Healthy Skepticism Library item: 17437

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

Nissen SE
Setting the RECORD Straight
JAMA 2010 Mar 24; 303:(12):1194-1195
http://jama.ama-assn.org/cgi/content/extract/303/12/1194

Abstract:

The Food and Drug Administration (FDA) recently announced another Advisory Panel scheduled to meet in July 2010 to consider whether or not to remove rosiglitazone from the market. Central to the discussion will be the results of a recently published cardiovascular outcomes trial that randomized patients to receive rosiglitazone or alternative diabetes therapies, the RECORD trial.1 On February 20, 2010, the US Senate Finance Committee released a 334-page investigation of rosiglitazone and drug maker GlaxoSmithKline (GSK).2 The documents released by the Senate include internal company e-mails that provide an extraordinary window into the conduct of an industry-sponsored clinical trial. The implications of these e-mails and other documents released by the Senate have profound consequences for academic oversight of commercially sponsored clinical trials.

On May 1, 2007, Wolski and I submitted for publication a meta-analysis of 42 randomized rosiglitazone clinical trials, showing a hazard ratio (HR) for . . .

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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