Thalidomide – Detailed History and Timeline
A Detailed History and Timeline
Rosaleen Moriarty-Simmonds OBE
– THALIDOMIDE –
MILLIONS TOOK IT;
THOUSANDS OF BABIES WERE MISCARRIED;
THOUSANDS OF SEVERELY DEFORMED BABIES BORN;
– MILLIONS OF PEOPLE AFFECTED –
During World War II, a number of German physicians conducted painful and often deadly experiments on thousands of concentration camp prisoners without their consent.
Some experiments were aimed at developing and testing pharmaceuticals and treatment methods for injuries and illnesses which German military and occupation personnel encountered in the field.
At many German concentration camps including Auschwitz-Monowitz, scientists tested immunisation compounds and sera for the prevention and treatment of contagious diseases including, malaria, typhus, tuberculosis, typhoid fever, yellow fever and infectious hepatitis.
Bone-grafting experiments and experiments to test the efficacy of newly developed sulfa (sulfanilamide) drugs were undertaken. At Natzweiler and Sachsenhausen, prisoners were subjected to phosgene and mustard gas in order to test possible antidotes.
In May, the notorious SS Captain and Physician Dr. Josef Mengele arrived at Auschwitz. So-called camp doctors, especially Mengele, tortured disabled children, Jewish children, gypsy children, twins, together with many others – including adults. “Patients” were put into pressure chambers, tested with drugs, castrated, frozen to death and, exposed to various other traumas.
Documents referred to Contergan (one of many names attributable to Thalidomide) as being tested on women prisoners of war at the Auschwitz concentration camp by Doctors Heinrich Mückter and Otto Ambros, who worked under the supervision of Mengele.
The pharmaceutical departments of IG Farben, the giant cartel of chemical and pharmaceutical companies involved in numerous war crimes, used prisoners for human experiments, testing new and unknown vaccines and drugs.
In the Auschwitz files, correspondence was discovered between the camp commander and Bayer Leverkusen (a part of IG Farben). The correspondence dealt with the sale of one hundred and fifty female prisoners for experimental purposes, “… With a view to the planned experiments with a new sleep-inducing drug we would appreciate it if you could place a number of prisoners at our disposal…”
In November 1944, Fritz ter Meer, Director and Board Member of IG Farben, sent a memo to Karl Brandt, the SS General who ran Hitler’s euthanasia programme, explaining that a drug numbered 4589 (with the same chemical formula as Thalidomide) had “been tested and was ready for use.”
It is now widely believed that this preparation was the forerunner for the preparation that was to become known the world over as Thalidomide.
The Distillers Company Limited, who made whisky and gin, having been approached by the British Government of the day, were engaged to work on the production of large quantities of penicillin. With a factory already in Liverpool, they located their new pharmaceutical operation close to their first base. Built and sponsored by the wartime Ministry of Supply, and run on behalf of the Government, The new Distillers factory was completed towards the end of the war, with the first batch of penicillin being produced on Christmas Eve 1945.
To exploit the post-war demand for antibiotics and other pharmaceutical lines, Chemie Grünenthal, was founded in Germany, by soap makers Maurer and Wirtz, enriched by wartime profiteering. Chemie Grünenthal later employed several ex-Nazis, some with knowledge of wartime chemical weapons research:
Martin Staemmler A leading proponent of the Nazi “racial hygiene” programme. At Chemie Grünenthal, he was Head of Pathology at the time Thalidomide was being sold.
Hans Berger-Prinz A euthanasia enthusiast, Berger-Prinz worked with Hitler’s personal physician, Karl Brandt.
Dr. Ernst-Günther Schenck A nutrition expert responsible for many camp deaths, Schenck found work and refuge at Chemie Grünenthal although, apparently not involved in the Thalidomide programme.
Dr Heinz Baumkötter The Chief Medical Officer in Sachsenhausen, returned to Germany in 1956, having previously been sentenced to life imprisonment in the Soviet Union, to work for Chemie Grünenthal.
Dr Otto Ambros Perhaps the best known of Chemie Grünenthal’s lethal employees, Ambros was one of the four inventors of the nerve gas Sarin. He was Hitler’s adviser on chemical warfare and committed crimes on a huge scale. As a senior figure in IG Farben, he set up a forced labour camp at Dyhernfurth to produce nerve gases, before creating the monolithic Auschwitz-Monowitz chemical factory making synthetic rubber and oil. Found guilty at Nuremberg in 1948 of mass murder and enslavement, Ambros was sentenced to eight years in prison. Four years later, he was released to aid the Cold War research effort, which he did, working for J. Peter Grace, Dow Chemical, and the U.S. Army Chemical Corps. Ambros was a Board member and Chairman of Grünenthal’s advisory committee at the time of the development of Thalidomide and, when Contergan [Thalidomide] was being sold.
Dr Heinrich Mückter Specialised in typhus work during the war. Outbreaks of the disease in the Army made finding a vaccination a high priority. As typhus culture cannot live outside the body, it was kept alive by injecting it into prisoners. Once injected with the disease, the prisoners were then used to try out the vaccines to test their viability. Mückter’s experiments were reportedly carried out in Auschwitz, Buchenwald, and Grodno as well as at Kraków. Responsible for the deaths of hundreds of prisoners, after the war Mückter was sought by the Polish authorities. However, his fate was spared after being caught by the Americans, Mückter was eventually offered an opportunity to carry on his work at Chemie Grünenthal. As the company’s Chief Scientist and Head of Research, Mückter was credited with the development of Thalidomide, and given the responsibility of marketing and promoting the drug. Mückter was a central figure in the 1968-1970 Chemie Grünenthal trial in Aachen.
December 9th, twenty three former SS doctors and scientists were tried before a U.S. Military Tribunal at Nuremberg. Sixteen were found guilty, with seven being hanged.
Two Chemie Grünenthal employees Otto Ambros and Heinrich Mückter were officially credited with inventing Thalidomide, but later denied involvement in developing it without adequate testing.
31st March 1953, The Distillers Company formed Distillers Company (Biochemicals) Limited, aimed at enhancing its position in the pharmaceuticals industry. This new company specialised in deep fermentation techniques and produced a series of antibiotics.
Thalidomide was patented in West Germany under the name Contergan, at a time when Chemie Grünenthal were looking for a lucrative new product to maintain post-war profits. The drug was soon being produced on a vast scale.
Prior to marketing, three physicians took part in a symposium arranged by Chemie Grünenthal, at which they reported unsatisfactory experiences with Thalidomide. However, these reports were ignored and Thalidomide was aggressively marketed as a ‘wonder drug’ for insomnia, headache and coughs. Worst of all, it was promoted for use by pregnant women to alleviate morning sickness. In reality, Thalidomide wreaked havoc to the developing foetus, causing catastrophic malformations.
Marketing brochures were prepared by Chemie Grünenthal but the launch of Thalidomide was delayed. However, Chemie Grünenthal and its licensees flooded potential markets with sample tablets given free to doctors and hospitals.
25th December, The first Thalidomide-affected baby was born in Germany to – a Chemie Grünenthal employee.
In July, a sixteen-year contract to market Thalidomide was signed by Distillers Company (Biochemicals) Limited.
On 1st October, Thalidomide was launched in Germany, under the trade name Contergan.
In April, the Cohen Committee approved the issuing of a licence to distribute Thalidomide throughout the United Kingdom and the British Empire, by Distillers Company (Biochemicals) Limited under the brand name Distaval. The sedative was promoted as a ‘wonder drug’ to treat a range of conditions including headaches, insomnia and morning sickness in pregnant women. Advertisements emphasised the drug’s safety using phrases such as ‘non-toxic’ and ‘no known toxicity’.
Chemie Grünenthal dismissed a warning by German Dr. Ralf Voss, a Dusseldorf neurologist, that ‘Thalidomide damages the central nervous system’.
German paediatricians and geneticists began to see the emergence of children with gross limb malformations of a most unusual pattern.
Dr Francis Kelsey, a Reviewer with the US Food and Drug Administration started investigations into poor supporting clinical evidence, which eventually blocked the distribution of Thalidomide throughout the United States. This action was still too late to prevent two million sample tablets being distributed in America.
At the same time Chemie Grünenthal was receiving numerous reports of Thalidomide’s toxic effect on the nervous system. However, company officials stepped up its promotional campaign to sustain income, as Thalidomide was proving to be incredibly lucrative.
Chemie Grünenthal sent out 250,000 leaflets extolling the virtues of Thalidomide and encouraging its use by pregnant women: saying that it can be “given with complete safety to pregnant women and nursing mothers without any adverse effect on mother and child…Outstandingly safe… “ “Completely harmless for infants” and “harmless even over a long period of use.”
German paediatrician, Doctor Wiedemann drew attention to thirteen affected infants who had been referred to him over a period of ten months. They had a number of associated malformations including congenital heart disease. He noted that this amounted to an epidemic.
Hamburg paediatrician, Dr Widukind Lenz and Australian Obstetrician Dr William McBride, simultaneously but independently linked birth defects to Thalidomide use. Thousands of babies were stillborn. Some died soon after birth, or suffered deformities – including missing limbs and internal defects that often proved fatal before adulthood. Thousands more survived to endure lives of misery.
27th November, Chemie Grünenthal reluctantly withdrew Thalidomide from the West German market.
2nd December, Distillers Company (Biochemicals) Ltd reluctantly withdrew Thalidomide from the British market.
16th December, a letter from Dr William McBride, was published in The Lancet. This was the first time a link had been publicly made between Thalidomide and birth defects.
Although no longer available for distribution, but not properly withdrawn from sale, Thalidomide was still available in many countries.
May, the British Government finally issued a letter to doctors instructing them to withdraw and destroy all stocks of Thalidomide.
The Thalidomide Society was established in the United Kingdom by a group of parents of babies affected by Thalidomide.
In Belgium, Brazil, Canada, Italy and Japan, Thalidomide continued to be sold for several months after its withdrawal from the West German and British markets.
A number of parents of Thalidomide children responded to a letter printed in the Daily Mail from Mr Edward Satherley (the father of a Thalidomide boy) to attend a meeting with a view to issuing proceedings against Distillers Company (Biochemicals) Limited. Following the meeting in London with an initial sixty two families, the parents were advised to issue writs alleging negligence and claiming damages against the Biochemicals division of Distillers. It was imperative that the parents acted immediately before the actions became statute-barred.
Writs were issued and filed in February 1963 seeking compensation, by the families of sixty two Thalidomide-affected babies born in the United Kingdom. This action was taken within months of the expiration of the Limitation Period of three years – starting from the date of conception.
Applications for legal aid were eventually granted and certificates issued in June 1963. These were not full legal aid certificates, but provided sufficient legal aid assistance to keep the actions alive until the first case was finally settled.
Dr Jacob Sheskin, a Lithuanian Jew and Professor of Dermatology and Venereology at Hadassah University Hospital in Jerusalem, used Thalidomide to provide some relief for a patient with leprosy. He found an old bottle of the drug in his medicine cabinet, and thought that the drug would act as a sedative and help the patient to sleep. This was the start of years of doctors and scientists, trying to find more uses, functions and treatments for Thalidomide.
In West Germany, a Government investigation resulted in charges being brought against nine men, including Chemie Grünenthal’s founder and owner Hermann Wirtz Sr and the company’s chief scientist Dr. Heinrich Mückter. The trial commenced on 27th May 1968. The indictments were for negligent manslaughter and causing grievous bodily harm, deformity, and sickness through the selling of Contergan (Thalidomide).
In Britain, an out-of-court settlement equivalent to only 40% of assessed damages was awarded to the initial sixty two Thalidomide-affected children against Distillers Company (Biochemicals) Limited. This infant settlement was the result of the parents’ legal battle which had lasted more than five years, with little or no media support.
As a direct result of the Thalidomide scandal, The Medicines Act 1968 was passed by the British Parliament. The aim of the Act was to bring together in a single Act, everything to do with the control of medicines, for both human and animal use. The Act included provisions on the promotion and sale of drugs.
The Chemie Grünenthal trial was brought to an abrupt end on 18th December 1970, as being “not in the public interest.” The company was granted immunity from future prosecution, although questions have now been raised as the legitimacy of this action.
In the United Kingdom, writs were issued on behalf of the remaining Thalidomide children in the United Kingdom against Distillers Company (Biochemicals) Limited.
A nation-wide poster campaign was surreptitiously undertaken, primarily by university students. It was an audacious tactic to circumvent the sub judice laws that were stifling public criticism of Distillers Company (Biochemicals) Limited. This was especially so, as Distillers were spending huge amounts of money on expensive lawyers, rather than properly compensating Thalidomide children affected by the drug, it had blithely supplied without checking on potential side effects. The damaging campaign was secretly funded by Rupert Murdoch, and insodoing, ensured the scandal could not be ignored.
In the United Kingdom, and building on the 1968 settlement, a final settlement was agreed by Distillers Company (Biochemicals) Limited. This included lump-sum payments for the remaining three hundred and sixty seven children affected. The terms were on exactly the same basis as the initial sixty two. Added to this, was the establishment of the Thalidomide Trust, to provide ‘support and assistance’ – including annual grants – to all of the British Thalidomide survivors.
The Thalidomide Trust commenced operation, following its formation under a Deed of Trust dated 10th August 1973.
The Congenital Disabilities (Civil Liability) Act 1976 was enacted as a direct result of the Thalidomide scandal. The Act provided that where a child was born disabled due to negligent treatment of the mother during pregnancy or childbirth, the limitation period for bringing such action, only commences when the child reaches the age of 18 years.
Penn Pharmaceuticals Limited was originally founded in 1979 as a pharmacy business in the village of Penn in Buckinghamshire and in 1986 moved to Tredegar in South Wales. By the mid-1990s Penn reported that volume manufacture of Thalidomide had increased, with production rising from 10,000 to 200,000 capsules per month because of a rekindled interest in the treatment.
Distillers Company (Biochemicals) Limited was acquired by Guinness PLC.
The Celgene Corporation, a multi-national integrated biopharmaceutical company, was formed. Since its formation, Celgene has undertaken considerable research into developing so called “cousins” of Thalidomide. As a result Celgene’s current revenue amounts to billions of dollars.
In a television documentary, Rosaleen Moriarty-Simmonds was quoted as saying, “In about sixty years time, Thalidomide People will be extinct. We will go down in the history books as a generation of people that would, or at least should, never appear again. We are just a blip in the history of mankind.” Sadly, this proved not to be the case.
The British Thalidomide Society celebrated its 40th Anniversary. An approach was made to the Government and the Greater London Council seeking permission to mark this special anniversary and to recognise the achievements of the “Thalidomide Family”. It was hoped that suitable recognition with a memorial plaque could have been placed at the Guildhall in the City of London. It was turned down.
Yorkshire Television, through its First Tuesday documentary series, found twenty one new cases of Thalidomide in Brazil alone, ranging in age from four to twenty three, in such diverse locations as Rio de Janeiro and in the heart of the Amazon Jungle.
Guinness PLC and Grand Metropolitan PLC merged to form Diageo PLC.
16th July, the U.S. Food and Drug Administration granted a licence to the Celgene Corporation for the marketing of THALOMID® for the acute treatment of “the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences.”
In December the Thalidomide Victims Association of Canada (TVAC) staged a conference in Canada, dedicated in whole to the subject of the re-licensing of Thalidomide. Amongst other things it considered the STEPS programme and of how one doctor was advocating the use of Thalidomide for patients with brain tumours.
The Pharmion Corporation, a global biotech company dedicated to identifying and developing products for global haematology and oncology markets, was formed on 26th August 1999. The rights to Thalidomide and the STEPS programme were acquired by them from the Celgene Corporation during the same year.
After a campaign led by the National Advisory Council of the (UK) Thalidomide Trust, on 15th July 2004 the British Government announced that payments made from the Trust (that had hitherto been taxed at 40%) would be discounted for income tax purposes.
In October the Penn group of companies was acquired by the Celgene Corporation for £67 million.
Diageo agreed an increased financial settlement with the Thalidomide Trust.
In May, Celgene was granted accelerated approval by the U.S. Food and Drug Administration for the use of Thalomid(R) (thalidomide) in combination with Dexamethasone for the treatment of newly diagnosed Multiple Myeloma.
1st March, the European Medicines Agency (EMEA) accepted for review, Pharmion’s marketing authorisation application to use Thalidomide Pharmion(R) for untreated Multiple Myeloma.
Rosaleen Moriarty-Simmonds published her autobiography ‘Four Fingers and Thirteen Toes’. Rosaleen is the only Thalidomide impaired person to have written her autobiography, and interspersed it with a definitive factual history of the drug Thalidomide from its early years of manufacture in Nazi Germany, and then into the new millennium.
The Celgene Corporation acquired The Pharmion Corporation, and was granted a licence to distribute Thalidomide for Multiple Myeloma.
Rosaleen Moriarty-Simmonds, Edward D. Freeman and Stephen Simmonds, all Thalidomide impaired adults, pledged to establish a permanent and lasting memorial to honour those persons and their families who have been, and continue to be affected by the Thalidomide tragedy.
Labour Government Health Minister Mike O’Brien made a formal apology to Thalidomide adults, expressing “sincere regret and deep sympathy” on behalf of the Government. The apology was greeted with a mixed response from the Thalidomide adults, some describing it as “too little, too late”.
At the same time, it was announced that the Government would provide a Health Grant (initially for a three year pilot period) to all Thalidomide survivors in the United Kingdom to help meet the increased health needs caused by their Thalidomide damage.
The Health Departments in all four nations of the United Kingdom agreed to pay the Health Grant for a ten year period until 2022.
© Rosaleen Moriarty-Simmonds OBE