Thalidomide

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Thalidomide was a sleeping-pill/sedative developed by the Grunenthal pharmaceutical company in Germany in the period 1946-54, and put onto the market with the brand-name Contergan in 1957. It is said to have had both animal tests and human trials, and it was believed to be extremely safe, because it was impossible for a user to overdose on it (as they could and did with some other sleeping pills).

The following year, Distillers, the UK drug company, licensed the rights and began to manufacture and sell it under the name "Distaval".

In the following four years (1959-61) complaints were made to Gruenthal and Distillers that patients taking the drug suffered nerve damage. There were also some early suspicions that it could be producing malformation of babies -- but these concerns were ignored by the manufacturers. There was no release of information to the medical world, and apparently no further research.

A single letter in the British Medical Journal in December 1960 by Scottish doctor Leslie Florence, however, linked thalidomide to nerve damage, and this alerted Frances Kelsey at the American FDA who was considering allowing Merrill to sell the drug in the USA. She was annoyed because Merrill had not advised the FDA of the nerve damage claims, and she will not license the drug until she is confident about its safety. She stalls the release for over six months - until the story broke. Thalidomide does not go on sale in the USA (however some free samples have been distributed).

Early in 1961 an Australian doctor who is trialiing the drug for Distillers (Dr William McBride) had reported to the company his suspicion that it has caused deaths and severe malformations in three babies born to his patients. Some were born with stunted limbs or without limbs. Later in the same year a German obstetrician, Widukind Lenz, asks Grunenthal to withdraw the drug because he has reached the same conclusions. They refuse.

However the story is leaked to the media in late 1961 and finally the drug is withdrawn. Many years later, seven Grunenthal executives were charged with negligent manslaughter.