September 5, 2012

Thalidomide was introduced in 1953 by the family-owned German pharmaceutical company, Grunenthal, and was used by thousands of women throughout Europe and Canada to treat morning sickness associated with pregnancy during the 1950s. It was available as an over-the-counter drug in Germany beginning in 1957 (it was available by prescription-only in Great Britain).

In 1961, thalidomide was withdrawn from the market due to reports of birth defects in babies of women who had taken the drug. The FDA never approved its use in the United States although about 20,000 women took the drug that was given to them by their physicians as part of a clinical trial in the United States.

More than 10,000 babies were born with birth defects due to their mothers’ use of thalidomide by the time it was withdrawn from the market in 1961. The birth defects included shortened arms, shortened legs, blindness, deafness, heart issues, and in some cases, brain damage. Between 5,000 and 6,000 “thalidomide babies” (as they became known) are still alive (an additional 7,500 died during early childhood). However, it has been estimated by some that as many as 10 babies died from birth defects due to thalidomide for each thalidomide baby who survived in the United Kingdom.

Grunenthal claimed that the birth defects due to thalidomide were not known before the drug was marketed.  The company’s chief executive has stated that the birth defects caused by thalidomide “could not be detected by the tests that we and others carried out before it was marketed.” However, there are those who question the extent of Grunenthal’s knowledge of the birth defects caused by thalidomide, when Grunenthal became aware of the side effects, and whether Grunenthal had sufficient information about the side effects to have withdrawn thalidomide from the market sooner.

On August 31, 2012, Grunenthal unveiled a bronze memorial statue in Germany of a child born without limbs due to thalidomide. At the unveiling, Grunenthal’s chief executive formally apologized, for the first time in 50 years, for the birth defects caused by thalidomide: “We ask for forgiveness that for nearly 50 years we didn’t find a way of reaching out to you from human being to human being. We ask that you regard our long silence as a sign of the shock that your fate caused in us.”

In the past, Grunenthal has stated it regrets regarding thalidomide babies but never admitted its liability. Grunenthal paid compensation to victims in Germany in the early 1970s by paying into a fund after which the German government provided Grunenthal with immunity from legal actions against it. The German government paid continuing compensation to thalidomide victims after the money in the fund ran out. Grunenthal pledged an additional 50 million euros in 2009 to help victims in Germany and elsewhere.

In 1968, distributors of thalidomide in the United Kingdom reached a settlement in the UK with families affected by thalidomide. The compensation payments were doubled in 2005.

Thalidomide is currently approved in the treatment of multiple myeloma (a form of bone cancer).


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