Why Human Enhancement Needs Regulation (But Not Too Much)

“Would you like me to give you a demo ?” she asks, while putting on a sort of spongey headband and placing electrodes against her forehead. “This is what we call a montage. It is supposed to improve your insightfulness, but really it makes me feel better, it improves my mood.”

Kate (not her real name) is the co-founder of a company manufacturing and selling tDCS devices. tDCS, which stands for Transcranian Direct Current Stimulation, is a method of neurostimulation that works by delivering a low current (from 12V to 24V) to the brain. Such devices have been used for decades by some to try and treat patients suffering from depression, as part of “electrocompulsive therapies”.

However, tDCS devices recently increased in popularity among the DIY (“do it yourself”, ed.) community, which started building and using their own devices at home, mostly to enhance their cognitive abilities and learning skills. The trouble is that using such “homemade devices” can be hazardous. “When people started, including myself, we would have these scars on our foreheads, these burns, and it was just completely acceptable,” Kate explains. “That is what we wanted to address by putting a meter and ramp-up feature on our devices.” The somewhat “amateurish” look of tDCS devices is a remnant of their DIY origin.

[Kate] finds herself in a precarious legal situation due to the lack of government regulation or guidance

Although Kate has links on her website leading to Reddit posts written by the DIY community, she disagrees with their approach. “They act like these things are not harmful, or no big deal, and they think that the retailers like myself are just positioning themselves to sell devices,” she says. “They say that meters or ramp-up features are merely luxuries, but they are not. The medical community wrote an open letter to the DIY community, saying that a difference of only 1 milliamp can significantly change how your brain reacts to electric stimulation.”

Despite these risks, the Food and Drug Administration is not regulating tDCS devices, as they are not regarded as medical devices. “We do not offer medical advice and these are not medical devices,” Kate stresses on her website. Indeed, the businesswoman denies (at least legally) any responsibility, and expects her consumers to do their own “due diligence” and to learn as much as they can before purchasing their own device. She finds herself in a precarious legal situation due to the lack of government regulation or guidance in this sector. “For instance, I am also a surf instructor in California, and a lawyer told me not to say on my website that I knew CPR, because if I say I know CPR and I don’t perform it properly, then I am liable. I find that saying these are not medical devices is a little disingenuous, but this is as legal as I can position myself.”

If tDCS were to be regulated by the FDA, consumers would have too high expectations about their efficiency, and would not be aware of the risks, however low those may be.

The renewed media interest in tDCS devices however raises another issue. “We have these waves of people who are very vulnerable,” Kate explains. “They are buying something off the internet that is unregulated, based on false claims. They can lose their jobs because their mind is not functioning properly, or suffer from schizophrenia or severe depression.” Herein lies the paradox. The tDCS market relies on it remaining a niche- as more and more people become interested in these devices, the risks are increasing and the need for regulation is becoming more evident. However, according to Kate, if tDCS technologies were to be regulated and approved by the FDA, consumers would have too high expectations about their efficiency, and would not be aware of the risks, however low those may be. “The regulatory bodies have not been responsible enough, and people tend to take regulatory bodies too seriously and not trust themselves to learn how to enhance themselves,” she explains. “Because these devices are not properly regulated, we need to have a really healthy dialogue around selling them, so that when somebody reaches for a device, and has done his due diligence and understands that this is really low risk, he does not have too much expectations.”

Of course, I asked Kate about the position of her new President on bioethics. “This is a personal position, but I think it is very very very dangerous to speculate about Donald Trump. I don’t think he is aware of anything subtle, that he can even take on the concept of bioethics, and I think that if someone were to present it to him he would have a very inappropriate and heavy-handed response. His executive order on abortion was to appeal to a certain part of the electorate, but I think this is going to kill his presidency, as there’s nothing that will organize the Left more than abortion rights.”

Regulation may become a necessity, but drafting ‘pre-regulation’ is crucial.

tDCS devices may still be a niche for the moment, but transcranian stimulation is currently one of several examples of human brain enhancement. In the future, this type of practices could become increasingly common, which will not come without risk. Kate is convinced that regulation may become a necessity, but she also thinks that drafting ‘pre-regulation’ is crucial. “This way,” she explains, “by the time the regulatory body is coming to check in on this, there is some degree of self-regulation between the user and the manufacturer, that they have to take into account.”

However, the question remains of how to ensure safe access to enhancement for everyone if not through government regulation of these technologies. “My personal belief”, Kate answers, “is that people should have access to these technologies and be able to educate and empower themselves, but the government should never have any position of yay or nay, and here’s why: the government has already released medications to the general public without knowing what the ramifications are. Those things have been approved and regulated, but they have caused harm. “However,” she continues, “what’s interesting is that, because the government has not approved something, then people don’t feel like they can trust this technology, and I don’t think this is a bad thing. That might be the first layer of protection for myself as a manufacturer, and for users. But I don’t think that we’ve yet seen a good answer to that question.”