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

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 co...

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Bibliographic Details
Published in:Accountability in research 2008-07, Vol.15 (3), p.152-167
Main Authors: McHenry, Leemon B., Jureidini, Jon N.
Format: Article
Language:English
Subjects:
Authorship
Central Medical Affairs Team
clinical trials
Clinical Trials as Topic - ethics
conflict of interest
Drug Industry - ethics
final clinical report
Fraud
GlaxoSmithKline
industry-sponsored ghostwriting
key opinion leader
off-label prescriptions
paroxetine (Paxil
Paroxetine - adverse effects
Paroxetine - therapeutic use
Paxil Team
primary efficacy variables
Scientific Therapeutics Information
secondary efficacy variables
serious adverse events
Serotonin Uptake Inhibitors - adverse effects
Serotonin Uptake Inhibitors - therapeutic use
Seroxat
SmithKline Beecham
Treatment Outcome
Writing
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Description
Summary: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.
ISSN:0898-9621
1545-5815
DOI:10.1080/08989620802194384