There are some people who do their job conscientiously and diligently, and really make a difference to the lives of others – but often get forgotten [or not known outside their own countries] Such a woman was Canadian doctor Frances Oldham Kelsey, who died at the weekend, at the age of 101. The Canadians honoured this great lady on their banknotes.
Fifty years ago, a new sedative was being developed in Germany. Thalidomide first entered the market in 1957 as an over-the-counter remedy, based on the maker’s safety claims. They advertised their product as “completely safe” for everyone, including mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to kill a rat.” By 1960, thalidomide was marketed in 46 countries, with sales nearly matching those of aspirin.
Around this time, an Australian obstetrician discovered that the drug also alleviated morning sickness, and started recommending this off-label use of the drug to his pregnant patients, setting a worldwide trend. Prescribing drugs for off-label purposes, or purposes other than those for which the drug was approved, is still a common practice in many countries today. In many cases, these off-label prescriptions are very effective, such as prescribing depression medication to treat chronic pain.
But in the USA, the Federal Drug Administration Inspector, Frances Kelsey, was unhappy. She felt there was insufficient data showing the safety of prescribing this drug. Displaying ‘respectful insolence’ [her term] towards the drug company, she repeatedly insisted on even more rigorous clinical trials in the USA – and then she refused to approve the drug. Her actions prevented the Americans from the tragedy that befell much of Europe in the 1960s, where over 10,000 babies were born with serious limb defects and other health problems. In this country alone, over 300 people continue to struggle with the dark legacy of thalidomide, taken by their mothers over 50 years ago. Having suffered appalling morning sickness myself, I can understand why these women might have trusted their doctors when offered something to help them feel better. I cannot imagine their distress at the outcome.
In 1962, President John F. Kennedy awarded Dr. Kelsey the Distinguished Civilian Service Medal, the nation’s highest federal civilian service award, saying she had prevented a major tragedy. Through Kelsey's actions, not only did regulation of the pharmaceutical industry change, but she changed people’s attitudes about women taking drugs during pregnancy.
It takes faith and courage for one individual to stand up against a giant – and it is always wonderful when David vanquishes Goliath.
RIP Frances Oldham Kelsey