Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder

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 ac...

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Bibliographic Details
Published in:Health Affairs 2011-02, Vol.30 (2), p.302-311
Main Authors: Fins, Joseph J., Mayberg, Helen S., Nuttin, Bart, Kubu, Cynthia S., Galert, Thorsten, Sturm, Volker, Stoppenbrink, Katja, Merkel, Reinhard, Schlaepfer, Thomas E.
Format: Article
Language:English
Subjects:
Brain surgery
Clinical trials
Deep brain stimulation
FDA approval
Federal regulation
Medical equipment
Neuroses
Obsessive compulsive disorder
Parkinson's disease
Patient safety
Product development
Studies
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Summary: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. [PUBLICATION ABSTRACT]
ISSN:0278-2715
1544-5208
DOI:10.1377/hlthaff.2010.0157