GlaxoSmithKline, the manufacturer of the diabetes drug Avandia, will pay tens of millions of dollars to resolve allegations that the company unlawfully promoted its drug.
In February 2010, a 334-page report by the Senate Finance Committee claimed that the drug was linked with tens of thousands of heart attacks and that GlaxoSmithKline knew of the risks for years but worked to keep them from the public. At the time, GlaxoSmithKline rejected any assertions that the drug is not safe.
"On November 15, 2012, GSK entered into a settlement with 37 states and the District of Columbia over allegations regarding the sales and promotion of Avandia. GSK has agreed to pay $90 million to be divided among the 37 states and the District of Columbia," Bernadette King, a U.S.-based spokeswoman for the company, said in a statement.
"With regards to Avandia, we firmly believe we acted responsibly in conducting the clinical trial program, in marketing the medicine, in monitoring its safety once it was approved for use and in updating information in the medicine's labeling as new information became available," she wrote.
Avandia and diabetes: Was the revolution worth the risks?
Arizona Attorney General Tom Horne, who along with 37 other attorneys general settled with the pharmaceutical company, said in a statement, "This court action is a stark reminder that consumers deserve full accountability from any entity that engages in potentially deceptive practices." He added, "This Consent Judgment is tough, fair and it holds GlaxoSmithKline accountable for how the company marketed Avandia."
"This was a very sad saga in American medical history," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, one of the harshest critics of the drug. In 2007, he published a study in the New England Journal of Medicine that found a 43% increased risk of a heart attack in patients taking the diabetes drug.
Nissen approves of the settlement, which he says gives the states some resources to protect the public. "It is like a warning shot across the bow and causes companies to think twice before they mis-promote drugs, and that's a good thing for the public."
The $90 million will be divided among Arizona, Florida, Illinois, Maryland, Pennsylvania, Oregon, Tennessee, Texas, Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Vermont, Washington and Wisconsin and the District of Columbia.
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