Power, expertise and the limits of representative democracy: genetics as scientific progress or political legitimation i
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ORIGINAL ARTICLE
Power, expertise and the limits of representative democracy: genetics as scientific progress or political legitimation in carcinogenic risk assessment of pharmaceuticals? John Abraham & Rachel Ballinger
Received: 1 April 2011 / Accepted: 6 July 2011 / Published online: 20 July 2011 # Springer-Verlag 2011
Abstract In modern ‘representative’ democratic states, the legitimacy of governments’ actions rests on their publicly declared commitment to protect the interests of their citizens. Regarding the pharmaceutical sector in most democracies, new drug products are developed and marketed by a capitalist industry, whose member firms, via shareholders, have commercial interests in expanding product sales. In those democracies, states have established government agencies to regulate the pharmaceutical industry on behalf of citizens. State legislatures, such as the US Congress and European Parliaments, have charged government drug regulatory agencies with the legal responsibility to protect public health. Yet, this paper argues that government drug regulatory agencies in the EU, Japan, and USA have permitted the pharmaceutical industry to reshape the regulatory guidance for carcinogenic risk assessment of pharmaceuticals in ways that are not techno-scientifically defensible as bases for improved, or even equivalent, protection of public health, compared with the previous techno-regulatory standards. By adopting the industry’s agenda of streamlining carcinogenicity testing in order to accelerate drug development and regulatory review, it is contended that these regulatory agencies have allowed the techno-regulatory standards for carcinogenic risk
Special Issue: Genetics and Demogracy J. Abraham (*) Centre for Research and Health in Medicine (CRHaM), Department of Sociology, University of Sussex, Sussex, UK e-mail: [email protected] R. Ballinger Cancer Research UK, Psychosocial Oncology Group, Brighton and Sussex Medical School, University of Sussex, Sussex, UK
assessment to be loosened in ways that are presented as scientific progress resulting from new genetics, but for which there is little evidence of progress in public health protection.
Introduction: industrial interests and state power in democracy and expertise Science, capitalist industry and the state all pre-date modern democracy. Nonetheless, they all lay claim to the betterment of society. Since the ‘enlightenment’ period, science has been justified as a progressive force in society capable of improving the conditions of humanity, while the advancement of capitalist industry, it is claimed, is necessary to generate technological and economic improvements (Easlea 1973; Schumpeter 1942). States, for their part, have always had pretensions to look after their populations, but with the onset of modern ‘representative’ democratic states in the twentieth century, the legitimacy of governments’ actions has to some extent rested on their publicly declared commitment to protect the interests of their citizens. Regarding the pharmaceutical secto
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