Kelsey%202 - FRANCES OLDHAM KELSEY FDA MEDICAL REVIEWER...

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F RANCES O LDHAM K ELSEY : FDA M EDICAL R EVIEWER L EAVES H ER M ARK ON H ISTORY See Dr. Frances Kelsey's Portrait By Linda Bren It was early 1942 and war was raging in the jungles of the Pacific. In addition to fighting the Japanese, Allied troops found themselves  under attack by malaria-carrying mosquitoes. And since enemy soldiers had already captured several plantations of cinchona trees, the  source of the anti-malarial quinine, the search was on for an effective quinine substitute to combat the disease. A possible treatment--in the  form of a dark, inky substance--arrived for testing in the pharmacology department at the University of Chicago. Pharmacologist Frances  Oldham Kelsey, like many other university researchers throughout the country, had enlisted in the search for synthetic cures for malaria. As it turned out, the inky substance had been sent by a veterinarian in Texas. "He said that he had just tried it on his secretary without ill  effects," says Kelsey, "and he planned next to try it on cattle. It showed the relative value placed on women and cattle in Texas at that  time," Kelsey says with amusement. The good humor and equanimity Kelsey displays at this slight are symptomatic of the way she  approached most of life's adversities. The war ended without finding a good substitute for quinine. But Kelsey did learn something valuable from the experience. She learned  that rabbits metabolized quinine rapidly, but pregnant rabbits had less ability to break down the drug, and embryonic rabbits could not  break it down at all. She also learned that drugs could pass through the placental barrier between mother and unborn child. These insights  would serve Kelsey well some 15 years later when in early 1960, as a new Food and Drug Administration employee, she was asked to  evaluate a drug most thought was harmless. That drug was thalidomide. Although pressured by the manufacturer to quickly approve a drug already in widespread  use throughout the rest of the world, Kelsey held her ground. When she repeatedly asked for  more data and effectively forestalled the approval of thalidomide, Kelsey did more than keep a  dangerous drug off the market. She set into motion a series of events that would forever  change the way drugs are tested, evaluated, and introduced in America. In recognition of Kelsey's vigilance, President John F. Kennedy, on Aug. 17, 1962,  presented her with the highest honor that can be bestowed upon a U.S. civilian: the medal for  Distinguished Federal Civilian Service. And nearly 40 years later, Kelsey was once again  honored. On Oct. 7, 2000, she was inducted into the National Women's Hall of Fame in 
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