Frances Oldham Kelsey: Nevertheless, She Persisted
March 17, 2017
Eight years ago, when I was touring New Zealand, I walked into a travel agency and was greeted politely by the middle-aged receptionist. With her short, flipper-like arms, the woman pointed me towards a desk containing the touring pamphlets I had requested.
The receptionist, as my Kiwi friend told me later, was “a thalidomide baby.”
Most people of a certain age remember the notorious sedative thalidomide, which in the late 1950s and early 1960s was given for morning sickness to thousands of pregnant women in Europe, Britain, Canada, the Middle East, and elsewhere.
The drug was never approved for use in the United States. And thus, the tragedy of thalidomide babies—born with severely deformed limbs and other major birth defects—was averted in America. For this, we can thank one person, and one person only: a young medical officer at the U.S. Food and Drug Administration (FDA) by the name of Frances Oldham Kelsey.
Dr. Kelsey died in 2015 at the age of 101. As we celebrate Women’s History Month, she is one of my favorite heroines.
Dr. Kelsey was new to the FDA post—responsible for reviewing requests to license new drugs—in September 1960 when the application to market thalidomide landed on her desk. Since the drug had “already been sold to pregnant women in Europe,” recounted her obituary in The New York Times, “the application seemed routine, ready for the rubber stamp.”
The former family doctor and teacher in South Dakota, however, saw some data on the drug’s safety that troubled her. She requested more information from the drug’s manufacturer, the William S. Merrell Company of Cincinnati.
The company “stood to make millions and was anxious to get moving,” according to The Times. “It had tons of [the drug] in warehouses, ready for marketing, and 1,000 American doctors had already been given samples for ‘investigational’ research. The company supplied more data but also mounted a campaign to pressure Dr. Kelsey. Letters, calls, and visits from Merrell executives ensued. She was called a fussy, stubborn, unreasonable bureaucrat.”
But Dr. Kelsey would not be hurried. She persisted.
The doctor did her own research and discovered the drug hadn’t even been tested on pregnant animals. She told Merrell the drug might affect the limbs of fetuses. The company called her evidence “inconclusive.”
Six months later, “European reports indicated the drug was linked to an epidemic of phocomelia, a rare but monstrous malformation of limbs in newborns.” Merrell withdrew its application.
No one knows, said The Times, “how many babies were affected by thalidomide, but estimates range into the tens of thousands in Europe alone. Many were born without arms or legs, some with no limbs or with withered appendages protruding directly from the trunk. Some had no external ears or deformities of the eyes, the esophagus, or intestinal tracts.”
In response to the public uproar that followed, in 1962 Congress passed the Kefauver-Harris amendments to the Federal Food, Drug and Cosmetic Act, requiring manufacturers to prove a drug was not only safe but also effective.
The new law also required full disclosure of side effects and generic names, and quick removal of unsafe drugs from the market.
The 1962 legislation ensured “the best drugs and treatments rose to the top, not simply those that were most heavily marketed,” says Dr. Margaret Hamburg, who served as FDA Commissioner under President Obama.
We should remember the thalidomide babies, and thank Dr. Kelsey that “nevertheless, she persisted.”
Jan Collins is a Columbia-based journalist, editor, and author. A former Nieman Fellow at Harvard and former Congressional Fellow in Washington, D. C., she is the coauthor of Next Steps: A Practical Guide to Planning for the Best Half of Your Life (Quill Driver Books, 2009).