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Report Says FDA Should Review Existing Drug Safety Data

Justin Sullivan
Getty Images

Critics of Avandia may get a boost in their efforts to get the diabetes drug taken off the market - or at least stop an ongoing clinical trial looking at the drug's safety compared to another.

At the FDA's request, the Institute of Medicine released a report offering the agency some advice on the ethically proper way to study the safety of drugs already on the market.

Bear with us. It's a little wonky. A key conclusion is found on page 6:


"Before a clinical trial is selected as the design of choice, it should be determined that no other research or information gathering effort - including a new observational study -- can reduce the uncertainty about a drug's risk-benefit profile," the report says.

English translation: Look at what you have before you subject more patients to more risks. It seems there's a whole lot of studies - observational and otherwise - pointing out an increased risk of heart attacks and stroke in people taking Avandia.

The IOM letter comes on the same day the FDA dumped 700-plus pages of documents revealing its long, conflicted battle to determine the drug's safety.

By and large, those documents suggest FDA is well aware of the risks. And an advisory panel will meet next week to discuss whether to take it off the market, increase the warnings on the label, or stop the ongoing safety trial Avandia maker GlaxoSmithKline is conducting.


As Mathew Herper points out in Forbes, the documents reveal deep divisions within the agency over the issue, but it generally looks bad for Avandia.

For example, Thomas A. Marciniak, a medical team leader in the FDA division that regulates heart and kidney drugs, reviewed the patient records from GSK's original trial. He found more heart attacks that should have been counted -- all in patients on Avandia.

In response, Ellis F. Unger, a deputy director in the FDA's Office of Drug Evaluation, argues that the missing heart attacks didn't make a big difference in the overall results.

GSK stands by the drug and says its studies show no increased risks of heart attack.

Tune in to All Things Considered this afternoon, when Joanne Silberner talks with Host Melissa Block, about what happens next on Avandia.

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