Blog post
Brain stimulation: proceed with care, whatever the purpose
Last week we published our latest report – Novel Neurotechnologies: intervening in the brain. In this post project leader Emily Postan explores some of the main recommendations in the report.
A central theme of this report is the need for ‘smarter regulation’ of neurotechnologies used in treatment. By this we mean neither more regulation, nor less, but rather a proportionate approach to oversight; one that works to promote innovation, while always putting the care and safety of patients and research participants first. The Working Party was keenly aware of the irony of seeking to protect patients with more regulation, while instead unintentionally delaying access to new technologies that offer the only prospect of treatment or assistance.
However, one category of novel neurotechnologies presented the Working Party with a different set of considerations: non-invasive neurodevices (those that work from outside the head) that are used to stimulate brain functions for non-medical purposes. There are a large number of studies looking at, for example, the ways in which transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (TDCS) might boost memory or reasoning. But the jury is still out on whether any small improvements measured observed under lab conditions would transfer in any meaningful way into real world situations. Nevertheless, you don’t have to be a futurologist to guess that, effective or not, ‘therapies’ supposedly offering these kinds of benefits could prove popular and that businesses might be interested in selling them.
You might ask, where’s the problem here? If people want to try these things they will and, as far as the evidence shows, the current use of non-invasive neurostimulation in research or treatment does not pose significant health risks. However, it is remarkable how little we understand about how the brain works generally and, more specifically, how it will respond to electrical or electromagnetic stimulation. We therefore cannot be sure what the unintended effects of TMS or TDCS might be if these were used in different ways outside the clinic or lab – for example, if the stimulation was longer, more frequent, or of higher intensity, or if the ‘customer’ had not undergone medical assessment for pre-existing risk factors. Moreover, uncertain or low level risks might be reasonable trade-offs when trying to treat serious conditions like depression or tinnitus, but it’s a very different story if the supposed benefits are dubious ‘improvements’ in a healthy person.
The prospective private use of neurostimulation devices outside the practical and ethical safeguards of healthcare makes it even more important that the products themselves are well regulated. Whether these devices are used to treat serious illness, or for more doubtful non-medical reasons, they are intervening in the brain in the same way. Yet in Europe a product will only be subject to the rules that apply to ‘medical devices’ if its intended purpose is itself categorised as ‘medical’. The Working Party judged, therefore, that the regulation of devices for non-medical purposes might need some more attention.
As it turned out, the European Commission had been thinking along parallel lines. In September 2012, the Commission published proposals for reforms to the regulation of medical devices. Amongst these is the suggestion that certain products, including dermal fillers for example, should be governed as medical devices irrespective of their intended use. Though the products currently listed in the Commission’s proposals have nothing to do with the brain, other similarities are clear: they too intervene in the human body and could be used outside healthcare. The especially important role that the brain plays in human life would seem to present an even stronger argument for including neurostimulation devices in this list – and this is one of the recommendations of the new Nuffield Council report. This has been misinterpreted by some media outlets as the Council calling for a quite different category of technologies – brain-computer interface controlled games – to be regulated as medical devices. The report’s recommendation in fact only relates to the regulation of non-invasive brain stimulation devices. The point is this: where a device stimulates the functions of our brains (for whatever purpose) it should be a) subject to the same kind of evidence requirements and post-market scrutiny deemed suitable for medical products and b) be overseen by a regulator that is accustomed to dealing with health matters.
We should rightly be wary of seeking to extend the reach of regulation where this presents greater hurdles to much needed therapies reaching patients. However, where there is no pressing medical need and the risks remain uncertain, a desire for more appropriate regulatory oversight is, we believe, a proportionate response.
A central theme of this report is the need for ‘smarter regulation’ of neurotechnologies used in treatment. By this we mean neither more regulation, nor less, but rather a proportionate approach to oversight; one that works to promote innovation, while always putting the care and safety of patients and research participants first. The Working Party was keenly aware of the irony of seeking to protect patients with more regulation, while instead unintentionally delaying access to new technologies that offer the only prospect of treatment or assistance.
However, one category of novel neurotechnologies presented the Working Party with a different set of considerations: non-invasive neurodevices (those that work from outside the head) that are used to stimulate brain functions for non-medical purposes. There are a large number of studies looking at, for example, the ways in which transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (TDCS) might boost memory or reasoning. But the jury is still out on whether any small improvements measured observed under lab conditions would transfer in any meaningful way into real world situations. Nevertheless, you don’t have to be a futurologist to guess that, effective or not, ‘therapies’ supposedly offering these kinds of benefits could prove popular and that businesses might be interested in selling them.
You might ask, where’s the problem here? If people want to try these things they will and, as far as the evidence shows, the current use of non-invasive neurostimulation in research or treatment does not pose significant health risks. However, it is remarkable how little we understand about how the brain works generally and, more specifically, how it will respond to electrical or electromagnetic stimulation. We therefore cannot be sure what the unintended effects of TMS or TDCS might be if these were used in different ways outside the clinic or lab – for example, if the stimulation was longer, more frequent, or of higher intensity, or if the ‘customer’ had not undergone medical assessment for pre-existing risk factors. Moreover, uncertain or low level risks might be reasonable trade-offs when trying to treat serious conditions like depression or tinnitus, but it’s a very different story if the supposed benefits are dubious ‘improvements’ in a healthy person.
The prospective private use of neurostimulation devices outside the practical and ethical safeguards of healthcare makes it even more important that the products themselves are well regulated. Whether these devices are used to treat serious illness, or for more doubtful non-medical reasons, they are intervening in the brain in the same way. Yet in Europe a product will only be subject to the rules that apply to ‘medical devices’ if its intended purpose is itself categorised as ‘medical’. The Working Party judged, therefore, that the regulation of devices for non-medical purposes might need some more attention.
As it turned out, the European Commission had been thinking along parallel lines. In September 2012, the Commission published proposals for reforms to the regulation of medical devices. Amongst these is the suggestion that certain products, including dermal fillers for example, should be governed as medical devices irrespective of their intended use. Though the products currently listed in the Commission’s proposals have nothing to do with the brain, other similarities are clear: they too intervene in the human body and could be used outside healthcare. The especially important role that the brain plays in human life would seem to present an even stronger argument for including neurostimulation devices in this list – and this is one of the recommendations of the new Nuffield Council report. This has been misinterpreted by some media outlets as the Council calling for a quite different category of technologies – brain-computer interface controlled games – to be regulated as medical devices. The report’s recommendation in fact only relates to the regulation of non-invasive brain stimulation devices. The point is this: where a device stimulates the functions of our brains (for whatever purpose) it should be a) subject to the same kind of evidence requirements and post-market scrutiny deemed suitable for medical products and b) be overseen by a regulator that is accustomed to dealing with health matters.
We should rightly be wary of seeking to extend the reach of regulation where this presents greater hurdles to much needed therapies reaching patients. However, where there is no pressing medical need and the risks remain uncertain, a desire for more appropriate regulatory oversight is, we believe, a proportionate response.
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