In the Matter of Carrot Neurotechnology, Inc., File No. 1423132
I am extremely concerned to learn that the FTC is applying the single standard of large scale, randomized, double blind, placebo controlled studies in order to accept the evidence based claims of cognitive and neurotherapeutic technologies. It is indeed essential that claims made for the therapeutic effect of any such therapeutic cognitive training or "brain training" product be backed by and translated directly from solid scientific evidence. This is almost certainly NOT the case for the vast majority of such products that are currently widely available and purchased in the marketplace currently. Thus, it is both disturbing to learn of the professional, financial and personal damage at which Carrot Neurotechnology and its principals are facing. This is because there are all too few scientists currently attempting to translate their very solidly developed, rigorously tested and widely evaluated data into therapeutic products that could benefit society widely. The few who are doing so are not motivated by profit and, in the case of those employed by public universities, frequently do not even own the intellectual property behind their inventions. Instead their goals are primarily to deliver on the contract of federal funding such as that provided by the NIH, which provides taxpayers' money to expert scientists so that, in many cases, they can work towards findings that improve public health, well-being and quality of life. I believe that is the case here. There are many other ways to firmly establish the evidence base behind a therapeutic technology without needing to carry out a double blind, placebo controlled trial though that is a gold standard for pharmacological treatments that can, and mostly at some point, should be applied to neurotherapeutic technologies in order to address most, but not aspects of efficacy and mechanism. Such trial designs are, in most but not all cases, sufficient but not necessary ways to assess some, but not all, scientific questions. The federal response to the case in question appears to be somewhat rigid in its interpretation and serious if not draconian in its response. Should this continue to be the standard then it will act as a huge disincentive to many other similar scientists who are hard at work on similar kinds of products based on similarly large, well founded and translationally significant evidence bases. The ultimate losers in such a scenario would be the general public that, by this action, the FTC believes it is acting to protect. As such it sets a very bad precedent and its actions should be reconsidered.