FDA’s Graham and the Tragedy of Vioxx

This two part article on David Graham and the tragedy of vioxx get off to a slow start but is well worth reading. Here is a brief excerpt from part 2.

“It is a bit difficult to get one’s mind around the magnitude of the tragedy of Vioxx. For comparisons sake, in 1936 a chemist didn’t realize that the raspberry flavor he was giving to a cold medicine was poisonous ethylene glycol, that is to say antifreeze. Some 100 people died from drinking the tainted Elixir of sulfanilamide and it led to the passage in 1937 of the Federal Food Drug and Cosmetic Act which mandated animal safety and toxicity studies before a drug could be marketed. In the 1960s the marketing of thalidomide in Europe led to some 10,000 to 20,000 children in Europe being born with birth defects. Notably novice FDA reviewer, Dr. Frances Kelsey refused to approve the drug in the United States, sparing the US from the vast majority of the tragedy. In sworn testimony before the US congress Dr. David Graham estimated that …”

http://healthjournalclub.blogspot.com/2010/02/david-graham-and-tragedy-of-vioxx.html

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