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

过时的：生物医学、内毒素检测和鲎的困境

• 批准号: 10577633
• 负责人: Kristoffer Whitney
• 金额: $ 4.94万
• 依托单位: ROCHESTER INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10577633
• 关键词: Academia; American; Animal Welfare; Animals; Asian; Atlantic Ocean; Biocompatible Materials; Blood; Books; Complex; Crabs; Detection; Development; Devices; Drug Industry; Economics; Endotoxins; Ensure; Environmental Protection; Europe; European; Far East; Fever; Fisheries; Future; Goals; Gram-Negative Bacteria; Health; Hemorrhage; Historiography; History of Medicine; Human; Humanities; Industry; Infrastructure; Intervention; Interview; Intravenous; Knowledge; Length; Light; Limulus; Limulus polyphemus; Manufacturer; Maps; Marketing; Medical Device; Medicine; Methods; Modeling; Modernization; Monograph; Movement; Oceans; Pacific Ocean; Phagocytes; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacopoeias; Policies; Policy Making; Population; Production; Public Health; Publishing; Recombinants; Recording of previous events; Regulation; Role; Safety; Scholarship; Science; Site; Social Sciences; Sociology; Structure; System; Technology; Testing; Time; Toxin; United States Food and Drug Administration; Vaccines; Work; Writing; Xiphosura; drug efficacy; drug maintenance; factor C; innovation; interest; manufacture; manufacturing process; marine; marine organism; medication safety; unpublished documents; welfare

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.

项目摘要 这个项目是写一本书的长度帐户的生物医学使用的美国马蹄铁 鲎（Limulus polyphemus）生产鲎变形细胞溶解物（LAL）-一种用于 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。本专著将 探索LAL的历史，其全球影响，以及围绕螃蟹的当代生物政治 在制药工业中，LAL的保护和合成替代品。这本书的 对健康和医学的贡献将是揭示一个基本上未知的组成部分， 公共安全，并帮助发展理论框架，以了解 药物和医疗器械制造相关政策制定的复杂性-特别是当 这些政策可能与环境保护等其他社会目标相冲突。 目前还没有LAL行业的完整专著，拟议中的书旨在 为跨学科、以人文为基础和与政策相关的工作做出贡献和建立模式， 通过加深我们对内毒素作用的理解来分析生物医学基础设施 公共卫生检测。更广泛地说，这个项目的方法将有助于理解 各种各样的公共卫生问题，其中不同的监管机构和利益相关者 团体参与。该项目的一个重要创新是将以下方面的关系概念化： 人类和动物健康作为生物医学既可以依赖又处于紧张状态的场所 ，保守。 拟议中的书将建立在美国的一系列历史编纂的基础上， 医学，包括药物开发和监管的历史，以及全球 医学史和环境史。此外，通过收集出版和 未出版的文件和进行利益相关者访谈，这本书将分析 当前的监管格局，其中LAL及其拟议的合成替代品，以及 目前正在评估其他生物医学创新。该项目将吸引学术界 学者，利益相关者和对生物医学和公共卫生感兴趣的广大受众。