What is Thalidomide?

 

The UK History

The drug thalidomide was originally developed in Germany in 1954 by the pharmaceutical company Chemi Grünenthal.   It was marketed in the United Kingdom by Distillers (Biochemicals) Ltd under the brand name Distaval from April 1958. It was also known as Asmaval, Distaval Forte, Tensival, Valgis, Valgraine (Source – TVAC 1999).

Distaval was commonly given to women in the first three months of their pregnancy to combat morning sickness or insomnia. It was marketed as being completely atoxic and so was considered to be a valuable drug, particularly for use in the geriatric field. In addition, it was exempt from purchase tax and available under the National Health Service. Following reports of what amounted to an epidemic of births of malformed babies and side effects of peripheral neuritis in adults in Germany,  Chemi Grünenthal reluctantly withdrew the drug in November 1961 and Distillers followed suit in the December of that year.

A UK Government warning was not issued until May 1962. The drug was also present in a number of medications including some cough mixtures. However, as the labelling did not use the word thalidomide it inevitably remained in some home drugs cabinets. Consequently at least 20 children were born during and after September 1962 showing typical thalidomide impairments more than nine months after Distaval was withdrawn.

Thalidomide in America

In the United States, the thalidomide experience was very different from that in Europe.   Fortunately Dr. Frances Kelsey of the US Food and Drug Administration was more alert and would not accept that the drug had been adequately tested for manufacture and distribution.  As a result only about 20 thalidomide impaired babies were born in America and these were as a result of the limited clinical trials that were carried out.

Thalidomide impairments

The main impairments caused by thalidomide affect the limbs and is usually bilateral – either both arms or both legs or all four limbs. The most severe impairment is known as phocomelia. This is a condition where the long bones of some or all limbs are misshapen and where the hands and feet, which can be either substantially fully-formed, malformed or rudimentary, arise almost on the trunk.

Other impairments cover a wide spectrum of limb disabilities ranging from a substantial shortening of the limbs or virtual limblessness to less physically disabling conditions such as fused fingers. Thalidomide also affected the eyes and ears, the cardiovascular system, the gastrointestinal tract and kidneys.

The drug harmed the developing foetus only if taken in the first three months of pregnancy. Studies have shown that the exact timing of the thalidomide intake affected the severity and type of resulting malformations. Ministry of Health Report 112 states that the children could “suffer reduction deficiencies of the limbs, malformations of the eyes, ears and deafness, defects of the heart and kidneys and malformations of the alimentary system.”

The late Professor Smithells, of the Department of Child Health and Paediatrics at Leeds University, has said, “There was a dramatic disappearance of this type of deformity within a year of the drug’s withdrawal.”

Thalidomide worldwide

The total number of babies damaged by thalidomide throughout the world is thought to be about 10,000. However, the number of people now living with thalidomide impairments is considerably less than this because there was a high infant mortality rate.

This was particularly true in Germany where the drug was contained in a preparation called Contergan, which was sold over the counter in pharmacies. The use of Contergan resulted in the births of 6,000 grossly malformed children, of whom 2,000 have survived. Lack of limbs, and therefore of skin area, resulted in extreme sensitivity to high temperatures and some deaths. Severe internal injuries have caused others.

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