Outside the United States
In the Matter of Carrot Neurotechnology, Inc., File No. 1423132
Dear FTC staff, Preventing unsubstantiated claims on products to protect consumers is indeed an important service to the public, and I agree that some of the statements on the Ultimeyes website were, at certain times, somewhat overstated and needed correction and toning-down. On the whole, however, I am deeply worried by the present regulation which, I feel, is unfair, is overly aggressive to a point where the scientific community will feel threatened, and in particular lacks a scientific basis. The crucial point in my view is the inappropriate decisive role that is ascribed to the double blind standard as the ultimate proof of effectiveness. Citing from the FTC guidelines, "For purposes of this Part, competent and reliable scientific evidence shall consist of human clinical testing of the Covered Product (…) based on standards generally accepted by experts in the relevant field, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall (1) be randomized, double-blind, and adequately controlled (…)" Now, while double blind studies are, without doubt, a sensible standard for pharmaceutical and many other medical treatments, their usefulness in sensory or cognitive training is doubtful at the least. The double-blind design is certainly not "generally accepted by experts in the relevant field(s)", which are the fields of visual learning, and sensory and cognitive training. The difference to pharmaceutical treatments is that for these a placebo can be made to be indistinguishable from the verum, so that the patient is unaware of the situation, whereas in sensory training an awareness of the visual stimulus cannot be prevented. It is, quite to the contrary, often a necessary prerequisite for the treatment. So, requesting blindness to the situation on the side of the subject in a sensory task borders on the absurd. By the same token, the distinction between a verum effect, i.e. the effect of the training itself, and a placebo effect, i.e. the effect of *administering* the training, becomes blurred or meaningless. Last not least, even if the effect of training were purely that of a placebo, that would not mean there is no real effect of the training: Placebo effects are real and can be substantial. As an aside, the secondary blinding, which is on the side of the experimenter and is used to prevent the Rosenthal effect, is easily achieved in testing the training effect. It is, however, of less importance since the outcome measures are typically quasi-objective (as in a forced-choice task), that is, depend little on the experimenter's expectations. In summary, the double blind procedure is of rather limited value as a scientific test for the efficacy of sensory or cognitive trainings. I am Hans Strasburger, Prof. of Medical Psychology, and bio-psychologist and vision scientist since more than 40 years. I have published extensively on all matters of vision and medical treatment including sensory training, with 70 journal papers, books and book chapters.