thalidomide scandal
{{Short description|Birth defects linked to thalidomide use}}
{{About|the thalidomide scandal and birth defect crisis|the drug itself|thalidomide}}
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In the late 1950s and early 1960s, the use of thalidomide in 46 countries was prescribed to women who were pregnant or who subsequently became pregnant, and consequently 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.{{Cite journal |last=Vargesson |first=Neil |date=June 2015 |title=Thalidomide-induced teratogenesis: history and mechanisms |journal= Birth Defects Research Part C: Embryo Today: Reviews|volume=105 |issue=2 |doi-access=free |pages=140–156 |doi=10.1002/bdrc.21096 |issn=1542-9768 |pmc=4737249 |pmid=26043938}}{{cite news | author = Bren L | title =Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History | url =http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/features/2001/201_kelsey.html | work =FDA Consumer|publisher =U.S. Food and Drug Administration | date =28 February 2001 | access-date =23 December 2009}}
Thalidomide was introduced in 1957 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.{{cite journal | last = Miller | first = Marylin T. | name-list-style = vanc | title = Thalidomide Embryopathy: A Model for the Study of Congenital Incomitant Horizontal Strabismus | journal = Transactions of the American Ophthalmological Society | year = 1991 | volume = 81 | pages = 623–674 | pmid = 1808819 | pmc = 1298636 }}{{cite book |last1=Loue |first1=Sana |last2=Sajatovic |first2=Martha | name-list-style = vanc |title=Encyclopedia of Women's Health |date=2004 |publisher=Springer Science & Business Media |isbn=9780306480737 |pages=643–644 |url=https://books.google.com/books?id=LbHWgd-mDbsC&pg=PA644 |language=en}} It was introduced as a sedative and medication for morning sickness without having been tested on pregnant women.{{cite book|last1=Sneader|first1=Walter | name-list-style = vanc |title=Drug discovery: a history|url=https://archive.org/details/drugdiscoveryhis00snea|url-access=limited|date=2005|publisher=Wiley|location=Chichester|isbn=978-0-471-89979-2|page=[https://archive.org/details/drugdiscoveryhis00snea/page/n380 367]|edition=Rev. and updated}} 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.{{cite book | title = The Oxford Companion to the Body | last = Cuthbert | first = Alan | name-list-style = vanc | year = 2003 | publisher = Oxford University Press | url = https://archive.org/details/oxfordcompaniont0000unse_z0k4/page/682 | doi = 10.1093/acref/9780198524038.001.0001 | isbn = 9780198524038 | url-access = registration | page = [https://archive.org/details/oxfordcompaniont0000unse_z0k4/page/682 682] }}
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Development of thalidomide
File:Grünenthal 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. 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.{{Cite news|last=Thomas|first=Katie|url=https://www.nytimes.com/2020/03/23/health/thalidomide-survivors-usa.html|title=The Unseen Survivors of Thalidomide Want to Be Heard|date=2020-03-23|work=The New York Times|access-date=2020-03-23|language=en-US|issn=0362-4331}} 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.{{cite news |last1=Williams |first1=Roger |title=The Nazis and Thalidomide: The Worst Drug Scandal of All Time |url=https://www.newsweek.com/nazis-and-thalidomide-worst-drug-scandal-all-time-64655 |access-date=25 August 2021 |publisher=Newsweek |date=September 10, 2012}}
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.{{cite web |title=Thalidomide Monograph for Professionals |url=https://www.drugs.com/monograph/thalidomide.html |website=Drugs.com |access-date=14 November 2019 |language=en}}{{cite news |author=Zimmer C |author-link=Carl Zimmer |date=15 March 2010 |title=Answers Begin to Emerge on How Thalidomide Caused Defects |url=https://www.nytimes.com/2010/03/16/science/16limb.html |access-date=2010-03-21 |newspaper=New York Times |quote=As they report in the current issue of Science, a protein known as cereblon latched on tightly to the thalidomide}} Those who survived had limb, eye, urinary tract, and heart defects. Its initial entry into the U.S. market was prevented by Frances Oldham Kelsey at the U.S. Food and Drug Administration (FDA). The birth defects of thalidomide led to the development of greater drug regulation and monitoring in many countries.
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.{{cite news |title=Thalidomide: The Fifty Year Fight (no longer available) |url=https://www.youtube.com/watch?v=_NLbhOyLLMY |access-date=13 September 2015 |publisher=BBC |date=15 May 2014}}{{cbignore}}{{Dead YouTube link|date=February 2022}}{{cite web |author=Miller M. T., Strömland K. |title=Teratogen update: Thalidomide: a review, with a focus on ocular findings and new potential uses |url=https://www.thalidomide.ca/wp-content/uploads/2017/12/article-miller-stromland-teratogen-update.pdf |date=November 1999}}
=United Kingdom=
File:Artificial limbs for a thalidomide child, 1961-1965. (9660575567).jpg'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.{{cite news|url=http://news.bbc.co.uk/1/hi/health/8458855.stm|title=Apology for thalidomide survivors|date=14 January 2010 |work=BBC News|access-date=14 January 2010}} 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.{{cite news |url=http://news.bbc.co.uk/1/hi/health/3589173.stm|title=They just didn't know what it would do |last=Ryan |first=Caroline | name-list-style = vanc |date=1 April 2004 |work=BBC News:Health|publisher=BBC News |access-date=1 May 2009 |archive-url=https://web.archive.org/web/20040707121708/http://news.bbc.co.uk/1/hi/health/3589173.stm |archive-date=2004-07-07 |url-status=live}}{{cite news |url=http://www.timesonline.co.uk/tol/life_and_style/health/article3602694.ece |title=Thalidomide: the battle for compensation goes on |last=Flintoff |first=John-Paul | name-list-style = vanc |date=23 March 2008|work=The Sunday Times |publisher=Times Newspapers Ltd. |access-date=2009-05-01 |location=London |archive-url = https://web.archive.org/web/20080513095824/http://www.timesonline.co.uk/tol/life_and_style/health/article3602694.ece |archive-date=2008-05-13}} Distillers Biochemicals paid out approximately £28m in compensation following a legal battle.
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.{{cite web |title=About Us |url=https://www.thalidomidetrust.org/about-us/ |website=The Thalidomide Trust |access-date=21 April 2020}} The UK government gave survivors a grant of £20 million, to be distributed through the Thalidomide Trust, in December 2009.{{cite news|url=http://news.bbc.co.uk/1/hi/8428838.stm |title=Thalidomide survivors to get £20m |work=BBC News |date=23 December 2009 |access-date=26 July 2011 |archive-url=https://archive.today/20130114042718/http://news.bbc.co.uk/2/hi/8428838.stm |archive-date=14 January 2013 |url-status=live }}
=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.{{cite news | last1 = Scott | first1 = Caroline | last2 = Haupt | first2 = Oliver | name-list-style = vanc | date = 3 May 2015 | title = The forgotten victims | url = http://www.thesundaytimes.co.uk/sto/Magazine/article1551306.ece | archive-url = https://web.archive.org/web/20150527225931/http://www.thesundaytimes.co.uk/sto/Magazine/article1551306.ece | url-status = dead | archive-date = May 27, 2015 | newspaper = The Sunday Times Magazine | pages = 12–19 | access-date = 8 May 2015 }}
=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.Swan, Norman (28 June 2018). [http://www.abc.net.au/news/health/2018-06-29/thalidomide-william-mcbride-flawed-character-norman-swan/9920608 "Dr William McBride: The Flawed Character Credited with Linking Thalidomide to Birth Defects."] ABC.net.au. Retrieved 29 May 2019. 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.{{cite web|url=http://www.whonamedit.com/doctor.cfm/1002.html|title=Widukind Lenz|last=Anon|work=who named it?|publisher= Ole Daniel Enersen|access-date=1 May 2009}}{{cite news|url=http://news.bbc.co.uk/1/hi/uk/2031459.stm|title=Thalidomide:40 years on|last=Anon|work=BBC News|publisher=BBC|access-date=1 May 2009 | date=7 June 2002}} McBride was later awarded a number of honors, including a medal and prize money by L'Institut de la Vie in Paris,{{cite web|url=http://embryology.med.unsw.edu.au/Defect/page5i.htm |title=Report of Thalidomide at University of New South Wales |publisher=Embryology.med.unsw.edu.au |access-date=30 December 2012 |url-status=dead |archive-url=https://web.archive.org/web/20121028204857/http://embryology.med.unsw.edu.au/Defect/page5i.htm |archive-date=28 October 2012 }} but he was eventually struck off the Australian medical register in 1993 for scientific fraud related to work on Debendox.Millikin, Robert (20 February 1993). [https://www.independent.co.uk/news/world/thalidomide-doctor-guilty-of-medical-fraud-william-mcbride-who-exposed-the-danger-of-one-anti-nausea-1474190.html "'Thalidomide Doctor' Guilty of Medical Fraud: William McBride, Who Exposed the Danger of One Anti-Nausea Drug, Has Been Disgraced by Experiments with Another."] The Independent. Retrieved 28 May 2019. Further animal tests were conducted by George Somers, Chief Pharmacologist of Distillers Company in Britain, which showed fetal abnormalities in rabbits.{{cite journal | vauthors = Somers GF | date = 1963 | title = The foetal toxicity of thalidomide | journal = Proc. European Soc. Study Drug Toxicity | volume = 1 |page = 49 }} Similar results were also published showing these effects in rats{{cite journal |last1=King |first1=C.T.G. |last2=Kendrick |first2=F.J. | name-list-style = vanc | title=Teratogenic effects of thalidomide in the Sprague Dawley rat |journal=The Lancet |volume=280 |issue=7265 |year=1962 |pages=409–17 |doi=10.1016/S0140-6736(62)90822-X |pmid=14288814}}{{cite journal | vauthors = McColl JD, Globus M, Robinson S | title = Effect of some therapeutic agents on the developing rat fetus | journal = Toxicology and Applied Pharmacology | volume = 7 | issue = 7265| pages = 409–17 | year = 1965 | pmid = 14288814 | doi = 10.1016/S0140-6736(62)90822-X }} and other species.{{cite book |last=Botting |first=Jack | name-list-style = vanc |date=April 2015 |title=Animals and Medicine: The Contribution of Animal Experiments to the Control of Disease |chapter-url=http://www.openbookpublishers.com/htmlreader/978-1-78374-117-5/Ch-18.xhtml |publisher=OpenBook Publishers |chapter=Chapter 18 |isbn=9781783741175 |access-date=12 August 2015}}
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.{{cite news|url=http://www.abc.net.au/news/2011-12-19/australian-thalidomide-victims-win-hearing-bid/3738116|title=Australian thalidomide victims win right for hearing|date=19 December 2011|newspaper=ABC News}} 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.{{cite news |last=Petrie |first=Andrea | name-list-style = vanc |date=19 July 2012 |title=Landmark thalidomide payout offers hope for thousands |url=http://www.smh.com.au/national/landmark-thalidomide-payout-offers-hope-for-thousands-20120718-22apa.html |newspaper=The Sydney Morning Herald |access-date=14 February 2017 }} 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.{{cite news|last=Farnsworth|first=Sarah| name-list-style = vanc |title=Supreme Court formally approves $89m compensation payout for Thalidomide victims|url=http://www.abc.net.au/news/2014-02-07/supreme-court-formally-approves-2489m-class-action-for-thalido/5245034|access-date=14 February 2017|publisher=Australian Broadcasting Corporation|date=7 February 2014}}{{cite news|author=Australian Associated Press|title=Thalidomide survivors' compensation approved|url=http://www.stuff.co.nz/national/health/9698482/Thalidomide-survivors-compensation-approved|access-date=14 February 2017|work=The Sunday Star-Times|date=7 February 2014|author-link=Australian Associated Press}}
=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.{{cite web |url=https://www.neues-deutschland.de/artikel/120351.html |title=DDR-Bürger schliefen ohne Contergan |trans-title=East German citizens slept without thalidomide |language=de |work=Neues Deutschland |date=4 November 2007 |access-date=June 6, 2013}} 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. Based on this, FDP whip Erich Mende requested an official statement from the federal government. 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.{{cite journal |archive-url=https://web.archive.org/web/20120728221612/http://www.aerzteblatt.de/archiv/57224 |archive-date=July 28, 2012 |url-status=live |url=http://www.aerzteblatt.de/archiv/57224/ |access-date=June 6, 2013 |first=Klaus-Dieter |last=Thomann |name-list-style=vanc |title=Die Contergan-Katastrophe: Die trügerische Sicherheit der "harten" Daten |trans-title=The thalidomide disaster: The false security of 'hard' data |language=de |journal=Deutsches Ärzteblatt |year=2007 |volume=104 |issue=41 |pages=A–2778 / B–2454 / C–2382 }} [http://www.contergan-ag50.de/Seiten/presse/20111125-27_artikel/2007_Die_Contergan-Katastrophe_Die_truegerische_Sicherheit_der_harten_Daten-Deutsches_Aerzteblatt.pdf Alt URL] {{Webarchive|url=https://web.archive.org/web/20131019052749/http://www.contergan-ag50.de/Seiten/presse/20111125-27_artikel/2007_Die_Contergan-Katastrophe_Die_truegerische_Sicherheit_der_harten_Daten-Deutsches_Aerzteblatt.pdf |date=2013-10-19 }} 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.{{cite book | vauthors = Zichner L, Rauschmann MA, Thomann KD | title = Die Contergankatastrophe eine Bilanz nach 40 Jahren | trans-title = The thalidomide catastrophe takes stock after 40 years | language = de | date = 2005 | publisher = Steinkopff | location = Darmstadt | isbn = 978-3-7985-1479-9 }} The parliamentary report rejected any relation with radioactivity and the abnormal increase of dysmelia. 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. 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. In West Germany approximately 2,500 babies were born with birth defects from thalidomide.
=Canada=
Despite its severe side effects, thalidomide was sold in pharmacies in Canada until 1962.{{cite journal | vauthors = Webb JF | title = Canadian Thalidomide Experience | journal = Canadian Medical Association Journal | volume = 89 | pages = 987–92 | date = November 1963 | issue = 19 | pmid = 14076167 | pmc = 1921912 }}{{cite web|url=http://www.history.ca/ontv/titledetails.aspx?titleid=21267 |title=Turning Points of History–Prescription for Disaster |publisher=History Television |access-date=24 February 2010 |url-status=dead |archive-url=https://web.archive.org/web/20110929135332/http://www.history.ca/ontv/titledetails.aspx?titleid=21267 |archive-date=September 29, 2011 }} 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.{{cite journal | vauthors = Racz WJ, Ecobichon DJ, Baril M | title = On-line sources of toxicological information in Canada | journal = Toxicology | volume = 190 | issue = 1–2 | pages = 3–14 | date = August 2003 | pmid = 12909394 | doi = 10.1016/S0300-483X(03)00192-6 | bibcode = 2003Toxgy.190....3R }} 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. 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.{{cite news |title=The plight of the thalidomide 'sample babies' who don't qualify for gov't compensation |url=http://www.ctvnews.ca/w5/the-plight-of-the-thalidomide-sample-babies-who-don-t-qualify-for-gov-t-compensation-1.3176590 |work=W5 |access-date=28 November 2016}}
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.{{cite journal | vauthors = Warren R | title = Living in a world with thalidomide: a dose of reality | journal = FDA Consumer | volume = 35 | issue = 2 | pages = 40 | year = 2001 | pmid = 11444250 | url = http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/departs/2001/201_word.html }}{{Cite web|url=http://www.thalidomide.ca/tvac-mission/|title=TVAC and its mission – Thalidomide|date=June 24, 2009|archive-url=https://web.archive.org/web/20090624192258/http://www.thalidomide.ca/tvac-mission/|archive-date=2009-06-24}} The members from the thalidomide victims association were involved in the STEPS programme, which aimed to prevent teratogenicity.{{cite journal | vauthors = Franks ME, Macpherson GR, Figg WD | title = Thalidomide | journal = Lancet | volume = 363 | issue = 9423 | pages = 1802–11 | date = May 2004 | pmid = 15172781 | doi = 10.1016/S0140-6736(04)16308-3 | s2cid = 208789946 | url = https://zenodo.org/record/1259793 }}
=United States=
File:Frances Oldham Kelsey and John F. Kennedy.jpg 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.{{cite web|url=https://www.huffingtonpost.com/whitny-braun/thalidomide-the-connectio_b_8881702.html|title=Thalidomide: The Connection Between a Statue in Trafalgar Square, a 1960s Children's Show Host and the Abortion Debate|last=Braun|first=Whitny | name-list-style = vanc | date = 29 December 2015 | website = Huffington Post | access-date = 2 December 2017}}{{cite web |url=http://www.birthdefects.org/research/bendectin_1.php |title=Bendectin Part 1: How a Commonly Used Drug Caused Birth Defects |last=Mekdeci |first=Betty| name-list-style = vanc | archive-url=https://web.archive.org/web/20131218004638/http://www.birthdefects.org/research/bendectin_1.php |archive-date=18 December 2013}} While pregnant, children's television host Sherri Finkbine took thalidomide that her husband had purchased over-the-counter in Europe.{{cite web|url=https://www.cliohistory.org/click/body-health/reproduction/|title=Click – Debating Reproductive Rights – Reproductive Rights and Feminism, History of Abortion Battle, History of Abortion Debate, Roe v. Wade and Feminists|website=www.cliohistory.org|access-date=2 December 2017}} 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.
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. 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.{{cite news | first = Gardiner | last = Harris | name-list-style = vanc | url = https://www.nytimes.com/2010/09/14/health/14kelsey.html|title=The Public's Quiet Savior From Harmful Medicines|date=13 September 2010|work=The New York Times}}
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.{{cite web |url=https://cfmedicine.nlm.nih.gov/physicians/biography_316.html |title=Dr. Helen Brooke Taussig |location=Bethesda, MD |work=U.S. National Library of Medicine |date=3 June 2015}}
=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.{{cite web |url=https://newsv1.orf.at/070930-17124/|title=10.000 Fälle von Missbildungen|trans-title=10,000 cases of malformations|language=de|publisher=ORF|access-date=July 5, 2023}}
=Japan=
In Japan there are 300 victims of this drug.
Aftermath of scandal
File:Thalidomide Memorial in Cardiff.jpg, 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. 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."
=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{{px2}}{{mdash}}{{hsp}}who served as the chief executive officer of Grünenthal GmbH from January 2009 to May 28, 2013{{px2}}{{mdash}}{{hsp}}apologized for the first time for producing the drug and remaining silent about the birth defects.{{cite web|title=Speech on the occasion of the inauguration of Thalidomide-Memorial|url=http://www.contergan.grunenthal.info/grt-ctg/GRT-CTG/Stellungnahme/Rede_anlaesslich_Einweihung_des_Contergan-Denkmals/224600963.jsp|website=Grünenthal GmbH Website|archive-url=https://web.archive.org/web/20120901184544/http://www.contergan.grunenthal.info/grt-ctg/GRT-CTG/Stellungnahme/Rede_anlaesslich_Einweihung_des_Contergan-Denkmals/224600963.jsp|archive-date=1 September 2012}} 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.{{cite news |title=Thalidomide apology insulting, campaigners say|date=September 1, 2012 |work=BBC News |url=https://www.bbc.com/news/health-19448046 |archive-url=https://web.archive.org/web/20160316085150/http://www.bbc.com/news/health-19448046 |archive-date=16 March 2016}}
=Australian National Memorial=
On 13 November 2023, the Australian Government announced its intention to make a formal apology to people affected by thalidomide with the unveiling of a national memorial site. Prime Minister Anthony Albanese described the thalidomide tragedy as a “dark chapter” in Australian history, and Health Minister Mark Butler said, “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.”{{Cite news |last=Jose |first=Renju |date=2023-11-13 |title=Australia to apologise half a century after 'Thalidomide tragedy' |language=en |work=Reuters |url=https://www.reuters.com/world/asia-pacific/australia-apologise-half-century-after-thalidomide-tragedy-2023-11-13/ |access-date=2023-11-13}}{{Cite web |title=Australian government will apologise to people affected by thalidomide tragedy {{!}} Health {{!}} The Guardian |url=https://www.theguardian.com/australia-news/2023/nov/13/australian-government-thalidomide-tragedy-apology |access-date=2023-11-13 |website=amp.theguardian.com}}
Notable cases
- Mercédes Benegbi, born with phocomelia of both arms, drove the successful campaign for compensation from her government for Canadians who were affected by thalidomide.{{cite web|author=|title=Outstanding eight to receive honorary doctorates at Convocation|url=http://www.uwindsor.ca/dailynews/2016-06-07/outstanding-eight-receive-honorary-doctorates-convocation|website=Daily News|publisher=University of Windsor|access-date=6 March 2017|location=Windsor, Ontario, Canada|date=9 June 2016}}
- Mat Fraser, born with phocomelia of both arms, is an English rock musician, actor, writer and performance artist. He produced a 2002 television documentary, Born Freak, which looked at this historical tradition and its relevance to modern disabled performers. This work has become the subject of academic analysis in the field of disability studies.{{Cite journal | vauthors = Mitchell D, Snyder S | title = Exploitations of embodiment: Born Freak and the academic bally plank. | journal = Disability Studies Quarterly | date = June 2005 | volume = 25 | issue = 3 |url=http://www.dsq-sds.org/article/view/575/752 | doi = 10.18061/dsq.v25i3.575 | doi-access = free }}
- Niko von Glasow, a thalidomide survivor, produced a documentary called NoBody's Perfect, based on the lives of 12 people affected by the drug, which was released in 2008.{{cite web |url=https://www.imdb.com/title/tt1266093/releaseinfo |title=NoBody's Perfect (2008): Release Info|publisher=IMDB |access-date=6 June 2013}}{{cite web|url=http://www.spiritualityandpractice.com/films/films.php?id=19559|title=Film Review: NoBody's Perfect |first1=Frederic |last1=Brussat |first2=Mary Ann |last2=Brussat | name-list-style = vanc |publisher=Spirituality & Practice|access-date=6 June 2013}}
- Josée Lake is a Canadian Paralympic gold medallist swimmer, thalidomide survivor, and president of the Thalidomide Victims Association of Canada
- Lorraine Mercer MBE of the United Kingdom, born with phocomelia of both arms and legs, is the only thalidomide survivor to carry the Olympic Torch.{{cite news | last = Tamplin | first = Harley | name-list-style = vanc | title = Mid Sussex residents honoured by Queen |newspaper=Mid Sussex Times |date=12 June 2015 |url=http://www.midsussextimes.co.uk/news/local/mid-sussex-residents-honoured-by-queen-1-6795898 |access-date=27 December 2015}}
- Thomas Quasthoff, an internationally acclaimed bass-baritone, who describes himself: "1.34 meters tall, short arms, seven fingers — four right, three left — large, relatively well-formed head, brown eyes, distinctive lips; profession: singer".{{cite web|url=http://www.portlandphoenix.com/archive/music/02/04/19/classical_Orpheus.html |title=Orpheus lives: A small good thing in Quastoff |work=The Portland Phoenix |date=April 19, 2002 |access-date=6 June 2013 |url-status=dead |archive-url=https://web.archive.org/web/20120306201745/https://www.portlandphoenix.com/archive/music/02/04/19/classical_Orpheus.html |archive-date=6 March 2012 }}
- Alvin Law, Canadian motivational speaker and former radio broadcaster.
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{{cite web|title=50 Years: The Kefauver-Harris Amendments|url=https://www.fda.gov/Drugs/NewsEvents/ucm320924.htm|publisher=Food and Drug Administration (United States)|access-date=6 June 2013}} (US), Directive 65/65/EEC1 (E.U.),{{cite web|title=Thalidomide |url=http://www.crncc.nihr.ac.uk/workforce_development/learning_and_development/gcp/gcp_resource/research_standards/history/thalidomide |publisher=National Health Service (England) |access-date=6 June 2013 |url-status=dead |archive-url=https://web.archive.org/web/20131203020225/http://www.crncc.nihr.ac.uk/workforce_development/learning_and_development/gcp/gcp_resource/research_standards/history/thalidomide |archive-date=3 December 2013 }} and the Medicines Act 1968 (UK).{{cite journal | vauthors = Conroy S, McIntyre J, Choonara I | title = Unlicensed and off label drug use in neonates | journal = Archives of Disease in Childhood: Fetal and Neonatal Edition | volume = 80 | issue = 2 | pages = F142–4; discussion F144–5 | date = March 1999 | pmid = 10325794 | doi = 10.1136/fn.80.2.F142 | pmc=1720896}}{{cite web | publisher = Royal Pharmaceutical Society | title = The evolution of pharmacy, Theme E, Level 3 Thalidomide and its aftermath | url = https://www.rpharms.com/museum-pdfs/e3a-thalidomide-and-its-aftermath-2011.pdf | archive-url = https://web.archive.org/web/20111014114005/https://www.rpharms.com/museum-pdfs/e3a-thalidomide-and-its-aftermath-2011.pdf | url-status = dead | archive-date = 14 October 2011 | date = 2011 }} 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. The FDA subsequently initiated the Drug Efficacy Study Implementation to reclassify drugs already on the market.
References
{{Reflist}}
Further reading
{{refbegin}}
- {{cite book |last1=Stephens |first1=Trent |last2=Brynner |first2=Rock |name-list-style=vanc |title=Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine |date=2001-12-24 |publisher=Perseus Books |isbn=978-0-7382-0590-8 |url-access=registration |url=https://archive.org/details/darkremedyimpact00step }}
- {{cite book | last1=Knightley |first1=Phillip|author-link= Phillip Knightley| last2 = Evans | first2 = Harold | name-list-style = vanc |title=Suffer The Children: The Story of Thalidomide |year=1979| publisher=The Viking Press|location=New York|isbn=978-0-670-68114-3|author-link2=Harold Evans}}
{{refend}}
External links
- [https://iris.who.int/bitstream/handle/10665/255810/WPN-2003-02-eng.pdf WHO Pharmaceuticals Newsletter No. 2, 2003 – See page 11, Feature Article]
- [http://www.cbc.ca/archives/topic/thalidomide-bitter-pills-broken-promises CBC Digital Archives – Thalidomide: Bitter Pills, Broken Promises]
- [http://theconversation.com/remind-me-again-what-is-thalidomide-and-how-did-it-cause-so-much-harm-46847 Remind me again, what is thalidomide and how did it cause so much harm?]. The Conversation, 7 December 2015
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Category:Congenital amputations
Category:20th-century health disasters
Category:Health disasters in the United Kingdom
Category:History of mental health in the United Kingdom
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Category:Medical controversies in the United Kingdom
Category:Medical controversies in Germany
Category:Medical controversies in Austria
Category:Medical controversies in Australia
Category:Medical controversies in New Zealand
Category:Medical controversies in the United States
Category:Medical controversies in Canada