>> The sedative was Kevadon, and the application to market it in America reached the new medical officer at the Food and Drug Administration in September 1960. The drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed routine, ready for the rubber stamp.
But some data on the drug’s safety troubled Dr. Frances Oldham Kelsey, a former family doctor and teacher in South Dakota who had just taken the F.D.A. job in Washington, reviewing requests to license new drugs. She asked the manufacturer, the William S. Merrell Company of Cincinnati, for more information.
Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, Thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.
... She was hailed by citizens’ groups and awarded honorary degrees. Congress bestowed on her a medal for service to humanity and passed legislation requiring drug makers to prove that new products were safe and effective before marketing them. President John F. Kennedy signed the landmark law that she had inspired, and presented her with the nation’s highest federal civilian service award.
“Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States,” Kennedy said at a White House ceremony.
.... In 1962, the F.D.A. set up a branch to test and regulate new drugs, and Dr. Kelsey was put in charge of it. Later, she became director of the agency’s Office of Scientific Investigations, and in a distinguished 45-year career with the F.D.A. helped rewrite the nation’s medical-testing regulations, strengthening protections for people and against medical conflicts of interest. The rules have been adopted worldwide. << ---- NYT
I've brought up Frances Kelsey several times here, usually for the benefit of the anarchists ("libertarians") crying the blues about the FDA impinging on citizens' right to get sick. Thalidomide caused phocomelia (malformation of the limbs) in tens of thousands of newborns around the world after it went on the market in 1957, less than half of whom even survived to cope with their deformity.But some data on the drug’s safety troubled Dr. Frances Oldham Kelsey, a former family doctor and teacher in South Dakota who had just taken the F.D.A. job in Washington, reviewing requests to license new drugs. She asked the manufacturer, the William S. Merrell Company of Cincinnati, for more information.
Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, Thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.
... She was hailed by citizens’ groups and awarded honorary degrees. Congress bestowed on her a medal for service to humanity and passed legislation requiring drug makers to prove that new products were safe and effective before marketing them. President John F. Kennedy signed the landmark law that she had inspired, and presented her with the nation’s highest federal civilian service award.
“Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States,” Kennedy said at a White House ceremony.
.... In 1962, the F.D.A. set up a branch to test and regulate new drugs, and Dr. Kelsey was put in charge of it. Later, she became director of the agency’s Office of Scientific Investigations, and in a distinguished 45-year career with the F.D.A. helped rewrite the nation’s medical-testing regulations, strengthening protections for people and against medical conflicts of interest. The rules have been adopted worldwide. << ---- NYT
That never happened in the US, because this woman, via the FDA, singlehandedly put up a stop sign. That act literally saved an untold number of lives, probably in the thousands. She's a heroine.
Frances Kelsey (1914-2015) passed away today in London Ontario (she's Canadian) at the age of a hundred and one.
