Abraham John
Department of Sociology, School of Social Science and Cultural Studies, University of Sussex, Arts D Building, Falmer, Brighton, BN1 9SN, UK.
Med Health Care Philos. 2008 Dec;11(4):415-26. doi: 10.1007/s11019-008-9155-x. Epub 2008 Jul 22.
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 will be accepted without independent de-construction-drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy.
借鉴英国、美国和欧洲现代药品监管时代的案例研究，我考察了监管机构、制药行业和医疗行业之间在药物测试和监测方面的信任程度及分布情况如何影响有关处方药疗效和安全性的知识及监管判断。引入监管信任的“默许”和“调查”规范概念后，我展示了监管信任的调查规范——这种规范阻止制药公司假定其数据分析无需独立解构就能被接受——如何出于健康利益提升药物评估的生物伦理和监管标准。相比之下，与行业俘获和利益的专业封闭相关的监管信任的默许规范，会促成宽松的标准，使患者能够服用对健康风险更大且治疗效果证据更少的药物。
