In June 2005, the FDA approved BiDil, a formulation of two unpatented drugs developed by NitroMed, to treat heart failure in African Americans.[114] As the first medicine designated for a specific racial group, as defined in OMB's 1997 Directive 15, this move by the FDA was unprecedented. It attracted considerable attention, and generated a rich dialogue, including sometimes sharp academic critique.[115] The analysis continues, although the marketing of BiDil has been halted and NitroMed is now struggling financially.[116] BiDil raised ethical and social issues related to scientific validity and integrity, beneficence, nonmaleficence, and justice. The use of race in research and clinical practice is fraught with complexity, and different constituencies used the term in different ways for different purposes. While some hailed the approval of BiDil as a step toward personalized medicine[117], critics felt that the marketing of BiDil could perpetuate the misconception that African Americans are biologically different from other groups.[118] There were also many others who felt that the patenting of BiDil and its marketing as a race-specific drug was driven primarily by NitroMed's business plan and commercial interests[119] and some who expressed concern about scientific validity and clinical implementation[120]. Other scholars provided more nuanced views of the complexity of the case, including the challenges in balancing scientific validity with social justice.[121] The story of BiDil did not necessarily change the """"""""race"""""""" conversation, but it made the discussion concrete and specific, and drew attention to scientific, medical, and economic issues as well as broader social conceptions of race. It is poised to become an important """"""""paradigm case"""""""", defined by DeGrazia and Beauchamp[122] as one that becomes an enduring and authoritative source for reflection and decision-making. A detailed scholarly interrogation of BiDil is needed, and has great promise to become such a paradigm case. The case study will not only increase our knowledge and understanding of the intricacies of this particular case, but will also probe the dominant thinking about race in science and medicine, and how that thinking influences research and practice. This inquiry will help move beyond BiDil to anticipate and better respond to future discoveries and medical applications that might be based on race or ancestry information. Careful examination of the case can probe the principles, rules, codes, duties and obligations, and rights relevant to research ethics, business ethics, and medical ethics, while producing a framework in which to strike an appropriate balance among competing interests. One particular focus will be nodes in the decision free of clinical research and translation into practice, in this case including granting of race-based patent claims and FDA premarket approval.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Specialized Center (P50)
Project #
2P50HG003391-06
Application #
8125698
Study Section
Special Emphasis Panel (ZHG1-HGR-P (J1))
Project Start
Project End
Budget Start
2011-04-15
Budget End
2012-03-31
Support Year
6
Fiscal Year
2011
Total Cost
$52,465
Indirect Cost
Name
Duke University
Department
Type
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
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Bubela, Tania; Vishnubhakat, Saurabh; Cook-Deegan, Robert (2015) The Mouse That Trolled: The Long and Tortuous History of a Gene Mutation Patent That Became an Expensive Impediment to Alzheimer's Research. J Law Biosci 2:213-262
Angrist, M; Jamal, L (2015) Living laboratory: whole-genome sequencing as a learning healthcare enterprise. Clin Genet 87:311-8
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Fernandez, Conrad V; O'Rourke, P Pearl; Beskow, Laura M (2015) Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families. J Law Med Ethics 43:514-22

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