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The tragedy that triggered clinical trials

 

It all begins in the 50s of the last century, in Chemie Grünenthal. This company first started producing penicillin in West Germany, and for 50 years it has grown into a strong pharmaceutical company. Western Germany was at that time without laws and guidelines that would require strict drug testing before being placed on the market. During the winter of 1956, the brand name Grippex® was launched on the market. It was intended for the treatment of influenza, but also for many other illnesses (from low concentration and mild depression to premature ejaculation, menstrual pain, etc.) in 1957, it was discovered that the medicine relieved morning sickness symptoms in pregnant women and changed their name to Contergan®. The manufacturer was convinced that the drug had no side effects because, no matter how much doses were given to rats and mice – they did not die, and they later noticed on dogs, cats and rabbits. Because of its properties, the drug is starting to be sold in 46 countries worldwide. However, some countries refuse to register such a drug (including the US).

One year later, some doctors already notice the side effects of their patients reporting to Grünenthal, which the company does not give an answer. Over time, more and more doctors are starting to report side effects of the drug, with the company still not responding.

 

 

Near the end of the age of 50, children are born in Hamburg with severe extremity deformations (“extremities like seals”) or even completely without extremities. In 1961, health authorities in Hamburg convened a meeting with the manufacturer, asked whether they would withdraw the medication-what they openly refused. However, a week later, the drug withdraws from the German market, but Grünenthal does not inform its partners in other countries that the drug has been withdrawn! And after the drug is withdrawn from the market, the company denies the association of malformations in children with Contergan® during pregnancy.

As the drug was completely withdrawn from the markets of all countries, over 10,000 children were disabled.

The active substance in the medicine, thalidomide, is the last substance placed on the market without complete data on the safety of the medicinal product during pregnancy and lactation. In 1961, the laws on placing new drugs on the market are getting stronger, which means that no new substance can no longer be marketed without previously studied clinical studies and evidence of safety.

However, thalidomide still has its place in the treatment, and it was approved in 1998 for the treatment of hare complications.

 

** Note: We did not want to put pictures of children who are the victims of thalidomide because they can be disturbing for readers.

 

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