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On April 16, 2010, we summarized an article on an industry-sponsored randomized trial of colchicine for acute gout flares (JW Gen Med Apr 16 2010). But why did a drug company choose to perform this study? The answer to that question sheds light on a new controversy surrounding an old drug.
In 2006, the FDA launched the “Unapproved Drugs Initiative,” which targeted old drugs that had never been approved by the FDA. The rationale was that older unapproved drugs, including colchicine, deserve as much scrutiny for efficacy and safety as do newer drugs. In response to this initiative, the drug company URL Pharma decided to conduct pharmacokinetic and clinical research on colchicine with the intention of bringing it to market as a brand-name produ…