It was a new job for Frances Oldham Kelsey, one she took quite seriously. Little did the reserved soft-spoken Dr. Kelsey suspect at the time that one of her first moves on the job would ruffle feathers, change the world of pharmaceuticals, and save the lives of untold thousands of babies around the world.
In 1960, Kelsey’s family relocated from South Dakota to Washington, DC, when her husband took a job at the National Institutes of Health. Kelsey herself landed a job at the Food and Drug Administration (FDA) where she evaluated applications from drug companies looking to win approval to market their products in the US.
The Champion’s Path
Kelsey was Canadian by birth, born on Vancouver Island in British Columbia in 1914. She earned a bachelor’s degree in 1934, a master of science degree in 1935, and a doctorate of pharmacology in 1936 from the University of Chicago, where she taught pharmacology.
In 1943, Dr. Frances Oldham married Dr. Fremont Ellis Kelsey, who was also a professor in the pharmacology department. They eventually had two daughters, Christine and Susan.
Kelsey earned her medical degree from the university in 1950 and, two years later, the family moved to South Dakota, where both the Kelsey doctors got jobs at the University of South Dakota in Vermillion. He was chairman of the physiology and pharmacology department and she taught pharmacology. In 1956, she became a naturalized American citizen.
Shortly after starting her new job with the FDA in Washington, an application for approval from the Richardson-Merrell pharmaceutical company of Cincinnati, Ohio, came across Kelsey’s desk. The company’s biggest seller at the time was Vicks VapoRub. The company wanted to sell a sedative in the US that had become wildly popular across Europe since making its debut in 1957. The drug, thalidomide, was marketed under the brand name Kevadon.
Kevadon, the Wonder Drug
Kevadon quickly relaxed a person enough to fall into a deep sleep without unpleasant druggy feelings and they’d wake refreshed with no traces of a hangover. Extensive animal tests found it impossible to die from a Kevadon overdose; the worst thing that would happen was a long, deep sleep. Pregnant women loved how it made morning sickness disappear.
This wonder drug could be bought in Europe over the counter, no prescription necessary. It was also getting rave reviews from Canada and the Middle East. Doctors in the US and the Merrell drug company were anxious to bring Kevadon to the American market. Merrell had warehouses stockpiled with Kevadon and had distributed 2.5 million sample tablets to more than 1,200 US doctors. The free samples went to roughly 20,000 Americans.
Kelsey v. Richardson-Merrell
Dr. Kelsey was not so enthusiastic, however. She wanted more info from Merrell and she got it. But she asked for more. Merrell tried to go over her head, complaining to FDA officials that she was nothing more than a petty bureaucrat getting in the way. Kelsey wasn’t swayed. She demanded more information. Her extensive background in pharmacology fueled her determination.
While Merrell was balking, alarming news was coming in from Europe in 1961. Kevadon was producing unpleasant side effects that included swelling, numbness, pain, and burning or tingling sensations in the hands and feet. These reports strengthened Kelsey’s suspicions and her demand for more data continued. She feared the drug might affect the developing limbs of a fetus. Merrell said there was no basis for her suspicions.
Six months after news of the unpleasant side effects was published, the news got worse. Much worse.
An epidemic of phocomelia was spreading across Europe. Phocomelia is a rare horrific birth defect that affects a baby’s limbs. Hands and feet don’t fully develop and can look more like flippers than hands and feet. In extreme cases, arms and legs were missing; flipper-like appendages grew directly from the child’s shoulders and hips. Some babies had no ears, others had eye deformities, and some had life-threatening problems with the gastrointestinal tract.
It is believed there were approximately 10,000 children around the world born with thalidomide-induced deformities. These deformities proved to be a rude trade-off for a nausea-free pregnancy.
Kelsey, with the backing of the FDA, refused to approve thalidomide for use in the US. Even so, 17 babies were born with deformities caused by thalidomide. They’d either gotten it abroad or they used samples Merrell gave to their doctors.
Stronger Drug Laws
In 1962, Congress quickly passed a law calling for stronger regulations in the drug approval process. The law called for the FDA to establish its own drug-testing labs to ensure more stringent testing required disclosure of generic drug names and all side effects when an application for approval was submitted and allowed dangerous drugs to be quickly removed from the market. Governments around the world soon followed suit, developing their own drug-testing policies and regulations.
President John F. Kennedy not only signed the bill without hesitation, but he also presented Kelsey with The President’s Award for Distinguished Federal Civilian Service, the highest civilian honor bestowed in the US. During the White House presentation ceremony, Kennedy said, “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.”
Kelsey was put in charge of the FDA’s new drug-testing department and eventually became director of the administration’s Office of Scientific Investigations. She retired from the FDA in 2005 after 45 years of tireless work making drugs safe for the American consumer.
Kelsey was widowed in 1966 and inducted into the National Women’s Hall of Fame in 2000. After her retirement, she returned to Canada to live with her daughter, Christine, in London, Ontario. In 2010, the administrator of the FDA presented her with the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health, an award that is now bestowed every year. One month before Kelsey died at the age of 101, she was presented with the Order of Canada, the nation’s second highest merit award.
Thalidomide is used in the US today as a prescription drug with the highest level of controls and warnings for:
- Multiple myelomas, a malignancy of the blood marrow.
- Erythema nodosum leprosum (ENL), a skin condition associated with Hansen’s disease (leprosy).
- Certain complications of HIV/AIDS.
The drug is almost never prescribed to a woman of reproductive age. When it is, it comes with very stringent and specific warnings about how to have sex safely while taking this drug although absolute abstinence is preferred.
Thalidomide is present in semen so men who take it must agree to abstain from sexual intercourse with a woman of reproductive age or use a condom correctly and faithfully before, during, and after a course of thalidomide treatment. Men under treatment are not allowed to donate semen or sperm.
Dow Chemical bought controlling interest of Richardson-Merrell in 1980 and changed the drug company’s name to Merrell Dow Pharmaceuticals.
- McFadden, Robert D. "Frances Oldham Kelsey, Who Saved U.S. Babies From Thalidomide, Dies at 101." The New York Times. The New York Times Company, 7 Aug. 2015. Web. 15 Sept. 2015.
- "Thalidomide." MedlinePlus. US Department of Health and Human Services, 25 Aug. 2015. US National Library of Medicine. Web. 15 Sept. 2015.