In the Matter of Carrot Neurotechnology, Inc., File No. 1423132 #00051

Submission Number:
00051
Commenter:
Frederick Gallun
State:
Oregon
Initiative Name:
In the Matter of Carrot Neurotechnology, Inc., File No. 1423132
My name is Frederick Gallun, PhD, and I am a Research Investigator at the Dept. of Veterans Affairs National Center for Rehabilitative Auditory Research and an Associate Professor in the Neuroscience Graduate Program at Oregon Health and Science University. These opinions are my own and I am not representing either institution. In addition to running a lab studying auditory dysfunction in clinical populations which has been funded by VA and NIH for the past decade, I serve as Associate Editor for the Journal of the Acoustical Society of American and am asked to review articles for many other journals each year. In addition to being a creator of basic and clinical research, I am one of the many evaluators of such research. I thus am deeply involved in the question of what constitutes scientific proof in our field on a daily basis. It was in this capacity that I first met Dr. Seitz and through this lens that I evaluated his research. I was deeply impressed by the rigor of his methods and the strength of his results and quickly invited him to assist me in developing auditory versions of his visual experiments. I am writing this response as I believe that the FTC has misapplied its criterion for evaluating claims that the effects of a device have been scientifically proven. According to previous decisions, the FTC in evaluating claims of scientific proof "determines what evidence would in fact establish such a claim in the relevant scientific community and then compares the advertisers' substantiation evidence to that required by the scientific community." In this case, it is my considered opinion that it is inappropriate to conclude based on the absence of randomly-assigned double-blind studies, that the claims made were not consistent with the standards of "the relevant scientific community". In perceptual experiments it is impossible to produce an intervention to which the participant is "blinded" in the way that a pill or a cream can appear to be identical regardless of whether or not the active ingredient is present. Because of this fundamental issue, the double-blind study is not the relevant standard of scientific proof. Rather, the use of precisely those methods upon which Dr. Seitz depended in his studies are the highest standard of proof currently available. Dr. Seitz is currently the head of the UCR Brain Game Center, which was founded to improve the state of the art in the field and to lead the search for clearer and more compelling methods. To mischaracterize his studies in this way and to fine him personally for the statements made will have a chilling effect on the field and will drive scientists away from attempting to make their findings available to the public. It is appropriate for the FTC to work with scientists to be sure that the ways in which their work is being portrayed is clear to the public. Dr. Seitz has been highly responsive to these requests, which is a fact that should be taken into account. The fine imposed may seem small in the arena of multinational corporations, but represents the majority of the savings of many scientists working at public universities. The translational of laboratory findings into clinical practice is an important and difficult goal on which an insufficient number of scientists are working. I urge the FTC to reverse this decision and show that it understands the chilling effect such a decision could have on the entire field. I do not believe any action is appropriate in this case, because the studies relied upon by Carrot meet the standards of the "relevant scientific community." I urge the Commission to reverse its sanctions entirely. This is particularly appropriate for cases such as Carrot where the device at issue is extremely low-risk and the respondents immediately changed their advertising as instructed by the FTC. However, in the event that it chooses not to do so, I urge the Commission to drop the fine against Dr. Seitz so as to minimize the chilling effect