Distaval was the UK trade name of a prescription only medicine containing the active ingredient thalidomide marketed as a sedative and sleep-inducing agent. However, thalidomide could cause considerable damage to the foetus in the early stages of pregnancy.
In 2013, Grünenthal itself took on the financing of the peer-to-peer initiative and is thus supporting the direct exchange and mutual support of thalidomide-affected people. There are also numerous networks, which are completely independent of Grünenthal, such as the Contergan network and the Contergan forum.
There is an extensive, well-established and international support network for thalidomide-affected people. This network includes financial support from the Contergan foundation and the financing of benefits in kind and projects by the Grünenthal-Foundation.
This is a link to information about the Grünenthal Foundation.
Grünenthal Pharma has set up a program to support the costs of the translations into German language of the relevant medical documents and applications of Spanish individuals willing to apply to the Contergan Foundation in Germany. More information can be found here.
The Spanish royal decree (RD 1006/2010) recognized 24 of 249 claimants as being affected by thalidomide. In the case of these 24 individuals a damage caused by thalidomide could not be excluded. The royal decree does not differentiate if a person had been affected by a thalidomide-containing product from Grünenthal or a product from another manufacturer, however. In Spain, three other companies namely Laboratorio Farmacológicos Nessa, Peyva Laboratorios and the Instituto Farmacológico Latino marketed thalidomide. The Contergan Foundation recognized ten Spaniards as affected by thalidomide-containing product from Grünenthal.
Grünenthal has meaningful dialogue with individuals affected by thalidomide in Germany and abroad. In order to better understand the needs of those affected and to implement sensible projects via the Grünenthal Foundation, the foundation organised a round table with representatives from thalidomide associations in the year 2013. This kind of exchange actually began in December 2007 when the former managing partner of Grünenthal GmbH, Sebastian Wirtz, met with representatives of the Federal Association of Thalidomide Victims for the first time.
Grünenthal has paid more than 100,000,000 Euros to the German Contergan Foundation. This foundation is independent of Grünenthal and provides financial support to affected people in 38 countries.
Grünenthal and its distribution and licensing partners sold thalidomide-containing drugs under a wide variety of brand names. These included Contergan, Softenon, Distaval and many more.
The thalidomide tragedy was one of the most defining pharmaceutical incidents in the Federal Republic of Germany. Years after its market launch, doctors discovered that the sedative thalidomide could cause deformities in newborns if it was taken by the mother within the first three months of pregnancy. Since there were hardly any regulations regarding the launch of drugs at that time, the tragedy triggered the introduction of a Drug Act , which stipulated appropriate tests for newly developed medicines, in the way we know today.
On the basis of the settlement agreement of April 1970 between the parents of the affected children and Grünenthal, the German parliament legislated on “Aid for Disabled Children” in December 1971 and thus paved the way for the Contergan Foundation. The goal of the German parliament was to help children in the long term without health insurers being able to make claims for repayment from the parents.
Until its market withdrawal, thalidomide was available on the market in a total of 46 countries under a wide variety of names.
According to the Thalidomide Trust 466 thalidomide-affected people are supported financially by the Trust in the UK today.
At the start of the 1970s, Grünenthal paid a total 100 million Deutsche Mark plus interest (approx. 58 million Euro) into the Contergan Foundation; the German parliament made a contribution of another 100 million Deutsche Mark (approx. 51 million Euro). In 2009, Grünenthal voluntarily paid another 50 million Euros into the Contergan Foundation.
The sedative was sold in West Germany under the name of Contergan from October 1, 1957.
If taken on a continuous basis, thalidomide caused permanent damage to the nervous system.
The embryo was damaged by thalidomide, if the substance was taken by the mother within the sensitive phase of pregnancy (between the 35th and 50th day of pregnancy, calculated from the first day of the last menstruation). Depending on when the drug was taken, children developed different deformities and malformations (e.g. underdevelopment of hands, feet, arms, legs or no earlobes). Children who were born with these deformities became known as “Thalidomide Children” in the 1950s and 1960s.
In the UK, there is the Thalidomide Trust, a fund which was established in 1973 and received financial resources from Distillers Company Ltd, the former licensee of Grünenthal and from the UK Government. Additionally, British thalidomide-affected people can apply for support for the financing of benefits in kind by the Grünenthal Foundation.
Distillers (Biochemicals) Ltd., Grünenthal’s licensee, marketed thalidomide in Great Britain from April 1958 and in Australia from November 1960.
In Germany, around 5,000 children were born with malformations between the end of the 1950s and the start of the 1960s. The number of people affected around the world is estimated at around 10,000; however, exact figures are not known.
Since 1972, the Contergan Foundation has paid out around 1.4 billion Euros to people affected around the world. It pays life-long pensions of up to 8,117 euros per month to people affected by a thalidomide-containing product of Grünenthal or one of its local distribution partners. Those affected are currently being supported in 38 countries.
Yes. Thalidomide-containing products were sold by a distributor of Grünenthal under the name Softenon since November 1960. However, three companies namely Laboratorio Farmacológicos Nessa, Peyva Laboratorios and the Instituto Farmacológico Latino had already been selling Thalidomide-containing products in Spain under several different trademarks. But these companies had no connection at all to Grünenthal.
Thalidomide was synthesised for the first time in March 1954.
The thalidomide patent was a manufacturing patent, not a substance patent. This means that the manufacturing procedure was protected, but not the substance itself. Grünenthal actually hired Spanish patent attorneys back then to consider taking action, but the matter was not taken forward after the discontinuation of the sale in Spain.
Grünenthal filed a patent application for thalidomide in West Germany in 1954.
Thalidomide is still used for a wide range of treatments. However, Grünenthal has no financial interests in the firms or drugs which use thalidomide. At no time after the drug was withdrawn from the market in 1961, has the company gained any commercial benefits from the use of thalidomide-containing substances around the world.
The active ingredient thalidomide was tested on specific animals in line with standards which were common for pharmaceutical companies back then. These test results showed no side effects. Based on the results, thalidomide was thus sold prescription-free in West Germany.
Thalidomide is a synthetic derivative of glutamic acid (alpha-phthalimido-glutarimide) and it is now known to have anti-angiogenic, immunomodulatory, anti-inflammatory and teratogenic properties. It is a slightly water-soluble solid, crystalline with the chemical formula C 13 H 10 N 2 O 4.
The criminal proceedings against nine senior members of Grünenthal’s staff represented one of the most complex cases in German legal history to date. The process before the First Grand Chamber of Aachen Regional Court lasted more than two and a half years – with 283 trial days. On December 18,1970, the criminal proceedings were discontinued with the agreement of the Public Prosecutor’s Office. Five independent judges provided an extensive justification of the decision to discontinue the proceedings over around 100 pages. All of the documents which were analysed and evaluated during the trial (around 600,000 pages) are kept in public archives.
Thalidomide was a sedative and sleep-inducing agent. Thalidomide-containing drugs were taken by men and women in order to remedy states of agitation and sleeping disorders. Due to its sedative effects, women also used it to counter pregnancy-related discomforts, such as morning sickness.
Thalidomide had the internal project name “K17”, because it was the 17th molecule that Dr. Wilhelm Kunz discovered during his time at Grünenthal.
Even after the criminal proceedings against nine senior members of Grünenthal´s staff before the First Grand Chamber of Aachen Regional Court had lasted for a period of more than two and a half years, during which numerous witnesses and experts had been heard, the conclusion of the trial was not yet in sight. In addition, claims of the people affected would have also had to be clarified in lengthy civil procedures. Grünenthal and the parent representatives thus knew that a solution had to be found quickly as to how the affected children and families could be supported. Discussions were held as to how this financial support could be guaranteed by Grünenthal. These discussions finally resulted in a settlement between the parents of the children affected and Grünenthal in April 1970; this settlement was reached independently of the continuing criminal proceedings.
No. When the product was launched in 1957, there was no knowledge of the teratogenic or polyneuritis side effects now known to be associated with the use of thalidomide.
When thalidomide was launched on the market in 1957, there was no uniform drug law as we know it today in the Federal Republic of Germany and other parts of the world. There was also no comprehensive legislation for identifying side effects. Companies tested their drugs according to the prevailing standards of the pharmaceutical industry at that time. At that time, drugs were not ordinarily tested for damage caused to unborn babies (teratogenic effects).
No, there was not. You can find more information about the background in this more extensive article.
On May 26, 1961, Grünenthal made an application to the North Rhine-Westphalia Ministry of the Interior for thalidomide to become a prescription-only drug. This came into force in North Rhine-Westphalia, Baden-Wuerttemberg and Hesse in August 1961.
At the time of the thalidomide tragedy, there were no guidelines as we know them today for the development of drugs in the Federal Republic of Germany. There was no Drug Law and there were no special regulatory or administrative bodies such as the Federal Institute for Drugs and Medical Devices (BfArM).
In a speech on August 31, 2012, the former CEO of Grünenthal, Dr. Harald F. Stock, apologised to the people affected, their mothers and families for the long silence. This is a link to the translation of the German speech.
Teratogenic means that a substance can cause malformations to the embryo in the womb. In the case of thalidomide, it related to the so-called thalidomide birth defects associated with its use.
It was only in 1964 that the German parliament defined the requirements for testing drugs in the “Law amending the Drug Law”. As a medical expert association, the German Pharmacological Society came up with accompanying scientific guidelines.
On November 15, 1961, Dr. Widukind Lenz, paediatrician and human geneticist in Hamburg, voiced his suspicions about teratogenicity during a phone call to Grünenthal. On November 17,1961, the suspicions of Dr. Lenz were submitted to Grünenthal in writing.
Polyneuritis was first reported in 1959. In 1960 Grünenthal amended its product information to include a warning relating to a risk of polyneuritis. By early 1961 increased evidence of the risk of polyneuritis associated with administration of thalidomide for several months led to a further warning being added to the product labelling.
No. The company Grünenthal was founded in 1946, thus after the Second World War. Thalidomide itself was synthesised for the first time in 1954 and the company filed a patent application in the same year.
In a letter received by Grünenthal on Friday, November 24, 1961, the British licensee Distillers informed Grünenthal that the Australian gynaecologist Dr. William G. McBride had raised his concerns about the potential teratogenic effects of thalidomide.
Polyneuritis is an inflammatory disease of the nervous system in adults, which affects several nerves. For example, those affected have described numbness in the tips of their fingers and feet. Polyneuritis can also result in a longer-lasting complaint of a pathologically detectable change to the nervous tissue.
Grünenthal informed its own sales personnel, doctors, hospitals and pharmacies as well as its international distribution partners and licensees via telephone and fax/letter.
On November 27, 1961 – just 12 days after the first suspicion about teratogenity had been reported to Grünenthal by Dr. Widukind Lenz – Grünenthal took the drug off the market. All licensees were informed about the decision and were each responsible for the market withdrawal in their territories.
Dr. Widukind Lenz was a Hamburg-based paediatrician and human geneticist, who voiced his concerns that there could be a connection between the increase in malformations of unborn babies and thalidomide and the increased use of thalidomide. He was thus the first to suspect a connection between thalidomide and teratogenicity and to inform Grünenthal.
Frances Kelsey was a pharmacologist and physician who worked as a reviewer for the U.S. Food and Drug Administration (FDA). During the process of authorizing thalidomide for the North-American market, she voiced her concerns about the drug’s safety and required more testing. Her concerns were not specifically related to teratogenicity, but did lead to the non-authorization of thalidomide for the U.S. In 1962, President John F. Kennedy awarded her the President’s Award for Distinguished Federal Civilian Service.