Summaries of health policy coverage from major news organizations
Focus on BiDil’s Approval, How Drug Will Be Covered, Detracts From Underlying Causes of Racial Health Disparities, Opinion Piece Says
FDA's approval of BiDil -- a heart failure medication targeted specifically toward blacks -- and an effort by the New England branch of the NAACP to require that Medicare cover the drug "set a dangerous precedent in the struggle to end racial disparities in health," Kirsten Bibbins-Domingo, an assistant professor of medicine and epidemiology and biostatistics at the University of California-San Francisco, and Alicia Fernandez, an associate professor of clinical medicine at UCSF, write in a San Francisco Chronicle opinion piece. According to Bibbins-Domingo and Fernandez, "BiDil is not designed to target heart failure in African-Americans; it is not even a new medication" but rather "an expensive 'new' pill made from two cheap old ones." NitroMed, BiDil's manufacturer, initially tried to receive FDA approval of the combination drug for use in all patients. However, FDA did not grant the request, and NitroMed then applied for and received patent protection on the drug to treat blacks with heart failure, citing research demonstrating the value of the drug in blacks and saying it would address racial health disparities, Bibbins-Domingo and Fernandez write. They add, "Claiming a race-specific effect not only helped NitroMed gain patent protection, it defined a market niche." According to the authors, "The issue here is not whether health plans should choose or be forced to cover BiDil or how much profit NitroMed makes. The issue is that the argument over coverage of BiDil deflects attention from the real issues involved in health disparities." They suggest investigating the "root causes" of disparities in heart disease, which could include an underuse of standard treatments among blacks, inadequate preventive care, "complex social problems" and access to care. Bibbins-Domingo and Fernandez write, "The struggle to end racial disparities in health is too important to allow Congress, the FDA and civil rights organizations, such as the NAACP, to be sidetracked by marketing ploys under the guise of civil rights issues" (Bibbins-Domingo/Fernandez, San Francisco Chronicle, 3/5).
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