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The paroxetine 352 bipolar trial: A study in medical ghostwriting

Jay D Amsterdam1, Leemon B McHenry

  • 1Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA. enopath@aol.com

The International Journal of Risk & Safety in Medicine
|November 9, 2012
PubMed
Abstract

Insights

Ghostwriting in corporate clinical trials is a concern. Analysis of GlaxoSmithKline (GSK) paroxetine study 352 revealed a negative trial was presented as positive, potentially impacting patient health.

Area of Science:

  • Clinical trial analysis
  • Bioethics
  • Pharmaceutical industry research

Background:

  • Ghostwriting in corporate-sponsored clinical trials raises ethical and regulatory concerns.
  • This study examines GlaxoSmithKline (GSK) paroxetine study 352, focusing on allegations of ghostwriting and research misconduct.
  • The analysis utilizes publicly available evidence from a research misconduct complaint.

Purpose of the Study:

  • To deconstruct the published report of GSK paroxetine study 352.
  • To demonstrate how outcome analyses were manipulated, transforming a negative trial into a positive one.
  • To highlight potential adverse effects on patient health due to misleading conclusions.

Main Methods:

  • The study involved a randomized, double-blind, placebo-controlled trial at 19 sites.
  • It compared paroxetine and imipramine in 117 patients with treatment-resistant bipolar depression.
  • Analysis focused on primary and secondary outcome measures as presented in the archival report.

Main Results:

  • Primary outcome analyses showed no statistically significant difference between paroxetine or imipramine and placebo.
  • The published article incorrectly concluded efficacy for a post hoc subgroup of patients.
  • This misrepresentation turned a negative trial into a positive study in its conclusions.

Conclusions:

  • Industry-sponsored studies often lack public scrutiny.
  • Transparency in reporting industry-sponsored research is crucial for the scientific and medical communities.
  • Ensuring accurate reporting protects patient health and maintains research integrity.

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