Healthy Skepticism Library item: 16059

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Publication type: Journal Article

Abraham J.
The politics and bio-ethics of regulatory trust: case-studies of pharmaceuticals.
Med Health Care Philos. 2008 Dec; 11:(4):415-26
http://www.springerlink.com/content/w6332232pw57g558/

Abstract:

Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust-which deter pharmaceutical companies from assuming that their data analyses will be accepted without independent de-construction-drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy.

Keywords:
Clinical Trials as Topic/ethics Clinical Trials as Topic/methods Depressive Disorder/drug therapy Disclosure Dopamine Uptake Inhibitors/therapeutic use Drug Industry/ethics* Drug Industry/legislation & jurisprudence Drug Industry/organization & administration* Ethics, Clinical* Government Regulation Humans Nomifensine/therapeutic use Politics* Risk Assessment Trust*