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Healthy Skepticism Library item: 6917

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

Rennie D.
Fair conduct and fair reporting of clinical trials.
JAMA 1999 Nov 10; 282:(18):1766-8
http://jama.ama-assn.org/cgi/content/full/282/18/1766


Abstract:

Meta-analysis is dependent on the identification of all available data from clinical trials. The editorial summarises a number of problems citing first a meta-analysis of 244 trials of non-steroidal anti-inflammatory drugs in rheumatoid arthritis which reported multiple publications, different authors of the same trials, discrepancies between versions of the same trial. Other citations refer to similar problems with meta-analyses on the effects of the anti-psychotic risperidone and the effects of ondansetron on post-operative emesis. Covert duplicate reporting of the same data artificially skews the balance of opinion in favor of the new drug. It is hard not to suspect that this practice is deliberate. In this issue Gotsche and Johansen describe additional problems when trying to get at the data behind a review of trials comparing the anti-fungals fluconazole and amphotericin B. Registration of trials and publication of all results is the way to prevent publication bias. There are now hundreds of trial registries. The biggest problem standing in the way of successful, all-inclusive registries is the reluctance of drug companies to cooperate. Two companies, Schering Health Care and Glaxo Wellcome, have agreed to do so. The editor urges other companies to follow their lead.

Keywords:
*editorial/United States/ Biomedical Research* Clinical Trials* Drug Industry Editorial Policies Information Dissemination* Meta-Analysis* Publication Bias*

 

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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.