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Thalidomide - The Facts - RMS Consultancy

Thalidomide – The Facts

Thalidomide is a non-barbiturate hypnotic drug, in essence, a sleeping aid.

It is believed to have first been synthesised in 1944 and tested on prisoners of war in Auschwitz.

The preparation tested in the concentration camps is considered to be the forerunner for the drug that was to become known the world over as Thalidomide.

Thalidomide was developed in 1954 by Chemie Grünenthal, a small pharmaceutical company located in the North Rhine-Westfalia industrial town of Stolberg near Aachen in Germany.

By 1957, the drug was being mass-produced and actively marketed in Germany, and many other countries, throughout the world to treat surprisingly minor ailments such as colds, coughs and flu.

By the time the drug was withdrawn in Germany on 27th November 1961, Thalidomide was marketed under fifty-one names, in eleven European, seven African, seventeen Asian and eleven countries throughout the Americas.

The drug was first marketed in Britain in April 1958, by Distillers Company (Biochemicals) Limited under the names Thalidomide, Distaval, Tensival, Asmaval, Valgis and Valgraine.

Thalidomide was promoted widely as a ‘Wonder Drug’, and just prior to its withdrawal in the UK, the Distillers marketing literature was stressing how safe the drug was … “without any risk to mother or child.”

It is now commonly known that if Thalidomide was taken throughout the sensitive period (counting from the 1st day of conception) between day 35 and day 49, the consequences were generally severe defects of ears, arms and legs and of internal malformations, which often led to early death.

Some estimate that there were 12,000 Thalidomide impaired babies born worldwide and approximately 40 per cent of that number died before their first birthday.  Some estimates put the total number of babies affected as high as 50,000.

In 1990, Yorkshire Television, through its First Tuesday documentary series, found twenty-one new cases of Thalidomide in Brazil alone, ranging in age from four to twenty-three, in such diverse locations as Rio de Janeiro and the heart of the Amazon Jungle.

Despite never having been available in America during the 1950’s and 60’s (as result of the vigilance of US Food and Drug Administration Reviewer – Dr. Frances Kelsey) in July 1998, the Federal Drugs Administration approved the marketing of THALOMID® for the acute treatment of “the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences.”

In Canada, the Canadian Thalidomide Victims Association (TVAC) was consulted during the process of licensing.  TVAC was given unprecedented access to all materials associated with the return of Thalidomide. This resulted in the development of the S.T.E.P.S.™ programme (‘System for Thalidomide Education and Prescribing Safety’) creating a comprehensive information package for both prescribers and patients.

In 2008 the Celgene Corporations was granted a licence to distribute Thalidomide for Multiple Myeloma.  As the current major manufacturer of Thalidomide, Celgene has worked on THALOMID® (thalidomide) to develop new families of pharmaceuticals called Immunomondulatory Drugs, or IMiDs™, and Selective Cytokine Inhibitory Drugs, or SelCIDs™.  It has also vigorously pursued the development of new applications and new drugs derived from THALOMID® (thalidomide).

These developments continue on a global basis.

More information on Thalidomide and its manufacture can be found in Four Fingers and Thirteen Toes by Rosaleen Moriarty-Simmonds (ISBN 9781438942995).


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