Healthy Skepticism Library item: 8793

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Publication type: Journal Article

Abraham J, Davis C.
Testing times: the emergence of the practolol disaster and its challenge to British drug regulation in the modern period.
Soc Hist Med 2006 Apr; 19:(1):127-47
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17153164&query_hl=4&itool=pubmed_DocSum

Abstract:

This article analyses how practolol, the first British drug disaster of the modern, post-thalidomide regulatory period, related to the pharmaceutical industry, the medical profession and government regulation of patients’ health. Drawing on comparison with the USA, it argues that, contrary to public expectation and perception, the aftermath of thalidomide did not give rise to strident British drug control, imposing the highest possible safety standards on the pharmaceutical industry. Rather, there existed a culture of reluctant regulation that was characterised by continued optimism about, and trust in the purported benefits of new drugs among manufacturers and regulators in the United Kingdom, together with commitment to the protection of the industry and its institutional support for the medical profession. In particular, British regulators were willing to allow new drugs on to the market, fully aware of uncertainty about their safety, but unwilling to be pro-active in issuing warning letters about risks and requiring ‘certainty’ before acting to withdraw a product. Even after the practolol disaster, the British system was unable to reform itself to construct more rigorous and pro-active monitoring of drug risks. This was because of conflicts with industry interests.

Keywords:
Publication Types: Historical Article Research Support, Non-U.S. Gov't MeSH Terms: Adrenergic beta-Antagonists/adverse effects Adrenergic beta-Antagonists/history* Drug Industry/history* Great Britain History, 20th Century Humans Legislation, Drug/history* Practolol/adverse effects Practolol/history* Substances: Adrenergic beta-Antagonists Practolol