THALIDOMIDE

The example of the Thalidomide disaster…illustrates this problem particularly clearly. Such a medicine-caused disaster could no more be prevented with adequate certainty through animal experimentation today than it could at that time." --Prof. Dr. Herbert Hensel, Director of the Institute of Physiology at Marburg University, 1975

Reproduction tests and particularly teragenicity tests on animal models are notoriously unreliable to predict risks in humans. According to the New England Journal of Medicine, of 1,200 chemicals known to cause teratogenic effects, only 30 cause similar effects in humans and numerous useful and safe drugs provoke birth defects in animals. The thalidomide tragedy is a very sad episode, testimony of the greed of pharmaceutical companies and cowarness or incompetence of scientific and medical authorities in the face of corporate influence.Thalidomide is a drug that caused terrible deformations in thousands of babies. It was given to pregnant women to alleviate the symptoms of morning sickness.

Thalidomide was tested for years, before, during and after some epidemiological indicators suggested a correlation between the drug and the birth defects in 1962. Back then, the Time magazine reported that the drug had been introduced in the market after three years of animal testing. Chemie Grünenthal was granted licences in Europe to commercialize the drug, when in fact it had already received 1,600 letters warning that the drug could be at the origin of birth defects. One German court concluded that the company had sufficient post-marketing elements about the drug to withdraw it from the market. However, it took years to really measure the impact of the drug because tests on animals were inconsistent, despite of unequivocal epidemiological data that provided evidence for many doctors. The company refuted the claims and continued to test on mice, cats, dogs, monkeys that were receiving high doses of the drug. When tested on some strains of rabbits, it appeared that the New-Zealand strain responded by showing birth defects.

In 1970, following a two-year trial, a german court, based on the testimonials of experts, concluded that the tests on animals conducted in a systematic manner could not be trusted. Meamwhile, in the U.S, FDA employe Dr.McBride took steps to prevent the drug from entering the American market, against all odds and the enmity of his peers. According to his judgment, the epidemiological data was overwhelmingly in favor of keeping the drug off the shelves. It was clear that authorities had given too much credit to the animal data. Today, the European Union, which has a budget and the legal obligation to research and develop alternatives to animal tests, has validated the Embryonic Stem Cell Test (EST) as an effort to improve teratogenicity testing.

A more detailed account of the Thalidomide tragedy and development can be found at: ANIMAL RESEARCH TAKES LIVES.