Mixed Race Studies

Race Based Medication BiDil and African Americans

New York University
2009-10-16

Ann Morning, Associate Professor of Sociology
New York University

Ann Morning, Assistant Professor of Sociology, discusses race-based medications.

From Medical Innovation to Sociopolitical Crisis: How Racialized Medicine Has Shifted the Scope of Racial Discourse and its Social Consequences

Wesleyan University, Middletown, Connecticut
May 2013
51 pages

Danielle Antonia Craig

An essay submitted to the faculty of Wesleyan University in partial fulfillment of the requirements for the Degree of Bachelor of Arts with Departmental Honors in Sociology

Using a case study of a congestive heart failure, BiDil, patented in 2005 for use only in African Americans, I attempt to understand and analyze how the movement of racialized medicine has informed and effected American understandings of race, racial identity, and health.

Read the entire essay here.

Book Review: Race in a Bottle

GeneWatch
Council for Responsible Genetics
Volume 26 Issue 1, March 2013

Lundy Braun, Royce Family Professor in Teaching Excellence and Professor of Medical Science and Africana Studies
Brown University

In Race in a Bottle, Jonathan Kahn tracks the contentious history of BiDil, the first drug targeted specifically to African Americans. Ironically, race-based drug treatment emerged in the wake of the sequencing of the human genome, a project that theoretically promised both to scientifically refute the notion of genetically distinct racial groups and to usher in an era of personalized medicine. Though hyped by researchers, the FDA, and the press as an important first step toward personalized medicine, BiDil is a drug administered to patients based on their membership in a group…

…Critical to Kahn’s argument regarding evidence is the fact that the clinical trials on which the company based its patent application for BiDil were never designed to compare racial difference in response to the drug. Using “care of the data” as an organizing theme, Kahn highlights one of the many troubling aspects of this controversy: the extraordinarily loose, if not sloppy, construction of what passed as evidence in the patent application and FDA hearings. From the use of misleading statistics on mortality from heart failure in African Americans, to the failure to define the central variable of race, to the design of a clinical trial (A-HeFT) that included only African Americans (and therefore could not determine differential efficacy) to the lack of any mechanistic understanding for a differential effect, Kahn shows that attention to the data was consistently problematic when it came to matters of race. The chapter on the FDA hearings is particularly illuminating…

Read the entire review here.

Race in Contemporary Medicine

Routledge
2007
208 pages
Hardback ISBN: 978-0-415-41365-7

Edited by:

Sander L. Gilman

With the first patent being granted to “BiDil,” a combined medication that is deemed to be most effective for a specific “race,” African-Americans for a specific form of heart failure, the on-going debate about the effect of the older category of race has been renewed. What role should “race” play in the discussion of genetic alleles and populations today? The new genetics has seemed to make “race” both a category that is seen useful if not necessary, as The New York Times noted recently: “Race-based prescribing makes sense only as a temporary measure.” (Editorial, “Toward the First Racial Medicine,” November 13, 2004) Should one think about “race” as a transitional category that is of some use while we continue to explore the actual genetic makeup and relationships in populations? Or is such a transitional solution poisoning the actual research and practice.

Does “race” present both epidemiological and a historical problem for the society in which it is raised as well as for medical research and practice? Who defines “race”? The self-defined group, the government, the research funder, the researcher? What does one do with what are deemed “race” specific diseases such as “Jewish genetic diseases” that are so defined because they are often concentrated in a group but are also found beyond the group? Are we comfortable designating “Jews” or “African-Americans” as “races” given their genetic diversity? The book answers these questions from a bio-medical and social perspective.

This book was previously published as a special issue of Patterns of Prejudice.

Contents

• Introduction: On Race and Medicine in Historical Perspective. Sander L. Gilman (Emory)
• Reflections on Race and the Biologization of Difference. Katya Gibel Azoulay (Grinnell)
• Against Racial Medicine. Joseph L. Graves, Jr. (North Carolina A&T State University) & Michael R. Rose (University of California, Irvine)
• Blood and Stories: How Genomics is Rewriting Race, Medicine and Human History. Patricia Wald (Duke)
• “Why are Genetic and Medical Researchers Accepting a Category Created by Slaveholders?” A Social History of the Reification of “Race” James Downs (Princeton)
• Eugenics and the Racial Genome: Politics at the Molecular Level. Sharon Snyder and David Mitchell (University of Illinois – Chicago)
• The Risky Gene: Epidemiology and the Evolution of Race. Philip Alcabes (Hunter College School of Health Sciences)
• Folk Taxonomy, Prejudice and the Human Genome: Using Heritable Disease as a Jewish Ethnic Marker. Judith S. Neulander (Case Western Reserve University)
• The price of science without moral constraints: German and American medicine before DNA and Today. Robert E. Pollack (Columbia)
• Deadly Medicine Today: The Impossible Denials of Racial Medicine. C. Richard King (Washington State University)
• Biobanks of a “Racial Kind”: Mining for Difference in the New Genetics. Sandra Soo-Jin Lee (Stanford)

The End of Race History? Not Yet

Center for Genetics and Society
2012-12-14

Osagie K. Obasogie, Associate Professor of Law
University of California, Hastings

Have we gone beyond race? Many argue society has now overcome centuries of strife to become “post-racial”—a moment that law professor Sumi Cho of DePaul University in Chicago refers to as “the end of race history”.

Two seemingly disparate developments have been used to lend support to this claim. In politics, Barack Obama’s 2008 election as the first racial minority-member to become US president has been lauded as a racially transcendent moment. In science, the completion of the Human Genome Project’s first draft in June 2000 offered seemingly definitive evidence that race is not real. As geneticist Craig Venter noted at the HGP announcement, “the concept of race has no genetic or scientific basis”…

…Two recent books by legal scholars address these issues. Jonathan Kahn’s Race in a Bottle provides a stunning case study of BiDil, the first drug to receive approval by the US Food and Drug Administration as a race-specific therapy. It was designed to treat African-Americans suffering from heart failure—based mainly on a mistaken belief that there are meaningful disparities in heart failure outcomes between blacks and whites caused by biological differences. Although BiDil was initially created as a race-neutral drug, Kahn offers a compelling account of the many influences that turned what is in essence a combination therapy of two widely available generic treatments into a pill “for black people only”…

…Dorothy Roberts’s Fatal Invention, now out in paperback, extends this insight to examine how the re-emergence of biological race is having a broader impact—not only on innovations such as genetic ancestry-testing and racialised aspects of DNA forensics, but also on how we think about basic notions of racial difference. Advocates of biological race argue that today’s use of race in biomedicine is different from past usages within science that supported racism, eugenics and questionable research practices…

Read the entire article here.

From Bang to Whimper: A Heart Drug’s Story

The New York Times
2012-12-24

Abigail Zuger, M.D.

Jonathan Kahn, Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age. Columbia University Press, December 2012, 336 pages.

On June 23, 2005, American medicine managed to take a small step forward and a giant step backward at precisely the same time, with government approval of the first medication to be earmarked for a specific racial group. It was BiDil, a drug designed to treat heart failure in blacks.

Enthusiasts hailed BiDil’s approval by the Food and Drug Administration as a landmark event in the nascent field of pharmacogenomics, which aims to create drugs tailored to fit an individual’s genetic makeup as precisely as a bespoke suit drapes its owner’s shoulders. Critics just winced and clocked one more misstep in medicine’s long history of race-related disasters.

You would think that the elucidation of the human genome would have cleared up most of the hoary untruths surrounding race and health. But as Jonathan Kahn makes clear in his worthy if convoluted review of the events surrounding the birth of BiDil, the genome has in many respects only made things worse.

It has been clear for decades that race has minimal relevance to the body’s inner workings. Research has repeatedly shown that the biologic variations among individuals of the same race are reliably great enough for race to retain little utility as a biologic predictor. You might as well sort people by height. Or, in the words of an editorial writer for Nature Biotechnology in 2005, “Pooling people in race silos is akin to zoologists grouping raccoons, tigers and okapis on the basis that they are all stripy.”…

Read the entire review here.

Medicating Race: Heart Disease and Durable Preoccupations with Difference

Duke University Press
October 2012
280 pages
5 illustrations
Paperback ISBN: 978-0-8223-5344-7
Cloth ISBN: 978-0-8223-5329-4

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

In Medicating Race, Anne Pollock traces the intersecting discourses of race, pharmaceuticals, and heart disease in the United States over the past century, from the founding of cardiology through the FDA’s approval of BiDil, the first drug sanctioned for use in a specific race. She examines wide-ranging aspects of the dynamic interplay of race and heart disease: articulations, among the founders of American cardiology, of heart disease as a modern, and therefore white, illness; constructions of “normal” populations in epidemiological research, including the influential Framingham Heart Study; debates about the distinctiveness African American hypertension, which turn on disparate yet intersecting arguments about genetic legacies of slavery and the comparative efficacy of generic drugs; and physician advocacy for the urgent needs of black patients on professional, scientific, and social justice grounds. Ultimately, Pollock insists that those grappling with the meaning of racialized medical technologies must consider not only the troubled history of race and biomedicine but also its fraught yet vital present. Medical treatment should be seen as a site of, rather than an alternative to, political and social contestation. The aim of scholarly analysis should not be to settle matters of race and genetics, but to hold medicine more broadly accountable to truth and justice.

Table of Contents

• Acknowledgments
• Introduction
• 1. Racial Preoccupations and Early Cardiology
• 2. Making Normal Populations and Making Difference in the Framingham and Jackson Heart Studies
• 3. The Durability of African American Hypertension as a Disease Category
• 4. The Slavery Hypothesis beyond Genetic Determinism
• 5. Thiazide Diuretics as a Nexus of Associations: Racialized, Proven, Old, Cheap
• 6. BiDil: Medicating the Intersection of Race and Heart Failure
• Conclusion
• Notes
• Works Cited
• Index

Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age

Columbia University Press
December, 2012
336 pages
Charts: 4, B&W Illus.: 1
Cloth ISBN: 978-0-231-16298-2

Jonathan Kahn, Professor of Law
Hamline University, Saint Paul, Minnesota

At a ceremony announcing the completion of the first draft of the human genome in 2000, President Bill Clinton declared, “I believe one of the great truths to emerge from this triumphant expedition inside the human genome is that in genetic terms, all human beings, regardless of race, are more than 99.9 percent the same.” Yet despite this declaration of unity, biomedical research has focused increasingly on mapping that .1 percent of difference, particularly as it relates to race.

This trend is exemplified by the drug BiDil. Approved by the FDA in 2005 as the first drug with a race-specific indication on its label, BiDil was originally touted as a pathbreaking therapy to treat heart failure in black patients and help underserved populations. Upon closer examination, however, Jonathan Kahn reveals a far more complex story. At the most basic level, BiDil became racial through legal maneuvering and commercial pressure as much as through medical understandings of how the drug worked. Using BiDil as a central case study, Kahn broadly examines the legal and commercial imperatives driving the expanding role of race in biomedicine, even as scientific advances in genomics could render the issue irrelevant. He surveys the distinct politics informing the use of race in medicine and the very real health disparities caused by racism and social injustice that are now being cast as a mere function of genetic difference. Calling for a more reasoned approach to using race in biomedical research and practice, Kahn asks readers to recognize that, just as genetics is a complex field requiring sensitivity and expertise, so too is race, particularly in the field of biomedicine.

Contents

• Acknowledgments
• INTRODUCTION: Race and Medicine: Framing [Is] the Problem
• 1. ORGANIZING RACE: Paths Toward the Re-Biologization of Race in Modern Biomedical Research, Practice, and Product Development
• 2. THE BIRTH OF BIDIL: How a Drug Becomes “Ethnic”
• 3. STATISTICAL MISCHIEF AND RACIAL FRAMES FOR DRUG DEVELOPMENT AND MARKETING
• 4. CAPITALIZING [ON] RACE IN DRUG DEVELOPMENT
• 5. RACE-ING PATENTS/PATENTING RACE: An Emerging Political Geography of Intellectual Property in Biotechnology
• 6. NOT FADE AWAY: The Persistence of Race and the Politics of the “Meantime” in Pharmacogenomics
• 7. FROM DISPARITY TO DIFFERENCE: The Politics of Racial Medicine
• CONCLUSIONS AND RECOMMENDATIONS
• Notes
• Index

Race in a Bottle

Scientific American
Volume 297 (January 1, 2007)
pages 40-45

Jonathan D. Kahn, Professor of Law
Hamline University, Saint Paul, Minnesota

Drugmakers are eager to develop medicines targeted at ethnic groups, but so far they have made poor choices based on unsound science. This article focuses on the drug, BiDil – a drug that combats congestive heart failure by dilating the arteries and veins of African American patients. The author expounds that there is no solid evidence that the drug should targeted towards only one ethnic group. The author includes the history of BiDil including its inception and then its reappearance with a race-based focus.

Read the entire article here.

Playing the Gene Card? A Report on Race and Human Biotechnology

Center for Genetics and Society
2009
95 pages

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

Preface by:

Dorothy Roberts, George A. Weiss University Professor of Law and Sociology; Raymond Pace and Sadie Tanner Mossell Alexander Professor of Civil Rights
University of Pennsylvania

Executive Summary

Race has become a prominent focus for human biotechnology. Despite often good intentions, genetic technologies are being applied in a manner that may provide new justification for thinking about racial difference and racial disparities in biological terms—as if social categories of race reflect natural or inherent group differences.

The Human Genome Project (HGP) and subsequent research showed that there is less than 1% genetic variation among all humans. Patterns of mating and geographic isolation over thousands of years have conferred genetic signatures to certain populations. Yet scientists have found little evidence to support lay understandings that social categories of race reflect discrete groups of human difference. While HGP findings initially led many to conclude that race (as it is commonly conceived and used) is not genetically significant, the hope that science would promote racial healing has largely not materialized.

In fact, trends in life science research have shifted the other way. There are increasing efforts to demonstrate the genetic relevance of race by mapping this less than 1% of variation onto social categories of race to find genetic explanations for racial disparities and differences.

From page 21

Figure 2: The essentialist and population concepts of race contrasted with the actual patterns of genetic variation (simplified to three geographic categories). Based on the work of Dr. Jeffrey Long at the University of Michigan and depictions created by the Race—Are We So Different? project of the American Anthropological Association.

A Essentialist concepts of race that were popular throughout the 19th and early 20th century held that the human species was divided into several mutually exclusive yet tangentially overlapping groups based largely upon physical features such as skin color and facial features.

B Population approaches treat race as clusters of local populations that differ genetically from one another, whereby each group is considered a race. As depicted, this concept suggests an outer periphery of unshared distinctiveness as well as substantial genetic similarity that is highlighted by the overlapping regions.

C Contemporary data on human diversity supports a “nested subset” approach to race. This reflects the fact that “people have lived in Africa far longer than anywhere else, which has allowed the population in Africa to accumulate more of the small mutations that make up [human] genetic variation. Because only a part of the African population migrated out of Africa, only part of Africa’s genetic variation moved with them. For this reason, most genetic variation found in people living outside Africa is a subset of that found among Africans.”

Many celebrate these developments as an opportunity to learn more about who we are and why certain groups are sicker than others. Yet some are struck by the extent to which these new conversations aimed at benefiting minority communities communities echo past discussions in which the science of biological difference was used to justify racial hierarchies.

Although this new research is rapidly evolving and is fraught with controversy, it is being used to develop several commercial and forensic applications that may give new credence to biological understandings of racial difference—often with more certainty than is supported by the available evidence. This unrestrained rush to market race-specific applications and to use DNA technologies in law enforcement can have significant implications for racial minorities:

• Race-based medicines have been promoted as a way to reduce inequities in healthcare and health outcomes. Yet the methodological assumptions behind them raise as many issues as the questionable market incentives leading to their development.
• Genetic ancestry tests rely on incomplete scientific methods that may lead to overstated claims. The companies that sell them often suggest that biotechnology can authoritatively tell us who we are and where we come from.
• DNA forensics have been used to exonerate those who have been wrongly convicted and can provide important tools for law enforcement. However, some forensic applications of genetic technologies might undermine civil rights—especially in minority communities.

While each of these applications has been examined individually, this report looks at them together to highlight a fundamental concern: that commercial incentives and other pressures may distort or oversimplify the complex and discordant relationship between race, population, and genes. Applications based on such distortions or oversimplifications may give undue legitimacy to the idea that social categories of race reflect discrete biological differences.

The concerns raised in this report should not be read as impugning all genetic research that implicates social categories of race. There is evidence that socially constructed notions of race may loosely reflect patterns of genetic variation created by evolutionary forces, and that knowledge about them may ultimately serve important social or medical goals. Yet, given our unfortunate history of linking biological understandings of racial difference to notions of racial superiority and inferiority, it would be unwise to ignore the possibility that 21st century technologies may be used to revive long discredited 19th century theories of race.

Advances in human biotechnology hold great promise. But if they are to benefit all of us, closer attention should be paid to the social risks they entail and their particular impacts on minority communities.

Contents

• Executive Summary
• About the Author
• Acknowledgments
• Preface by Dorothy Roberts, Kirkland & Ellis Professor of Law, Northwestern Law School
• Race Cards and Gene Cards: A Note About the Report’s Title
• Introduction | Are 21st Century Technologies Reviving 19th Century
  • Theories of Race?
  • How Have New Genetic Theories of Racial Difference Developed?
  • Context: After the Human Genome Project
  • Key Concern: Will Commercial and Forensic Applications Revive Biological Theories of Race?
  • In This Report
  • Sidebar: What Does It Mean to Say that Race Is Not Biologically Significant or that It Is a Social Construction?
• Chapter 1 | Race-Based Medicine: One Step Forward, Two Steps Back?
  • Pharmacogenomics: The Concept Behind Race-Based Medicine
  • First on the Scene: BiDil
  • Concerns about BiDil
  • Addressing Disparities in Health Through Race-Specific Pharmaceuticals
  • Conclusion: Evaluating Race-Based Medicine
  • Recommendations
  • Sidebars: Major Projects on Human Genetic Variation
    • Why Genetic Variations Matter
    • Top-Down Marketing to the Black Community
    • Historical Theories of Race
    • Are More Race-Based Medicines Around the Corner?
    • The Slavery Hypothesis
• Chapter 2 | Ancestry Tests: Back to the Future?
  • African American Ancestry
  • Context: Population Genetics
  • From Groups and Populations to Individuals
  • Techniques Used by Ancestry Tests
  • Concerns about the Genetic Ancestry Industry
  • Conclusion: Resisting Racial Typologies
  • Recommendations 30
  • Sidebars: Native Americans and Ancestry Tests
    • Race, Intelligence, and James Watson
    • Bioprospecting and Biopiracy
    • From Race to Population and Back
    • The Business of DNA Ancestry Testing
    • Special Types of DNA
    • Human Genetic Variation—A Work in Progress
• Chapter 3 | Race and DNA Forensics in the Criminal Justice System
  • How Does It Work?
  • How Reliable Are DNA Forensic Technologies?
  • DNA Databases
  • Cold Hits and Partial Matches
  • Whose DNA Is in These Databases?
  • Sifting DNA Databases to Catch Family Members
  • Predicting Criminality
  • Using DNA to Build Racial Profiles
  • Conclusion: Effects on Minority Communities
  • Recommendations
  • Sidebars: DNA Entrapment?
    • The Scandal in Houston
    • The Innocence Project
    • “The Informer in Your Blood”
    • Juking Stats
    • “The Birthday Problem” and the Limits of Forensic Database Matches
    • Minority Communities and the War on Drugs
    • Civil Liberties and DNA Databases
    • Phrenology, a Classic Pseudo-Science
• Conclusion
  • Racial Categories in Human Biotechnology Research
  • Race Impact Assessments
  • Responsible Regulation
• Endnotes
• About the Center for Genetics and Society

Read the entire report here.