 Hello and welcome to a pilot of sorts of a new series. It will delve into the history of some of the world's worst scandals, some you may know and some you may not. It has been inspired in part by an RTE program called Scannel. Although rather than focusing on events linked to Ireland, I plan to widen the scope of what I'll cover. Well, without further delay, let's get started. It is the late 1950s and a woman is at a regular pregnancy checkup in a doctor's office in Kilburn, Northwest London. She mentions to the doctor that she is experiencing morning sickness, nothing unusual as this is quite an often complaint for a pregnant woman. She is offered a drug that may help with her symptoms, but for whatever reason, she decides to turn it down. This would turn out to be a very good decision. The drug she was offered was called Distable and would turn out to be a worldwide scandal that would burden the lives of many innocent young children. Used in the correct situation, the drug can really change lives for the good, but its name would become synonymous with sadness and pain. It would forever be tied to what many contemporary news reports would dub the biggest man-made medical disaster in modern history. The drug was also sold under a number of different names. Contagane, Tallidex, Thalomid, or its better known name, Thalidomide. Welcome to Scandal, a new, plenty difficult series. It is the early 1950s and Swiss company Ciba is working on a new tranquilizer for animals. They were hoping to synthesise a drug less harmful than barbiturates. During the research, they synthesised Thalidomide in 1953, but chemical industry basil, Ciba quickly abandoned their creation, due to it not yielding the preferred results in animals in 1954. And this in many cases would have been the end of the drug's legacy, but a chance discovery would renew the interest in the drug and its money-making potential. In the mid-1950s, German company, Kemi Grunentau, stumbled into the drug, but I should first pause to talk about the company that would be the centre of the future scandal. Here comes one of my side notes. Kemi Grunentau was a company with some pretty shady beginnings, with high-up members of its management and research team having in some cases a few million skeletons in the closet. I'll be brief, but I think you'll find this interesting nonetheless. Bounded by Hermann Vertz Sr, a Nazi party member and an advocate of racial hygiene and eugenics, hardly a surprise now for a plainly difficult video, well, Kemi Grunentau had set up in 1946 in the wake of World War II, originally as a soap company, but were looking into various places for their revenue routes. As part of this, Vertz put out the word for the need of scientists with experience in antiviral research. Well, with the war over, concentration camps closed, and the doctor's trial being undertaken in Nuremberg, prosecuting the leaders of the human experimentation programs, there were a few unemployed, and most importantly, unemprisoned Nazi scientists kicking around. Well, Vertz saw this as an opportunity at gaining some valuable scientific experience for his fledgling company. He hired a handful of scientists, who had committed multiple crimes on many poor concentration camp inmates. His new team would be headed by 32-year-old Dr Heinrich Muckter, who was the director of the Krakow Institute for Typhus and Virus Research during the Nazi occupation. He had experimented on prisoners in Birkenwald concentration camp against their will. Muckter narrowly avoided justice from a Polish war crimes court by fleeing back to Germany and into the open arms of Vertz and a position of head of research in his new company. As a side note to the side note, Vertz also took on Otto Ambrose as an advisor after he had come out of prison. He was serving an eight-year sentence, but released after four, for crimes against humanity for his work at IG Farben developing poisonous gases, which he had also been testing on forced labour camp inmates. His work also helped bring around another infamous product, Zyklon B. Kemi Grunntow had a fascist stream team of Nazi scientists. Vertz put them to work and this leads us back to the 1950s. Validomide was rediscovered as a byproduct during research into glutamic acid. With this new substance, the company patented it in 1954 and they set about finding a use for it. It was found by scientists at Kemi that Validomide did work as a sensitive on humans. Brilliant, something to sell. It was found that Validomide produces deep sleep without hangover or risk of dependency. Before it could be brought to market, the drug was tested on rodents and much to the joy of the zig-hiling scientists, no lethal dose could be discovered and in 1956 it was introduced under the name Contagan and sales began in October 1957. Initially, it was marketed to epilepsy sufferers, but the market was pretty small, time to expand. It was discovered that the drug also had the benefit of being an effective anti-metic that is a substance that can reduce or stop nausea and vomiting. Something that pregnant women can experience known as morning sickness. Although pregnant women became the target for Contagan's marketing, tests on the effects of the drug on unborn life were not undertaken. Although seemingly a terrible decision today, in the 1950s it was not even considered for many medications. This was due to the conventional knowledge at the time thinking that anything taken by pregnant women couldn't pass across the placental barrier. Towards the end of the 1950s Contagan was one of the best selling sedatives in Germany. It was relatively cheap and accessible without a prescription. But the product wouldn't be confined to just Germany. Under license, Validomide was produced internationally and sold across the world. 14 pharmaceutical companies would sell the product in 46 countries under 37 different product names. In the UK, British pharmaceutical company, the Distillers company Biochemicals Limited, were producing and selling the drug to customers across the UK, New Zealand and Australia under the name Distavill, aimed at mothers with its license being granted in 1958. It was even advertised using the following in its marketing. Distavill can be given with complete safety to pregnant women and nursing mothers without adverse effect on the mother or child. Questionable to say the least. On top of this, in some markets it was touted as a curable medication. Again, the hallmark of less-than-trustable advertising. Somewhat reminiscent of the quackery of magic tonics of the last couple of centuries. With the money rolling in, to Grunental, the company must have been loving the financial boom. By the end of the 1950s, roughly 14 tonnes were being sold per year. There had been rumours amongst medical communities in the countries for mid-high to have been sold that a number of people had started to develop peripheral neuritis. And worse still, a spike in miscarriages, stillbirths and children born with birth defects were starting to be seen. The issues with patients experiencing nerve issues made Grunental start to place inserts into its medication boxes with the following warning of side effects including prickling and a sensation of numbness in hands or feet in 1960. But the link between drug and birth deformities proved a tough issue. In 1961, reluctantly, Grunental applied to make validamide prescription only. But the downfall of the profitable drug was only just beginning. Grunental had heard complaints from several sources of the drug causing issues in newborns and adults alike. Initially just batted off as rare allergy cause reactions publicly, privately the company set out to investigate. Not the health links, but to put complainants under surveillance. It's arguable if it was a type of surveillance that made it obvious whether you are being watched or not. But pressurizing and discrediting victims was the ultimate goal. Dr. Wooducund Lenz in West Germany in November 1961 had started to suspect the issues with validamide and birth defects. I should also note here that Lenz was also an ex-Nazi party member and part of the SA. His concern led him to investigate a link between the two. And he found that as early as 1956 that a child had been born with deformities likely caused by the drug. With this ongoing concern and mounting evidence, Lenz contacted Grunental and warned them of his findings on 16 November 1961. After 10 days of arguing the points, reluctantly, Grunental withdrew the drug on November 21st. But Lenz wouldn't be the only concern, and this time it would come from well outside of Germany's borders. It's late 1961 and an Australian midwife, sister Pat Sparrow was starting to notice a worrying trend with children born with limb defects. She has seen birth defects before, but not in such numbers. This worrying trend had started after a Dr William McBride had started prescribing validamide to mothers at the Crown Street Hospital in Sydney. Sparrow put her concerns to Dr McBride, but initially saw no concern from the doctor. But not long after, the concern led McBride to reevaluate his thoughts on the new wonder drug. In doing so, he wrote a letter to the Lancet, a weekly peer-reviewed general medical journal. The short letter asks if anyone else in the medical community had seen a sudden increase in birth deformities. The letter helped inform the wider medical community of the drug's damaging effects to unborn children, and in Australia, New Zealand, and the UK, validamide was removed from sale in 1961. Even though taken off the shelves, scientists had to find what the actual link was. Lenz would not be the only one. Dr George Summers, chief pharmacologist at Distillers Company, the organisation responsible for UK distribution of the drug, started testing on rabbits. Repeated experiments showed the damage that the drug could inflict, but rather cruelly, it would only damage the fetus in a very short window during early pregnancy of just 42 days. It was found that the earlier the mother took the drug into pregnancy, the more drastic the birth deformities. If taken from the 20th day of pregnancy, central brain damage would be caused, day 21 would damage the eyes, day 22 the ears and face, day 24 the arms, and leg damage would occur if taken up to day 28. Although we may never know the exact numbers, estimates are around 10,000 children born with various health issues. One thing we will never know is the countless miscarriages and stillbirths caused by flamidaeide usage. Even after 1961 and its withdrawal from many countries, it was still marketed in Canada until 1962, and Spain all the way into the 1970s. But one country that usually appears in my videos is missing, and this thankfully is down to one person. Can you guess the country? Medical reviewer for the US FDA, Francis Cafflin, Oldham Kelsey, had Validamide come across her desk in 1960. Pretty late in the game, and because of this rumours about the drug from Europe had made their way to America. She refused to authorise the drug, in lieu of further studies into reported cases of peripheral neuritis. In addition, she requested proof that the drug wouldn't cause damage to any unborn fetuses. Even under pressure from Richardson Merrill, the pharmaceutical company looking at licensing the drug in the USA, and manufacturer Grunenthal, Kelsey refused the licence unless the appropriate test had been undertaken. Unsurprisingly, the drug companies were not too happy about being made to pay out for extra testing, and they didn't, which doesn't inspire confidence in the product they were trying to sell. But we'll come to the reasons why shortly. Her failing to crumble under the pressure saved thousands of children from developing health issues. As such, in 1962, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by John F. Kennedy on the 7th of August. Although not officially sold, Validamide did cause some birth defects in the USA. These were mainly caused in clinical testing in roughly 20,000 people, of which around 17 would be born with defects. Scarily though, around 2.5 million tablets made their way into the US. All throughout the discovery of Validamide's horrific side effects, Grunenthal vehemently denied liability. The company was first made aware of complications from pregnancy when Validamide was involved, as early as 1956, when one of its own employees gave birth to a child suffering from birth deformities. The company actively ignored multiple warning signs. Hiding behind the fact, it had conducted the relevant tests and industry standard tests on rodents. But this is just a convenient way to shirk the responsibility if they were just following the standards of the day. How did the FDA find so many holes in the evidence given to it for the safety of Validamide? Grunenthal's lack of enthusiasm for further testing requested by the FDA tells us all we need to know. And that is, they too knew of the dangers. And a published study would have removed any plausible deniability. Hence why so much pressure was put onto Kelsey. Even Dr. Lenz mentioned in his 1992 lecture to the UNITH Congress. Kemi Grunenthal continued to deny terror-togenic effects of Validamide for years. But there was a growing suspicion that this was not due to honest ignorance, but to the purpose of weakening the accusations against the firm. Although mostly off the shelves by 1962, the story didn't end there. As the German authorities couldn't ignore so many dead and injured children. And this would lead to the 1968 Grunenthal trial at the first grand criminal chamber of the regional court of Arkham. The trial of the worst human tragedy in human history since the Holocaust began on the 27th May 1968. And it was the culmination of six years of investigations. Grunenthal was less than helpful to say the least, requiring the police to raid the company's vaults several times. The company had asserted the deformities that the thousands of children affected were merely an act of God. Grunenthal meant business, showing up to court with a team of nearly 40 lawyers. Nine senior company staff members were indicted, 451 coplanetiffs and 351 witnesses were against them. The prosecution had over 70,000 pages of evidence. Hermann Wirtz, one of the eldest accused in his 70s, was allowed to not attend court due to health issues. Don't forget that point. The main tactic on display for the formidable defence team was stall, stall, stall. Waste time, delay and even threatened multiple times to walk out. Lenses 11 hours over 4 days of testimony was attacked by the defence for 11 full days. Only for it to be thrown out of court a year and 2 months later into the trial, due to an apparent bias of Lens against Grunenthal. I think you might be able to see the bias towards the large pharmaceutical company instead. With so much delaying and slowing down of proceedings, many feared the trial would eat considerably into the 1970s. But abruptly, just 2 years and 6 months later in December 1970, the trial would end. You may be thinking surely this is due to the overwhelming weight of legal and moral strain led to a guilty plea from a sudden change of heart of the accused. Or maybe some magic golden bullet of evidence so impossible to rebut became available into the trial. Or even the link between birth defects and philidomide wasn't so strong as originally thought. Well, actually none of these. The state and prosecution just decided it wouldn't be in the public interest to continue. The nine men were set free and made immune from further prosecution. And even more repulsive, 2,554 of the most affected German families were slapped with a gagging order. All of this was linked to one thing. Grunenthal had offered to put their hands in their pocket, but only on their very favourable terms. No admission of guilt and everyone has to shut up about it. This deal was brokered in secret between Grunenthal's founder, Hermann Wirtz, you know the ex-Nazi and supposedly too old and ill to attend court, and the German Ministry of Health, without the knowledge of the victims or the wider public. But the conflict of interests in this scandal goes even deeper. Dr Joseph Neuberger, the Minister of Justice, had previously worked with Wirtz when his law firm, Neuberger, Pick and Grieven, had been contracted by the pharmaceutical company in 1966. Neuberger had tried at every corner to hinder the prosecution's case. The price Grunenthal offered to make it all go away under the guise of concern for the affected families was 100 million Deutsche Marks. Not directly paid outmined, but to a fund to find the best use for the money. A slap in the face might have been a better payment to the families. It would work out roughly 10% the figure claimed by the victims, which was around 40,000 marks per child, around $22,000 for a lifetime of suffering. It wouldn't be paid out all at once though, instead a poultry lump sum would be followed by a monthly stipend. As a result, the financial burden fell squarely at the feet of the state. The compensation story would be similar in other countries, with victims in the UK, for example reaching a settlement with Distillers Biochemical Limited in 1968. The scandal would not only scar a generation, but so much deeper distrust between pregnant women and the medical community. Even in the current day, the lidomide is mentioned when the question came up of COVID vaccination during pregnancy. Needless to say, the damage caused by the drug has traumatized society. The drug would never fall out of use though. In 1964, it was discovered in Israel to have benefits in leprosy treatment. From 1965, the drug was used as the first choice of leprosy in Brazil, but the lidomide story doesn't even end here. It would go on to actually find some use in the treatment of certain cancers such as multiple meloma, after a clinical trial in 1999. The FDA this time around would license the drug, but only under strict circumstances. An apology from the company wouldn't arrive until 2012, which to many victims felt was an insult, especially as by then, the German government had picked up most of Grudenthal's stipend payments to victims. Now I hope you enjoyed this new type of video. Let me know if you liked it in the comments below. This is a plain difficult production. All videos on the channel are Creative Commons attribution share alike licensed. Plain difficult videos are produced by me, John, in the currently wet and miserable southeastern corner of London, UK. Help the channel grow by liking, commenting and subscribing. Check out my Twitter for all sorts of photos and odds and sods as well as hints on future videos. 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