According to a story in Life Magazine from 1962, Dr. Frances Oldham Kelsey said the pharmaceutical representatives “came to Washington in droves” to drive her back from her stand at the Food and Drug Administration over a drug being pushed by a muscular company and the men who ran it. She claimed the drug was dangerous, and had the data to prove it. She was, in the parlance of the times, “a woman in a man’s job” despite her bedrock-strong credentials as a doctor and researcher, and she stood her ground when those men tried to brush her aside.
Dr. Kelsey was originally from Canada, and after much work done and many degrees achieved, she found herself at the University of Chicago, where she did copious drug research on teratogens that cause birth defects while earning her Ph.D. She joined the University of Chicago faculty, and bent her efforts toward finding a cure for malaria, which led to her focus on drugs that can cross the placental barrier and affect a fetus in utero. She became an MD, wrote for the prestigious AMA Journal, and later took a position teaching pharmacology at the University of South Dakota.
In 1960, Dr. Kelsey was hired by the Food and Drug Administration as one of only eleven federal reviewers of new drug applications in the United States. Before she could hang her coat in the closet, she was handed review responsibilities for a drug called Kevadon, produced by a pharmaceutical company named Richardson-Merrell, which later became a Dow subsidiary, and now goes by the name Sanofi.
Kevadon is more commonly known as thalidomide, a substance that came to be one of the most dangerous and damaging drugs ever unleashed on the human population.
Thalidomide, like other drugs Dr. Kelsey researched, can cross the placental barrier. It was peddled as a soothing agent for pregnant women suffering from morning sickness, and for a time was wildly successful in the marketplace, especially in Europe and Africa … until the babies started being born.
Dr. Kelsey did her work, and said, “No.” Her research had shown deeply disturbing results, and she withheld her approval of thalidomide. Richardson-Merrell ran wild, calling her bosses several times a week demanding her approval – they had warehouses of the stuff ready to be sold to US customers – but she refused to buckle under the intense pressure being applied, and stood her ground.
… and then, the babies were born in Europe, Canada and Africa, babies without arms, without legs, without either. It all traced back to the use of thalidomide by the mothers, and Dr. Frances Oldham Kelsey was hailed a hero for not only declaring the dangers of the drug, but for throwing her body and her will in front of its distribution in the United States, sparing thousands of children from its effects. Thalidomide was discarded as a medicine for pregnant women.
In 1962, President John F. Kennedy awarded her the President’s Award for Distinguished Federal Civilian Service, and she went on to earn a trophy room’s worth of similar honors throughout her long and distinguished career.
There is no accounting for the great good accomplished by Dr. Frances Oldham Kelsey during her years of service at the FDA – she worked there for 45 years and retired at the amazing age of 90 years old – but it can be certainly said that she changed, improved and protected the planet. Simply by thwarting thalidomide, she positively altered the lives of thousands – if not tens of thousands – of children and families in the US, and even more around the globe … and then spent four more decades working to make sure the medicines we take are safe.
Dr. Kelsey died last week at the age of 101 years old. Her impact on this nation, and this planet, is vast, valorous and entirely simple: she had the strength of endurance, faith in the truth of science, and knew the awesome power of “No.”
Word of Dr. Kelsey’s thalidomide stand, and her ultimate vindication, led to a slew of new and vital legislation, including the Kefauver-Harris Drug Amendments which significantly improved and altered not only the FDA, but the manner in which drug companies approach the manner of production and approval in the first place. Among other reforms, her work led to the process of Phase I, II, III and IV drug trials that fundamentally changed the industry forever.
Certain US politicians have been flexing their sorry intellects of late at the expense of women. Whether it be post-debate quips about the hormones of female moderators or truly frightening attempts to invade women’s most basic privacy, the grim fact remains that too many men are timorous and fearful in the face of the fact of woman, too many of them run for public office and win, and the rest of us are left to sweep up after them like the broomkeeper following the last elephant in the parade.
In September of 2010, The New York Times ran an article on Dr. Kelsey titled, “The Public’s Quiet Savior From Harmful Medicines.” The article notes, “Dr. Kelsey might never have reached the FDA in the first place if her first name hadn’t sounded like a man’s.”
And therein lies the point.
Dr. Frances Oldham Kelsey changed the world, and for the better. Those who butter their daily bread with snide misogyny would do well to find a mirror, stare deeply into it, and realize they do not possess the mental or professional acumen to tie Dr. Kelsey’s shoes, much less insult her and the many millions of women who are smarter, sharper and more talented than they can ever hope to be.
Thank you, Doctor.