Misuse of the FDA's humanitarian device exemption in deep brain stimulation for obsessive-compulsive disorder
Abstract
Deep brain stimulation — a novel surgical procedure — is
emerging as a treatment of last resort for people diagnosed with
neuropsychiatric disorders such as severe obsessive-compulsive disorder.
The US Food and Drug Administration granted a so-called humanitarian
device exemption to allow patients to access this intervention, thereby
removing the requirement for a clinical trial of the appropriate size and
statistical power. Bypassing the rigors of such trials puts patients at risk,
limits opportunities for scientific discovery, and gives device
manufacturers unique marketing opportunities. We argue that Congress
and federal regulators should revisit the humanitarian device exemption
to ensure that it is not used to sidestep careful research that can offer
valuable data with appropriate patient safeguards.