In this article
Earlier this year the Thalidomide Society celebrated its Diamond Jubilee. It was formed in 1962 by the parents of children affected by the drug Thalidomide to provide mutual support and a social network. The Society also aimed to seek compensation for the children who had been affected by this drug. That same year (1962) writs were issued by families of an initial 62 Thalidomide-affected babies born in the UK, within months of the then deadline of three years from conception, to secure compensation.
It was a further six years before a sum equivalent to 40% of assessed damages was awarded from Distillers, the UK distributors of Thalidomide, to the 62 Thalidomide-affected children whose families had issued the writs. This was the result of an initial (infant) settlement, following a legal battle led by their families, who had, at that time, received little or no media support for their case.
At the time that the Thalidomide scandal began, there was fragmented legislation in the UK to regulate drugs, normally centred on controlling the quality and promotion of drugs, and there was no legal requirement for the independent testing of a marketed drug in relation to quality, safety and efficiency.
In 1968, the Medicines Act was enacted, and it came into effect in 1971. The Act established a formal regulatory system, with the then Committee on the Safety of Drugs replaced by the Committee on Safety of Medicine with the power to change a product’s usage or to remove it from sale.
The Thalidomide scandal has been as much about the way that culpability and compensation for those affected by Thalidomide has been acknowledged and dealt with by the pharmaceutical companies and governments, as it has been about the fact that the drug was licensed and prescribed to unsuspecting people based on limited research.
What is thalidomide?
Thalidomide is a drug that was first developed by Chemie Grünenthal GmbH in West Germany in 1954. The drug was introduced into the UK in 1958 as a sedative, and used as a treatment for morning sickness in pregnant women in the late 1950s and early 1960s. It was primarily prescribed by doctors in the UK mainly under the brand name Distaval.
Chemie Grünenthal GmbH withdrew the drug from use in November 1961 and the UK distributors Distillers withdrew it from use in the UK in December 1961.
Thalidomide is now synonymous with children being born without limbs and with other birth defects.
What is the thalidomide scandal?
When the West German pharmaceutical company Chemie Grünenthal GmbH first developed Thalidomide in the early 1950s, its initial intended use was as a sedative or tranquilliser. Early testing of the drug showed that it was virtually impossible to give test animals a lethal dose of the drug and, based on this research, the drug was deemed to be harmless to humans.
In Germany, Thalidomide was licensed for without prescription, over-the-counter sale in 1956. Very soon after licensing, Thalidomide was being used for treating a wide range of other conditions, including colds, flu, nausea and morning sickness in pregnant women, despite very limited clinical trials on humans and none on pregnant women.
Thalidomide was marketed and sold extensively in Europe, Australia, and in some South American countries, as a treatment for pregnancy-related morning sickness. Thalidomide very soon became available in 46 countries including in the UK, as 14 pharmaceutical companies, amongst them the UK distributor the Distillers Company (Biochemicals) Ltd, produced and marketed the drug under licence from Chemie Grünenthal GmbH.
Thalidomide then had at least 37 different trade or brand names around the world including:
This drug subsequently became a source of anguish when it became clear that it was responsible for birth defects and caused babies to be born with a range of disabilities. Although Thalidomide was never approved for use in the United States, samples of the drug were made by American drug companies and given to mothers, resulting in birth defects in dozens of babies.
As soon as news about the effects of Thalidomide began to circulate and the drug was withdrawn by the pharmaceutical companies, a number of parents of Thalidomide-affected children began to seek legal redress and compensation. In the UK, the manufacturer Distillers Biochemicals Ltd, now known as Diageo, reached a compensation settlement after a legal battle with the families of those affected, lasting some six years. But this initial settlement was far from satisfactory.
Chemie Grünenthal GmbH was brought to trial in West Germany charged with intent to commit bodily harm and involuntary manslaughter. However, Grünenthal insisted that it was blameless, and that the thousands of abnormal births were an “act of God”.
The company had the discreet support of the politically well-connected chemical industry, mindful that a conviction would raise their insurance premiums. The case took six years to examine 5,000 case histories of expectant mothers who had taken Thalidomide and given birth to deformed and dead babies, and of the men and women who had suffered irreversible nerve damage. The bill of indictment that was prepared against nine Grünenthal employees ran to 972 pages.
The case against Chemie Grünenthal GmbH was shut down on 18 December 1970. The nine men charged with intent to commit bodily harm and involuntary manslaughter went free. The judges said this was with the explicit approval of the prosecution and they granted Chemie Grünenthal GmbH immunity from any further criminal proceedings.
Silence was imposed on the 2,554 German families who had children with foreshortened limbs or no limbs, many of whom had damaged organs, and some were blind. The parents were pressured to end their civil suits.
The scheme that emerged from all the secret meetings without parents attending amounted to just 10% of their claims, and an average sum of $22,000 was awarded for each child for a lifetime of disability.
In the UK, the Sunday Times published a front-page lead under the banner “Our Thalidomide children, a cause for national shame” in 1972, as part of a campaigning series of articles concerning the settlement negotiations for the Thalidomide children. The newspaper had criticised the settlement proposals and, subsequently, an injunction was issued based on the claim that future publications would constitute Contempt of Court.
The court observed that the right to freedom of expression guarantees not only the freedom of the press to inform the public but also the right of the public to be properly informed, and the Thalidomide disaster was a matter of undisputed public concern. The court noted that the proposed article was moderate and balanced in its arguments on a topic that had been widely debated in society; however, the injunction was granted.
The Sunday Times filed a motion for the injunction to be removed, but it was unsuccessful. At the same time, several members in Parliament and other newspaper articles were debating the same issues that were the subject of the restricted article. Finally, in 1976, the injunction was lifted. The Documentary film Attacking the Devil recounts the long journalistic and legal battle by Harry Evans and the Sunday Times to win proper compensation for Thalidomide victims.
The Thalidomide Trust was set up in 1973 as a discretionary Trust, as part of the £20 million legal settlement between Distillers Company Ltd and 429 children with Thalidomide-related disabilities then registered with the Trust.
Distillers was then brought by Guinness PLC, which committed to honour the annual payments until 2022, and following another merger in 1997 (the company is now known as Diageo), they inherited the Thalidomide liabilities through its merger with Guinness. In 2005 Diageo agreed an increased financial settlement with the Thalidomide Trust.
Since 1973, the Trust has accepted 543 people as beneficiaries. Sadly, 103 have passed away and today they are supporting the 440 who remain, all of whom are now aged in their late 50s and early 60s.
A public inquiry into the causes of the Thalidomide tragedy was repeatedly demanded but was never carried out; in fact, it was finally refused by the Government Minister in the summer of 1976.
However, in the same year, The Congenital Disabilities (Civil Liability) Act 1976 was enacted as a direct result of the Thalidomide scandal. The Act provided that where a child was born disabled due to negligent treatment of the mother during pregnancy or childbirth, the limitation period for bringing such action only commences when the child reaches the age of 18 years. This is a separate right from that of the mother.
In 2010 the health minister Mike O’Brien made a formal apology to Thalidomide victims, expressing “sincere regret and deep sympathy” on behalf of the Labour Government. The apology received a mixed response from victims, with some describing it as too little, too late. Eighteen Northern Irish Thalidomide survivors received a formal apology from the devolved assembly and £1m compensation.
In 2012 the Health Departments in all four nations of the United Kingdom agreed to pay the Health Grant for Thalidomide-related disabilities for a ten-year period until 2022. This and the annual payments from Diageo are due to finish this year so the topic of the Thalidomide scandal still remains a discussion topic in UK Government, particularly as the remaining 440 victims are near retirement age and are or will experience various individual increasing health needs as they age.
Currently, a group of UK Thalidomide survivors, led by members of the Thalidomide Trust’s National Advisory Council (NAC), are currently campaigning to get the German Government to acknowledge the role it played in the Thalidomide scandal and to address the funding gap that still exists.
Thalidomide scandals affected many other countries around the world and many of the Thalidomide-affected victims are still pursuing their country’s pharmaceutical companies and governments for redress and compensation.
When was the first thalidomide-affected baby born?
The first Thalidomide-affected baby was born in Germany on 25 December 1956 to a Chemie Grünenthal GmbH employee.
Conservative figures indicate that there were around 147,000 Thalidomide-affected pregnancies worldwide and, of those, only 24,600 resulted in live births. In Germany alone, 10,000 babies were born affected by Thalidomide. In the UK, out of the 12,000 recorded Thalidomide pregnancies, only 2,000 resulted in live births and most babies did not survive infancy.
Louise Medus was one of the last babies born with the effects of the drug Thalidomide in the UK. Louise was born at Chase Farm Hospital in Enfield, Hertfordshire, on 23 June 1962. Louise’s mother, Vicki, had been prescribed the drug only a few weeks prior to its withdrawal from the market, and the irreversible damage was done. Sadly, Louise died in 2018.
What birth defects were caused from thalidomide?
Distaval (Thalidomide) in the UK was prescribed to anyone experiencing symptoms of colds, flu, headaches, anxiety and insomnia, as well as for symptoms of morning sickness in pregnancy; it was hailed at first as a wonder drug.
As the standard test for pregnancy at the time was three missed periods, some of the women who took Thalidomide on their doctors’ advice were unaware that they were pregnant; however, at that time in the late 1950s and early 1960s there was no indication that taking the drug would cause any harm to mother or baby.
It was then discovered in late 1961 that, if taken during the first three months of pregnancy, a single tablet of Thalidomide caused impairments such as:
- Limb difference, short or missing arms and legs.
- Sight loss.
- Hearing loss.
- Facial paralysis.
- Nerves and vessels located in unexpected places in the body.
- Impact to internal organs such as heart, intestines and kidneys.
- Effects on the cardiovascular system.
Research recorded by the Thalidomide Trust shows that Thalidomide-affected people experience significantly poorer physical health than people of similar ages in the general population. Two-thirds reported their physical health was the same or worse than the lowest 2% of the general population.
The key health problems that have been highlighted through research are:
- Pain – Often severe and/or continuous, which is experienced by more than 90% of the Thalidomide Trust’s beneficiaries.
- Reduced flexibility and mobility – In particular a reduced ability to reach, stretch and bend, which makes it difficult to undertake everyday tasks.
- Tingling and numbness – Which for many people results in a loss of strength/grip.
- Poor mental and emotional health – Including depression and anxiety.
Many Thalidomide-affected individuals rely on adapted vehicles, electronic wheelchairs, prosthetic limbs or specialised hearing aids/implants. Others have lost or seriously damaged their teeth by using them instead of hands to undertake a multitude of day-to-day tasks, and they now need expensive dental implants. It is also frequently necessary for them to adapt their homes to accommodate their disabilities.
Many Thalidomide-affected individuals have gone on to have children of their own and, because their own disabilities do not have a genetic cause, they have not been passed on to their children or to other future generations.
For many, their Thalidomide-related disabilities have also impacted their ability to work, with over 40% unable to work because of their disability or related health problems. Around a quarter of people, particularly as they get older, are having to change their job or the type of work that they do for the same reasons.
Identifying the link between thalidomide and birth defects
The link between Thalidomide and the birth defects that it caused was not made straight away, as birth defects with similarities to those caused by Thalidomide had been known about for some years. These had been mostly attributed to rare genetic conditions such as Holt-Oram Syndrome and TARS Syndrome affecting the upper limbs; Poland Syndrome affecting the hands; and Talipes Equinovarus affecting the feet and ankles.
So, any link between other birth defects and the new drug Thalidomide went unrecorded for the first few years of its worldwide use. It took more than five years from the introduction of Thalidomide in 1954 for the connection between Thalidomide taken by pregnant women and the impact on their babies to start to be made.
Dr William McBride, an Australian doctor, was one of the first doctors who found that Thalidomide caused birth defects; he wrote a letter which was published in The Lancet in 1961 outlining a probable link between Thalidomide and birth defects. In this letter he highlighted his observations of the number of severe congenital abnormalities in babies whose mothers were taking Distaval (Thalidomide) during their pregnancy.
His initial observations were not proof of a link, but he enquired in his letter whether other medical professionals worldwide had observed the same, or similar severe congenital abnormalities in babies whose mothers had taken Distaval (Thalidomide) during their pregnancy. His letter prompted the withdrawal from use of Distaval (Thalidomide) and any other preparations containing Thalidomide, by the distributors Distillers, pending further investigations.
Around the same time, links between Thalidomide and birth defects were being made by Widukind Lenz, a German Paediatrician. In 1961, he was the first to report Thalidomide’s teratogenic effects directly to German authorities. Lenz suspected the influx of birth defects in German hospitals was correlated with pregnant mothers taking the Thalidomide drug.
Lenz’s claims were backed up with X-rays of deformed infants, all from mothers who had taken Thalidomide. His evidence was strong enough for the German Government to remove Thalidomide from the German pharmaceutical market in late 1961.
Whilst it was widely recognised for many years that Thalidomide was the cause of the birth defects in children whose mothers had taken the drug during pregnancy, it was more than 60 years after Thalidomide first caused these birth defects in thousands of children that scientists at the Dana-Farber Cancer Institute discovered the actual reason why Thalidomide causes such severe birth defects.
They found that the drug interferes with transcription proteins that can shut off a gene crucial to limb development. The researchers found that Thalidomide acts by promoting the degradation of an unexpectedly wide range of transcription factors, that is cell proteins that help switch genes on or off, including one called SALL4. The result is the complete removal of SALL4 from cells. The degradation of SALL4 interferes with limb development and other aspects of foetal growth and the result is the spectrum of complications indelibly linked to Thalidomide.
The results of this research will be critical as pharmaceutical companies are currently developing a promising new generation of anticancer drugs that share a basic chemical architecture with Thalidomide. The researchers have stated that “Knowing the mechanism by which Thalidomide produces birth defects will be critical as drug developers devise and test new drugs that use the same structural ‘scaffold’ as Thalidomide.
As new derivatives are tested, we’ll be able to explore whether they have the same potentially damaging effects as Thalidomide. We know that the therapeutic effect of these drugs is based on their ability to degrade specific proteins. Our findings will help drug developers distinguish between proteins whose degradation is likely to be beneficial and whose may be harmful.”
Is thalidomide still being used today?
Thalidomide is used today for the treatment of myeloma (a type of cancer that starts in the bone marrow), brain cancer, kidney cancer, Kaposi’s sarcoma (a cancer involving the blood vessels of the skin), and also for the treatment of Hansen’s disease, once known as leprosy. In the UK, there are very tight restrictions on the use of the drug in women of childbearing age to avoid babies being born with birth defects.
The National Institute for Clinical Excellence (NICE) has recommended Thalidomide for multiple myeloma. The decision marks a watershed in the drug’s slow return to respectability. For cancer treatment, Thalidomide works in different ways.
- Stops cancer cells developing by stopping cancer cells from dividing and growing.
- Stops cancers making their own blood vessels, that they need to be able to grow.
- Stimulates some of the immune system cells to attack myeloma cells.
In the UK the drug costs £2,100 per treatment cycle and is estimated to be suitable for 2,000 patients with multiple myeloma a year.
Whilst many countries that experienced the Thalidomide scandal from the 1950s have now recognised the potential damage the drug can cause, many other countries are discovering the drug as a solution to health issues such as leprosy.
For example, Thalidomide is being currently prescribed in Brazil, where there are a large number of leprosy patients, but children are still being born today in South America with limb defects because of ignorance of Thalidomide’s effects during pregnancy.
Lessons that were learnt from the 1950s and 1960s about Thalidomide must be shared across the world, particularly in developing counties, otherwise there will be another Thalidomide scandal in the making.