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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Race is a Social Construct

Center for Health Progress
2017-10-24

Sarah McAfee
Golden, Colorado

On a recent road trip with my sister, a doctor, we were talking about how race is a social construct. (We’re not the best conversationalists.) She asked, “If there’s no biological basis for race, then why do some medications work better for people of some races than others?” Which is a good question. Since we had a long drive ahead of us, I stalled by pointing out the window at a pretend elk and changed the subject, then did some furious Googling when we stopped for gas.

For hundreds of years, we’ve been told that each race is a discrete group of people defined by specific genetic and biological differences. As a result, we’ve used race as a way of explaining observed differences in health: Sickle Cell Anemia is considered a black person disease; Cystic Fibrosis is considered a white person disease; we’ve said people of color are genetically pre-disposed to diabetes, high blood pressure, obesity, and other chronic conditions; the FDA has approved drugs for different races; and through “race-based medicine” we’ve established care standards (such as responding to patients’ pain) that vary by race. But it’s all wrong…

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Hidden in Plain Sight — Reconsidering the Use of Race Correction in Clinical Algorithms

The New England Journal of Medicine
Volume 2020, Number 383
pages 874-882
2020-08-27 (published on 2020-06-17, at NEJM.org.)
DOI: 10.1056/NEJMms2004740

Darshali A. Vyas, M.D., Resident Physician
Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts
Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts
Harvard University, Cambridge, Massachusetts

Leo G. Eisenstein, M.D., Resident Physician
New York University Langone Medical Center, New York, New York

David S. Jones, M.D., Ph.D., A. Bernard Ackerman Professor of the Culture of Medicine
Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts
Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts

Physicians still lack consensus on the meaning of race. When the Journal took up the topic in 2003 with a debate about the role of race in medicine, one side argued that racial and ethnic categories reflected underlying population genetics and could be clinically useful.¹ Others held that any small benefit was outweighed by potential harms that arose from the long, rotten history of racism in medicine.² Weighing the two sides, the accompanying Perspective article concluded that though the concept of race was “fraught with sensitivities and fueled by past abuses and the potential for future abuses,” race-based medicine still had potential: “it seems unwise to abandon the practice of recording race when we have barely begun to understand the architecture of the human genome.”³

The next year, a randomized trial showed that a combination of hydralazine and isosorbide dinitrate reduced mortality due to heart failure among patients who identified themselves as black. The Food and Drug Administration granted a race-specific indication for that product, BiDil, in 2005.⁴ Even though BiDil’s ultimate commercial failure cast doubt on race-based medicine, it did not lay the approach to rest. Prominent geneticists have repeatedly called on physicians to take race seriously,^5,6 while distinguished social scientists vehemently contest these calls.^7,8

Our understanding of race and human genetics has advanced considerably since 2003, yet these insights have not led to clear guidelines on the use of race in medicine. The result is ongoing conflict between the latest insights from population genetics and the clinical implementation of race. For example, despite mounting evidence that race is not a reliable proxy for genetic difference, the belief that it is has become embedded, sometimes insidiously, within medical practice. One subtle insertion of race into medicine involves diagnostic algorithms and practice guidelines that adjust or “correct” their outputs on the basis of a patient’s race or ethnicity. Physicians use these algorithms to individualize risk assessment and guide clinical decisions. By embedding race into the basic data and decisions of health care, these algorithms propagate race-based medicine. Many of these race-adjusted algorithms guide decisions in ways that may direct more attention or resources to white patients than to members of racial and ethnic minorities…

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