US FDA honours woman who rejected thalidomide and saved millions of American children's from thalidomide.
Dr Frances Oldham Kelsey a former US FDA employee a medical officer and doctorate in pharmacology from University of Chicago and was honoured by FDA on 13 sep 2010.
As in 1960s as she played a vital role in ensuring that the tragedy drug thalidomide do not get marketing approval in United States of America.
Dr Frances Oldham Kelsey, Now 96 year old lady and a retired US FDA employee refused to approve Kevadon a brand that contained thalidomide manufactured by pharmaceutical company William S Merrell was restricted to distribute thalidomide in the US after she learnt that the drug is linked with birth defects in Europe.
At that time thalidomide was prescribed to pregnant women for to treat morning sickness and to get good sleep. and, it was not known that thalidomide taken by a mother could affect the foetus.
In the late 1950s and early 60s in Europe thousands of babies were born without limbs, and it was reported later that the birth defects in children’s were developed where ever the mothers of these children’s were prescribed drug thalidomide in pregnancy.
But in US at that time about 40 children’s were born with birth defect as the drug was already distributed through physicians to about 20,000 patients as a part of trial without need for an approval (it was allowed at that time) most of the women took the drug and were not informed about the trial.
Dr Frances Oldham Kelsey was under tremendous pressure from pharma industry for approving the drug , as the drug was already approved in other 20 countries in Europe.
Her decision at that time saved millions of American children’s from the drug thalidomide and the story led the US Congress to set rigid rules for testing and marketing any new drugs in United States of America, which also included a requirement from pharmaceutical companies conduct trials wher the patients participating in clinical trial are well informed and a well informed consent is required by patients participating in clinical trial.
Dr Frances Oldham Kelsey was awarded highest civilian award by then President John F. Kennedy and became the second woman to receive it.
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