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US: V.A. Is Limiting Use of Diabetes Drug

by Stephanie SaulNY Times
October 18th, 2007

The Department of Veterans Affairs has decided to severely limit the use of Avandia, the once-popular drug for Type 2 diabetes, delivering another blow to the product’s maker, GlaxoSmithKline.

The decision by the V.A. is likely to further reduce sales of Avandia, once a $2.2 billion franchise in this country alone. Sales of the drug in the United States have declined by an estimated 60 percent since May, when the New England Journal of Medicine published an analysis questioning the drug’s safety.

The V.A. makes up about 8 percent of Avandia’s sales, according to a Glaxo spokeswoman.

The May journal article suggested that using Avandia increased the risk of heart attack by more than 40 percent. The analysis, written by Dr. Steven E. Nissen and his colleagues at the Cleveland Clinic, prompted a review of Avandia by the Food and Drug Administration that is still under way.

As part of that review, an agency advisory panel overwhelming recommended in July that the drug remain on the market. But such recommendations are not binding, and the agency is deeply split, with some officials pushing for Avandia’s withdrawal. One safety officer at the agency, Dr. David Graham, argued to the advisory panel that Avandia had caused up to 205,000 heart attacks and strokes since its approval in 1999.

The V.A. decided to remove Avandia, known generically as rosiglitazone, from its formulary on Oct. 5, according to a statement yesterday. “The Department of Veterans Affairs conducted its own review and has concluded that, for some patients, rosiglitazone may not afford the same margin of safety as alternative drug therapies,” the statement said.

The agency, which treated more than five million veterans last year, issued Avandia prescriptions to more than 161,000 individuals from September 2006 to August 2007, according to Terry Jemison, a V.A. spokesman.

The V.A. said Avandia would be available for patients already using it, if they decided to continue, but the agency is urging doctors to inform patients about the drug’s risks and benefits. “The V.A. will not provide it to patients for whom it is not currently prescribed,” the agency said.

Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said it was too soon to gauge the impact of the V.A. decision, because it was not clear how many of the V.A. patients currently using Avandia would choose to keep taking it.

“We are surprised and disappointed by the V.A. central office decision,” Ms. Rhyne said. “We do not believe it is in the best interest of patients.”

Glaxo has said there were shortcoming in the methodology of Dr. Nissen’s study, a so-called meta-analysis of various clinical trials conducted by other researchers. The company argues that Avandia’s effect on the risk of heart attacks is similar to that of other oral medications for diabetes, including the older, widely used drugs metformin and sulfonylurea.

Dr. Nissen’s findings, however, seemed to have been bolstered by another analysis, conducted at Wake Forest University and published in September in The Journal of the American Medical Association. That study’s conclusion was similar to his.

Dr. Jon LeCroy, a senior pharmaceuticals analyst for the investment and research firm Natixis Bleichroeder, said that before Dr. Nissen’s article last May, about one million prescriptions were being written each month for Avandia.

As of September, Avandia prescriptions had declined about 60 percent, to 426,000 a month, according to Dr. LeCroy.

But he said there had not been a corresponding increase in the use of other drugs for diabetes, indicating that some patients who had stopped taking Avandia had not replaced it in their drug regimens. Diabetes patients often take more than one medication at a time for their conditions.

Actos, a drug similar to Avandia that some studies indicate does not carry the same heart risk, has picked up 100,000 prescriptions a month, but that does not account for the drop of almost 600,000 in Avandia prescriptions.

Ms. Rhyne, of Glaxo, said a survey had shown that 50 percent of patients who discontinued Avandia did not begin another therapy as a substitute. She questioned whether those patients were placing themselves at risk for uncontrolled diabetes.





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