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

描述(由申请人提供)： 这个项目的目的是为20世纪末21世纪初美国医学中鼓励合理使用治疗学的系统性尝试写一本书。这笔赠款将提供非全日制研究经费，以支持PI在此期间进行三年的手稿准备和最后档案研究。当代几乎所有旨在提高美国医疗保健质量、同时削减成本的提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)可能会被另一种(更昂贵、风险更高)的药物取代，以产生整体上更有效的医疗保健。仔细观察，在过去的半个世纪里，支持合理用药的相似性科学在方法学、临床和政治上一直存在争议，这些审议的结果继续影响着当前的卫生政策选择。该手稿将叙述在20世纪末美国建立和利用治疗等效性概念的三个相关尝试的历史：(1)在试图确保化学上相同的品牌药物和仿制处方药之间的仿制等效性时出现的科学、法规和政治冲突；(2)在分子不同但临床上相似的药物治疗类别中出现的私人和公共竞争，以及(3)引导医生更合理地开出治疗等价物以支持更安全和更便宜的治疗药物的计划遗产。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，并且它 具有极大的潜力，可以为正在进行的关于推进医疗改革的国内和国际对话提供信息。

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.