title: Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.
abstract: The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.
authors.affiliation: a Department of Counseling and School Psychology , University of Massachusetts Boston , Boston , MA , USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Cosgrove
authors.affiliation: a Department of Counseling and School Psychology , University of Massachusetts Boston , Boston , MA , USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Vannoy
authors.affiliation: b Faculty of Pharmacy and Charles Perkins Centre , University of Sydney , Sydney , Australia.
authors.forename: Barbara
authors.initials: B
authors.lastname: Mintzes
authors.affiliation: c Department of Family Medicine , Tufts University School of Medicine , Boston , MA , USA.
authors.forename: Allen F
authors.initials: AF
authors.lastname: Shaughnessy
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use; D015982:Bias; D016265:Conflict of Interest; D004345:Drug Industry / Q000941:ethics / Q000458:organization & administration*; D005060:Europe; D006801:Humans; D007880:Legislation, Drug / Q000458:organization & administration*; D010879:Piperazines / Q000627:therapeutic use; D011643:Publishing / Q000941:ethics / Q000458:organization & administration*; D013440:Sulfides / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration / Q000941:ethics / Q000458:organization & administration*; D000078784:Vortioxetine
chemical_list: D000928:Antidepressive Agents; D010879:Piperazines; D013440:Sulfides; D000078784:Vortioxetine
keywords: Antidepressants; clinical trials; conflict of interest; ghostwriting; medical journals; regulatory process