Report on diabetes drug Avandia raises questions about FDA accountability

The diabetes drug, Avandia is back in the news--if you noticed the article in the Cleveland Plain Dealer--because of its association with increasing the risk of heart attack.

Dr. Steven Nissen , who chairs cardiovascular medicine at the Cleveland Clinic, was the author of a study in the New England Journal of Medicine in 2007, which found Avandia was associated with a 43-percent increased risk of heart attacks. (See Nissen's paper here; rosiglitazone is the generic name for Avandia.) His paper prompted the FDA to issue a warning.

"The drug's maker, GlaxoSmithKline, defended the product," Sarah Jane Tribble writes in the newspaper. "Now, it turns out, the drug maker privately confirmed Nissen's findings."

The story references a government report that was released over the weekend. The New York Times also wrote about the report, starting a story with the alarming assertion that: "Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market."

It goes on to say the drug was linked to 304 deaths during the third quarter of 2009.

The FDA issued a drug safety communication today, saying its officials are still reviewing a long-term clinical study of the drug and have no conclusions or recommendations yet about its use. The posting on the FDA Web site says, "Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional."

Read the Cleveland Plain Dealer story.

Read The New York Times story.