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Friday, April 29, 2016

History of "safe" products: thalidomide

Thalidomide was a drug first marketed in West Germany in 1957. During this time the effects on pregnant women and the fetus was not studied carefully. It was used as a sedative, and used to treat anxiety, gastritis, insomnia, and nausea and excessive morning sickness in pregnant women. Shortly after the drug was introduced in West Germany about 5000-7000 babies were born with malformed or missing limbs. Only about 40% of these babies survived. Limbs could have appeared as stumps, or missing altogether. An example is hands joined at the shoulder with no arm bones in between.

Thalidomide is currently used for treating immune system problems such as Crohn's disease, skin problems that won't respond to other treatments, HIV/AIDS, sarcoidosis, rheumatoid arthritis.

In 1958 Chemie Grünenthal approached William S Merrell Company in Cincinnati, Ohio who then approached the US FDA six times to market the drug in the US but the FDA declined as Chemie Grünenthal provided no test results to show the safety of thalidomide. The FDA approved the drug for testing in the US and huge quantities entered the US.

In November 1961 thalidomide was taken off the US market after a large amount of pressure from the media and the public. Thalidomide was sold in pharmacies in Canada until 1962.

In 1962, FDA pharmacologist Frances Oldham Kelsey received the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy for blocking sale of thalidomide in the United States.

Since 1965 Brazilian physicians used thalidomide to treat ENL, a painful skin condition, caused by leprosy.

In 1968 an agreement was reached with the Distillers Company, who distributed the drug in the UK, with victims of thalidomide.  The settlement, called the Thalidomide Trust, was increased in 2005 by Distillers.

Chemie Grünenthal continued to deny harmful effects for nearly 50 years. Until...
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, apologized for the first time for producing the drug and remaining silent about the birth defects.[91] At a ceremony, Stock unveiled a statue of a disabled child to symbolize those harmed by thalidomide and apologized 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"...


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