The decision, made by a 22 to 1 majority vote by its advisory panel, surprised many in the industry, who thought the drug for type II diabetes would be taken off the shelves after studies revealed it increased the risk of heart attack by 45 per cent.
The panel was clearly not convinced by the evidence - not even by the FDA's own scientist Dr David Graham who told them that the drug's heart risks, combined with a lack of unique short-term benefits for the diabetic, meant it was no great loss to ban it.
They were much more impressed by Dr Roland Krall, chief medical officer for GlaxoSmithKline, the company that happens to make Avandia. He told the committee that there was no increased heart risk, and he should know because he was citing the company's own analyses of the research, whereas the risk was revealed by mere independent researchers.
The committee was impressed, as evidenced by member Rebecca Killion, the panel's patients' representative. She said: "We've been asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision."
Instead of listening to Dr Krall, the panel should perhaps have paid attention to a new study published this week. It has discovered that Avandia, and Actos (pioglitazone), another anti-diabetes drug from the same family of thiazolidinediones, doubles the risk of heart failure. This means that one out of every 50 people taking one of the drugs would suffer serious heart problems.
Researchers from Wake Forest University School of Medicine found that the drugs increased fluid retention, which could trigger heart failure.
"These drugs are currently used by more than 3 million diabetic patients in the United States alone, suggesting that several thousand could be harmed," commented lead researcher Sonal Singh.
(Source: Associated Press, July 30, 2007; Diabetes Care, 2007; 30: 2146-53).
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