In the 1950s, thalidomide was hailed as a medical breakthrough - a safe sedative that could ease morning sickness for pregnant women. Yet, within a few short years, it became a symbol of pharmaceutical negligence, leaving thousands of children with devastating birth defects.

The tragedy was meant to serve as a permanent warning about the dangers of inadequate testing and rushed approvals. However, as the world witnessed the rapid rollout of COVID-19 vaccines, many questioned whether governments and pharmaceutical companies had forgotten the hard-earned lessons of thalidomide. Have we once again placed speed above safety, risking consequences that may take years to fully reveal?

Thalidomide has a chequered past that began with a Nazi War Criminal. Sometimes, history is our best teacher. Perhaps that is why the left want to stop it being taught? So let's dive into the story of one of the worst disasters in pharmaceutical history. 

Babies born in the late 1950's and early 1960's suffered the effects of the drug thalidomide that their mothers had taken for morning sickness, depression or anxiety.

More than 10,000 little ones were born throughout the world with missing or poorly formed limbs.  The severity was determined, it seems, by how far advanced the pregnancy was at the time the mother took the drug.

In the first 3 weeks it would affect the development of the brain; one more day and the eyes would be affected; day 22 the ears and face; day 24 the arms and by day 28 the development of the legs would be affected. By 42 days into the pregnancy, the baby would develop normally.

“Look what happened last time I took a tablet.”

Those devastating words broke the heart of Trish Jackson, as her 94-year-old mother steadfastly refused to take medication in her nursing home. Now an artist, Jackson from Queensland, Australia is one of 3,000 global survivors of the drug thalidomide.

Thalidomide was developed by the German pharmaceutical company Chemie Grünenthal in the early 1950s. The key figure credited with its discovery is Heinrich Mückter, the company's head of research. During World War II, Mückter was a Nazi war criminal who worked as a medical officer for the German army. He was involved in typhus vaccine research and was allegedly linked to medical experiments conducted on prisoners in Nazi-occupied Poland, particularly at the Cracow Institute for Typhus and Virus Research. After the war, Mückter escaped prosecution for war crimes and was recruited by Grünenthal, where he led the development of thalidomide.

There have been allegations that thalidomide itself may have been based on chemical compounds developed by the Nazis for warfare or experimentation. However, there is no definitive proof of this, and the exact origins of thalidomide remain unclear. Despite his Nazi ties, Mückter was never charged with war crimes. He went on to become wealthy from thalidomide’s commercial success, even after the birth defect scandal.

Sometimes sold under the brand name Distaval, it was marketed between 1957 and 1961 as a cure for pregnancy morning sickness and a non-addictive sleeping tablet, and was claimed to be safe for all. Sadly, that wasn’t the case, and it was found to cause significant birth defects.

Meanwhile, Trish Jackson’s mother, Margaret, didn’t know she was pregnant when she went to a doctor complaining of migraines. Trish said, “He gave mum an injection and threw a packet of Distaval across the table and said ‘Here, take this, it might help with the vomiting.’ His last words were, ‘at least they won’t hurt you.’

Her mother took one tablet, but returned soon after.

Jackson continued, “She realised she was pregnant after the news broke about thalidomide. She went back to the doctor only to find he had destroyed all her medical records. He absolutely denied mum was ever a patient of his.”

Trish Jackson was born with no arms, with her hands, which have three fingers, joined to her shoulders. She said, “I was whisked away and mum didn’t see me for three days, as the doctors decided I was too grossly deformed for her to love me. The doctors said to mum: ‘The kindest thing you can do for Trish is take her home and smother her.’”

In later years,  Trish Jackson was given government assistance with her bathroom and offered a set of handrails.

The oblivious civil servant was shocked when she asked, “Do the arms actually come with the handrails? As I’ve got no arms.” 

But back to the beginning: Once the babies were born, countries throughout the world started realising what a terrible and tragic situation had occurred - too late, of course, for those children who had been born, and too late for their guilt ridden mothers who would find it difficult to ever forgive themselves for having innocently swallowed a tablet that would have such long and far-reaching consequences.

However, In 1960, American mothers and babies had a stroke of luck. That was when the application to begin mass-marketing the drug thalidomide in the United States landed on the desk of Frances Oldham Kelsey, a reviewer at the Food and Drug Administration. 

As a medical reviewer, Kelsey had the power to prevent a drug from going to market if she found the application to be lacking sufficient evidence for safety. After a thorough review, Kelsey rejected the application for thalidomide on the grounds that it lacked sufficient evidence of safety through rigorous clinical trials.

Kelsey was first introduced to the dangers of mass-marketed unsafe pharmaceuticals in 1937, when the FDA enlisted Geiling to solve the mystery of Elixir of Sulfanilamide. Sulfanilamide effectively combated infections, but it came in a large and bitter pill that needed to be taken in large dosages. To make the drug more appealing, especially to children, manufacturers added it to a solvent with artificial raspberry flavour.

The problem was that the solvent they chose was diethylene glycol, commonly known as antifreeze. Between September and October, the drug killed 107 people.

Geiling and his lab of graduate students, including Kelsey, set out to determine what exactly in the elixir was killing people: the solvent, the flavour or the sulfanilamide. Through a series of animal studies, which at the time were not required by federal law for a drug to go to market, Geiling and his lab were able to determine that it was the diethylene glycol that was the cause of death.

The public outcry to this tragedy prompted Congress to pass the Federal Food, Drug, and Cosmetic Act of 1938, which added a New Drug section requiring manufacturers to present evidence that a drug was safe before going to market. Though this new law “provided for distribution of a new drug for testing purposes,” FDA historian John Swann says “the law did not provide in any explicit or detailed way how oversight of that testing should be conducted.” In other words, clinical trials continued to undergo little to no oversight.

By November of 1961, physicians in Germany and Australia had independently discovered birth defects in infants whose mothers had taken thalidomide during early pregnancy. 

The application was eventually withdrawn in April of 1962. But the drug had already been distributed to “more than 1200 physicians, about 15,000-20,000 patients - of whom over 600 were pregnant,” according to Swan. In the U.S., 17 cases of congenital deformities were reported, but as Swan says via email, “that could have been thousands had the FDA not insisted on the evidence of safety required under the law (despite ongoing pressure from the drug’s sponsor).”

In 1962, soon after the application had been withdrawn and the dangers of the drug became internationally known, Congress passed the Kefauver-Harris Amendment. This key amendment required more oversight for clinical studies, including informed consent by patients in the studies and scientific evidence of the drug’s effectiveness, not just its safety. In the wake of its passage, President Kennedy awarded Kelsey the President’s Award for Distinguished Federal Civilian Service, making her the second woman to receive such a high civilian honor. source:  

The Kefauver–Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. Before the Thalidomide scandal in Europe, Australia, New Zealand, Britain and Canada, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA New Drug Application (NDA) would have to show that a new drug was both safe and effective (previously the 1938 Food, Drug and Cosmetic Act was the main law that regulated drug safety). Informed consent was required of patients participating in clinical trials, and adverse drug reactions were required to be reported to the FDA. source

To wrap this piece up then. As our future mothers were coerced into thinking that having the vaccine for Covid would protect them and their unborn child, one has to wonder if any of them have ever heard of thalidomide?

Today, there is frustration and anger that German manufacturer Grünenthal has stonewalled attempts by the survivors to get justice. 

Grünenthal does acknowledge its role in the thalidomide story and has contributed to a charitable foundation for victims, as well as agreeing an out of court settlement with affected families in Germany in 1970. But, crucially, it has never admitted liability. 

History does have a nasty habit of repeating itself, doesn't it?