Alexandra Ayears

A woman one month into a new job at the FDA was handed an application to approve a sleeping pill. It looked routine. They gave it to her because she was new and it seemed like an easy one to start on. She read the file and something was missing. No evidence at all that the drug was safe in pregnancy, and it was being sold as a remedy for morning sickness. The drug was thalidomide, and West Germany was getting through a million doses a day. Frances Kelsey asked for more data. The company sent representatives to her office, then telephoned her at all hours, then went over her head to her supervisors. Between them they contacted her and her boss around fifty separate times. She later said most of what they called her could not be printed. Ten million tablets were already sitting in warehouses waiting for her signature. She said no six times. And while she held the line, doctors in Germany and Australia were piecing together what was happening to babies whose mothers had taken it. Limbs that had never formed, hands and feet attached directly at the shoulder and hip, in at least 4,000 children across Europe. The company withdrew its American application in 1962. Seventeen cases turned up in the United States, all from free samples doctors had handed out before any approval. Without her it would have been thousands. Congress passed a new law that same year requiring companies to prove a drug is both safe and effective, and requiring informed consent from anyone in a trial. Those rules are now used worldwide. Kennedy gave her the highest civilian award in the country and she was the second woman ever to receive it. She stayed at the FDA another 45 years and died in 2015 at 101. Every American woman handed a pill in pregnancy is downstream of one woman refusing to sign a form six times while men shouted at her. smithsonianmag.com/science-n…