Mixed Race Studies

Race-Based Medicine: Déjà Vu All Over Again?

Biopolitical Times: The weblog of the Center for Genetics and Society
2012-09-18

Osagie K. Obasogie, Associate Professor of Law
University of California, San Francisco
Also: Senior Fellow
Center for Genetics and Society

Race-based medicine has been one of the more contentious issues in pharmaceutical research and development over the past few years. Some argue that drugs specifically labeled to treat particular racial groups offer an invaluable way to fight racial disparities in health by targeting at-risk populations. Others claim that race-based medicine inappropriately treats race as a biological cause of racial disparities when broader social and environmental factors may offer better explanations.

Much of this debate involves the FDA’s 2005 approval of BiDil, which became the first drug to be labeled for a specific racial group – African Americans with heart failure. The heat generated from this debate has largely faded due to BiDIl’s market failure.  But, it seems like a new drug may reignite a few flames.

Tradjenta was developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly to treat Type 2 diabetes. But results from a Phase III clinical trial recently showed that Tradjenta was particularly beneficial for controlling African Americans’ blood sugar levels…

…Is another BiDil on the horizon? It’s important to acknowledge that Tradjenta had already received FDA approval to treat type 2 diabetes in the general population prior to the announcement of these race-specific results. This is different from BiDil, where investigators sought a race-specific indication from the FDA because they could not otherwise win regulatory approval as a race-neutral drug. Despite these differences, treating racial disparities in diabetes as a naturally observed group difference that can be at least partially resolved with a pill shares some similarities with the BiDil saga. In both cases, there is a tendency to naturalize racial disparities as a function of group difference rather than having a deeper engagement with the social determinants of health.

This leads to an important question: if Tradjenta already received approval for use in the general population, why would it not be effective in African Americans? Put differently, why go through the time and expense of conducting a clinical trial to demonstrate efficacy in a particular racial group when the drug has already been approved for everyone regardless of race?

It’s unclear how these recent clinical trial results might be used. Perhaps this is another example of using a clinical trial as a marketing device in the hopes of capturing a larger share of the market…

Read the entire article here.

Slooooooow Sales for BiDil^®

Biopolitical Times: The weblog of the Center for Genetics and Society
2006-10-18

Osagie K. Obasogie, Associate Professor of Law
University of California, San Francisco
Also: Senior Fellow
Center for Genetics and Society

Today’s Wall Street Journal reports that sales for BiDil^®—the first drug to receive FDAapproval to treat a specific race—are unexpectedly slow. Marketed as treating heart failure in African-Americans, BiDil^® was expected to generate $130 million in sales this year; thus far, only a little over $5 million has come in. Estimates show that only 1% of the 750,000 Blacks suffering from heart failure are using it.

There’s no shortage of explanations for why Black people are about as unlikely to take BiDil^® as they are to name a newborn child Katrina…

…But, perhaps there’s another explanation that the Wall Street wing tips are missing: a sense of history.

During a conference I attended earlier this year on BiDil^® and race specific medicines, an older Black woman in the audience stood up and said “If I were sick and somebody told me that they had a drug just for Black people to help me, I’d say to them: give me what the white people are taking.”…

Read the entire article here.

Personalizing Medicine: Beyond Race

Virtual Mentor: American Medical Association Journal of Ethics
Volume 14, Number 8 (August 2012)
pages 628-634

Timothy Chang, MD-PhD Student
University of Wisconsin, Madison

McNearney TA, Hunnicutt SE, Fischbach M, et al. Perceived functioning has ethnic-specific associations in systemic sclerosis: another dimension of personalized medicine. J Rheumatol. 2009;36(12):2724-2732.

Considering the explosion in medical technology, from genomics and genetic biomarker testing to computerized imaging and detailed electronic medical records, personalized medicine may one day be common practice in our medical system. In “Perceived Functioning Has Ethnic-specific Associations in Systemic Sclerosis: Another Dimension of Personalized Medicine,” Terry McNearney et al. [1] found that “clinical, psychosocial, and immunogenetic variables had ethnic-specific associations with perceived functioning” in patients being treated for systemic sclerosis (SSc). The relationship of ethnicity both to the clinical, psychosocial, and immunogenetic variables and to perceived functioning raises ethical questions, especially if clinicians “personalize” treatment based on these findings.

Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and internal organs, commonly preceded by autoantibody production and vasculopathy [3]. Although management of complications has improved, the median survival after diagnosis is 11 years [4]. Currently, SSc is incurable, and health-related quality-of-life (QOL) measures are important indicators of disease outcome [5-9].

Conclusions from Study
 
In this cross-sectional study, Caucasian, Hispanic, and African American patients with recent-onset SSc were assessed for perceived physical and mental functioning using validated surveys and a self-reported physical disability instrument. Perceived functioning scores were then tested for association with demographic, socioeconomic, clinical, immunogenetic, psychological, and behavioral variables. Among Caucasians, immunogenetics, fatigue severity, helplessness, and social support were associated with perceived functioning, while among African Americans and Hispanics, immunogenetics, autoantibodies, illness behavior, and helplessness were associated with perceived functioning. This study is the first to identify associations between perceived SSc functioning and ethnically specific genetic markers and autoantibodies…

…Limitations…

..Using race and ethnicity to alert clinicians to greater likelihoods of certain health conditions became more controversial with the development of what was considered a race-specific drug. In 2005, the FDA approved isosorbide dinitrate/hydralazine (BiDil), a combination antihypertensive and vasodilator drug, specifically for African Americans. Major controversy ensued over whether a drug should be approved for use in a specific race since most drugs have long been tested on white subjects but not approved only for whites. Moreover, approval of BiDil for African Americans was not granted for biological or genetic reasons—the proposed differences in mechanism of nitric oxide uptake in African Americans were never tested…

…Is race a biological concept? Until now, I have been talking as though race has biological meaning. There is clear evidence, however, that race is not a genetic concept , and some would argue that it has no biologic basis. Only 5-10 percent of genetic diversity is explained by one’s membership in a given “race”. In actuality there is as much or more genetic diversity within a racial group as there is between racial groups.

Race is more a sociopolitical concept than a biologic one. The concepts of race and ethnicity were not developed for scientific use but are popular concepts, which, in the United States, were made official for census taking by the Office of Management and Budget Race and Ethnic Standards.

Membership in race is defined differently across research studies, time, and geography. Most studies do not report how race information is obtained, e.g., self-identified or clinician determined, let alone standardize the process. The definition of race is also time- and geography-dependent. How “black” and “white,” for example, are defined in the United States has changed from the 1800s to the 1900s. Because race is identified by one’s parents at birth and can be assigned by the medical examiner at death, a person may be born “black” but die “white”. Geographically, a light-skinned person may be considered white in the Bahamas but black in the United States. Inconsistencies in the definitions of race make its usage problematic at best…

Read the entire article in HTML or PDF format.

Race Finished: Book Review

American Scientist
April-May, 2012

Jan Sapp, Professor of Biology and History
York University, Toronto

Race?: Debunking a Scientific Myth. Ian Tattersall and Rob DeSalle. xviii + 226 pp. Texas A&M University Press, 2011.

Race and the Genetic Revolution: Science, Myth, and Culture. Edited by Sheldon Krimsky and Kathleen Sloan. xiv + 296 pp. Columbia University Press, 2011. cloth.

Few concepts are as emotionally charged as that of race. The word conjures up a mixture of associations—culture, ethnicity, genetics, subjugation, exclusion and persecution. But is the tragic history of efforts to define groups of people by race really a matter of the misuse of science, the abuse of a valid biological concept? Is race nevertheless a fundamental reality of human nature? Or is the notion of human “races” in fact a folkloric myth? Although biologists and cultural anthropologists long supposed that human races—genetically distinct populations within the same species—have a true existence in nature, many social scientists and geneticists maintain today that there simply is no valid biological basis for the concept.

The consensus among Western researchers today is that human races are sociocultural constructs. Still, the concept of human race as an objective biological reality persists in science and in society. It is high time that policy makers, educators and those in the medical-industrial complex rid themselves of the misconception of race as type or as genetic population. This is the message of two recent books: Race?: Debunking a Scientific Myth, by Ian Tattersall and Rob DeSalle, and Race and the Genetic Revolution: Science, Myth, and Culture, edited by Sheldon Krimsky and Kathleen Sloan. Both volumes are important and timely. Both put race in the context of the history of science and society, relating how the ill-defined word has been given different meanings by different people to refer to groups they deem to be inferior or superior in some way.

Before we turn to the books themselves, a little background is necessary. A turning point in debates on race was marked in 1972 when, in a paper titled “The Apportionment of Human Diversity,” Harvard geneticist Richard Lewontin showed that human populations, then held to be races, were far more genetically diverse than anyone had imagined. Lewontin’s study was based on molecular-genetic techniques and provided statistical analysis of 17 polymorphic sites, including the major blood groups in the races as they were conventionally defined: Caucasian, African, Mongoloid, South Asian Aborigines, Amerinds, Oceanians and Australian Aborigines. What he found was unambiguous—and the inverse of what one would expect if such races had any biological reality: The great majority of genetic variation (85.4 percent) was within so-called races, not between them. Differences between local populations accounted for 8.5 percent of total variation; differences between regions accounted for 6.3 percent. The genetic divergence between geographical populations in the course of human evolution does not compare to the variation among individuals. “Since such racial classification is now seen to be of virtually no genetic or taxonomic significance either, no justification can be offered for its continuance,” Lewontin concluded…

…Race?: Debunking a Scientific Myth is a beautifully presented book, elegantly reasoned and skillfully written. Tattersall, a physical anthropologist, and DeSalle, a geneticist, are both senior scholars at the American Museum of Natural History. Their aim is to explain human diversity in terms of human evolution and dispersal since our ancestors walked out of Africa some 100,000 years ago. The patterns of diversity, they write, reflect the processes of divergence and reintegration, the yin and yang of evolution.

In biology, a grouping has biological meaning based on principles of common descent—the Darwinian idea that all members of the group share a common ancestry. On this basis, and on the ability to interbreed, all humans are grouped into one species as Homo sapiens, the only surviving member of the various species that the genus comprised. Species are arranged within the “tree of life,” a hierarchical classification that situates each species in only one genus, that genus only in one family and so on. Nothing confuses that classification more than the exchange of genes between groups. In the bacterial world, for example, gene sharing can occur throughout the most evolutionarily divergent groups. The result is a reticulate evolution—a global net or web of related organisms, and no species. Among humans, reticulation occurs when there is interbreeding within the species—mating among individuals from different geographical populations. The result of such genetic mixing of previously isolated groups—due to migrations, invasions and colonization—is that no clear boundaries can be drawn around the variety of humans, no “races” of us…

…Although race is void of biological foundation, it has a profound social reality. All too apparent are disparities in health and welfare. Despite all the evidence indicating that “race” has no biological or evolutionary meaning, the biological-race concept continues to gain strength today in science and society, and it is reinforced by those who design and market DNA-based technologies. Race is used more and more in forensics, medicine and the genetic-ancestry business. Tattersall and DeSalle confront those industries head on and in no uncertain terms, arguing that “race-based medicine” and “raced-based genomics” are deeply flawed. Individuals fall ill, not populations. Belonging to any socioculturally defined race is a poor predictor of an individual’s genes, and one’s genes a poor predictor of one’s health.

Race and the Genetic Revolution: Science, Myth, and Culture arose from two projects, both funded by the Ford Foundation and organized by the Council for Responsible Genetics, that “examined the persistence of the concept of human races within science and the impacts such a concept has had on disparities among people of different geographical ancestries.” The first project brought together academics and social-justice advocates to discuss “racialized” forensic DNA databases and seek policy solutions. The second focused on the effects of modern genetic technology in reinscribing and naturalizing the concept of race in science and society. The resulting book is a fine and richly textured compilation, in which a multidisciplinary group of scholars explore racialized medicine, various uses of genetic testing in forensics and the genetic-ancestry industry, and attempts to link intelligence and race.

Sociologist Troy Duster argues that the growing genetic-ancestry industry not only reinforces a biological conception of race but is sorely in need of government regulation in regard to claims made and accuracy of methods used to pinpoint ancestry, as was suggested by the American Society of Human Genetics in 2008…

…A different aspect of racial profiling is evident in the growing industry of racialized medicine, whose proponents might argue that even if race has no evolutionary or biological meaning, it can still be useful for medical treatments. After all, more and more diseases are reportedly correlated with ethnicity and race. But as evolutionary biologists Joseph L. Graves Jr. and Jonathan Kahn argue in their respective chapters on the subject, racialized medicine is a bad investment and is bound to fail for two reasons. First, although individual ancestries are useful on medical questionnaires, ancestry should not be conflated with race. “The issue is not primarily one of whether to use racial categories in medical practice but how,” Kahn writes.

Carefully taking account of race to help understand broader social or environmental factors that may be influencing health disparities can be warranted. . . . But it is always important to understand that race itself is not an inherent causal factor in such conditions.

As an example, he considers the drug called BiDil, FDA approved as an anti–heart-attack agent specifically marketed to African Americans on the grounds that they have a biological propensity for heart disease brought on by high blood pressure. Not only is the drug not effective for all African Americans, it is quite effective for many individuals who self-identify as Caucasian…

Read the entire review here.

Race and the Genetic Revolution: Science, Myth, and Culture

Columbia University Press
September 2011
304 pages
1 illus; 4 tables
Paper ISBN: 978-0-231-15697-4
Cloth ISBN: 978-0-231-15696-7

Edited by:

Sheldon Krimsky, Professor of Urban & Environmental Policy & Planning; Adjunct Professor of Public Health and Family Medicine
Tufts School of Medicine
Tufts University, Medford, Massachusetts

Kathleen Sloan

Do advances in genomic biology create a scientific rationale for long-discredited racial categories? Leading scholars in law, medicine, biology, sociology, history, anthropology, and psychology examine the impact of modern genetics on the concept of race. Contributors trace the interplay between genetics and race in forensic DNA databanks, the biology of intelligence, DNA ancestry markers, and racialized medicine. Each essay explores commonly held and unexamined assumptions and misperceptions about race in science and popular culture.

This collection begins with the historical origins and current uses of the concept of “race” in science. It follows with an analysis of the role of race in DNA databanks and racial disparities in the criminal justice system. Essays then consider the rise of recreational genetics in the form of for-profit testing of genetic ancestry and the introduction of racialized medicine, specifically through an FDA-approved heart drug called BiDil, marketed to African American men. Concluding sections discuss the contradictions between our scientific and cultural understandings of race and the continuing significance of race in educational and criminal justice policy.

Table of Contents

• A short history of the race concept / Michael Yudell
• Natural selection, the human genome, and the idea of race / Robert Pollack
• Racial disparities in databanking of DNA profiles / Michael T. Risher
• Prejudice, stigma, and DNA databases / Helen Wallace
• Ancestry testing and DNA : uses, limits, and caveat emptor / Troy Duster
• Can DNA witness race? Forensic uses of an imperfect ancestry testing technology / Duana Fullwiley
• BiDil and racialized medicine / Jonathan Kahn
• Evolutionary versus racial medicine : why it matters? / Joseph L. Graves Jr.
• Myth and mystification : the science of race and IQ / Pilar N. Ossorio
• Intelligence, race, and genetics / Robert J. Sternberg … [et al.]
• The elusive variability of race / Patricia J. Williams
• Race, genetics, and the regulatory need for race impact assessments / Osagie K. Obasogie.

Medicating Race: Heart Disease and Durable Preoccupations with Difference

Massachusetts Institute of Technology
2007
250 pages

Anne Pollock, Assistant Professor of Science, Technology and Culture
Georgia Institute of Technology, Atlanta, Georgia

Submitted to the Program in Science, Technology and Society In Partial Fulfillment of the Requirements of the Degree of Doctor of Philosophy in the History and Social Study of Science and Technology At the Massachusetts Institute of Technology

This dissertation is an examination of intersections of race, pharmaceuticals, and heart disease over the course of the 20th century and today. Each of these parts has had a dynamic history, and when they are invoked together they provide a terrain for arguments about interventions in health and in justice in the present.

An enduring aspect of discourses of heart disease over the past century has been articulating connections between characterizations of the modem American way of life and of heart disease. In that process, heart disease research and practice has participated in differentiating Americans, especially by race. This dissertation uses heart disease categories and the drugs prescribed for them as windows into racialized medicine.

The chapters are organized in a way that is roughly chronological, beginning with the emergence of cardiology as a specialty just before World War II and the landmark longitudinal Framingham Heart Study that began shortly thereafter. A central chapter tracks the emergence and mobilization of African American hypertension as a disease category since the 1960s. Two final chapters attend to current racial invocations of two pharmaceuticals: thiazide and BiDil. Using methods from critical historiography of race, anthropology, and science studies, this thesis provides an account of race in medicine with interdisciplinary relevance.

By attending to continuities and discontinuities over the period, this thesis illustrates that race in heart disease research and practice has been a durable preoccupation. Racialized medicine has used epistemologically eclectic notions of race, drawing variously on heterogeneous aspects that are both material and semiotic. This underlying ambiguity is central to the productivity of the recorded category of race. American practices of medicating race have also been mediating it, arbitrating and intervening on new and renewed articulations of inclusion and difference in democratic and racialized American ways of life.

Table of Contents

• Abstract
• Acknowledgements
• Chapter 1: Introduction
• Chapter 2: Preoccupations with Racialized Modernity in Early Cardiology
• Chapter 3: Constructing and Supplementing Framingham’s Normal White Americans: The Framingham and Jackson Heart Studies
• Chapter 4: The Durability of African American Hypertension as a Disease Category
• Chapter 5: Thiazide and Racialization of a Generic Drug
• Chapter 6: BiDil: Medi©ating the Intersection of Race and Heart Failure
• Epilogue: Tracking Plural Noninnocent Discourses
• Works Cited

…Early Framingham investigators did their research in an all-white population, but they participated in larger conversations about black/white differences, too. The Framingham investigators themselves participated in the simultaneous constructions of hypertension and African American hypertension in the 1960s, an era that saw the ascendance both of hypertension as a risk factor and of the Civil Rights Movement. Their own study’s lack of inclusion of African Americans did not preclude their participation in arguments about racial differences in hypertension. Addressing “Environmental Factors in Hypertension” in a 1967 publication, the investigators wrote:

The principal population groups among whom blood pressures have been reported to be lower than among Americans and Europeans are various primitive peoples. The sample size has usually been small, especially in the older ages, and conclusions about age trends are complicated both by this fact, and by the fact that it is often not possible to accurately determine the age of the subjects. Among those population groups studied adequately, the following may be said:

Blood pressure distributions are similar among such diverse groups as: Caucasians living in Europe, the United States, and the West Indies; among Chinese living in Taiwan, and among Japanese in Japan.

Negro populations have higher blood pressures than whites living in the same areas and studied by the same investigators, particularly among females and in the older age groups. Distributions of blood pressures among Negro populations living in the United States and in the West Indies, whether rural or urban, high or low salt eaters, are similar. Their blood pressures are higher than those of Negroes in Liberia, a principal source of Negro migration to the Western Hemisphere. Admixture of the Negro races in the Western Hemisphere makes the interpretation of this data difficult. It is in this general background of unencouraging experience that the study of particular environmental factors, which could conceivably affect the blood pressure level, must be approached.

I will return to the question of African American Hypertension as a disease category in Chapter 4, but for now attend to other aspects of this quote. Here, we can see the distance between direct evidence or argument and the invocation of a common sense of racialization of cardiovascular disease. Although their phrasing evokes neutral grammars of data, there are no citations or evidence for these assertions about “Negro populations,” suggesting that the authors conceive of these statements less as arguments than as reflecting the consensus of the field. Unable to grapple with the embodied admixture that is not merely biological but also historical and cultural, much history is paved over in word choices such as “migration” to describe the slave trade and “admixture” to describe oppressive sexual relations under slavery.

Paucity of data is not actually the problem. The investigators make an odd claim about the cause of the difficulty of research into environmental causes of racial disease disparities: that “admixture” gets in the way of interpretation. Logically, assimilation would be the kind of mixing that would pose a problem for separating out environmental causes of disease by race, but the investigators lacked a language for cultural, in addition to biological admixture. The peculiarity of the investigators’ framing should alert us both to the fact of racialized hypertension’s existence at the nexus of the biological and the environmental, and that Framingham is telling both a white story and a universal one…

Read the entire dissertation here.

“Racially-Tailored” Medicine Unraveled

American University Law Review
Volume 55, Number 2 (December 2005)
pages 395-452

Sharona Hoffman, Professor of Law, Professor of Bioethics, and Associate Director of the Law-Medicine Center
Case Western Reserve University School of Law

Table of Contents

• Introduction
• I. “Race-Based” Research and Therapeutic Practices
  • A. The Story of BiDil
  • B. “Race-Based” Research
  • C. A Growing Interest in “Race-Based” Medicine: Why Now?
• II. Does “Race” Mean Anything?
  • A. “Race” in the Medical and Social Sciences
  • B. “Race” and the Law
  • C. Shifting the Focus Away from “Race”
• III. The Dangers of “Racial Profiling” in Medicine
  • A. Medical Mistakes
  • B. Stigmatization and Discrimination
  • C. Exacerbation of Health Disparities
• IV. Violation of Anti-Discrimination Provisions
  • A. Constitution and Federal Civil Rights Laws
  • B. State Laws Prohibiting Discrimination in the Medical Arena
    • 1. Civil rights statutes
    • 2. Hospital and medical facility licensing requirements
    • 3. Patients’ bill of rights laws
    • 4. Public services regulation
    • 5. Insurance codes
  • C. Violation of Research Regulations and Guidelines
    • 1. NIH policy and guidelines
    • 2. Federal research regulations
  • D. Discrimination Theory
• V. Recommendations
  • A. Review of Research Studies by Scientific Review Boards and IRBs
    • 1. Scientific reviews
    • 2. Institutional review boards
  • B. Investigators and Health Care Providers
  • C. Public Discourse Concerning Attribute-Based Medicine:The Responsibilities of Investigators, Institutions, and the Media
• Conclusion

Introduction

F.D.A. Approves a Heart Drug for African-Americans. This June 2005 headline announced the arrival of BiDil, a heart failure edication that is approved for African-Americans only. BiDil is the first drug in pharmaceutical history that will constitute standard therapy for only one particular “race.”Health care professionals are becoming increasingly interested in “racebased” medicine in the research and therapeutic contexts. Many researchers are attempting to discern “racial” differences in disease manifestation, biological functioning, and therapeutic response rates. As this approach develops, physicians may prescribe different dosages of medication for people of separate “races” or may provide them with entirely different drugs. In light of the success of BiDil, investigators are also likely to pursue the development of additional “racially-tailored” medications. In fact, several academic and professional conferences have already devoted significant time to the discussion of “race-based” medicine. On April 18, 2005, the University of Minnesota hosted aconference entitled Proposals for the Responsible Use of Racial & Ethnic Categories in Biomedical Research: Where Do We Go From Here? Likewise, the Eighth World Congress on Clinical Pharmacology and Therapeutics, held in 2004 in Brisbane, Australia, devoted an afternoon to ethnopharmacology.While “racial profiling” in medicine has generated significant discussion in medical and bioethics circles, it has thus far gained relatively little attention in legal literature. This Article aims to develop the discourse concerning this important topic. It argues that “race-based” medicine is an inappropriate and perilous approach. The argument is rooted partly in the fact that the concept of “race” is elusive and has no reliable definition in medical science, the social sciences, and the law.  Does “race” mean color, national origin, continent of origin, culture, or something else? What about the millions of Americans who are of mixed ancestral origins—to what “race” do they belong? To the extent that “race” means “color” in colloquial parlance, should physicians decide what testing to conduct or treatment to provide based simply on their visual judgment of the patient’s skin tone? “Race,” consequently, does not constitute a valid and sensible foundation for research or therapeutic decision-making.

Further, this Article contends that “racial profiling” in medicine can be dangerous to public health and welfare. A focus on “race,” whatever its meaning in the physician’s eye, can lead to medical mistakes if the doctor misjudges the patient’s ancestral identity or fails to recall that a particular condition affects several vulnerable groups and not just one “race.” The phenomenon can also lead to stigmatization and discrimination in the workplace and elsewhere if the public perceives certain “races” as more diseased or more difficult to treat than others. In addition, “racial profiling” could exacerbate health disparities by creating opportunities for health professionals to specialize in treating only one “race” or to provide different and inferior treatment to certain minorities. It could also intensify African-Americans’ distrust of the medical profession. Finally, “race-based” medicine might violate numerous anti-discrimination provisions contained in federal law, state law, and federal research regulations and guidelines…

…The Article will proceed as follows. Part I of the Article will describe “race-based” research and therapeutic practices and will examine the growing interest in “race-based” medicine and the reasons for it. Part II will argue that “race” is a concept that has no coherent meaning and that is potentially pernicious. Part III will focus on the dangers of “raciallytailored” medicine, and Part IV will analyze a variety of anti-discrimination mandates that could potentially be violated by the practice. Finally, Part V will detail recommendations for the development of attribute-based medicine in a manner that will promote the health and welfare of all population groups…

…This Article argues against substantial use of the concept of “race” in medical settings. A primary reason for this restriction is that “race” has no coherent meaning, and therefore, reliance upon it for research or treatment purposes can be confusing at best and can lead to significant adverse consequences at worst. This section will build the argument that based on medical science, the social sciences, and the law, “race” has no reliable definition or real meaning. Moreover, it is a pernicious concept that has been used to suggest that human beings can be divided into subspecies, some of which are morally, intellectually, and physically inferior to others. Thus, medical professionals should focus on more precise and meaningful aspects of human identity rather than on the amorphous concept of “race.”…

Read the entire article here.

How Culture and Science Make Race “Genetic”: Motives and Strategies for Discrete Categorization of the Continuous and Heterogeneous

Literature and Medicine
Volume 26, Number 1 (Spring 2007)
pages 240–268
DOI: 10.1353/lm.2008.0000

Celeste Condit, Distinguished Research Professor
University of Georgia

Scientists, medical personnel, and others have recently re-asserted the equivalence of human genetic variation and social categories of “race”. This essay identifies strong cultural and scientific motives for creating, defending, and deploying that equivalence. However, the essay employs visual depictions of human genetic variation and critical analysis of scientific and lay vocabularies to show that human genetic variation has a complex structure that cannot be directly fit into a simple category set of race terms. The essay suggests that efforts to equate patterns of human genetic variation and social terms for “race” rely on the rhetorical strategies of casuistic stretching and the deployment of a mediating term through a two-step argumentative structure. The essay closes by discussing the difficulties involved in implementing social policies based on this procrustean category system, utilizing the case of the “race-based” heart disease drug Bi-Dil.

One of the most contentious issues in contemporary genetics is the status of the concept of “race.” Critics of the research program in human genomics regularly cite the historical and contemporary associations between racism and genetics as a reason to be suspicious or non-supportive of genetic research. These criticisms operate on varying underlying assumptions about the nature of science and its relationship to culture. The predominant account, however, holds that science is the handmaiden of the dominant forces in the culture. In this account, because genetic science is a tool of the dominant forces in society, which are structured in a racist fashion, genetic science is predetermined to support racism. Substantial research in science studies has complicated the account of the relationship between science and culture, but the topic of racism and genetics has only recently begun to receive similarly sophisticated attention. I wish to contribute to this on-going exploration by analyzing the processes by which and the motives for which race terms are fit to the patterns of human genetic variation by scientists and medical research personnel.

My essay presumes and shows that human genetic variation has a complex structure that cannot be directly fit into a simple category set of race terms. Nevertheless, the essay identifies strong cultural and scientific motives for creating, defending, and deploying such a set of terms to describe that variation. Given the tension between the nature of human genetic variation and the scientific vocabularies proposed to define it, the essay reveals two specific rhetorical strategies used by scientific proponents of such categorization: casuistic stretching and the deployment of a mediating term through a two-step argumentative structure.

The essay proceeds in five movements. The first briefly overviews the historical trajectory of the naming of race in the U.S. The second enumerates the diverse motive structures that drive the contemporary categorization of human genetic variation into “race” groups, focusing particularly on the work of Neil Risch and his colleagues. The next provides a conceptually- and visually-based depiction of the nature of human genetic variation that highlights its clinal and brecciated character.  The essay then offers an analysis of the rhetorical strategies by which these heterogeneous and continuous materials are organized into simple, discrete categories by the scientific proponents of a biological foundation for “race.” In the final movement, the essay discusses the difficulties involved in implementing social policies based on this procrustean category system. It examines the case of the “race-based” heart disease drug BiDil to suggest that the inherent slippages in the category system make proposed programs of race-based medicine unworkable, but that they will also mask the failures of such initiatives…

…This inherent variability suggests that programs in race-based medicine are doomed to failure, at least to the extent that they are presumed to be based on underlying genetics. Figures 1–3 remind us that genetic heterogeneity among people who have relatively recent African ancestry is greater than anywhere in the world. Although this heterogeneity may have been reduced in African Americans by geographically selective and forced migration, it is re-enhanced by admixture. The “Black” population in the U.S. is also continually diversifying, as recent migrants come from other parts of Africa or from the Carribbean, where different patterns of migration and admixture have existed. Consequently, it is not reasonable to expect that dark skinned people as a group will respond to a particular drug more uniformly than the broader population, based on their skin color alone. If BiDil really does work better for African Americans (in the narrow range of parts of the country where it has been systematically tested) its beneficial effects will more likely result from shared experience of social discrimination than from shared genes. But BiDil’s success will be used as evidence to support what everybody believes—or fears—that Black people are genetically different from White people, in ways that truly matter.

BiDil’s failures will also be masked by the ambiguities of language. Doctors will not know to which patients they should prescribe BiDil. How dark should your skin be before you are a candidate for this medicine? If you have brown skin, but self-identify as “African American,” do you get the drug? What if you are dark skinned, but self-identify as Caribbean? What if your grandfather was from Ireland but your other relatives were from Sierra Leone? What if you are a recent immigrant from Ethiopia? The genetic ambiguities are blackwashed with a simple label: “Black” (or is it “African American”?). The promoters of the idea that people can be grouped into genetically discrete piles called “races” will never have to face the fact that these clinical problems invalidate their views. Whether a drug does or does not work for an “African American” with an Irish grandparent will not be attributed to the fact that the labels don’t work. It will be dismissed as irrelevant on the grounds that no medication works all the time, even for a targeted group. Only if BiDil proves to have a relatively high rate of fatal or serious side effects will it face real scrutiny. Only then will the spectre of the Tuskegee Syphilis study return. Even its return, however, will probably further reify “Black” against “White” rather than call into question the underlying assumptions that human beings can be placed into discrete genetic categories and treated based on those categories instead of the unique genetic constellation that each person represents….

Read the entire article here.

The fallacy of racial pharmacogenomics

Brazilian Journal of Medical and Biological Research
Volume 44, Number 4 (April 2011)
pages 268-275
DOI: 10.1590/S0100-879X2011007500031

S. D. J. Pena
Departamento de Bioquímica e Imunologia, Universidade Federal de Minas Gerais
Belo Horizonte, MG, Brasil
GENE – Núcleo de Genética Médica, Belo Horizonte, MG, Brasil

Personalized pharmacogenomics aims to use individual genotypes to direct medical treatment. Unfortunately, the loci relevant for the pharmacokinetics and especially the pharmacodynamics of most drugs are still unknown. Moreover, we still do not understand the role that individual genotypes play in modulating the pathogenesis, the clinical course and the susceptibility to drugs of human diseases which, although appearing homogeneous on the surface, may vary from patient to patient. To try to deal with this situation, it has been proposed to use interpopulational variability as a reference for drug development and prescription, leading to the development of “race-targeted drugs”. Given the present limitations of genomic knowledge and of the tools needed to fully implement it today, some investigators have proposed to use racial criteria as a palliative measure until personalized pharmacogenomics is fully developed. This was the rationale for the FDA approval of BiDil for treatment of heart failure in African Americans. I will evaluate the efficacy and safety of racial pharmacogenomics here and conclude that it fails on both counts. Next I shall review the perspectives and the predicted rate of development of clinical genomic studies. The conclusion is that “next-generation” genomic sequencing is advancing at a tremendous rate and that true personalized pharmacogenomics, based on individual genotyping, should soon become a clinical reality.

Introduction

The American astrophysicist Neil deGrasse Tyson defined the “perimeter of ignorance” as the boundary where scientists face a choice: continue the quest for knowledge or invoke a deity or other supernatural forces. He used as an example no less than Isaac Newton himself, whose law of gravity enabled calculation of the force of attraction between any two objects. When computing the orbits of the planets around the sun, Newton feared that the mutual attraction between them would render the solar system unstable. He then concluded that God occasionally stepped in to make things right. A century later, the French astronomer Pierre-Simon de Laplace created a new mathematical tool called perturbation theory and used it to demonstrate that the solar system is in fact stable over periods of time much longer than Newton could predict. Laplacian science, therefore, no longer needed to postulate the interference of supernatural forces to explain astronomical facts.

Newton’s appeal to God, however unnecessary, may at first sight appear as a humble attitude of a great man. However, Tyson demonstrates that, on the contrary, it represented presumptuousness on his part: if his mathematics was not good enough to explain the phenomenon, then the problem was too complicated for any other human mind to figure out, then or anytime in the future. By “embracing ignorance” Newton’s attitude negatively infused a temporary stage of incomplete knowledge with a false permanency, running counter to the philosophy of open-mindedness and discovery that characterizes Science.

Pharmacogenetics and pharmacogenomics are likewise in a dilemma right at the edge of the perimeter of ignorance…

…To try to deal with this situation it has been proposed to use interpopulational variability as a reference for drug development and prescription, leading to the development of “race-targeted drugs”, as exemplified by the case of BiDil for treatment of heart failure in African Americans. The rationale for such strategy is that, since we still lack the pharmacogenomic knowledge necessary to implement true personalized treatment, we make do by using the race or the ethnic-geographic affiliation of a given patient as the replacement of the germane individual genotyping at critical loci.

Therein lies the fallacy of racial pharmacogenomics – being predicated on the idea that individual genotyping will be impossible to achieve in the near future, it “embraces ignorance”. Moreover, it often does so under false premises. For instance, in the FDA news release entitled “FDA Approves BiDil Heart Failure Drug for Black Patients” it is stated that this represents “a step toward the promise of personalized medicine”. But racial medicine is group medicine – most definitely it is not personalized medicine…

…I propose that, rather than thinking about populations, ethnicities or races, we should focus on the unique genome of a particular individual, which is structured as a mosaic of polymorphic haplotypes with diverse genealogical histories. This shifts the emphasis from populations to persons. We should strive to see each individual as having a singular genome and a unique life history, rather than try to impose on him/her characteristics of a group or population. Under this model, ideas such as that of human races or “race-targeted drugs” become meaningless and vanish like smoke.

The safety of racial pharmacogenomics

The adoption of racial pharmacogenomics by the FDA has serious implications that extend much beyond the restricted limits of the medical arena. Thus, it has to be evaluated not only scientifically, but also within a historical, sociological and philosophical context.

In the past, the belief that human races had substantial and clearly delimited biological differences contributed to justify discrimination and was used to oppress and foment injustices, even within the medical context. The concept of race is still loaded with ideology and carries within it relationships of power and domination. It is similar to a banana peel: empty, slippery and dangerous.

Thus, our final conclusion is that racial pharmaco-genomics fails on grounds of insufficient benefit/cost ratio: it has much to recommend against it and very little scientific justification in its favor.

To use racial pharmacogenomics as a palliative measure is tantamount to “embracing ignorance”. It erroneously confers persistence and credence to the idea that human races do exist. As pointed out by the sociologist Paul Gilroy, such persistence is toxic, contaminating and weakens all society…

Read the entire article here.

A race-based detour to personalized medicine

Canadian Medical Association Journal
Volume 184, Number 7 (2012-03-12)
DOI: 10.1503/cmaj.109-4133

Roger Collier, News Staff

Few experts in medical genetics would argue that June 23, 2005 wasn’t an important day. Consensus on whether it was a good or bad day is another matter. Some claim a major step on the long road to personalized medical care was taken. Others are far less convinced, suggesting it was the day the United States government decided, unwisely, to push the field of medical genetics into the heated realm of racial politics.

On that date, the US Food and Drug Administration (FDA) approved, for the first time, a drug for a specific race, to wit, the fixed-dose combination drug isosorbide dinitrate and hydralazine (BiDil) for use as a heart disease medication within the black population, who have a much higher risk of heart failure than whites…

…The licensing of isosorbide dinitrate/hydralazine thus became a turning point in discussions on the merits of race-based medicine, a debate that continues to rage. Critics of race-specific therapies argue that focusing on genetics rather than on social and economic inequalities will not reduce disparities in health outcomes and access to care among different ethnic groups. Furthermore, they say, race is a social, rather than a biological, construct.

“Using race is a bad proxy for genetic ancestry,” says Althea Grant, chief of the Epidemiology and Surveillance Branch, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, at the US Centers for Disease Control and Prevention.

This opinion is shared by one of the world’s most famous geneticists: Craig Venter, the genetics pioneer who led the team that first sequenced the human genome in 2001. He has referred to the use of race and ethnicity in medical genetics as a crude tool and a personal pet peeve, suggesting that it will no longer be necessary once the price of sequencing genomes falls to an amount that would make it reasonable to sequence everybody’s genome, a figure he pegged at US$1000…

…The first problem with using race in medical genetics is determining which races constitute a part of someone’s background. Few people have extensive knowledge of their ancestral lineage, and skin colour and other external markers don’t tell the full story. Even people who are aware of their mixed heritage often place themselves in one camp — or are put there by others. Prominent examples include US President Barack Obama and professional golfer Tiger Woods, who are often referred to as black even though the former has a white mother and the latter’s mother hails from Thailand.

“People tend to self-identify with a particular race more than another even if there is a mix,” says Grant. “They might not even know all the ancestries that are in the mix.”

In some areas of medicine, using race as a screening tool has already been shown to create problems, both practical and ethical. That’s why states abandoned the practice of screening only black newborns for hemoglobinopathies, such as sickle cell disease, Grant and colleagues concluded (Ethn Health 2011;16:377–88). The state of Georgia, the last holdout for ethnicity-based newborn screening, discontinued its use in 1998…

“If we go back to its origins, we find that BiDil did not begin as an ethnic drug. Rather it became ethnic over time and through a complex array of legal, commercial, and medical interventions, that transformed the drug’s identity,” wrote Jonathan Kahn, a law professor at Hamline University in Saint Paul, Minnesota (www.councilforresponsiblegenetics.org/pageDocuments/PLMVM6FTAO.pdf). Unlike “racialized medicine, which treats race as genetic, the use of race in medical practice has many legitimate and important places. Collecting broad-based epidemiological data is perhaps foremost among these. Only by using social categories of race is it possible to identify and track racial disparities in health, health care access and outcomes.”

Read the entire article here.