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Healthy Skepticism Library item: 20498

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

Svensson S, Menkes DB, Lexchin J
Surrogate Outcomes in Clinical Trials: A Cautionary Tale
JAMA 2013 Mar 25; (1-2 ):
http://archinte.jamanetwork.com/article.aspx?articleid=1672283


Abstract:

Surrogate outcomes are often used as proxies for hard clinical outcomes, as they enable smaller, faster, and thus cheaper clinical trials. In addition, pharmaceutical companies argue that using surrogates means that fewer patients are exposed during testing, and beneficial new medications reach the market faster. Their main disadvantage is that favorable effects on surrogates do not automatically translate into benefits to health.

To illustrate the perils of relying on surrogates, we compiled a table of drugs, approved on the basis of surrogate outcome data, which after adoption into practice were shown to be harmful through clinical trials or meta-analyses (eTable).

 

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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