Thalidomide has been called one of the biggest medical tragedies in modern times. In the late 1950s and early 1960s over 10,000 children were born world wide with shocking deformities caused by the drug. Of those 10,000 cases only 17 were in the United States. That number would have been much higher if not for the vigilance of Frances Oldham Kelsey.
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In 1960 Richardson-Merrell, a Cincinnati based pharmaceutical company, applied to the Food and Drug Administration to sell Thalidomide in the United States.
The drug, touted as a non-addictive and safe sleeping aid, had the benefit of relieving morning sickness for women in their first trimester of pregnancy. Thalidomide had already been on the market for three years in Europe, Canada, Australia and other parts of the world. It was even included in over the counter products in Germany. Richardson-Merrell might have expected a swift and easy approval, but they hit a road block when their application was given to pharmacologist Frances Kelsey. Mrs. Kelsey was new to her job at the FDA, but she had almost 25 years of experience testing drug safety.
Born in Canada, Frances Oldham, (not yet married,) applied to Dr. E.M.K Geiling to study under him at the University of Chicago. The irony of the greeting in his letter of acceptance was not lost on her. It began, “Dear Mr. Oldham.” "To this day, I do not know if my name had been Elizabeth or Mary Jane, whether I would have had that first big step up," Kelsey has said. "And to his dying day, Professor Geiling would never admit one way or the other." While studying under Geiling she was involved in investigating the deaths of 107 people, many of them children, who had taken ‘Elixir Sulfanimide’ to combat bacterial infection.
Later she authored a paper with her husband, Fremont Ellis Kelsey, on the metabolism of drugs and the effects they could have on fetuses. She also reviewed articles for the Journal of American Medical Association and taught Pharmacology at the University of South Dakota. Her experience more than qualified her for a job at the FDA, still, for her first case, her superiors assigned her what they thought would be an easy application, Thalidomide. As she reviewed the application she began to have misgivings about the studies proving the drug’s safety.
She felt they hadn’t been conducted long enough or were inadequate. "The clinical reports were more on the nature of testimonials rather than the results of well-designed, well-executed studies,” she has stated. Indeed much of the data Richardson-Merrell had collected came from distributing over two million Thalidomide tablets to doctors across the country who then gave the drug to their patients. Later, when attempts were made to locate patients who had taken Thalidomide, it was discovered that many of those doctors had not kept complete records. Stalling Thalidomide’s approval, Kelsey asked Richardson-Merrell to provide more thorough data. When the new studies still didn’t satisfy her, the drug company complained to her superiors at the FDA with claims that she was nitpicking.
Kelsey wouldn’t cave to the pressure and soon there was evidence that she wasn’t just nitpicking. In December of 1960 a letter was published in the British Medical Journal from a doctor who reported cases of painful tingling in the arms and legs of his patients who had taken Thalidomide for an extended period of time. In the fall of 1961 doctors in Australia and Germany made the connection between Thalidomide taken to combat morning sickness during pregnancy and the rise of a specific birth defect. The direct translation of Phocomelia is “seal limbs.” It’s a condition where the bones of the arms and legs fail to form properly, producing limbs that can resemble flippers. Up until the late 1950s it had been considered extremely rare, but suddenly thousands of babies were being born with it.
When doctors finally connected Phocomelia to Thalidomide the drug was immediately pulled from the market in most countries and Richardson-Merrell withdrew its application in the US. The Washington Post heralded Kelsey as the “Heroine of the FDA” and credited her with preventing “what could have been an appalling American tragedy, the birth of hundreds or indeed thousands of armless and legless children.” The FDA promoted her to the head of its investigational branch and in the summer of 1962 Kelsey received the highest honor bestowed on a civilian, The President’s Award for Distinguished Civilian Service.