Today, I am thankful for those individuals who stand their ground, and, in turn, save lives.
Doing the right thing in the face of opposition is never easy. When someone feels they are the lone voice advocating for a noble cause in a sea of disparate viewpoints, it’s easy to question one’s own assumptions and revisit one’s own position. Yet, these particular instances may often be the defining moments in one’s career, or, more importantly, the difference between life and death. Thomas Paine once wrote in December 1776, in the midst of the British near defeat of the dwindling revolutionary army: “These are the times that try men’s souls. The summer soldier … will, in this crisis, shrink from the service of their country; but he that stands by it now, deserves the love and thanks of man and woman. Tyranny, like hell, is not easily conquered; yet we have this consolation with us, that the harder the conflict, the more glorious the triumph.”
The only problem I have with this statement is that it was not sufficiently broad. In the setting of a looming crisis, the person who stands up to address the adversary need not be a man.
I wanted to share with you the story of Dr. Frances Oldham Kelsey, a name probably unfamiliar to many of you but someone of immense fortitude and resiliency, even in the face of enormous opposition. Born on Vancouver Island in British Columbia in late July 1914, the young Frances, or “Frankie’ as she was called, loved science. She spent many days exploring nature in the surrounding Canadian woods, often choosing to bring home frogs to dissect in her backyard. Not surprisingly, she pursued a scientific degree in pharmacology at McGill University in Montreal, where she received a Master’s Degree in 1935. She applied for a research assistant role at the University of Chicago. There, she worked to evaluate the effects of a new, liquid form of an antibiotic, sulfanilamide, to treat streptococcal infections. She showed in her laboratory that the solvent used to create the liquid formulation, known as diethylene glycol, was killing animals. Eventually, it was determined that this antibiotic was responsible for the death of more than 100 individuals; this finding sparked the passage of the Federal Food, Drug, and Cosmetic Act of 1938, which mandated the need for all new agents to confirm their safety prior to entry to market. Frances’ research on other anti-infective agents was integral in confirming that drugs could cross the placenta, a finding she never forgot.
In due time, Frances would gain both a PhD in pharmacology and a medical degree from the University of Chicago. From there, she accepted a job at the FDA in 1960 as one of the first reviewers of drug applications. She was asked to review the marketing application for a branded drug called KEVADON, a tranquilizer and analgesic used to prevent morning sickness and insomnia in pregnant women. Already approved in 20 countries, she refused to grant her support for its approval in the United States because some animal studies suggested a neurologic side effect. She was also concerned that the Company had performed no studies on pregnant animals. Additionally, at that time, English doctors were reporting some expectant mothers on KEVADON having painful tingling sensations in their extremities. She held firm for nearly 19 months, despite enormous pressure from scientific experts and company representatives who called her ‘nitpicky’ and a ‘petty bureaucrat.’ Meanwhile, as she held her ground, numerous reports began trickling in of babies being born without extremities or seal-like flippers, at an alarming rate of 1 in 4 infants. The drug was quickly pulled from the market in Europe in 1961 and the drug application was withdrawn in the US in March 1962. However, the damage was done, with more than 10,000 children born with deformities. The disaster was largely averted in the United States because this drug, known as thalidomide, was never formally approved.
This incident compelled the US Congress later that year in October 1962 to pass a law, known as the Kefauver-Harris Amendment, that mandated public reporting to the FDA of all adverse events, the requirement for clinical studies to confirm the drug’s effectiveness, and the clear requirement for informed consent of all participants in clinical trials. The little-known Frances became a heroine for her steadfast resolve and adamant refusal to give in, lauded by President Kennedy as the stalwart behind the bill. Meanwhile, the public outcry in Europe was swift. An 11-year court battle would ensure, resulting in a massive payout on this day (July 30) in 1973 to nearly 400 children born with deformities in the UK.
Frances Kelsey went on to become the chief of the FDA investigational drug branch until 1967, and then the head of the new FDA Office of Scientific Investigations. She retired from the FDA in 2004 at the age of 90. Thereafter, she returned home to Canada, where she died at the age of 101. However, despite her death, her legacy lives on as the person who stood her ground, leading to necessary drug reform. To paraphrase the words of Thomas Paine, her “public service deserves the love and thanks of [every] man and woman.”
コメント