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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

项目概要近年来，DIY（DIY）医疗运动和直接面向消费者（DTC）的健康技术向公众提供了以前被隐藏的信息、产品和服务科学和医学的“象牙塔”，而科学和医学的民主化有着巨大的意义。潜力，它也带来了前所未有的公共卫生问题：个人有潜在的自我管理能力有害的实验疗法（例如粪便移植）、购买未经测试的消费品（例如脑刺激设备）很少或根本没有监管监督，并且需要自费接收除了公众之外，在未经许可的执业医师经营的“大脑健康”诊所中进行未经证实的神经治疗。健康问题，这些现象给科学家和科学家带来了伦理、社会和监管方面的挑战为了表彰这些挑战，FDA、NIH、美国国家医学院和美国艺术学院科学界（除其他外）最近都召开了有关这些主题的会议。然而迄今为止，还缺乏DIY运动和DTC健康技术的实证数据和服务，以及缺乏对公共卫生问题和监管挑战的分析我的长期目标是建立一个结合经验的跨学科研究议程。以社会学研究为基础，对伦理和监管问题进行务实分析，目的是制定新颖的战略，以最大限度地提高效益并最大限度地减少公共卫生风险本项目的目标是全面研究（和）医学和科学的民主化。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，以及确定相关的政策差距拟议的研究旨在： (a) 调查通过进行 DIY 医疗运动的创造、发展和采用的机制对三个案例研究进行比较分析；(b) 找出 DTC 监管的弱点神经技术并制定新的政策解决方案；(c) 研究“大脑”带来的公共卫生问题；通过对这些诊所进行研究并分析其在州一级的法规，来建立“健康”诊所。该提案具有创新性，因为它结合了社会学技术（即访谈和调查）和深入研究法律分析是为了解决不适合单一方法的复杂问题。研究意义重大，因为它将对那些积极应对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，包括个体科学家和追随者、专业医疗和科学组织以及监管机构，例如 FDA、联邦贸易委员会、国家卫生许可机构、患者和公众。