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The Genomic Fight for Social Justice
By Catherine Bliss
Stanford University Press
Copyright © 2012 Board of Trustees of the Leland Stanford Junior University
All right reserved.
Chapter One The New Science of Race
Conceptions of race are never a closed case of self-evident truths. "Race" is a cipher for a set of relational meanings—meanings of difference that are always underdetermined, pliant, and manifold. Although the term seems to connote a specific set of physical or cultural characteristics, there is actually no fixed referent for race. It is "constantly resignified, made to mean something different in different cultures, in different historical formations, at different moments of time."
Scientists make new meaning of race as they pragmatically respond to a range of official and unofficial policies, norms, and values, which are constantly being reworked. Knowing the historical background of policies surrounding official racial classification is but a first step in understanding how legacies frame present-day practice and how the political climate informs choices made in the lab and field.
Technologies like haplotype mapping and principal components analysis—the state of the art in the production of genomic taxonomies—also shape how scientists define populations, compare their classifications with self-reported identities, and create new avenues for identity formation. The application of these technologies around the world in the present U.S.-dominated bio-economy has led to a hegemony of American racial taxonomies. Meanwhile, just as race-based medicine has hit the market, "whole genome sequencing" (technologies that map and interpret individual genomes in full) and the promise of a move to personalized medical healthcare are forecasting a departure from racial grouping. We must uncover what it means for scientists to create a biology of race that follows egalitarian and prodiversity goals, as opposed to colorblind or race-neutral goals, when that science is part of a larger economy of identity-based goods and services.
In the popular realm, genomics precipitates a greater emphasis on defining race with biological factors. New television and cinematic productions on race use genetic ancestry tests to fill in the blanks in histories lost to colonialism and slavery. They create an atmosphere where DNA technology is in public demand for solving identity quests and seeking political resources. These events signal a global interest in recreating social bonds based on new biological evidence.
These elements of the social milieu create a nurturing ground for race that has framed the past two decades of genomic science. They suggest that conditions are ripe for scientists to maintain race as an analytical lens in research, even as they attempt to offer new insight into human difference. Genomic efforts to understand race thread through the tangibles of genomic technology to produce a situation where investigating race and criticizing it from a biological standpoint go hand in hand.
The Backdrop of Official Classification
A long-standing system of governmental classification requires scientists to design all their research with official racial categories. These categories were established in 1977 at the behest of the U.S. Congress. In the wake of the Civil Rights Acts of 1964 and 1968, the Voting Rights Act of 1965, and a massive formation of new federal offices and agencies, Congress directed its Office of Management and Budget (OMB) to produce a government-wide set of race categories in order to monitor and redress social inequality. The OMB Directive No. 15 of 1977 directed federal agencies to use the U.S. Census' racial taxonomy to collect and monitor minority participation in public services. The directive explicitly stated:
These classifications should not be interpreted as being scientific or anthropological in nature, nor should they be viewed as determinants of eligibility for participation in any Federal program. They have been developed in response to needs expressed by both the executive branch and the Congress to provide for the collection and use of compatible, nonduplicated, exchangeable racial and ethnic data by Federal agencies.
Despite the warning, committee reports show that Census race was still based on biological assumptions about essential, continentally clustered genetic differences. Directive No. 15's initial classifications were: American Indian or Alaska Native, Asian or Pacific Islander, Black, and White. "Hispanic" was defined as an ethnicity. Respondents have since been directed to report their Hispanic subgroup and mark more than one box if self-defined as a member of more than one category.
Most significant about Directive No. 15 is the bureaucratic reach of this policy over American life. Census race was initially applied to collect population statistics on such varied topics as dairy product consumption, effects of prices, personal income, traffic deaths and rates, military deaths, minority business contracts, federal agency employment, voting age population, child abuse and neglect cases, drug law violation arrests, homicide rates, jail population, doctoral graduates, and employment and salaries of science and engineering graduates. Today we can add to this list home mortgage disclosure, sterilization of persons in federally assisted family planning, homeless management, and more. The bureaucratic expansion of federal agencies and streamlining of information systems has exponentially expanded the directive's role. Presently, official classifications profoundly structure the work of agencies in terms of data collection and the administration of public services.
Still, in public health it took nearly two decades to fully implement Directive No. 15. Though Census race was immediately used in the reporting of vital and epidemiological statistics, not until minority and feminist advocates pressured the Department of Health and Human Services to take the inclusion of minorities in health-related research studies seriously was Census race incorporated into National Institutes of Health (NIH), Food and Drug Administration (FDA), and Center for Disease Control and Prevention (CDC) regimes. Following a 1989 Surgeon General's report on the status of American health, Health and Human Services formulated the first set of top-priority national health goals that considered race. Data collection on racial health disparities—something notably absent from the first agenda—was designated as a key priority.
Drafted in the early 1990s, Healthy People 2000—the Health Department's decennial statement of national health objectives—set three broad goals: to "increase the span of healthy life for Americans," to "reduce health disparities among Americans," and to "achieve access to preventive services for all Americans."
While significant improvements have been made in the Nation's health over the past decade, gains have not been universal. Therefore, many of the year 2000 objectives focus upon specific populations that have a higher risk of disease or disability compared to the total population. Minority populations are growing faster than the population as a whole. Eliminating health disparities is of critical importance in the 1990s.
Contributors from the Public Health Department, Institute of Medicine of the National Academy of Sciences, and over three hundred membership organizations and fifty-four state and local health departments stressed that an expansion of national health statistics on "non-black" and "non-white" groups was severely needed. Inclusion of minority research subjects thus became a leading goal for all federal health agencies.
Amid Health and Human Services deliberations, in 1993, the NIH passed the Revitalization Act, a statute setting strict guidelines for the inclusion and surveillance of women and minorities in clinical research and clinical trials. Building on previous policy statements that loosely encouraged tabulation by race, and on its recent establishment of an office for clinical research on women, the agency directed investigators to publish how their clinical research would affect women and minorities and to generate "outreach programs" to ensure inclusion. For the first time, cost was barred as a consideration over whom to include in a study. Minority exclusion was permitted only if the variables studied could be proven to have the same effect across national subpopulations. Until the Revitalization Act was signed into law, federal race policy had been vague and unenforceable. Today the act continues to require all biomedical research—even research conducted outside of the United States on foreign subjects—to use Census race categories. NIH directors, advisory councils and staff, but also academic institutional review boards and peer review boards across the country have clear stipulations for enrollment and tabulation. The Revitalization Act has made federal race categories a prism for health research across the world and provided a population-defining context for subsequent research into genomic variation.
The FDA has followed a similar course since the mid-1990s. In 1998 it ruled that all new drug applications must "present effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups." 16 This "demographic rule" requires race to be tabulated to ensure inclusion and reliability of data across the population because:
(1) Different subgroups of the population may respond differently to a specific drug product and (2) although the effort should be made to look for differences in effectiveness and adverse reactions among such subgroups that effort is not being made consistently.
In other words, like the NIH Revitalization mandate, the FDA frames inclusion as socially relevant—important to consistent implementation of Congressional goals—and biologically relevant—important to the validity of findings across biological populations.
Since these major inclusionary policies were first established, each of these departments and agencies has revised and expanded its goals. In 1998 the Department of Health and Human Services formulated two in-house working groups on race: the Working Group on Racial and Ethnic Data and the Data Work Group of the Health and Human Services Initiative to Eliminate Racial and Ethnic Health Disparities in Health. In 1999 the department released a mandate stating that all department-sponsored research would thereafter use Census race classifications in "(1) data collection, (2) data analysis and interpretation, (3) data dissemination and use, and (4) data research and maintenance." Improving the Collection and Use of Racial and Ethnic Data in HHS continues to guide all sponsored research to collect data on race.
The NIH expanded its inclusion policy in 2000 and 2001. The upshot is an emphasis on "subpopulation" inclusion and surveillance for Phase III Clinical Trials. The agency now requires investigators to "include a description of plans to conduct analyses to detect significant differences in intervention effect." 21 In essence, investigators must collect drug and treatment efficacy data using Census race. Even in the case of testing an intervention for which prior studies have proven no significant difference between subpopulations, the agency "strongly" encourages further data collection by race. This reorganization of trials into racial subpopulations affects more than the social composition of studies: it creates racial sorting in the initial population design of trials. Differential results by race are nearly a guaranteed outcome of such studies. Furthermore, contrary to OMB's original warning, biological conclusions are being drawn from socially defined racial classifications.
The 2001 revisions also provide stricter guidelines for implementation of Census race in circumstances where other categories might be applicable, such as foreign research. The NIH acknowledges the need "to explore collecting additional types of information on race and ethnicity that will provide additional insights into the relationships between race and ethnicity and health." However, researchers are instructed to report such data separately from their main body of data and attach it to the standard enrollment form. The revisions stipulate that in the case of research on foreign populations all classifications are to be "designed in a way that they can be aggregated into the required [OMB] categories." In other words, alternate classifications may be reported, but they are not incorporated by the agency.
The FDA's policy revisions, made in 2003 and 2005, most explicitly exhibit the current drive to apply Census race biologically and globally:
FDA recommends that the drug manufacturers use the OMB race and ethnicity categories during clinical trial data collection to ensure consistency in evaluating potential differences in drug response among racial and ethnic groups. Some differences in response to medical products have already been observed in distinct groups of the U.S. population. These differences may be attributable to intrinsic factors such as genetic differences; to extrinsic factors like diet, environmental exposure, socio-cultural issues, or to interactions between these factors.
The agency now requires researchers to report racial differences in the toxicological effects of drugs and in disease susceptibility, and to offer Census race to research subjects in place of free-form self-identification. It maintains that improving patient safety and drug efficacy requires streamlined classifications. The FDA's guidelines have enormous significance abroad, as the pharmaceutical industry increasingly locates drug development in developing nations. Aware of the practical difficulty of imposing domestic classifications onto foreign populations, the agency offers a manual, Reference Information Model Structural Vocabulary Tables, to instruct investigators on allocating unruly responses. It "recommends using more detailed race and ethnicity categories when appropriate to the study or locale, but recommends that the OMB categories be identified for all clinical trial participants when submitting data to the agency." As with the NIH Phase III Trial policy, the FDA explicitly excludes alternate data.
These policies mandate genomicists to consider human variation in light of Census race. Scientists are supposed to structure their studies by it from the inception of research design, sample by government classifications, and interpret and report data in a racial framework. Implementation of the government's taxonomy in genomics gives the federal system an imprimatur of science, while giving genomics an imprimatur of political truth. While the official policy is not the only stratagem scientists abide by, scientists must reconcile the government's policy with domestic and foreign conventions in their every effort at understanding human variation. It is a going concern for all scientists governed by these mandates to develop taxonomies that respect these most widely shared categories while finding new ways to conceive of human difference.
Technologies of Difference
Genomics and its signature brand of science activism attempt to provide biological and social resources to the public in this fast-globalizing field of inclusion. As molecular medicine moves from the "bench to the bedside," there are many technologies at play that empower scientists to study variation in a race-positive manner while also empowering everyday people to learn more about their ancestry and construct new racial identities. As such, objective and technical, but also subjective and personal, interests are embedded in the very technologies that establish genomics as the leading science of variation.
Excerpted from RACE DECODED by Catherine Bliss Copyright © 2012 by Board of Trustees of the Leland Stanford Junior University. Excerpted by permission of Stanford University Press. All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
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