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

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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.