The Tragedy of Thalidomide
Frances Oldham Kelsey, PhD, MD (July 24, 1914 - August 7, 2015) is most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug's safety. Thalidomide was developed by German company Grunenthal in the 1950s and considered a wonder drug as an effective tranquilizer and painkiller and also used to treat insomnia, coughs, colds, and headaches. The drug was prescribed in Canada, Europe, Australia, and parts of Asia in the late 1950s-1960s to pregnant women in their first trimester to treat nausea and vomiting caused by morning sickness. Tragically, during this period, more than 10,000 children in 46 countries were born with deformities such as phocomelia (limb deformity) as a consequence of thalidomide use during pregnancy.
This incident encouraged the passage of laws strengthening the FDA's oversight of pharmaceuticals. In 1962, the United States Congress enacted the Kefauver Harris Amendment, requiring tests for safety during pregnancy and the establishment of effectiveness before a drug can receive approval for sale. In the same year, Dr. Kelsey received the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy for her work and insight. She continued to work at the FDA, retiring in 2005 at the age of 90. In her honor the FDA established the Dr. Frances O. Kelsey Drug Safety Excellence Award.
Following tragedy, regulation was enacted to improve drug safety. Is similar safety assessment needed for the many industrial chemicals we are exposed to?