<v Speaker 1>I'm Jerry Broadway, and this is Anonymous America where we

<v Speaker 1>take a deep dive into American history to find those

<v Speaker 1>unknown heroes who did incredible things and then slip through

<v Speaker 1>the cracks of time. How many lives can one person

<v Speaker 1>save by doing absolutely nothing, not by charging a hill

<v Speaker 1>or pulling somebody out of a fire, just by sitting

<v Speaker 1>at a government desk, reading paperwork and refusing to sign it.

<v Speaker 1>In the fall of nineteen sixty, there was a brand

<v Speaker 1>new employee at a federal agency in Washington and she

<v Speaker 1>was handed her very first assignment. Her supervisors considered it

<v Speaker 1>a no brainer. It was a warm up, a simple

<v Speaker 1>approval for a drug that was already being sold in

<v Speaker 1>forty six countries. All it needed was a rubber stamp

<v Speaker 1>to be sold in America. The company behind that drug

<v Speaker 1>had a massive launch ready to go. Millions of tablets

<v Speaker 1>had been made, a sales force was primed and ready.

<v Speaker 1>All they needed was one signature from one one reviewer

<v Speaker 1>that nobody had ever heard of. Well, they never got it.

<v Speaker 1>This is the story of one of the most important

<v Speaker 1>knows in the history of American medicine. For mad Ad Productions.

<v Speaker 1>This is Anonymous America. Salo to doctor Francis Oldham Kelsey.

<v Speaker 1>She was born in nineteen fourteen on Vancouver Island in Canada,

<v Speaker 1>and she was brilliant. She earned numerous degrees in science

<v Speaker 1>by her early twenties, at a time when women were

<v Speaker 1>quietly steered away from all of that sort of thing. Now,

<v Speaker 1>when she applied to a doctoral program in pharmacology at

<v Speaker 1>the University of Chicago, the acceptance letter came back addressed

<v Speaker 1>to mister Oldham. The professor in Chicago advised her not

<v Speaker 1>to correct the mistake, just show up, and she did.

<v Speaker 1>She would later joke that her entire career may have

<v Speaker 1>hinged on a man misreading her name. Now, in nineteen

<v Speaker 1>thirty seven, Francis was still a graduate student. Then, more

<v Speaker 1>than one hundred Americans, many of them children, died after

<v Speaker 1>taking a liquid medication called Elixir sulfonilamide, which had been

<v Speaker 1>mixed with a poisonous solvent and shipped without a single

<v Speaker 1>safety test, and she learned a lesson that she never forgot.

<v Speaker 1>A drug is guilty until proven innocent. Years later, her

<v Speaker 1>own research revealed something else that would matter enormously, that

<v Speaker 1>an unborn baby does not process drugs the same way

<v Speaker 1>an adult does. The medical world of the day mostly

<v Speaker 1>assumed the womb was just a protective shield around the

<v Speaker 1>baby and no harm could come to it, but Francis

<v Speaker 1>had data suggesting otherwise. Shared a medical degree, taught, married,

<v Speaker 1>raised two daughters, and in nineteen sixty she took a

<v Speaker 1>job in Washington at the Food and Drug Administration as

<v Speaker 1>one of only a small handful of physicians reviewing every

<v Speaker 1>new drug application in the United States, and within a

<v Speaker 1>month that first file landed on her desk. The drug

<v Speaker 1>was called Kevedon. It was a sedative, a sleeping pill,

<v Speaker 1>but it was also being promoted from morning sickness and

<v Speaker 1>pregnant women. It was already a blockbuster across Europe. It

<v Speaker 1>was sold over the counter in some countries. Marketed is

<v Speaker 1>so safe you couldn't overdose on it if you tried.

<v Speaker 1>The American distributor expected approval in sixty days, just in

<v Speaker 1>time for a massive launch, and while they waited, under

<v Speaker 1>the loose rules of that era, they shipped some two

<v Speaker 1>and a half million tablets to more than one thousand

<v Speaker 1>American doctors as so called investigational samples. Francis opened the

<v Speaker 1>file and frowned. The application was thick with glowing testimonial

<v Speaker 1>from doctors, but it was thin on actual science. The

<v Speaker 1>absorption data didn't make sense to her. The safety claims

<v Speaker 1>read lack advertising. So she did the thing that would

<v Speaker 1>make her famous, though no one knew it yet. She

<v Speaker 1>sent it back marked insufficient evidence, Please try again. The

<v Speaker 1>company read submitted. Francis sent it back. They resubmitted again.

<v Speaker 1>Francis sent it back. Executives began phoning her supervisors, they

<v Speaker 1>visited the agency in person. In their internal communications, they

<v Speaker 1>dismissed her as a stubborn, nitpicking bureaucrat, a difficult woman

<v Speaker 1>standing between them and the American market. The application would

<v Speaker 1>ultimately come back to her desk six times, and six

<v Speaker 1>times Francis said the same thing. You have not proven

<v Speaker 1>this drug is safe. Then, around Christmas time nineteen sixty,

<v Speaker 1>she spotted a letter in a British medical journal. A

<v Speaker 1>physician reported that long term users of Kevedon were developing

<v Speaker 1>nerve damage in their hands and feet. That alone was alarming,

<v Speaker 1>but her mind went straight back to her old research

<v Speaker 1>and she asked the question. Almost no one in the

<v Speaker 1>world was asking. If this drug can damage the nerves

<v Speaker 1>of an adult, what is it doing to a developing baby.

<v Speaker 1>She demanded the company answer that question with evidence. Their response,

<v Speaker 1>we can't. While Francis held the line in Washington, the

<v Speaker 1>answer was being written in delivery rooms across Europe, Canada,

<v Speaker 1>and dozens of other countries. Doctors began reporting a wave

<v Speaker 1>of babies born with catastrophic deformities, missing limbs, hands, emerging

<v Speaker 1>from shoulders, damaged organs. In November nineteen sixty one, researchers

<v Speaker 1>connected it to the sedative Kevedon and Germany pulled it

<v Speaker 1>from the market worldwide and estimated ten thousand babies were

<v Speaker 1>born damaged by the drug, and that's not counting the miscarriages.

<v Speaker 1>Roughly forty percent of babies exposed to Cavedon died, and

<v Speaker 1>in the United States, a market of one hundred and

<v Speaker 1>eighty million people at the time where the drug was

<v Speaker 1>supposed to have launched more than a year earlier, the

<v Speaker 1>cases numbered only about seventeen, traced largely to those investigational samples,

<v Speaker 1>not because America got lucky, but because one reviewer, on

<v Speaker 1>her very first assignment read the file, trusted her training

<v Speaker 1>and refused to be rushed, flattered, or bullied into signing.

<v Speaker 1>In July, of nineteen sixty two, a Washington Post reporter

<v Speaker 1>put her on the front page, and overnight, the anonymous

<v Speaker 1>bureaucrat became the national heroine. President Kennedy personally presented her

<v Speaker 1>with the President's Award for Distinguished Federal Civilian Service. At

<v Speaker 1>the time, she was only the second woman ever to

<v Speaker 1>receive it, and Congress, moved by how close the country

<v Speaker 1>had come to disaster, unanimously passed sweeping new drug laws,

<v Speaker 1>requiring companies to not only prove their products actually work,

<v Speaker 1>but to report side effects and to get informed consent

<v Speaker 1>from trial patients. The modern American drug approval system, the

<v Speaker 1>one protecting your medicine cabinet right now, was built on

<v Speaker 1>the foundation of Francis Oldham Kelsey saying no. And here's

<v Speaker 1>the thing that says the most about Francis. She didn't

<v Speaker 1>try to cash in, and she didn't leave. She stayed

<v Speaker 1>at the FDA, reviewing drugs and pursuing scientific integrity for

<v Speaker 1>another four and a half decades. She returned tired at

<v Speaker 1>the age of ninety. The FDA eventually created an award

<v Speaker 1>named in her honor and gave her the first one.

<v Speaker 1>Francis died in twenty fifteen at one hundred and one

<v Speaker 1>years old, receiving one of Canada's highest honors at her

<v Speaker 1>bedside in her final hours. Francis never thought of herself

<v Speaker 1>as a hero. She insisted she was just doing her job,

<v Speaker 1>that the system worked because someone was willing to ask

<v Speaker 1>hard questions and wait for real answers. Most heroes we

<v Speaker 1>could point to save the life or ten or one hundred.

<v Speaker 1>Francis Kelsey saved a generation of American children, armed with

<v Speaker 1>nothing but a desk, a file, and the courage to

<v Speaker 1>keep saying the least popular word in Washington, d C.

<v Speaker 1>That's Francis Kelsey, and that's anonymous America.