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Prior to 1966, almost all available information on drug safety for marketed medicines was strictly qualitative. It was predominantly based on anecdotal reports and clinical opinions derived primarily from the known pharmacology of particular drugs. While the medical environment for identifying and quantifying drug toxicity was generally informal and undirected, the use of anecdotal reports to detect serious drug toxicity was sufficient for identifying the toxicity associated with thalidomide.1,2 But the mechanism of discovery was unacceptably inefficient since an estimated 9000 babies were born with thalidomide‐caused phocomelia before the toxic effect was recognized and described in 1960.

Learning how to control biases in studies to identify adverse effects of drugs: a brief personal history