12:01 A.M. ET
Tuesday, October 11, 2005


Jon Gardner,


Approval Of Drug Marketed To African Americans Raises Political And Economic Issues, Clouds Understanding Of Health Disparities

Health Affairs Article Analyzes BiDil’s Path To FDA Endorsement;
Questions Approach To Curing Disparities Through Drug Development

BETHESDA, MD — The Food and Drug Administration’s decision to allow a pharmaceutical manufacturer to market a heart medication to African Americans “distorts public understanding of health disparities and of efforts to address them,” according to a new paper published today on the Health Affairs Web site.

Pamela Sankar, an assistant professor in the University of Pennsylvania Department of Medical Ethics, and Jonathan Kahn, an assistant professor at the Hamline University School of Law, analyze the political and economic implications of the approval of BiDil, the first drug with a race-specific indication.

BiDil combines two generic medications long recognized as beneficial for all patients with congestive heart failure. NitroMed has a patent covering the use of BiDil in the general population without regard to race. This patent, however, expires in 2007. In 2000, NitroMed obtained a second, race-specific patent covering BiDil based on a retrospective analysis of positive outcomes for 49 African American subjects in a study in the 1980s. This patent extends NitroMed’s exclusive marketing rights until 2020. In June, 2005, the FDA approved BiDil with a race-specific indication based on a truncated study that tested BiDil’s effectiveness only on African American heart failure patients.

The authors argue, however, that while the FDA’s approval was in part an effort to help reduce health disparities, it instead perpetuates myths about biological differences between African Americans and whites because BiDil’s creators did not demonstrate scientifically that it benefits African Americans more than whites.

To do so would have required a separate clinical trial testing BiDil’s effectiveness on whites, and if its effectiveness had been proven, this would have negated the basis on which BiDil’s makers applied for FDA approval to begin with, the authors write.

“The uproar over BiDil has been that it reifies and biologizes racial groups, which it does, and much of the exchange has taken place over the meaning of race and the relation between race and biology,” the authors write.

“But an additional risk posed by BiDil is that it will cheat consumers—African Americans as well as everyone else,” they write. “Furthermore, it threatens to set in motion a trend in the pharmaceutical industry for turning other widely used and cost-effective generics into patented, expensive drugs in the name of alleviating health disparities.”

A Perspective by Rick Carlson, a professor at the University of Washington School of Public Health, accompanies the paper.

You can read Sankar’s paper at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.455.

You can read Carlson’s Perspective at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.464.

Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears bimonthly in print with additional online-only papers published weekly as Health Affairs Web Exclusives at www.healthaffairs.org. The full text of each Health Affairs Web Exclusive is available free of charge to all Web site visitors for a two-week period following posting, after which it will switch to pay-per-view for nonsubscribers. The abstracts of all articles are free in perpetuity. Web Exclusives are supported in part by a grant from the Commonwealth Fund.

©2005 Project HOPE–The People-to-People Health Foundation, Inc.