A political sociology of drug testing and regulation with particular reference to the benoxaprofen controversy.
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
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.