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[DOLLY]

"The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released Saturday.

The 334-page report by the Senate Finance Committee also criticized the Food and Drug Administration, saying that the federal agency that regulates food, tobacco and medications overlooked or overrode safety concerns found by its staff. . .

GlaxoSmithKline rejected any assertions Saturday that the drug is not safe. "We disagree with the conclusions in the report," company spokeswoman Nancy Pekarek told CNN. "The FDA had reviewed the data and concluded that the drug should be on the market." Seven clinical trials on the drug prove that it is not linked to heart attacks, Pekarek said. "None of that data shows a statistically significant correlation between Avandia and myocardial ischemia or myocardial infarction [heart attack]," she said.

The Senate committee investigation stems from concerns that Avandia and other high-profile drugs put "public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks," the report states. FDA Commissioner Margaret Hamburg said she is waiting for the recommendations of an advisory committee that will hear reports on the drug this summer. . .

According to the Senate report:

• FDA scientists estimated in July 2007 that Avandia was associated with approximately 83,000 heart attacks since the drug came to market.

• GlaxoSmithKline undertook attempts to undermine information critical of Avandia.

• Two FDA safety officials sounded a clear alarm in October 2008 writing, "There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [rival drug on market]." They concluded and trials comparing the two would be "unethical and exploitive." Yet, the trial is still under way, the senators say.

GlaxoSmithKline counters that the Senate report relies on outdated information."In essence, the report is a compilation of information and events that took place years ago," spokeswoman Pekarek said. "There's no new data there." The FDA has evaluated at the drug, Pekarek said, and updated product labeling in 2007 to say information on Avandia's relationship to myocardial ischemia is inconclusive. . .

Avandia has been under scrutiny for years. The New England Journal of Medicine called the drug's safety into question in 2007. The Journal of the American Medical Association also questioned whether Avandia was safe in 2007."

http://edition.cnn.com/2010/HEALTH/02/20/a...a.study/?hpt=T1