BiDil for Heart Failure in Black Patients
Authors: Jonathan D. Kahn
Journal: Annals of Internal Medicine (2007)

Letters7 August 2007BiDil for Heart Failure in Black PatientsJonathan D. Kahn, JD, PhDJonathan D. Kahn, JD, PhDFrom Hamline University School of Law, St. Paul, MN 55104.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-147-3-200708070-00019 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:At first glance, Temple and Stockbridge (1) present an apparently reasonable rationale for the FDA's approval of the heart failure drug BiDil (NitroMed, Lexington, Massachusetts) with a race-specific label for use only in “self-identified black patients.” Upon closer examination, however, their arguments fail to convince. Bibbins-Domingo and Fernandez (2) clearly show the limits of the post hoc subgroup analysis that the FDA used to justify the race-specific approval.Beyond this, it is worth noting that since BiDil's approval, NitroMed—BiDil's corporate marketer—has made much of a recent FDA announcement that the coadministration of the much cheaper generic components ...References1. Temple R, Stockbridge NL. BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective. Ann Intern Med. 2007;146:57-62. [PMID: 17200223] LinkGoogle Scholar2. 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 Scholar3. NitroMed. FDA confirms no drugs are therapeutically equivalent to BiDil [Press release]. Lexington, MA: NitroMed; 4 May 2006. Accessed at phx.corporate-ir.net/phoenix.zhtml?c=130535&p=irol-newsArticle&ID=852400&highlight= on 4 January 2007. Google Scholar4. Center for Drug Evaluation and Research approval package for application number NDA 20-727: administrative/correspondence reviews. Accessed at www.fda.gov/cder/foi/nda/2005/020727_S000_Bidil_AdminCorres.pdf on 4 January 2007. Google Scholar5. 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 Scholar6. Proceedings of the U.S. Food and Drug Administration Center for Drug Evaluation and Research Cardiovascular and Renal Drugs Advisory Committee, Gaithersburg, Maryland, 16 June 2005 [Transcript]. Rockville, MD: U.S. Food and Drug Administration; 2005. Accessed at www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4145T2.pdf on 4 January 2007. Google Scholar Author, Article, and Disclosure InformationAuthors: Jonathan D. Kahn, JD, PhDAffiliations: From Hamline University School of Law, St. Paul, MN 55104.Disclosures: Dr. Kahn testified at the FDA Advisory Committee hearing on BiDil and urged that it be approved without a race-specific label. 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 Robert Temple and Norman L. Stockbridge BiDil for Heart Failure in Black Patients Kirsten Bibbins-Domingo and Alicia Fernandez Metrics Cited byMedicine, anti-realism and ideology: Variation in medical genetics does not show that race is biologically real 7 August 2007Volume 147, Issue 3Page: 215KeywordsAlcoholismConflicts of interestDrugsFood and Drug AdministrationHearingHeart failureHypertensionLongitudinal studiesMotivationRacial and ethnic issues ePublished: 7 August 2007 Issue Published: 7 August 2007 Copyright & PermissionsCopyright © 2007 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...