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

> **NIH NIH DP5** · UNIVERSITY OF PENNSYLVANIA · 2021 · $402,500

## Abstract

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
Tra...

## Key facts

- **NIH application ID:** 10247744
- **Project number:** 5DP5OD026420-04
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** ANNA WEXLER
- **Activity code:** DP5 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $402,500
- **Award type:** 5
- **Project period:** 2018-09-17 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247744

## Citation

> US National Institutes of Health, RePORTER application 10247744, Do-it-Yourself and Direct-to-Consumer Medicine and Science: Assessing the Public Health Issues and Regulatory Gaps (5DP5OD026420-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247744. Licensed CC0.

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