What is Thalidomide?
The UK history
The drug thalidomide was originally developed in Germany in 1954 by the pharmaceutical company Chemie Grunenthal. 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 sleeplessness. It was described as completely atoxic and said to be almost impossible to take an overdose. It was considered therefore to be a valuable drug particularly for use in the geriatric field. 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, Chemie Grunenthal 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born during and after September 1962 showing typical thalidomide impairments more than nine months after Distaval was withdrawn.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 is 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 there. As a result only about 20 thalidomide impaired babies were born in America and these were as a result of limited clinical trials that were carried out.
The main impairments caused by thalidomide affected the limbs. The usual disturbance was bilateral – either both arms or both legs – or all four limbs. The most severe of these malformations is 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.
Although the main category of foetal malformation was phocomelia, there were other impairments covering a wide spectrum of limb disabilities ranging from a substantial shortening of the limbs or virtual limblessness to less physically disabling conditions. Other malformations occurred affecting the cardiovascular system, the gastrointestinal tract, kidney and the special sense organs.
These disabilities cause difficulties with mobility and dexterity. Limited dexterity creates difficulties with manipulation, reach and the ability to become individually responsible for personal care.
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 and the severity and type of resulting malformations follow the recognised sequence of organ development. 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.” There were very few instances of children with additional learning disabilities.
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.”
The total number of babies damaged by thalidomide throughout the world was thought to be about 10,000. However, the number of people now living with thalidomide impairment 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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