Dr. Frances Oldham Kelsey was appointed to her position at the Food and Drug Administration in 1960. She was in charge of reviewing drugs and the department put her in charge of the drug, Thalidomide. It was supposed to be an easy task because Thalidomide was widely used in other parts of the world and considered safe. Pregnant women used Thalidomide for nausea and it was given out freely. Pregnant women loved it, not knowing that their children could be born with missing and deformed limbs. In spite of enormous pressure, Dr. Frances did not want to expedite the approval of the drug. She was concerned by some data indicating that it had adverse side effects in patients who took the drug repeatedly. The manufacturers stood to make a lot of money from the drug in the U.S. and they tried everything to get fast approval.
The pharmaceutical company had not supplied any test results so Dr. Kelsey wanted to perform tests and see the results. The company pressured her for approval six times and each time they were denied. Laws governing new drugs had been around for decades but were not always strongly enforced. F.D.A. approval was often routine. Dr. Oldham blocked drug approval long enough for damaging evidence from abroad to surface. The drug was never approved in the United States. In all, just seventeen American babies are known to have been born with birth defects originating from Thalidomide. Their mothers had been given doctors’ samples of the unapproved drug. Before review of the drug, 1,000 samples had been given to doctors by the pharmaceutical company. Thousands of children were likely spared deformity and death by Dr. Kelsey’s thorough review of the drug.
In the few years Thalidomide was on the market (not in the U.S.) at least 10,000 children worldwide (likely significantly more) were born with birth defects as a result of their mothers taking the drug during pregnancy. For decades, no one knew why the drug caused birth defects, but Dana Farber Cancer Institute scientists have discovered the drug interferes with transcription proteins that can shut off a gene crucial to limb development.
That is very sad that so many kids had deformities. Thankfully there are some people who do the right thing and not approving the drug was clearly the right thing to do.