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首页> 外文期刊>Science, Technology and Human Values >Rethinking Innovation Accounting in Pharmaceutical Regulation: A Case Study in the Deconstruction of Therapeutic Advance and Therapeutic Breakthrough
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Rethinking Innovation Accounting in Pharmaceutical Regulation: A Case Study in the Deconstruction of Therapeutic Advance and Therapeutic Breakthrough

机译：对药品监管中的创新会计的反思：以解构治疗进展和突破性治疗为例

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摘要

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 to demonstrate rapid approval of therapeutic advances to their budgetary masters, especially in the context of patient demands for access to new drugs; and the increasing capacity of patient groups, sometimes in collaboration with pharmaceutical manufacturers, to challenge techno-scientific expertise and evidence with experiential testimony. It is concluded that regulatory policy-makers need much more sophisticated accounting systems for differentiating between drugs defined as significant therapeutic advances, and between drugs ('therapeutic breakthroughs' fast-tracked to treat serious or life-threatening conditions. Contrary to some STS analyses, the desirability of an ascendancy of patients' anecdotal evidence in regulatory decisions for public health is questioned.
机译：为了研究在处方药创新和监管中被允许算作“治疗进展”和“治疗突破”的问题，对处方药alosetron的争议进行了审查。有人认为，这些官方会计类别可以通过参考官方技术科学证据掩盖某些药物的非常适度的功效，从而导致人们对公众健康风险的接受度令人怀疑。可以通过以下解释来解释：制造商的商业利益确定的药品供应选项； FDA管理层需要证明其预算主管可以快速批准治疗进展，特别是在患者对获得新药的需求方面；以及有时与药品制造商合作的患者群体不断增强的能力，以经验证明来挑战技术科学的专业知识和证据。结论是，监管政策制定者需要更加复杂的会计系统来区分定义为重大治疗进展的药物和药物之间的区别（快速治疗严重或危及生命的疾病的“治疗突破”。与某些STS分析相反，在公共卫生的监管决策中是否需要增加患者的轶事证据受到质疑。

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