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Thalidomide was first synthesised in West Germany in 1953 by drug company Chemie Grunenthal. Scientists were unsuccessfully attempting to develop an anti-histamine at the time, when they noticed that the drug they were testing acted as an effective tranquilliser and painkiller. Its market value was exploited by the company and it became publicly available in 1957, proclaimed as a wonder drug for insomnia, coughs, colds and headaches.
It was soon discovered that the drug also had an inhibitory effect on morning sickness. Thousands of pregnant women took the drug to relieve their symptoms. Thalidomide, under licence from Chemie Grunenthal, travelled the world under many brand names and was sold in over 40 countries. But applause for thalidomide was not to last.
Though marketed as non-toxic, safe for women and without side effects, none of these claims turned out to be true. When it became apparent that the number of children born with phocomelia (stunted arms) had markedly increased in Europe, suspicions arose. A link was made to women who had taken thalidomide to combat morning sickness and the drug was withdrawn in 1961.
The drug had not been tested for its effects during pregnancy and it was not known that thalidomide molecules could pass through the placental wall and affect the foetus. Taking thalidomide early in pregnancy when the foetus is developing limbs caused stunted growth of foetal arms and legs. Births with no limbs at all were not uncommon.
There were many other foetal defects caused by thalidomide, including deafness, blindness and cleft palates. Internal damage to the kidneys, digestive tract, genitals and nervous system was also common. Many babies died soon after birth.
Children from 46 countries were damaged by the drug. It’s not accurately known just how many world-wide victims of thalidomide there have been, though estimates range from 10 to 20,000. Currently, it’s believed something like 8000 people are living with thalidomide disabilities. There are 455 ‘thalidomiders’ in the UK.
Through the 1960s and 1970s, compensation battles began around the world with the companies that manufactured or distributed the drug. Settlements were usually in the form of regular payments based on the severity of a thalidomider’s disability.
In the UK, an out-of-court settlement was reached with the manufacturers, Distillers Biochemicals Limited. This led to the establishment of The Thalidomide Trust, set up to administer compensation payments. Though the drug had been withdrawn in 1961, the first UK settlements were not made until 1968. Today it is felt by some, that victims have never been sufficiently compensated.
After the global shock waves, medical interest in thalidomide waned but never completely disappeared. Thalidomide is experiencing a resurgence of interest. It’s involved in trials for several serious conditions, including tuberculosis, sepsis, rheumatoid arthritis, Crohn’s disease, lupus, leprosy, macular degeneration, HIV and AIDS, and various cancers.
One of the promising properties of thalidomide under scrutiny is its suspected ability to lower the levels of cachectin in the body. Cachectin, also known as tumour necrosis factor (TNF), is a naturally occurring chemical, released by white blood cells to attack invading organisms. Cachectin levels rise in response to infection by diseases like tuberculosis, sepsis, cancer and AIDS.
HIV sufferers can have high levels of cachectin. These high levels are believed to accelerate the progression of HIV to AIDS. Too much cachectin may also be a factor in weight loss and may reduce the effectiveness of the immune system in victims. Laboratory tests indicate that thalidomide might be able to lower these cachetin levels.
Trials have also shown thalidomide to be an effective treatment for AIDS patients suffering from painful ulcers in the mouth and throat.
Macular degeneration is a condition which commonly causes poor sight in people aged over 60. It is caused by an overgrowth of new blood vessels in the central portion of the eye retina, where focus is controlled. Thalidomide’s ability to block the development of new blood vesselsoffers hope for sufferers of this condition.
After being approved in 1998 by the Food and Drug Administration (FDA) in the US, thalidomide is available under prescription in Brazil and Mexico to treat and banish the painful and disfiguring open sores of leprosy, a skin and nerve disease. In Brazil, 38,000 new cases of leprosy are diagnosed each year.
As the same pregnancy dangers remain, the drug must be well regulated. It’s only available from specialist clinics and women of childbearing age must have a monthly contraceptive injection to ensure they don’t fall pregnant.
Although thalidomide has been associated with foetal defects, users can also be affected.. As a sedative, the drug can induce drowsiness, along with a host of other side effects like anaemia, loss of balance and constipation. But more seriously, particularly after prolonged use, thalidomide can cause peripheral neuropathy - nerve damage that results in painful numbness in hands and feet. This is often irreversible.
A blind rush for profit was blamed for the thalidomide disaster that changed drug licensing laws and altered society’s view of drug safety. Forty years on, if tests show thalidomide to be an effective medication against conditions for which no other remedy exists, the drug that for years stood as a precautionary example could stage an unexpected and widespread comeback.