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But even if regulators relax limits on Avandia, it's highly unlikely the drug will regain its blockbuster status. "It's very difficult to rehabilitate a drug, any drug, after it's been through a process like this," said Rebecca Killion, the panel's patient representative. This week's meeting marked the third time that the FDA has assembled its experts to answer a seemingly basic question: Does Avandia increase the risk of heart attacks? A firm answer has proved elusive, in part because patients with diabetes are already predisposed to heart problems. That makes it extremely difficult to tell which heart attacks are drug-related and which are simply a result of the underlying disease. The initial concerns about Avandia came from outside researchers who pooled thousands of reports of heart attack and stroke from dozens of unrelated studies. One of these so-called meta-analyses combined 42 studies and appeared to show a higher risk of heart attack among patients taking Avandia compared to other diabetes drugs. The FDA added a boxed warning about heart attack risks to Avandia in 2007, while noting the shortcomings of the analysis that produced the concern. FDA leadership generally argues that mixing data from multiple studies can lead to misleading trends and conclusions. The agency tries to base its decisions on head-to-head controlled clinical trials, which most medical experts consider the gold standard of research. That has focused the agency's attention on the RECORD trial, a six-year study of 4,400 patients that compared heart attack rates in patients taking Avandia versus metformin and sulphonylurea, a standard drug combination for diabetics. The initial results reported by Glaxo in 2009 showed no signal for heart attacks, but those findings have been questioned because of missing data and other issues. Under instructions from the FDA, Glaxo hired Duke University to reanalyze the RECORD study, reviewing each report of heart attack or stroke at a patient-by-patient level. Duke's findings matched Glaxo's initial conclusion: Avandia did not appear to increase the risk of heart attack. At least one FDA reviewer said this week that Duke's review was not truly independent, since the university was paid $3 million by Glaxo and relied on records provided by the drugmaker. But FDA leadership said there was no evidence of "systematic or intentional manipulation" of the RECORD reevaluation. The agency's panelists almost unanimously backed that conclusion. While there are well over a dozen diabetes medications on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. Both drugs increase patients' sensitivity to insulin, a key protein needed to break down carbohydrates.
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