Misuse of the FDA's Humanitarian Device Exemption in Deep Brain Stimulation for Obsessive-Compulsive Disorder
Fins, Joseph J
Mayberg, Helen S
Kubu, Cynthia S
Schlaepfer, Thomas E
Health affairs (Project Hope) 2011 Feb; 30(2): 302-11
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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Ethical Guidance for the Management of Conflicts of Interest for Researchers, Engineers and Clinicians Engaged in the Development of Therapeutic Deep Brain Stimulation Fins, Joseph J; Schlaepfer, Thomas E; Nuttin, Bart; Kubu, Cynthia S; Galert, Thorsten; Sturm, Volker; Merkel, Reinhard; Mayberg, Helen S (2011-06)The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, ...
Electrodes in the Brain -- Ethical Criteria for Research and Treatment With Deep Brain Stimulation for Neuropsychiatric Disorders Synofzik, Matthis; Schlaepfer, Thomas E (2011-01)Deep brain stimulation (DBS) has been used for neuropsychiatric disorders in clinical and research settings for almost 50 years now. Recent evidence demonstrates some efficacy in treating obsessive-compulsive disorder and ...