Speaker
Jason Schnittker
Professor of Sociology
University of Pennsylvania
Abstract
Pharmaceutical side effects are common, though their origins are not well understood and they are generally treated as a scientific and clinical nuisance. This study advances a sociological approach to appreciating the origins and consequences of side effects. Using historical data on FDA approval processes attached to information on the side effects of specific drugs, this particular study demonstrates that the frequency of side effects is strongly influenced by FDA organizational dynamics, including the number of people evaluating an application, the political demands made on the FDA at the time, the speed of approval, and the therapeutic niche a drug will eventually fill. These influences are comparable to those of the molecule itself, as in the difference between the active and placebo arm in a clinical trial. This talk will also address the consequences of pharmaceutical side effects for understanding facets of population health, especially considering the rapid growth in pharmaceutical consumption.