- Grünenthal GmbH
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Grünenthal GmbH (Chemie Grünenthal of Stolberg (Rhineland)) is a German pharmaceutical company in Stolberg (Rhineland) near Aachen, which holds the patent to Ultram (Tramadol), and its much stronger derivative Nucynta (Tapentadol), both used as analgesics (painkillers) with Norepinephrine Reuptake Inhibition. Unlike Ultram, which is not a scheduled medication, Tapentadol HCI is Schedule II(C-II) in the U.S. (meaning it is a potent agonist, therefore subject to abuse similar to other C-II opioids such as Oxycodone and Levorphanol). The firm was a branch of a soaps, toiletries, and cosmetics business which was formed a short time after World War II.
Contents
Initiatives
Since 2004 Grünenthal GmbH in cooperation with the EFIC (European Federation of Chapters of the International Association for the Study of Pain) supports young scientists in carrying out innovative and exploratory clinical pain research projects. The EFIC-Grünenthal-Grant, totalling up to 200,000 EUR, is one of the highest research awards for clinical and human experimental research projects on the subject of pain. Research grants are valued at up to € 30,000 per project.
Thalidomide
Main article: ThalidomideAccording to Grünenthal, the company invented and marketed Thalidomide (Contergan or Softenon) in the 1950s. The drug was responsible for teratogenic deformities in children born after their mothers used it during pregnancies, prior to the third trimester.
Recent research however, originating from different sources, suggest that the history of Thalidomide might stretch past 1953 to the World War II. It has been claimed that Thalidomide was actually first developed as a possible antidote to nerve toxins, such as sarin, by Otto Ambros, a Nazi scientist who joined Grünenthal after the war. Correspondence between various drug companies, French firm Rhône-Poulenc, which was under Nazi control during the war years, Astra, which held the Swedish licence to distribute Thalidomide, and IG Farben, the German pharmaceutical firm, seem to confirm the alternative past of the product. Furthermore, a relation has been suggested between testing Thalidomide and the Nazi death camps.[1]
Grünenthal has reacted to these claims by stating: “To our knowledge there was no collaboration between Grünenthal and Rhône-Poulenc for the development of Contergan/thalidomide. Three Grünenthal employees discovered thalidomide and Grünenthal is the sole inventor on the patent.” According to Grünenthal, Dr. Heinrich Mückter was one of those responsible for inventing Thalidomide. Other sources mark Dr Mückter as a fledgling pharmacologist who carried out wartime experiments on Polish prisoners to find a cure for typhus. He caused the death of hundreds in the process.[2]
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. Mückter, who joined Chemie Grünenthal in 1946.
An early member of the Mückter's research team was Wilhelm Kunz, who became a pharmacist in World War II. His job involved synthesizing organic compounds with the goal of finding new compounds which Chemie Grünenthal might use.
Grünenthal 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.[3]
Grünenthal 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.[4]
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 Grünenthal was negligent in not testing the Thalidomide preparation, and failing to warn of its effects on unborn children.[5]
In 1968 Grünenthal 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.[3]
Grünenthal 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.[6]
In addition, Grünenthal has been under investigation and reprimanded frequently by Regulatory Authorities for unlawful, and regulation breaching practices.
In July 2010, the British Prescription Medicines Code of Practice Authority (PMCPA) received an complaint from a Grünenthal employee, stating that Grünenthal produced and distributed incorrect and misleading data on its own products. After review, it was concluded that Grünenthal produced and distributed Versatis material/ data on a congress to healthcare professionals that contained off label promotion, flawed cost comparison calculations (in favour of its own product), and knowingly concealed the fact that one of the authors was a Grünenthal employee. Hence, the Panel considered that the company’s activities reduced confidence in the pharmaceutical industry and thus ruled a breach of the ABPI Code of Practice for the Pharmaceutical Industry.[7]
In November 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) advised the British authorities that it was concerned that Grünenthal was promoting its unlicensed medicine, tapentadol, to health professionals. Furthermore, these promotional activities included misleading comparisons with competitor pharmaceutical products and the deliberate pressuring of healthcare decision makers to make sure that the new Grünenthal would be sold after registration. In summary, Grünenthal was found guilty of misleading and unlawful behaviour, and as a result the Appeal Board decided to carry out multiple audits at Grünenthal in 2009 and 2010 to review its practices.[8] These cases have been preceded by similar cases in 2007, where Grünenthal was found guilty of distributing misleading information on its pharmaceutical products to healthcare professionals.[9]
References
- ^ The Sunday Times, Daniel Foggo , February 8, 2009 , Thalidomide 'was created by the Nazis' http://www.timesonline.co.uk/tol/life_and_style/health/article5683577.ece
- ^ The Sunday Times, Daniel Foggo , February 8, 2009 , Thalidomide 'was created by the Nazis' http://www.timesonline.co.uk/tol/life_and_style/health/article5683577.ece
- ^ 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.
- ^ Prescription Medicines Code of Practice Authority, AUTH/2332/7/10 - Anonymous v Grünenthal http://www.pmcpa.org.uk/?q=node/851
- ^ MHRA v Grünenthal, CASE AUTH/2327/6/10 http://www.pmcpa.org.uk/files/2327%2020%20December%20INTERIM.pdf
- ^ Prescription Medicines Code of Practice Authority, Overview cases v Grünenthal http://www.pmcpa.org.uk/?q=taxonomy/term/43
External links
Categories:- Pharmaceutical companies of Germany
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