by Hannah Brown and Rebecca Brown, Ulster University
The thalidomide tragedy is one of the worst medical scandals in history.[1] Thalidomide was advertised as an extraordinary drug which could be used to treat a plethora of problems including depression, colds, anxiety, insomnia and headaches.[2] Thalidomide was also effective in alleviating morning sickness in pregnant women. It was developed in 1954, by the West German pharmaceutical company, Chemie Grunenthal.[3] The toxicity of thalidomide was negligible, meaning that it was nearly impossible to overdose as the new drug lacked the typical addictive characteristics of barbiturates.
Drug testing on Thalidomide
Drug testing on thalidomide was minimal, with testing carried out on animals and humans. Thalidomide was initially tested on mice with no adverse effects, and then on mice, guinea pigs, rabbits and rats for a 30-day period, with success. It was thought that thalidomide would decrease the risk of suicide as it was deemed non-toxic at any dose. Human trials were small, with only 300 participants. Dr Widukind Lenz condemned these studies, stating that they held ‘little scientific value’. Furthermore, in the United States of America (USA), the Food and Drug Administration, under the pharmacist France Kelsey, did not approve thalidomide for use. Around 20,000 Americans did try thalidomide under supervision and there were 17 thalidomide babies born in the USA.[4] In the United Kingdom, in 1958, thalidomide was classified by the Cohen Committee, who considered it to have ‘proved value’. The complimentary recommendation led to doctors prescribing the drug to expectant mothers on the National Health Service.[5]
From 1956, in mainland Europe, thalidomide was widely sold without a medical prescription.[6] By 1960, thalidomide was available in fifty countries in Europe, Africa, Asia, and the Americas. In 1958, in the United Kingdom thalidomide was licenced, manufactured by Distillers Ltd under the commercial names Distaval, Valgraine, Tensival and Asmaval. In 1959, credible publications such as the British Medical Journal described thalidomide as a drug ‘free-from untoward side effects.’[7]
Thalidomide during Pregnancy
Thalidomide was not tested on pregnant animals which would have aided assessment of its impact on foetal development.[8] An enduring myth from the Middle Ages until the 1950s, stated that harmful substances ingested by a pregnant person could not penetrate the placenta. A discovery in the 1950s proved that substances with a molecular weight lower than 1000 could be absorbed by the placenta and enter the foetal blood. Thalidomide had a molecular weight of 258. While in utero, 10,000 babies globally were exposed to thalidomide.[9] In the United Kingdom, there are currently 449 people living with the consequences of thalidomide, including 18 in Northern Ireland.[10]
Jacqueline Fleming is a thalidomide survivor, a Connect Volunteer for the Thalidomide Trust and an artist based in County Down.[11] Fleming’s mother was prescribed thalidomide while she was in utero. In Flemings words, thalidomide caused a ‘shortening’ of her arms. Fleming states that the consequences of thalidomide on her body have left her in a state of ‘where you just have to be thinking ahead of yourself at all times’. Fleming explains that she had ‘spent your [her] whole time being told you couldn’t do things’. Despite that, Fleming has enjoyed a rich life and has three adult children.
Image: Pack of Thalidomide Tablets. Stephen C. Dickson, CC BY-SA 4.0.
Problems with Thalidomide
In 1960, Scottish doctor Alexander Leslie Florence was the first to raise concerns about thalidomide. He announced that ‘these symptoms could possibly be a toxic effect of thalidomide’.[12] The use of thalidomide by pregnant women was first linked to congenital abnormalities by an Australian obstetrician, William McBride.[13] In December 1961, McBride was the first to publish his findings, that thalidomide was toxic to foetuses. He published these in the Lancet. Thalidomide was found to cause birth defects to the extremities of babies, issues with hearing and sight, and genital deformities. Moreover, thalidomide caused problems in the heart, lungs, kidneys and digestive system of babies.[14] Thalidomide resulted in the deaths of 2000 and 10,000 children were born with birth defects. Those subjected to thalidomide’s side effects were from across the world.[15] In Germany, an inquiry was launched; thalidomide was removed from shelves in late 1961. The United Kingdom followed suit in December 1961. Subsequently, the use of thalidomide was outlawed in most countries.[16]
Thalidomide in Belfast
The Belfast Telegraph reported in 1962 that doctors who prescribed Distaval should immediately contact their patients. The article also reassured readers that there had not yet been any reports of the thalidomide tragedy in Belfast.[17] However, the Belfast Telegraph reported the following year that four Belfast parents were seeking legal action.[18] In 1962, the British Medical Journal began to gather a ‘census’ of ‘thalidomide mothers.’ The census would include information on the pregnant persons medical history, the history of the first three months of pregnancy and a family medical history.[19] Moreover, the British Medical Journal, published findings for all Birmingham births in the years 1957 to 1961, showing a rise in birth defects and still births while thalidomide was on the market.[20]
Image: Distaval (Thalidomide), The Distillers Company, c.1960 by Photographer Marita Dyson. Licensed under CC BY 4.0.
The Thalidomide Society was created in 1962, with a branch in Belfast.[21] It was set up by the parents of the survivors, initially as a support network for the families, subsequently, they also sought financial compensation. In 1963, the Belfast branch went to Stormont to meet education minister Ivan Neill, to discuss the suitability of educational facilities for those children. There was a lack of facilities for the children; the minister promised to consult local education authorities to recertify the issue.[22] In 1966, the Belfast telegraph reported that there was a £200 fund for parents in Belfast Hospital to cover the burden of travel costs for parents of survivors to facilitate visiting their children.[23] In 1972, member of parliament, Lewis Carter Jones appealed to Westminster to provide financial support for Fleming Fulton, a Belfast school, to accommodate children that survived thalidomide.[24]
Drug Legislation
In the 1950s and 1960s, in the United Kingdom, mirroring the rest of Europe, there was fragmentated legislation to regulate drugs, normally centred on controlling the quality and promotion of drugs.[25] Additionally, there was no legal requirement for the independent testing of a marketed drug in relation to quality, safety and efficiency.[26] The tragedy sparked an overhaul of the regulation, licensing, selling, and marketing of drugs.[27]
In 1964, a voluntary scheme was established, under the Committee on the Safety of Drugs, which consisted of sixteen experts, led by Derrick Dunlop, to work with pharmaceutical industry.[28] However, the committee was purely advisory, holding no legal powers. In 1968, the Medicines Act was enacted, and came into effect in 1971. The Act established a formal regulatory system, with the Committee on the Safety of Drugs replaced by the Committee on Safety of Medicine. Subsequently, the new Committee was bestowed with the power to change a product’s usage or remove it from sale. [29]
Thalidomide Settlements
In 1968, a settlement for 65 of the thalidomide children in the United Kingdom was reached against Distillers. Each family received between £5,000 to £45,000. The Sunday Times, in 1972, launched an energetic media campaign against Distillers, seeking compensation for all thalidomide survivors.[30] In 1972, chairman of the All-Party Group on Disablement and member of parliament, Jack Ashley, stated that Distillers fought tirelessly and without repentance for ten years and refused to compensate the thalidomide children. Ashley stated that it was ‘a shocking example of man’s inhumanity to man, not to mention this firm’s inhumanity to the children.’[31] In 1972, Distillers finally offered the parents of thalidomide survivors in Northern Ireland compensation. The parents choose to accept the settlement. Children from the south of Ireland did not benefit from the settlement as their case was against the manufacturing company in Germany. Some of the families in the north, settled outside of court with Distillers. However, these settlements were deemed to be unsatisfactory. The Belfast Telegraph stated that some of the parents spent the settlement on buying appropriate housing for their children and that the families experienced great trauma, feeling ‘numb and bewildered’.[32] In 1973, the Thalidomide Trust was created to issue annual payments to thalidomide survivors. The funding totalled £14,000,000, Distillers was brought by Guinness PLC, and they have committed to honour the annual payments until 2022.[33]
Image: Jacqueline Fleming. Courtesy of Jacqueline Fleming.
Uses of Thalidomide Today
In 1965, at the Jerusalem Hadassah University Hospital, Dr Jacob Sheskin discovered by chance that thalidomide with its anti-inflammatory benefits could treat complications, associated with Hansen’s disease (leprosy).[34] In collaboration with the World Health Organisation (WHO), Sheskin conducted extensive tests. From 1967, in countries such as Brazil where Hansen disease was common, thalidomide was used as a treatment.[35] Tragically, in Brazil, a new generation of thalidomide survivors were born because patients who shared their medicine with pregnant individuals did not understand its risk.[36] Sadly, in Brazil between 2015 and 2018, five new cases of the use of thalidomide during pregnancy were reported.[37] Additionally, in 1991, in the USA Dr Gilla Kaplan at the Rockefeller University, found that thalidomide could be used to treat acquired immunodeficiency syndrome (AIDS) related illnesses such as Kaposi’s sarcoma, aphthous ulcers and wasting syndrome. In 1997, the US Food and Drug Administration approved the use of thalidomide for the treatment of AIDS, certain forms of cancer and Hansen’s disease. Today in the United Kingdom thalidomide is used to treat certain forms of cancer such as brain, kidney and multiple myeloma.[38] However, there are nowadays stricter controls to accessing thalidomide which tends to be offered only on a named patient basis, with the individuals placed on birth control and requiring counselling to understand the drug’s potential risks.[39]
© The Author(s) 2021. Published by the Epidemic Belfast team on behalf of Ulster University. Any unauthorised broadcasting, public performance, copying or re-recording will
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[1] Sharon B. Jacobs, ‘Crises, Congress, and Cognitive Biases: A Critical Examination of Food and Drug Legislation in the United States’, Food and Drug Law Journal, 64:4 (2009), pp. 599-629.
[2] https://thalidomidesociety.org/what-is-thalidomide/ Accessed 3 June 2021.
[3] Stefan Timmermans and Valerie Leiter, ‘The Redemption of Thalidomide: Standardizing the Risk of Birth Defects’, Social Studies of Science, 30 (2000), pp. 41-71; S. Vincent Rajkumar, ‘Thalidomide: Tragic Past and Promising Future August’, Mayo Clinic Proceedings, 79 (2004), pp. 899-903.
[4] Ballard C. Campbell, Disasters, Accidents, and Crises in American History: A Reference Guide to the Nation’s Most Catastrophic Events (New York, NY: Facts on File, 2008), p. 390.
[5] ‘Mr. Jack Ashley’ (29 November 1972), House of Commons Debates, vol. 847, c. 434; House of Commons Debates (4 November 2009).
[6] Spain’s forgotten Thalidomide victims see glimmer of hope – BBC News Accessed 19 September 2021.
[7] British Medical Journal, ii:5147 (1959), p. 5.
[8] Jack H. Botting, Animals and Medicine: The Contribution of Animal Experiments to the Control of Disease (Cambridge: Open Book Publishers, 2015), pp. 183-198; W Lenz, ‘A Short History of Thalidomide Embryopathy’, Teratology, 38 (1988), pp. 203-15.
[9] Timmermans and Leiter, ‘The Redemption of Thalidomide’; Ian Miller, Medical History (Theory and History) (London: Springer, 2018), p. 141; https://www.thalidomidetrust.org/about-us/about-thalidomide/ Accessed 3 June 2021.
[10] Neil Vargesson, ‘Thalidomide-Induced Limb defects: Resolving a 50-year-old Puzzle’, BioEssays,31 (2009), pp. 1327-36; https://www.thalidomidetrust.org/about-us/about-thalidomide/ Accessed 3 June 2021.
[11] Belfast Telegraph (25 July 2020).
[12] Alexander Leslie Florence, ‘Is Thalidomide to Blame?’, British Medical Journal, ii:5217 (1960). DOES THIS HAVE A PAGE NUMBER?.
[13] Vargesson, ‘Thalidomide-Induced Limb Defects’.
[14] ‘Science and the Citizen’, Scientific American, 207 (1962), pp. 98-11; Neil Vargesson, ‘Thalidomide‐Induced Teratogenesis: History and Mechanisms’, Embryo Toda: Reviews, 105 (2015), pp. 140-56.
[15] Rebecca Coombes, ‘Attacking the Devil: The Thalidomide Story’, British Medical Journal, 352 (2016).
[16] Thalidomide | Science Museum Accessed 16th September 2021.
[17] Belfast Telegraph (20 July 1962).
[18] Belfast Telegraph (17 January 1963).
[19] D.H.M. Woollam, ‘Census of Thalidomide Mothers’, British Medical Journal, ii (1962), p. 1321.
[20] Ian M. Leck and E.L.M. Millar, ‘Incidence of Malformations Since the Introduction of Thalidomide’, British Medical Journal ii: 5296 (1962), pp. 16-20.
[21] Belfast Telegraph (24 November 1964).
[22] Belfast Telegraph (18 December 1963).
[23] Belfast Telegraph (8 April 1966).
[24] House of Commons Debates (29 November 1972), vol. 847, c. 472.
[25] http://news.bbc.co.uk/1/hi/programmes/panorama/3705268.stm Accessed 16 September 2021.
[26]The Place Of The UK In EU Medicines Regulation – Past, Present And Future | FPM Accessed 16 September 2021.
[27] Birmingham Daily Post (31 December 1969).
[28] Daily Herald (28 February 1964).
[29] Max Sherman and Steven Strauss, ‘Thalidomide: A Twenty-Five Year Perspective Food, Drug, Cosmetic’, Law Journal, 41 (1986), pp. 458-66.
[30] Sonia Macleod and Sweta Chakraborty, Pharmaceutical and Medical Device Safety: A Study in Public and Private Regulation (London: Bloomsbury, 2019), pp. 85-7.
[31] House of Commons Debates (29 November 1972).
[32] Belfast Telegraph (14 December 1972).
[33] Macleod and Chakraborty, Pharmaceutical and Medical Device Safety, pp. 85-7.
[34] Elaine Flether-Jansen, Encyclopaedia of Special Education: A Reference for the Education of Children, Adolescents, and Adults with Disabilities and Other Exceptional Individuals (New York, NY: Wiley 2007).
[35] Sarah Ferber, Bioethics in Historical Perspective (Basingstoke: Palgrave Macmillan, 2013), p. 139.
[36] Dorothy Nelkin, David P Willis and Scott V Parris, ‘A Disease of Society: Cultural Responses to AIDS (Part 1): Introduction’, Milbank Quarterly, 68 (1990), pp. 1-9; Lisa A. Seidman, ‘Frances Kelsey and Thalidomide in the US: A Case Study Relating to Pharmaceutical Regulations’, American Biology Teacher,64 (2002), pp. 495-500; Waqas Rehman, Lisa M. Arfons, Hillard M. Lazarus, ‘The Rise, Fall and Subsequent Triumph of Thalidomide: Lessons Learned in Drug Development’, Therapeutic Advances in Haematology, 2 (2011), pp. 291-308.
[37] Soraya Machado de Jesus, Rafael Santos Santana and Silvana Nair Leite, ‘The Organization, Weaknesses, and Challenges of the Control of Thalidomide in Brazil: A Review’, Plos Neglected Tropical Diseases,14 (2020), pp. 1-24.
[38] Independent (28 October 2011).
[39] https://www.sciencemuseum.org.uk/objects-and-stories/medicine/thalidomide Accessed 15 June 2021.