The 90s Pill Scare, and Real-World Drug Safety Advice

Abstract

It is well known that enormous costs, and years of research, are required to collect the data that drug regulators rely on when making a licensing decision. It is less well known that the true place of technical data in drug licensing decisions is far from being well defined, and that the multitude of drug regulations that actually exist have little to do with technical parameters. This paper uses the third-generation pill debate of a decade ago to illustrate the inadequacy of technical risk and benefit data to explain real world pharmaceutical policy choices. It suggests that human factors such as risk perception and bureaucratic culture are more important in determining the regulatory response to a drug safety dilemma, particularly in a time of crisis and uncertain safety information, than objective assessments of risk. These factors are well below the radar of both the public and the medical profession, and deserve to be more widely recognized.