Many scientists establish their reputations through discovery or new interpretations of older observations. Dr. Frances Oldham Kelsey, who died at age 101 earlier this year, gained prominence for a steadfast “no” to an application for release of a new drug in the United States.
Born in Canada, Frances Kelsey earned her bachelor and master degrees at McGill University before moving to the University of Chicago for studies leading to a Ph.D. in pharmacology and a subsequent M.D. Her research director accepted her application for doctoral study believing she was a male.
Clif CleavelandOver ensuing years, she taught pharmacology, conducted research in drug-induced birth defects and helped edit a medical journal. In 1960, she began work at the Food and Drug Administration, where her first assignment involved the evaluation of a new medication for insomnia. The drug was thalidomide.
Starting in 1957, a German pharmaceutical company marketed thalidomide for the treatment of anxiety and insomnia. Soon, physicians from across Europe adopted the drug as an effective means of relieving “morning sickness” for pregnant women. Initially available by prescription, thalidomide was cleared for over-the-counter purchase in Germany late in 1957.
During subsequent months, scattered reports surfaced of severe fetal malformations in women who had taken thalidomide during pregnancy. Deformities of limbs, heart defects, blindness and deafness were reported, along with many miscarriages. Despite a rising tide of adverse reactions, no one connected the dots to implicate thalidomide.