BiDil for Heart Failure in Black Patients
Authors: Robert Temple, Norman L. Stockbridge
Journal: Annals of Internal Medicine (2007)

Letters7 August 2007BiDil for Heart Failure in Black PatientsRobert Temple, MD and Norman L. Stockbridge, MD, PhDRobert Temple, MDFrom the U.S. Food and Drug Administration, Silver Spring, MD 20993-0002.Search for more papers by this author and Norman L. Stockbridge, MD, PhDFrom the U.S. Food and Drug Administration, Silver Spring, MD 20993-0002.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-147-3-200708070-00020 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Critics of the FDA's approval of BiDil for treating heart failure in self-identified black persons have taken 2 positions: 1) Approval for blacks was premature because further testing should have been performed before approval to discover what characteristics in black and white patients might predict responses (1, 2), and 2) the FDA should have approved BiDil, but for the broader population (3). We note that Dr. Kahn, in his letter, states the latter is what he meant—not that there should have been no approval.Our paper focused on why delaying approval would have been intolerable, given the dramatic ...References1. Avorn J. FDA standards—good enough for government work? N Engl J Med. 2005;353:969-72. [PMID: 16148281] CrossrefMedlineGoogle Scholar2. Kahn J. How a drug becomes “ethnic”: law, commerce, and the production of racial categories in medicine. Yale J Health Policy Law Ethics. 2004;4:1-46. [PMID: 15052858] MedlineGoogle Scholar3. Bibbins-Domingo K, Fernandez A. BiDil for heart failure in black patients: implications of the U.S. Food and Drug Administration approval. Ann Intern Med. 2007;146:52-6. [PMID: 17200222] LinkGoogle Scholar4. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA. 1991;266:93-8. [PMID: 2046134] CrossrefMedlineGoogle Scholar5. Dahlöf B, Devereux RB, Kjeldsen SE, Julius S, Beevers G, de Faire U, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet. 2002;359:995-1003. [PMID: 11937178] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From the U.S. Food and Drug Administration, Silver Spring, MD 20993-0002.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoBiDil for Heart Failure in Black Patients: The U.S. Food and Drug Administration Perspective Robert Temple and Norman L. Stockbridge BiDil for Heart Failure in Black Patients: Implications of the U.S. Food and Drug Administration Approval Kirsten Bibbins-Domingo and Alicia Fernandez BiDil for Heart Failure in Black Patients Kirsten Bibbins-Domingo and Alicia Fernandez BiDil for Heart Failure in Black Patients Jonathan D. Kahn Metrics 7 August 2007Volume 147, Issue 3Page: 215-216KeywordsConflicts of interestDrug abuseDrugsHealth disparitiesHeart failureHypertensionLongitudinal studiesStrokeTouch ePublished: 7 August 2007 Issue Published: 7 August 2007 CopyrightCopyright © 2007 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...