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.
"Had GSK considered Avandia's potential increased cardiovascular risk more seriously when the issue was first raised in 1999 ... some of these heart attacks may have been avoided," the report states.
• GlaxoSmithKline undertook attempts to undermine information critical of Avandia.
"GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk," the report says.
As an example, committee investigators say they found that GlaxoSmithKline experts verified an outside study showing the cardiac problem, but the company publicly attacked the findings as incorrect.
• 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GlaxoSmithKline counters that the Senate report relies on outdated information.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.
"The FDA exists to ensure patient safety," she said. "That is their purpose."