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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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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.