Abstract
It is close to 60 years since thalidomide was created by the German company, Chemie-Grünenthal, and launched as “Contergan.” This was soon to be followed in England by the launch of “Distaval.” Of all the drugs developed in the intervening years, thalidomide has undoubtedly had the greatest influence on shaping the Pharmaceutical Industry as we know it today.
Strong marketing pressure in an Industry hungry for new medicines brought an inadequately tested drug to the market, targeted outsourcing quickly expanded the client base and finally market forces prevented timely withdrawal, even when evidence was emerging of disastrous side-effects. The full story of thalidomide was told by the Sunday Times in “Suffer The Children” (Kingsley et al., Suffer the children: the story of thalidomide, the insight team of the Sunday times (UK), 1979).
Many preventative measures have been taken in the intervening years in light of the lessons learned with thalidomide. However, many of the pressures that led to the thalidomide disaster exist today with record high management and shareholder pressures to achieve success, parallel worldwide marketing, increased numbers of targeted outsourcing by small companies forming alliances with “Big Pharma” and, according to some commentators, a breakdown in the system of checks and balances that have existed in the regulatory authorities in the intervening years.
Using thalidomide as a point of reference, this chapter looks at drug development and testing, regulatory authorities and guidelines, outsourcing and in-licensing, pharmacovigilance, and factors that influence withdrawal of a drug from the market.
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Banerjee U, Geh SL (1976) A comparative study of several methods for recording spontaneous motor activity in mice under drug effects. Indian J Physiol Pharmacol 20:53–58
Burley DM, Dennison TC, Harrison W (1959) Clinical experience with a new sedative drug. Practitioner 183:57–61
Kingsley P et al (1979) Suffer the children: the story of thalidomide, the insight team of the Sunday times (UK). Futura Publications Ltd, London
Sjostrom H (1972) Thalidomide and the power of the drug companies. Penguin, Harmondsworth
Collins FS et al (1998) Guidelines for evaluation of reproductive and developmental toxicity of food additives in females. Int J Toxicol 17:299–325
Wilson JG (1973) Environment and birth defects (environmental science series). Academic, London
Agranat I, Caner H, Caldwell J (2002) Putting chirality to work: the strategy of chiral switches. Nat Rev Drug Discov 1:753–768
Schardein J (1976) Drugs as teratogens. CRC, Cleveland
Briggs G, Freeman R, Yaffe S (2011) Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. Williams and Wilkins, Lipencott
Schumacher H et al (1972) The teratogenic activity of a thalidomide analogue, EM12 in rabbits, rats and monkeys. Teratology 5:233–240
Collins T (2006) History of evolution of reproductive and developmental toxicology guidelines. Curr Pharm Des 12:1449–1465
The History of the International Conference of Harmonisation Guidelines (1990) http://www.ich.org/about/history.html. Accessed 19 Aug 2011
Norbert C (2010) Outsourcing in drug development. Drug Development, 48–49
European Paediatric Regulation (2006): Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 Dec 2006, on Medicinal Products for Paediatric Use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004. Official Journal L378, 27/12/2006, P001-0019
Stanford University Medical Center (2008) 14 Drugs identified as most urgently needing study for off-label use. ScienceDaily. http://www.sciencedaily.com/releases/2008/11/081124130939.htm. Accessed 17 Aug 2011
Horen B, Montastru JL, Lapeyre-Mestre M (2002) Adverse drug reactions and off-label use in paediatric outpatients. Br J Clin Pharmacol 54:665–670
Clark R et al (2008) Developmental toxicity of artesunate in the rat: comparison to other artemisinins, comparison of embryotoxicity and kinetics by oral and intravenous routes, and relationship to maternal reticulocyte count. Birth Defects Res B Dev Reprod Toxicol 83:397–406
Clark R (2009) Embryotoxicity of the artemisinin antimalarials and potential consequences for Use in women in the first trimester. Reprod Toxicol 28:285–296
World Health Organisation (2006) Assessment of the safety of artemisinin compounds in pregnancy. Report of two informal consultations convened by the special program for research and training in tropical diseases and the global malaria program of the World Health Organisation. WHO/CDS/MAL/20903.1094. WHO/GMP/TDR/Artemesinin/07.1.ISBN 978 92 4 159 611 4
Reuben B (2007) Contributory factors in recent drug disasters. http://Eyeforpharma.com. Accessed 18 Aug 2011
Drug Firms Hit by Safety Scares (2004) BBC News. http://news.bbc.co.uk/1/hi/business/4025001.stm. Accessed 18 Aug 2011
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Ridings, J.E. (2013). The Thalidomide Disaster, Lessons from the Past. In: Barrow, P. (eds) Teratogenicity Testing. Methods in Molecular Biology, vol 947. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-62703-131-8_36
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DOI: https://doi.org/10.1007/978-1-62703-131-8_36
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