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The company which invented thalidomide has "insulted" those affected by the drug by issuing an "insincere" apology, campaigners have said. The drug, sold in the 1950s as a cure for morning sickness, was linked to birth defects and withdrawn in 1961. German-based Gruenenthal has issued its first apology in 50 years, but said the drug's possible side-effects "could not be detected" before it was marketed.
But the UK's Thalidomide Trust said any apology should also admit wrongdoing. Nick Dobrik, a member of the trust's national advisory council, said it "should be an unreserved apology, not a conditional apology".
"We feel that a sincere and genuine apology is one which actually admits wrongdoing. The company has not done that and has really insulted the thalidomiders."
Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based on the maker’s safety claims. They advertised their product as “completely safe” for everyone, including mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to kill a rat.” By 1960, thalidomide was marketed in 46 countries, with sales nearly matching those of aspirin.
At the time, clinical trials did not require FDA approval, nor were they subject to oversight. The “clinical trials” of thalidomide involved distributing more than two and a half million tablets of thalidomide to approximately 20,000 patients across the nation—approximately 3,760 women of childbearing age, at least 207 of whom were pregnant. More than one thousand physicians participated in these trials, but few tracked their patients after dispensing the drug.
Several countries never approved the drug, or restricted its use. Ingeborg Eichler, a member of the Austrian pharmaceutical admission conference enforced Thalidomide (tradename Softenon) being sold under the rules of Prescription medication and as a result relatively few affected children were born in Austria and Switzerland. In the United States, pharmacologist Frances Oldham Kelsey M.D. withstood pressure from the Richardson-Merrell company and refused Food and Drug Administration (FDA) approval to market thalidomide, saying further studies were needed. This reduced the impact of thalidomide in United States patients. Although thalidomide was never approved for sale in the United States, millions of tablets had been distributed to physicians during a clinical testing program. It was impossible to know how many pregnant women had been given the drug to help alleviate morning sickness or as a sedative./ex]