Appalling reports continued to roll in. So far as is known, close to 8,000 babies have been born deformed because their mothers used a sleeping-pill-tranquilizer called thalidomide (TIME, Feb. 23). All this added up to the greatest prescription disaster in medical history. Thanks to the intuition of the Food and Drug Administration's Dr. Frances Kelsey,* the U.S. has got off lightly because the drug was never licensed for general use. In the half dozen reported U.S. cases of birth malformations due to thalidomide, the drug was obtained from abroad. Even so, the testing and marketing of new drugs in the U.S. are now almost certain to get close federal regulation.
President Kennedy led off his press conference last week with a demand for "additional protection to American consumers from harmful or worthless drug products. The United States has the best and most effective food and drug law of any country in the world . . .Nevertheless, the drug was given to many patients on an investigational basis."
Same day, Minnesota's Senator Hubert Humphrey (who used to be a pharmacist himself) summoned his Government Operations subcommittee to hear FDA Commissioner George P. Larrick and Pharmacologist Kelsey. Canadian-born Dr. Kelsey, 48, a low-heeled, no-nonsense woman who has practiced medicine besides teaching pharmacology, was a new employee at FDA in September 1960. Her first major assignment was to pass on the application of Cincinnati's William S. Merrell Co. for a license to market thalidomide in the U.S. under the trade name Kevadon.* Along with the application came a sheaf of reports on years of animal testing and human use of the drug in Europe. There was no hint that the drug had any undesirable side effects, and Merrell pressed hard for quick approval. But Dr. Kelsey was puzzled because the drug did not put animals to sleep. She wondered about other possible differences between its effects in animals and in man. Dr. Kelsey asked Merrell for more tests.
While she waited, Dr. Kelsey chanced on a British report that thalidomide might cause a tingling neuritis in some patients. From World War II work on antimalarial drugs, she suspected that this minor effect on adults might signal a more serious effect on the unborn. But not until nearly ten months later, in the last days of November 1961, did German reports link thalidomide with the European epidemic of seal-like, limbless babies.
Though Dr. Kelsey had kept Kevadon off the U.S. market for more than a year, this did not mean that no U.S. doctors were using the drug. (It was licensed in Canada, where at least 56 cases of deformed babies have been reported.) Last week Merrell reported that instead of the 100 or so U.S. physicians previously estimated to have got samples of the drug "for investigational use only," 1,231 had received Kevadon. How much of the drug each doctor got and used was unknown, so there was no way of estimating how many of the terrible blue tablets were still around. (In December 1961, the company warned U.S. doctors not to give Kevadon to women who might be or might become pregnant. In March 1962, Merrell called back all Kevadon tablets.)