Medical Reviewer Disputes Findings That Avandia is Safe

A medical reviewer for the U.S. Food and Drug Administration contends drug giant GlaxoSmithKline got it wrong when it proclaimed a study found its popular diabetes drug Avandia is safe.

In fact, Dr. Thomas Marciniak, in a posting on the FDA web site, said the study actually shows the opposite - Avandia may cause heart attacks.

Marciniak's review is part of an FDA effort to brief an expert panel scheduled to convene later this month to determine whether questions about Avandia are serious enough to require its removal from the marketplace. GSK's analysis was part of its case that the drug should not be removed.

But in looking at the data, Marciniak wrote that the information in the study was so misinterpreted that it's hard not to conclude it was done on purpose.

"One does not have to be a mathematician or to perform calculations to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks," Marciniak writes.

Some health advocates have long demanded Avandia's removal from the market. In 2008 the consumer group Public Citizen petitioned the FDA to institute an immediate ban of the drug. The group said at the time the drug is dangerous and can cause death from liver failure and many other life-threatening risks.

At the time, Public Citizen released new research about the drug, used to treat Type 2 diabetes, that is said raised concerns about the drug's risks.

"The scientific consensus against Avandia is overwhelming," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, when the research was released two years ago. "The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug."

Some patients taking Avandia have complained to ConsumerAffairs.com over the years about health complications while taking the drug.

"I was prescribed Avandia and took it for about a year," Wayne, of Seffner, Fla., told ConsumerAffairs.com in 2009. "After having chest pains I had to do the stress test and was put into the hospital . After the heart specialist determined my heart was OK he told me to stop taking the medication. Several thousand dollars later!" (More complaints)

GSK, meanwhile, stands behind its assessment that Avandia is safe.

"Since 2007, we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia, and together they show that this medicine does not increase the overall risk of heart attack, stroke, or death," said Dr. Murray Stewart, GSK's vice president for clinical development.