The scientific world was shocked by the 1971 discovery of the devastating effects in young women of a drug, diethylstilbestrol (DES), taken by their mothers twenty years earlier. The story of DES, from its discovery and widespread marketing without adequate testing or proof of efficacy, to the banning of its use by pregnant women, provides a good example of the serious harm that can result from inadequately protective regulation of new drugs and technologies.

Historical Development

In 1938, Sir E. Charles Dodd formulated DES, the first orally active, synthetic estrogen. This (nonsteroidal) estrogen, estimated to be five times as potent as estradiol, was very inexpensive and simple to synthesize. Because it was not patented, the developing pharmaceutical industry quickly began worldwide production; it was ultimately marketed under more than two hundred brand names for a wide range of indications. DES underwent very limited toxicological testing, a...