title: The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance.
abstract: OBJECTIVE
  Deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States.
  
  
  METHODS
  Approximately 750 documents from the Celexa and Lexapro Marketing and Sales Practices Litigation: Master Docket 09-MD-2067-(NMG) were deconstructed.
  
  
  RESULTS
  The published article contained efficacy and safety data inconsistent with the protocol criteria. Procedural deviations went unreported imparting statistical significance to the primary outcome, and an implausible effect size was claimed; positive post hoc measures were introduced and negative secondary outcomes were not reported; and adverse events were misleadingly analysed. Manuscript drafts were prepared by company employees and outside ghostwriters with academic researchers solicited as 'authors'.
  
  
  CONCLUSIONS
  Deconstruction of court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram was safe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.
authors.affiliation: Critical and Ethical Mental Health Research Group, University of Adelaide, Adelaide, Australia.
authors.forename: Jon N
authors.initials: JN
authors.lastname: Jureidini
authors.affiliation: Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
authors.forename: Jay D
authors.initials: JD
authors.lastname: Amsterdam
authors.affiliation: Department of Philosophy, California State University, Northridge, CA, USA.
authors.forename: Leemon B
authors.initials: LB
authors.lastname: McHenry
mesh_terms: D000293:Adolescent; D018687:Antidepressive Agents, Second-Generation; D002648:Child; D015283:Citalopram / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D003627:Data Interpretation, Statistical; D003863:Depression / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram
keywords: Citalopram; FDA; SSRI antidepressants; depression; escitalopram; ghostwriting; key-opinion-leaders; psychiatric litigation; research misconduct