Industry-Sponsored Ghostwriting in Clinical Trial Reporting: A Case Study

Abstract

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

Keywords:

• Central Medical Affairs Team
• clinical trials
• conflict of interest
• final clinical report
• GlaxoSmithKline
• industry-sponsored ghostwriting
• key opinion leader
• off-label prescriptions
• paroxetine (Paxil
• Seroxat)
• Paxil Team
• primary efficacy variables
• secondary efficacy variables
• Scientific Therapeutics Information
• serious adverse events
• SmithKline Beecham

Acknowledgments

L. B. McHenry is research consultant for Baum Hedlund law firm of Los Angeles, California. J. N. Jureidini is engaged by Baum Hedlund to provide an independent analysis of the data in Study 329 and is chair of Healthy Skepticism, an international non-profit organization with a main aim of countering misleading drug promotion.

Authorship: L.B.M. initiated the article and prepared the first draft. Both authors studied all documents and contributed to redrafting the piece. Both are guarantors for the article. The authors would like to thank Skip Murgatroyd, Ron Goldman, Michael Baum, and Cindy Hall from Baum Hedlund, who read drafts and gave legal advice, and Richard Smith and Liz Wager from the BMJ review of an earlier draft, and anonymous reviewers from this journal, who made helpful suggestions.

Funding: Baum Hedlund paid L.B.M. and J.N.J. to analyze documents relating to Study 329, but there was no funding to discuss, prepare, or write this article, the idea for which originated with the authors.