Medical science and health care do not exist independently, apart from society. As new applications of knowledge are proposed, some of which will not be totally benign and will be pervasive in their impact, controversies will arise over the distribution of the risks, benefits, and costs involved for different groups that can only be resolved politically. To survive the increasing demands placed on diminishing resources, we must learn to efficiently make the “best” possible political decisions on scientific and technological issues. This seems especially important in health matters, where not only money but life and limb may literally be at stake.

In this paper, I will discuss three issues related to the federal regulation of Laetrile: (1) the federal regulation of drugs; (2) the nature of the scientific and political controversies surrounding Laetrile; (3) the political success of Laetrile. My discussion is not based on formal research and analysis on the Laetrile controversy. I am untrained and unqualified as a medical historian or as a social or political scientist. My presentation is a subjective synthesis of many hours of listening to arguments for and against the unrestricted distribution of Laetrile in two-dozen state legislative hearings, in federal and state courts, and in media “encounters.” I have argued against the distribution of Laetrile.

The underlying assumption of the current regulatory scheme is that defective drug products, or improperly – that is, carelessly or ignorantly – administered drug products may needlessly harm patients. Premarket tests can detect defective products, and instructions for safe use can be given.