Transnational industrial power, the medical profession and the regulatory state: adverse drug reactions and the crisis over the safety of Halcion in the Netherlands and the UK.

Full Abstract

Taking the controversy over the safety of the hypnotic, Halcion, in the Netherlands and the UK, as a case study, this article examines the problems for public health associated with responses to warnings about drug hazards by regulatory agencies, governmental expert advisers, the pharmaceutical industry and the medical profession. It is argued that regulators and the medical profession rely too heavily on manufacturers to investigate warnings from doctors' spontaneous reporting of adverse effects of drug products on the market. It is demonstrated that a pharmaceutical firm's commitment to search effectively for evidence against the safety of its own product in order to confirm doctors' warnings can have severe limitations. Deficiencies in the socio-institutional responses to post-market 'early warning systems' about drug hazards imply that the regulatory policies of 'early licensing' and minimal pre-market checks for new drugs are misconceived and threaten public health. To improve public protection from drug injury, the regulators should abandon their conviction that compelling evidence of drug hazards are required to confirm doctors' warning signals prior to regulatory intervention. Instead, they should adopt a policy of measured regulatory intervention as an immediate response to warning signals, while investigators, independent of the manufacturers, assess the significance of the signal.

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Author information

Author/s: Abraham, John (J);

Affiliation: School of Social Sciences, Centre for Research in Health and Medicine (CRHAM), Arts E Building, University of Sussex, Falmer, Brighton, UK. j.w.abraham(-atsign-)sussex.ac.uk

Journal and publication information

Publication Type: Journal Article; Legal Cases; Research Support, Non-U.S. Gov't

Journal: Social science & medicine (1982) (Soc Sci Med), published in England. (Language: eng)

Reference: 2002-Nov; vol 55 (issue 9) : pp 1671-90

Dates: Created 2002/09/25; Completed 2002/11/22; Revised 2006/11/15;

PMID: 12297251, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adverse Drug Reaction Reporting Systems - legislation & jurisprudence
Anti-Anxiety Agents - administration & dosage; adverse effects
Disclosure - legislation & jurisprudence
Drug Approval - legislation & jurisprudence
Drug Industry - standards
Government Agencies - standards
Great Britain
Humans

Humans
International Cooperation
Netherlands
Physician's Role
Power (Psychology)
Product Surveillance, Postmarketing
Public Health
Triazolam - administration & dosage; adverse effects

Associated Chemicals: Anti-Anxiety Agents (0) ; Triazolam (28911-01-5)

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