Article ID: CBB000770617

Testing Times: The Emergence of the Practolol Disaster and Its Challenge to British Drug Regulation in the Modern Period (2006)

unapi

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.

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Authors & Contributors
Hess, Volker
Davis, Courtney
Daemmrich, A.
Balz, Viola
Abraham, John
Tobbell, Dominique Avril
Journals
Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences
Pharmacy in History
Social Studies of Science
Social History of Medicine
Medical History
Korean Journal of Medical History
Publishers
Max-Planck-Institut für Wissenschaftsgeschichte, Berlin
University of Minnesota
Concepts
Pharmaceutical industry
Pharmacy
Legislative and administrative regulations
Materia medica
Medicine and government
Pharmacology
Time Periods
20th century, late
21st century
19th century
20th century
Places
United States
Great Britain
Germany
Prussia (Germany)
France
Europe
Institutions
United States. Food and Drug Administration (USFDA)
United States. Food and Drug Administration
Imperial Chemical Industries
American Medical Association
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