Regulating At-Home Medicine

In a conversation with The Regulatory Review, Anna Wexler, an expert in emerging health technologies, discusses the rise of do-it-yourself (DIY) medicine and how regulators can intervene to protect consumers.

With the rise of telehealth services during the COVID-19 pandemic—including telemedicine and wearable technologies that allow for self-monitoring of one’s health—the convenience of accessing care at home has become commonplace. Today, more patients are experimenting with health care treatments at home, which Wexler argues stems from a growing dissatisfaction with mainstream medicine.

Wexler contextualizes the emergence of the DIY medicine movement. She describes how patients may find available treatments insufficient to meet their needs. Often tech-savvy, these individuals turn to online forums to connect with others, where they exchange information on how to self-administer experimental or inaccessible therapies without medical supervision.

Wexler also identifies safety concerns associated with DIY medicine that regulators should work to address, but she recognizes the barriers to regulating in ways that promote consumer safety. For example, DIY medicine often involves the exchange of information rather than products regulated by the U.S. Food and Drug Administration (FDA). Given the difficulties associated with devising a comprehensive regulatory scheme, Wexler emphasizes that federal agencies should prioritize educational and warning efforts to protect consumers.

Wexler is an assistant professor of medical ethics and health policy at the University of Pennsylvania. She is the principal investigator of the Wexler Lab, where she studies the ethical, legal, and social issues associated with emerging technologies. Wexler is on the board of the International Neuroethics Society and is a senior fellow at the Leonard Davis Institute for Health Economics at the University of Pennsylvania. She is an associate editor of AJOB Neuroscience, and her work has been published in media outlets such as The New York Times and The Washington Post.

The Regulatory Review is pleased to share the following interview with Anna Wexler.

What is DIY medicine?

Wexler: DIY medicine refers to health practices that exist outside the mainstream. The term is most commonly used to describe lay individuals—those without professional medical training—who self-administer therapeutics outside of traditional medical or scientific settings. Examples include DIY brain stimulation, which refers to those who stimulate their own brains with electricity outside of scientific settings; DIY fecal microbiota transplants, which involve those who self-administer stool transplants to treat bacterial infections; those who use psilocybin to treat cluster headaches; patients with diabetes who hack into devices used to manage their diabetes; and DIY hormone replacement therapy, whereby transgender individuals source and self-administer black-market hormones.

What factors lead to the emergence of DIY medicine?

Wexler: I’ve argued that there are four key factors that set the stage for individuals to participate in a DIY medical movement.

First, it involves a population suffering from a disease or condition for which current treatments are ineffective. Second, the internet and online discussion forums provide outlets for these individuals, and their loved ones, to rapidly share information about treatments. Third, individuals face some type of access barrier to an effective treatment: Either a therapy is still experimental, or it exists, but individuals lack access to it due to cost, geographic barriers, or stigma.

Finally, for a DIY movement to gain momentum, the treatment must be relatively easy to access or create. For example, in DIY neurostimulation, users build at-home brain stimulation devices using parts sourced from electronics stores. DIY fecal microbiota transplants involve sourcing stool, a material that anyone can access, and online pharmacies readily provide hormones to those interested in DIY hormone replacement therapy.

Are there recognizable demographic trends or patterns among people who participate in DIY medicine? 

Wexler: The population of users varies by type of DIY medical movement, and there are no clear demographic trends across all movements. Because these movements often coalesce around online forums, individuals—or their loved ones—are often internet-savvy. Research on users of DIY neurostimulation, DIY fecal microbiota transplants, and DIY diabetes treatments has found that users tend to be white, highly educated, and of higher socioeconomic status. But the population of users of DIY hormone-replacement therapy does not appear to share these same demographic characteristics.

What concerns, if any, do you have about DIY medicine?

Wexler: DIY medicine can present significant safety concerns. For example, in DIY fecal microbiota transplants, individuals transplant donor stool into their own bodies, but they typically do so without testing the stool for pathogens. In DIY diabetes treatments, in which users hack together insulin pumps and glucose monitors to create closed-loop systems that administer insulin, there is a risk of accidental insulin overdoses. And for other movements, such as DIY brain stimulation, the long-term effects of electrical stimulation on brain function are unknown.

How might regulators address these concerns?

Wexler: DIY medicine presents significant regulatory challenges. Even though FDA regulates drugs and medical devices sold in interstate commerce, DIY medicine primarily involves the exchange of information about medical practices rather than the sale of medical products. FDA doesn’t regulate information being exchanged among patients on online forums regarding their at-home treatment practices.

Still, FDA does have a broader public health role to play in regulating DIY medicine. For example, in 2019, the agency issued a warning against the use of unauthorized devices for diabetes management after a patient suffered an accidental insulin overdose. Similarly, in 2017 FDA cautioned against the self-administration of gene therapy. FDA can—and probably should—significantly enhance its public education and engagement efforts in this area.

Does the adoption of DIY medicine reflect any broader trends or weaknesses in the U.S health care system?

Wexler: Absolutely! This is a topic that often comes up in my classes—how DIY medical movements arise in response to perceived weaknesses in our health care system. Patients don’t feel like they are getting access to effective therapies, even when those therapies do exist. Often they are desperate, so they turn to whatever means possible—even at-home DIY medicine—in an attempt to relieve symptoms for themselves or loved ones.

What are the biggest challenges associated with regulating devices used in the DIY medicine movement?

Wexler: Much of DIY medicine involves information exchange and not the sale of devices. In some movements, however, like DIY brain stimulation, there are companies that sell devices, such as at-home brain stimulation devices. The challenges here include the fact that some of these companies do not make medical claims—instead selling their products, for example, as mere electrical devices. Or they make more ambiguous wellness-like claims, such as how their devices can “enhance your brain.” The accuracy of these claims can be hard to assess.

Both FDA and the U.S. Federal Trade Commission have roles to play here. But the biggest challenge is probably the limited size of these agencies relative to their significant responsibilities. This makes adequate enforcement particularly difficult, especially when confronted with a proliferation of smaller mom-and-pop DIY companies.