As part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, President Obama asked the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.”
This morning, the Bioethics Commission resumed its consideration of ethical issues related to direct-to-consumer (DTC) neuroscience, including products like dietary supplements, neurofeedback devices, and even memory games. At its last meeting, the Bioethics Commission heard from experts representing the U.S. Food and Drug Administration and the neurotechnology sector. Today, another regulatory expert from the U.S. Federal Trade Commission (FTC) kicked off the discussion.
Serena Viswanathan, J.D., assistant director of the Division of Advertising Practices in the FTC’s Bureau of Consumer Protection, addressed what companies that produce, advertise, and market DTC neuroscience products must do to meet the FTC’s regulatory requirements.
“The basic principles of FTC advertising law are that advertising must be truthful and not be misleading and that advertisers of products must have a meaningful basis for their advertising claims,” said Viswanathan. “Neuroscience is a complicated area but the basic evaluation we would do is similar to any other health case.”
Margaret Eaton, Pharm, D., J.D., former research scholar at the Stanford University Center for Biomedical Ethics and former lecturer at the Stanford University Graduate School of Business and School of Medicine, gave a presentation entitled “Ethical Responsibilities of DTC Neuroscience Companies.” Eaton focused on the potential ethical responsibilities of DTC neuroscience companies to customers around concerns such as validity and safety requirements, protection of consumer privacy, and transparency of conflicts of interest.
As an example of problematic advertisements for neuroscience-based products, Eaton described how some manufacturers of psychotropic drugs have sought to create a perceived need for their products by encouraging consumers to take self-assessment tests developed by or for the company. Eaton said she took one such test, which included 20 questions such as did she ever feel “down-hearted, blue, or sad.” The available answers were “not often,” “sometimes,” “often” or “all the time.” To every question, she answered “sometimes.”
“Most people sometimes have felt these symptoms; in other words, I think it’s normal,” Eaton said. “However, my answers resulted in a recommendation to see my doctor for an evaluation of depression.”
Eaton also acknowledged that when it comes to the issue of conflict of interest, the main focus has been financial gain. However, she agreed that in academia the conflicts could be stronger when it comes to what she called “reputational perks.” Such perks, she said, “lead to promotion, recognition, grants, and they are intricately linked. We do a disservice when we exclude these from conflicts of interest.”
The Bioethics Commission will use this discussion to transition into sessions it has scheduled for the rest of the day during which it will deliberate and formulate its recommendations related to neuroscience research for the President.