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  1.  1
    The Neoliberal Regulatory State, Industry Interests, and the Ideological Penetration of Scientific Knowledge: Deconstructing the Redefinition of Carcinogens in Pharmaceuticals.Rachel Ballinger & John Abraham - 2012 - Science, Technology, and Human Values 37 (5):443-477.
    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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  2.  1
    Deficits, Expectations and Paradigms in British and American Drug Safety Assessments: Prising Open the Black Box of Regulatory Science.Courtney Davis & John Abraham - 2007 - Science, Technology, and Human Values 32 (4):399-431.
    This article examines the regulation of nonsteroidal anti-inflammatory drugs, with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued both that (...)
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  3. Democracy, Technocracy, and the Secret State of Medicines Control: Expert and Nonexpert Perspectives.Julie Sheppard & John Abraham - 1997 - Science, Technology and Human Values 22 (2):139-167.
    This article explores the social frameworks guiding expert and nonexpert perspectives on medicines safety in the U.K. Scientific experts from the Committee on the Safety of Medicines and the Medicines Commission were interviewed, and three nonexpertgroups, including patients and health professionals, were studied by the administration of questionnaires and focused group discussions. The research examined to what extent these groups subscribed to technocratic or democratic approaches to medicines regula tion and how this might be related to values toward technological risk. (...)
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  4. Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety.John Abraham - 1994 - Science, Technology and Human Values 19 (4):493-522.
    This article examines how scientists and regulators distribute the benefit of the doubt about drug safety under conditions of scientific uncertainty. The focus of the empirical research is the regulatory controversy over the hepatorenal toxicity of benoxaprofen in the United Kingdom and the United States. By scrutinizing the technical coherence of the arguments put forward by industrial and government scientists, it is concluded that these scientists are willing to award the commercial interests of the pharmaceutical industry an enormous benefit of (...)
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  5.  36
    The Politics and Bio-Ethics of Regulatory Trust: Case-Studies of Pharmaceuticals. [REVIEW]John Abraham - 2008 - Medicine, Health Care and Philosophy 11 (4):415-426.
    Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming that their data analyses (...)
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  6.  1
    Rethinking Innovation Accounting in Pharmaceutical Regulation: A Case Study in the Deconstruction of Therapeutic Advance and Therapeutic Breakthrough. [REVIEW]John Abraham & Courtney Davis - 2011 - Science, Technology, and Human Values 36 (6):791-815.
    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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