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Drug Maker Accused of False Advertising

Clinical trials showed a connection between Avandia and heart problems

A county in the U.S. state of California is suing GlaxoSmithKline, the maker of Avandia, a controversial diabetes drug. The lawsuit was spurred by a report on the drug released by the U.S. Senate last week (March 22). That report accused the drug company of withholding information about side effects of serious heart problems, including death. At issue now is whether Avandia should be taken off the market.

A U.S. Senate report on the diabetes drug Avandia says both the manufacturer, GlaxoSmithKline, and the U.S. Food and Drug Administration should have warned patients about the dangers of the drug years before they did. The report recommends taking Avandia off the market.

In 2007, Dr. Steven Nissen published a study showing that those taking Avandia had a 43 percent higher risk of having a heart attack and a 64 percent greater chance of dying from a heart attack than those not taking the drug. "We've been warning about this for two and a half years," he said. "There really isn't a good reason for physicians to continue to prescribe the drug. It's time to get it off the market."

But doctors still prescribe Avandia to hundreds of thousands of patients worldwide.

Dr. Yasser Ousman at Washington Hospital Center prescribes it for some pre-diabetic patients or those in the early stages of diabetes. "There are a number of drugs that have been tested in these individuals and Avandia is one of them, and actually, it is quite effective in improving the blood sugar, in normalizing the blood sugar or delaying the occurrence of diabetes in these individuals," Dr. Ousman said.

"What bothers me the most is that every month that goes by, more people are harmed by a drug that people simply don't need," Dr. Nissen said. Dr. Nissen's report was based on 42 clinical trials that showed a connection between Avandia and heart problems.

"I think when you look at the information and the statistics from the initial study, the initial paper by Dr. Nissen in 2007, the increase in the risks of heart attacks is actually small," Dr. Ousman points out. He says that many over the counter drugs - aspirin, ibuprofen, acetaminophen or paracetamol - can be toxic if used improperly.

"If you look at the large studies, that were published over the last several years, including a large number of patients comparing Avandia to a placebo or other drugs, there was actually no increase in that risk. That risk was based on smaller studies," Dr. Ousman said.

A study on Avandia funded by GlaxoSmithKline published last year, found no increase in heart attacks. But it found a significant increase in the risk of heart failure where the heart cannot pump enough blood to the organs or muscles. A number of cases resulted in hospitalization or death.

The Food and Drug Administration says it will review Avandia for heart risks and has scheduled a meeting of its advisory panel in July. The agency warns those taking Avandia not to discontinue use without consulting with a doctor.