Working for the FDA -Frances Kathleen Oldham Kelsey refused to authorize thalidomide for market!
This evening I saw that among the recent deaths listed at Wikipedia I saw the name Frances Kathleen Oldham Kelsey. I didn’t recognize the name, so I decided to find out about Ms. Kelsey, Frankly I should have known the name, because Ms. Kelsey saved many Americans from major tragedies, when she refused to authorize thalidomide for market use because she had concerns about the drug’s safety!
From Wikipedia…..Frances Kathleen Oldham Kelsey, CM (July 24, 1914 – August 7, 2015) was a Canadian pharmacologist and physician. She was most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug’s safety.[1] Her concerns proved to be justified when it was proven that thalidomide caused serious birth defects. Kelsey’s career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals…..
…..In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she “was one of only seven full-time and four young part-time physicians reviewing drugs”[3] for the FDA. One of her first assignments at the FDA was to review an application by Richardson Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness.
Even though it had already been approved in Canada and more than 20 European and African countries,[7] she withheld approval for the drug and requested further studies.[2] Despite pressure from thalidomide’s manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.[3]
Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects in infants.[6] She was hailed on the front page of The Washington Post as a heroine[8] for averting a similar tragedy in the U.S.[9] Morton Mintz, author of The Washington Post article, said “[Kelsey] prevented… the birth of hundreds or indeed thousands of armless and legless children.”[8] Kelsey insisted that her assistants, Oyam Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well. The narrative of Dr. Kelsey’s persistence, however, was used to help pass rigorous drug approval regulation in 1962. Read More
Frances Kathleen Oldham Kelsey died in London, Ontario on August 7, 2015 at the age of 101.Soon after her passing, Ontario’s Lieutenant-Governor, Elizabeth Dowdeswell, visited her home to present her with the insignia of Member of the Order of Canada for her role against thalidomide! The US says – Thank You Frances Kathleen Oldham Kelsey!
