It’s the early 1960s and the German pharmaceutical market is booming. A sedative called Contergan is one of the bestselling drugs. Contergan’s active ingredient is thalidomide and it is touted as a wonder drug, a non-addictive sedative safer than barbiturates. In the U.S., the drug is called Kevadon, and its distributor is impatient to get the drug on the market. But Dr. Frances Kelsey, a medical examiner at the U.S. Food and Drug Administration, is stalling the approval of Kevadon. She wants more information from the manufacturer to prove it is safe. Meanwhile, doctors in Scotland and Australia are beginning to suspect thalidomide might, in fact, be very toxic. And in Germany, reports are beginning to emerge of a mysterious epidemic of babies born with missing limbs and other serious medical conditions, but doctors have no idea what's causing it.

In this first chapter of a new five-part season we meet Dr. Frances Oldham Kelsey, a physician and pharmacologist who joined the U.S. Food and Drug Administration as a medical reviewer in 1960. Before the year is out, Dr. Kelsey finds herself standing up to big pharma.

It’s September 1960 and a thick New Drug Application lands on Dr. Kelsey’s desk. The drug has already been on the market in Europe for three years and Dr. Kelsey’s supervisors expect her to rubber stamp the application. The drug is called Kevadon. Active ingredient: thalidomide. And to Frances Kelsey’s keen eye, something looks off.

In the 1950s, a German drug company developed a new sedative that was supposed to be 100% safe: thalidomide. So safe, in fact, it was promoted to women as a treatment for morning sickness. It quickly became a bestseller. But in the early 1960s, shocking news started coming out of Europe. Thousands of babies were being born with shortened arms and legs, heart defects, and other serious problems. Many died.

In the United States things were different, thanks to one principled, strong-minded skeptic who joined the Federal Drug Administration in 1960 as a medical reviewer. One of her first assignments was to review the approval application of that very wonder drug, thalidomide. But the application was, to her mind, flawed.

Dr. Frances Oldham Kelsey was a physician, a pharmacologist, and a nitpicker who refused to be intimidated by big pharma.

Starting in September, a new five-part series from Lost Women of Science: The Devil in the Details, the story of Frances Oldham Kelsey, The Doctor Who Said No To Thalidomide.