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Thalidomide

Pair of artificial arms for a child, Roehampton, England, 1964

Pair of artificial arms for a child, Roehampton, England, 1964

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The thalidomide disaster is one of the darkest episodes in pharmaceutical research history. The drug was marketed as a mild sleeping pill safe even for pregnant women. However, it caused thousands of babies worldwide to be born with malformed limbs. The damage was revealed in 1962. Before then, every new drug was seen as beneficial. Now there was suspicion and rigorous testing.

The development and sale of thalidomide

Thalidomide was developed in the 1950s by the West German pharmaceutical company Chemie Grünenthal GmbH to expand the company’s product range beyond antibiotics. It was an anticonvulsive drug, but instead it made users sleepy and relaxed. It seemed a perfect example of newly fashionable tranquilisers.

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During patenting and testing, scientists realised it was practically impossible to achieve an LD50 level, or deadly overdose, of the drug. Animal tests did not include tests looking at the effects of the drug during pregnancy. The apparently harmless thalidomide was licensed in July 1956 for prescription-free over-the-counter sale in Germany and most European countries. The drug also reduced morning sickness, so it became popular with pregnant women.

First suspicions and the disaster

By 1960 doctors were concerned about possible side effects. Some patients had nerve damage in their limbs after long-term use. Grünenthal did not provide convincing clinical evidence to refute concerns. In the United States, the Food and Drug Administration (FDA)’s drug examiner Frances Oldham Kelsey did not approve the drug for use.

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There was an increase in births of thalidomide-impaired children in Germany and elsewhere. However, no link with thalidomide was made until 1961. The drug was only taken off the market after the German Widukind Lenz and the Australian William McBride independently suggested the link. Over 10,000 children were born with thalidomide-related disabilities worldwide. Well-known people in the UK affected by thalidomide include actor and writer Mat Fraser.

The aftermath and thalidomide’s controversial rehabilitation

There was a long criminal trial in Germany and a British newspaper campaign. They forced Grünenthal and its British licensee, the Distillers Company, to financially support victims of the drug. Thalidomide led to tougher testing and drug approval procedures in many countries, including the United States and the United Kingdom.

In 1964 a leprosy patient at Jerusalem’s Hadassah University Hospital was given thalidomide when other tranquilisers and painkillers failed. The Israeli doctor Jacob Sheskin noticed the drug also reduced other leprosy symptoms. Research into thalidomide’s effects on leprosy resulted in a 1967 World Health Organisation (WHO) clinical trial. Positive results saw thalidomide used against leprosy in many developing countries. It is also used successfully to control some AIDS-related conditions, and its effects on various cancers are under investigation.

The renewed use of thalidomide remains controversial. The positive effects are undeniable. However, there is a risk of new thalidomide births, particularly in countries where controls may not be efficient. Black-market trade of unlicensed thalidomide by people with leprosy may increase the risks.

Bibliography

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 (Massachusetts: Perseus Pub., 2001)

L Zichner, M A Rauschmann and K D Thomann (eds), Die Contergankatastrophe – EIne Bilanz nach 40 Jahren (Darmstadt: Steinkopff Verlag, 2005)

B Gault and H Rogers, Look, no Hands! The Inspiring Story of Brian Gault (London: Hodder & Stoughton, 2000)

The Insight Team of the Sunday Times, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979)

A Daemmrich, ‘A tale of two experts,’ Social History of Medicine, 15/1 (2002), pp 137-158

H Sjöstrom and R Nilsson, Thalidomide and the power of the drug companies (Harmondsworth: Penguin, 1972)

Glossary:

Pregnancy

The condition of having a developing unborn embryo or foetus in the body. A human pregnancy is usually of 40 weeks gestation.

Patent

Grants made by a government to an inventor, assuring the inventor the sole right to make, use, and sell the invention for a certain period of time.

Leprosy

A chronic disease that affects the skin, mucous membrane and nerves. It is now confined mainly to the tropics and is transmitted by direct contact. Previously a widely feared disease, leprosy is not highly infectious.

Aids

Acquired Immune Deficiency Syndrome (AIDS) is a disease caused by infections resulting from a weakened immune system due to the HIV virus. It leads to failure of the immune system and is usually fatal. It is spread through direct contact with bodily fluids.