Key result
The FDA's humanitarian device exemption for deep brain stimulation in severe obsessive-compulsive disorder bypasses rigorous clinical trials, putting patients at risk and limiting scientific discovery.
The authors argue that the FDA's humanitarian device exemption for deep brain stimulation in OCD bypasses necessary clinical trials, putting patients at risk.
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.
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Fins et al. (2011) conducted an editorial in Severe obsessive-compulsive disorder. Deep brain stimulation under humanitarian device exemption was evaluated. The FDA's humanitarian device exemption for deep brain stimulation in severe obsessive-compulsive disorder bypasses rigorous clinical trials, putting patients at risk and limiting scientific discovery.
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