50 years later, remembering the horrors brought on by thalidomide
Drug makers 50 years ago finally removed the drug thalidomide from the market as evidence mounted that it caused terrible birth defects, especially in Europe. But for an alert, determined FDA employee, it could have been as bad or worse in the United States.
Thalidomide was supposed to help pregnant women deal with morning sickness.
Instead, it led to a horror show of birth defects and other problems for the infants born after their mothers took the drugs. It was 50 years ago that the drug was withdrawn from the market.
Thousands of families, especially in Europe, were impacted.
Dr. John Swann, historian at the Food and Drug Administration, said that current laws in the United States required the drug maker, the William S. Merrell Company of Cincinnati, to prove its safety before it could be marketed. Therefore, some women also received the drug during trials, but an alert pharmacologist at the Food and Drug Administration, Dr. Frances Oldham Kelsey, refused to approve its use.
She said further studies were needed sparing countless American families very likely saving the lives of many children.
"The law did work in this case," Swann said. "The evidence that was presented by the sponsor looked more like testimonials rather than scientific evidence."
Kelsey was under enormous pressure, as well as the FDA, to get the drug approved. But she resisted. Ultimately, for her efforts, she was honored by President John F. Kennedy.
The FDA now gives an award every year named for Kelsey in recognition of an employee's outstanding service.
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