Title: Thalidomide scandal Content: thumb|Baby born to a mother who had taken thalidomide while pregnant Thalodomide is a drug that was developed in the 1950s. It was used as as a sedative, to treat sleeping problems, and anxiety. Its use in pregnant women in 46 countries resulted in the "biggest man‐made medical disaster ever": more than 10,000 children were born with severe deformities, as well as thousands of miscarriages. A common condition was that hands or feet were directly attached to the body, with all or part of the arm or leg missing. This condition is known as phocomelia. Thalidomide was introduced in 1956. The German pharmaceutical company Grünenthal marketed it as a medication for anxiety, trouble sleeping, "tension", and morning sickness. When it was introduced, it had not been tested on pregnant women. At the start, people thought it was safe in pregnancy. The first concerns regarding birth defects were noted in 1961, and the drug was removed from the market in Europe that year. == Birth defect crisis == Thalidomide was developed and first released by the German pharmaceutical company Chemie Grünenthal in 1953. The company had started as a soap maker after World War II to address the urgent market need for antibiotics. Chemist Heinrich Mückter, who was a known Nazi war criminal, was appointed to head the discovery programme based on his experience researching and producing an anti-typhus vaccine for Nazi Germany. It is estimated than more than 10.000 people were affected by their mothers using thalidomide during their pregnancy; about forty percent of the children died at birth or shortly afterwards. Those who survived had limb, eye, urinary tract, and heart defects. Its initial entry into the US market was prevented by Frances Kelsey at the FDA. The birth defects of thalidomide led to the development of greater drug regulation and monitoring in many countries. The severity and location of the deformities depended on how many days into the pregnancy the mother was before beginning treatment; thalidomide taken on the 20th day of pregnancy caused central brain damage, day 21 would damage the eyes, day 22 the ears and face, day 24 the arms, and leg damage would occur if taken up to day 28. Thalidomide did not damage the fetus if taken after 42 days' gestation. The total number of victims worldwide is unknown, estimates range from 10,000 to 20,000. == Aftermath of scandal == Because there were many reports of malformations in babies, people were made aware of the side effects of the drug. The drug causes moderate to severe malformations. Most often, limbs are malformed, sometimes they are missing. Some side effects affect the formation of bones, the ear, the heart or other internal organs. The most common form of birth defects from thalidomide is shortened limbs, with the arms being more frequently affected. This syndrome is the presence of deformities of the long bones of the limbs resulting in shortening and other abnormalities. === Grünenthal criminal trial === 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 stipends 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 into the foundation in 2008. On 31 August 2012, Grünenthal chief executive Harald F. Stock apologised for the first time for producing the drug and remaining silent about the birth defects. Stock was the Chief Executive Officer of Grünenthal GmbH from January 2009 to May 28, 2013; he was also a Member of Executive Board until 28 May 2013. At a ceremony, Stock unveiled a statue of a disabled child to symbolise 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. They also criticised the company for their claim that no one could have known the harm the drug caused, arguing that there were plenty of red flags at the time. == Notable cases == right|thumb|Niko von Glasow, German filmmaker * Lorraine Mercer MBE of the United Kingdom, born with phocomelia of both arms and legs, is the only thalidomide survivor to carry the Olympic Torch. * Thomas Quasthoff, an internationally acclaimed bass- baritone, who describes himself: "1.34 meters tall, short arms, seven fingers — four right, three left — large, relatively well-formed head, brown eyes, distinctive lips; profession: singer". * Niko von Glasow produced a documentary called NoBody's Perfect, based on the lives of 12 people affected by the drug, which was released in 2008. * Mercédes Benegbi, born with phocomelia of both arms, drove the successful campaign for compensation from her government for Canadians who were affected by thalidomide. * Mat Fraser, born with phocomelia of both arms, is an English rock musician, actor, writer and performance artist. He produced a 2002 television documentary, Born Freak, which looked at this historical tradition and its relevance to modern disabled performers. This work has become the subject of academic analysis in the field of disability studies. * Kevin Donnellon, subject of a 1972 documentary A day in the Life of Kevin Donnellon and later a novel, Flid by Colin Stewart. == Change in drug regulations == The disaster prompted many countries to introduce tougher rules for the testing and licensing of drugs. In the United States, the new regulations strengthened the FDA, among other ways, by requiring applicants to prove efficacy and to disclose all side effects encountered in testing. The FDA subsequently initiated the Drug Efficacy Study Implementation to reclassify drugs already on the market.