Journal of Law, Medicine and Ethics 36 (3):449-457 (2008)
Authors |
|
Abstract |
The U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials , which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act
|
Keywords | No keywords specified (fix it) |
Categories | (categorize this paper) |
DOI | 10.1111/j.1748-720X.2008.290.x |
Options |
![]() ![]() ![]() ![]() |
Download options
References found in this work BETA
Citations of this work BETA
Grassroots Marketing in a Global Era: More Lessons From BiDil.Britt M. Rusert & Charmaine D. M. Royal - 2011 - Journal of Law, Medicine and Ethics 39 (1):79-90.
Ethical Dimensions of Disparities in Depression Research and Treatment in the Pharmacogenomic Era.Lisa S. Parker & Valerie B. Satkoske - 2012 - Journal of Law, Medicine and Ethics 40 (4):886-903.
Ethical Dimensions of Disparities in Depression Research and Treatment in the Pharmacogenomic Era.Lisa S. Parker & Valerie B. Satkoske - 2012 - Journal of Law, Medicine and Ethics 40 (4):886-903.
Grassroots Marketing in a Global Era: More Lessons From BiDil.Britt M. Rusert & Charmaine D. M. Royal - 2011 - Journal of Law, Medicine and Ethics 39 (1):79-90.
Similar books and articles
Grassroots Marketing in a Global Era: More Lessons From BiDil.Britt M. Rusert & Charmaine D. M. Royal - 2011 - Journal of Law, Medicine and Ethics 39 (1):79-90.
Stimulating the Development of Drug Treatments to Improve Cognition in Schizophrenia.Micahel F. Green - manuscript
Patients' Health or Company Profits? The Commercialisation of Academic Research.Nancy F. Olivieri - 2003 - Science and Engineering Ethics 9 (1):29-41.
Ethical Issues in New Drug Prescribing.Lindsay W. Cole, Jennifer C. Kesselheim & Aaron S. Kesselheim - 2012 - Journal of Bioethical Inquiry 9 (1):77-83.
The Approval of Over-the-Counter HIV Tests: Playing Fair When Making the Rules. [REVIEW]Melissa Whellams - 2008 - Journal of Business Ethics 77 (1):5 - 15.
The Ausfta and 'Fast Track' Regulatory Approval of Medicines: Problems and Opportunities for Australian Academic Innovations in Nanotherapeutics.Steven Speldewinde & Thomas Alured Faunce and - unknown
Nurses' Attitudes Towards Artificial Food or Fluid Administration in Patients with Dementia and in Terminally Ill Patients: A Review of the Literature. [REVIEW]E. Bryon, B. D. de Casterle & C. Gastmans - 2008 - Journal of Medical Ethics 34 (6):431-436.
Views of Patients with Heart Failure About Their Role in the Decision to Start Implantable Cardioverter Defibrillator Treatment: Prescription Rather Than Participation.A. Agard, R. Lofmark, N. Edvardsson & I. Ekman - 2007 - Journal of Medical Ethics 33 (9):514-518.
The US' Food and Drug Administration, Normativity of Risk Assessment, Gmos, and American Democracy.Zahra Meghani - 2009 - Journal of Agricultural and Environmental Ethics 22 (2):125-139.
The Probability of Treatment Induced Drug Resistance.Rinaldo B. Schinazi - 2006 - Acta Biotheoretica 54 (1):13-19.
Ethics of the Heart: Ethical and Policy Challenges in the Treatment of Advanced Heart Failure.Anjali V. Fields & James N. Kirkpatrick - 2012 - Perspectives in Biology and Medicine 55 (1):71-80.
Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health.Elizabeth Weeks Leonard - 2009 - Journal of Law, Medicine and Ethics 37 (2):269-279.
How Confidential Trial Negotiations and Agreements Between the Food and Drug Administration and Sponsors Marginalize Local Institutional Review Boards, and What to Do About It.Howard Mann - 2006 - American Journal of Bioethics 6 (3):22 – 24.
On Regularity and Regulation, Health Claims and Hype.Jonathan H. Marks - 2011 - Hastings Center Report 41 (4):11-12.
Analytics
Added to PP index
2010-09-13
Total views
17 ( #585,173 of 2,403,328 )
Recent downloads (6 months)
3 ( #256,954 of 2,403,328 )
2010-09-13
Total views
17 ( #585,173 of 2,403,328 )
Recent downloads (6 months)
3 ( #256,954 of 2,403,328 )
How can I increase my downloads?
Downloads