Mixed Race Studies

Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU

Social Science & Medicine
Volume 280, July 2021, 114049
DOI: 10.1016/j.socscimed.2021.114049

Shai Mulinari, Senior Lecturer
Department of Sociology, Faculty of Social Sciences
Lund University, Sweden

Andreas Vilhelmsson, Associate Researcher
Division of Social Medicine and Global Health, Department of Clinical Sciences Malmö
Lund University, Malmö, Sweden

Piotr Ozieranski, Senior Lecturer
Department of Social and Policy Sciences
University of Bath, Bath, United Kingdom

Anna Bredström, Senior Lecturer, Docent; Associate Professor of Ethnicity and Migration
Institute for Research on Migration, Ethnicity and Society (REMESO)
Linköping University, Sweden

Highlights

• We compare race/ethnicity labeling of hundreds of new drugs in the USA and the EU.
• Many labels report race/ethnicity demographics of trials, more often in the USA.
• Fewer labels report race/ethnicity differences in response, more often in the EU.
• Racial/ethnic taxonomy used in labels is variable and inconsistent.
• The racialization of pharmaceutical regulation differs between the USA and the EU.

Recent decades have seen much interest in racial and ethnic differences in drug response. The most emblematic example is the heart drug BiDil, approved by the US Food and Drug Administration in 2005 for “self-identified blacks.” Previous social science research has explored this “racialization of pharmaceutical regulation” in the USA, and discussed its implications for the “pharmaceuticalization of race” in terms of reinforcing certain taxonomic schemes and conceptualizations. Yet, little is known about the racialization of pharmaceutical regulation in the USA after BiDil, and how it compares with the situation in the EU, where political and regulatory commitment to race and ethnicity in pharmaceutical medicine is weak. We have addressed these gaps by investigating 397 product labels of all novel drugs approved in the USA (n = 213) and the EU (n = 184) between 2014 and 2018. Our analysis considered statements in labeling and the racial/ethnic categories used. Overall, it revealed that many labels report race/ethnicity demographics and subgroup analyses, but that there are important differences between the USA and the EU. Significantly more US labels specified race/ethnicity demographics, as expected given the USA’s greater commitment to race and ethnicity in pharmaceutical medicine. Moreover, we found evidence that reporting of race/ethnicity demographics in EU labels was driven, in part, by statements in US labels, suggesting the spillover of US regulatory standards to the EU. Unexpectedly, significantly more EU labels reported differences in drug response, although no drug was restricted to a racial/ethnic population in a manner similar to BiDil. Our analysis also noted variability and inconsistency in the racial/ethnic taxonomy used in labels. We discuss implications for the racialization of pharmaceutical regulation and the pharmaceuticalization of race in the USA and EU.

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The Color Of Health: Skin Color, Ethnoracial Classification, And Discrimination In The Health Of Latin Americans

Social Science & Medicine
Available online: 2014-06-01
DOI: 10.1016/j.socscimed.2014.05.054

Krista M. Perreira, Professor of Public Policy and Associate Dean Office for Undergraduate Research
University of North Carolina, Chapel Hill

Edward E. Telles, Professor of Sociology
Princeton University, Princeton, New Jersey

Highlights

• Uses newly collected data on 4921 adults from Brazil, Columbia, Mexico, and Peru
• Examines multiple measures of race/ethnicity and their associations with health
• Finds significant skin-color gradients in self-reported health.
• Finds significant skin-color gradients in class-based discrimination and low SES.
• SES and class-based discrimination largely account for disparities in health by skin color.

Latin America is one of the most ethnoracially heterogeneous regions of the world. Despite this, health disparities research in Latin America tends to focus on gender, class and regional health differences while downplaying ethnoracial differences. Few scholars have conducted studies of ethnoracial identification and health disparities in Latin America. Research that examines multiple measures of ethnoracial identification is rarer still. Official data on race/ethnicity in Latin America are based on self-identification which can differ from interviewer-ascribed or phenotypic classification based on skin color. We use data from Brazil, Columbia, Mexico, and Peru to examine associations of interviewer-ascribed skin color, interviewer-ascribed race/ethnicity, and self-reported race/ethnicity with self-rated health among Latin American adults (ages 18-65). We also examine associations of observer-ascribed skin color with three additional correlates of health – skin color discrimination, class discrimination, and socio-economic status. We find a significant gradient in self-rated health by skin color. Those with darker skin colors report poorer health. Darker skin color influences self-rated health primarily by increasing exposure to class discrimination and low socio-economic status.

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Mismatched racial identities, colourism, and health in Toronto and Vancouver

Social Science & Medicine
Volume 73, Issue 8, October 2011
pages 1152–1162
DOI: 10.1016/j.socscimed.2011.07.030

Gerry Veenstra, Associate Professor of Sociology
University of British Columbia

Using original telephone survey data collected from adult residents of Toronto (n=685) and Vancouver (n=814) in 2009, I investigate associations between mental and physical health and variously conceived racial identities. An ‘expressed racial identity’ is a self-identification with a racial grouping that a person will readily express to others when asked to fit into official racial classifications presented by Census forms, survey researchers, insurance forms, and the like. Distinguishing between Asian, Black, South Asian, and White expressed racial identities, I find that survey respondents expressing Black identity are the most likely to report high blood pressure or hypertension, a risk that is slightly attenuated by socioeconomic status, and that respondents expressing Asian identity are the most likely to report poorer self-rated mental health and self-rated overall health, risks that are not explained by socioeconomic status. I also find that darker-skinned Black respondents are more likely than lighter-skinned Black respondents to report poor health outcomes, indicating that colourism, processes of discrimination which privilege lighter-skinned people of colour over their darker-skinned counterparts, exists and has implications for well-being in Canada as it does in the United States. Finally, ‘reflected racial identity’ refers to the racial identity that a person believes that others tend to perceive him or her to be. I find that expressed and reflected racial identities differ from one another for large proportions of self-expressed Black and South Asian respondents and relatively few self-expressed White and Asian respondents. I also find that mismatched racial identities correspond with relatively high risks of various poor health outcomes, especially for respondents who consider themselves White but believe that others tend to think they are something else. I conclude by presenting a framework for conceptualizing multifaceted suites of racial identities and relating their various components and inconsistencies between them to health outcomes.

Racial Taxonomy in Genomics

Social Science & Medicine
Volume 73, Issue 7, October 2011
pages 1019–1027
DOI: 10.1016/j.socscimed.2011.07.003

Catherine Bliss, Andrew W. Mellon Postdoctoral Fellow, Race and Science Studies
Department of Africana Studies
Brown University

This article examines the reflexive, biosocial nature of genomic meaning making around race, drawing on discourse analysis of 732 articles on genomics and race published from the years 1986 to 2010, in-depth interviews with 36 of the world’s most elite genomics researchers, interviews with 15 critics, policymakers, and trainees involved in debates over race, and participant observation at a core genotyping facility that specializes in ancestry estimation. I reveal how biomedical researchers identify with, value, and make sense of the taxonomies they construct. My analysis goes beyond a consideration of instrumental rationales to analyze the experiential and political motivations that shape how researchers get involved in racial ethical dilemmas. I theorize taxonomic practice as a reflexive form of biosociality, a conscious shaping of social notions about biology and race to produce a future that researchers themselves want to live in. I demonstrate how reflexive biosociality paradoxically leads researchers to advance social explanations for race while investing in genomics as a solution to racial quandaries.

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A number of serious problems with using race/ethnicity as a variable in genetics research have emerged in our analysis of our interviews with this group of genetic scientists. At the most basic level, the common racial/ethnic classifications they routinely use are of questionable value for delineating genetically related groups. The ubiquitous OMB categories in fact were designed for political and administrative purposes; they were not designed for use as scientific variables (Kertzer & Arel, 2002; Shields et al., 2005). These are notably ambiguous and arbitrary categories, based on strikingly diverse criteria such as skin color, language, or geographic location. They do not compose clear classifications, but instead are overlapping and not mutually exclusive. In the absence of clear principles for applying the labels, in practice, different aspects of an individual’s identity are arbitrarily prioritized, in order to fit individual cases into the schema.

A serious conceptual problem that reinforces the use of these questionable categories is that many of the researchers presume racial admixture is relatively rare and recent, and that specific geographically defined groups, such as Finnish or Japanese, can unproblematically be equated with broad socially designated racial/ethnic groups, such as white or Asian. However, this logic relies on several unsubstantiated assumptions: that historically there were pure racial types associated with particular geographic locations; that migrations were sporadic and relatively rare; and that racial/ethnic groups are primarily endogamous. (A recent study of the views of genetics journals editors reports similar findings: Outram & Ellison, 2006.) These assumptions are contrary to much of what is known about human population history. Genetic isolation among humans is in fact quite rare: human populations have always exchanged mates across broad geographic areas throughout time, producing clinal variation (gradual variation between places), rather than clearly distinct genetic stocks. Furthermore, racial admixture is not an exceptional event; indeed, there has been significant intermarriage between socially designated groups throughout history (Weiss, 1998; Harry & Marks, 1999; Race Ethnicity and Genetics Working Group, 2005). Compounding these conceptual problems is the practical fact that assigning these labels to individuals is often done in the absence of any specific knowledge of their actual familial migration histories.

Linda M. Hunt and Mary S. Megyesi, “The Ambiguous Meanings of the Racial/Ethnic Categories Routinely used in Human Genetics Research,” Social Science & Medicine, Volume 66, Number 2 (2008): 349-361. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213883.

The Ambiguous Meanings of the Racial/Ethnic Categories Routinely used in Human Genetics Research

Social Science & Medicine
Volume 66, Issue 2 (January 2008)
pages 349-361
DOI: 10.1016/j.socscimed.2007.08.034

Linda M. Hunt, Professor of Anthropology
Michigan State University

Mary S. Megyesi, M.Sc.
Michigan State University

Many researchers are currently studying the distribution of genetic variations among diverse groups, with particular interest in explaining racial/ethnic health disparities. However, the use of racial/ethnic categories as variables in biological research is controversial. Just how racial/ethnic categories are conceptualized, operationalized, and interpreted is a key consideration in determining the legitimacy of their use, but has received little attention. We conducted semi-structured, open-ended interviews with 30 human genetics scientists from the US and Canada who use racial/ethnic variables in their research. They discussed the types of classifications they use, the criteria upon which they are based, and their methods for classifying individual samples and subjects. We found definitions of racial/ethnic variables were often lacking or unclear, the specific categories they used were inconsistent and context specific, and classification practices were often implicit and unexamined. We conclude that such conceptual and practical problems are inherent to routinely used racial/ethnic categories themselves, and that they lack sufficient rigor to be used as key variables in biological research. It is our position that it is unacceptable to persist in the constructing of scientific arguments based on these highly ambiguous variables.

…A number of serious problems with using race/ethnicity as a variable in genetics research have emerged in our analysis of our interviews with this group of genetic scientists. At the most basic level, the common racial/ethnic classifications they routinely use are of questionable value for delineating genetically related groups. The ubiquitous OMB categories in fact were designed for political and administrative purposes; they were not designed for use as scientific variables (Kertzer & Arel, 2002; Shields et al., 2005). These are notably ambiguous and arbitrary categories, based on strikingly diverse criteria such as skin color, language, or geographic location. They do not compose clear classifications, but instead are overlapping and not mutually exclusive. In the absence of clear principles for applying the labels, in practice, different aspects of an individual’s identity are arbitrarily prioritized, in order to fit individual cases into the schema.

A serious conceptual problem that reinforces the use of these questionable categories is that many of the researchers presume racial admixture is relatively rare and recent, and that specific geographically defined groups, such as Finnish or Japanese, can unproblematically be equated with broad socially designated racial/ethnic groups, such as white or Asian. However, this logic relies on several unsubstantiated assumptions: that historically there were pure racial types associated with particular geographic locations; that migrations were sporadic and relatively rare; and that racial/ethnic groups are primarily endogamous. (A recent study of the views of genetics journals editors reports similar findings: Outram & Ellison, 2006.) These assumptions are contrary to much of what is known about human population history. Genetic isolation among humans is in fact quite rare: human populations have always exchanged mates across broad geographic areas throughout time, producing clinal variation (gradual variation between places), rather than clearly distinct genetic stocks. Furthermore, racial admixture is not an exceptional event; indeed, there has been significant intermarriage between socially designated groups throughout history (Weiss, 1998; Harry & Marks, 1999; Race Ethnicity and Genetics Working Group, 2005). Compounding these conceptual problems is the practical fact that assigning these labels to individuals is often done in the absence of any specific knowledge of their actual familial migration histories.

Heavy reliance on self-identification, as reported by these researchers, further amplifies the imprecision to these variables. Despite its popularity, this method for classifying cases is extremely problematic. Racial/ethnic identities are inherently amorphous constructs; they are multiple and fluid, and may change as a person moves between social, economic and geographic contexts (Berry, 1993; Hunt, Schneider & Comer, 2004). There is no way to know what criteria an individual may apply when classifying their own racial/ethnic identity, and the criteria is likely to vary dramatically from person to person. Although some researchers collect additional information about parents and grandparents, this is only done for certain racial/ethnic groups, and never with others, and there appears to be no standard criteria for assigning group membership based on the additional information…

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