Thalidomide: Australia gives national apology to survivors and families

Developed in Germany in the 1950s, thalidomide was originally used as a sedative or tranquiliser, but soon became widely promoted around the world as a morning sickness drug.

As usage increased, so too did reports of birth defects – usually in the form of significantly shortened limbs.

It was an Australian report in The Lancet medical journal that first warned the world of thalidomide’s dangers in 1961, and it was taken off the market soon after.

By then an estimated 10,000 babies globally had been born with disabilities.

For decades, survivors have fought for acknowledgments of wrongdoing and compensation.

Canada introduced financial assistance for survivors in 1991, and in 2010 the UK issued a national apology to those affected.

But it wasn’t until a landmark Senate inquiry in 2019 that Australia took action to support survivors.

Its financial scheme provided a one-off payment of up to A$500,000 ($332,000; £261,000) to survivors, followed by annual payments of between A$5,000 and A$60,000.

The programme was later closed to new applicants, but on Wednesday Mr Albanese reopened it “to ensure that anyone who may have missed the previous opportunity to apply does not miss out”.

In East Germany, thalidomide was rejected by the Central Committee of Experts for the Drug Traffic in the GDR, and was never approved for use. There are no known thalidomide babies born in East Germany.

Meanwhile, in West Germany, it took some time before the increase in dysmelia at the end of the 1950s was connected with thalidomide. In 1958, Karl Beck, a former pediatric doctor in Bayreuth, wrote an article in a local newspaper claiming a relationship between nuclear weapons testing and cases of dysmelia in children. Based on this, FDP whip Erich Mende requested an official statement from the federal government.[

For statistical reasons, the main data series used to research dysmelia cases started by chance at the same time as the approval date for thalidomide.

After the Nazi regime with its Law for the Prevention of Hereditarily Diseased Offspring used mandatory statistical monitoring to commit various crimes, western Germany had been very reluctant to monitor congenital disorders in a similarly strict way. The parliamentary report rejected any relation with radioactivity and the abnormal increase of dysmelia.

Also the DFG research project installed after the Mende request was not helpful. The project was led by pathologist Franz Büchner, who ran the project to propagate his teratological theory. Büchner saw lack of healthy nutrition and behavior of the mothers as being more important than genetic reasons. Furthermore, it took a while to appoint a Surgeon General in Germany; the Federal Ministry of Health was not founded until 1962, some months after thalidomide was banned from the market. In West Germany approximately 2,500 babies were born with birth defects from thalidomide.

In the U.S., the FDA refused approval to market thalidomide, saying further studies were needed.

‘This reduced the impact of thalidomide in U.S. patients. The refusal was largely due to pharmacologist Frances Oldham Kelsey who withstood pressure from the Richardson-Merrell Pharmaceuticals Co. Although thalidomide was not approved for sale in the United States at the time, over 2.5 million tablets had been distributed to over 1,000 physicians during a clinical testing programme.

It is estimated that nearly 20,000 patients, several hundred of whom were pregnant women, were given the drug to help alleviate morning sickness or as a sedative, and at least 17 children were consequently born in the United States with thalidomide-associated deformities.  While pregnant, children’s television host Sherri Finkbine took thalidomide that her husband had purchased over-the-counter in Europe.  When she learned that thalidomide was causing fetal deformities she wanted to abort her pregnancy, but the laws of Arizona allowed abortion only if the mother’s life was in danger. Finkbine traveled to Sweden to have the abortion. Thalidomide was found to have deformed the fetus.

For denying the application despite the pressure from Richardson-Merrell Pharmaceuticals Co., Kelsey eventually received the President’s Award for Distinguished Federal Civilian Service at a 1962 ceremony with President John F. Kennedy. In September 2010, the FDA honored Kelsey with the first Kelsey award, given annually to an FDA staff member. This came 50 years after Kelsey, then a new medical officer at the agency, first reviewed the application from the William S. Merrell Pharmaceuticals Company of Cincinnati.

Cardiologist Helen B. Taussig learned of the damaging effects of the drug thalidomide on newborns and in 1967, testified before Congress on this matter after a trip to Germany where she worked with infants with phocomelia (severe limb deformities). As a result of her efforts, thalidomide was banned in the United States and Europe.