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August 22, 2007

Humana and UM join in effort to examine Avandia risk

A joint Humana Insurance and University of Miami research effort will study the effects of drugs already on the market. One of its first focuses will be on diabetic patients and how they have been affected by the drug Avandia. It will take time before the study is finished because of the more than 40,000 diabetic patients in Humana's 11 million person database. A preliminary paper, led by UM professor Hermes Florez, questions the work on the drug done by Steven Nissen at the Cleveland Clinic. The Florez paper said the pooled results of the Nissen meta-analysis of 14,000 Avandia patients found that 86 had suffered heart attacks, compared to 72 of 11,634 diabetics who weren't taking the drug, which the Cleveland researchers said meant a 43 percent higher risk for Avandia group. The Florez paper, from the Southern Medical Journal, noted the ''widespread panic and confusion'' caused by the Nissen findings. “The use of odds ratios to compare a small number of events occurring in a large pool of patients and using summary trial-data would seem disingenuous, especially considering the experience of the authors.”

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