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

Journal of Law, Medicine and Ethics

Volumn 36, Issue 3, 2008, Pages 449-457

  Ellison, George T H ^a   Kaufman, Jay S ^b   Head, Rosemary F ^a   Martin, Paul A ^c   Kahn, Jonathan D ^d  

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b University of North Carolina at Chapel Hill   (United States)

^c UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^d HAMLINE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HYDRALAZINE; ISOSORBIDE DINITRATE; ISOSORBIDE HYDRALAZINE COMBINATION; ISOSORBIDE-HYDRALAZINE COMBINATION; VASODILATOR AGENT;

CONFERENCE PAPER; DRUG APPROVAL; DRUG COMBINATION; ETHNOLOGY; FOOD AND DRUG ADMINISTRATION; HEART FAILURE; HUMAN; NEGRO; UNITED STATES;

AFRICAN CONTINENTAL ANCESTRY GROUP; DRUG APPROVAL; DRUG COMBINATIONS; HEART FAILURE; HUMANS; HYDRALAZINE; ISOSORBIDE DINITRATE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VASODILATOR AGENTS;

EID: 50249149724     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.290.x     Document Type: Conference Paper

References (45)

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3. K. Bibbins-Domingo and A. Fernandez BiDil for Heart Failure in Black Patients: Implications of the U.S. Food and Drug Administration Approval Annals of Internal Medicine 146, no. 1 (2007 52 56.
4. Id.
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8. See Temple and Stockbridge, supra note 1.
9. Id.
10. P. Carson, S. Ziesche, G. Johnson, and J. Cohn 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.
11. See Bibbins-Domingo and Fernandez, supra note 3.
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13. See Kahn, supra note 5.
14. See Bibbins-Domingo and Fernandez, supra note 3.
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21. Id.
22. See Cohn, Archibald, Ziesche, Cobb, Franciosa, and Harston et al., supra note 12 Cohn, Johnson, Ziesche, Cobb, Francis, and Tristani et al., supra note 12 J. N. Cohn, D. G. Archibald, G. S. Francis, S. Ziesche, J. A. Franciosa, and W E. Harston et al. Veterans Administration Cooperative Study on Vasodilator Therapy of Heart Failure: Influence of Pre-Random-ization Variables on the Reduction of Mortality by Treatment with Hydralazine and Isosorbide Dinitrate Circulation 75, no. 5 (1987 IV49 IV54. G. Johnson, P. Carson, G. S. Francis, and J. N. Cohn 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.
23. See Temple and Stockbridge, supra note 1 Carson, Ziesche, Johnson, and Cohn, supra note 10.
24. Id. (Carson et al.).
25. Id.
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27. See Carson, Ziesche, Johnson, and Cohn, supra note 10. 28. See Temple and Stockbridge, supra note 1, at 57. 29. See Taylor, Ziesche, Yancy, Carson, D'Agostino, and Ferdinand, supra note 2.
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29. See Temple and Stockbridge, supra note 1.
30. Id.
31. Id.
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33. See Kahn, supra note 5.
34. See Temple and Stockbridge, supra note 1, at 58. 37. See Ellison, supra note 7.
35. See Temple and Stockbridge, supra note 1, at 61.
36. See also D. La Parra Casado and A. M. Perez Scientifically Correct Racism: Health Studies' Unintentional Effects Against Minority Groups Language and Intercultural Communication 7, no. 2 (2007 152 162.
37. NIH Revitalization Act, Pub. L. No. 103-43 (1993).
38. See Temple and Stockbridge, supra note 1, at 60.
39. Id., at 60.
40. See Kahn, supra note 5.
41. 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).
42. See Temple and Stockbridge, supra note 1, at 61.
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44. See Temple and Stockbridge, supra note 1, at 61.
45. Center for Drug Evaluation and Research, "Approval Package for: Application Number NDA 20-727. Administrative/Correspondence Reviews. Nd.," available at http://www.fda.gov/cder/foi/nda/2005/ 020727_S000_Bidil_AdminCorres.pdf (last visited May 19, 2008).