Perspectives in Biology and Medicine

The principle of avoiding harm, though still cited here and there in the literature, is regarded by many as a bit of antiquarianism with no relevance to actual medical practice and decision-making. But while treatment necessarily entails trading off risks against benefits, it is not so easy to defend harm caused in the name of prevention. Drugs intended for preventive use by the general population must meet high standards of safety—that is, they should not harm. This principle came to the fore in a recent meeting of an FDA Advisory Committee tasked with deciding whether or not to recommend two drugs for the prevention of prostate cancer. As the transcript of this charged meeting shows, the principle of avoiding harm is far from an inert doctrine without application to medicine.