Flaws in the U.S. Food and Drug Administration's Rationale for Supporting the Development and Approval of BiDil as a Treatment for Heart Failure Only in Black Patients

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See Temple Stockbridge , supra note 1.

Carson P. Ziesche S. Johnson G. Cohn J. , “Racial Differences in Response to Therapy for Heart Failure: Analysis of the Vasodilator-Heart Failure Trials,” Journal of Cardiac Failure 5, no. 3 (1999): 178–187.

See Bibbins-Domingo Fernandez , supra note 3.

Cohn J. N. Archibald D. G. Ziesche S. Cobb F. Franciosa J. A. Harston W. E. , “Effect of Vasodilator Therapy on Mortality in Chronic Congestive Heart Failure: Results of a Veterans Administration Cooperative Study,” New England Journal of Medicine 314, no. 24 (1986): 1547–1552; Cohn J. N. Johnson G. Ziesche S. Cobb F. Francis G. Tristani F. , “A Comparison of Enalapril with Hydralazine-Isosorbide Dinitrate in the Treatment of Chronic Congestive Heart Failure,” New England Journal of Medicine 325, no. 5 (1991): 303–310.

See Kahn , supra note 5.

See Bibbins-Domingo Fernandez , supra note 3.

Ellison G. T. H. , “Medicine in Black and White: BiDil, Race and the Limits of Evidence-Based Medicine,” Significance 3, no. 3 (2006): 118–121; Kent D. Hayward R. , “When Averages Hide Individual Differences in Clinical Trials,” American Scientist 95, no. 1 (2007): 60–68; Wang R. Lagakos S. W. Ware J. H. Hunter D. J. Drazen J. M. , “Statistics in Medicine: Reporting of Subgroup Analyses in Clinical Trials,” New England Journal of Medicine 357, no. 21 (2007): 2189–2194.

See Cohn Johnson Ziesche Cobb Francis Tristani , supra note 12.

See Cohn Archibald Ziesche Cobb Franciosa Harston , supra note 12.

See Cohn Johnson Ziesche Cobb Francis Tristani , supra note 12.

See Kent Hayward , supra note 15.

See Carson Ziesche Johnson Cohn , supra note 10.

See Cohn Archibald Ziesche Cobb Franciosa Harston , supra note 12; Cohn Johnson Ziesche Cobb Francis Tristani , supra note 12; Cohn J. N. Archibald D. G. Francis G. S. Ziesche S. Franciosa J. A. Harston W. E. , “Veterans Administration Cooperative Study on Vasodilator Therapy of Heart Failure: Influence of Pre-Randomization Variables on the Reduction of Mortality by Treatment with Hydralazine and Isosorbide Dinitrate,” Circulation 75, no. 5 (1987): IV49–IV54; Johnson G. Carson P. Francis G. S. Cohn J. N. , “Influence of Pre-Randomisation (Baseline) Variables on Mortality and on the Reduction of Mortality by Enalapril: Veterans Affairs Cooperative Study on Vasodilator Therapy of Heart Failure (V-HeFT II),” Circulation 87, no. 6 (1993): VI32–VI39.

See Temple Stockbridge , supra note 1; Carson Ziesche Johnson Cohn , supra note 10.

Id. (Carson et al.)

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See Carson Ziesche Johnson Cohn , supra note 10.

See Temple Stockbridge , supra note 1, at 57.

See Taylor Ziesche Yancy Carson D'Agostino Ferdinand , supra note 2.

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See Temple Stockbridge , supra note 1.

See Ellison , supra note 7; Editorial, “Census, Race and Science,” Nature Genetics 24, no. 2 (2000): 97–98.

See Kahn , supra note 5.

See Temple Stockbridge , supra note 1, at 58.

See Ellison , supra note 7.

See Temple Stockbridge , supra note 1, at 61.

See also La Parra Casado D. Perez A. M. , “Scientifically Correct Racism: Health Studies' Unintentional Effects Against Minority Groups,” Language and Intercultural Communication 7, no. 2 (2007): 152–162.

NIH Revitalization Act, Pub. L. No. 103–43 (1993).

See Temple Stockbridge , supra note 1, at 60.

Id., at 60.

See Kahn , supra note 5.

See “NitroMed Reports Financial Results for First Fiscal Quarter 2008,” availaible at <http://phx.corporate-ir.net/phoenix.zhtml?c=130535&p=irol-newsArticle&ID=1141115&highlight=> (last visited May 20, 2008).

See Temple Stockbridge , supra note 1, at 61.

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See Temple Stockbridge , supra note 1, at 61.

Center for Drug Evaluation and Research, “Approval Package for: Application Number NDA 20–727. Administrative/Correspondence Reviews. N.d.,” available at <http://www.fda.gov/cder/foi/nda/2005/020727_S000_Bidil_AdminCorres.pdf> (last visited May 19, 2008).