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document
The paroxetine 352 bipolar trial : A study in medical ghostwriting . BACKGROUND The problem of ghostwriting in corporate-sponsored clinical trials is of concern to medicine , bioethics , and government agencies . We present a study of the ghostwritten archival report of an industry-sponsored trial comparing antidepressant treatments for bipolar depression : GlaxoSmithKline ( GSK ) paroxetine study 352 . This analysis is based upon publicly available evidence presented in a complaint of research misconduct filed with the Office of Research Integrity of the Department of Health and Human Services . OBJECTIVES We performed a deconstruction of the published study to show how primary and secondary outcome analyses were conflated , turning a 'negative ' clinical trial into a 'positive ' study - with conclusions and recommendations that could adversely affect patient health . METHODS The paroxetine 352 study was a randomized , double-blind , placebo-controlled , 19-site trial comparing paroxetine and imipramine in 117 patients with bipolar type I major depressive episode which was unresponsive to prior lithium carbonate therapy . RESULTS Analysis of the primary outcome measures found no statistically significant difference between paroxetine or imipramine versus placebo . However , the published article concluded that both drugs were efficacious versus placebo for a post hoc subgroup of patients . CONCLUSIONS Few industry-sponsored studies gain public scrutiny . It is important to make these articles transparent to the scientific and medical community .
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Intervention_Pharmacological
paroxetine
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Intervention_Pharmacological
paroxetine
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Intervention_Pharmacological
paroxetine
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Intervention_Pharmacological
paroxetine
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Intervention_Pharmacological
imipramine
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Intervention_Pharmacological
paroxetine
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Intervention_Pharmacological
imipramine
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Intervention_Control
placebo
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Outcome_Mental
bipolar depression
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Outcome_Mental
bipolar type I major depressive episode
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Outcome_Other
efficacious
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Participant_Condition
bipolar
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Participant_Condition
bipolar depression
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Participant_Sample-size
117
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Participant_Condition
bipolar type I major depressive episode