On July 22, 2013, Dr. Thomas Brown, Assistant Clinical Professor of Psychiatry and Associate Director, Yale Clinic for Attention and Related Disorders, published an open letter expressing his concern about recent FDA approval of a diagnostic device for ADHD that is not adequately supported by research and may become a barrier to diagnosis for some.
This open letter to Margaret A. Hamburg, M.D., Commissioner of Food and Drug Administration, begins:
Dear Commissioner Hamburg:
On July 15, 2013, your agency issued a press release reporting that the “FDA permits marketing of the first brain wave test to help assess children and teens for ADHD.” In this action your agency, apparently on the basis of a single unpublished study of 275 children, has created significant risks for those affected with ADHD.
Dr. Brown goes on to discuss the risk of giving undue weight to data from such a device at the expense of careful assessment of “how the individual functions in meeting the multiple demands of daily life.”
Bravo, Dr. Brown!