عنوان

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

Number

TLets327221

Title Proper

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

General Material Designation

[Thesis]

First Statement of Responsibility

Abraham, John.

Name of Publisher, Distributor, etc.

University of Sussex

Date of Publication, Distribution, etc.

1992

Dissertation or thesis details and type of degree

Ph.D.

Body granting the degree

University of Sussex

Text preceding or following the note

1992

Text of Note

This Thesis examines the testing and regulation of drugs in the UnitedKingdom and the United States with particular emphasis on a case-study ofthe benoxaprofen controversy. An analysis of the relationships between thepharmaceutical industry and the regulatory authorities is provided,including their respective handling of technical data regarding theefficacy and toxicity of drugs, and possible attendant biases.Chapter one reviews the literature pertinent to the study of the socialand political aspects of scientific knowledge, culminating in thedevelopment of a theoretical and methodological framework for exploringcommercial and regulatory bias in the control of drugs. A realistphilosophy of science is proposed as a basis for conducting the empiricalresearch discussed later in the Thesis.Chapter two presents an historical account of the development ofBritish and American regulation from the Industrial Revolution to the early1980s, focussing on government-industry relations and the extent ofregulatory capture and corporate bias therein. It is argued that althoughthe perspectives of industry and the State on drug regulation have variedover time according to a complex of factors, corporate bias has played amajor role in defining the scope and timing of regulatory reform.Chapter three is a brief description of the scientific and economicreasons for the increasing innovation in non-steroidal anti-inflammatorydrug therapy since the early 1950s. This provides an important technicalbackground which is necessary to understand some of the scientificcontroversies over the value of benoxaprofen as a non-steroidal antiinflammatorydrug.Chapters four, five, six and seven contain detailed scrutinies of allthe major technical controversies regarding the efficacy and safety ofbenoxaprofen in order to elucidate the relationships between interests,commercial bias and scientific knowledge. It is concluded that the bestinterests of consumers were compromised fairly consistently by thedecisions taken by senior scientists working for the manufacturers and theregulatory authorities, though to different degrees.In chapter eight I address the question of the generalisability of thebenoxaprofen case-study across the pharmaceutical sector by discussing thetesting, regulation and marketing of some other drug products. Finally, inchapter nine I return to the theoretical issues raised in chapter one inorder to draw out some of the implications of the prior discussion forunderstanding the politics of regulatory decision-making and the scientificnature of drug testing. I also consider the implications of the empiricalfindings for political change and further research.

Political science

Abraham, John.

University of Sussex

Electronic name

p

[Thesis]

276903

a

Y