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At FDA's request, Glaxo agreed in 2007 to conduct a six-year study between its drug and Actos, to give a definitive picture of Avandia's safety. The study, which will involve 16,000 participants, is still enrolling patients.
But FDA researchers quoted in the report called the study "unethical and exploitative," since patients will continue taking Avandia, a drug with known risks, over Actos, which has not shown any links to heart prblems.
FDA spokesman George Strait said the FDA is reviewing new data on Avandia and will present those findings to an advisory committee this summer.
"Meanwhile, Commissioner Hamburg is reaching out to ensure that she has a complete understanding and awareness of all of the data and issues concerning this drug," Strait said.
Avandia was Glaxo's third best-selling drug in 2006 with revenue of $2.2 billion. But the safety concerns disclosed the following year slashed revenue to $1.2 billion by the end of 2008.
Avandia is intended to control blood sugar by increasing the body's sensitivity to insulin, a protein critical to digesting sugars.
Insulin-regulating treatments have long been presumed to lessen the heart risks already associated with diabetes, which is linked to obesity.
On the Net:
Finance Committee letter and report
Food and Drug Administration
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