Read by QxMD icon Read


Nathan Nobis
No abstract text is available yet for this article.
October 2015: American Journal of Bioethics: AJOB
Koffi N Maglo, Jack Rubinstein, Bin Huang, Richard F Ittenbach
BACKGROUND: The African American Heart Failure Trial (A-HeFT) and the FDA approval of BiDil for race-specific prescription have stirred the debate about the scientific and medical status of race. Yet there is no assessment of the potential fallouts of this dispute on physicians' willingness to prescribe the drug. We present here an analysis of the factors influencing physicians' prescription of BiDil and investigate whether exposure to the controversy has an impact on their therapeutic judgments about the drug...
October 2, 2014: AJOB Empirical Bioethics
Chamika Hawkins-Taylor, Angeline M Carlson
BACKGROUND: The American population's diversity continues to grow, and its racial and ethnic mixes are changing. The US healthcare system must confront this changing reality. The introduction of isosorbide dinitrate/hydralazine hydrochloride (BiDil) to the US marketplace was a move toward recognizing these changing consumer needs. BiDil was approved specifically as a secondary treatment for heart failure in African-American patients. It remains the first and only drug approved by the US Food and Drug Administration for a race-based indication...
September 2013: American Health & Drug Benefits
Lisa Eckstein
In 2005, the Food and Drug Administration's approval of BiDil for use only in self-identified African Americans brought to the fore the longstanding debate about the use of race and ethnicity in medical research and practice. While this issue has received considerable attention in science and social science literature, thus far there has been little consideration about the legal and regulatory implications of "race-based medicine." This paper seeks to fill this gap by advocating the use of Institutional Review Boards (IRBs) in balancing the social and medical implications of race-based research...
2011: Food and Drug Law Journal
Timothy A A Sontoredjo, Anthonius de Boer, Anke H Maitland-van der Zee
Individuals originating from different ethnic groups can respond differently to certain medicines. In this article, we differentiated persons with a European, African and Asian origin into three main groups. The combination of a fixed dose of isosorbide dinitrate and hydralazine (known as BiDil) was marketed specifically in the US for Afro-Americans with heart failure, as patients from this group respond less well to ACE inhibitors. Ethnic differences in the effects of medications are partly linked to genetic variations...
2013: Nederlands Tijdschrift Voor Geneeskunde
John Otrompke
Two presentations at the 2006 Scientific Sessions of the American Heart Association debated the effect of genetics on such drugs as warfarin and isosorbide dinitrate/hydralazine (BiDil). The speakers emphasized that the pharmacogenetics field is advancing quickly, but is not yet mature in terms of therapeutic options.
February 2007: Biotechnology Healthcare
Robert J Meier
Now that a composite human genome has been sequenced (HGP), research has accelerated to discover precise genetic bases of several chronic health issues, particularly in the realms of cancer and cardiovascular disease. It is anticipated that in the future it will be possible and cost effective to regularly sequence individual genomes, and thereby produce a DNA profile that potentially can be used to assess the health risks for each person with respect to certain genetically predisposed conditions. Coupled with that enormous diagnostic power, it will then depend upon equally rapid research efforts to develop personalized courses of treatment, including that of pharmaceutical therapy...
March 2012: Collegium Antropologicum
S D J Pena
Personalized pharmacogenomics aims to use individual genotypes to direct medical treatment. Unfortunately, the loci relevant for the pharmacokinetics and especially the pharmacodynamics of most drugs are still unknown. Moreover, we still do not understand the role that individual genotypes play in modulating the pathogenesis, the clinical course and the susceptibility to drugs of human diseases which, although appearing homogeneous on the surface, may vary from patient to patient. To try to deal with this situation, it has been proposed to use interpopulational variability as a reference for drug development and prescription, leading to the development of "race-targeted drugs"...
April 2011: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas M├ędicas e Biol├│gicas
Britt M Rusert, Charmaine D M Royal
No abstract text is available yet for this article.
2011: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
Danielle Frank, Thomas H Gallagher, Sherrill L Sellers, Lisa A Cooper, Eboni G Price, Adebola O Odunlami, Vence L Bonham
BACKGROUND: There is little to no information on whether race should be considered in the exam room by those who care for and treat patients. How primary care physicians understand the relationship between genes, race and drugs has the potential to influence both individual care and racial and ethnic health disparities. OBJECTIVE: To describe physicians' use of race-based therapies, with specific attention to the case of BiDil (isosorbide dinitrate/hydralazine), the first drug approved by the FDA for a race-specific indication, and angiotensin-converting enzyme (ace) inhibitors in their black and white patients...
May 2010: Journal of General Internal Medicine
Joel Z Garrod
No abstract text is available yet for this article.
January 2006: McGill Journal of Medicine: MJM: An International Forum for the Advancement of Medical Sciences By Students
Jonathan Kahn
This paper explores events surrounding the US Food and Drug Administration's formal approval of the heart failure drug BiDil in 2005. BiDil is the first drug ever to be approved with a race-specific indication, in this case to treat heart failure in 'self-identified black patients'. BiDil has been cast by many as a step toward the promised land of individualized pharmacogenomic therapies. This paper argues, however, that when examined in context, the approval of BiDil emerges as a new model of how a pharmaceutical company may exploit race in the marketplace by literally capitalizing on the racial identity of minority populations and leveraging the disproportionate risk of adverse health outcomes they suffer into a cheaper, more efficient way to gain the US Food and Drug Administration's approval for drugs...
October 2008: Social Studies of Science
Joon-Ho Yu, Sara Goering, Stephanie M Fullerton
No abstract text is available yet for this article.
2009: Cambridge Quarterly of Healthcare Ethics: CQ: the International Journal of Healthcare Ethics Committees
Anne Pollock
In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.
2008: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
Timothy Caulfield, Simrat Harry
The BiDil story offers an ideal opportunity to explore the nature and tone of media representations of race and genetics. For example, was a biological view of race emphasized? Or was the notion of race presented in a critical fashion?
2008: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
Susan M Reverby
BiDil, a drug approved in 2005 by the FDA only for African Americans, was seen by many as almost reparations for the horrors of the Tuskegee Syphilis Study (1932-72) where treatment for black men was denied. The logic of race, however, rather than racism, links BiDil to the past many thought it was escaping.
2008: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
Richard Tutton, Andrew Smart, Paul A Martin, Richard Ashcroft, George T H Ellison
The ongoing debate about the FDA approval of BiDil in 2005 demonstrates how the first racially/ethnically licensed drug is entangled in both Utopian and dystopian future visions about the continued saliency of race/ethnicity in science and medicine. Drawing on the sociology of expectations, this paper analyzes how scientists in the field of pharmacogenetics are constructing certain visions of the future with respect to the use of social categories of race/ethnicity and the impact of high-throughput genotyping technologies that promise to transform scientific practices...
2008: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
George T H Ellison, Jay S Kaufman, Rosemary F Head, Paul A Martin, Jonathan D Kahn
The U.S. Food and Drug Administration's (FDA) rationale for supporting the development and approval of BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials (V-HeFT I and II), 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...
2008: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
Gregory Michael Dorr, David S Jones
No abstract text is available yet for this article.
2008: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
Brady Huggett
No abstract text is available yet for this article.
March 2008: Nature Biotechnology
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"