The New Scientist reports that Brain Plasticity, Inc. a developer of cognitive training games, has entered into discussions with the FDA to market one of its brain training software packages as a bona fide therapeutic. The issue is of interest on many accounts, and the New Scientist article covers many of the obvious ones that were discussed at the Entertainment Software and Cognitive Neurotherapeutics Society meeting held last week in San Francisco. Noteworthy among them are the hope that FDA approval will bring validity to a field that has both serious practitioners and
charlatans others who cut corners, as well as the concern that FDA approval might slow down progress, as the approval process is likely to be glacial compared to the pace of change in software development.
But if we unpack this a bit, we find that there are deeper levels of significance, and at least one of these are is worthy of further discussion.
Regulatory authorities such as the FDA have as their mandate to insure that products are both safe and effective. Let’s assume for a moment that the cognitive training game brought before the FDA is effective (evaluating this sort of claim should be fairly straightforward). However, if a particular cognitive training game is effective, by definition, it has changed the brain in some way; there is simply no other way that it could be effective (or at least none that I can think of). While everyone hopes for improvements in cognitive function with these games, there is no guarantee that the resultant changes will all be benign, or put more correctly, that they will be benign in everyone who tries the games. This lurking safety issue has been discussed, at least in passing, at the Sharp Brains Summit both this past year and the year before, and now will rise to the level of at least discussion with the FDA, if not actual guidance on the kinds of safety assessments that they would ask for before considering a submission.
But if one continues to pursue this line of thinking a bit, one is led inexorably to a nettlesome conclusion that I have harped on more than once: everything that we do, from reading a book to walking the dog to eating an apple, changes the brain in some way. I have discussed it most pointedly when raising concerns about the effects of repeated multitasking on our ability to pay attention, but the truth is that our brains are constantly inundated with information that causes them to change. Sometimes for the better. Other times, maybe not so much.
It turns out that the public is at least minimally aware that cognitive training games may have side effects. In our research group, we are running experiments which utilize contrastive vignettes to examine attitudes towards cognitive enhancement, and for various reasons we wanted to compare how people perceived pharmacological versus non-pharmacological interventions. In order to insure that our vignettes had veracity, in a pilot experiment run on MTurk we included a description of a mild side-effect that arose with the drugs, and to balance matters, told survey respondents that the same side-effect was present in a matching vignette that described a software program. As part of our pilot experiment, we wanted to insure that people found the side-effect plausible, and so we asked them what they thought. Remarkably, people found it equally plausible that the software would have a side-effect as they found it when we told them there was no side-effect.
The public may be somewhat more neuroessentialist than we think.