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Healthy Skepticism Library item: 13569

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Jureidini JN, McHenry LB, Mansfield PR.
Clinical trials and drug promotion: Selective reporting of study 329
The International Journal of Risk and Safety in Medicine 2008 May; 20:(1-2):73-81
http://iospress.metapress.com/content/k36834543w9063rr/?p=8b89494c5d4c4f42946f75de3efdefa1&pi=6


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.

Keywords:
Selective reporting, SSRI, litigation, industry sponsorship


Notes:

Full text at:
http://www.pharmalot.com/wp-content/uploads/2008/04/329-study-paxil.pdf

Documents available at:
http://healthyskepticism.org/documents/PaxilStudy329.php

 

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What these howls of outrage and hurt amount to is that the medical profession is distressed to find its high opinion of itself not shared by writers of [prescription] drug advertising. It would be a great step forward if doctors stopped bemoaning this attack on their professional maturity and began recognizing how thoroughly justified it is.
- Pierre R. Garai (advertising executive) 1963