Frances Oldham Kelsey, a Canadian-born doctor and F.D.A. officer, argued tirelessly to keep the harmful drug out of the U.S.
ONTARIO, Canada – Frances Oldham Kelsey, the doctor and pharmacologist who refused to allow thalidomide into America, died on Friday.
Kelsey died at her daughter’s home in London, Ontario, where she had been inducted into the Order of Canada less than 24 hours before.
Thalidomide – then marketed as Kevadon – was popular in Europe, Canada and the Middle East, where pregnant women were taking it for morning sickness. It began to be noted that the babies of women who took the drug often had major defects, especially underdeveloped limbs.
Kelsey was born in British Columbia in 1914. She became qualified in both medicine and pharmacology at a time when very few women studied either. In 1960, she was put in charge of licensing new drugs for the U.S. Food and Drug Administration.
When the William S. Merrell Company applied for a license for Kevadon, Kelsey insisted that they prove its safety. The company failed to do so, but tried to pressure Kelsey into letting the drug through.
Months later, a link was established between thalidomide and increasing deformities among European newborns. Babies do not have the enzymes to cope with the drug, which can enter their systems via the placenta. The number of ‘thalidomide babies’ may be in the tens of thousands for Europe alone.
Kelsey became a national heroine. Following the Kevadon case, tougher drugs regulations were adopted in America and abroad. She was given the President’s Award for Distinguished Federal Civilian Service by John F. Kennedy, and was later inducted into the National Women’s Hall of Fame. An F.D.A. award for Drug Safety Excellence, and a school in British Columbia, are both named after her.
By Robbie Carney