Frances Oldham Kelseythe ObservatoryINTJ

In early September 1960, a month into her new job at the Food and Drug Administration, Frances Kelsey was handed the easy file. She was 46. Her supervisors told her as much: “Well, this is a very easy one. There will be no problems with sleeping pills.”

The drug company Merrell wanted to sell a sedative in the United States under the name Kevadon. The drug was thalidomide, already on sale in Europe. Kelsey was, in her own words, “the newest person there and pretty green.”

She had been underestimated before. Born Frances Oldham on Vancouver Island in 1914, she was offered her first research post in Chicago by a letter that began “Dear Mr. Oldham.” Her professor told her to accept, sign her name, “put Miss in brackets afterwards, and go!” She went.

In 1960 the law gave the agency sixty days to object to a new drug. If it said nothing, the drug was approved automatically. The default was yes, and the careful reader was the only safeguard.

She took the clinical reports; a chemist and a pharmacologist took the rest. Many of the reports read more like testimonials than science. All three reviewers found gaps, and near the sixty-day mark she declared the application incomplete, which stopped the clock. Each time the company sent more, she said exactly what was still missing and waited. She never tried to win by a trick.

Merrell pushed hard. Its man telephoned, visited, and finally complained over her head. Her supervisors backed her.

Then a delayed copy of the British Medical Journal reached her desk. In it was a short letter from a British doctor, Leslie Florence: some of his patients on the drug had developed nerve damage in their hands and feet.

Observatories notice small items. “But the peripheral neuritis did not seem the sort of side effect that should come from a simple sleeping pill,” she wrote. When she raised it with the company, on about the third phone call, it was clear they had known and “had not volunteered the information.”

Then she asked the long-range question. If this drug could reach an adult's nerves, what could it do to a child in the womb?

The company offered a warning on the label. She wanted a study. For eighteen months she kept saying, calmly and in writing, that the evidence was not there. Late in 1961 the drug was withdrawn in Germany after it was linked to severe birth defects, and on 8 March 1962 Merrell withdrew its American application.

Something had got through, and she said so. Before any approval, samples had gone out to over a thousand American doctors, and some seventeen affected children were born in the United States.

In August 1962, at 48, she received the President's Award for Distinguished Federal Civilian Service from John F. Kennedy. “This was really a team effort,” she said. She lived to 101, and she kept correcting anyone who called her a lone heroine.

The newest person in the building had simply been the one who read the file.