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Title: A political sociology of drug testing and regulation with particular reference to the benoxaprofen controversy.
Author: Abraham, John.
ISNI:       0000 0001 2437 7337
Awarding Body: University of Sussex
Current Institution: University of Sussex
Date of Award: 1992
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This Thesis examines the testing and regulation of drugs in the United Kingdom and the United States with particular emphasis on a case-study of the benoxaprofen controversy. An analysis of the relationships between the pharmaceutical industry and the regulatory authorities is provided, including their respective handling of technical data regarding the efficacy and toxicity of drugs, and possible attendant biases. Chapter one reviews the literature pertinent to the study of the social and political aspects of scientific knowledge, culminating in the development of a theoretical and methodological framework for exploring commercial and regulatory bias in the control of drugs. A realist philosophy of science is proposed as a basis for conducting the empirical research discussed later in the Thesis. Chapter two presents an historical account of the development of British and American regulation from the Industrial Revolution to the early 1980s, focussing on government-industry relations and the extent of regulatory capture and corporate bias therein. It is argued that although the perspectives of industry and the State on drug regulation have varied over time according to a complex of factors, corporate bias has played a major role in defining the scope and timing of regulatory reform. Chapter three is a brief description of the scientific and economic reasons for the increasing innovation in non-steroidal anti-inflammatory drug therapy since the early 1950s. This provides an important technical background which is necessary to understand some of the scientific controversies over the value of benoxaprofen as a non-steroidal antiinflammatory drug. Chapters four, five, six and seven contain detailed scrutinies of all the major technical controversies regarding the efficacy and safety of benoxaprofen in order to elucidate the relationships between interests, commercial bias and scientific knowledge. It is concluded that the best interests of consumers were compromised fairly consistently by the decisions taken by senior scientists working for the manufacturers and the regulatory authorities, though to different degrees. In chapter eight I address the question of the generalisability of the benoxaprofen case-study across the pharmaceutical sector by discussing the testing, regulation and marketing of some other drug products. Finally, in chapter nine I return to the theoretical issues raised in chapter one in order to draw out some of the implications of the prior discussion for understanding the politics of regulatory decision-making and the scientific nature of drug testing. I also consider the implications of the empirical findings for political change and further research.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available
Keywords: Political science