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Switch to: References
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It is argued that neoliberal political ideology has redefined the regulatory state to have greater convergence of interests and goals with the pharmaceutical industry than previously, particularly regarding acceleration and cost reduction of drug development and regulatory review. Consequently, the pharmaceutical industry has been permitted to set the agenda about how shorter term and cheaper alternative carcinogenicity testing systems are investigated for validity. The authors contend that, with the tacit approval of the neoliberal regulatory state, the commercial interests of the (...) |
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This article examines the way in which public controversies affect regulatory science. It describes the controversy that unfolded in Europe around the use of the ninety-day rat-feeding tests for the risk assessment of genetically modified plants. This type of test had been criticized for almost two decades by toxicologists, nongovernmental organizations, and industry alike for its inability to capture the specific health effects of GM plants. But GM risk assessment experts showed great reluctance to move toward a more systematic use (...) |
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There is a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at least three (...) |
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Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body in Europe and a key (...) |
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The article analyses what we term governmental ethics regimes as forms of scientific governance. Drawing from empirical research on governmental ethics regimes in Germany, Franceand the UK since the early 1980s, it argues that these governmental ethics regimes grew out of the technical model of scientific governance, but have departed from it in crucial ways. It asks whether ethics regimes can be understood as new ‘‘technologies of humility’’ and answers the question with a ‘‘yes, but’’. Yes, governmental ethics regimes have (...) |
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Scholars in science and technology studies, as well as economics and innovation studies, utilize the trajectory metaphor in describing a technology’s maturation. Impetus and purpose may differ, but the trajectory serves as a shared tool for assessing social change either in society at large or within a market sector, a firm, or a discipline. In reverse, the lens of a technology trajectory can be a basis for assessing technology, estimating economic growth, and selecting among plausible product development pathways. Emerging technologies (...) |
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Few empirical studies have explored how different types of knowledge are associated with diverse objectivities and moral economies. Here, we examine these associations through an empirical investigation of the public policy debate in Israel around medical cannabis, which may be termed a contested medicine because its therapeutic effects, while subjectively felt by users, are not generally recognized by the medical profession. Our findings indicate that beneath the MC debate lie deep-seated issues of epistemology, which are entwined with questions of ethics (...) |
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The controversy over the prescription drug, alosetron, is examined in order to investigate what is permitted to count as ‘therapeutic advance’ and ‘therapeutic breakthrough’ within pharmaceutical innovation and regulation. It is argued that those official accounting categories can mask very modest efficacy of some drugs by reference to the official techno-scientific evidence, thus leading to questionable acceptance of risks to public health. This is explained by: the drug availability options set by the commercial interests of manufacturers; the FDA management's need (...) |
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