The Obituary of a Canadian Doctor and a Lesson for Those Who Demonize Federal Agencies
Last week Dr. Frances Oldham Kelsey died at the age of 101 at the home of her daughter in London, Ontario. She may not have had a famous name, but she played a very important role in largely averting a true human tragedy in the United States. I feel strongly her story holds an important lesson for the many critics of federal regulatory agencies.
Dr. Kelsey was hired by the Food and Drug Administration in Washington DC in 1960 to review applications for new drugs. One of her earliest assignments was a drug the William S. Merrell company intended to market under the name Kevadon. It had been approved in more than 20 countries as a cure for insomnia and morning sickness in pregnant women since its development in Germany in the late 1950s. Even so, Kelsey was immediately alarmed by incomplete safety studies, as well as side effect warnings present on British and German labels but absent from the US application. This substance is best known today as thalidomide.
Kelsey rejected the application numerous times and requested more data. Merrell representatives, who had large potential profits riding on the application, began to complain to her bosses and show up at her office, with respected clinical investigators in tow, to protest the hold-up.
Kelsey’s FDA superiors backed her as she conducted her research. By February 1961, she had found more evidence to support her suspicions, including a letter in the British Medical Journal by an English doctor who reported that his patients on thalidomide experienced a painful “tingling” in the arms and feet.
Another reason for her concern was that the company had apparently done no studies on pregnant animals. At the time, a prevailing view among doctors held that the placental barrier protected the fetus from what Kelsey once called “the indiscretions of the mother,” such as abuse of alcohol, tobacco or illegal drugs. Earlier in her career, however, she had investigated the ways in which drugs did in fact pass through the placenta from mother to baby.
While Kelsey stood her ground on Kevadon, infant deaths and deformities were occurring at an alarming rate in places where thalidomide had been sold. The development of seal-like flippers, a condition known as phocomelia that previously affected an estimated 1 in 4 million infants began to crop up by the dozens in many countries.
The drug’s German manufacturer began removing the drug from the European market in 1961. Unfortunately Merrell did not withdraw its US application until 1962. In the interim it had distributed samples to 1200 US doctors on an experimental basis. The result was at least 17 “thalidomide babies” born in the United States. This was a tragedy, but the actions of Kelsey and her FDA colleagues greatly mitigated what could have been a massive public health nightmare that might well still be impacting the country even today.
In recognition of her service to her adopted home country, Kelsey was recognized with the President’s Award for Distinguished Federal Civilian Service in 1962. Kelsey was only the second woman ever to receive this award, and it was presented to her by President John F. Kennedy.
In our country today, there is a great deal of polemical fire directed toward federal regulatory agencies. They are frequently seen as enemies of innovation and progress, and existing largely to oppose business interests. This GOP primary season seems likely to feature yet another contest to find out who can promise to eliminate the most federal agencies altogether. In the memory of Dr. Kelsey and in further recognition of her service, let us never forget that brave, tenacious and knowledgable regulators can have the power to prevent catastrophe.
