drug thalidomide, which caused massive birth defects and fetal deaths throughout the world. At the time, the drug was available in more than 20 nations, including Britain and Germany, where it was given to pregnant women to ease morning sickness. Swann dubs the thalidomide case the agency’s “most impactful near-miss.” It was a drama in which the University of Chicago loomed large. Kelsey had trained at the University and later became a faculty member alongside her future husband, F. Ellis Kelsey, PhD, another key player in the thalidomide case. The University also was home to the revered scientist Eugene Geiling, MD, PhD, who mentored Kelsey and brought her to the agency. Geiling was part of a clutch of University of Chicago alumni and faculty who shaped the course of drug regulation. It was at the University of Chicago that Kelsey got her first exposure to the perils of lax drug oversight. As a graduate student in 1937, she played a part in the other landmark drug regulation case of the 20th century — one that triggered an earlier round of regulatory reform and bequeathed to the FDA the very powers that Kelsey would wield to such effect more than two decades later.
“A quaint little course called pharmacology” Growing up on Vancouver Island, Kelsey’s chance meeting with a vacationing teacher ignited an interest in biology. As a high school senior, she took biology classes at nearby Victoria College. There, Kelsey discovered a passion for zoology, and in 1932 she traversed Canada on the transcontinental railroad to Montreal to pursue a degree at McGill. But she found zoology “dull” as an undergraduate, branching into biochemistry and “a quaint little course called pharmacology.” She stayed on to pursue a master’s degree in it, and when Eugene Geiling, fresh from Johns Hopkins, established a pharmacology department at the University of Chicago, she was accepted as his first PhD student in 1937.
Frances Kelsey, now 96, at home in Chevy Chase, Maryland. Photo by Robb Hill
Chicago Connections
After earning her PhD, Kelsey remained at the University during World War II to conduct research into antimalarials — work that sensitized her to the distinct effect of drugs on fetuses. Having married colleague F. Ellis Kelsey in 1943, the couple faced restrictions on spouses serving on the same faculty, so Frances Kelsey — who was more interested in medicine and had already completed most of the basic sci“What Geiling, his students and his colleagues ence courses required — enrolled in the School of Medicine in 1946. While attending medioffered was a combination of basic medicine, cal school, Kelsey bore her two daughters. After up-to-date pharmacological training, specialty earning her MD in 1950, she worked for a knowledge in toxicology, and professional time as an editor for the Journal of the American Medical Association, then located in Chicago. esteem.” — Daniel Carpenter, PhD It was Geiling who recruited Kelsey at the FDA in 1960. Geiling had been hired the previous Kelsey got to Chicago in the midst of a national emergency. year to head its new Pharmacodynamics Branch. The agency had The FDA was scrambling to impound supplies of the S. E. long made a habit of poaching Chicago’s brightest talents. In his Massengill Co.’s Elixir Sulfanilamide, a medicine widely pre- authoritative study of the FDA, “Reputation and Power,” alumnus and Harvard political scientist Daniel Carpenter, PhD ’96, scribed for colds and other infections that was linked to a mounting nationwide death toll. Kelsey was assigned to a writes of a “fluid recruitment” between Geiling’s pharmacology center and the FDA. team assembled by Geiling to identify the toxic agent. The “What Geiling, his students and his colleagues offered,” group identified the culprit as diethylene glycol, used as a solvent in the preparation. It is better known today as the Carpenter wrote, “was a combination of basic medicine, up-todate pharmacological training, specialty knowledge in active ingredient in antifreeze. The scandal exposed the inadequacy of existing regulation. toxicology, and professional esteem.” Just one month in, Kelsey was assigned to review an applicaMassengill had failed to conduct any toxicology testing on a drug that claimed 107 lives, yet the only negligence it had com- tion to sell a sleeping aid already widely prescribed in other mitted under the law was an infraction in billing the product nations for morning sickness, among other conditions. as an “elixir,” a description reserved for alcohol-based solutions. The case spurred legislation in 1938 requiring companies “This couldn’t be the perfect drug” to file an application with the FDA to market a new drug. If Kelsey’s memory of her first reaction to the application from the the agency was not satisfied the drug was safe, it had a 60-day William S. Merrell Co. to market thalidomide, under license window in which to reject the application. from German manufacturer Chemie-Grünenthal, in the United
Medicine on the Midway Summer 2011
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