Whose lifestyle benefits? Regulatory risk-benefit assessment of enhancement devices

Nearly everyone would agree that a device or drug that relieves pain, or alleviates symptoms of depression confers a benefit – plausibly, a substantial benefit – on its user. No matter what your goals are, no matter what you enjoy, you are likely to agree that your life will go better if you are not in pain and not depressed: whether you’re a painter, a footballer, a Sudoku-enthusiast or a musician, you will be better able to pursue your projects and engage in the activities you love. It is unlikely that you will even question whether pain relief or alleviation of depression indeed constitute benefits.

This general consensus with respect to medical benefits makes it relatively straightforward for regulators to conduct risk-benefit assessments of medical products when they decide whether a particular product can be put on the market. A very small risk of a mild rash or gastrointestinal upset, for example, will be considered reasonable in the context of effective pain relief, as long as patients or consumers are informed. Even as the risks get more significant, substantial pain relief will be considered a large enough benefit to out-weigh a range of negative side effects in many cases.

So far, so straightforward.

However, a new class of consumer devices, promising enhancement effects, create a challenge for this sort of risk-benefit assessment, were a similar approach to be adopted. Whilst there is a general consensus that pain relief is a benefit, and that the size of this benefit can be substantial, it is much harder to say how beneficial a small improvement to ‘healthy’ working memory is, for example. Things would get even harder if we imagine enhancements resulting, perhaps, in a more discerning palate for wine, or higher resolution colour differentiation in art and design. Determining how beneficial these effects are would be of little importance if they came at no cost, but emerging devices, promising a whole range of cognitive and physiological enhancement effects, are far from risk-free.

In 2004, Martha Farah and colleagues predicted,

Regulatory agencies might find their responsibilities expanding into considerations of ‘lifestyle’ benefits and the definition of acceptable risk in exchange for such benefits.

Twelve years on, the proliferation of devices such as foc.us (for enhanced gaming and athletic performance) and thync (for energy and relaxation) are generating precisely this challenge. Given the risks posed by brain stimulation, any regulatory assessment of risks and benefits must, it might seem, involve difficult judgments about the nature and relative significance of the benefits, if any, of using the device.

The problem arises because, unlike the consensus with respect to the simple examples of pain relief and similar medical benefits, there is much less agreement regarding the extent to which a person benefits from improved gaming skills, athletic performance, or some other putative enhancement. There is less consensus because the value that individuals place on different enhancement or ‘lifestyle’ effects diverges much more than the value individuals place on paradigmatic effects of medical products. We value things that help us perform well at activities we enjoy or find important: not being in pain is helpful to pretty much everyone, but slightly better gaming focus or working memory is only going to be beneficial to you if it helps you pursue your valued goals.

This is not to say that we can’t measure the improvements that enhancement devices promise. Improvements in memory or verbal fluency, for example, can be measured in experimental conditions. The problem, rather, is in determining how beneficial these functional improvements are – determining their ‘worth’ or ‘value’ – and whether they are beneficial enough to justify any associated risks and side effects. Would the risk of nausea and visual disturbances be a fair price to pay for improved gaming skills? What if a brain stimulation device poses a serious and permanent risk to brain function – would this still be a fair price? Views will differ considerably.

The point is brought out even more clearly if we consider potential enhancement devices which achieve their promised effects through functional impairment. For example, whilst not currently available as a consumer device, studies have shown that transcranial magnetic stimulation of part of the left side of the brain (the left fronto-temporal lobe) can be used to create a ‘virtual lesion’, inhibiting the usual activity of the brain that continuously tries to ‘make sense’ of the things we see and hear – to make things meaningful in light of what we know and have experienced before. The study showed that inhibiting this top-down prior pattern matching improved proof-reading and drawing skills, amongst other things.

How would regulators even begin to measure the size of the ‘benefit’ of this functional impairment? Clearly, if there were a consumer device available for this purpose, proof-readers and some artists might find its effects hugely valuable and thus see them as substantial benefits. Most of us, however, would not: the brain’s propensity to match what we perceive to prior experience is essential to healthy functioning in many other domains of cognitive activity.

I suggest that this difficulty in conceptualizing and quantifying lifestyle, or enhancement benefits points to allowing consumers the freedom to make these assessments themselves. Indeed, people’s ideas about which enhancements will be beneficial to them will plausibly show much more variation than their ideas relating to standard treatment effects. This does not mean, however, that there is no role for regulators in the emerging market for cognitive enhancement devices. Given the right framework, regulators can require that manufacturers provide consumers with sufficient information about risks and benefits. They can also protect consumers from devices that are unnecessary risky or demonstrably ineffective by preventing such rogue devices from entering the market.

As more and more devices promising lifestyle benefits enter the market, regulators may indeed have to extend their considerations in order to protect consumers from falling for outlandish claims and from selecting devices that are unnecessarily dangerous. However, I suggest that regulators cannot – indeed – should not try to ascertain how valuable a particular lifestyle benefit is but, instead, attempt through regulatory oversight to promote safety whilst empowering consumers to exercise their own judgments about whether their own lives will benefit.

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One Response to Whose lifestyle benefits? Regulatory risk-benefit assessment of enhancement devices

  • Alexander Schacht says:

    Hi, this is a Great article as it goes to the extreme and therefore highlights the problem with not taking patient preferences into account. I’m writing a blog about benefit risk. Would you be open for a contribution there?

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