In the Matter of Carrot Neurotechnology, Inc., File No. 1423132 #00013

Submission Number:
00013
Commenter:
C. Shawn Green
State:
Wisconsin
Initiative Name:
In the Matter of Carrot Neurotechnology, Inc., File No. 1423132
I have deep reservations about this particular section of the complaint against Carrot Neurotechnology: "...competent and reliable scientific evidence [must be of sufficient] quality and quantity, based on standards generally accepted by experts in the relevant field...Such testing shall (1) be randomized, double-blind, and adequately controlled." First, it is not clear to me that a behavioral training study can ever truly be "double-blind" - in that it is always necessarily going to be the case that participants will know exactly what they're being asked to do during training. There is simply no way to ask a participant to perform a task while simultaneously blinding them to what they are doing. It *may* be possible to hide the "intent" of the training - but there is currently no agreed upon consensus in the field as to how to do this or even how to measure the efficacy of any manipulation designed to hide intent. Second, it is not clear to me that there is any scientific consensus whatsoever as to what constitutes "adequate control" in this domain. There is no behavioral training "sugar pill." There is definite consensus that some control is necessary in behavioral training. But there are large variations in what different researchers would consider "adequate." It is also essential to note that controls that scientific investigators would consider to be adequate are likely somewhat unrelated to what would be considered an adequate control for an efficacy study. Typically, scientific investigators are less interested in questions about base efficacy and more interested in questions related to mechanism leading to very different standards for controls. Thus, in all it is troubling to see the phrase "standards generally accepted by experts" followed immediately by requiring standards that are not those currently accepted by experts. Indeed, if I were tasked by a company with designing a study that would meet the criteria listed above, I would tell the company that it is unclear to me whether such a study can in fact be designed. I would urge the commission to very carefully consider the differences between behavioral training products and other products whose advertising has historically been under the purview of the FTC (e.g. herbal supplements). While efficacy studies of herbal supplements can absolutely utilize the traditional medical "double-blind, placebo controlled" model, the fundamentals surrounding behavioral training studies make this much less possible.