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  • EELS (Ethical Economic Legal and Social) Article
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EELS

Bidil: recontextualizing the race debate

The Pharmacogenomics Journal volume 8, pages 169–173 (2008)Cite this article

June 2007 marked the second anniversary of the Food and Drug Administration (FDA)'s approval of BiDil, the first drug to be licensed for a specific ethnic population, namely self-identified blacks. However, BiDil remains mired in controversy over race-based medicine. This controversy has played out mainly in the United States (US), but has important implications world wide for the trajectory of personalized medicine. There is compelling evidence of BiDil's efficacy. No other drug combination has been shown, under the same circumstances, to have such a large survival advantage, and improvement in time to first hospitalization and quality of life in African Americans with heart failure.1 African Americans are a minority with a particularly high risk of heart failure. The American College of Cardiologists, the American Heart Association and others2 (http://circ.ahajournals.org/cgi/content/full/112/12/e154) have accepted these findings and made recommendations in keeping with the evidence. Yet today, only a very small proportion3 of African-American patients, who might benefit from it, are currently receiving it.

The series of prior scientific and clinical studies leading to the African-American Heart Failure Trial (A-HeFT) and the approval of BiDil are well known.1, 4, 5, 6, 7, 8, 9 They provide adequate scientific justification for a clinical trial to have recruited self-identified blacks exclusively. Following the eruption of the race-based medicine controversy, the FDA strongly defended its decision.10 There is little doubt it was acting within its mandate and primarily with a view to benefiting the African-American community of heart failure patients that had little other choice. To understand the BiDil case and by extension, potential opportunities and harms of marketing drugs targeted at specific populations, we interviewed 18 key informants including scientists, clinicians involved in the A-HeFT clinical trial, representatives of groups that supported or cosponsored the trial, including the Association of Black Cardiologists, regulators at the FDA, ethicists and the management team of NitroMed, the company that developed BiDil. The opinions expressed here are based on these interviews, on the published literature and on our own perspective of exploring emerging technologies to improve global health.11, 12, 13 We found that a very substantial part of the discourse did indeed focus on the risks and threats of race-based medicine. This subject has been covered well in the literature,14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and we have summarized the concerns and recommendations from our data in Table 1. We found that this concern, in some instances, seems to be very narrowly conceived and overshadows the broader context in which the BiDil case exists. We conclude that to make race-based medicine the defining issue of BiDil overlooks other, more compelling perspectives.

Table 1 Concerns associated with the use of race in medical research
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Acknowledgements

We gratefully acknowledge Anna Dabu and Samina Essajee's contributions to this project. The McLaughlin-Rotman Centre for Global Health, Program on Life Sciences, Ethics and Policy (formerly the Canadian Program on Genomics and Global Health) is primarily supported by Genome Canada through the Ontario Genomics Institute, the Ontario Research Fund, and the Bill and Melinda Gates Foundation. Other matching partners are listed at http://www.mrcglobal.org. ASD and PAS are supported by the McLaughlin Centre for Molecular Medicine. PAS is supported by a Canadian Institutes of Health Research Distinguished Investigator award.

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Authors and Affiliations

  1. Program on Life Sciences, Ethics and Policy, McLaughlin-Rotman Centre for Global Health, University Health Network/McLaughlin Centre for Molecular Medicine at University of Toronto, MaRS Centre, South Tower, Toronto, Ontario, Canada

    B Séguin, B Hardy, P A Singer & A S Daar

  2. Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada

    B Séguin

  3. Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    B Hardy, P A Singer & A S Daar

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  1. B Séguin
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Correspondence to A S Daar.

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The authors declare no competing financial interests.

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Séguin, B., Hardy, B., Singer, P. et al. Bidil: recontextualizing the race debate. Pharmacogenomics J 8, 169–173 (2008). https://doi.org/10.1038/sj.tpj.6500489

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