The U.S. has more thalidomide survivors than the government admits
Survivors of the thalidomide drug tragedy in the U.S. are seeking formal government recognition for the health complications they have faced since birth. The article details how unregulated clinical trials in the 1960s led to children being born with severe limb deformities.
Why it matters
It highlights the long-term human cost of regulatory failures and the ongoing struggle for accountability and recognition by victims of pharmaceutical negligence.
When Cincinnati-based pharmaceutical company William S. Merrell applied for Food and Drug Administration approval for a German-made sedative in late 1960, it expected the application to sail through the process and be on store shelves in time for Christmas.
The drug, thalidomide, was not approved that year or the next. A persistent medical reviewer at the FDA kept the drug from being approved for general use. Dr. Frances Oldham Kelsey's actions fundamentally changed the agency's testing and approval process, leading to the robust regulations that exist today.
President John F. Kennedy publicly praised Kelsey for sparing "us this terrible human tragedy which has been visited on families in Germany."
Doctors were already giving thalidomide to thousands of U.S. patients , including pregnant women. Some children whose mothers were given the drug during pregnancy were born with severely deformed limbs.
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