CiteULike: elsiatcase Kahn

Genes, race, and population: avoiding a collision of categories.

J Kahn — 2007-09-26T18:24:21-00:00

Am J Public Health, Vol. 96, No. 11. (November 2006), pp. 1965-1970.

A wide array of federal mandates have a profound impact on the use of racial and ethnic categories in biomedical research, clinical practice, product development, and health policy. Current discussions over the appropriate use of racial and ethnic categories in biomedical contexts have largely focused on the practices of individual researchers. By contrast, our discussion focuses on relations between the daily practices of biomedical professionals and federal regulatory mandates. It draws upon the legal doctrine of equal protection to move beyond such debates and to propose guidelines to address the structural forces imposed by federal regulations that mandate how data about race and ethnicity are used in biomedical research. It offers a framework to manage the tension involved in using existing federally mandated categories of race and ethnicity alongside new scientific findings about human genetic variation.

"Genetics & Disability Insurance Ethics, Law & Policy"

Jeffrey Kahn — 2007-09-26T14:22:19-00:00

JLME. Special Supplement : Genetic Testing and Disability Insurance, Vol. 35, No. 2. (Summer 2007)

Genetic testing for susceptibility to adult-onset cancer. The process and content of informed consent.

G Geller — 2006-10-11T13:38:51-00:00

JAMA, Vol. 277, No. 18. (14 May 1997), pp. 1467-1474.

OBJECTIVE: To provide guidance on informed consent to clinicians offering cancer susceptibility testing. PARTICIPANTS: The Task Force on Informed Consent is part of the Cancer Genetics Studies Consortium (CGSC), whose members were recipients of National Institutes of Health grants to assess the implications of cancer susceptibility testing. The 10 task force members represent a range of relevant backgrounds, including various medical specialties, social science, genetic counseling, and consumer advocacy. EVIDENCE: The CGSC held 3 public meetings from 1994 to 1996. At its first meeting, the task force jointly established a list of topics. The cochairs (G.G. and J.R.B) then developed an outline and assigned each topic to an appropriate writer and reviewer. Writers summarized the literature on their topics and drafted recommendations, which were then revised by the reviewers. The cochairs compiled and edited the entire manuscript. All members were involved in writing this report. CONSENSUS PROCESS: The first draft was distributed to task force members, after which a meeting was held to discuss its content and organization. Consensus was reached by voting. A subsequent draft was presented to the entire CGSC at its third meeting, and comments were incorporated. CONCLUSIONS: The task force recommends that informed consent for cancer susceptibility testing be an ongoing process of education and counseling in which (1) providers elicit participant, family, and community values and disclose their own, (2) decision making is shared, (3) the style of information disclosure is individualized, and (4) specific content areas are discussed.

BiDil: Race Medicine Or Race Marketing?

Pamela Sankar — 2006-09-29T14:16:11-00:00

Health Aff (Millwood) (11 October 2005)

Recent Food and Drug Administration (FDA) approval of the first drug with a race-specific indication has fueled the controversy over the meaning of race and ethnicity and raised questions over whether this move should be seen as an advance or a setback in the struggle to address disparities in health status associated with race. The drug, BiDil, combines two generics long recognized as benefiting patients with heart failure, irrespective of race or ethnicity. The push to bring these drugs to market as a race-specific treatment was motivated by the peculiarities of U.S. patent law and a willingness to exploit race to gain commercial and regulatory advantage.