Article | Pharmacy in History | 2007

Pharmacovigilance and the Missing Denominator: The Changing Context of Pharmaceutical Risk Mitigation

by Arthur A. Daemmrich

Abstract

In the wake of Vioxx, Avandia, and other recent prominent cases of drugs found to cause side effects after marketing, the safety of pharmaceuticals has come to the forefront of American public policy. Press attention, congressional investigations, and legislative debates are highlighting the complex risk choices faced by patients, physicians, industry, and regulators in the post-market arena. To put current events in context, this article reviews historically the key institutions that have collected and responded to reports of side effects in the United States since the early 19th century. Three major periods emerge from this survey: an era of professional control; an era of regulation by the state; and a still-emerging information era dominated by statistical analysis of consumer populations. In each period, reformers sought to extend methods for uncovering side effects from the clinic to the market, yet a fundamental lack of consensus on how to determine the scope and magnitude of any one side effect plagued risk management efforts. The article concludes that it is critical to make institutions in our current "consumer era" more attentive to individual patients who are put at risk.

Keywords: Brands and Branding; Policy; Risk Management; Government Legislation; Risk and Uncertainty; Goals and Objectives; Customers; Pharmaceutical Industry; Health Industry; United States;

Citation:

Daemmrich, Arthur A. "Pharmacovigilance and the Missing Denominator: The Changing Context of Pharmaceutical Risk Mitigation." Pharmacy in History 49, no. 2 (2007): 61–75.