Thalidomide was a miracle drug that crippled 10,000 children

Thalidomide was developed by German pharmaceutical company Chemie Grünenthal as a sedative and antiemetic. Launched in West Germany on 1 October 1957 under the brand name Contergan, it was marketed as a safer alternative to barbiturates and sold over the counter without a prescription. For its use against morning sickness, it was advertised as harmless to the unborn child. There was no requirement to test drugs for effects on the human fetus, and Grünenthal had conducted none.

By 1960, thalidomide was sold in 46 countries under at least 37 brand names by different licensees. In the UK, Distillers Company marketed it as Distaval, advertising it could be given 'with complete safety to pregnant women and nursing mothers.' An estimated 10,000 to 20,000 children were born with severe malformations — phocomelia (seal-like limb stumps), amelia (missing limbs), and damage to eyes, hearts, and urinary tracts. About 40% died around the time of birth.

In the United States, the disaster was largely averted by Dr. Frances Kelsey of the FDA, who repeatedly refused to approve the application from Richardson-Merrell. She demanded more safety data, which the company could not provide. Her persistent scepticism prevented a wider American catastrophe, though 17 children were born with deformities from unapproved distribution. President Kennedy awarded Kelsey the Distinguished Federal Civilian Service Award in 1962.

Thalidomide was withdrawn worldwide in November 1961. The disaster prompted sweeping regulatory reforms: the US Kefauver Harris Amendment (1962) required drug manufacturers to prove both safety and efficacy before approval, ending the era of unregulated pharmaceuticals. The case remains the most catastrophic drug testing failure in history, and a permanent warning against trusting a company's safety claims when the testing was never done.