Ethical, Legal & Social Aspects

Race-Based Therapeutics

Bloche, MG, 2004. N. Engl. J. Med. 351(20):2035-2037.

Intro. Paragraph

Are we moving into a new era of race-based therapeutics? The publication, in this issue of the  Journal,  of the African-American Heart Failure Trial (A-HeFT) (pages 2049-2057), a clinical trial of a medication intended for a single racial group, poses this awkward question. The study's most striking finding - that the addition of isosorbide dinitrate and hydralazine to conventional therapy for heart failure reduced relative one-year mortality by 43 percent among blacks - will provoke wide discussion. The trial's sponsor, NitroMed, which holds a patent on the fixed-dose combination of isosorbide dinitrate and hydralazine that was used, posits that heart failure has a different pathophysiology in blacks than in whites, necessitating different treatment strategies.

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Comments

This editorial is interesting in it general discussion of application genomics.  However, it also is provocative since it frames the application of pharmacogenomics not in the scientific sense of genetic lineage but in the social context of racial differences.  As such, it performs the important task of raising one's awareness of some perhaps unintended implications of these new approaches, especially to some minority patient populations.

Ethical, legal and social implications of genomic medicine

Clayton, E.W.,  2003. N. Eng. J. Med. 349(6) 562-569

Introduction

As detailed in other articles in the Genomic Medicine series, genomics has contributed greatly to our understanding of the molecular basis of disease and, to a lesser but growing extent, to the development of effective interventions. Clinicians and society at large, however, are concerned about the effect genetic knowledge will have on the well-being of individual persons and groups. Much effort is being devoted to trying to anticipate, understand, and address the ethical, legal, social, and political implications of genetics and genomics.

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Comment

A clear and compelling consideration of ways in which genetic information can be used harmfully, relating to access to the information, use by employers and insurers and the effect on the doctor-patient relationship.  It includes data on statues protecting patient privacy rights in the various states of the U.S.

Genetic testing: Practical, ethical, and counseling considerations

Ensenauer, R.E., Michels, V.V. and Reinke, S.S., 2005. Mayo Clin. Proc. 80(1): 63-73

Abstract

Genetic testing is becoming a much more common practice in medicine today. This presents a unique set of challenges for medical professionals in virtually all specialties. The practical aspects of determining which test to order, and in interpreting the result accurately in the context of the family history, can be difficult. Additionally, the ethical conundrums that frequently present themselves when genetic risk assessment and/or genetic testing is being considered can be daunting. These challenges present real concerns for medical professionals and patients alike. Included in this article is a review of some of the practical and ethical complexities associated with genetic testing. Pretest and posttest genetic counseling is also emphasized as an important and essential process in today's medical practice.

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Comment

Good illustrations of translation from basic genetics to clinical practice. Specific examples ranging from monogenic disorders to complex traits and genetic susceptibility. Clear and concise statement of ethical and genetic counseling issues of genetic and genomic medicine.

Prescribing BiDil: is it black and white?

Haga, SB & Ginsburg, GS, 2006. J. Am. Coll. Cardiol. 48(1) 12-14

Abstract

The approval of BiDil as an adjunct treatment in self-identified blacks with heart failure raises questions regarding the underlying etiology of drug response in this target population and the ability to accurately identify patients who are most likely to benefit. Preliminary data have indicated that differences in nitric oxide synthesis between groups may account for differences in response to BiDil and genetic studies have begun to elucidate the mechanism of these differences. Until more accurate selection criteria are developed to identify patients who are most likely to benefit, both clinicians and the general public will need to consider the unique issues raised by BiDil.

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Comment

This Viewpoint article addresses social issues that almost certainly will appear with increasing frequency as more and more ethnic difference in allele frequencies are identified. The fundamental pharmacogenomic applications from screening for allele frequencies are well established. What is less clear are the effects on the public mind set of ethnic-based or race-based medical practices.