|Type||Gesellschaft mit beschränkter Haftung|
|Founder(s)||Hermann Wirtz, Sr.|
|Key people||Eric-Paul Pâques
Klaus D. Langner
|Revenue||€ 973 million (2012)|
|Employees||ca. 4400 (2012)|
Grünenthal is a German pharmaceutical company headquartered in Aachen. It was founded in 1946 and has been continuously family owned. The company was the first to introduce penicillin into the German market in the post-war period, after the Allied Control Council lifted its ban. In the 1960s, Grünenthal became infamous through the development and sale of the teratogenic drug Thalidomide. It was marked as the sleeping pill Contergan, and promoted as a morning sickness preventative. However it caused severe deformities in the children born to mothers who took it.
It has two offices in Germany. In addition Grünenthal has subsidiaries in Europe, Latin America, the USA and China.
The occupying powers had prohibited the research and manufacture of penicillin by German companies. When the ban was lifted Grünenthal was the first company, who introduced penicillin in the post-war period onto the German market. This investment achieved a big financial boost for the company.
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 off the market due to massive pressure from the press and public. Experts estimate that the drug thalidomide led to the death of approximately 2,000 children and serious birth defects in more than 10,000 children, about 5,000 of them in West Germany. The East Germans did not approve thalidomide. One reason for the initially unobserved side effects of the drug and the subsequent approval in Germany was that at that time drugs did not have to be tested for (teratogenic effects). They had only been tested on rodents, as was usual at the time.
In the U.S., the Food and Drug Administration (FDA) refused to approve thalidomide for sale. It was distributed in large quantities for testing purposes, after the American manufacturer Richardson-Merrell had applied for its approval in September, 1960. The official in charge of the FDA, 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 report the results. The company refused and demanded approval six times, and was refused each time. Nevertheless, a total of 17 children with thalidomide-induced malformations were born.
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 organized a group of victims and began an international campaign to force compensation payments. On 8 May, 2008, Grünenthal announced it would voluntarily pay € 50 million to the Thalidomide Foundation to help to improve the lives of thalidomide victims.
As a result of the thalidomide scandal, the Health Law in Germany was strengthened and new requirements for pharmaceutical testings were created; and the Federal Ministry of Health was established in 1962.
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 the testing of thalidomide, and that they failed to warn of its effects on unborn children.
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.
In 1964 the Israeli physician Jacob Sheskin discovered the positive effect of thalidomide in the treatment of leprosy. Since the 1970s Grünenthal has delivered thalidomide tablets to leprosy clinics to assist the fight against leprosy. The delivery takes place under strict conditions and by virtue of an agreement with the World Health Organization (WHO). 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 skin. The company discontinued exporting thalidomide because of liability fears. A lack of insurance coverage for those requiring the drug was also a problem.
In August 2012, the company issued its first apology in a half-century saying it regretted the consequences of the drug that led to the births of children without limbs or with shortened limbs during the 1950s and 1960s. Harald Stock, Grunenthal's chief executive, said the company had failed to reach out "from person to person" to the victims and their mothers over the past 50 years.
British issues 2010
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 and data at a congress of healthcare professionals that contained off label information, 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 concluded 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.
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 product 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.
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.
The company has focused on the treatment of pain, and is doing its own research and development in this field. Grünenthal developed the drug Tramadol, which is marketed under the brand name Tramal is one of the best-selling painkillers in the opioid field. Other business units are gynecology, dermatology and anti-infectives. Other current products are the birth control pill Belara and the matrix pain patch Transtec. Unlike Tramadol, which is not a scheduled medication, the drug Tapentadol HCl, as licensed by Grünenthal, 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).
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, totaling 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.
- 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
- 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.
- Pharmazeutische Zeitung concerning Jacob Sheskin 6. July 2011.
- Orphan Drugs: Caught In Limbo, New York Times, July 20, 1986, pg. F1.
- "Thalidomide maker issues apology". UPI. Retrieved 1 September 2012.
- 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