The Thalidomide Controversey

Thalidomide was first marketed in 1957 in West Germany as an over-the-counter drug initially promoted to treat anxiety, trouble sleeping and morning sickness. It was developed in the 1950s by the West German pharmaceutical company Chemie Grünenthal GmbH where some of the key staff had previous Nazi party connections. Thalidomide was very effective for the morning sickness in pregnancy and by the early 1960s was available on prescription in over 46 countries by women who were pregnant or who subsequently became pregnant resulting an estimated over 10 000 children being born with a range of severe deformities and many more miscarriages. Of the live births, around half died within months of being born. Thalidomide was never tested if it was safe during pregnancy. It led to what is probably the world’s worst pharmaceutical scandal.

While it was initially approved in 46 countries, it was not approved for marketing and distribution in the USA, where it was rejected by the FDA.

Thalidomide scandal

Statue in Trafalgar Square, London, England, titled “Pregnant Thalidomide Woman”. The statue is of thalidomide victim, Alison Lapper when she was pregnant by the artist Marc Quinn in 2005.

In 1961, William McBride, an Australian obstetrician wrote in the Lancet medical journal about his observations of an increase in the number of deformed babies born at his hospital, all of whom mothers were taking thalidomide.

McBride’s 1961 letter in The Lancet:

THALIDOMIDE AND CONGENITAL ABNORMALITIES

SIR,—Congenital abnormalities are present in approximately 15% of babies. In recent months I have observed that the incidence of multiple severe abnormalities in babies delivered of women who were given the drug thalidomide (‘Distaval’) during pregnancy, as an anti-emetic or as a sedative, to be almost 20%.
These abnormalities are present in structures developed from mesenchyme—i.e., the bones and musculature of the gut. Bony development seems to be affected in a very striking manner, resulting in polydactyly, syndactyly, and failure of development of long bones (abnormally short femora and radii).

Have any of your readers seen similar abnormalities in babies delivered of women who have taken this drug during pregnancy?

W. G. MCBRIDE. Hurstville, New South Wales.

At about the same time, the pediatrician Widukind Lenz in Germany noted many similar cases where the drug was still over-the-counter. Others were noticing the same thing and different countries subsequently started to ban the drug. The teratogenic effects and the characteristics of the deformities will depend on when during the pregnancy that the mother starts taking the thalidomide: if taken on the 20th day of pregnancy, then this will likely cause central brain damage; around day 21, the eyes are damaged; on day 22 the ears and face are affected; on days 24 to 28 there is arm and leg deformity. If taken after 42 days since gestation, there appears to be no deformity.

“Thalidomiders”, which many survivors use to describe themselves were involved in multiple cases of litigation in multiple countries, some of which were only recently settled or apologies received. In 1968 Chemie Grünenthal GmbH was brought to trial in Germany with the company settling the case out of court and German victims compensated. No one from the company was found guilty of any crimes. A compensation settlement with the UK victims of the drug was also made by the UK distributor. A class action in Australia was settled in 2014.

The birth defects of thalidomide and the surrounding controversy led to the development of greater drug regulation and monitoring in most countries.

Research is continuing into derivatives of thalidomide that might have non-teratogenic effects as a potential treatment for cancer and inflammatory diseases. It is being used as a treatment for leprosy and multiple myeloma.


Books on the The Thalidomide Controversey:

Dark Remedy The Impact Of Thalidomide And Its Revival As A Vital MedicinePurchase Dark Remedy: The Impact Of Thalidomide And Its Revival As A Vital Medicine here:
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Commentary:

  • The thalidomide controversy or scandal is often used by those with a beef against ‘Big Pharma’ as evidence that they can not be trusted. The opposite is probably the case as a result of the controversy has been better monitoring and regulation so that it could not happen again. To argue otherwise is often greeted with the shill gambit.

Related Pages:
Therapeutic drug monitoring | Evaluation of new drugs | Official regulation of medicines | Drug use in pregnancy | Thalidomide

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