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Healthy Skepticism Library item: 14605

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

McHenry LB, Jureidini JN.
Industry-sponsored ghostwriting in clinical trial reporting: a case study.
Account Res 2008 Jul-Sep; 15:(3):152-67
http://www.ncbi.nlm.nih.gov/pubmed/18792536


Abstract:

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

Keywords:
Authorship* Clinical Trials as Topic/ethics* Drug Industry/ethics* Fraud* Paroxetine/adverse effects Paroxetine/therapeutic use Serotonin Uptake Inhibitors/adverse effects Serotonin Uptake Inhibitors/therapeutic use Treatment Outcome Writing*

 

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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.