Mixed Race Studies

Racial profiling in medicine

Nature Medicine
Volume 19, Number 7 (July 2013)
page 808
DOI: 10.1038/nm.3254

Aravinda Chakravarti, Professor of Medicine
McKusick-Nathans Institute of Genetic Medicine
Johns Hopkins University

Jonathan Kahn, Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age, Columbia University Press, 2012. 28 pp., ISBN: 0231162987

The field of human genetics is moving beyond using genomics as a tool for deeper understanding of human disease pathophysiology to the possibility of translating this knowledge for efficient treatment. A particular emphasis is being placed on Individualized medicine’, promising to tailor treatment based on each of our genomes. This ideal vision, however, can cause unease when our notions of genetic individuality intersect with those of ancestry and race. Jonathan Kahn’s book, Race in a Bottle, is a contemporary medical story born of this nexus. In it, he skillfully uses the story of the drug BiDil, a therapeutic for heart failure marketed specifically for African Americans (but whose use has declined markedly because it provides no unique benefit in comparison to similar drugs), as the backdrop for examining the expanding role of race in medical genomics, even when the same science has called the existence of race into serious doubt.

As Kahn highlights in the book, the innocuous birth of BiDil in 1992 was no predictor of its contorted history. BiDil is a combination of two vasodilators, hydralazine and isosorbide dinitrate (H-I), which are presumed to act through the nitric oxide pathway to provide benefit to patients with congestive heart failure. They were combined into one pill for easier administration, although each was already available in generic form. Between 1980 and 1991, two major clinical trials in the United States, involving patients of both European and African ancestries, clearly established that angiotensin-converting-enzyme inhibitors should be the preferred drug for patients with heart failure and that the H-1 combination should be used in individuals who did not benefit from this frontline therapy. Sensing a market opportunity, Medco Research obtained the intellectual property rights to BiDil, demonstrated its bioequivalence to the H-1 formulation and approached the US Food and Drug Administration(FDA) in 1996 for approval to market this ‘new’ drug. The FDA refused, arguing that clinical trials showing the utility of H-1 for heart failure did not meet the stiff criteria for such approval.

There was a suspicion that the nitric oxide response, and heart failure, was somehow different in blacks than in whites. So Jay Cohn, a respected cardiologist and owner of the original BiDil patent, reanalyzed the original clinical trial data to demonstrate that H-1 did work better in blacks than whites, a contention described and contested in the book. This finding not only led to a new patent but prompted its new owner, NitroMed, to conduct a fresh clinical trial in 2001, involving only African-American patients with heart failure, to demonstrate BiDils utility in this group. None of these facts are in doubt. What is doubted, however, is the implicit assumption that BiDil is not useful for white patients, the chronology of key events and the motivations of various actors in medicine, industry and government—factors that morphed an otherwise convenient drug formulation into a race-specific drug. Kahn makes the charge that “BiDil was not about personalizing medicine; it was about exploiting race to obtain cheaper, quicker FDA approval for a drug.”…

…Genetic analysis strongly suggests that early humans first arose in Africa and emerged out of Africa only ~100,000 years ago, a fairly recent development, evolutionarily speaking, which explains why we are all closely related. Any classification of biological races within our species is arbitrary because there are no major discontinuities in our diversity across the globe. Importantly, genetic data show that currently populous groups are not necessarily reflected by their past abundance, and human history is one of repeated admixture, not maintenance of purity. It is this genetic admixture that has left an imprint on every human disease with a genetic component, including common chronic ones. Thus, it is quite unlikely that the genetic variations underlying our diseases, which represent only a small fraction of our genetic diversity, will vary markedly across humanity…

Read or purchase the article here.

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.