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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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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963