Abstract
Fifty years ago, in December 1961, a letter from an Australian obstetrician alerted the world to thalidomide-induced teratogenicity. That tragedy became a key driver of the evolution of evidence standards for drug development and licensing. It also reinforced the notion that a knowledgeable and trusted third party – the drug regulator – is needed to protect patients' interests and to decide for them which drugs would be available to them; this is allegedly because patients are not able to make informed decisions about such complex matters as drug treatment and manufacturers could not be trusted to present information on their products in an unbiased way.
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