Australian Prime Minister Officially Apologizes Late for Government Regulatory Lapses
'Thalidomide' Cited as Worst Case of Drug Side Effects
About 80,000 Pregnant Women Taking the Drug Experienced Miscarriages
The Australian Prime Minister has decided to issue a belated official apology for the government's failure to properly regulate a morning sickness drug in the 1950s and 1960s that carried a high risk of birth defects.
According to The Australian and other local media on the 14th (local time), Anthony Albanese, the Australian Prime Minister, said in a statement the day before, "The thalidomide tragedy is a dark chapter in Australian and world history," adding, "Survivors, families, and friends have courageously and steadfastly called for an official government apology for years."
He announced that on the 29th, he would offer a public apology on behalf of the Australian government and parliament regarding the incident at the time, and that a national memorial would be erected in Canberra. Prime Minister Albanese explained, "This is the nation's recognition of all the babies who died, their grieving families, and those who survived but whose lives have been made much harder due to the terrible effects of the drug."
Morning Sickness Drug 'Thalidomide' That Caused Birth Defects
In December 2013, Renet Low, an Australian thalidomide survivor (front), is seen leaving the Melbourne High Court in Australia after attending a compensation lawsuit against the thalidomide distributor with her lawyer and family. [Image source=EPA Yonhap News]
According to the Australian government, thalidomide was sold in the 1950s as a morning sickness remedy for pregnant women. At the time, it was recognized as a safe drug without side effects based on animal testing.
However, it had side effects that caused birth defects, and babies with deformities were born one after another around the world due to this drug. The Australian government did not properly inspect the drug before approving its sale in Australia, and this incident led to the establishment of Australia's Therapeutic Goods Administration (TGA).
The Australian government explained, "At that time, there was no system to evaluate the safety of drugs before they were released to the market," adding, "Although thalidomide was eventually withdrawn from the market, many pregnant women in Australia had already taken the drug."
In particular, the Australian Department of Health received reports about the dangers of thalidomide in 1961 but did not immediately discard the drug or impose a ban, which exacerbated the damage.
Australia re-investigated the incident at the Senate level in 2019, acknowledged the government's fault based on this, and paid victims up to 500,000 Australian dollars (about 420 million Korean won) in 2020. However, an official public apology was not made at that time.
At Least 146 Surviving Victims of Thalidomide... US FDA Rejected Approval at the Time
The decision to issue an official apology this time was welcomed by thalidomide victims and their families in Australia, although they criticized the government for apologizing too late.
According to the Australian government, there are 146 registered surviving victims born with birth defects due to thalidomide. However, the exact number of victims remains unknown.
Thalidomide was developed in 1953 by the former West German pharmaceutical company Gr?nenthal as a morning sickness drug and was sold in about 50 countries including the UK, Australia, and Canada. However, controversy arose as pregnant women who took the drug gave birth to babies with severe deformities, such as missing arms and legs.
Globally, about 80,000 pregnancies ended in miscarriage, and more than 20,000 babies were born with deformities such as missing limbs due to mothers taking this drug.
Meanwhile, the U.S. Food and Drug Administration (FDA) refused approval for sale, unlike other countries, due to lack of data and requests for additional information on toxicity. Later, as side effects of the drug were discovered, this incident became a case that enhanced the FDA's reputation.
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