JONATHAN KAHN
RECENT DEBATES over the appropriate use of racial and ethnic categories in biomedical contexts have often concentrated on the practices of individual researchers with the aim, in part, to help researchers appreciate the nuances and complexities of the racial categories they use (e.g., Burchard et al. 2003; Cooper et al. 2003; Krimsky and Sloan 2011; Gomez and Lopez 2013). Since the inception of the Human Genome Project, much time and attention has been devoted to ensuring that biological knowledge emerging from advances in genetic research is not used inappropriately to make racial categories appear biologically given or “natural.” Scientists may and do disagree on the utility of using particular racial or ethnic categories as surrogates for genetic groupings, arguing about different frequencies of particular genetic variations. But race is not a coherent genetic concept; rather, it is best understood as a complex and dynamic social construct (e.g., American Anthropological Association 1998; Collins 2004). Since Richard Lewontin’s ground-breaking work on blood group polymorphisms in different groups and races in the 1970s, scientists have understood that race will statistically explain only a small portion of genetic variations (Lewontin 1972). As a 2005 editorial in Nature Biotechnology put it, “Race is simply a poor proxy for the environmental and genetic causes of disease or drug response….Pooling people in race silos is akin to zoologists grouping raccoons, tigers and okapis on the basis that they are all stripey” (Editorial 2005).
A focus on individual practices, while necessary, overlooks the myriad structural forces that teach researchers and clinicians to see and use race in particular and often problematic ways. The U.S. Food and Drug Administration’s (FDA) evolving practices with respect to the use of racial and ethnic categories in pharmaceutical research and development must be understood within a historical and institutional context that has been becoming increasingly concerned with the place of race in biomedicine. Federal initiatives that shape the production and use of racial categories in biomedical research provide the starting point for approaching the broader racialization of contemporary biomedicine. While there may be certain legitimate uses for racial classifications in the regulatory process (e.g., keeping track of health disparities), it is imperative that regulatory bodies be alert to preventing slippage into unwarranted and dangerous uses of race as genetic. The basic concern here, then, is to explore how particular mandates developed to serve bureaucratic needs of data management, political needs of inclusiveness, and commercial needs of market expansion may be shaping scientific research and medical practice in problematic ways that threaten to reinvigorate long-discredited notions of race as a fixed genetic construct.
Prominent among these forces is a wide array of federal mandates that dictate the characterization and application of genetically based biomedical interventions, such as pharmaceuticals and diagnostic tests, in relation to socially defined categories of race. Key federal mandates include: the NIH Revitalization Act of 1993 (Pub. L. No. 103-43, 107 Stat. 122 (1993), which directs the National Institutes of Health to establish guidelines for including women and minorities in clinical research; the Food and Drug Administration Modernization Act of 1997 (FDAMA), which directs that “the Secretary [of Health and Human Services] shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials” (Food and Drug Modernization Act: § 115); and two subsequent Food and Drug Administration Guidances for Industry. The first, a 1999 guidance entitled “Population Pharmacokinetics” (FDA 1999), made recommendations on the use of population pharmacokinetics in the drug development process to help identify differences in drug safety and efficacy among population subgroups, including race and ethnicity. The second, a 2005 guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials” (FDA 2005), recommends a standardized approach based on federal census categories promulgated by the Office of Management and Budget (OMB) for collecting and reporting race and ethnicity information in clinical trials that produce data for applications to FDA for drug approval.
The NIH Revitalization Act requires researchers to certify that they have enrolled adequately diverse populations, have made sufficient efforts to enroll diverse populations, or could provide a biomedical justification for not enrolling diverse populations (for example, not enrolling women in a study of prostate cancer). At the time of the act’s passage, Otis Brawley, then director of the National Cancer Institute’s Office of Special Populations research, worried that the NIH Revitalization Act’s “emphasis on potential racial difference” might “foster…the racism that its creators want to abrogate by establishing government sponsored research on the basis of the belief that there are significant biological differences among the races” (Epstein 2007:95–96).
Along with the NIH, FDA showed an increasing interest in issues of inclusion in the late 1980s and early 1990s. FDAMA and related Guidances for Industry, however, do not mandate the same sort of subgroup analyses as the NIH Revitalization Act. They simply urge that companies collect data by sex, race, and ethnicity and be on the lookout for “differences of clinically meaningful size” (Epstein 2007:129).
These federal mandates have had a profound effect upon the use of racial categories in biomedical research, clinical practice, product development, and health policy. Their construction and definition of racial categories is structured by Office of Management and Budget’s Revised Directive 15 on “Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity.” The standards were developed “to provide a common language for uniformity and comparability in the collection and use of data on race and ethnicity by Federal agencies” (Office of Management and Budget 1997). Directive 15 set forth the basic categories of race and ethnicity that are currently used in the census and inform data collection and monitoring across a wide array of federal programs: American Indian or Alaska Native, Asian, black or African American, Native Hawaiian or Other Pacific Islander, and white. In addition, there are two categories for data on ethnicity: “Hispanic or Latino” and “Not Hispanic or Latino” (Office of Management and Budget 1997). By conditioning grants and approvals on the collection of data according to the OMB categories, they provide powerful incentives to introduce race into biomedical contexts, regardless of its relevance.
I. FDA GUIDELINES ON RACE AND ETHNICITY
In January 2003, FDA announced the promulgation of a Draft Guidance for Industry on the Collection of Race and Ethnicity Data for Clinical Trials for FDA Regulated Products (68 Fed. Reg. 4788; FDA 2003a). After notice and comments, FDA issued the final guidance in September 2005, which recommends that individuals or corporations submitting drug approval applications use “a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products” (FDA 2005). As any federally funded researcher knows, these mandates impose significant requirements and provide incentives to identify and collect research data according to categories of race and ethnicity.
In a “Talk Paper” discussing the issuance of the Draft Guidance in 2003, FDA elaborated upon their nature and purpose: “FDA regulations require drug sponsors to present an analysis of data according to age, gender and race. An analysis of modifications of dose or dosage intervals for specific groups is also required when manufacturers submit a new drug application for approval by FDA. To accomplish this, 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” (FDA 2003b).
Consistency was a key theme throughout the Draft Guidance. It exhibited a general concern to regularize the collection and submission of data on race and ethnicity across the spectrum of clinical trials and the drug development process. The Draft Guidance specifically recommended the use of the OMB categories of race and ethnicity, first, to “help ensure consistency in demographic subset analyses across studies” and, second, to help evaluate “potential differences in the safety and efficacy of pharmaceutical products among population groups” (FDA 2003a). The Guidance elaborated the rationale for this concern by referencing some studies that show on average members of certain OMB racial groups may respond differently to certain drugs than members of other OMB racial groups. That is, the Guidelines connected race and physiology.
The Guidelines themselves were promulgated against a backdrop of a perceived need to harmonize the use of racial categories across national regulatory regimes to facilitate the globalization of pharmaceutical markets. A central initiative in this regard was led by the International Conference on Harmonization (ICH), formally known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The ICH was formed in 1990 at a meeting in Brussels hosted by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is structured around the three regions of the United States, European Union (EU), and Japan and includes major regulatory agencies and pharmaceutical trade associations from each region.
The ICH was born of a concern to address the problems created by diverse regulatory standards imposed by the governments of the major pharmaceutical markets. Founding members believed that the harmonization of standards for product development and regulatory approval would greatly increase the efficiency and economy of drug development and pave the way for the creation of a truly global pharmaceuticals market (International Conference on Harmonization n.d.; Lee 2005).
A key consideration for global drug development and registration involves the acceptability of data in different regions. To address this issue, in 1998, the ICH adopted Guideline E5, “Ethnic Factors in the Acceptability of Foreign Clinical Data.” ICH E5 is intended to facilitate drug registration in the different ICH regions by recommending a framework for evaluating the impact of ethnic factors on a drug’s safety and efficacy in a manner that will enable appropriate evaluation of ethnic factors (International Conference on Harmonization 1998). Together with the NIH Revitalization Act, and the FDAMA, ICH E5 provides a critical backdrop to FDA guidance. ICH E5 defines “ethnic factors” as “factors relating to races or large populations grouped according to common traits and customs” (International Conference on Harmonization 1998:9). It makes a further key distinction between what it characterizes as “intrinsic” versus “extrinsic” ethnic factors. It defines “intrinsic ethnic factors” as “factors that help define and identify a subpopulation and may influence the ability to extrapolate clinical data between regions. Examples of intrinsic factors include genetic polymorphism, age, gender, height, weight, lean body mass, body composition, and organ dysfunction.” In contrast, it defines “extrinsic ethnic factors” as “factors associated with the environment and culture in which a person resides. Extrinsic factors tend to be less genetically and more culturally and behaviorally determined” (International Conference on Harmonization 1998:9–10). At first blush, this distinction seems straightforward and relatively unproblematic. However, ICH E5 elaborates upon these definitions in a chart that situates race as an intrinsic genetic characteristic. That is, it constructs race as some sort of genetic component of a larger category of ethnicity (Kuo 2008). This is problematic for a number of reasons, not least of which being that whatever they are, race and ethnicity are not genetic.
In contrast to the ICH E5 Guideline, the FDA Guidance contains the OMB caveat that its racial and ethnic categories are not to be interpreted as biological or genetic. Nonetheless, its recommendations, which are based on physiological processes, exist in tension with the caveat. This tension was recognized and seized upon by many pharmaceutical companies in offering comments to the Draft Guidelines in 2003. The response of pharmaceutical companies, however, was not uniform. Large pharmaceutical companies with global marketing concerns focused in particular on inconsistencies between FDA mandated use of the distinctively American OMB categories of race and ethnicity (e.g., “African American,” “Hispanic”) and those used internationally in other ICH regions of Japan and Europe. Their comments tended to call for a more sophisticated use of population categories that could be more easily integrated with the structure of ICH E5 and more readily translatable across regions. Smaller biotechnology companies tended to be less concerned with the international ramifications of the Guidance but rather urged the adoption of new genetic technologies to provide more precise population categories for the collection of data.
Generally speaking, comments submitted by pharmaceutical corporations expressed concern over (1) inconsistent definitions of race and ethnicity; (2) questionable accuracy of definitions of race and ethnicity; (3) the negative impact that using OMB categories of race and ethnicity might have on global trial recruitment; and (4) the creation of unnecessary and unscientific differences among populations through the use of inappropriate racial and ethnic categories. Underlying the concerns of large pharmaceutical corporations in particular was a perceived need to develop a globally applicable standard for the collection of racial and ethnic data—clearly more in line with the mandate of ICH E5. In short, where the ethnic categorizations of ICH E5 were perceived as opening up global markets, the OMB-based racial and ethnic classifications of the FDA Guidance were perceived as potential barriers to globalization of drug markets.
II. INCONSISTENT DEFINITIONS
The Pharmaceutical Research and Manufacturers of America (PhRMA) is a pharmaceutical trade association describing itself as representing “the country’s leading pharmaceutical research and biotechnology companies,” whose mission is “to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical and biotechnology research companies” (PhRMA n.d.). It opened its comments to the FDA Draft Guidance with an admonition that “for these categories to be valuable globally and to permit identification of ethnic differences, there should be only one set of agreed ethnic/racial categories” (PhRMA 2003). It therefore recommended that the issue be brought to the ICH as a forum for the development of globally consistent categories. Comments submitted by Pharmacia (2003) (subsequently acquired by Pfizer) that largely replicated comments submitted by PhRMA focused in particular on the myriad ways in which the Guidance threatened to obstruct pharmaceutical globalization. With regard to inconsistent definitions of race and ethnicity, Pharmacia observed that
The OMB race and ethnicity categories can be used only in the US, not in the EU or in Japan; this is especially true for the ethnicity questions (Hispanic/Latino vs. Not Hispanic/Latino). A definition of the ethnicity varies among the ICH countries, as well as non-ICH countries. There will be more opportunities for the US to utilize foreign clinical data in evaluating safety and efficacy of new drugs in the future. Therefore, it is recommended that the race and ethnicity categories should be more scientific and globally accepted so that the data comparison becomes more meaningful and provides valuable information in evaluating potential differences or similarities in safety and efficacy of new drugs among population subgroups.
—(PHARMACIA 2003:1)
There was a clear recognition here that the OMB definitions of race and ethnicity were not static, scientifically objective categories. Pharmacia (and PhRMA) was concerned that imposing the U.S. regulatory definitions of race on the pharmaceutical industry would inhibit the globalization of pharmaceutical markets.
Comments submitted by Abbot Laboratories expressed a similar concern that the OMB categories were “oversimplified” and “vague” and urged that FDA “recommend a better definition of race and ethnicity that can be understood by a subject in a study and be consistent across the board” (Abbot 2003:3). Bristol Meyers Squibb also noted that the Guidance’s “proposed ethnicity and racial categories may be understood differently in different parts of the world” and urged the development of “better defined categories” (Bristol Meyers Squibb 2003). Thus, for example, it proposed that the OMB category of “Black or African American” be revised to “Black, of African heritage or African American” (ibid.). Given the OMB’s own caveat that its categories were not genetic or biological, the clear concern with such a proposal was not to present a more “scientific” definition of race but rather to produce a more globally acceptable definition. The two are not necessarily the same.
Of all the OMB categories incorporated in the Guidance’s mandate, the ethnicity category of “Hispanic or Latino” caused particular concern in terms of consistent global application. Bristol Meyers Squibb noted that “the requirement that Hispanic or Latino versus not Hispanic or Latino ethnicity be collected even in trials that are conducted entirely outside the U.S. seems contradictory to the spirit of the ICH guidelines. If ethnicity designations, as per the guidance, are to reflect the sociocultural construct of the society, then the proposed category is generally inappropriate outside the United States” (ibid.). Again, there was an explicit concern for potential conflict with the ICH E5 guidelines and resulting barriers to the efficient globalization of markets.
III. QUESTIONABLE ACCURACY
Pharmacia also used the asserted inappropriateness of the Latino/Hispanic category in a global context to highlight the questionable accuracy of the Guidance’s terminology, asserting that “[t]he terms Hispanic and Latino will not have the same meaning outside the U.S. as they do within the U.S. According to the definition, Spaniards are considered Hispanic, but they are both culturally and racially more similar to French than Mexicans” (Pharmacia 2003). Similarly, Bristol Meyers Squibb noted that “terminology—like ‘Latino’—can be confusing outside the United States, while the medical relevance of such category is not demonstrated inside the US” (Bristol Myers Squib 2003). Pharmacia went on to make similar criticisms of the accuracy of other OMB categories, noting that “there is no distinction among the Asian group, which may be more genetically variable” (Pharmacia 2003). In mentioning similarity and difference, “medical relevance,” and “genetic variability,” these comments go beyond the earlier stated concern for globally consistent definitions to the basic scientific accuracy of the categories themselves.
Significantly, however, smaller biotechnology companies specializing in genetic research urged a different approach to overcoming similar problems of definitional accuracy. Biotech companies such as Genaissance Pharmaceuticals and DNAPrint Genomics did not have the global reach of corporations such as Pharmacia or Bristol Meyers Squibb. Genaissance, for example, marketed its technology to large pharmaceutical corporations rather than engaging directly in global drug development and marketing. The focus of their criticisms of FDA Guidance, therefore, was less on developing globally consistent categories of race and ethnicity and more on using their own proprietary genetic technologies to provide purportedly more scientifically objective and accurate definitions of race and ethnicity.
In its comments on the OMB Categories employed by the Draft Guidance, Genaissance focused on genetic accuracy, observing that
Although these categories may be useful for national demographics, they are substandard with regard to the state-of-the-art in genetic analysis of ancestry. In a population such as the United States that increasingly is mixed, the boundaries between these classifications are likely to be blurred further. For example, Genaissance has conducted genetic analysis of Hispanic populations from Florida and California. It is very clear that the label “Hispanic” encompasses individuals with African descent and Native American descent, as well as Caucasian descent.
—(GENAISSANCE 2003)
Genaissance here very subtly introduced the concept of genetic ancestry as a metric to assess the validity of the OMB categories of race and ethnicity. Nonetheless, Genaissance recognized the questionable accuracy of using any racial or ethnic categories in the context of pharmaceutical research and development. Commenting on the Draft Guidance’s discussion of the relation between race and drug metabolism, Genaissance noted that “the link between these clinical outcomes and race is anecdotal at best and discriminatory at worst. New genetic technologies offer much more precise relationships between the genotype of an individual and the clinical management of disease” (Genaissance 2003).
Genaissance presented a solution to this problem in the form of its proprietary technology, which it asserted “would afford a high-resolution genetic identification of ancestry, consistent analysis of ethno-geographic backgrounds, and possible use directly to diagnostics for improvement of drug therapy” (Genaissance 2003). That is, it urged FDA to replace OMB categories of race with genetic categories of ancestry, recommending “the adoption of new genetic systems for ancestry determination rather than antiquated and potentially inaccurate racial denominations” (Genaissance 2003).
Unlike the suggestions from large pharmaceutical corporations, Genaissance here was less concerned with global uniformity per se and more with the purported scientific accuracy of the categories—accuracy to be provided by its own technology. One basic problem with Genaissance’s claim to more rigorous scientifically based categories of ancestry was that its own discussion of them was premised on definitions of ancestral population that essentially replicated the OMB categories. Thus, in discussing its genetic analysis of samples from U.S. populations, it grouped the samples as “African American, Asian, Caucasian, and Hispanic/Latino” (Genaissance 2003).
In a similar vein, the comments from DNAPrint Genomics urged that “for the sake of science and the health of us all…it is time to incorporate molecular anthropological data metrics” to supplement the OMB categories in the collection of racial and ethnic data for clinical trials (DNAPrint 2003). It argued that its own proprietary genetic concept of “Biogeographical Ancestry” (BGA) was better suited to evaluating drug response than the OMB categories of race and ethnicity. Like Genaissance, DNAPrint emphasized the lack of accuracy inherent in self-reporting of race and suggested “that the FDA should pay more attention to molecular characterization of population structure when evaluating and assisting with the construction of clinical trials” (DNAPrint 2003).
Ironically, the genetic approaches taken by Genaissance and DNAPrint comport well with ICH E5’s own categorization of race as an intrinsic genetic factor. However, the genetic approaches also suffer from the same dangers and inaccuracies as the ICH E5 definition despite the patina of scientific rigor layered upon them in the comments. In the end, where big pharmaceutical corporations simply wanted to regularize race and ethnic categories in whatever form they take so as to facilitate global drug development, small biotech companies wanted to take control of the actual process of racial and ethnic categorization and transform it into a function of genetics as applied through their proprietary technologies.
IV. NEGATIVE IMPACT ON GLOBAL TRIAL RECRUITMENT
Beyond inconsistency and inaccuracy, large pharmaceutical companies also expressed a pragmatic concern that being required to collect data according to the OMB categories could have a significant detrimental impact on their ability to recruit human subjects for clinical trials in a global environment. Here again, the category of Hispanic/Latino was of particular concern. Pharmacia addressed this issue most directly, noting that “Asking subjects about their race/ethnicity may be very sensitive in many circumstances and could be viewed as a bureaucratic burden. Conducting a study in Japan, e.g., and asking a subject whether they are Hispanic may result in patients taking questionnaires less seriously and compromising other data being collected” (Pharmacia 2003).
The specific reference to Japan echoes discussions surrounding the adoption of ICH E5 regarding the need to open up Japanese markets to Western pharmaceuticals. Companies wishing to conduct clinical studies in Japan in accordance with the ICH E5 guidelines certainly would not have wanted their efforts complicated or even subverted by the dictates of the FDA Guidance. Recruiting human subjects for clinical trials is difficult under the best of circumstances. In a commercial environment where ever-increasing numbers of clinical trials are being outsourced to countries around the world, Pharmacia recognized that the regulatory construction of race and ethnicity might pose a great barrier to the globalization of markets. This was a result of the medical construction of racial and ethnic difference that underlay Japanese barriers to the approval of Western pharmaceuticals.
V. THE CREATION OF UNNECESSARY AND UNSCIENTIFIC DIFFERENCE
Many of the comments challenged the accuracy and consistency of the OMB categories as a basis for collecting clinical data. An important subset of these concerns was a recognition by both Pharmacia and PhRMA that using the social categories of the OMB in the context of drug development might lead to the creation of the perception of relevant differences where in fact nonexistent differences would present unnecessary barriers to global drug development. Pharmacia noted that “The first paragraph [of the Draft Guidance] states that the categories are not based on scientific principles. It is understandable that the U.S. government wants to sort issues by various socio/cultural groups. However, if there is no scientific basis for examining the effects (either positive or negative) in these groups, doing so may provide an opportunity for identifying differences where none exist. Collecting the data by these definitions is one thing, using it to distinguish effects in different populations is another” (Pharmacia 2003).
Pharmacia recognized that racial and ethnic data was a double-edged sword. While it might be used to open up Japanese markets, it also might be misused and misinterpreted in a manner that obstructed markets. Once again, the OMB categories were criticized as barriers to globalization. Ironically, here commercial considerations to avoid having race be used as a barrier to commercial market expansion aligned with broader social and political concerns that race not be employed in a genetically reductivist manner.
FDA responded to the comments and issued its final Guidance in September 2005. The final Guidance remained substantially the same as the draft. Among the significant revisions was added text that allowed the omission of the characterization of Hispanic or Latino for international clinical trials and a change in the characterization of “Black, of African Heritage” to “Black” for studies conducted abroad (70 Fed. Reg. 54946). The Guidance continued to recommend the use of the OMB categories when collecting data, even for studies conducted outside the United States, but recognizes that “these categories may not adequately describe racial and ethnic groups in foreign countries” (FDA 2005). FDA, therefore, did seem to have been at least somewhat responsive to the concerns expressed by large pharmaceutical companies that the categories not impede global research, development, and marketing. Nonetheless, the final Guidance made no concession toward the suggestions to adopt purportedly more genetically based classifications of ancestry proposed by Genaissance and DNAPrint.
The story of the FDA Guidelines points up the enduring conceptual power of race and ethnicity to shape understandings of human populations in diverse venues. Of greatest concern, perhaps, is that the drive to regulate race also threatens to geneticize race. Throughout this story, race and ethnicity were presented largely as barriers to globalization—differences that need to be somehow overcome in order for markets to grow. Harmonization, both as an explicit concern of the ICH and as the unavoidable backdrop to the FDA Guidance, provided the impetus to produce regular, standardized categories of race and ethnicity. In the discussions surrounding FDA Guidance, a prominent attribute of calls for arguments about the proper treatment of race was an appeal to genetics—whether as an “intrinsic” aspect of race or as a component of “Biogeographical Ancestry.” These purportedly more objective or scientific understandings of race and ethnicity as a function of genetics were proposed as a means to stabilize the inconsistency of social categories and provide a basis for unifying global markets. In the drive to harmonize international drug development, we must be careful to avoid adopting a harmonized conception of race as genetic.
This chapter draws extensively on the following article published previously by the author: “Harmonizing Race: Competing Regulatory Paradigms of Racial Categorization in International Drug Development.” 5 Santa Clara Journal of International Law 35 (2006).
REFERENCES
68 Fed. Reg. 4788 (January 24, 2003).
70 Fed. Reg. 54,946 (September 19, 2005).
Burchard, E. G., E. Ziv, N. Coyle, S. L. Gomez, H. Tang, A. J. Karter, et al. 2003. “The Importance of Race and Ethnic Background in Biomedical Research and Clinical Practice.” New England Journal of Medicine 348:1170–75.
Collins, Francis. 2004. “What We Do and Don’t Know About ‘Race,’ ‘Ethnicity,’ Genetics and Health at the Dawn of the Genome Era.” Nature Genetics 36:S13–S15.
Cooper, R. S., J. S. Kaufman, and R. Ward. 2003. “Race and Genomics,” New England Journal of Medicine 348:1166–70.
Epstein, Steven. 2007. Inclusion: The Politics of Difference in Medical Research. Chicago: University of Chicago Press.
Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997).
Gomez, Laura and Nancy Lopez, ed. 2013. Mapping ‘Race’: Critical Approaches to Health Disparities Research. New Brunswick: Rutgers University Press.
Krimsky, Sheldon and Kathleen Sloan, ed. 2011. Race and the Genetic Revolution. New York: Columbia University Press.
Kuo W. H. 2008. “Understanding Race at the Frontier of Pharmaceutical Regulation: An Analysis of the Racial Difference Debate at the ICH.” Journal of Law, Medicine & Ethics 36:498–505.
Lee, J. John. 2005. “Comment: What Is Past Is Prologue: The International Conference on Harmonization and Lessons Learned from European Drug Regulations Harmonization.” University of Pennsylvania Journal of International Economic Law 26:155.
Lewontin, Richard. 1972. “The Apportionment of Human Diversity,” Evolutionary Biology 6:381–84.
NIH Revitalization Act of 1993, Pub. L. No. 103-43, 107 Stat. 122 (1993).
