It was 1936. Frances Oldham had applied for a research position at the University of Chicago's pharmacology department. The department head, impressed by her credentials, offered her a scholarship and assistantship.
But he thought she was a man. Frances—with an "e," not an "i"—knew the mistake. She also knew that men were "the preferred commodity in those days." So she asked her professor at McGill what to do. Should she write back and explain?
"Don't be ridiculous," he told her. "Accept the job. Show up. Let him discover the truth for himself." She did. Twenty-four years later, that same stubborn refusal to back down would save thousands of American children from catastrophe.
Frances Kathleen Oldham was born on Vancouver Island, British Columbia, in 1914. By age fifteen, she had graduated high school. By twenty, she held a bachelor's degree from McGill. By twenty-four, she had earned her PhD in pharmacology from the University of Chicago—and married a fellow pharmacologist, F. Ellis Kelsey.
In 1950, she added an MD to her credentials. For the next decade, she taught pharmacology, practiced medicine, and raised two daughters. Then, in 1960, the Kelseys moved to Washington, D.C., where Frances took a job at the Food and Drug Administration. She was one of only seven full-time physicians reviewing new drugs for the American market.
Her second month on the job, an application landed on her desk.
The drug was called thalidomide.
Thalidomide was a sensation. Introduced in West Germany in 1957, it was marketed as a sedative—a sleeping pill so safe it was sold over the counter. By 1960, West Germans were consuming one million doses per day. The drug had been approved in Canada and more than twenty European and African countries.
Now the American pharmaceutical company Richardson-Merrell wanted to sell it in the United States under the brand name Kevadon. They expected approval to be a formality. Frances Kelsey was not impressed.
The application was sloppy. The testimonials contained no scientific methodology. Some of the authors had published suspicious articles before. And something about the drug's side effects—particularly reports of peripheral neuritis, a nerve condition—troubled her deeply.
"The peripheral neuritis did not seem the sort of side effect that should come from a simple sleeping pill," she later explained.
Under FDA rules, she had sixty days to approve or reject the application. If she did neither, the drug would automatically go to market. So Kelsey did something clever: every sixty days, she requested more information from the company. Each request reset the clock. Richardson-Merrell was furious.
The pressure campaign began immediately. Company representatives crowded into her office. They called her phone day and night. They contacted her and her supervisors more than fifty times over the next eighteen months. When she still wouldn't approve the drug, they got belligerent. "Most of the things they called me," Kelsey later said, "you wouldn't print." But she had backup. Her husband, Ellis, helped her check her conclusions. Her superiors at the FDA stood by her. And her own scientific training—decades of studying how drugs cross the placental barrier—told her something was wrong.
She demanded animal studies proving the drug wouldn't harm unborn babies.
The company sent more data. Kelsey scrutinized it with suspicion. What she didn't know—what Richardson-Merrell had concealed—was that the company had already discovered birth defects when thalidomide was tested on rats. They sent her misleading partial data instead. Month after month, she held the line.
Then the reports started coming from Europe. In late 1961, two doctors—Widukind Lenz in Germany and William McBride in Australia—independently linked thalidomide to a horrifying epidemic. Babies were being born with severe deformities: missing arms, missing legs, hands and feet projecting directly from shoulders and hips. The condition was called phocomelia—from the Greek words for "seal limbs."
The numbers were staggering. Over 10,000 babies worldwide were affected. Approximately 2,000 died. More than half the victims were in West Germany, where the drug had been most popular.
In March 1962, Richardson-Merrell finally withdrew their FDA application. By then, they had already distributed thalidomide samples to more than a thousand American doctors as part of unregulated "clinical trials." Approximately 20,000 patients had taken the drug—including several hundred pregnant women.
The official count of American babies born with thalidomide-related defects was seventeen.
The true number is almost certainly higher. Dozens of victims were likely never identified. Scores of miscarriages and stillbirths were never counted. To this day, American halidomide survivors—now in their sixties—continue to find each other, discovering they were never officially recognized.
But because of Frances Kelsey, America was largely spared.
On July 15, 1962, Washington Post reporter Morton Mintz broke the story on the front page. Kelsey was hailed as a national hero. "She prevented," Mintz wrote, "the birth of hundreds or indeed thousands of armless and legless children."
On August 7, 1962, President John F. Kennedy presented Frances Kelsey with the President's Award for Distinguished Federal Civilian Service. She was only the second woman ever to receive it.
But Kelsey insisted she wasn't the only hero. Her assistants, Oyama Jiro and Lee Geismar, deserved credit. So did her FDA superiors who backed her against corporate pressure.
The thalidomide disaster transformed American drug regulation. In October 1962, Congress unanimously passed the Kefauver-Harris Amendment. For the first time, pharmaceutical companies were required to prove their drugs were both safe and effective before marketing them. They had to report adverse reactions to the FDA. They had to obtain informed consent from patients in clinical trials.
The modern era of drug safety had begun.
Frances Kelsey didn't retire after her moment of fame. She continued working at the FDA for another fifty years, eventually leading the Division of Scientific Investigations. She worked into her nineties, taking on the challenges of other dangerous drugs seeking approval.
She died on August 7, 2015—exactly fifty-three years after receiving her medal from President Kennedy.
She was 101 years old.
Today, thalidomide is back. Under strict controls and rigorous pregnancy prevention measures, it treats certain cancers and complications of leprosy. In the United States, the prescribing doctor must ensure the patient is using two forms of contraception and taking regular pregnancy tests.
The drug that once caused the largest man-made medical disaster in history is now saving lives—because someone finally learned how dangerous it could be.
And we learned that because a young woman showed up at the University of Chicago in 1936, even though the acceptance letter was addressed to "Mr. Oldham."
She didn't correct them. She just proved them wrong.
