Healthy Skepticism Library item: 13244

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

Coombes R.
UK government tightens rules on drug trial results
BMJ 2008 Mar 15; 336:(7644):576
http://www.bmj.com/cgi/content/extract/336/7644/576-b

Abstract:

The UK government is to increase drug companies’ responsibility to pass on information about clinical trials.

The move comes after the regulators announced last week that it could not prosecute GlaxoSmithKline (GSK) for non-disclosure of trial data that showed it was unsafe for children younger than 18 to take the antidepressant paroxetine (Seroxat).

The Medicines and Healthcare Products Regulatory Agency (MHRA) issued the final report of its four year investigation into GlaxoSmithKline, during which investigators sifted through one million pages of evidence. It concluded that the drug company hadn’t broken the law but criticised it for not reporting the information earlier. GlaxoSmithKline denied it had broken any regulations.

Fears about the safety of paroxetine for children younger than 18 first surfaced in 2003 after a comprehensive review of selective serotonin reuptake inhibitors (SSRIs) by the Committee on Safety of Medicines. The review uncovered clinical trial data that show an increased . . .

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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