Studies Suggest Heart Risk With Diabetes Drug Avandia

People with diabetes have a higher than average risk of having a heart attack or stroke, more than twice as often as people without diabetes, according to the American Diabetes Association.

"The whole purpose of treating diabetes in the first place is to prevent the complications of diabetes -- chief of which is heart disease, stroke, and premature mortality," said Graham. "What sense does it make to give a drug that increases all three?"

And many experts agree, saying they stopped prescribing Avandia to patients when reports were first released about its potential harm.

"I have not used Avandia for years," said Dr. John Messmer, associate professor of family and community medicine at Pennsylvania State College of Medicine. "I noted that too many of my patients retained fluid, became hypertensive and even had worsening heart failure, so I discontinued using it even before the warnings came out."

These Studies Don't Say Much, Some Experts Said

Some experts said these reports do not show enough evidence to pull the drug from the market.

Dr. Christopher Cannon, cardiologist at Brigham and Women's Hospital in Boston, said both of the studies drew opposite conclusions. The first study found a higher risk of heart attacks compared to other drugs, while the second one, which compared to Avandia to Actos, did not.

"This raises questions on what to believe, and thus more randomized data would be the key here," said Cannon.

Besides the actual data, some experts said the premise of these studies feeds into a long-standing motivation by the authors to persuade the FDA to pull Avandia from the market.

"I feel the publication and presentation of these studies were orchestrated for political motives, not for scientific reasons," said Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York. "These two newer reports will undoubtedly contribute to the political football played by the FDA, even when they did not contribute to relevant new data."

According to the Dr. Domenic Sica, chairman of clinical pharmacology and hypertension at Virgina Commonwealth University in Richmond, many studies released on Avandia are not as strong as the study authors typically present.

"Sometimes the motivation for attacking a drug is personal, and it is often quite difficult in separating out the really bad with a drug from the perception of bad on the part of an author," said Sica. "Do I think that this drug should be pulled from the market? No."

According to a statement released by GlaxoSmithKline, the company also reviewed the updated studies on Avandia and said that stronger studies, such as the randomized control trial Record, do not find an increased heart attack risk with the drug.

"GSK also has updated its prior meta-analysis to include data from 52 clinical trials, and it does not show an increase in [angina]," GlaxoSmithKline wrote in a statement. "Review of these studies with tighter confidence intervals have risk ratios that are very close to one, indicating no difference in the risk of [heart attack] between rosiglitazone [Avandia] and pioglitazone [Actos]."

Call for Action

Doctors prescribe Avandia to lower blood sugar in diabetes patients, but there are more than a dozen classes of diabetes treatments available that are now used as alternatives to Avandia, many experts said.

"Almost everyone can see the clear difference between public health and public endangerment," said Wolfe.

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