Do-it-Yourself and Direct-to-Consumer Medicine and Science: Assessing the Public Health Issues and Regulatory Gaps

自己动手和直接面向消费者的医学和科学：评估公共卫生问题和监管差距

• 批准号: 10247744
• 负责人: ANNA WEXLER
• 金额: $ 40.25万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-17 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247744
• 关键词: Academia; Academy; Address; Affect; American; American Association for the Advancement of Science; Anthropology; Archives; Area; Arts; Attention; Award; Bachelor' s Degree; Brain; Case Study; Clinic; Cognitive Science; Communities; Complex; Data; Devices; Doctor of Philosophy; Educational workshop; Empirical Research; Environment; Ethical Analysis; Ethics; Faculty; Feces; Foundations; Funding; General Population; Genetic Transcription; Goals; Growth; Health; Health Policy; Health Services; Health Technology; Individual; Industry; Insulin; Interdisciplinary Study; International; Interview; Investigational Therapies; Laws; Lead; Legal; Licensing; Medical; Medical Ethics; Medicine; Methodology; Methods; Movement; Nature; Neurosciences; Patients; Pennsylvania; Policies; Policy Analysis; Positioning Attribute; Postdoctoral Fellow; Public Health; Publications; Publishing; Qualitative Methods; Recording of previous events; Regulation; Research; Research Assistant; Research Personnel; Resources; Risk; Running; Schools; Science; Scientist; Self Administration; Services; Societies; Sociology; Study Subject; Surveys; System; Techniques; Technology; Training; Translating; Transplantation; United States Federal Trade Commission; United States National Institutes of Health; Universities; Work; authority; base; career; citizen science; comparative; consumer product; cost; design; digital health; doctoral student; experience; fecal transplantation; graduate student; innovation; instructor; interdisciplinary approach; journal article; medical schools; meetings; member; neurotechnology; novel; novel strategies; professor; programs; scientific organization; social; success; tenure track; uptake

PROJECT SUMMARY In recent years, do-it-yourself (DIY) medical movements and direct-to-consumer (DTC) health technologies have made information, products and services available to the public that were previously sequestered in the “ivory tower” of science and medicine. While the democratization of science and medicine holds tremendous potential, it also presents unprecedented public health issues: individuals are self-administering potentially harmful experimental therapies (such as fecal transplants), purchasing untested consumer products (such as brain stimulation devices) that have little or no regulatory oversight, and paying out-of-pocket to receive unproven neuro-treatments at “brain wellness” clinics run by unlicensed practitioners. In addition to the public health concerns, these phenomena present ethical, social and regulatory challenges for scientists and clinicians, professional medical and scientific organizations, and federal and state regulators. In recognition of these challenges, the FDA, NIH, the National Academy of Medicine, and the American Academy of Arts and Sciences (among others) have all recently convened meetings on these topics. To date, however, there has been a lack of empirical data on DIY movements and DTC health technology and services, as well as a lack of analysis of the public health issues and regulatory challenges that these phenomena raise. My long-term goal is to build an interdisciplinary research agenda that combines empirically grounded sociological studies with pragmatic analyses of ethical and regulatory questions, with the intent of developing novel strategies for maximizing the benefits and minimizing the public health risks of the democratization of medicine and science. The objective of the present project is to comprehensively study (and anticipate) the health issues posed by DIY medical movements, DTC neurotechnologies, and brain wellness clinics, as well as to identify the relevant policy gaps. The proposed research aims to: (a) investigate the mechanisms that lead to the creation, growth, and uptake of DIY medical movements, by conducting a comparative analysis across three case studies; (b) identify weaknesses in the regulation of DTC neurotechnology and develop novel policy solutions; and (c) examine the public health issues posed by “brain wellness” clinics by conducting studies of these clinics and analyzing their regulations at a state level. This proposal is innovative because it combines sociological techniques (i.e., interviews and surveys) with in-depth legal analyses to address a complex problem that does not lend itself to a single methodology. The proposed research is significant because it will have a direct impact on those who are actively grappling with or affected by the rise of DIY medicine and DTC health technologies and services, including individual scientists and clinicians, professional medical and scientific organizations, and regulatory bodies such as the FDA, Federal Trade Commission, state health licensing authorities, patients and members of the general public.

项目摘要 近年来，DIY（DIY）医疗运动和直接面向消费者（DTC）健康技术 向公众提供了以前被隔离在 科学和医学的“象牙塔”。虽然科学和医学的民主化对人类的健康 潜在的，它也提出了前所未有的公共卫生问题：个人自我管理潜在的 有害的实验性疗法（如粪便移植），购买未经测试的消费品（如 脑刺激装置），很少或根本没有监管监督，并自掏腰包接受 未经证实的神经治疗在“脑健康”诊所由无证从业者运行。除了公共 这些现象给科学家带来了伦理、社会和监管方面的挑战， 临床医生、专业医疗和科学组织以及联邦和州监管机构。以表彰 这些挑战，FDA，NIH，国家医学院和美国艺术学院， 科学界（除其他外）最近都就这些主题召开了会议。 然而，迄今为止，一直缺乏关于DIY运动和DTC健康技术的经验数据 以及缺乏对公共卫生问题和监管挑战的分析， 现象上升。我的长期目标是建立一个跨学科的研究议程， 扎根社会学研究，对道德和监管问题进行务实分析，目的是 制定新的战略，以最大限度地提高利益，最大限度地减少公共卫生风险， 医学和科学的民主化。本项目的目标是全面研究（和 预测）DIY医疗运动、DTC神经技术和大脑健康带来的健康问题 诊所，以及找出相关的政策差距。本研究的目的是：（a）调查 机制，导致创建，增长，和吸收DIY医疗运动，通过进行一个 对三个案例研究进行比较分析;（B）找出DTC监管方面的弱点 （c）研究“脑”所带来的公共健康问题 通过对这些诊所进行研究并分析其在州一级的规定，建立“健康”诊所。这 建议是创新的，因为它结合了社会学技术（即，访谈和调查）， 法律的分析，以解决一个复杂的问题，不适合于一个单一的方法。拟议 研究是重要的，因为它将对那些积极努力或受影响的人产生直接影响。 DIY医学和DTC健康技术和服务的兴起，包括科学家个人， 临床医生、专业医疗和科学组织，以及FDA、联邦 贸易委员会、州卫生许可机构、病人和公众。