Controlling Pharmaceutical Risks: Science, Cancer and the Geneticization of Drug Testing

This book is about the politics of regulatory science – specifically the regulatory science concerned with assessing whether or not prospective new pharmaceutical products might cause cancer in humans. That is to say it is about the politics of the carcinogenic risk assessment of pharmaceuticals within pre-market screening. John Abraham traces the origins of this regulatory science, including its intimate links with industry and government agencies. Due to the long onset time for most human cancers, it is not practical to evaluate carcinogenicity within human clinical trials. Nor would it be ethical because after experimenting with the new drug in clinical trials for 10-20 years, many of the trial participants, who may have relatively minor illnesses, could have been given cancer by the new pharmaceutical. Consequently, the science of carcinogenicity evaluation relies largely on studies using animal models. As a regulatory science, it has evolved to be closer to toxicology than medicine. The main focus of Controlling Pharmaceutical Risks is of the changes in drug testing since the late 1990s, specifically geneticization of carcinogenic risk assessment and regulation of pharmaceuticals. At stake are issues fundamental to bio-science, medical treatment and patients’ health in wider society, such as what kind of knowledge is judged necessary to decide whether or not a drug is a carcinogen and when does a drug pose a significant carcinogenic risk to humans? Given that all new drugs, many with prospective world-wide markets, are potential carcinogens, this is an extremely important socio-political issue, but has been largely neglected in social science and indeed medicine. This is the first social science/policy book on the geneticization of international pharmaceutical testing and pharmaceutical toxicology. Controlling Pharmaceutical Risks analyses international developments in the field, especially in Europe and the US. While Abraham discussed science-push aspects of geneticization of pharmaceutical carcinogenic risk assessment (e.g. ‘scientist activism’), it also analyses how the political economy of the pharmaceutical industry and government regulatory agencies relates to changes in the techno-science of carcinogenicity testing.

The evidence from this book is that the ostensibly progressive nature of geneticization has been conceptualized too narrowly. Moreover, this can be explained by understanding how it emerged and its subsequent integration into regulatory toxicology. Geneticization has undoubtedly produced new toxicological knowledge for scientists, but there is also the possibility that our societies will know less, rather than more, about the potential carcinogenicity of pharmaceuticals as a result of geneticization. This latter possibility raises the spectre of increased pharmaceutical risks to public health. Rather, like the film version of a book, geneticization has provided elaborate knowledge about those mechanisms identified for coverage, but the risk is that having seen the film people will no longer read the whole book, thereby missing important insights about the carcinogenicity of novel drugs, whose dangers reside in non-reductionist mechanisms. John Abraham shows that careful and sustained social scientific analysis can trace how specific political, institutional and commercial interests influence the development of regulatory science in particular directions that increase the risks to public health. This book helps to ensure that even in drug toxicology – the darkest corner of medicine – there can be an appreciation both of the technical significance of geneticization and the need to understand its bio-ethical, socio-political, and public health dimensions.