Social History of Medicine Advance Access published online on November 5, 2009
Social History of Medicine, doi:10.1093/shm/hkp049
Discovery and Management of Adverse Drug Reactions: The Nomifensine Hypersensitivity Syndrome, 1977–1986
* Professor of Sociology and Director Centre for Research in Health and Medicine (CRHaM)
Lecturer in Sociology, Centre for Research in Health and Medicine (CRHaM), Department of Sociology, University of Sussex, Falmer, Brighton BN1 9SN, UK. E-mail: J.W.Abraham{at}sussex.ac.uk and C.M.Davis{at}sussex.ac.uk.
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Abstract |
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Taking the antidepressant, nomifensine, this article focuses on the discovery and management of adverse drug reactions (ADRs) manifested in doctors' spontaneous post-marketing reports. Company-friendly experts, free-lancer research scientists, public servant physicians and regulatory scientists are shown to have made distinct contributions to ADR discovery. However, institutional and international fragmentation delayed synthesis of ADR reports into unambiguous discovery. Qualitative and quantitative interpretative standards of what counted as ADR discovery affected regulatory warning systems and decisions about when to withdraw a drug from the market. The timing and definition of an ADR as ‘irreversible’ or ‘rare’ was, in part, a function of the uncertainty and estimation criteria chosen by the party managing the discovery. UK regulators accepted relatively low levels of uncertainty, so the timing of discovery, warnings and regulatory action was relatively late, but US regulators chose higher thresholds of uncertainty about discovery when interpreting the need to warn of suspected serious ADRs. The implications of these practices for the founding ideals of a post-marketing ‘early warning system’ are considered.
Keywords: drug safety; pharmaceutical industry; regulatory agencies; FDA; CSM