FDA Scientists Do Not Find Misconduct in Avandia Trial Data

FDA Scientists Do Not Find Misconduct in Avandia Trial Data

June 3rd, 2013 // 11:57 pm @

Latest FDA and cGMP Compliance News

A review of clinical trial data on the safety of Avandia did not reveal any fraud or misconduct, according findings by FDA scientists that were posted today on the agency website.

These conclusions got a good deal of heat from the FDA scientist who first called foul on the study. FDA officials posted various viewpoints on the issue online just before a two day advisory panel is going to meet this week that is going to go back over the acrimonious debate on the diabetes drug. The use of Avandia has been restricted since 2010 when several analyses showed that there was a major risk for heart attacks when some patients were on the drug. European regulators have removed the drug from the market entirely.

The FDA advisory panel this week is going to determine if access to the drug should be increased, to keep the restrictions, change them or to take Avandia off the market. Avandia once was a huge seller but now is only a last resort for the patients who do not respond to other drugs, or have such a serious condition that it is worth the risk of heart attack.

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Dr. Thomas Marciniak, the FDA reviewer who argues against the use of Avandia, stated online this week on the agency website that he did not think the review would be objective because it was done by researchers at Duke, and the study was financed by GSK. He noted that the drug firm had given all documentation to Duke, which, he said, compromised the researchers’ independence.

FDA staff  have verified the conclusions of the reviewers at Duke, that any errors made by GSK did not have effects on the trial’s conclusions.

A frank memo was posted on the agency site today, where three top FDAers blasted Dr. Marciniak. They said his criticisms were not professional and were actually an insult to FDA.

The Duke review did not find any difference in the rate of death for patients who took Avandia and patients who took another diabetes drug.

Some experts wonder why FDA is taking time to reevaluate the drug because most evidence shows Avandia is risky. An analysis of 50 studies showed Avandia carries a higher risk of heart attack.

The advisory panel will make a recommendation after the conclusion of the two day meeting this week.


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