In the Matter of Carrot Neurotechnology, Inc., File No. 1423132 #00005

Submission Number:
Ione Fine
Initiative Name:
In the Matter of Carrot Neurotechnology, Inc., File No. 1423132
To whomever it may concern, Having worked in the field of visual prostheses and perceptual learning I would like to express my concern on the recent FTC decision. The first concern I have is that a decision regarding quality of science should not based on whether or not a double-blind placebo control trial has been carried out. While double-blind placebo trials are rightly considered the gold standard for medical intervention protocols, they are not always appropriate or feasible. In the case of visual prostheses (for example) it would obviously be unethical and unfeasible to carry out a genuine double-blind trial. It would be better if the FTC used as a criterion - 'does the science meet a similar quality of evidence that would be provided by a double-blind placebo trial, or as close to it as is practicably and ethically possible'. My second concern is that differences in how different disciplines evaluate science may have resulted in this plaintiff being unfairly penalized. Within the field of neuroscience/psychology the perceptual learning claims made by the plaintiff are well established within extremely respected journals. The issue is that these were neuroscience journals not medical journals, and therefore rely on different (not weaker) criteria for scientific evidence. I am not clear what the FTC regulations are, but unless they clearly specify the need for a double-blind placebo trial and/or clearly specify which journals (i.e. medical not neuroscience) are considered acceptable then this should be considered an ambiguity in the regulations that the plaintiff should not be penalized for. Finally I'd like to point out that perceptual training should be considered more closely analogous to psychotherapy or speech therapy than a medical intervention. Like psychotherapy the goal is to make the brain (whether emotional management, speech, or vision) work better, without any physical intervention. I am not sure what standards are required for psychotherapy or speech therapy treatments to be considered effective, but these are the standards that should be applied to perceptual learning treatments for vision. Ione Fine Professor of Psychology Associate Professor of Ophthalmology and Radiology Co-Director of the University of Washington Imaging Center University of Washington