Thalidomide (alpha-phthalimido-glutarimide) was developed by the German firm Chemie Grunenthal as an anticonvulsant drug. Early trials showed it to be unsuitable for this purpose but indicated that it had sedative properties. Furthermore, it had one remarkable property; overdoses simply caused prolonged sleep, not death (Smithells & Newman, 1992).
In the mid-1950s there were no guidelines for the development, production and marketing of medicinal products, no uniform federal medicines act, and no licensing authority such as the present Federal Institute for Drugs and Medical Devices (BfArM), it was therefore possible to introduce thalidomide on the German market on 1 October 1957 without any governmental review of the documentation (The Thalidomide Tragedy – Grunenthal).
The drug was first marketed in Germany in 1957 under the name Contergan, and in the UK in April 1958 as Distaval. Later, compound preparations, which combined thalidomide with other drugs, were marketed for a wide variety of indications; Asmaval for asthma, Tensival for hypertension, Valgraine for migraine, and so forth. The promotion of these products laid great stress on the safety of thalidomide, based on the remarkable property described above (Smithells & Newman, 1992).
Between 1958 and 1961, the drug thalidomide was used by expectant mothers to control the symptoms of morning sickness. Tragically, this led to many babies being born with often severe physical disabilities (Commons Hansard: Statement - Thalidomide survivors 14 January 2009).
The suffering experienced by people who took thalidomide during the period from 1957 to 1961 is incalculable. The reported number of those harmed varies, but more recent scientific studies indicate that 10,000 people worldwide were affected (The Thalidomide Tragedy – Grunenthal)
The first European Community Pharmaceutical Directive (65/65/EEC) was issued in 1965. Much of the impetus behind Directive 65/65/EEC stemmed from a determination to prevent a recurrence of the thalidomide disaster in the early 1960. This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation.
Since 1965 there has been a plethora of clinical trial-related guidelines and regulations which has culminated in the adoption of the ICH Guideline for Good Clinical Practice (ICH E6) in 1996 and the publication of the Clinical Trials Directive (2001/20/EC) in 2001 and the GCP Directive (2005/28/EC) in 2005 with their subsequent adoption and enforcement into UK law in 2004 (SI 2004/1031) and 2006 (SI 2006/1928), respectively (McCully; GCP Considerations: Informed Consent, 2011).
On the 14 January 2010 Health minister Mike O'Brien expressed the government's "sincere regret and deep sympathy" for victims of the drug thalidomide.
It comes four decades after expectant mothers suffering from morning sickness took the drug between 1958 and 1961. Thousands of their offspring suffered from physical disabilities as a result.
Of them, 466 members of the UK’s Thalidomide Trust remain. The government has announced a £20 million three-year pilot scheme, which will meet survivors' needs "in a more personalised way".
Mr O'Brien told MPs: "The government wishes to express its sincere regret and deep sympathy for the injury and suffering endured by all those affected when expectant mothers took the drug thalidomide between 1958 and 1961.
"We acknowledge both the physical hardship and the emotional difficulties that have faced both the children affected and their families as a result of this drug, and the challenges that many continue to endure, often on a daily basis."
The new funding for 'thalidomiders' will prioritise looking after their health needs for the long-term.
After the drug's negative side-effects were first realised the government launched a major review of the machinery for marketing, testing and regulating drugs, which resulted in the Medicines Act 1968.
Source: Thalidomide UK Website
