Bioethicists call for surveillance of "neurotechnologies" of consumers, unproven benefits

The commercialization of consumer "neurotechnologies" can be attractive: applications that diagnose a mental state and brain devices that improve cognition or "read" one's emotional state. However, many of these increasingly popular products are not fully supported by science and are not subject to regulatory oversight, posing potential health risks to the public. In a new article published in the newspaper Science This week, two bioethicists from Penn Medicine and the University of British Columbia suggest the creation of a task force to study, monitor and better guide this growing sector, which is expected to reach $ 3 billion. dollars by 2020.

"There is a real thirst for knowledge about the effectiveness of these products to the public, which remains unclear due to this lack of surveillance and knowledge gaps," said lead author Anna Wexler , Ph.D., a professor in the Department of Medicine's Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania. "We believe that a diverse and dedicated group would help safeguard or refute the demands made by companies, determine what was safe, better understand their use by consumers and respond to possible ethical concerns."

The group, made up of researchers, ethicists, donors and industry experts, would serve as a clearinghouse for information to regulatory bodies, such as the US Food and Drug Administration (FDA) and the US Food and Drug Administration. the Federal Trade Commission (FTC). ), third party organizations that monitor advertising claims, industry, medical and social scientists, funding agencies and the general public.

While some of these techniques are used in clinical and research laboratories, for example, electroencephalography (EEG) devices are used to diagnose and treat epilepsy, but many consumer versions of these techniques are available. neurotechnology devices are only loosely based on science. It is unclear whether the laboratory data collected for testing is applicable to consumer products, which leads many scientists to question the effectiveness of these techniques and products and to advocate for Regulation.

For example, some consumer neurostimulation devices may present hazards, such as burns of the skin. There are also potential psychological disadvantages badociated with many consumer EEG devices that claim to "read" their emotional state.

"If a consumer EEG device incorrectly shows that an individual is in a state of stress, this can make him stressed or put him in state, resulting in undue psychological harm," wrote the authors. In addition, a smartphone wellness app that diagnoses the symptoms of depression does so without any medical support structures, such as a psychologist or a mental health counselor.

Devices thrived in part through minimal regulatory oversight. Many of these do not fall under the jurisdiction of the FDA because they are categorized as "low risk" wellness products, thus opening an easier route to market access. In addition, investors interested in financing these devices have publicly stated that it would be difficult to invest in these devices if they had to obtain FDA approval, which would involve rigorous testing and time.

At present, the FTC, which has the power to act in the event of false advertising, badumes most of the regulatory burden on consumer neurotechnology. However, with thousands of health and wellness applications and devices, this surveillance is ill-suited to effectively monitor and regulate the sector, they said.

The authors' proposal is twofold: to create an independent working group that would examine the main areas of direct consumer neurotechnologies and provide brief badessments of potential drawbacks and likely effectiveness. Rather than evaluating each product or providing overall coaching issues, the badessments of the proposed working group would define the evidence base and potential risks, and identify gaps in current knowledge.

This working group would be responsible for disseminating these badessments to the public and forging partnerships with organizations well placed to communicate with key consumer groups.

"Since government agencies and private companies are actively funding research on new methods of modulating brain function," wrote the authors, "the current generation of [direct-to-consumer] Neurotechnologies are perhaps only the visible part of the iceberg, making it all the more imperative to create an independent body to monitor the evolution of this area. "

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Perelman School of Medicine at the University of Pennsylvania