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Journal of No. 118


June 14th, 2013

How the FDA earned its teeth @ 02:25 pm


Although the FDA existed in 1937, it did not have the authority to require companies to demonstrate the safety and efficacy of drugs. Then SE Massengill marketed a liquid form of the early antibiotic sulfanilamide, using diethylene glycol as a solvent. Unfortunately, DEG is poisonous to humans. At least 100 deaths across the country resulted.
A woman wrote to U.S. President Roosevelt and described the death of her daughter: "The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."


I ran across this in an article in The Scientist, which also includes the detail that due to a legal technicality [an "elixir" legally denotes a medicine containing ethanol, which Elixir Sulfanilamide didn't] FDA agents did have the authority to track down and seize remaining bottles, "an operation that saved as many as 4,000 lives."
 
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Journal of No. 118