Welcome to a New Series

Hello and welcome to a pilot of sorts of a new series, it will delve into the history of some of the worlds worst scandals, some you may know some you may not. It has been inspired in part by an RTÉ 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 any further delay let’s get started.

Intro

///// 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 often a complaint for a pregnant person. She is offered a drug that may help with her symptoms but for whatever reason she turns it down, this would turn out to be a very good decision. The drug she was offered was called distaval 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 it’s name would become synonymous with sadness and pain. It would be forever tied to what many contemporary news reports would dub the biggest man made medical disaster in modern history. The drug also was sold under a number of different names, contergen, talidex, thalomid or it’s better known name thalidomide. Welcome to scandal, a new plainly difficult series.

Background

//// It is the early 1950s and Swiss company ciba is working on a new tranquilliser for animals. They were hoping to synthesise a drug less harmful than barbiturates. During the research they synthesised thalidomide in 1953, but Chemical Industry Basel (CIBA) quickly abandoned their creation due to it not yielding the preferred results in animals in 1954. And this in many cases could have been the end of the drugs legacy, but a chance discovery would renew the interest in the drug and its money making potential.

Drugs Discovery

In the mid 50s German company Chemi Grunenthal stumbled into the drug but I should first pause to talk about the company that would be at the center of the future scandal. Here comes one of my side notes, Chemi Grunenthal was a company with some pretty shady beginnings with Hugh 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. Founded by Herman wurtz sr a Nazi party member and an advocate of racial hygiene and eugenics, hardly a suprise for a plainly difficult video. Well Chemi Grunenthal had set up in 1946 in the wake of ww2 originally as a soap company but were looking into various places for their revenue routes. As part of this wirtz put out the word for the need of scientists with experience in antiviral research. Well with the war over concentration camps closed and the doctors trial being undertaken in Nuremberg, prosecuting the leaders of the human experimentation programs, there were a few unemployed, and most importantly unimprisoned Nazi scientists kicking around. Well wirtz 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 internees. His new team would be headed by 32 year old Dr Heinrich Mückter, who was the deputy director of the Kraków Institute for Typhus and Virus Research during the Nazi occupation. He had experimented on prisoners in Buchenwald concentration camp against their will. Muckter had narrowly avoided justice from a polish war crimes court, by fleeing back to Germany and into the open arms of wirtz and a position of head of research in his company. As a side note to the side note wirtz also took on Otto Ambros as an advisor after he had come out of prison, he was serving an 8 year sentence, released after 4, for crimes against humanity for his work at ig farben developing poison gases which he had also been testing on forced labour camp inmates. His work also helped bring around another infamous product zyclon b. Well needless to say Chemi Grunenthal had a fascists dream team of Nazi scientists, wirtz put them to work and this leads us back to the 1950s. Thalidomide was rediscovered as a byproduct during research into glutamic acid, with this new substance the company patetened it in 1954 and they set about finding a use for it. It was found by scientists at Chemi that thalidomide did work as a sedative on humans. Brilliant, something to sell, it was found that thalidomide 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 zigheiling scientists no lethal dose could be discovered. and in 1956 it was introduced under the name contergan and sales began in October 1957. Initially it was marketed to epilepsy sufferers but this market is pretty small time to expand. It was discovered that the drug also had the benefit of being an effective antiemetic, 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 contergens 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 any medications. This was due to the conventional knowledge at the time thinking that anything taken by a pregnant woman could pass across the placental barrier. Towards the end of the 50s contergen was one of the best selling sedatives in Germany it was cheap and accessible without a prescription. But the product wouldn’t be confined to just Germany, under licence thalidomide was produced internationally and sold. 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) Ltd, were producing and selling the drug to customers across the uk new zealand and Australia under the name Distaval aimed at mothers with its licence being granted in 1958. It was even advertised using the following in its marketing: “Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child ...” Questionable to say the least on top of this in some markets it was touted as a cure all 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 Grünenthal, the company must have been loving the financial boom, by the end of the 1950s roughly 14 tons were being sold per year.

Troubling Rumours

Troubling Rumours But there had been murmurs amongst medical communities in the countries thalidomide had been sold in that a number of people had started to develop peripheral neuritis and worse still a spike in miscarriages, still births and children born with birth defects was starting to be seen. The issues with patients experiencing nerve issues made Grünenthal start to place inserts into its medication boxes with the following warning of side effects including “prickling and a sensation of numbness in the hands and/or feet” in 1960. But the link between the drug and birth deformities proved a tough issue. In 1958 Karl Beck a German pedotritrion published his theory of the increase in deformities, this would not be thalidomide but the increasing literal fall out of the Cold War. You see throughout the 1950s both the east and west were ever increasing their nuclear weapons tests, and beck put the blame squarely at the arms races feet. In 1961 reluctantly grunethal applied to make thalidomide prescription only, but the downfall of the profitable drug was only just beginning. Thalidomide babies proving the link. Grunenthal had heard complaints from several sources of the drug causing issues in newborns and adults alike. Initally just batted off as rare allergy caused 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 the type of surveillance that made it obvious whether you are being watched or not but pressuring and discrediting victims was the ultimate goal. Dr Widukund lenz, in west Germany in November 1961 had started to suspect the issues with thalidomide and birth defects. I should also note here lenz was also an ex Nazi party member and part of the Sturmabteilung. 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 Gruthenal and warned them of his findings on the 16th November 1961. After 10 days of arguing the points reluctantly grunthal withdrew the drug on November 21st. But lenz wouldn’t be the only concern for the drug and this time it would come from well outside Germany’s borders.

International Attention

International attention It's Late 1961 and an Australian midwife's 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 thalidomide to mothers at the Crown Street hospital Sydney. Sparrow put her concerns to dr Mcbride but initially saw no concern from the dr. But not long after the concern led MCBRIDE to re-evaluate 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 asked if anyone else in the medical community had seen the sudden increase in birth deformities. The letter helped inform the wider medical community of the drugs damaging effects to unborn children and in Australia New Zealand and the uk thalidomide 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. Summers' paper released in 1962 saw a link between Fetal abnormalities and thalidomide, but not the actual method of damage to the foetus. Repeated experiments showed the damage that the drug could inflict, but rather cruelly it would only damage a fetus in a very short window during early pregnancy, 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 exact numbers, estimates are around 10,000 children born with various health issues, one thing we will never know is the countless miscarriages and still births caused by thalidomide useage. Even after 1961 and it’s 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 Frances Kathleen Oldham Kelsey had thalidomide come across her desk in 1960, pretty late in the game and because of this rumors 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 foetuses. Even under pressure from Richardson-Merrell the pharmaceutical company looking at licensing the drug in the USA and manufacturer Grünenthal, Kelsey refused a licence unless the appropriate tests 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 will 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 7 August 1962. Although not officially sold thalidomide did cause some birth defects in the USA, these were Mainly caused in clinical testing in roughly 20,000 people, around 17 would be born with defects. Scarily around 2.5 million tablets made its way into the US.

Aftermath

The aftermath All throughout the discovery of thalidomides horrific side effects grunenthal vehemently denied liability. The company was first made aware of complications from pregnancy when thalidomide was involved as early as 1956 when one of its 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 and industry standard tests on rodents. But this is just a convenient way to shirk the responsibility of striving to make the safest products for the market. 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 thalidomide. Gruthenals lack of enthusiasm for the 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 the plausible deniability. Hence why so much pressure was put onto Kelsey. Even Dr Lenz mentioned this in his 1992 lecture at the UNITH Congress. “Chemie Grunenthal continued to deny the teratogenic effects of thalidomide 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.. Grunenthal had a legal case to answer. This would lead to the 1968 Grunenthal trial at the First Grand Criminal Chamber of the Regional Court of Aachen. The trial of the worst human tragedy in German history since the Holocaust began on the 27 May 1968, it was the culmination of 6 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 of the thousands of affected children were merely an act of god. Grunenthal meant business, showing up to court with a team of 40 lawyers. 9 senior company staff members were indicted, 451 co plaintiffs and 351 witnesses were against them, the prosecution had over 70,000 pages of evidence. Herman 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 from the formidable defence team was stall stall stall. Waste time, delay and even threatened multiple times to walk out, Lenz's 11 hours over 4 days of testimony was attacked by the defence for 11 days. Only for it to be thrown out a year and 2 months later in the trial, due to an apparent bias of Lenz against Grunenthal, I think you might be able to see the bias towards the large pharmaceutical company. With so much delaying and slowing down of the proceedings on display many feared the trial would eat considerably into the 1970s, but abruptly just 2 years and 6months later in December 1970 the trial would end. You may be thinking surely this is due to an 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 availablelate into the trial. Or even maybe the link between birth defects and thalidomide wasn’t so strong as thought? Well.... Actually none of these. The state and prosecution just decided that it wouldn’t be in the public interest to continue. The 9 men were set free and made immune from further prosecution, and even more repulsive 2554 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 favorable terms. No admission of guilt and everyone has to shut up about it. This deal was brokered in secret between Grunenthals founder Herman wirtz you know the exNazi 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 of this scandal goes even deeper, Dr Joseph Neuberger, the minister of justice had previously worked with wirtz when his law firm Neuberger, Pick and Greeven 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 100m Deutsche marks, not directly paid out mind....., 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, about $22k for a lifetime of suffering. It wouldn’t be paid out at once tho, 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 ltd in 1968. The scandal would not only scar a generation but sew a much deeper distrust between pregnant women and the medical community. Even in the current day thalidomide 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, however this would lead to at least 33 cases of children born with birth defects. But thalidomides story doesn’t end here, it would go on to actually find some use in the treatment of certain cancers such as multiple myeloma after a clinical trial in 1999. The FDA this time around would licence the drug but only under strict circumstances. The actual cause of the birth defects would elude scientists for decades, until fairly recently. An apology from the company wouldn’t arrive until 2012, to which many victims felt was an insult especially as by then the German government had picked up most of Grunenthals stipend payments to victims. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573415/ https://www.thalidomide.ca/wp-content/uploads/2017/12/Dr-Lenz-history-of-thalidomide-1992.pdf By RuthAS - Own work, CC BY 3.0, https://commons.wikimedia.org/w/index.php?curid=15457029 Copyright Museums Victoria / CC BY Attribute this image Photographer: Marita Dyson Museums Victoria https://collections.museumsvictoria.com.au/items/259289