Dr. Kelsey, who was born on Vancouver Island, died early on Friday with her daughter, Christine Kelsey, by her side. The two were living in London, Ontario.
She is remembered in the United States and around the world as the heroine who, in the words of President John F. Kennedy, “prevented a major tragedy,” by refusing approval of the drug, thalidomide for use in pregnant women in the U.S.
Dr. Kelsey joined the U.S. Food and Drug Administration in Washington in 1960. She was presented with an application from the drug manufacturer Merrill to market thalidomide in the U.S. The drug was already being marketed as a treatment for nausea in pregnant women in countries from Canada, the UK, and Germany to Australia.
But much to the consternation of the drug company, Kelsey was not convinced of the drug’s safety record and demanded more information from Merrill. According to the BBC, the drug company, in turn, complained about her attitude, and the ongoing war-of-words kept the drug from being approved for what turned out to be a critical 19-month period.
One year later, while Kelsey was still refusing to give thalidomide approval, reports started pouring in from Europe, describing the tens of thousands of “thalidomide babies” born with severe deformities. In looking back on that time, the birth of “thalidomide babies” was a horror story of international scope.
Thousands of babies died in the womb, and about 10,000 children were born in 46 countries with the severest of deformities. Some children were born without arms and legs while others had limbs that resembled flippers. In some cases, eyes, ears and other organs or tissues failed to develop normally.
Merrill withdrew its application to market the drug, and eventually, Kelsey was given praise for her fortitude in standing firm against the drug company. Besides the praise and medals for her service to the country, a new drug safety department was established within the FDA in 1962, and Dr. Kelsey was put in charge.
Dr. Kelsey was the one responsible for rewriting medical testing regulations for the FDA, and those regulations are now used around the world. In 2000, Dr. Kelsey was inducted into the National Women’s Hall of Fame, joining other great women who have helped to shape our world, such as Helen Keller and Eleanor Roosevelt. Dr. Kelsey retired from the FDA in 2005.
Nearly 60 years ago, thalidomide was launched by the German company, Chemie-Grünenthal, and marketed as “Contergan.” It was soon marketed in England under the name “Distaval.” In the fall of 1960, a Cincinnati, Ohio-based drug company, William S. Merrell, licensed the drug and began distributing thalidomide under the trade name “Kevadon” to 1,200 U.S. doctors, figuring the drug would meet quick approval from the FDA.
Because of the decision to distribute thalidomide without approval by the government agency, around 2.5 million tablets were given to about 20,000 patients, including several hundred pregnant women. By the time Merrill had withdrawn its application in March of 1962, 17 babies had been born in the U.S. with thalidomide-related defects, according to the FDA.
On Thursday, one day before Dr. Kelsey’s death, Ontario Lt.-Gov. Elizabeth Dowdeswell traveled to London, Ontario to present Kelsey with the Order of Canada, which was bestowed on her in the spring. Dowdeswell said that Dr. Kelsey had only returned to Canada in November last year, and that may have played a part in her not being recognized sooner in Canada.
Dowdeswell said she was privileged to present Kelsey with the medal, according to CBC News. “She immediately woke up and she was clearly aware that I was there. She didn’t speak, but she tried to speak and she got animated immediately. It was just such an honor. This was a person who dedicated her life to public service and for me to be able to say words of thanks, words of gratitude, it was so important to her family,” said Dowdeswell.
