THALIDOMIDE - CREATION and CAUSATION

CREATION - What is Thalidomide

Thalidomide is a non-barbiturate hypnotic drug, in essence, a sleeping aid.

It is believed to have first been synthesised in 1944 and tested on prisoners of war in Auschwitz.

The preparation tested in the concentration camps, is considered to be the forerunner for the drug that was to become known the world over as Thalidomide.

Thalidomide was developed in 1954 by Chemie Grünenthal, a small pharmaceutical company located in the North Rhine-Westfalia industrial town of Stolberg near Aachen in Germany.

By 1957, the drug was being mass-produced and actively marketed in Germany, and many other countries, throughout the world to treat surprisingly minor ailments such as colds, coughs and flu.

The drug was first marketed in Britain in April 1958, by Distillers Company (Biochemicals) Limited, under the names Thalidomide, Distaval, Tensival, Asmaval, Valgis and Valgraine.

Thalidomide was promoted widely as a ‘Wonder Drug’, and just prior to its market withdrawal in the United Kingdom in 1961, the Distillers marketing literature was stressing how safe the drug was … “without any risk to mother or child.”

As a consequence of these claims, it was also marketed as a short-term treatment for pregnant women, typically in the first three months of their pregnancy, to combat morning sickness or insomnia, although it was also prescribed for bronchitis and influenza amongst other things. It also appeared in cough medicines for children and, almost by default, would have remained in many family medicine cabinets long after its withdrawal from the market.

CAUSATION - What damage did Thalidomide cause

Crucially, if pregnant women took Thalidomide during the first three months from conception the growing foetus would be seriously damaged.

The main impairments caused by Thalidomide affect the limbs and are 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 mostly fully-formed, malformed or rudimentary, arise almost on the trunk. Limb damage ranged from a substantial shortening of the limbs or entire limblessness, to less physically disabling conditions such as fused fingers.

Thalidomide also affected the eyes and ears, the nerve supplies to the face, the eye muscles, and the lacrimal (tear) glands. Internal defects were commonly found affecting the heart, the kidneys and urinary tract, the gastrointestinal tract, the alimentary tract, and the genital tract.

A small, but important group of Thalidomide related problems, includes conditions which are not present at birth but develop later. Abnormalities of the spine were recognised early, and of the knees sometime later. Other bones and/or joints may also be affected. It is to be expected that Thalidomide impaired people will also be prone to the same ills as beset the rest of the population.

According to Dr Widukind Lenz speaking at the 1992 United International Thalidomide Congress (UNITH)

"Thalidomide may cause quite different malformations in different children. In one case, the ears are missing, there is deafness and paralysis of the muscles of the eyes and the face, but the limbs are normal. In another case, the ears are normal, but the arms are missing. In a third case there are severely shortened arms with only 2 or 3 fingers, often accompanied by internal malformations. In a fourth case, only the thumbs are abnormal with three joints, possibly accompanied by narrowing of the anus. The individual type of thalidomide malformation depends on the time of intake. Thalidomide does not produce malformations if only taken before the 34th day after the last menstruation and usually no malformation if taken only after the 50th day.

Within the sensitive period from day 35 to day 49 there is the following sequence:

• Absence of ears and deafness: 35th - 37th day
• Absence of arms: 39th - 41st day
• Phocomelia with 3 fingers: 43rd - 44th day
• Thumbs with 3 joints: 46th - 48th day.

If thalidomide has been taken throughout the sensitive period, the consequence may be severe defects of ears, arms and legs and of internal malformations, which often led to early death."

By the time the drug was withdrawn in Germany on 27th November 1961, and the United Kingdom on 2nd December 1961, Thalidomide was marketed under fifty-one names, in eleven European, seven African, seventeen Asian and eleven countries throughout the Americas.

It is almost impossible to accurately state how many babies were affected by Thalidomide, but it runs to over 100,000 worldwide.

Many were miscarried, still born or died soon after birth. Recent estimates state that over 24,000 babies were born worldwide of which 2,000 were born in the UK.

In addition, based on medical evidence, experts conservatively estimate that those babies still-born and miscarried, due to Thalidomide, would add a further 123,000 worldwide of which 10,000 would have been in the UK. These figures do not include those babies born alive who became victims of state infanticide and so were never registered.

Furthermore, there are no figures available to calculate how many family members (parents, siblings, partners and children of Thalidomide impaired people) have been affected as a consequence of Thalidomide.

One can only guess at that figure running into hundreds of thousands of people.

© Rosaleen Moriarty-Simmonds OBE