In 1954 the German company Chemie Grunenthal first synthesized the drug thalidomide to be used as a sedative that provided sound sleep. The drug seemed safe when tested on rats it wasn t found to be toxic at all. Indeed, no matter how much was given, the rats survived. It was thought to be so safe that it was approved for over-the-counter (without a prescription) sales in Germany.
In the UK (and subsequently in Canada, Australia and New Zealand) thalidomide was marketed as a remedy for morning sickness in pregnant women; and by the mid 1950s it was sold under various brand names by 14 different companies in 46 countries.
But not in the US.
In 1956 the William S. Merrell Company (now part of Sanofi) agreed to market and distribute the drug in the United States. But when the company applied to the FDA for approval in 1960 it hit a wall. Dr. Frances Kelsey, newly appointed to be in charge of licensing new drugs (thalidomide was one of her first applications), asked the company to perform safety tests before a license would be approved. The company declined to do so and reapplied 5 more times for approval. In spite of pressure from the company, Dr. Kelsey stood her ground.
By late 1961 the effects of thalidomide on babies born to mothers who had taken the drug during the first trimester of pregnancy were widely apparent. Thousands infants around the world were born with deformed or missing limbs, heart, eye and other defects. But in the US, there were only 17 documented cases of thalidomide-damaged babies a result of early testing of the drug in the attempt to obtain a license.
Dr. Kelsey was a true heroine in this tragic story. But for her insistence on better data, the disastrous results seen in other countries would certainly have been replicated here. Her influence is far greater than the thalidomide story, however. Because of the thalidomide tragedy, the FDA uses a much tighter safety and efficacy procedure before approving new drugs, and safety during pregnancy is always a concern.
ACSH s senior nutrition fellow Dr. Ruth Kava had this to say Rarely do we see the actions of one administrator have such a wide-ranging effect on public policy. Dr. Kelsey s intransigence will benefit many because of the changes in drug approval policies post-thalidomide.
