Thalidomide scandal

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Phocomelia
Thalidomide effects.jpg
Cases of severe thalidomide-induced phocomelia
Baby born to a mother who had taken thalidomide while pregnant NCP14053.jpg
Baby born to a mother who had taken thalidomide while pregnant

In the late 1950s and early 1960s, the use of thalidomide in 46 countries by women who were pregnant or who subsequently became pregnant resulted in the "biggest anthropogenic medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as phocomelia, as well as thousands of miscarriages. [1] [2]

Contents

Thalidomide was introduced in 1953 as a tranquilizer, and was later marketed by the German pharmaceutical company Chemie Grünenthal under the trade name Contergan as a medication for anxiety, trouble sleeping, tension, and morning sickness. [3] [4] It was introduced as a sedative and medication for morning sickness without having been tested on pregnant women. [5] While initially deemed to be safe in pregnancy, concerns regarding birth defects were noted in 1961, and the medication was removed from the market in Europe that year. [3] [6]

Development of thalidomide

Grunenthal logo green.png

Thalidomide was first developed as a tranquilizer by Swiss pharmaceutical company Ciba in 1953. In 1954, Ciba abandoned the product, and it was acquired by German pharmaceutical company Chemie Grünenthal. [4] The company had been established by Hermann Wirtz, Sr, a Nazi Party member, after World War II as a subsidiary of the family's Mäurer & Wirtz company. The company's initial aim was to develop antibiotics for which there was an urgent market need. Wirtz appointed chemist Heinrich Mückter, who had escaped prosecution for war crimes for his experiments on prisoners of Nazi concentration camps, to head the development programme because of his experience researching and producing an anti-typhus vaccine for Nazi Germany. [7] He hired Martin Staemmler, a medical doctor and leading proponent of the Nazi eugenics programme, as head of pathology, as well as Heinz Baumkötter, the chief medical officer at the Sachsenhausen concentration camp, and Otto Ambros, a chemist and Nazi war criminal. Ambros was the chairman of Grünenthal's advisory committee during the development of thalidomide and was a board member when Contergan was being sold. [8]

Birth defect crisis

The total number of embryos affected by the use of thalidomide during pregnancy is estimated at more than 10,000, and potentially up to 20,000; of these, approximately 40 percent died at or shortly after the time of birth. [3] [9] [10] Those who survived had limb, eye, urinary tract, and heart defects. [6] Its initial entry into the U.S. market was prevented by Frances Oldham Kelsey at the U.S. Food and Drug Administration (FDA). [4] The birth defects of thalidomide led to the development of greater drug regulation and monitoring in many countries. [4] [6]

The severity and location of the deformities depended on how many days into the pregnancy the mother was before beginning treatment; thalidomide taken on the 20th day of pregnancy caused central brain damage, 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. Thalidomide did not damage the fetus if taken after 42 days' gestation. [11]

United Kingdom

Artificial limbs made for an affected child in the 1960s by the Department of Health and Social Security's Limb Fitting Centre in Roehampton, London Artificial limbs for a thalidomide child, 1961-1965. (9660575567).jpg
Artificial limbs made for an affected child in the 1960s by the Department of Health and Social Security's Limb Fitting Centre in Roehampton, London

In the UK, the drug was licensed in 1958 and withdrawn in 1961. Of the approximately 2,000 babies born with defects, around half died within a few months and 466 survived to at least 2010. [12] In 1968, after a long campaign by The Sunday Times , a compensation settlement for the UK victims was reached with Distillers Company (now part of Diageo), which had distributed the drug in the UK. [13] [14] Distillers Biochemicals paid out approximately £28m in compensation following a legal battle. [15]

The British Thalidomide Children's Trust was set up in 1973 as part of a £20 million legal settlement between Distillers Company and 429 children with thalidomide-related disabilities. In 1997, Diageo (formed by a merger between Grand Metropolitan and Guinness, who had taken over Distillers in 1990) made a long-term financial commitment to support the Thalidomide Trust and its beneficiaries. [16] The UK government gave survivors a grant of £20 million, to be distributed through the Thalidomide Trust, in December 2009. [15]

Spain

In Spain, thalidomide was widely available throughout the 1970s, and perhaps even into the 1980s. There were two reasons for this. First, state controls and safeguarding were poor; it was not until 2008 that the government even admitted the country had ever imported thalidomide. Second, Grünenthal failed to insist that its sister company in Madrid warn Spanish doctors, and permitted its sister company not to warn doctors of the defects. The Spanish advocacy group for victims of thalidomide estimates that in 2015, there were 250–300 living victims of thalidomide in Spain. [17]

Australia and New Zealand

Although the Australian obstetrician William McBride took credit for raising concern about thalidomide, it was a midwife called Sister Pat Sparrow who first suspected the drug was causing birth defects in the babies of patients under McBride's care at Crown Street Women's Hospital in Sydney. [18] German paediatrician Widukind Lenz, who also suspected the link, is credited with conducting the scientific research that proved thalidomide was causing birth defects in 1961. [19] [20] McBride was later awarded a number of honors, including a medal and prize money by L'Institut de la Vie in Paris, [21] but he was eventually struck off the Australian medical register in 1993 for scientific fraud related to work on Debendox. [18] [22] Further animal tests were conducted by George Somers, Chief Pharmacologist of Distillers Company in Britain, which showed foetal abnormalities in rabbits. [23] Similar results were also published showing these effects in rats [24] [25] and other species. [26]

Lynette Rowe, who was born without limbs, led an Australian class action lawsuit against the drug's manufacturer, Grünenthal, which fought to have the case heard in Germany. The Supreme Court of Victoria dismissed Grünenthal's application in 2012, and the case was heard in Australia. [27] On 17 July 2012, Rowe was awarded an out-of-court settlement, believed to be in the millions of dollars and providing precedence for class action victims to receive further compensation. [28] In February 2014, the Supreme Court of Victoria endorsed the settlement of $89 million AUD to 107 victims of the drug in Australia and New Zealand. [29] [30]

Germany

In East Germany, thalidomide was rejected by the Central Committee of Experts for the Drug Traffic in the GDR, and was never approved for use. There are no known thalidomide babies born in East Germany. [31] Meanwhile, in West Germany, it took some time before the increase in dysmelia at the end of the 1950s was connected with thalidomide. In 1958, Karl Beck, a former pediatric doctor in Bayreuth, wrote an article in a local newspaper claiming a relationship between nuclear weapons testing and cases of dysmelia in children. [32] Based on this, FDP whip Erich Mende requested an official statement from the federal government. [32] For statistical reasons, the main data series used to research dysmelia cases started by chance at the same time as the approval date for thalidomide. [32] After the Nazi regime with its Law for the Prevention of Hereditarily Diseased Offspring used mandatory statistical monitoring to commit various crimes, western Germany had been very reluctant to monitor congenital disorders in a similarly strict way. [33] The parliamentary report rejected any relation with radioactivity and the abnormal increase of dysmelia. [32] Also the DFG research project installed after the Mende request was not helpful. The project was led by pathologist Franz Büchner, who ran the project to propagate his teratological theory. Büchner saw lack of healthy nutrition and behavior of the mothers as being more important than genetic reasons. [33] Furthermore, it took a while to appoint a Surgeon General in Germany; the Federal Ministry of Health was not founded until 1962, some months after thalidomide was banned from the market. [32] In West Germany approximately 2,500 babies were born with birth defects from thalidomide. [20]

Canada

Despite its severe side effects, thalidomide was sold in pharmacies in Canada until 1962. [34] [35] The effects of thalidomide increased fears regarding the safety of pharmaceutical drugs. The Society of Toxicology of Canada was formed after the effects of thalidomide were made public, focusing on toxicology as a discipline separate from pharmacology. [36] The need for the testing and approval of the toxins in certain pharmaceutical drugs became more important after the disaster. The Society of Toxicology of Canada is responsible for the Conservation Environment Protection Act, focusing on researching the impact to human health of chemical substances. [36] Thalidomide brought on changes in the way drugs are tested, what type of drugs are used during pregnancy, and increased the awareness of potential side effects of drugs.

According to Canadian news magazine programme W5 , most, but not all, victims of thalidomide receive annual benefits as compensation from the Government of Canada. Excluded are those who cannot provide the documentation the government requires. [37]

A group of 120 Canadian survivors formed the Thalidomide Victims Association of Canada, the goal of which is to prevent the approval of drugs that could be harmful to pregnant individuals and babies. [38] [39] The members from the thalidomide victims association were involved in the STEPS programme, which aimed to prevent teratogenicity. [40]

United States

1962: FDA pharmacologist Frances Oldham Kelsey receives the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy for blocking sale of thalidomide in the United States. Frances Oldham Kelsey and John F. Kennedy.jpg
1962: FDA pharmacologist Frances Oldham Kelsey receives the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy for blocking sale of thalidomide in the United States.

In the U.S., the FDA refused approval to market thalidomide, saying further studies were needed. This reduced the impact of thalidomide in U.S. patients. The refusal was largely due to pharmacologist Frances Oldham Kelsey who withstood pressure from the Richardson-Merrell Pharmaceuticals Co. Although thalidomide was not approved for sale in the United States at the time, over 2.5 million tablets had been distributed to over 1,000 physicians during a clinical testing programme. It is estimated that nearly 20,000 patients, several hundred of whom were pregnant, were given the drug to help alleviate morning sickness or as a sedative, and at least 17 children were consequently born in the United States with thalidomide-associated deformities. [41] [42] While pregnant, children's television host Sherri Finkbine took thalidomide that her husband had purchased over-the-counter in Europe. [43] When she learned that thalidomide was causing fetal deformities she wanted to abort her pregnancy, but the laws of Arizona allowed abortion only if the mother's life was in danger. Finkbine traveled to Sweden to have the abortion. Thalidomide was found to have deformed the fetus. [41]

For denying the application despite the pressure from Richardson-Merrell Pharmaceuticals Co., Kelsey eventually received the President's Award for Distinguished Federal Civilian Service at a 1962 ceremony with President John F. Kennedy. [2] In September 2010, the FDA honored Kelsey with the first Kelsey award, given annually to an FDA staff member. This came 50 years after Kelsey, then a new medical officer at the agency, first reviewed the application from the William S. Merrell Pharmaceuticals Company of Cincinnati. [44]

Cardiologist Helen B. Taussig learned of the damaging effects of the drug thalidomide on newborns and in 1967, testified before Congress on this matter after a trip to Germany where she worked with infants with phocomelia (severe limb deformities). As a result of her efforts, thalidomide was banned in the United States and Europe. [45]

Austria

Ingeborg Eichler, a member of the Austrian pharmaceutical admission conference, enforced restrictions on the sale of thalidomide (tradename Softenon) under the rules of prescription medication and as a result relatively few affected children were born in Austria and Switzerland. [46]

Aftermath of scandal

Thalidomide Memorial in Cardiff, Wales Thalidomide Memorial in Cardiff.jpg
Thalidomide Memorial in Cardiff, Wales

The numerous reports of malformations in babies brought about the awareness of the side effects of the drug on pregnant women. The birth defects caused by the drug thalidomide can range from moderate malformation to more severe forms. Possible birth defects include phocomelia, dysmelia, amelia, bone hypoplasticity, and other congenital defects affecting the ear, heart, or internal organs. [40] Franks et al. looked at how the drug affected newborn babies, the severity of their deformities, and reviewed the drug in its early years. Webb in 1963 also reviewed the history of the drug and the different forms of birth defects it had caused. "The most common form of birth defects from thalidomide is shortened limbs, with the arms being more frequently affected. This syndrome is the presence of deformities of the long bones of the limbs resulting in shortening and other abnormalities." [34]

Grünenthal criminal trial

In 1968, a large criminal trial began in West Germany, charging several Grünenthal officials with negligent homicide and injury. After Grünenthal settled with the victims in April 1970, the trial ended in December 1970 with no finding of guilt. As part of the settlement, Grünenthal paid 100 million DM into a special foundation; the West German government added 320 million DM. The foundation paid victims a one-time sum of 2,500–25,000 DM (depending on severity of disability) and a monthly stipend of 100–450 DM. The monthly stipends have since been raised substantially and are now paid entirely by the government (as the foundation had run out of money). Grünenthal paid another €50 million into the foundation in 2008.

On 31 August 2012, Grünenthal chief executive Harald F. Stock – who served as the chief executive officer of Grünenthal GmbH from January 2009 to May 28, 2013 – apologized for the first time for producing the drug and remaining silent about the birth defects. [47] At a ceremony, Stock unveiled a statue of a disabled child to symbolize those harmed by thalidomide and apologized for not trying to reach out to victims for over 50 years. At the time of the apology, there were between 5,000 and 6,000 people still living with Thalidomide-related birth defects. Victim advocates called the apology "insulting" and "too little, too late", and criticized the company for not compensating victims and for their claim that no one could have known the harm the drug caused, arguing that there were plenty of red flags at the time. [48]

Australian National Memorial

On 13 November 2023, the Australian Government announced that they will issue a formal apology to people affected by thalidomide with the unveiling of a national memorial site, with Prime Minister Anthony Albanese describing “the thalidomide tragedy” as a “dark chapter” in Australia history and Health Minister Mark Butler saying “ While we cannot change the past or end the physical suffering, I hope these important next steps of recognition and apology will help heal some of the emotional wounds.” [49] [50]

Notable cases

Niko von Glasow, German filmmaker Niko von Glasow.jpg
Niko von Glasow, German filmmaker

Change in drug regulations

The disaster prompted many countries to introduce tougher rules for the testing and licensing of drugs, such as the Kefauver Harris Amendment [57] (U.S.), Directive 65/65/EEC1 (E.U.), [58] and the Medicines Act 1968 (UK). [59] [60] In the United States, the new regulations strengthened the FDA, among other ways, by requiring applicants to prove efficacy and to disclose all side effects encountered in testing. [2] The FDA subsequently initiated the Drug Efficacy Study Implementation to reclassify drugs already on the market.

Related Research Articles

<span class="mw-page-title-main">Thalidomide</span> Immunomodulatory drug known for its ability to cause birth defects

Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers, graft-versus-host disease, and many skin disorders. While thalidomide has been used in a number of HIV-associated conditions, such use is associated with increased levels of the virus.

<span class="mw-page-title-main">Phocomelia</span> Medical condition

Phocomelia is a congenital condition that involves malformations of human arms and legs which results in a flipper-like appendage. A prominent cause of phocomelia is the mother's use of the drug thalidomide during pregnancy; however, the causes of most cases are to be determined.

Teratology is the study of abnormalities of physiological development in organisms during their life span. It is a sub-discipline in medical genetics which focuses on the classification of congenital abnormalities in dysmorphology caused by teratogens. Teratogens are substances that may cause non-heritable birth defects via a toxic effect on an embryo or fetus. Defects include malformations, disruptions, deformations, and dysplasia that may cause stunted growth, delayed mental development, or other congenital disorders that lack structural malformations. The related term developmental toxicity includes all manifestations of abnormal development that are caused by environmental insult. The extent to which teratogens will impact an embryo is dependent on several factors, such as how long the embryo has been exposed, the stage of development the embryo was in when exposed, the genetic makeup of the embryo, and the transfer rate of the teratogen.

Morning sickness, also called nausea and vomiting of pregnancy (NVP), is a symptom of pregnancy that involves nausea or vomiting. Despite the name, nausea or vomiting can occur at any time during the day. Typically the symptoms occur between the 4th and 16th week of pregnancy. About 10% of women still have symptoms after the 20th week of pregnancy. A severe form of the condition is known as hyperemesis gravidarum and results in weight loss.

<span class="mw-page-title-main">Birth defect</span> Condition present at birth regardless of cause

A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities can range from mild to severe. Birth defects are divided into two main types: structural disorders in which problems are seen with the shape of a body part and functional disorders in which problems exist with how a body part works. Functional disorders include metabolic and degenerative disorders. Some birth defects include both structural and functional disorders.

<span class="mw-page-title-main">Grünenthal</span> German pharmaceutical company

Grünenthal is a pharmaceutical company headquartered in Aachen in Germany. It was founded in 1946 as Chemie Grünenthal and has been continuously family-owned. The company was the first to introduce penicillin into the German market in the postwar period, after the Allied Control Council lifted its ban.

<span class="mw-page-title-main">Frances Oldham Kelsey</span> Canadian-American physician and pharmacologist (1914–2015)

Frances Kathleen Oldham Kelsey was a Canadian-American pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.

The Distillers Company plc was a leading Scotch whisky company and, at one time, a constituent of the FTSE 100 Index. It was taken over in 1986 by Guinness & Co. in a transaction that was later found to have involved fraudulent activity, becoming known as the Guinness share-trading fraud.

Pyridoxine/doxylamine, sold under the brand name Diclectin among others, is a combination of pyridoxine hydrochloride (vitamin B6) and doxylamine succinate. It is generally used for nausea and vomiting of pregnancy (morning sickness); even though its efficacy has not been proven and subsequent research has led to the removal of recommendations in medical journals.

Astra AB was a former international pharmaceutical company headquartered in Södertälje, Sweden. Astra was formed in 1913 and merged with the British Zeneca Group in 1999 to form AstraZeneca. Product development was focused on therapeutics for gastrointestinal, cardiovascular and respiratory disorders and pain control. At the time of the fusion, Astra was the largest Swedish pharmaceutical company. Astra also operated Astra Tech, a medical devices company, and marketed pharmaceuticals outside their primary development area, including anti-infective agents.

<span class="mw-page-title-main">Amelia (birth defect)</span> Medical condition

Amelia is the birth defect of lacking one or more limbs. The term may be modified to indicate the number of legs or arms missing at birth, such as tetra-amelia for the absence of all four limbs. The term is from Greek ἀ- 'lack of' plus μέλος 'limb'.

<span class="mw-page-title-main">Kefauver–Harris Amendment</span>

The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.

<span class="mw-page-title-main">Dysmelia</span> Congenital disorder of a limb

Dysmelia is a congenital disorder of a limb resulting from a disturbance in embryonic development.

Marion Merrell Dow and its predecessor Marion Laboratories was a U.S. pharmaceutical company based in Kansas City, Missouri, from 1950 until 1996.

Women should speak to their doctor or healthcare professional before starting or stopping any medications while pregnant. Non-essential drugs and medications should be avoided while pregnant. Tobacco, alcohol, marijuana, and illicit drug use while pregnant may be dangerous for the unborn baby and may lead to severe health problems and/or birth defects. Even small amounts of alcohol, tobacco, and marijuana have not been proven to be safe when taken while pregnant. In some cases, for example, if the mother has epilepsy or diabetes, the risk of stopping a medication may be worse than risks associated with taking the medication while pregnant. The mother's healthcare professional will help make these decisions about the safest way to protect the health of both the mother and unborn child. In addition to medications and substances, some dietary supplements are important for a healthy pregnancy, however, others may cause harm to the unborn child.

<span class="mw-page-title-main">Developmental toxicity</span>

Developmental toxicity is any developmental malformation that is caused by the toxicity of a chemical or pathogen. It is the structural or functional alteration, reversible or irreversible, which interferes with homeostasis, normal growth, differentiation, development or behavior. Developmental toxicity is caused by environmental insult, which includes drugs, alcohol, diet, toxic chemicals, and physical factors.

<span class="mw-page-title-main">Primodos</span> Hormone-based pregnancy test

Primodos was a hormone-based pregnancy test, produced by Schering AG, and used in the 1960s and 1970s that consisted of two pills that contained norethisterone and ethinylestradiol. It detected pregnancy by inducing menstruation in women who were not pregnant. The presence or absence of menstrual bleeding was then used to determine whether the user was pregnant. In South Korea it was also used, "perhaps as a double dose" to induce abortions.

Mercédes Benegbi is a Canadian disabilities activist who has been recognized for her advocacy for the rights of disabled people. In 2000, she was honored by the Council of Canadians with Disabilities and in 2014, she drove a successful initiative to gain support for the survivors of thalidomide. Her efforts resulted in life-time compensation for Canadian "thalidomiders", as well as a special fund for specific medical treatments or modifications to homes and vehicles to accommodate their disabilities.

Heinrich Mückter was a German medical doctor, pharmacologist and chemist.

<i>Wonder Drug</i> (book) Nonfiction book by Jennifer Vanderbes

Wonder Drug: The Secret History of Thalidomide in America and Its Hidden Victims is a nonfiction book authored by Jennifer Vanderbes and published by Random House in 2023. It tells the story of how Frances Oldham Kelsey of the Food and Drug Administration (FDA) found flaws in thalidomide research. Contrary to the initial opinion that the FDA declined the drug a license for morning sickness in pregnancy and the US was therefore spared the thalidomide scandal, Vanderbes claims that the drug was still widely distributed there in the late 1950s and 1960s. As a result, many more babies were affected by phocomelia than originally believed.

References

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