The Facts About Thalidomide
Thalidomide is a non-barbiturate hypnotic drug, and was first discovered in Germany in 1954. By 1957, it was 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By the time the drug was withdrawn in Germany on 27th November 1961, Thalidomide, was marketed under fifty-one names, in eleven European, seven African, seventeen Asian and eleven countries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, Distillers, were actively marketing Thalidomide even with literature stressing how safe the drug was, "without any risk to mother or child."
If Thalidomide was taken throughout the sensitive period (counting from 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.
There were 12,000 Thalidomide impaired babies born world wide, and about another 40 per cent of that number died before their first birthday. Some estimates put the figure of babies affected, as high as 50,000.
In 1993, 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.
On 16th July 1998, the Federal Drugs Administration in the United States 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.
The Thalidomide Victims association of Canada (TVAC) was consulted in the process of licensing, and was given unprecedented access to all materials associated with the return of Thalidomide.
Celgene is also working with THALOMID® (thalidomide) to develop new families of pharmaceuticals called Immunomondulatory Drugs, or IMiDs™, and Selective Cytokine Inhibitory Drugs, or SelCIDs™; including vigorously pursuing the development of new applications and new drugs derived from THALOMID® (thalidomide).
Celgene and TVAC developed S.T.E.P.S.™ ‘System for Thalidomide Education and Prescribing Safety’ - a comprehensive information package for both prescribers and patients.
In 2008 Celgene was granted a licence to distribute Thalidomide for Multiple Myeloma.
More information on the current status of Thalidomide and its manufacturers can be found in Four Fingers and Thirteen Toes by Rosaleen Moriarty-Simmonds (ISBN 9781438942995).