The Food and Drug Administration's meeting next week to decide the fate of the blockbuster diabetes drug Avandia promises to be a nail-biter—on a par with last night's ESPN special to reveal which lucky team basketball star LeBron James had chosen. But just like ESPN's LeBron prognosticators, I'll make a prediction: I'm guessing Avandia's fate may already be decided—if the meeting materials posted by the FDA today are any indication. While some prominent researchers (including those at the FDA) have demonstrated that Avandia is associated with an increased risk of strokes, heart attacks, and heart-related deaths, clinical trials conducted by manufacturer GlaxoSmithKline have found no increase in cardiovascular risks.
But here's the rub: When Thomas Marciniak, an FDA medical team leader, analyzed one of the recent GSK-sponsored trials, he discovered that the company had made mistakes in its data analysis and that increased heart risks were indeed present in Avandia users. In some cases, the researchers who conducted the so-called "Record" study, one of the trials cited by GSK, failed to count heart attacks and hospitalizations as heart-related conditions and didn't investigate some deaths in Avandia users to see whether they may have been caused by the drug. In a memo posted today on the FDA website, Marciniak called the study "inadequately designed" and alleged it was conducted to reassure the public of the drug's safety even though the data suggested otherwise. Another analysis comparing Avandia with Actos, the only other diabetes drug in the same class, found that the likelihood of major heart events like heart attacks or strokes "tended to be less" with Actos and "tended to be greater" with Avandia, according to FDA statistician Bradley McEvoy.
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