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dc.creatorFins, Joseph Jen
dc.creatorMayberg, Helen Sen
dc.creatorNuttin, Barten
dc.creatorKubu, Cynthia Sen
dc.creatorGalert, Thorstenen
dc.creatorSturm, Volkeren
dc.creatorStoppenbrink, Katjaen
dc.creatorMerkel, Reinharden
dc.creatorSchlaepfer, Thomas Een
dc.date.accessioned2016-01-09T00:35:07Zen
dc.date.available2016-01-09T00:35:07Zen
dc.date.created2011-02en
dc.date.issued2011-02en
dc.identifierdoi:10.1377/hlthaff.2010.0157en
dc.identifier.bibliographicCitationHealth affairs (Project Hope) 2011 Feb; 30(2): 302-11en
dc.identifier.urihttp://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=Misuse+of+the+FDA's+humanitarian+device+exemption+in+deep+brain+stimulation+for+obsessive-compulsive+disorder.&title=Health+affairs+&volume=30&issue=2&date=2011-02&au=Fins,+Joseph+J;+Mayberg,+Helen+S;+Nuttin,+Bart;+Kubu,+Cynthia+S;+Galert,+Thorsten;+Sturm,+Volker;+Stoppenbrink,+Katja;+Merkel,+Reinhard;+Schlaepfer,+Thomas+Een
dc.identifier.urihttp://dx.doi.org/10.1377/hlthaff.2010.0157en
dc.identifier.urihttp://hdl.handle.net/10822/1018636en
dc.description.abstractDeep 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.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:337478en
dc.subjectBrainen
dc.subjectFooden
dc.subjectMarketingen
dc.subjectPatientsen
dc.subjectPoweren
dc.subjectResearchen
dc.subjectRisken
dc.subject.classificationElectrical Stimulation of the Brainen
dc.subject.classificationPsychosurgeryen
dc.subject.classificationBehavioral Researchen
dc.titleMisuse of the FDA's Humanitarian Device Exemption in Deep Brain Stimulation for Obsessive-Compulsive Disorderen
dc.provenanceCitation prepared by the Library and Information Services group of the Kennedy Institute of Ethics, Georgetown University for the ETHXWeb database.en
dc.provenanceCitation migrated from OpenText LiveLink Discovery Server database named EWEB hosted by the Bioethics Research Library to the DSpace collection EthxWeb hosted by DigitalGeorgetown.en


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