The diabetes drug Avandia is linked with tens of thousands of heart attacks
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, a Senate committee report released Saturday says.
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.
“Americans have a right to know there are serious health risks associated with Avandia, and GlaxoSmithKline had a responsibility to tell them,” said Sen. Max Baucus, D-Montana, the committee chairman. “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”
GlaxoSmithKline rejected Saturday any assertions 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,” 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.
The FDA did not immediately answer a telephone message Saturday asking for comment.
The Senate report was developed over the past two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA and several research institutes. Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistle blowers.