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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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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909