Pharmaceutical giant GlaxoSmithKline knew of possible heart attack risks tied to its controversial diabetes drug Avandia years before evidence of a link became public, according to a U.S. Senate report released Saturday.
Based on its knowledge of those risks, GlaxoSmithKline "had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner," said the Senate Finance Committee report, which followed a two-year inquiry. Instead, the company tried to play down findings that the drug could increase cardiovascular risks while also working to minimize findings that a rival medication might reduce such risks, according to the report.
The senators who released the report -- Max Baucus (D-Mont.), chairman of the Finance Committee, and Charles E. Grassley (Iowa), the committee's ranking Republican -- are also asking the Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.
The Senate report suggests sharp disagreements remain at the FDA over how to handle Avandia's risks.
GlaxoSmithKline said in a statement that the drug is safe and that the committee report took data out of context from analyses of Avandia.
"Contrary to the assertions in the report, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events," the company said.
At the FDA's request, GlaxoSmithKline agreed in 2007 to conduct a six-year study of its drug and rival Actos, to give a definitive picture of Avandia's safety. The study, which will involve 16,000 participants, is still enrolling patients.
But FDA researchers quoted in the Senate report called the study "unethical and exploitative," since patients will continue taking Avandia, a drug with known risks, over Actos, which has not been linked to heart problems.
FDA spokesman George Strait said the agency is reviewing new data on Avandia and will present those findings to an advisory committee this summer.
Avandia was GlaxoSmithKline's third-best-selling drug in 2006, with revenue of $2.2 billion. But the safety concerns disclosed the following year slashed revenue to $1.2 billion by the end of 2008.
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