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 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.
McHenry
Leemon B
LB
Department of Philosophy, California State University, Northridge, California 91330, USA. leemon.mchenry@csun.edu
Jureidini
Jon N
JN
D001319:Authorship; D002986:Clinical Trials as Topic / Q000941:ethics*; D004345:Drug Industry / Q000941:ethics*; D005607:Fraud; D017374:Paroxetine / Q000009:adverse effects / Q000627:therapeutic use; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014956:Writing
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors