The paroxetine 352 bipolar trial: A study in medical ghostwriting.
Author(s): Amsterdam JD, McHenry LB.
Affiliation(s): Depression Research Unit, Department of Psychiatry, University of Pennsylvania
School of Medicine, Philadelphia, PA, USA. enopath@aol.com
Publication date & source: 2012, Int J Risk Saf Med. , 24(4):221-31
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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