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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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What these howls of outrage and hurt amount to is that the medical profession is distressed to find its high opinion of itself not shared by writers of [prescription] drug advertising. It would be a great step forward if doctors stopped bemoaning this attack on their professional maturity and began recognizing how thoroughly justified it is.
- Pierre R. Garai (advertising executive) 1963