Dr. Frances Kelsey died August 7 at the age of 101. One of my heroes, she shows the good do not always die young.
In the early 1960s, a drug known as Thalidomide was marketed in Europe, Australia, Canada, and elsewhere to treat insomnia and nausea. Thalidomide’s manufacturer, William S. Merrell Company, was trying to get the drug approved for use in the United States. They expected a routine rubber-stamp approval. The company made glowing claims for Thalidomide’s safety and effectiveness. It had been developed in West Germany, and since 1957 had been widely sold as an excellent sedative, Merrell said, giving prompt, deep, natural sleep without hangovers. Moreover, doctors had recently been prescribing it to women to suppress morning sickness and insomnia in pregnancy. Dr. Kelsey, the new medical officer at the US Food and Drug Administration, was troubled by initial information about side effects. Merrill complained to her boss, labeled her a “petty bureaucrat”. She was brutally attacked by drug companies. She was stifling innovation with petty regulations.
Merrell stood to make millions and was anxious to get moving. It had tons of Thalidomide in warehouses, ready for marketing, and 1,000 American doctors had already been given samples for “investigational” research. Dr. Kelsey was bombarded with letters, telephone calls, and visits.
Eventually researchers learned that thalidomide crossed the placental barrier and disrupted fetal development. No one knows how many babies were affected by thalidomide, but estimates range into the tens of thousands in Europe alone. Many were born without arms or legs, some with no limbs or with withered appendages protruding directly from the trunk. Some had no external ears or deformities of the eyes, the esophagus or intestinal tracts.
Ironically, Dr. Kelsey only got her first job (before in-person interviews were the norm) because the employer thought she was “Francis”, not “Frances” and sent a letter to “Mr.” informing Dr. Kelsey she was hired.
She received the nation’s highest civilian award from President Kennedy in 1962. The Thalidomide scandal was largely responsible for changes in FDA regulations requiring manufacturers’ of new drugs to submit evidence of safety, and Dr. Kelsey was placed in charge of the new regulatory department.
No telling how many tens of thousands of American families were spared children with severe, even lethal, birth defects because Dr. Kelsey stood firm and insisted that science, not “free market”, determine policy.