Out of Time: Biomedicine, Endotoxin Detection, and the Plight of the Horseshoe Crab

项目摘要 这个项目是写一本书那么长的描述美国马蹄铁的生物医学用途。 螃蟹(河蟹)生产凝胶细胞裂解物(LAL)--所用化合物 检测所有静脉注射药物、疫苗和 医疗设备和全球公共卫生基础设施的重要组成部分。这本专著将 探索LAL的历史，它的全球影响，以及围绕螃蟹的当代生物政治 制药工业中LAL的保护和合成替代品。这本书 对健康和医学的贡献将是揭示一种基本未知的成分 公共安全，并帮助开发理论框架，以了解 围绕药品和医疗器械制造制定政策的复杂性--特别是当 这些政策可能会与环境保护等其他社会目标发生冲突。 目前还没有关于LAL行业的全长专著，建议的书旨在 跨学科、以人文为基础、与政策相关的工作的贡献和模式 通过加深对内毒素作用的理解来分析生物医学基础设施 公共卫生中的检测。更广泛地说，该项目的方法将有助于理解 广泛的公共卫生问题，涉及不同的监管机构和利益相关者 团体也参与其中。该项目的一个重大创新是概念化了 人类和动物健康是生物医学既可以依赖又可以紧张的地方 有了，保护。 拟议中的这本书将建立在美国一系列史学的基础上，并对其做出贡献 医药，包括医药发展和监管的历史，以及全球 医学史和环境史。此外，通过收集已出版的和 未出版的文件，并进行利益相关者采访，该书将分析 在当代监管格局中，LAL、其拟议的合成替代品以及 其他生物医学创新目前正在评估中。这个项目将吸引学术界人士。 对生物医学和公共卫生感兴趣的学者、利益相关者和广大受众。

Project Summary This project is to write a book-length account of the biomedical use of American horseshoe crabs (Limulus polyphemus) to produce Limulus Amebocyte Lysate (LAL) – a compound used to detect the presence of potentially deadly toxins in all intravenous drugs, vaccines, and medical devices and a vital part of global public health infrastructure. This monograph will explore the history of LAL, its global implications, and the contemporary biopolitics around crab conservation and synthetic replacements for LAL in the pharmaceutical industry. The book’s contribution to health and medicine will be to shed light on a largely unknown component of public safety, and to aid in the development of theoretical frameworks for understanding the complexities of policymaking around drug and medical device manufacture – particularly when those policies may be in tension with other societal goals, such as environmental protection. No full-length monograph of the LAL industry currently exists, and the proposed book aims to be a contribution and model for cross-disciplinary, humanities-based, and policy-relevant work in analyzing biomedical infrastructures by deepening our understanding of the role of endotoxin detection in public health. More broadly, this project’s approach will lend itself to understanding a wide range of public health issues in which diverse regulatory agencies and stakeholder groups are involved. A significant innovation of this project is to conceptualizes the nexus of human and animal health as a site where biomedicine can both rely upon, and be in tension with, conservation. The proposed book will build upon and contribute to a range of historiography in American medicine, including histories of pharmaceutical development and regulation, as well as global histories of medicine and environmental history. In addition, by collecting published and unpublished documentation and conducting stakeholder interviews, the book will analyze the contemporary regulatory landscape in which LAL, its proposed synthetic replacements, and other biomedical innovations are currently being assessed. This project will appeal to academic scholars, stakeholders, and broad audiences interested in biomedicine and public health.