Thursday, September 18, 2008

What do you mean by "race"? A call for standards and empirical ethics research.

You've probably read an article or two that reports the results of a race-based investigation. Perhaps it was a study of health disparities, a survey of patient attitudes, an examination of a race-based intervention or new medication to be marketed to a specific race-based demographic. If you wanted to do a systematic review of these papers, you might be vexed by the difficulty of finding a common, valid definition of "race". As a socially-constructed category, defining the limits of race and ethnicity is a slippery business and one that has a problematic past in the history of science and medicine. With this in mind, Vural Ozdemir, Janice E. Graham and Beatrice Godard make a call for clarity in "Race as a variable in pharmacogenomics science: from empirical ethics to publication standards" (Pharmacogenet Genomics. 2008 Oct;18(10):837-41. - PubMed CiteULike). The authors argue for the use of empirical ethics research to inform the development of new publication standards to "minimize the drift from descriptive to attributive use of race in publications". In this context, empirical ethics, or "applied social science methodologies … to better understand, for example, the 'lived' experiences of user groups", would identify blind-spots in predictive health research and would help researchers, regulators, policy-makers, and editors "differentiate between an imprecise (yet measurable) predictive biomarker, from a construct such as race".

Given the uproar around BiDiL and other race-based pharmacogenomic ventures, the authors have made a timely, if not over-due, call for publishers and ethics researchers to collaborate in developing standards for the use of the controversial category in published research. - J.O.

Thursday, September 4, 2008

Personalized Therapeutics at IU

In August 2008, the Indiana University Department of Medicine’s Division of Clinical Pharmacology began a new series of compelling seminars that may be of great interest to those involved in predictive health research ethics. The Personalized Therapeutics Seminar series commenced on August 5th with a presentation on the FDA’s Sentinel System for Post-market Drug Safety Surveillance given by Barbara Evans, J.D., Ph.D. from the Health Law and Policy Institute at the University of Houston Law Center. Additional speakers this fall, all from the Indiana University School of Medicine, have included Dr. Noah Hahn presenting on the Indiana University Cancer Biomarker Study, Dr. David Haas addressing PREGMED and the search for individualized pharmacotherapy in pregnancy, Dr. Zeruesenay speaking about emerging in vivo phenotyping methods and Dr. Tatiana Foroud addressing the results of whole genome association studies and how they may change our approach to medicine. The next seminar, entitled Personalized Therapeutics in Breast Cancer: A Model for Translating Pharmacogenomics, will be presented Dr. David Flockhart, Chief of the Division of Clinical Pharmacology, on September 9th. All seminars in this series are held on Tuesdays from 12:00pm – 1:00pm, in room W7120 on the 7th floor of the Wishard Myers Building.

For a complete schedule, please see: [link edited 9-18-09]

Amy Lewis Gilbert