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Chemie Grünenthal of Stolberg-am-Rhein is a German pharmaceutical company in Stolberg (Rhineland) near Aachen. It holds the patent to Tramadol, used as an analgesic (painkiller). The firm was a branch of a soaps, toiletries, and cosmetics business which was formed a short time after World War II.
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Thalidomide
In the 1950s Chemie Grünenthal invented and marketed Thalidomide (Contergan or Softenon). The drug was responsible for teratogenic deformities in children born after their mothers used it during pregnancies, prior to the third trimester.
Beginning with the production of antibiotics, the company entered the field of synthetic drug development by the mid-1950s. To do this the business vacated a section of its packing plant and hired a research staff numbering a half dozen scientists and technicians. The employees were placed under the direction of Dr. Heinrich Mueckter, who joined Chemie Grunenthal in 1946 after becoming a doctor in the 1930s. Earlier he was a part of the German army's virus research organization.
An early member of the Mueckter's research team was Wilhelm Kunz, who became a pharmacist after service as a sergeant in World War II. His job invloved synthesizing organic compounds with the goal of finding new compounds which Chemie Grunenthal might use. It is believed that Kunz's lack of a scientific background is responsible for his lack of curiosity about the possible adverse effects of Thalidomide. In the late 1970s he continued to demonstrate only a slight knowledge of his firm's investigations of the drug prior to producing it.
Chemie Grunenthal contended that Thalidomide was suitable for both pregnant women and nursing mothers. In reply to a query from a Heilbrunn physician, the corporation maintained that there was no evidence that the drug would pass through the placental membrane after entering a pregnant mother's blood.[1]
Chemie Grunenthal withdrew Thalidomide and all compounds containing it from the market on November 26, 1961. A study published in August 1962 revealed the instances of phocomelia and use of the drug. In fifty case histories all but five women had taken Thalidomide between the thirtieth and fiftieth day after their last menstrual period. The five exceptions took the sedative between the fiftieth and sixtieth day after. In the twenty-one instances in which a date of conception could be ascertained, the mother had taken the drug between the twenty-eighth and forty-second day after conception.[2]
Litigation
A Long Island, New York family sued the drug maker after their twins were born with deformities in May 1961. Their son was born without arms, with hands growing from his shoulders, and their daughter suffered from a number of internal deformities. The mother, a German, met her husband in 1959, while studying at the University of Florence. She came to the United States with Contergan tablets she brought from Germany, and a prescription from her physician. The lawsuit alleged that Chemie Grunenthal was negligent in not testing the Thalidomide preparation, and failing to warn of its effects on unborn children.[3]
In 1968 Chemie Grunenthal executives were tried for involuntary manslaughter. By this time the company stated that Thalidomide was not recommended for use during pregnancy as such. The qualifying term obstetrics was employed. It was used in hindsight to strengthen the argument that doctors would interpret the word to mean that Thalidomide was safe during the final stage of pregnancy only. This is a fallacious form of reasoning according to the German Medical Association, which defines obstetrics as starting with conception.[1]
Chemie Grunenthal provided more than 1,000 leprosy victims in the United States with Thalidomide until a few months before July 1986. The drug is especially helpful to lepers in treating an extremely painful allergic reaction on their skins. The company discontinued exporting Thalidomide because of liability fears. A lack of insurance coverage for those requiring the drug was also a problem.[4]
References
- ^ a b Suffer The Children:The Story of Thalidomide, The Insight Team of the Sunday Times (UK), Viking Press, 1979, pp. 10 - 48.
- ^ Thalidomide, New York Times, August 5, 1962, pg. 135.
- ^ Thalidomide Maker Is Sued by Parents Of Deformed Twins, New York Times, October 19, 1962, pg. 33.
- ^ Orphan Drugs: Caught In Limbo, New York Times, July 20, 1986, pg. F1.
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