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BiDil for Heart Failure in Black Patients: Implications of the U.S. Food and Drug Administration Approval
- Kirsten Bibbins-Domingo, PhD, MD; and
- Alicia Fernandez, MD
Abstract
In 2005, the combination of hydralazine hydrochloride and isosorbide dinitrate was approved by the U.S. Food and Drug Administration (FDA) for treating heart failure in black patients. In departing from its long history of approving drugs for general clinical indications without regard to demographic classification, the FDA cited the need to address racial disparities in health as an important contributor to their decision. The authors argue that this decision, although perhaps well-intentioned, was based on flawed scientific interpretation of trial results that claimed differential drug response by race and ignored the considerable literature on the cause of racial disparities in health and health care. Because of its potential impact on future drug approvals, the FDA's decision is a setback in the scientific and policy discourse on medical therapeutics and race and specifically hinders the efforts aimed at eliminating health and health care disparities.
Article and Author Information
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Acknowledgments: The authors thank the organizers and participants of the special symposium on the implications of BiDil at the 2005 Society of General Internal Medicine Annual Meeting, New Orleans, Louisiana, 11–14 May 2005, including Drs. Giselle Corbie-Smith, Carol Horowitz, Valerie Stone, Christopher Phillips, and Jack Geiger.
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Grant Support: Dr. Bibbins-Domingo is supported by grants from the Robert Wood Johnson Foundation (Amos Medical Faculty Development award) and the National Heart, Lung, and Blood Institute (contract no. N01-HC-95095), and Dr. Fernandez is supported by a K23 award from the National Center for Research Resources of the National Institutes of Health (K23 RR01832401).
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Potential Financial Conflicts of Interest: None disclosed.
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Requests for Single Reprints: Kirsten Bibbins-Domingo, PhD, MD, Division of General Internal Medicine, San Francisco General Hospital, University of California, San Francisco, Box 1364, San Francisco, CA 94143-1364; e-mail, bibbinsk{at}medicine.ucsf.edu.
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Current Author Addresses: Drs. Bibbins-Domingo and Fernandez: Division of General Internal Medicine, San Francisco General Hospital, University of California, San Francisco, Box 1364, San Francisco, CA 94143-1364.
