When is a Medicine Good Enough? The Problem of Therapeutic Equivalence, 1959-2009

描述（由申请人提供）： 这个项目的目的是产生一本书的长度帐户的系统尝试，以鼓励合理使用治疗在20世纪末和世纪初的美国医学。该补助金将提供兼职研究资金，以支持PI在此期间进行三年的手稿准备和最终档案研究。几乎所有当代提高美国医疗质量同时削减成本的建议都依赖于治疗等效性的前提：如果药物具有相同的疗效，一种药物（更便宜，更安全）可能被另一种药物（更昂贵，更危险）所取代，以产生更有效的整体护理。在过去的半个世纪里，支持合理用药的相似性科学在方法论、临床和政治上都受到了争议，这些讨论的结果继续影响着当前的卫生政策选择。手稿将叙述在世纪后期美国建立和利用治疗等效概念的三次相关尝试的历史：（1）在试图确保化学上相同的品牌和仿制处方药之间的仿制药等效性时出现的科学、监管和政治冲突，（2）在分子上不同但临床上相似的“我也是”药物的治疗类别中，在定义一种药物对另一种药物的治疗替代界限时出现的私人和公共竞赛，和（3）指导医生更合理地开治疗等效化合物的方案的异质遗产，以支持更安全和更便宜的治疗剂。这项工作将代表美国医疗实践和卫生政策中合理用药的第一个历史， 有很大的潜力，为正在进行的国家和国际卫生保健改革对话提供信息。

DESCRIPTION (provided by applicant): The aim of this project is to produce a book-length account of systematic attempts to encourage the rational use of therapeutics in late 20th and early 21st century American medicine. The grant will provide for part-time research funding to support the PI for three years of manuscript preparation and final archival research during this period. Nearly all contemporary proposals to improve the quality of US health care while cutting its costs depend on the premise of therapeutic equivalence: if drugs have identical efficacy one medicine (cheaper, safer) might be substituted for another (costlier, riskier) to produce more effective care overall. On closer examination, the science of similarity that underpins rational pharmaceutical use has been methodologically, clinically, and politically contested for the past half-century, and the results f these deliberations continue to influence current health policy options. The manuscript will narrate the history of three related attempts to establish and utilize notions of therapeutic equivalence in late 20th century America: (1) the scientific, regulatory, and political conflicts tat arise in trying to ensure generic equivalence between chemically identical brand-name and generic prescription drugs, (2) the private and public contests that emerge in defining the boundaries of therapeutic substitution of one drug for another within a therapeutic class of molecularly-different but clinically similar 'me too' drugs, and (3) the heterogeneous legacy of programs to guide physicians towards more rational prescribing of therapeutically equivalent compounds to favor safer and less expensive therapeutic agents. This work will represent the first history of rational pharmaceutical use in American medical practice and health policy, and it has great potential to inform ongoing national and international conversations on health care reform moving forwards.