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Healthy Skepticism Library item: 18861

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

Steinbrook R, Kassirer JP
Data availability for industry sponsored trials: what should medical journals require?
BMJ 2010 Oct 12; 341:
http://www.bmj.com/content/341/bmj.c5391.extract


Abstract:

Concerns about the reliability of the data in the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial1 2 have once again raised an uncomfortable question-what criteria should medical journals use when they consider reports of industry sponsored clinical trials for publication? As published, the open label RECORD trial, which was sponsored by GlaxoSmithKline, showed that the addition of rosiglitazone (Avandia) to metformin or sulfonylurea was not inferior to treatment with a combination of these drugs for a composite endpoint of cardiovascular events and death, and was inconclusive about any possible effect on myocardial infarction.2 However, during the course of the review of the study by the United States Food and Drug Administration (FDA), a reviewer who audited the raw data found that potential bias and omissions in the adjudication of cardiovascular endpoints had downplayed the risk of myocardial infarction associated with taking rosiglitazone.3 4 Another FDA official said of the reviewer’s report, “ I think you could sum [the review] up in one word, and the word is truth. Can we trust the sponsor with the results of RECORD?”5 In September 2010, regulatory agencies announced that medicines containing rosiglitazone would be taken off the …

 

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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