Clinical trials and drug promotion: Selective reporting of study 329
Date
2008
Authors
Jureidini, J.
McHenry, L.
Mansfield, P.
Editors
Advisors
Journal Title
Journal ISSN
Volume Title
Type:
Journal article
Citation
The International Journal of Risk and Safety in Medicine: side effects of drugs - devices - surgery - prevention - liability, 2008; 20(1-2):73-81
Statement of Responsibility
Jon N. Jureidini, Leemon B. McHenry, Peter R. Mansfield
Conference Name
Abstract
Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in adolescents”. By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm.