Healthy Skepticism Library item: 14605

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

McHenry LB, Jureidini JN.
Industry-sponsored ghostwriting in clinical trial reporting: a case study.
Account Res 2008 Jul-Sep; 15:(3):152-67
http://www.ncbi.nlm.nih.gov/pubmed/18792536

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:
Authorship* Clinical Trials as Topic/ethics* Drug Industry/ethics* Fraud* Paroxetine/adverse effects Paroxetine/therapeutic use Serotonin Uptake Inhibitors/adverse effects Serotonin Uptake Inhibitors/therapeutic use Treatment Outcome Writing*