The road to hell is paved with good intentions. The FDA has reaffirmed the truth of this aphorism with its policy about Colchicine. Here's the story: I recently spoke with a friend who has a family member suffering from Familial Mediterranean Fever (FMF), an auto-inflammatory disorder, most commonly seen in eastern Mediterranean populations. The condition is characterized by recurrent painful inflammation of the abdomen, chest and joints, accompanied by fever. FMF is associated with mutation of a gene on chromosome 16 involved with regulating Pyrin, a protein that is part of the inflammatory response. There is no specific test for the disease. Diagnosis is made on the basis of symptoms, family history, and ruling out other conditions. Since the 1960s, Colchicine, a plant extract first used for treatment of gout two thousand years ago, has been used for treating FMF. As an ancient treatment widely used prior to formation of the FDA, Colchicine did not require FDA approval as a new ...
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