When Doctor Frances Oldham Kelsey took the FDA job, the first drug she reviewed the license request for was Kevadon.
Or, better known under the generic title, thalidomide. The battle that ensued between Frances Kelsey and the drug manufacturer, William S. Merrell turned Mrs. Kelsey in an American heroine.
Her audacity and relentless work to uncover the hidden effects of thalidomide started in 1960. At that point Merrell’s drug was already sold in Europe, the Middle East, Canada and Britain as a preventive for morning sickness with pregnant women.
Thalidomide’s safety record were unsettling for Frances Kelsey, who had professed as a family doctor before. To clear the record she asked Merrell for additional information. What the company sent back was not sufficient to put Mrs. Kelsey’s mind at peace.
So further requests ensued, until Merrell called the FDA employee a ‘petty bureaucrat’. By the end of 1961, however, the truth surfaced. Thalidomide was proven to cause deformities in newborns, such as limbs resembling flippers and others.
Ever since, Doctor Frances Kelsey was celebrated as the American heroine who saved the lives of millions of U.S. newborns, who would have otherwise been born with untold deformities. Not only that, but her work is the stepping stone of the pharmaceutical regulations.
The U.S. Congress awarded Mrs. Kelsey with a medal for service to humanity. Further, strict legislation ensuring that drug manufacturers provide data that proves the safety of the drugs before the marketing efforts ensue was passed. The legislation was signed into force by U.S. President John F. Kennedy.
An excerpt of the President’s speech at the White House reads:
“Her exceptional judgement in evaluation a new drug for safety for human use had prevented a major tragedy of birth deformities in the United States”.
Last month only, Frances Kelsey was appointed to the highest honor in Canada, the Order of Canada. One day before her death the honor was presented to her in London, in Christine Kelsey’s home.
Many successes spinned in Doctor Frances Kelsey’s 45-year long career in the FDA. The crown jewel, her life work on medical-testing regulations is now mirrored in legislations worldwide.
American heroin Doctor Frances Kelsey died at 101 years old, on Friday, August 7th 2015.
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