title: 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.
authors.affiliation: Division of Medical Ethics at the Weill Medical College of Cornell University, in New York City, NY, USA. jjfins@med.cornell.edu
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Fins
authors.forename: Helen S
authors.initials: HS
authors.lastname: Mayberg
authors.forename: Bart
authors.initials: B
authors.lastname: Nuttin
authors.forename: Cynthia S
authors.initials: CS
authors.lastname: Kubu
authors.forename: Thorsten
authors.initials: T
authors.lastname: Galert
authors.forename: Volker
authors.initials: V
authors.lastname: Sturm
authors.forename: Katja
authors.initials: K
authors.lastname: Stoppenbrink
authors.forename: Reinhard
authors.initials: R
authors.lastname: Merkel
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Schlaepfer
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D057176:Compassionate Use Trials / Q000191:economics / Q000331:legislation & jurisprudence*; D046690:Deep Brain Stimulation / Q000379:methods*; D004059:Diffusion of Innovation; D004864:Equipment and Supplies / Q000191:economics*; D006300:Health Services Misuse / Q000331:legislation & jurisprudence; D006801:Humans; D009771:Obsessive-Compulsive Disorder / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration