Frances Oldham Kelsey, the FDA reviewer whose opposition to an anti-nausea drug for pregnant women in the 1960's helped spare the U.S from one of the worst public health tragedies, has died on Aug. 7 at the age of 101.
Soon after the sedative Kevadon, more known by its generic name thalidomide was sold in Europe to alleviate morning sickness and nausea in pregnant women, thousands of babies died in the womb.
At least 10,000 babies in 46 countries were also born with severe deformities with some having arms and legs resembling those of a seal's flippers. Some were missing limbs and many of the babies had organs and tissues that did not develop properly.
The tragedy was attributed to thalidomide, which was marketed as a miracle cure for women suffering from the discomforts of pregnancy during the four years that it was commercially sold in a number of countries from Germany to Australia.
The tragedy affected the countries where thalidomide was widely used and can be bought over the counter but Americans were saved from the horrors brought about by this drug all because of Kelsey.
Kelsey was a former family doctor who was working as a medical officer at the Food and Drug Administration when the application to market Thalidomide in the U.S. was sought in September 1960.
Although the drug is already widely used in Europe, some data on the safety of the drug troubled Kelsey, whose job was to review requests to license new drugs so she asked the drug's manufacturer, the William S. Merrell Company of Cincinnati to provide more information.
Despite being called a petty bureaucrat, Kelsey persisted asking for more data on the drug and by 1961, evidence emerged that the drug was responsible for babies in Canada, Britain, the Middle East and Europe to be born with severe defects.
It made Kelsey a 20th century American heroine for sparing the U.S. from widespread birth defects and helping pave way to the rise of modern laws that until today regulate pharmaceuticals. Kelsey continued to work with the FDA until she retired at the age of 90.
Kelsey, who was born in Shawnigan Lake, British Columbia, passed away less than 24 hours after the received the Order of Canada for the part she played in stopping thalidomide from further causing damage. Kelsey died in London, Ontario.
