Chapter | The Fragmentation of U.S. Health Care: Causes and Solutions | 2010

From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance

by Arthur A. Daemmrich


Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of side effects, with the Food and Drug Administration (FDA) playing the central role in the United States. In recent years, however, this centralized approach to the collection and analysis of adverse events through doctor-initiated case reports has been superseded by innovative, though episodic, pharmacoepidemiological studies of large databases that identify the probability of side effects in a population. This chapter advances a historical comparison of these two methods—individual case reports and population meta-analysis—and draws attention to the fragmentation of the institutional basis for assessing pharmaceutical risk. Our analysis of the evolution of techniques for identifying and responding to adverse drug reactions suggests that only government regulators are in a position to integrate case report and statistical analysis. Despite the appeal of fragmented post-market drug safety studies, centralization may be necessary to achieve faster and better integrated pharmacovigilance in the present era of large-scale pharmaceutical use for chronic conditions.

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Business and Government Relations; Risk and Uncertainty; Safety; Pharmaceutical Industry; United States;


Daemmrich, Arthur A. "From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance." Chap. 13 in The Fragmentation of U.S. Health Care: Causes and Solutions, edited by Einer Elhauge, 301–322. Oxford: Oxford University Press, 2010.