title: Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature.
abstract: This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper.
  
  
  
  For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as 'non-FDA' concerns.
  
  
  
  Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design.
  
  
  
  Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns.
authors.affiliation: University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), Groningen, The Netherlands.
authors.forename: Lian
authors.initials: L
authors.lastname: Beijers
authors.affiliation: University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), Groningen, The Netherlands.|University of Groningen, Department of Developmental Psychology, Groningen, The Netherlands.
authors.forename: Bertus F
authors.initials: BF
authors.lastname: Jeronimus
authors.affiliation: Behavioral Health and Neurosciences Division, VA Portland Health Care System, Portland, Oregon, USA.|Departments of Psychiatry and Pharmacology, Oregon Health & Science University, Portland, Oregon, USA.
authors.forename: Erick H
authors.initials: EH
authors.lastname: Turner
authors.affiliation: University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), Groningen, The Netherlands.|University of Groningen, Department of Developmental Psychology, Groningen, The Netherlands.
authors.forename: Peter
authors.initials: P
authors.lastname: de Jonge
authors.affiliation: University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), Groningen, The Netherlands.
authors.forename: Annelieke M
authors.initials: AM
authors.lastname: Roest
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy*; D006801:Humans; D015588:Observer Variation; D017594:Publication Bias; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D058028:Research Report / Q000592:standards; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000928:Antidepressive Agents; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors
keywords: Bias; Food Drug Administration; PSYCHIATRY; RCTs; Spin