Jonathan Kahn
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- book
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.001.0001
- Subject:
- Public Health and Epidemiology, Public Health
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 ...
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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 0.1 percent of difference, particularly as it relates to race. This trend is exemplified by the drug BiDil. This drug was originally touted as a groundbreaking therapy to treat heart failure in black patients and help underserved populations. However, the book 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. The book 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. It 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.Less
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 0.1 percent of difference, particularly as it relates to race. This trend is exemplified by the drug BiDil. This drug was originally touted as a groundbreaking therapy to treat heart failure in black patients and help underserved populations. However, the book 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. The book 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. It 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.
Donna Dickenson
- Published in print:
- 2016
- Published Online:
- November 2015
- ISBN:
- 9780231159753
- eISBN:
- 9780231534413
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231159753.003.0003
- Subject:
- Public Health and Epidemiology, Public Health
This chapter focuses on the components and implications of pharmacogenetics, which refers to the relationship between heritable variations and individual differences in drug response. ...
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This chapter focuses on the components and implications of pharmacogenetics, which refers to the relationship between heritable variations and individual differences in drug response. Pharmacogenetics aims to alter pharmaceutical patterns in cancer treatment and other branches of medicine in accordance to the patient’s individual genome. Some commentators believe that investment in pharmacogenetics is the most effective way to deliver the public health welfare originally pledged by the Human Genome Project. The chapter aims to devise a balanced judgment about pharmacogenetics, taking into consideration not only the medical evidence but also issues about justice, patenting, and drug rationing—including issues surrounding BiDil, a controversial personalized drug.Less
This chapter focuses on the components and implications of pharmacogenetics, which refers to the relationship between heritable variations and individual differences in drug response. Pharmacogenetics aims to alter pharmaceutical patterns in cancer treatment and other branches of medicine in accordance to the patient’s individual genome. Some commentators believe that investment in pharmacogenetics is the most effective way to deliver the public health welfare originally pledged by the Human Genome Project. The chapter aims to devise a balanced judgment about pharmacogenetics, taking into consideration not only the medical evidence but also issues about justice, patenting, and drug rationing—including issues surrounding BiDil, a controversial personalized drug.
Jonathan Kahn
- Published in print:
- 2011
- Published Online:
- November 2015
- ISBN:
- 9780231156974
- eISBN:
- 9780231527699
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231156974.003.0007
- Subject:
- Sociology, Race and Ethnicity
This chapter discusses the use of racialized medicine, specifically BiDil, and the concerns that emerge over the dangers of reifying race in a manner that could lead to new forms of discrimination. ...
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This chapter discusses the use of racialized medicine, specifically BiDil, and the concerns that emerge over the dangers of reifying race in a manner that could lead to new forms of discrimination. Approved by the Food and Drug Administration (FDA) in 2005, BiDil was offered as a drug to treat heart failure for only African Americans. NitroMed, the biotech company that produced the drug, requested race-specific approval based on the results of their African-American Heart Failure Trial (A-HeFT), where the trial population happened to be all “self-identified” African American. The chapter explains how BiDil is part of much larger dynamic of reification in which the purported “reality of race” as genetic may be used to obscure the social reality of “racism.” This matter should be addressed as it reductively reconfigures health and other types of disparity in terms of genetic difference.Less
This chapter discusses the use of racialized medicine, specifically BiDil, and the concerns that emerge over the dangers of reifying race in a manner that could lead to new forms of discrimination. Approved by the Food and Drug Administration (FDA) in 2005, BiDil was offered as a drug to treat heart failure for only African Americans. NitroMed, the biotech company that produced the drug, requested race-specific approval based on the results of their African-American Heart Failure Trial (A-HeFT), where the trial population happened to be all “self-identified” African American. The chapter explains how BiDil is part of much larger dynamic of reification in which the purported “reality of race” as genetic may be used to obscure the social reality of “racism.” This matter should be addressed as it reductively reconfigures health and other types of disparity in terms of genetic difference.
Sheldon Krimsky
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.003.0002
- Subject:
- Public Health and Epidemiology, Public Health
This chapter explores the origins of BiDil as a drug for everyone and considers how it became racialized primarily in response to a FDA ruling that placed in jeopardy the value of its owner's ...
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This chapter explores the origins of BiDil as a drug for everyone and considers how it became racialized primarily in response to a FDA ruling that placed in jeopardy the value of its owner's original nonracial patent. Obtaining a second, race-specific patent was driven primarily by concerns to extend the commercial life of the product. Its development depended upon the strategic appropriation of the social category of race to justify patenting and regulatory approval of a drug that purports to act on a “true” biological basis of heart failure. In the story of BiDil, race played the role of a valuable surrogate—i.e. it was presented as having no medical value in its own right but took on significance to the extent that researchers tie it to a “real” biological group through statistical correlations.Less
This chapter explores the origins of BiDil as a drug for everyone and considers how it became racialized primarily in response to a FDA ruling that placed in jeopardy the value of its owner's original nonracial patent. Obtaining a second, race-specific patent was driven primarily by concerns to extend the commercial life of the product. Its development depended upon the strategic appropriation of the social category of race to justify patenting and regulatory approval of a drug that purports to act on a “true” biological basis of heart failure. In the story of BiDil, race played the role of a valuable surrogate—i.e. it was presented as having no medical value in its own right but took on significance to the extent that researchers tie it to a “real” biological group through statistical correlations.
Sheldon Krimsky
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.003.0003
- Subject:
- Public Health and Epidemiology, Public Health
This chapter unfolds around the story of an inaccurate statistic claiming that African-Americans suffered mortality from heart failure at a rate twice that of whites. The origins and circulation of ...
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This chapter unfolds around the story of an inaccurate statistic claiming that African-Americans suffered mortality from heart failure at a rate twice that of whites. The origins and circulation of this statistic provides a sustained analysis of the power of race to take on a life of its own once introduced into a conceptual system for making sense of health disparities. BiDil's proponents used this statistic, in conjunction with equally problematic assertions that angiotensin-converting enzyme (ACE) inhibitors (another class of drugs to treat heart failure) do not work well in blacks, to create a racial frame for BiDil that played a central role in driving the drug toward its race-specific approval by the FDA.Less
This chapter unfolds around the story of an inaccurate statistic claiming that African-Americans suffered mortality from heart failure at a rate twice that of whites. The origins and circulation of this statistic provides a sustained analysis of the power of race to take on a life of its own once introduced into a conceptual system for making sense of health disparities. BiDil's proponents used this statistic, in conjunction with equally problematic assertions that angiotensin-converting enzyme (ACE) inhibitors (another class of drugs to treat heart failure) do not work well in blacks, to create a racial frame for BiDil that played a central role in driving the drug toward its race-specific approval by the FDA.
Sheldon Krimsky
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.003.0004
- Subject:
- Public Health and Epidemiology, Public Health
This chapter provides a close reading of the FDA hearing that approved the race-specific indication for BiDil, in which the racial frame played a critical role in shaping how the committee reviewed ...
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This chapter provides a close reading of the FDA hearing that approved the race-specific indication for BiDil, in which the racial frame played a critical role in shaping how the committee reviewed the data. The story of BiDil had presented a new model for development of targeted therapeutics that exploited race to cast the drug as an advance toward individualized pharmacogenomics. Specifically, BiDil's proponents used race to first resurrect the fortunes of an apparently failed drug; then to gain faster and cheaper FDA approval; and finally, to expand its potential market by informally promoting off-label use of the product to the general population. BiDil is situated at the forefront of a drive to bring the long-established corporate practice of “ethnic niche marketing” into the world of pharmaceuticals.Less
This chapter provides a close reading of the FDA hearing that approved the race-specific indication for BiDil, in which the racial frame played a critical role in shaping how the committee reviewed the data. The story of BiDil had presented a new model for development of targeted therapeutics that exploited race to cast the drug as an advance toward individualized pharmacogenomics. Specifically, BiDil's proponents used race to first resurrect the fortunes of an apparently failed drug; then to gain faster and cheaper FDA approval; and finally, to expand its potential market by informally promoting off-label use of the product to the general population. BiDil is situated at the forefront of a drive to bring the long-established corporate practice of “ethnic niche marketing” into the world of pharmaceuticals.
Sheldon Krimsky
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.003.0005
- Subject:
- Public Health and Epidemiology, Public Health
This chapter situates BiDil in the larger context of the rising use of racial categories in biotechnology patents. A central theme here is the interplay among commercial interests, regulatory ...
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This chapter situates BiDil in the larger context of the rising use of racial categories in biotechnology patents. A central theme here is the interplay among commercial interests, regulatory structures, and scientific practice in generating distinctively racialized conceptions of biomedicine in the field of intellectual property. This chapter provides an introduction to some of the core concepts and rationales of patent law and then presents the results of a study showing the steady rise of racial biotechnology patents over the past decade. The use of race in these patents is often premised on an unstated white norm implying some sort of racial difference at the genetic level. Yet while race may be used as a surrogate for statistical correlations and genetics frequencies in the body of the patent, it often becomes solidified into a static and bounded genetic category in the legally operative claims section of the patent.Less
This chapter situates BiDil in the larger context of the rising use of racial categories in biotechnology patents. A central theme here is the interplay among commercial interests, regulatory structures, and scientific practice in generating distinctively racialized conceptions of biomedicine in the field of intellectual property. This chapter provides an introduction to some of the core concepts and rationales of patent law and then presents the results of a study showing the steady rise of racial biotechnology patents over the past decade. The use of race in these patents is often premised on an unstated white norm implying some sort of racial difference at the genetic level. Yet while race may be used as a surrogate for statistical correlations and genetics frequencies in the body of the patent, it often becomes solidified into a static and bounded genetic category in the legally operative claims section of the patent.
Leszek Koczanowicz
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.003.0009
- Subject:
- Public Health and Epidemiology, Public Health
This introductory chapter explores the intersections of race, science, law, and commerce and shows how a larger scheme of institutional, legal, and commercial imperatives is shaping the use of race ...
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This introductory chapter explores the intersections of race, science, law, and commerce and shows how a larger scheme of institutional, legal, and commercial imperatives is shaping the use of race in biomedicine. The drug BiDil is used as an entry point into this study. BiDil is a combination of two generic drugs used to dilate blood vessels—hence “Bi” (two) and “Dil” (dilators). Its development into a racialized drug is worth taking into account—this study does so by unearthing five themes in BiDil's history and the overall issue of racialized medicine: the institutional mandates that promote the introduction of race into biomedical research and practice.Less
This introductory chapter explores the intersections of race, science, law, and commerce and shows how a larger scheme of institutional, legal, and commercial imperatives is shaping the use of race in biomedicine. The drug BiDil is used as an entry point into this study. BiDil is a combination of two generic drugs used to dilate blood vessels—hence “Bi” (two) and “Dil” (dilators). Its development into a racialized drug is worth taking into account—this study does so by unearthing five themes in BiDil's history and the overall issue of racialized medicine: the institutional mandates that promote the introduction of race into biomedical research and practice.
