163923 Clinical Trials and bioethics: A review of the Valtrex 2006 trials and lessons learned

Monday, November 5, 2007

Meghana Aruru, PhD, MBA, BSPharm , Department of Clinical, Administrative and Social Sciences, Roosevelt University College of Pharmacy, Schaumburg, IL
Jack Warren Salmon, PhD , Pharmacy Administration, University Of Illinois-Chicago, Chicago, IL
Clinical trials are regulated through a system of Institutional Review Boards. The World Medical Association developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. In 1970s, the field of medical ethics evolved into a more philosophical analysis and Bioethics emerged as an independent field when developments in the medical and biological sciences started challenging the ethical implications of scientific progress and established principles of medical ethics were unable to satisfactorily address these issues, let alone answer them. Bioethics encompasses both medical ethics and environmental ethics, including areas like public health. It is a multidisciplinary subject including medicine, environmental sciences, humanities and philosophy. Balancing of ethical principles can aid rational decision making. However, the application of bioethics is dependent upon established social norms and may really depend upon historical context and social experience. This case study looks at the Valtrex clinical trials of 2006 that put vulnerable, minority, pregnant women at risk by placing them in a control group for an approved drug. The Valtrex study did not appear to have made prior provisions for care or post-trial access for the women in the control group. This study raises several ethical questions that challenge the principles of good science such as upholding human rights and valuing moral judgments.

Learning Objectives:
* To understand the emergence of human subjects protection in the context of bioethics. * To understand the importance of background norms, historical context and social experience in applying bioethical principles. * Articulate through a case study of a clinical trial factors placing a vulnerable population at risk. * To evaluate deficits in the ethics of care and post-trail access for a control group in a major clinical trial.

Keywords: Research Ethics, Drug Test

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.