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，自己动手（DIY）医疗运动和直接面向消费者（DTC）健康技术 已经向公众提供了以前被隔离的信息，产品和服务 科学与医学的“象牙塔”。而科学和医学的民主化则具有巨大的 潜力，它还提出了前所未有的公共卫生问题：个人正在自我管理 有害的实验疗法（例如粪便移植），购买未经测试的消费产品（例如 大脑模拟设备）几乎没有监管的监督，并且自付费用以接收 未经执照的从业者经营的“大脑健康”诊所的未经证实的神经治疗。除了公众 健康问题，这些现象给科学家带来了道德，社会和监管挑战 临床医生，专业医学和科学组织以及联邦和州监管机构。认可 这些挑战，FDA，NIH，美国国家医学院以及美国艺术学院 科学（包括）最近都召集了有关这些主题的会议。 但是，迄今为止，缺乏有关DIY运动和DTC卫生技术的经验数据 和服务，以及对公共卫生问题和监管挑战的分析 现象加剧。我的长期目标是建立一个跨学科研究议程，以经验结合 基于伦理和监管问题的务实分析的社会学研究，目的是 制定新的策略来最大化收益并最大程度地降低公共卫生的风险 医学和科学的民主化。本项目的目的是全面研究（和 预期）DIY医疗运动，DTC神经技术和大脑健康带来的健康问题 诊所以及确定相关政策差距。拟议的研究旨在：（a）调查 导致DIY医疗运动的创造，成长和吸收的机制，通过进行 在三个案例研究中进行比较分析； （b）确定DTC调节中的弱点 神经技术和开发新颖的政策解决方案； （c）检查“大脑 健康诊所通过对这些诊所进行研究并在州一级分析其法规。这 提案具有创新性，因为它结合了社会学技术（即访谈和调查）和深入 法律分析以解决一个不适合单一方法的复杂问题。提议 研究很重要，因为它将直接影响那些积极努力或受到影响的人 通过DIY医学和DTC健康技术和服务的兴起，包括个人科学家和 临床医生，专业医学和科学组织以及法规机构，例如FDA，联邦 贸易委员会，州卫生许可当局，患者和公众。