If you are about 50 years old and have fully developed arms and legs, and grew up in North America, you might wish to pay homage to a 96 year old pharmacologist now living in Chevy Chase, Maryland, a suburb of Washington, D.C. She is Frances Kelsey, born in British Columbia on Vancouver Island in 1914.
Dr. Kelsey was almost single-handedly responsible for refusing to authorize thalidomide for the American market due to her concerns about the drug’s safety. She was working at the FDA in 1960 when the drug came up for approval as a medication for the prevention of morning sickness in pregnant women. This was exactly the group that never should have received the drug, as it was unfortunately devastating in its efficiency to cause phocomelia (from the Greek words for seal and limb), a rare malformation in which babies are born with limbs that look like flippers. Apparently the drug intercalated with DNA at just the wrong place where the promoter regions of the genes controlling limb development take place. As the medication was widely available in Europe, some 10,000 babies were affected, including German baritone Thomas Quastoff, featured a few years ago on “60 Minutes” as well as a remarkable guitarist from Nicarauga, Tony Menendez; who plays beautifully with his toes.
In Canada, thalidomide became available in “sample tablet form” in 1959 and was licensed for prescription use in 1961 before being pulled from the market in 1962. Some 125 Canadians were affected, but the situation would have been far worse had it not been for Dr. Kelsey’s dogged persistence in preventing its U.S. approval.
Kelsey obtained her B.Sc. and M.Sc. degrees from McGill in the 1930s and her Ph.D. in pharmacology at the University of Chicago in 1938. There, she worked with Professor E.M.K Geiling on the large number of unusual deaths related to the use of the antibiotic sulfanilamide. Eventually the team discovered that the deaths were due not to sulfanilamide itself, but to diethylene glycol, the solvent used to prepare an “elixir” version prescribed mostly to children. Kelsey thus contributed not only to saving tens of thousands of people from a life of no small challenge, but also helped to save many lives with her timely work on sulfanilamide.
For her actions, Dr. Kelsey was presented with the President’s Award for Distinguished Federal Civilian Service by John F. Kennedy in 1962. This year, the FDA has created a new distinction in her name on the 50th anniversary of her stopping thalidomide from being marketed in the U.S.. The “Kelsey Award” will be given to an FDA employee. Dr. Kelsey retired from the FDA in 2005 at the age of 90 after 45 years of service.
David Harpp
McGill University