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The Fragmentation of U.S. Health CareCauses and Solutions$
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Einer Elhauge

Print publication date: 2010

Print ISBN-13: 9780195390131

Published to Oxford Scholarship Online: May 2010

DOI: 10.1093/acprof:oso/9780195390131.001.0001

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From Visible Harm to Relative Risk

From Visible Harm to Relative Risk

Centralization and Fragmentation of Pharmacovigilance

Chapter:
(p.301) 13 From Visible Harm to Relative Risk
Source:
The Fragmentation of U.S. Health Care
Author(s):

Arthur Daemmrich

Jeremy Greene

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195390131.003.013

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.

Keywords:   adverse effects, thalidomide, rosiglitazone, pharmacoepidemiology, pharmacovigilance, FDA

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