HONR 288L

Also offered as BIOE150. Credit will be granted for only one of the following: HONR288L or BIOE150.

Ethical theories provide a basis for making decisions, using logic and reason to act in our long-term interest. Applied ethics is the application of ethical theories to real life situations. In this course we will use case studies from the professor’s experience as a regulatory consultant and as the former Director of the Division of Cardiovascular Devices at the FDA. We will examine how controversial decisions were made by the FDA, manufacturers, physicians, and other government organizations, and whether those decisions were ethical. We will also examine other current issues from the literature and news media. Case studies will include controversies concerning breast implants, genetic testing, allegations of scientific misconduct (the David Baltimore case), artificial hearts, transplants, and deaths due to mechanical heart valves.

Ethics provides guidance on how people should act. The relationships that exist between physicians and patients, between medical device manufacturers and physicians, and between medical device manufacturers and patients determine the rights and obligations of each group. Ethics helps us to understand the obligations that each individual has in these relationships. When we read about failures of medical devices in the news, it often appears that someone has acted unethically; the company management didn’t test the device enough to assure that it was safe and effective, the public wasn’t notified of the problem is often much more complex than it first appears. There is often more than one right answer depending on one’s ethical perspective. Most of us will make important, controversial decisions in our lives–this course will give you a process by which to make those decisions.

Readings include:

M. Angell, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case

C. Levine, Taking Sides: Clashing Views on Controversial Bioethical Issues