Do you remember when the FDA justified its existence because it refused to approve thalidomide due to lack of evidence of its safety?
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Frances Oldham Kelsey, recipient of the highest recognition attainable for a U. S. civil servant for her role in saving perhaps thousands from death or life-long incapacitation, had a long an impressive career both before that turning point in medical history and afterwards. Born in Cobble Hill, Vancouver Island, B. C., she had an early interest in science. In 1934 she earned her B. Sc. from McGill University, and in the following year received the Master’s degree in pharmacology. She continued her work in pharmacology at the University of Chicago, where she earned her Ph. D. in 1938 and also the M. D. in 1950. During this period she also did editorial work for the American Medical Association, where she reviewed papers on the latest in therapeutics. Beginning in 1954 Dr. Kelsey taught pharmacology at the University of South Dakota and practiced general medicine.
Six years later she accepted an offer from the Food and Drug Administration to become one of just a handful of medical officers. Their principal duty was to review new drug applications, a legal requirement in which manufacturers had to provide evidence of a drug’s safety before it could go on the market. One of the first applications she was assigned was for thalidomide, which was already available in dozens of countries around the world. Dr. Kelsey, despite constant pressure from the company, refused to approve the application because of its inadequate evidence.
The company continued to send in what they believed was proof of thalidomide’s safety, but Dr. Kelsey adamantly insisted on scientifically reliable evidence, which she felt the application sorely lacked. Approximately a year later researchers in Germany and Australia linked thalidomide to clusters of rare, severe birth defects—hands and feet projecting directly from the shoulders and hips—that eventually were shown to involve thousands of babies. The drug was never marketed in the U. S., and the impact of the near disaster here helped to pass a pending bill that fundamentally changed drug regulation, the 1962 Drug Amendments.
That was the FDA then; this is the FDA today:
FDA pushing vaccine boosters for infants based upon trials in just 24 children
This to “prevent” (it doesn’t) a disease that poses absolutely no risk to infants.
