GlaxoSmithKline diabetes drug Avandia faces more criticism

Two prominent consumer groups have warned that diabetes patients should not take GlaxoSmithKline P.L.C.'s drug Avandia because of dangerous side effects and the availability of equally effective treatments.

Public Citizen, a consumer advocacy group, called on Thursday for the U.S. Food and Drug Administration to take Avandia off the market, citing several life-threatening risks, including heart and liver damage.

That followed updated treatment guidelines issued last week by the American Diabetes Association, a leading patient advocacy group, which recommended against using Avandia. The group said it's not clear whether Avandia increases heart-attack risks but argued that other treatments are available. The association's Web site says it receives funding from pharmaceutical companies, though not currently from GlaxoSmithKline.

But another group, the American Association of Clinical Endocrinologists, whose members treat diabetic patients, continues to support using Avandia.

The physicians' group said Avandia has "been shown useful and effective in controlling glucose, a crucial step to preventing diabetes complications" such as loss of vision. The group's Web site says it gets support from pharmaceutical firms, including GlaxoSmithKline.

A GlaxoSmithKline statement urged patients taking Avandia or other medicines to control blood sugar levels to remain on therapy, unless their doctor advises a change. The company said two large, long-term studies have shown Avandia to be safe.

GlaxoSmithKline also denied Public Citizen's claim that Avandia increases the risk of liver toxicity. The company, which has U.S. headquarters in Philadelphia and Research Triangle Park, N.C., said an outside panel of experts has reviewed liver effects of Avandia repeatedly and considers the drug safe.

"There is currently no evidence of liver concern with Avandia, with most information actually suggesting liver benefit," said Zachary T. Bloomgarden, an endocrinologist at Mount Sinai Medical Center in New York, who chaired AACE's recent position statement on Avandia. He also has received grants and fees from many drug firms, including GlaxoSmithKline.

The FDA said it will carefully review Public Citizen's petition to pull Avandia off the market, "as we do all citizen petitions."

Avandia already has suffered from bad publicity surrounding the drug.

Avandia sales shrank 67 percent to $230 million in the first four months of 2008 compared to the same period in 2007, according to data provider IMS Health.

The drug's sales started shrinking after a New England Journal of Medicine article in May 2007 raised questions about whether Avandia increased heart-attack risk. Some reasearchers, including Bloomgarden, disagree with the methodology used in that article.