Grünenthal GmbH
| Type | Gesellschaft mit beschränkter Haftung |
|---|---|
| Industry | Pharmaceutical industry |
| Founded | 1946 |
| Founder(s) | Hermann Wirtz, Sr. |
| Headquarters | Aachen (Rhineland), Germany |
| Area served | Worldwide |
| Key people | Harald F. Stock (CEO) Stefan Genten Eric-Paul Pâques Alberto Grua Klaus D. Langner Jan Van Ruymbeke Thomas Senderovitz Heinz-Gerd Suelmann |
| Products | Pharmaceutics |
| Revenue |  € 910 million (2010) [1] |
| Employees | ca. 2.400 (2010) [1][2] |
| Website | www.gruenenthal.com |
Grünenthal GmbH is a German researching pharmaceutical company in Aachen (Rhineland). It was founded in 1946 and has been in family ownership since than. The company was the first that introduced Penicillin onto the German market in the post-war period, during which it was forbidden by the Allied Control Council. In the 1960s, however, Grünenthal achieved awareness through the development of Thalidomide, the active substance of the sleeping pill Contergan, which caused teratogenic deformities in children. Today the firm generates more than 50% of its turnover with pain medications, such as the own developed drug Tramadol. Grünenthal has besides the two offices in Germany, subsidiaries in Europe, Latin America, the USA and China. Related firms of the same family tree are the soaps, toiletries, and cosmetics companys Dalli Group and Mäurer & Wirtz.
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[edit] History
Grünenthal was founded 1946 by Hermann Wirtz, Sr. as Chemie Grünenthal GmbH in Stolberg (Rhineland), later it was renamed in Grünenthal GmbH and the headquarter was moved to Aachen.
[edit] Penicillin
Grünenthal was the first company, who introduced Penicillin in the post-war period onto the German market. The occupying powers had prohibited the research and manufacture of penicillin by German companys before. The almost certain bankruptcy of the company was prevented by the introduction of Penicillin.
[edit] Thalidomide (Contergan)
The company invented and marketed Thalidomide as Contergan in 1957. The drug was responsible for teratogenic deformities in children born after their mothers used it during pregnancies, prior to the third trimester. In November 1961 Thalidomide was taken due to massive pressure from the press and public off the market.[3] Experts estimate that from the drug Thalidomide lead to the death of approximately 2,000 children and serious birth defects of more than 10,000 children, about 5,000 of them in Germany. One reason for the initially unobserved side effects of the drug and the subsequent approval in Germany was that drugs did not have to be tested for damage on unborn children (teratogenic effects).[4][5]
In the U.S., thalidomide was refused admission, but it was distributed in large quantities for testing purposes, after the American manufacturer Richardson-Merrell had firstly applied for the approval in September 1960. The official in charge of the U.S. Food and Drug Administration, Frances Oldham Kelsey did not rely on information from the company of Richardson-Merrell, which did not include any test results. Richardson-Merrell was called on to perform tests and reporting the results. The company refused it and demanded a re-admission six times, which was refused each time. Nevertheless, a total of 17 children with thalidomide-induced malformations were born.[6].
In 1970 DM 100 million were paid by Grünenthal and about DM 320 million by the federal government of Germany to the Foundation for Disabled People. Between 1997 and 2008 Grünenthal declined further payments to the Thalidomide victims, because at that time the settled payments were exhausted. At the end of 2007, the British entrepreneur Nicholas Dobrik planned together with a group of victims a international campaign to enforce compensation payments.[7] On 8 May 2008 Grünenthal announced to voluntarily pay € 50 million to the Thalidomide Foundation to help to improve the lives of Thalidomide victims to a long term.[8]
In consequence of the Thalidomide scandal, the Medical Law in Germany was aggravated and new requirements for pharmaceutical testings were created. In 1964 the Israeli physician Jacob Sheskin discovered the positive effect of Thalidomide in the leprosy treatment. Since the 1970s Grünenthal delivers Thalidomide tablets to leprosy clinics to assist the fight against the leprosy. The delivery took place under strict conditions and by virtue of an agreement with the World Health Organization (WHO).[9] 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.[10]
[edit] 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.[11]
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.[12]
In July 2010, the British Prescription Medicines Code of Practice Authority (PMCPA) received a 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.[13]
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.[14] 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.[15]
[edit] Further development
The company has focused on the treatment of pain later and is working in this field with its own research and development. The by Grünenthal developed drug Tramadol, which is marketed under the brand name Tramal is one of the best-selling painkiller in the opioid field. Other business units are gynecology, dermatology and anti-infectives.[2] Other current products are the birth control pill Belara and the matrix pain patch Transtec. Unlike Tramadol, which is not a scheduled medication, the by Grünenthal licensed drug 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).
[edit] 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.
[edit] References
- ^ a b Jürgen Salz: Schmerzhafte Entscheidung bei Grünenthal. from wiwo.de, 15. December 2009 german
- ^ a b Grünenthal GmbH - Facts and Figures, 3. July 2011.
- ^ Bundesverband Contergangeschädigter e.V. 6. July 2011.
- ^ VFA: teratogenic effects 6. July 2011.
- ^ Contergan info page of Grünethal GmbH 3. July 2011
- ^ Report on the website of the U.S. Food and Drug Administration
- ^ Thalidomide Company threaten billions in debt to Spiegel 10. November 2007.
- ^ Grünenthal donates € 50 million to the Foundation
- ^ Pharmazeutische Zeitung concerning Jacob Sheskin 6. July 2011.
- ^ Orphan Drugs: Caught In Limbo, New York Times, July 20, 1986, pg. F1.
- ^ Thalidomide Maker Is Sued by Parents Of Deformed Twins, New York Times, October 19, 1962, pg. 33.
- ^ Suffer The Children:The Story of Thalidomide, The Insight Team of the Sunday Times (UK), Viking Press, 1979, pp. 10 - 48.
- ^ 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
