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Thalidomide scandal

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Baby born to a mother who had taken thalidomide while pregnant
Baby born to a mother who had taken thalidomide while pregnant

Thalodomide is a drug that was developed in the 1950s. It was used as as a sedative, to treat sleeping problems, and anxiety. Its use in pregnant women in 46 countries resulted in the "biggest man‐made medical disaster ever": more than 10,000 children were born with severe deformities, as well as thousands of miscarriages.[1] A common condition was that hands or feet were directly attached to the body, with all or part of the arm or leg missing. This condition is known as phocomelia.

Thalidomide was introduced in 1956. The German pharmaceutical company Grünenthal marketed it as a medication for anxiety, trouble sleeping, "tension", and morning sickness.[2][3] When it was introduced, it had not been tested on pregnant women.[4] At the start, people thought it was safe in pregnancy. The first concerns regarding birth defects were noted in 1961, and the drug was removed from the market in Europe that year.[5]

Birth defect crisis

Thalidomide was developed and first released by the German pharmaceutical company Chemie Grünenthal in 1953. The company had started as a soap maker after World War II to address the urgent market need for antibiotics. Chemist Heinrich Mückter, who was a known Nazi war criminal,[6] was appointed to head the discovery programme based on his experience researching and producing an anti-typhus vaccine for Nazi Germany.

It is estimated than more than 10.000 people were affected by their mothers using thalidomide during their pregnancy; about forty percent of the children died at birth or shortly afterwards.[2][7] Those who survived had limb, eye, urinary tract, and heart defects.[5] Its initial entry into the US market was prevented by Frances Kelsey at the FDA.[3] 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.[8]

The total number of victims worldwide is unknown, estimates range from 10,000 to 20,000.[9]

These artificial limbs were made for an affected child in the 1960s by the Department of Health and Social Security's Limb Fitting Centre in Roehampton, London
These artificial limbs were made for an affected child in the 1960s by the Department of Health and Social Security's Limb Fitting Centre in Roehampton, London
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.
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.

Aftermath of scandal

Because there were many reports of malformations in babies, people were made aware of the side effects of the drug. The drug causes moderate to severe malformations. Most often, limbs are malformed, sometimes they are missing. Some side effects affect the formation of bones, the ear, the heart or other internal organs.[10] 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.[11]

Grünenthal criminal trial

In 1968, a large criminal trial began in 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 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 apologised for the first time for producing the drug and remaining silent about the birth defects.[12] Stock was the Chief Executive Officer of Grünenthal GmbH from January 2009 to May 28, 2013; he was also a Member of Executive Board until 28 May 2013. At a ceremony, Stock unveiled a statue of a disabled child to symbolise those harmed by thalidomide and apologised for not trying to reach out to victims for over 50 years. At the time of the apology, there were 5,000 to 6,000 sufferers still alive. Victim advocates called the apology "insulting" and "too little, too late", and criticised the company for not compensating victims. They also criticised the company 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.[13]

Notable cases

Niko von Glasow, German filmmaker
Niko von Glasow, German filmmaker
  • 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.[14]
  • 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".[15]
  • Niko von Glasow produced a documentary called NoBody's Perfect, based on the lives of 12 people affected by the drug, which was released in 2008.[16][17]
  • Mercédes Benegbi, born with phocomelia of both arms, drove the successful campaign for compensation from her government for Canadians who were affected by thalidomide.[18]
  • 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.[19]

Change in drug regulations

The disaster prompted many countries to introduce tougher rules for the testing and licensing of drugs. 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.[1] The FDA subsequently initiated the Drug Efficacy Study Implementation to reclassify drugs already on the market.

References

  1. 1.0 1.1 Bren L (28 February 2001). "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History". FDA Consumer. U.S. Food and Drug Administration. Retrieved 23 December 2009.
  2. 2.0 2.1 Miller, Marylin T. (1991). "Thalidomide Embryopathy: A Model for the Study of Congenital Incomitant Horizontal Strabismus". Transactions of the American Ophthalmological Society. 81: 623–674. PMC 1298636. PMID 1808819.
  3. 3.0 3.1 Loue, Sana; Sajatovic, Martha (2004). Encyclopedia of Women's Health. Springer Science & Business Media. p. 644. ISBN 9780306480737.
  4. Sneader, Walter (2005). Drug discovery: a history (Rev. and updated ed.). Chichester: Wiley. p. 367. ISBN 978-0-471-89979-2.
  5. 5.0 5.1 Cuthbert, Alan (2003). The Oxford Companion to the Body. Oxford University Press. p. 682. doi:10.1093/acref/9780198524038.001.0001. ISBN 9780198524038.
  6. Thomas, Katie (2020-03-23). "The Unseen Survivors of Thalidomide Want to Be Heard". The New York Times. ISSN 0362-4331. Retrieved 2020-03-23.
  7. "Thalidomide Monograph for Professionals". Drugs.com. Retrieved 14 November 2019.
  8. "Thalidomide: The Fifty Year Fight (no longer available)". BBC. 15 May 2014. Retrieved 13 September 2015.
  9. Zimmer C (15 March 2010). "Answers Begin to Emerge on How Thalidomide Caused Defects". New York Times. Retrieved 2010-03-21. As they report in the current issue of Science, a protein known as cereblon latched on tightly to the thalidomide
  10. Franks ME, Macpherson GR, Figg WD (May 2004). "Thalidomide". Lancet. 363 (9423): 1802–11. doi:10.1016/S0140-6736(04)16308-3. PMID 15172781.
  11. Webb JF (November 1963). "Canadian Thalidomide Experience". Canadian Medical Association Journal. 89: 987–92. PMC 1921912. PMID 14076167.
  12. "Speech on the occasion of the inauguration of Thalidomide-Memorial". Grünenthal GmbH Website. Archived from the original on 1 September 2012.
  13. "Thalidomide apology insulting, campaigners say". BBC News. September 1, 2012. Archived from the original on 16 March 2016.
  14. Tamplin, Harley (12 June 2015). "Mid Sussex residents honoured by Queen". Mid Sussex Times. Archived from the original on 2 January 2016. Retrieved 27 December 2015.
  15. "Orpheus lives: A small good thing in Quastoff". The Portland Phoenix. April 19, 2002. Archived from the original on 6 March 2012. Retrieved 6 June 2013.
  16. "NoBody's Perfect (2008): Release Info". IMDB. Retrieved 6 June 2013.
  17. Brussat, Frederic; Brussat, Mary Ann. "Film Review: NoBody's Perfect". Spirituality & Practice. Retrieved 6 June 2013.
  18. "Outstanding eight to receive honorary doctorates at Convocation". Daily News. Windsor, Ontario, Canada: University of Windsor. 9 June 2016. Retrieved 6 March 2017.
  19. Mitchell D, Snyder S (June 2005). "Exploitations of embodiment: Born Freak and the academic bally plank". Disability Studies Quarterly. 25 (3). doi:10.18061/dsq.v25i3.575.

Further reading

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