These are difficult times for science in the zone where it converges with public policy. Of course it should not be expected that peer-reviewed science, even carefully done, will be a commanding presence in policy discussions, even where scientific issues are prominent. Other matters, like the relationship between costs and benefits of a project or distributive justice implications, may be more decisive, for perfectly good reasons. But science has been playing a critically important role in several areas that have become important exercises of government responsibility, including, but not limited to, environmental quality regulations, litigation over damages associated with the external costs of private activity (“toxic torts”), and the legal responsibility of manufacturers for product harms. What has happened, in this more political contemporary environment, to science and the people who practice it? That is the subject of this book. In this prologue, I hope to provide a quick overview of some features of the new terrain. In later chapters, others will deliver a much closer and more scholarly look at them.

In the mid-1970s – a few years after the first volley of laws protecting environmental quality – there was little public skepticism about, and only limited political pressure against, the role of science in regulation under these statutes, or its influence in legal proceedings about product harms. When I became commissioner of the Food and Drug Administration early in 1977, the Medical Devices Amendments were only a year old, and we were just trying to figure out how to implement them.