Drug safety legislation and pharmaceutical R&D in Britain, c.1950s–70s
By Viviane Quirke
Medical historians have increasingly engaged with the public–private dichotomy, and as a result of their work it has become clear that there has been a porous and fluid frontier between the different sectors involved in organising and providing healthcare. This is no less true of the boundary between regulatory agencies and the pharmaceutical industry, the subject of my current research.
As it emanates from regulatory agencies and its main aim is to protect the health of patients by controlling the pharmaceutical industry, drug safety legislation can be assumed to belong to the public sphere. Conversely, it can be argued that pharmaceutical R&D, which has the principal purpose of generating profits for drug companies, is squarely situated within the private arena. However, some scholars have claimed that ‘corporate bias’ has moulded drug regulation, often at the expense of consumers/patients, thus advocating a clearer separation to be introduced between the public and private spheres in relation to pharmaceuticals. Yet companies and their activities are often left out of these analyses. Using the organisational files and research reports of Imperial Chemical Industry’s (ICI) Pharmaceutical Division, which became one of Britain’s foremost drug companies in the second half of the 20th century, I have endeavoured to redress this imbalance and fill a significant gap by examining the impact of drug safety legislation on pharmaceutical R&D.
My research highlights the extent to which this legislation was internalised, helping to shape the organisation and practices of firms such as ICI. Indeed, ICI adopted organisational and other R&D practices in response to the British regulatory authorities, and – as it turned its attention towards the lucrative US market – to the Food and Drug Administration’s requirements. More specifically, the need to demonstrate the safety and efficacy of drugs before marketing, which became a legal requirement in the USA in 1962 and the UK in 1968, stimulated the integration of biomedical disciplines and the adoption of statistical methods and physical instrumentation within ICI. However, this evolution participated in a longer trend, which began in the mid-1950s and reflected not only the development of academic disciplines in the era of biomedicine but also the growing complexity of drug discovery in an increasingly competitive environment.
The impact of drug safety legislation on ICI, which exemplifies the development of Britain’s pharmaceutical industry after World War II, can therefore be summarised thus:
- Drug safety legislation encouraged the standardisation, formalisation and codification of R&D practices (as illustrated by ICI’s Inderal or Nolvadex Development Reports).
- It stimulated the integration and assimilation of biomedical disciplines (e.g. pharmacology, biochemistry, toxicology) in the drug industry.
- It led to an alignment of pharmaceutical R&D and clinical research.
- It helped to institutionalise links between industry and the clinic (with the creation in 1969 of ICI’s Clinical Research Department, for example).
- It helped to institutionalise links between industry and regulatory authorities (with ICI’s Safety of Medicines Department, created in 1971).
Moreover, the history of ICI’s beta-blocker project, which this research has examined in greater detail, also shows that drug safety is a flexible concept. Like the drugs themselves, it circulates between the public and private domains, evolving along with the scientific and clinical knowledge accumulated in the process of searching for successful products. The search for commercially and therapeutically successful beta-blockers confronted researchers with numerous scientific and clinical uncertainties and dilemmas. As well as propranolol (Inderal) and atenolol (Tenormin), which helped to prolong and improve the quality of life, it led to the practolol (Eraldin), responsible in the early 1970s for blindness or even death in a significant number of patients. Thus, ICI’s beta-blocker project helps to highlight the changing and contested nature of drug safety, which is shaped by related and at times competing interests, whether those of industrial or academic scientists, of clinical researchers, of company managers, or of regulatory agency officials, on both sides of the public–private divide.
My research therefore adds to the growing corpus of literature on the changing definitions, perceptions, experiences and expectations of public and private spheres that are at the heart of our understanding of the dynamics of the mixed economy of healthcare, and contributes to the Centre for Health, Medicine and Society’s Wellcome Trust Strategic Award.
Dr Viviane Quirke is RCUK Academic Fellow in Twentieth-Century Biomedicine and Pharmaceuticals, Oxford Brookes University.