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Thalidomide

The drug Thalidomide was developed by German pharmaceutical company Chemie Grünenthal (now Grünenthal GmbH) for the treatment of respiratory infections under the trade name Grippex, a combination drug that contained thalidomide, quinine, vitamin C, phenactin and acetylsalicylic-acid.

Researchers at Chemie Grünenthal also found that thalidomide was a particularly effective antiemetic that had an inhibitory effect on morning sickness. So, on October 1, 1957, the company launched thalidomide and began aggressively marketing it under the trade name Contergan®

During this time period the use of medications during pregnancy was not strictly controlled, and drugs were not thoroughly tested for potential harm to the foetus. Thousands of pregnant women took the drug to relieve their symptoms. At the time of the drug's development, scientists did not believe any drug taken by a pregnant woman could pass across the placental barrier and harm the developing foetus, even though the effect of alcohol on foetal development had been documented by case studies on alcoholic mothers since at least 1957.

There soon appeared reports of findings of abnormalities in children being born, traced back to the use of the drug thalidomide.

Babies subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and deafness. Many thousands were also born with internal deformities and some 3,500 died before their first birthday.

All in all, more than 10,000 children in 46 countries were born with deformities such as phocomelia as a consequence of thalidomide use. It is not known exactly how many worldwide victims of the drug there have been, although estimates range from 10,000 to 20,000. Despite the side effects, thalidomide was sold in pharmacies in Canada until 1962; Canada was the last country to end sales of the drug.

In the United Kingdom, the drug was licensed in 1958 and withdrawn in 1961. Of the approximately 2,000 babies born with defects, around half died within a few months and 466 survived to at least 2010.

In 1968, a large criminal trial began in Germany, charging several Grünenthal officials with negligent homicide and injury. After Grünenthal settled with the victims in April 1970, the trial ended in December 1970 with no finding of guilt. As part of the settlement, Grünenthal paid 100 million DM into a special foundation; the German government added 320 million DM. The foundation paid victims a one-time sum of 2,500-25,000 DM (depending on severity of disability) and a monthly stipend of 100-450 DM. The monthly payments have since been raised substantially and are now paid entirely by the government (as the foundation had run out of money). Grünenthal paid another 50 million Euros into the foundation in 2008.

The numerous reports of malformations in babies brought about the awareness of the side effects of the drug on pregnant women. The birth defects caused by the drug thalidomide can range from moderate malformation to more severe forms. Possible birth defects include phocomelia, dysmelia, amelia, bone hypoplasticity, and other congenital defects affecting the ear, heart, or internal organs.

In 1968, after a long campaign by The Sunday Times, a compensation settlement for the UK victims was reached with Distillers Company (now part of Diageo), which had distributed the drug in the UK. This compensation, which is distributed by the Thalidomide Trust in the UK, was substantially increased by Diageo in 2005. The UK Government gave survivors a grant of £20 million, to be distributed through the Thalidomide Trust, in December 2009. 460 UK survivors were compensated by this scheme but eight of those who were rejected have recently launched a legal action against the drug's manufacturer and distributor. 

In Australia, a Melbourne woman Lynette Rowe, who was born without limbs, is brought a class action lawsuit against, Grünenthal, which fought to have the case heard in Germany. The Victorian Supreme Court dismissed Grünenthal's application in 2012, and the case was heard in Australia. More than a hundred Australian thalidomide survivors were involved and in July 2012, Lynette Rowe was awarded an out-of-court settlement, believed to be in the millions of dollars and paving the way for class action victims to receive further compensation.

On 31 August 2012, Grünenthal chief executive Harald F. Stock, PhD, who served as the Chief Executive Officer of Grünenthal GmbH from January 2009 to May 28, 2013 and was also a Member of Executive Board until May 28, 2013, apologised for the first time for producing the drug and remaining silent about the birth defects. At a ceremony, Stock unveiled a statue of a disabled child to symbolize those harmed by thalidomide and apologised for not trying to reach out to victims for over 50 years. At the time of the apology, there were 5,000 to 6,000 sufferers still alive. Victim advocates called the apology "insulting" and "too little, too late", and criticised the company for not compensating victims.

The drug thalidomide's birth defects in children affected many people's lives, and from these events came the formation of the group called The Thalidomide Victims Association of Canada, a group of 120 Canadian survivors. Their goal was to prevent future usage of drugs that could be of potential harm to mothers and babies.

Thalidomide brought on changes in the way drugs are tested, what type of drugs are used during pregnancy, and increased the awareness of potential side effects of drugs.

Thalidomide is still used today to treat the complications of leprosy and multiple myeloma and is still causing birth defects in Brazil today. It is being given to people suffering from leprosy to ease some of their symptoms, and some women have taken it unaware of the risks they run when pregnant.

For more information visit: http://www.thalidomideuk.com/  This website is dedicated to the history of the drug 'thalidomide' and explores the various disabilities that the drug caused to babies worldwide.

Thalidomide

 

 
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