Accountability in Research · 2008 · 66 citations · 7 references
PharmacyPharmacologyPharmacotherapyClinical PharmacologyDrug Approval ProcessesPharmacovigilanceAdverse Drug Event ReportingClinical Trial DocumentationClinical Trial EthicsClinical TrialsPediatric Clinical TrialsSpontaneous Reporting SystemsClinical Trial DisclosureClinical Trial MisconductClinical Trial Outcome ReportingClinical Trial ReportingClinical Trial ReportsClinical Trial Safety DataPediatric Adverse Drug Event ReportingSponsor Influence
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.
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