Sunday, May 15, 2016

Unmasked: another ghosted, manipulated study of an antidepressant for depression in children

This time it's Celexa, brought to you by The American Journal of Psychiatry and psychiatrist Karen Wagner of the University of Texas Medical Branch in Galveston.

The unmasking comes courtesy of Jon Jureidini, Jay Amsterdam and Leemon McHenry, in the International Journal of Risk & Safety in Medicine,

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’.

CONCLUSION:
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.

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