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FDA panel scrutinizes diabetes drug

There's a lot of attention Tuesday on a special meeting of federal scientific advisers who are meeting outside Washington. The Food and Drug Administration convened the panel for an unusual two-day hearing to help the agency decide whether a controversial diabetes drug should stay on the market.

The drug, called Avandia, was approved in 1999 and quickly became the world's most popular drug to treat Type 2 diabetes, which is the most common form of the disease. The drug does a good job of lowering blood sugar levels by making the body more sensitive to insulin.

But in 2007 Cleveland Clinic cardiologist Steven Nissen published a study that concluded that the drug significantly increased the risk for cardiovascular problems. That's a huge concern because heart attacks and strokes are the biggest threat to people with diabetes. So the idea that a drug that is supposed to protect them from those threats actually increases it is a major worry. Sales of Avandia plummeted and the FDA issued strong new warnings about the drug's safety. But after a special panel of advisers voted to keep the drug on the market, the FDA decided not to pull it.

Critics have charged that the decision to leave Avandia on the market illustrated the agency's failure to protect the public from dangerous drugs, especially in the wake of high-profile drug safety problems such as Vioxx. Since 2007, more evidence has continued to emerge that Avandia is dangerous. Two recent new studies, including an update of Nissen's original analysis and another by an FDA scientist, concluded once again the drug is dangerous. There also have been allegations that the company that makes Avandia knew about the risks but hid them.

GlaxoSmithKline, which makes Avandia, has steadfastly defended the drug, arguing that other studies have found no increased risk from the drug. The company, some diabetes doctors and even some patients say it should stay on the market to give diabetics the option of using it if they need it.

For its part, the FDA has been deeply divided about Avandia. Those divisions were clear when the agency posted more than 700 pages of documents on its Web site last week in preparation for this week's meeting. Among those documents was a devastating critique by one FDA scientist of a study GlaxoSmithKline sponsored and has held up as the best evidence of the drug's safety. Another FDA investigator challenged that critique.

So it should be an intense couple of days in a hotel outside Washington where the panel is meeting. The experts will vote Wednesday. They could recommend a variety of options, ranging from allowing the drug to stay on the market to pulling it.

Whatever they recommend, it will be up to FDA Commissioner Margaret Hamburg to make a final decision. FDA commissioners usually follow the advice of the agency's expert panels, but they don't have to. Hamburg, who was appointed by President Obama, has promised to make drug safety a priority for the agency. So many observers are watching what the agency does about Avandia as a potentially defining moment for the FDA under the new administration.

By Rob Stein  |  July 13, 2010; 11:15 AM ET
Categories:  Diabetes , Health Policy , Obesity  
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Next: Do doctors rat on each other?


There are a few interesting related write-ups to this at the Skeptic's Health Journal club. Avandia and Earwax
provides the background of what the Senate funded investigation into Avandia found. David Graham and the tragedy of Vioxx parts I and II discuss in part I, some of the culture at FDA and in part II the specifics of what occured with the withdrawal of Vioxx. If anyone is interested those may be accessed here.

Yes Avandia needs to be recalled, the risk/benefit ratio is not there for a me-too diabetes drug and how strange and sad that a senator had to use his own staff resources to research and bring attention to this issue, something FDA should have done on its own.

Posted by: LincolnsWisdom | July 13, 2010 8:00 PM | Report abuse

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