Makers of Avandia Sued by the State of Utah

Salt Lake City, UTA lawsuit was recently filed against the makers of Avandia by the state of Utah over what the state's Office of the Attorney General calls misleading claims by GlaxoSmithKline that the Type 2 diabetes drug is a "wonder drug" when in fact, the allegations claim, Avandia increases the risk of heart attack and other serious cardiovascular events.

Avandia has been pulled in Europe by regulators, while the drug remains available in the US with severe restrictions and is the target of numerous lawsuits. Lately, individual states have been getting into the act, attempting to recoup losses after the drug was funded by state Medicaid programs.

Specifically, the Deseret Morning News of Salt Lake City contained details November 10 of a lawsuit filed by Utah Attorney General Mark Shurtleff against GlaxoSmithKline with regard to Avandia side effects and the allegation of fraud. To wit, the lawsuit accuses GlaxoSmithKline of defrauding the state of Utah to the tune of $7.8 million, an amount equal to that spent by the State Medicaid Program on Avandia between January 1, 2001 and June 20 of this year.

The lawsuit alleges that GlaxoSmithKline claimed Avandia to be superior in the reduction of diabetic cardiovascular risks and the lowering of blood sugars when compared to older, established diabetic drugs.

To that end, the lawsuit identifies a number of learned and medical studies, including a major study published in the New England Journal of Medicine that identified risk factors for Avandia heart attack and other adverse reactions associated with Avandia.

What's more, at a price seen to be higher than more established, less-expensive drugs, Avandia represented a significant cost to the state's Medicaid program for a drug alleged to be inferior.

"The State Medicaid Program paid significantly more for a drug that in fact was no more effective than traditional drugs that were less expensive," said Robert C. Morton, an assistant attorney general with the Utah Medicaid Fraud Control Unit. "Unlike the less expensive traditional drugs, Avandia exposed Utah Medicaid recipients to greater risks of heart attacks and other cardiac complications."

An expert panel meeting earlier in the summer advised the US Food and Drug Administration (FDA) that while the benefits of Avandia continued to outweigh the Avandia risks, restrictions were warranted. Avandia side effects are also said to include risks for liver failure, bone fracture and even death.