What Was Thalidomide Tragedy? Australia Now Sorry For Babies Born With Birth Defects
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Thalidomide Tragedy: The Australian government will formally apologise to the people affected by the ‘thalidomide tragedy’, more than six decades after thalidomide, the active ingredient in a sedative drug, resulted in birth defects in the babies of the mothers who consumed the medicine as a treatment for morning sickness while they were pregnant. Australia’s prime minister Anthony Albanese will deliver the apology on November 29, 2023, on behalf of the Australian Government, Parliament, and the Australian people.
In a November 13, 2023 statement, the prime minister called the thalidomide tragedy a “dark chapter” in the history of Australia and the world. “In giving this apology, we will acknowledge all those babies who died and the families who mourn them, as well as those who survived but whose lives were made so much harder by the effects of the terrible drug”.
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All about thalidomide and the thalidomide tragedy
The sedative drug which contained thalidomide was widely distributed to many pregnant women in Australia and around the world in the late 1950s and early 1960s, but it was later discovered that thalidomide resulted in birth defects such as the malformation of limbs, internal organs, and facial features in unborn children.
As many as 146 thalidomide survivors are registered with the Australian Thalidomide Survivors Support Program, but the exact number of babies affected is not known.
It is estimated that 40 per cent of the babies damaged by the effects of thalidomide died in their first year of life, according to the Thalidomide Group Australia, an organisation that has been advocating for justice to the victims of thalidomide for several years.
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Scientists at Chemie Grünenthal in Germany developed thalidomide. This is an Aachen-based pharmaceutical company. In 1957, thalidomide entered the German market. It was marketed as an over-the-counter sedative and sleeping tablet used to cure anxiety, insomnia, gastritis, and tension.
At that time, researchers found that thalidomide was a useful anti-nausea drug. In Australia, the drug was marketed as Distaval. In the beginning, patients who consumed thalidomide experienced minimal side effects. If thalidomide was taken in large doses, it led to nerve irritation.
However, pregnant women who consumed thalidomide between eight to fourteen weeks of gestation either died or gave birth to babies with defects.
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In 1958, thalidomide was first licensed for use in the United Kingdom. It was sold under the brand name Distaval.
By 1960, thalidomide’s sales matched those of aspirin as it was marketed in 46 countries around the world.
The babies with birth defects born to women who consumed thalidomide while they were pregnant went on to be known as thalidomide babies. The first thalidomide baby was born to a Grünenthal employee on December 25, 1956.
The birth defects thalidomide babies were born with included defects of the eye and face muscles, absence of arms, femur and tibia defects, spine defects, deafness, thumbs with three joints or no fingers at all, congenital heart disease, ocular abnormalities, malformations of the heart, uterus, gallbladder, bowel, and digestive tract, among others. Some babies were born with missing or shortened limbs.
This went on to be known as the thalidomide tragedy or scandal.
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How the thalidomide tragedy came to an end
In March 1961, Distaval was declared a potent drug in Victoria, Australia, as a result of which its sale was restricted to chemists.
In April 1961, Australian obstetrician Dr William McBride, who suspected a link between thalidomide and the birth defects, notified Chemie Grünenthal’s Australian distributor Distillers about his doubts.
However, Distillers claimed that they never received a written report.
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Despite rising suspicions, the sales of Distaval were increased, and a quarter of a million leaflets claiming that the drug was “harmless” were distributed.
However, Dr McBride did not give up and continued his efforts to convince his superiors to withdraw thalidomide from use.
In June 1961, Dr McBride succeeded in convincing his superiors at the Women’s Hospital in Sydney to stop prescribing thalidomide to pregnant women. Dr McBride and midwife Sister Pat Sparrow had observed several cases of birth defects and connected them to thalidomide.
In December 1961, Dr McBride’s observations highlighting the connections between thalidomide and birth defects were published in The Lancet.
Thalidomide was withdrawn from use in the United Kingdom on December 2, 1961, and from Australia on August 9, 1962.
It was because of Dr McBride that the thalidomide tragedy came to an end.
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Dr Frances Kelsey of the US Food and Drug Administration (FDA) did not give approval to the sale of thalidomide in the United States, as a result of which the thalidomide tragedy was averted in the country.
Dr Kelsey did not put a hold on the approval of thalidomide because of birth defects, which had not been attributed to thalidomide at that time, but because of his concerns about peripheral neuropathy, a condition in which nerves located outside of the brain and spinal cord are damaged.
In the few years that thalidomide was available in the market, the drug affected over 10,000 babies worldwide, according to the Science Museum.
Due to the thalidomide tragedy, the UK’s Committee on the Safety of Drugs and the Medicines Act of 1968 was formed.
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What happened to thalidomide after it was banned in most countries?
While thalidomide was banned in most countries in the early 1960s, it later on proved to be a useful treatment for leprosy and multiple myeloma, a cancer of plasma cells.
However, in rural areas which lack proper medical facilities, thalidomide treatment of pregnant women with leprosy continues to cause malformations.
Several lessons were learnt from the thalidomide tragedy. For instance, scientists obtained insights on toxicity testing, and the United States and international regulatory agencies developed toxicity testing protocols to design safer drugs.
Researchers who study developmental biology have used thalidomide as a tool to understand the biochemical pathways of limb development.
However, thalidomide can never be prescribed to a pregnant woman or a woman who wants to become pregnant.
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