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

项目总结 近年来，自己动手(DIY)医疗运动和直接面向消费者(DTC)的健康技术 已向公众提供以前被隔离在 科学和医学的“象牙塔”。虽然科学和医学的民主化持有巨大的 潜在的，它也带来了前所未有的公共卫生问题：个人可能自我管理 有害的实验性疗法(如粪便移植)，购买未经测试的消费品(如 大脑刺激设备)，几乎没有监管监督，并自掏腰包接受 未经证实的神经治疗在“大脑健康”诊所由无证从业者经营。除了公众之外 健康问题，这些现象对科学家和 临床医生、专业医疗和科学组织以及联邦和州监管机构。承认…… 这些挑战，FDA，NIH，国家医学科学院，美国艺术学院和 科学界(以及其他)最近都召开了关于这些主题的会议。 然而，到目前为止，还缺乏关于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，这些 现象产生了。我的长期目标是建立一个跨学科的研究议程，将经验与 以对伦理和监管问题的务实分析为基础的社会学研究，目的是 制定新的战略，以最大限度地提高卫生保健服务的效益并将公共卫生风险降至最低 医学和科学的民主化。本项目的目标是全面研究(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 并找出相关的政策差距。拟议的研究旨在：(A)调查 导致DIY医学运动的产生、发展和吸收的机制，通过进行 对三个案例研究进行比较分析；(B)查明DTC监管方面的弱点 神经科技及发展新的政策解决方案；及。(C)研究由“大脑”引起的公共健康问题。 通过对这些诊所进行研究，并分析它们在州一级的法规，可以获得“健康”诊所的服务。这 提案是创新的，因为它结合了社会学技术(即访谈和调查)和深入的 法律分析，以解决一个复杂的问题，而不适合于单一的方法。建议数 研究意义重大，因为它将对那些积极与之搏斗或受到影响的人产生直接影响 随着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、专业医疗和科学组织以及监管机构，如FDA、联邦 贸易委员会、国家卫生许可机构、患者和普通公众。

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.