm." The name reflects two substantive goals: the inclusion of members of various groups generally considered to have been underrepresented previously as subjects in clinical studies; and the measurement, within those studies, of differences across groups with regard to treatment effects, disease progression, or biological processes.
This way of thinking and doing is by no means the only, or the most important, way in which biomedical research has changed in recent decades. During those same years, as the sociologist Adele Clarke and her coauthors have noted, medicine itself has been remade "from the inside out"-through innovations in molecular biology, genomics, bioinformatics, and new medical technologies; through vast increases in public and private funding for biomedical research; through the ascendance of evidence-based medicine; through the rapid expansion of a global pharmaceutical industry constantly searching for new markets and engaging in new ways with consumers; and through the resurgence of dreams of human enhancement or perfectibility by means of biotechnologies. The point, then, is not to understand how the inclusion-and-difference paradigm has changed "medicine," as if the latter were a fixed target, but rather to consider how this particular emphasis has intersected with the other transformations that have taken place in the domain of biomedical research and the health care sector generally.
The Time and Place of Difference
Although a shift away from the inclusion-and-difference paradigm could certainly occur, at present this model is reasonably well institutionalized within DHHS agencies. Unlike policies that depend for their survival on the support of a particular politician, bureaucrat, or political party in power, the inclusion-and-difference paradigm has sunk roots and seems to have developed its own staying power. It grew up in the Republican administrations of the 1980s and early 1990s, flourished under the Democratic administration of President Bill Clinton, and mostly has survived-despite some explicit attempts to roll it back and halt its expansion-under Republican President George W. Bush.
Excerpted from Inclusion by Steven Epstein Copyright © 2007 by The University of Chicago. Excerpted by permission.
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Table of Contents
List of Abbreviations
Introduction: Health Research and the Remaking of Common Sense
1 How to Study a Biopolitical Paradigm
2 Histories of the Human Subject
3 The Rise of Resistance: Framing the Critique of the Standard Human
4 The Path to Reform: Aligning Categories, Targeting the State
5 Opposition to Reform: Controversy, Closure, and Boundary Work
6 Formalizing the New Regime
7 From the Standard Human to Niche Standardization
8 Counts and Consequences: Monitoring Compliance
9 The Science of Recruitmentology and the Politics of Trust
10 To Profile or Not to Profile: What Difference Does Race Make?
11 Sex Differences and the New Politics of Women’s Health
12 Whither the Paradigm?
Conclusion: Identity, Difference, Disparities, and Biopolitical Citizenship