Onder invloed: Het samenspel van industrie, tijdschriften, en registratieautoriteiten

PublicatieNr. 6 - 7 juli 2016
Jaargang50
RubriekHoofdartikel
AuteurLisa Cosgrove et al.

Copyright 2016 From Lisa Cosgrove Ph.D., Steven Vannoy Ph.D., Barbara Mintzes Ph.D. & Allen F. Shaughnessy Pharm. D., M. Med.Ed. (2016) Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation. Accountability in Research: Policies and Quality Assurance 23 (5): 257-279. DOI: 10.1080/08989621.2016.1153971 Reproduced by permission of Taylor & Francis, LLC (http://www.tandfonline.com).

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Samenvatting

De relaties tussen universiteiten, publicatie-industrie en de farmaceutische industrie faciliteren commerciële bias bij het verkrijgen, interpreteren en presenteren van gegevens over de werkzaamheid en bijwerkingen van geneesmiddelen aan de registratieautoriteiten en voorschrijvers. Met een kritische beschouwing van gepubliceerde en niet-gepubliceerde onderzoeken die zijn aangeboden aan de Food and Drug Administration (FDA) en de European Medicines Agency (EMA) ten behoeve van de registratie van een nieuw antidepressivum, vortioxetine, wordt een casus gepresenteerd van het ’ghost-management’ bij het proces van informatieoverdracht. De huidige geaccepteerde praktijk ondermijnt de waarborgen van de registratieautoriteit die zijn bedoeld om het publiek te beschermen tegen niet-veilige of onwerkzame geneesmiddelen. De beïnvloedingseconomie die bewust of onbewust evidence biased, in plaats van evidence based, geneeskunde produceert wordt geïdentificeerd. Dit is een eenvoudig verhaal over financiële belangenverstrengelingen bij auteurs, maar een complex verhaal van ghost-management van het gehele proces om een geneesmiddel op de markt te brengen. Deze casus toont dat de zwakte van het registratieproces leidt tot keuzen voor onderzoekopzetten en manieren van rapporteren waardoor marginale geneesmiddelen nieuw lijken, werkzamer en veiliger dan ze in werkelijkheid zijn. Ook toont dit hoe de selectieve en niet-gebalanceerde rapportage van gegevens uit klinisch onderzoek in medische tijdschriften leidt tot de marketing van dure me too’s met een twijfelachtige balans van werkzaamheid en veiligheid. Afgesloten wordt met oplossingen om deze beïnvloedingseconomie te neutraliseren.

Het originele artikel kunt u via deze link inzien: http://www.ncbi.nlm.nih.gov/pubmed/?term=Cosgrove+Mintzes+2016

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