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Thalidomide

Published: 11 December 2019

Thalidomide changed our relationship with new medicines for ever.

It took five years for the connection between thalidomide taken by pregnant people and the impact on their children to be made. Not only did thalidomide change people’s lives, but it resulted in tighter drug testing and reporting of side-effects.

Thalidomide is a compound that was developed in the 1950s by the West German pharmaceutical company Chemie Grünenthal GmbH. It was originally intended as a sedative or tranquiliser but was soon used for treating a wide range of other conditions, including colds, flu, nausea and morning sickness in pregnant people.

During early testing, researchers at the company found that it was virtually impossible to give test animals a lethal dose of the drug (based on the LD50 test). Largely based on this, the drug was deemed to be harmless to humans. Thalidomide was licensed in July 1956 for over-the-counter sale (no doctor’s prescription was needed) in Germany.

Thalidomide in the marketplace

Around the world, more and more pharmaceutical companies started to produce and market the compound under license from Chemie Grünenthal. By the mid-1950s, 14 pharmaceutical companies were marketing thalidomide in 46 countries under at least 37 different trade names.

In 1958, thalidomide was produced in the United Kingdom by The Distillers Company (Biochemicals) Ltd, under the brand names Distaval, Tensival, Valgraine and Asmaval. Their advertisement claimed that

Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child.

Distaval (thalidomide) made by Chemie Grünenthal GmbH's British counterpart, 1958–1962.
Science Museum Group Collection More information about Distaval (thalidomide) made by Chemie Grünenthal GmbH's British counterpart, 1958–1962.

The drug was prescribed for a range of conditions including pneumonia, colds and flu and for relieving the symptom of nausea often experienced in early pregnancy.

One country that did not approve thalidomide for marketing and distribution was the USA, where it was rejected by the Food and Drug Administration (FDA). However, an early-stage clinical trial did distribute the compound to 1200 physicians and their estimated 20,000 patients of whom 600 were pregnant.

Pharmacologist Frances Oldham Kelsey turned down several requests from the distributing company for approval as they did not provide clinical evidence to refute reports of adults who developed nerve damage in their limbs after long-term thalidomide use. This was only her second case for the FDA.

Thalidomide and pregnancy

In the 1950s, scientists did not know that the effects of a drug could be passed through the placental barrier and impact a foetus in the womb, so the use of medications during pregnancy was not strictly controlled. And in the case of thalidomide, no tests were done involving pregnant people.

As the compound was traded under so many different names in 49 countries, it took five years for the connection between thalidomide taken by pregnant people

Thalidomide causes nerve damage in the hands and feet of adults, but when taken in early pregnancy it causes impairments such as limb difference, sight loss, hearing loss, facial paralysis, and impact to internal organs. One tablet is enough to cause significant impairments, and this might not always be visible. One reason why researchers and doctors were slow to make this connection was due to the wide range of changes to foetal development. Later, they found that the impact on development was linked to when during pregnancy the drug was taken, and effects only occurred between 20 and 37 days after conception.

Another reason why it took so long to establish the link to thalidomide was that some of the limb difference impairments caused by the drug was very similar to certain genetic conditions that cause limb difference.

The thalidomide scandal

The first time the link between thalidomide and its impact on development was made public was in a letter published in The Lancet from an Australian doctor William McBride, in 1961.

The drug was formally withdrawn by Chemie Grünenthal on 26 November 1961 and a few days later, on 2 December 1961, the UK distributors followed suit. However, it remained in many medicine cabinets under many different names.

In the few short years that thalidomide was available, it's estimated that over 10,000 babies were affected by the drug worldwide. Around half died within months of being born. The babies who survived and their families live with the effects of the drug.

The Thalidomide Society was formed in 1962 by the parents of children living with thalidomide impairments to support each other, to fundraise to help families who were struggling financially and to start the long battle for recognition and compensation. The Society’s work continues today, and they continue to preserve the memories of their members through their oral history projects.

In 1968 Chemie Grünenthal was brought to trial in Germany. The company settled the case out of court and arrangements were made to compensate German victims. No one was found guilty of any crimes.

The same year, the British licensee, the Distillers Company, also reached a compensation settlement with the UK families living with thalidomide impairments. In the UK, payments from Distillers, as well as government compensation, were and continue to be administered by the Thalidomide Trust.

In 1972, a highly publicised campaign led by the Sunday Times newspaper helped to secure a further settlement for children living with thalidomide in the UK. Many people living with thalidomide impairments and their families feel they have not yet received moral justice.

Six pairs of prosthetic limbs made for Tracey Baynam, whose limb development was affected by thalidomide, throughout her childhood and teenage years.
Science Museum Group More information about Six pairs of prosthetic limbs made for Tracey Baynam, whose limb development was affected by thalidomide, throughout her childhood and teenage years.

The consequences of thalidomide

Thalidomide forced governments and medical authorities to review their pharmaceutical licensing policies. As a result, changes were made to the way drugs were marketed, tested and approved both in the UK and across the world.

One key change was that drugs intended for human use could no longer be approved purely on the basis of animal testing. And drug trials for substances marketed to pregnant people also had to provide evidence that they were safe for use in pregnancy.

The easy, over-the-counter access to thalidomide prompted many countries to improve their classification and control of medicines. In the UK the 1968 Medicines Act, passed as a result of the thalidomide scandal, made distinctions between prescription drugs, drugs only available in pharmacies and drugs available for general sale.

The Yellow Card Scheme was set up for doctors to share previously unknown side effects of medications they prescribed. The Scheme has now widened so anyone can report a side effect through paper forms or online.

In the UK thalidomide is only prescribed by a doctor under strict controls. Women taking thalidomide are required to use two forms of birth control and take regular pregnancy tests. Men are required to use contraception when taking thalidomide. People who are prescribed thalidomide undergo counselling and are talked through the risks.

Mini Clubman car adapted for use by Eddie Freeman, who was born with disabilities caused by thalidomide.
Science Museum Group Collection More information about Mini Clubman car adapted for use by Eddie Freeman, who was born with disabilities caused by thalidomide.

Uses of thalidomide today

In 1964, doctor Jacob Sheskin at Jerusalem’s Hadassah University Hospital, gave one of his patients thalidomide to help with a severe complication of leprosy.

As a result, the World Health Organisation (WHO) ran a clinical trial on the use of thalidomide for leprosy in 1967. And after more positive results, thalidomide was used as a treatment for leprosy in many countries.

More recently, it has been used successfully to control some AIDS-related conditions, and as a targeted cancer drug for treating the symptoms of cancers such as multiple myeloma.

But the renewed use of thalidomide remains controversial because of its past history.

Living with thalidomide impairments

Each person’s experience of living with thalidomide impairments is different. Thalidomide’s impact rippled from people’s births shaping their lives and those around them. For those born with limb difference, prosthetic or artificial limbs were in part meant to act as reparations for the impairments that thalidomide had caused. They were frequently used as a way of visually “normalising” the bodies of people living with thalidomide impairments. Some children underwent operations to make the prosthetic limbs fit better which could include amputations. Children had little input into these decisions and the trauma of some of these medical interventions is still felt today, both emotionally and physically.

A study by the Thalidomide Trust found that 80% of people are living with chronic pain because of wear and tear on their bodies. Many have become ambassadors for disability awareness, not because they wanted to, but because they had to, facing prejudice and exclusion from society. Many people have come up with adaptations for their everyday lives which they share with others.

As of March 2022, 443 people are living with thalidomide impairments in the United Kingdom. In 2016, the Thalidomide Memorial – To Remember is to Care was unveiled in Wales to pay tribute to all of the lives impacted by thalidomide. Every year on 30 June, people come together to remember, and a roll call is given to those who have lost their lives in the previous 12 months.

A photograph of the thalidomide memorial in Cardiff, Wales © The Thalidomide Memorial

However, many people living with thalidomide impairments have defied expectations of what society thought their lives should or would be like. Many have raised families, are carers, have successful careers, be artists, entrepreneurs, and continue to raise awareness about thalidomide so that their story is never forgotten.

Find out more

  • A Leslie Florence, ‘Is Thalidomide to Blame?’, British Medical Journal, 2 (1960), p 1954
  • T Stephens and R Brynner, Dark Remedy: The Impact of Thalidomide and its Revival as a Vital Medicine, 2001
  • B Gault and H Rogers, Look, No Hands! The Inspiring Story of Brian Gault, 2000
  • The Insight Team of the Sunday Times, Suffer the Children: The Story of Thalidomide, 1979
  • A Daemmrich, ‘A tale of two experts,’ Social History of Medicine, 15/1 (2002), p 137-158
  • H Sjöstrom and R Nilsson, Thalidomide and the Power of the Drug Companies, 1972