Race in a Bottle

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

Copyright Date: 2013
Pages: 328
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    Race in a Bottle
    Book Description:

    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.

    eISBN: 978-0-231-53127-6
    Subjects: Health Sciences, Political Science

Table of Contents

  1. Front Matter
    (pp. i-iv)
  2. Table of Contents
    (pp. v-vi)
    (pp. vii-xiv)
  4. INTRODUCTION: Race and Medicine: Framing [Is] the Problem
    (pp. 1-24)

    In june 2000, at a White House ceremony announcing the completion of the first draft of the human genome, President 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.” Following President Clinton, geneticist Craig Venter asserted that this accomplishment illustrated “that the concept of race has no genetic or scientific basis.”¹ This was not news to most geneticists and social scientists, but merely confirmed what most had long accepted: “race is not...

  5. 1 ORGANIZING RACE: Paths Toward the Re-Biologization of Race in Modern Biomedical Research, Practice, and Product Development
    (pp. 25-47)

    Race enters biomedicine through many pathways. Foremost among these are federal initiatives that shape the production and use of racial categories in biomedical research. Recent debates over the appropriate use of racial and ethnic categories in biomedical contexts have often concentrated on the practices of individual researchers with the aim, in part, to help researchers appreciate the nuances and complexities of the racial categories they use.¹ A focus on individual practices, while necessary, overlooks the myriad structural forces that teach researchers and clinicians to see and use race in particular and often problematic ways. Prominent among these forces are a...

  6. 2 THE BIRTH OF BIDIL: How a Drug Becomes ʺEthnicʺ
    (pp. 48-70)

    On june 23, 2005, the FDA approved BiDil to treat heart failure in African Americans, andonlyAfrican Americans. BiDil was not a new drug but a combination in a single pill of two existing generic drugs that had been used to treat heart failure, regardless of race, for over a decade based on evidence from two clinical trials conducted in the 1980s. BiDil was brought to the FDA by NitroMed, a small Massachusetts biotech company with no other products on the market. NitroMed explicitly requested race-specific FDA approval for its drug based on clinical data produced by its African-American...

    (pp. 71-86)

    In 2001, nitromed framed its announcement of the forthcoming A-HeFT trial for BiDil with a striking statistic: “Death rates from heart failure are more than twice as high in black patients than in white patients.”¹ It heralded BiDil as presenting an opportunity to address “the disparity in outcomes for African American heart failure patients.”² NitroMed posited that the disparity might be due to “a pathophysiology found primarily in black patients that may involve nitric oxide (NO) insufficiency.”³ A follow-up press release reiterated both the 2:1 statistic and the proposition that “observed racial disparities in mortality and therapeutic response rates in...

    (pp. 87-123)

    The story of bidil elucidates an alternative model to developing tailored therapies that promises to fill in the gap between the promise and reality of pharmacogenomic medicine. It is a model that exploits race to gain regulatory and commercial advantage, while ignoring its power to promote a regeneticization of racial categories in society at large.

    The moment at which NitroMed succeeded in its strategy of creating a racial frame for the approval of BiDil is buried deep in the FDA medical review of its application. Dated May 12, 2005, section 1.2.6 of the review found, “The effect of BiDil in...

  9. 5 RACE-ING PATENTS/PATENTING RACE: An Emerging Political Geography of Intellectual Property in Biotechnology
    (pp. 124-156)

    Emerging with the rise of racial branding in drug marketing is a powerful new legal and commercial phenomenon that has led to a far more focused and instrumental capitalization of race in biomedicine: the strategic use of race as a genetic category to obtain patent protection. Patent law is supposed to promote the invention of new and useful products.¹ In recent biotechnology patents, race and ethnicity are being exploited in new ways that do not spur the invention of new products, but rather the reinvention or recharacterization of existing products as racial or ethnic. In so doing, patent law racializes...

  10. 6 NOT FADE AWAY: The Persistence of Race and the Politics of the ʺMeantimeʺ in Pharmacogenomics
    (pp. 157-192)

    In 1878, Friedrich Engels famously wrote that on the road to realizing the communist utopia, “the state is not abolished, it withers away.”¹ In a similar manner, biomedical researchers tell us that come the promised land of individualized genomic medicine, the need for using race will also “wither away” in the face of scientific progress. Such millennial hopes are, no doubt, sincere, but they enable the continued casual proliferation of racial categories throughout biomedical research, product development, marketing, and clinical practice. My contrasting quotation to frame this chapter is drawn from the twentieth-century pioneer of rock and roll, Buddy Holly,...

  11. 7 FROM DISPARITY TO DIFFERENCE: The Politics of Racial Medicine
    (pp. 193-224)

    The story of bidil and the related rise of race in biomedical practice and patenting clearly raise concerns over the dangers of reifying race in a manner that could lead to new forms of discrimination. BiDil, however, is part of a much larger dynamic in which the purported “reality of race” as genetic is used to obscure the social reality of racism. To the extent that this dynamic succeeds in reductively reconfiguring health (and other types of disparities) in terms of genetic difference, it casts personal responsibility and the market as the appropriate arenas for addressing differential outcomes, and undermines...

    (pp. 225-246)

    Sociologist troy duster cautions that “it is … a mistake to uncritically accept old racial classifications when we study medical treatments. The task is to determine how the social meaning of race can affect biological outcomes.”¹ The story of BiDil and the subsequent expanding embrace of race in biomedicine is a story of the failure of a wide variety of actors—from medical researchers to federal regulators to drug company executives—to heed Duster’s admonition. Some doctors and scientists expressed similar concerns from the outset. One news report on BiDil quoted Craig Venter, who was CEO of Celera Genomics when...

  13. NOTES
    (pp. 247-302)
  14. INDEX
    (pp. 303-314)