Complacent and Conflicting Scientific Expertise in British and American Drug Regulation: Clinical Risk Assessment of Triazolam

Abraham, John and Sheppard, Julie (1999) Complacent and Conflicting Scientific Expertise in British and American Drug Regulation: Clinical Risk Assessment of Triazolam. Studies of Science, 29 (6). pp. 803-843. ISSN 0306-3127

Full text not available from this repository.

Abstract

This paper presents a case study in the production and interpretation of regulatory science, focusing on the conflicting British and American clinical risk assessments of triazolam (Halcion) - the most controversial sleeping pill in the world. The regulation of triazolam is shown to be more permissive in the USA than in the UK. Six principal socio-political factors are put forward to explain this: differential regulatory trust; regulators' socio-technical data selections; medico-scientific disciplinary influences; organizational and professional interests; conflicts of interest of expert advisers; and the growth of the neo-liberal regulatory state. The risk assessments of both the British and American regulatory agencies are shown to be complacent relative to technical standards which the agencies themselves later accepted. It is suggested that, when the interests of pharmaceutical manufacturers and patients diverge, regulatory assessments are crucially affected by whether regulators are predisposed to award the benefit of the scientific doubts to the manufacturers or patients, and by the balance of such predispositions both within and between regulatory institutions of scientific expertise. The triazolam case indicates that the amount of trust placed in the pharmaceutical industry by the British and American regulatory systems may hamper detection of flaws in manufacturers' medical data in a timely manner and, as a consequence, compromise patients' interests. Some policy implications for drug regulation are sketched.

Item Type: Article
Schools and Departments: School of Law, Politics and Sociology > Sociology
Depositing User: John Abraham
Date Deposited: 06 Feb 2012 20:21
Last Modified: 28 Mar 2012 15:53
URI: http://srodev.sussex.ac.uk/id/eprint/25583
📧 Request an update