From Visible Harm to Relative Risk

Arthur Daemmrich, Jeremy Greene

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Adverse drug reactions pose distinct but potentially catastrophic risks to patients, doctors, 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. The case report approach to handling adverse reactions is currently being supplemented by proactive surveillance studies that identify the probability of side effects on a population basis. This chapter advances a historical comparison of Contergan (thalidomide) in the 1960s and Avandia (rosiglitazone) in the early 2000s. The analysis of the evolution of techniques for identifying and responding to adverse drug reactions reveals an emerging divide between population-level observations and individual action decisions taken by doctors and patients in defining adverse effects. This finding carries particular significance as FDA advances the Sentinel Initiative.

Original languageEnglish (US)
Title of host publicationThe Fragmentation of U.S. Health Care
Subtitle of host publicationCauses and Solutions
PublisherOxford University Press
ISBN (Electronic)9780199775934
ISBN (Print)9780195390131
DOIs
StatePublished - Feb 24 2010

Keywords

  • Adverse effects
  • FDA
  • Pharmacoepidemiology
  • Pharmacovigilance
  • Rosiglitazone
  • Thalidomide

ASJC Scopus subject areas

  • Social Sciences(all)

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  • Cite this

    Daemmrich, A., & Greene, J. (2010). From Visible Harm to Relative Risk. In The Fragmentation of U.S. Health Care: Causes and Solutions Oxford University Press. https://doi.org/10.1093/acprof:oso/9780195390131.003.013