The History of the Thalidomide Tragedy
The Thalidomide tragedy will always be a part of our company’s history. We deeply regret the wide-ranging consequences for the people affected by Thalidomide and their families. We will never forget what happened.
In this article, we aim to provide an overview of the Thalidomide tragedy in Germany. What is Thalidomide and what is it used for? What happened in the “Thalidomide trial” and what were the consequences? And what is being done today for people affected by Thalidomide?
The history of the Thalidomide tragedy is multi-faceted and complex. For this reason, we have taken great care to include different perspectives in the presentation and to back up the most important events addressed in this text with external sources.
What was Thalidomide and what was it used for?
Thalidomide was a sleep aid and sedative sold in many countries around the world. In Germany, the drug was sold between 1957 and 1961 under the name of “Contergan” and other names. The medication was also taken by women for morning sickness during pregnancy because doctors found Thalidomide to have a positive effect. However, Grünenthal itself did not promote taking the medication for morning sickness.
In November 1961, it became known that the drug caused severe deformities in newborn children if it was taken between the 34th and 50th day of pregnancy, counting from the first day of the last menstrual cycle.
The fate of the Thalidomide babies and subsequent court proceedings in Germany are still known today as the “Thalidomide scandal”.
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How Thalidomide was developed and brought to marketGrünenthal scientists Dr. Wilhelm Kunz and Dr. Herbert Keller synthesized Thalidomide for the first time in March 1954. They created the substance as a byproduct of their research into glutamic acid. Creating new substances first and then attempting to find a possible use for them was a common approach in the pharmaceutical industry at the time. Grünenthal registered a patent for Thalidomide in the same year.
With today’s knowledge of Thalidomide's side effects, it may be difficult to understand why the product was allowed to be sold at all.
It is important to explain that knowledge about the safety of products and medical products was not as far advanced in the 1950s and 1960s as it is today. There were no guidelines in Germany for the development, production, and marketing of pharmaceuticals as we know them today. Procedures for authorizing and monitoring medicines in their current form were only established after the Thalidomide tragedy.
At the time, testing whether an active ingredient of a pharmaceutical substance could harm unborn life was not common in pharmaceuticals. Such tests were not required in Germany or in other countries. Consequently, Thalidomide was also not tested on pregnant animals.
According to our information, the development and introduction of Thalidomide corresponded to the state of knowledge at that time and the applicable standards in the pharmaceutical industry. These standards were substantially altered in the years that followed, as a reaction to the tragedy.
In August 1956, the Ministry of the Interior of North Rhine-Westphalia issued the authorisation for the manufacture of Contergan (25 mg) and Contergan Forte (100 mg). The product was then made available nationwide starting on 1 October 1957.
When was Thalidomide taken off the German market?
Grünenthal received isolated reports from doctors about possible nerve damage (polyneuritis)in patients treated with Thalidomide starting in 1959. Other suspected cases of nerve damage multiplied over the course of 1960. This increasing number of suspected cases then led Grünenthal to include warnings about side effects such as “prickling and a sensation of numbness in the hands and/or feet” in the packaging insert for Thalidomide. Finally, in May 1961, Grünenthal applied for prescription-only status because of the reported cases of polyneuritis. The Thalidomide trial showed that our company’s actions with this side effect risk were not adequate to meet the requirements for a proper, conscientious drug manufacturer.
At the same time, towards the end of the 1950s, some doctors noted that an increasing number of children with deformities were being born in Germany. However, the true cause remained hidden at first. Bayreuth paediatrician Karl Beck alleged in a newspaper article in May 1958 that nuclear tests were responsible for the disabilities. 1
The explanation of the teratogenic effect of Thalidomide is inseparably linked with the doctors Widukind Lenz and William McBride. Numbers of deformity cases increased in Lenz’ clinic in the city of Hamburg as well as in McBride’s hospital in Australia. Both doctors attempted to find the causes and, independently, came to the assumption that Thalidomide could be a possible cause.
Lenz was a paediatrician and lecturer in human genetics based in the city of Hamburg. In his investigations, he came to the conclusion that Thalidomide could have a teratogenic effect. He informed Grünenthal about his suspicions on 15 November 1961. He could not prove his suspicion at that time – on 8 November 1961, Lenz wrote to a colleague that “medications (...) [do] not [seem] probable as a cause.”2
McBride was an Australian gynaecologist at Crown Street Women’s Hospital in Sydney. A midwife in his hospital expressed the suspicion that Thalidomide might be responsible for the deformities in some babies born in the hospital. He then informed Distillers, the company marketing Thalidomide-containing medical products in Australia. Its parent company in the UK then wrote to Grünenthal about McBride's suspicion on 24 November 1961.
The fate of the “Thalidomide children”
The German Contergan Foundation estimates that around 10,000 children worldwide were born3 with deformities that could be attributed to Thalidomide. About half of them died at or shortly after birth. The deformities of the Thalidomide babies included shortened arms and legs, underdeveloped outer ears, and others.
Through our exchanges with Thalidomide-affected people, we have learned that the possibility of living a self-determined life is especially important to them. That is as true now as it was then. For this reason, when they were children, many of them rejected the prostheses that were common at that time because they found them limiting.
Today, the Thalidomide-affected people are in their late fifties to early sixties. As they grew older, their physical limitations cause them greater difficulties.To enable people affected by Thalidomide to continue to manage their lives actively, our Grünenthal Foundation offers support in financing modifications to living areas and transportation. Affected individuals receive life-long financial support through the federal Contergan Foundation.
What was the “Thalidomide trial”?
The “Thalidomide trial” was a criminal proceeding against nine senior Grünenthal employees. The trial began on 27 May 1968 in Alsdorf before the First Grand Criminal Chamber of the Regional Court of Aachen and was concluded two and a half years later, on 18 December 1970.
The Thalidomide trial was long considered the most complex criminal proceedings in German legal history. The trial ran for a total of 283 trial days during which dozens of witnesses and medical experts were heard.
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The investigative proceedings by the Public Prosecutor’s Office and subsequent criminal proceedings were lengthy. Between the initiation of the investigative proceedings by the Public Prosecutor’s Office in December 1961 and the admittance of the indictment by the Aachen Criminal Court in January 1968, a total of six years passed.
The actual trial lasted an additional two and a half years, until it was terminated by the Aachen Criminal Court in December 1970. At that point, four of the nine accused had been eliminated from the trial due to illness or death. The Presiding Judge of the Court also had to be replaced during the proceedings due to illness.
The substantive issues and results of the Thalidomide trial
The Thalidomide trial focused on clarifying issues of whether actions or omissions of the accused employees of our company caused nerve damage in adults or deformities in children in utero and whether such damage could be assigned to culpable conduct of such former employees.
The criminal proceedings did not, however, deal with the question of whether the affected families had claims for compensation from the company. Those were to be clarified in separate civil proceedings.
The Court found it difficult to reach a definitive answer to the question of the culpability of the people accused. The trial was finally terminated without judgement. The Court founded its decision in approximately 100 pages that it issued in December 1970.
We summarise the results of the decision below.
- It was proven that taking Thalidomide resulted in nerve damage (Polyneuritis). With regard to this nerve damage, Grünenthal had not met the requirements for a proper, conscientious pharmaceutical manufacturer.
In addition, the Court ruled that continuation of the criminal proceedings was not proportionate. There were two reasons for this.
- Even in the hypothetical case that, after an orderly completion of the proceedings, misconduct by the accused had been found, the individual culpability of the accused would have been considered minor, despite the serious consequences. Among other factors, the Court took into consideration that there had been no explicit advertising for the use of Thalidomide during pregnancy. In addition, the company withdrew its Thalidomide-containing products just a relatively short time after Prof. Lenz expressed his suspicions for the first time.
- Furthermore, it was no longer necessary to continue the criminal proceedings for overriding reasons (designated as in “the public interest” in the Code of Criminal Proceedings). The Court referred to the fact that Grünenthal and the attorneys for the affected families had already reached a settlement in April 1970 in which Grünenthal was obligated to pay 100 million German marks. In its concluding remarks, the Court stated:
“The claims of the deformed children for compensation are satisfied on the grounds of the legally-binding obligation of Chemie-Grünenthal to pay '110 million German marks, including interest,' far more quickly and probably more extensively than would have been possible through civil proceedings. (...) Thus, the by far overwhelming majority of victims participating in these proceedings as joint plaintiffs did not object to termination.”
Was there political interference in the Thalidomide trial?
There have been isolated allegations that German politicians interfered in the Thalidomide trial in favour of Grünenthal, leading to a premature termination of the proceedings. This allegation is false. It was a conspiracy theory created by British activists to develop claims for compensation against the German federal government. A research report by the historian Dr. Lenhard-Schramm, which was ordered by the State of North Rhine-Westphalia, confirmed in 2016 that the allegations about political influence were based on falsely-dated documents and intentional misrepresentations.
The conspiracy theorists also misjudged the German legal system. They alleged that the State government at the time had exerted unethical influence on their subordinate Public Prosecutor's Office. However, according to the German Code of Criminal Proceedings, the decision to terminate the criminal proceedings was not made by the Public Prosecutor's Office, but rather by the independent court, i.e. by the Aachen Criminal Court consisting of five independent judges. Beyond that, the court made its decision in public proceedings that were followed very intently by the public and the media. Finally, the court explained its decision to terminate the proceedings in a public hearing and justified its decision in a document of almost 100 pages.
The settlement and the creation of the German Federal Contergan Foundation
Independent of the outcome of the ongoing Thalidomide trial, a solution had to be found for the most urgent problem: helping the affected families and making them financially secure. Because even if the accused had been convicted in the criminal proceedings, it would not have been linked with a judgement on any obligation for Grünenthal to pay compensation. Each affected family would then have had to assert any claims for compensation against the company in separate civil proceedings. More years would have passed before a final clarification.
Together with the affected families, our company found a solution outside of the Thalidomide trial. On 10 April 1970, long before the later termination of the proceedings in December of the same year, the affected families reached an out-of-court settlement with Grünenthal through their attorneys. The most important result of the settlement was the commitment by Grünenthal to pay 100 million German marks to support Thalidomide-affected children.
Before the money could be paid to the affected families, however, two preconditions had to be met:
- Grünenthal had committed to pay the amount of the settlement to the affected families with the reservation that the company would be freed from further claims by health and pension insurers, as well as other social insurance carriers.
- The Thalidomide-affected children were also threatened that the social benefits owed to them by the State would be reduced by the payments they would receive from the settlement with Grünenthal. All things considered, the children would not have received any additional financial support despite the settlement.
Both preconditions were met by the legislature with the creation of a foundation under public law. The law establishing the Contergan Foundation came into effect on 31 October 1972.
With the approval of the majority of affected families, Grünenthal paid the 100 million German marks promised in the settlement of April 1970 (converted to approximately 51 million euros in 2002) plus 10 million German marks in incurred interest into the foundation. In this way, the claims under the settlement of the people affected were replaced with life-long support benefits from the Contergan Foundation.
With regard to Grünenthal's financial contribution, the Foundation Act established that no more extensive claims existed against the company and that also social insurance carriers had no claims. The Foundation Act also established that benefits from the Contergan Foundation could not be offset against any social insurance claims of Thalidomide-affected people, which would have been detrimental to the affected people.
The federal government paid an additional 100 million German marks into the foundation's endowment fund. The resources now at hand created the basis for extensive financial support for Thalidomide-affected people. The Contergan Foundation has supported Thalidomide-affected people in 38 countries to date.
The international dimension of the Thalidomide tragedy
Although most Thalidomide-affected people were born in Germany, Grünenthal also distributed the medicine either by themselves, through third-party distributors, or as part of a licensing deal in different countries. For example, in the United Kingdom and Australia, independent companies produced and marketed their Thalidomide products under a contractual license from Grünenthal in their own responsibility.
The list below and the exploration of Thalidomide’s history are not exhaustive and only serve as a brief overview and introduction.
In Australia, Distiller Biochemicals, a UK firm, was responsible for the distribution and marketing of Thalidomide products under its own name. Distillers (its legal successor is Diageo) launched their first Thalidomide product in Australia in 1960 and withdrew it from the Australian market in December 1961 following Grünenthal’s withdrawal in Germany. During the 1960s and early 1970s, civil actions were brought by those affected by Thalidomide against Distillers companies. While there are no exact figures of how many people were affected, 107 were awarded compensation. In addition to a trust fund established by Diageo in 2010, the Australian state supports Thalidomide survivors.
Distillers/Diageo also manufactured and distributed their medicines containing Thalidomide in the United Kingdom under a license obtained from Grünenthal. In the UK, approximately 2000 babies were born affected by Thalidomide. Around 440 Thalidomide survivors are still alive today. In 1973, the Thalidomide Trust was established after a 20-million-pound settlement between Distillers and 429 Thalidomide survivors. Additionally, since 2010, the affected people have been supported by a Health Grant by the British government.
In Ireland, Thalidomide was distributed by a local distributor of Grünenthal starting in 1959. Today, more than 30 Thalidomide survivors receive life-long financial support from the Irish government and the German Federal Contergan Foundation.
The history of Thalidomide in Spain is complex. In Spain, Grünenthal sold its own products containing Thalidomide through a local distributor. However, other producers also manufactured and marketed their own medicines containing Thalidomide in Spain independently and without a license from Grünenthal. This makes it very difficult to correctly track the number of Thalidomide-affected people. Today, Spanish residents who have been affected by a Grünenthal product containing Thalidomide are supported by the German Federal Contergan Foundation. In addition, Thalidomide affected persons are also financially supported by the Spanish government.
Grünenthal never distributed any thalidomide containing product in Italy, neither themselves nor through any distribution partner. However, independent companies manufactured and marketed their own products containing Thalidomide in Italy without a license or permission from Grünenthal. The Italian government provides support to the approximately 250 Thalidomide-affected people in Italy.
In Brazil, Grünenthal marketed its Thalidomide-containing products through its local distribution partner Instituto Pinheiro as a sleeping drug until the drug was withdrawn from the market. Similar to the situation in Spain, there were however also other companies that manufactured and sold their own products containing Thalidomide in Brazil independently from Grünenthal and without Grünenthal’s license or permission. Today, 63 Thalidomide survivors in Brazil are supported by the German Federal Contergan Foundation.
A few years after the market withdrawal of the Thalidomide-containing medicines by Grünenthal and Instituto Pinheiro, independent scientists discovered that Thalidomide was an effective symptomatic treatment against leprosy. Therefore, at the request of the WHO and the Brazilian authorities, Grünenthal made Thalidomide once more available to dedicated clinics and leprosy centers under strict medical control until the 1980s.
The role of Frances Kelsey and the FDA: Thalidomide in the United States
Thalidomide was never approved for sale in the United States. Two independent U.S. companies conducted separate clinical trials of their own Thalidomide-containing drugs. One of these companies obtained a license from Grünenthal to test, produce and market Thalidomide-containing products in the U.S. under its own name and brand and pursuant to its own control and responsibility.
That U.S. licensee also applied for marketing authorization for its Thalidomide product with the U.S. Food and Drug Administration (FDA). When a German geneticist and pediatrician, Professor Lenz, discovered the harmful effects of Thalidomide in late November 1961, the licensee’s application in the U.S. was still pending. The day Grünenthal withdrew its Thalidomide products from the German market on November 27, 1961, it also notified the United States licensee of its withdrawal.
The U.S. licensee’s clinical testing of its Thalidomide products in the U.S. was conducted under its own control and responsibility. These trials were performed among the general population, and pregnant women, among others, participated in these trials and were thus exposed to Thalidomide. Thus, there are some Thalidomide survivors living in the U.S. despite the product never being approved by the FDA.
Frances Kelsey, a pharmacologist and physician who worked as a reviewer for the FDA, had repeatedly requested that the U.S. licensee amend its application with additional data. This was one reason why the U.S. authorization process was still pending by the time of Thalidomide’s market withdrawal in Germany and other countries worldwide. In retrospect, this delay in approval was fortunate. In 1962, President John F. Kennedy awarded Dr. Kelsey the President’s Award for Distinguished Federal Civilian Service.
How the Thalidomide tragedy changed the handling of medical products in Germany
The Thalidomide tragedy highlighted the importance of regulation and standardized testing of medical products. Governments around the globe later adopted laws to improve the authorization controls on medical products.
In Germany, a new Medicinal Products Act was adopted in 1978. The law established a uniform, comprehensive process for medical product control for the first time. Since then, manufacturers have been required to prove, in pharmacological and clinical trials, that their medications are high-quality, safe, and effective.
In this context, an agency was founded in 1975 that developed into today’s Federal Institute for Drugs and Medical Devices one of its tasks is monitoring the authorization of pharmaceuticals.
How Thalidomide-affected people are supported today
It is important to contribute to improve the daily lives of Thalidomide-affected people. For this reason, we voluntarily paid an additional 50 million euros into the German government’s Contergan Foundation in 2009.
Beginning of 2012, the Grünenthal Foundation was established. It finances actions that promote the autonomy and self-determination of affected people in everyday life, such as modifications of residences and vehicles. You can learn more about how we improve the living situation of people affected by Thalidomide here.
1Source in German: Klaus-Dieter Thomann (2007): „Die trügerische Sicherheit der „harten“ Daten“, in: Deutsches Ärzteblatt (41), available at: https://www.aerzteblatt.de/pdf.asp?id=57224.
2Source in German: The scientific papers of Prof. W. Lenz; Folder 540 correspondence L-N. The Orthopaedic University Hospital Friedrichsheim, Frankfurt am Main, (now in the archive of the University of Munster, quoted from: Anna Christiane Schulze (2015): Die Rolle Widukind Lenz‘ bei der Aufdeckung der teratogenen Wirkung von Thalidomid (Contergan), Dissertation).
3Source in German: Contergan Foundation, available at: https://www.contergan-infoportal.de/stiftung/historie/contergan-zeitstrahl/, under 27 November 1961.