This sedative was given to pregnant women to prevent morning sickness from 1957 to 1962 in 46 countries under 37 different names (Softénon, Talimol, Kevadon, Nibrol, Distaval, Sedimide, Quietoplex, Contergan, Neurosedyn, etc.).
Its teratogencity (fetus malformation) and neuropathy (damage to nerves of the peripheral nervous system) wasn't to be discovered until more than 12 000 children were born malformed or with organ dysfunctions. Three years of pre-clinical tests on animals and clinical tests on humans didn’t reveal these malformations. It has to be mentioned that in these days, teratogencity side effects weren’t tested, but as you will understand later, scientists wouldn’t have revealed them with animal experimentation.
Since it has been commercialized, this drug had the reputation to be very sure for pregnant women-so much that you could buy it without prescription in western Germany.1
Doctors and epidemiologists rapidly noticed the link between the drug and the malformations observed in new born babies, yet the laboratory Chemie Grünenthal denied it for a long period of time. The drug was finally withdrawn in 1962.
Dr Jarrod Bailey, consultant for safer Medicines Trust, studied the tests which, 40 years after the Thalidomide case, were used to detect whether certain drugs and chemicals may cause congenitalmalformations on Humans. His results highlighted the fact that animal experimentation is relevant only once out of two times. As he tells: “We are betting the health of our children on odds just slightly better than a coin flip” where the in vitro studies predicts Human reaction with 80 % accuracy.2
From this date, they increased experimentation on animals to create the same teratogenic effects – probably trying to validate the animal experimentation itself. According to Doctor John Schardein, a birth malformation expert, Thalidomide has been tested on more than 50 different races and species of animals, rarely causing non-significant malformations.3
In December 1970, after a 2 years trial, a German law court, inspired by the work of several animal experimentation experts, has admitted that : “systematic tests on animals cannot be reliable for Humans security”.
More tests on animals wouldn’t have stop Thalidomide’s release on the market, for its teratogencity effects rarely occurs on other animals, even with high doses.
Nowadays, stem cells are used in many different tests in direct link with teratogencity. 4
