Avandia: The RECORD study

GSK rushes out interim results hoping to calm the Avandia backlash, and the headlines and quotes are all over the place:

An interim analysis of a study involving GlaxoSmithKline PLC’s Avandia showed the diabetes drug was associated with an increased heart-failure rate, but there appeared to be no increase in the death rate from heart attacks or strokes, researchers said.

“Overall, we feel these results are very reassuring.”

AP headline:
“Newest Avandia Study Not Reassuring”

Steven Nissen:
The heart risk trend in patients on Avandia “is going in the wrong direction.”

“In short, this means that there is continued uncertainty about the cardiovascular safety of rosiglitazone . . . In this age of freely available information, drugs cannot easily be parsed into ‘safe’ and ‘unsafe’ categories. Instead, there will be shades of safety that must be graded against shades of efficacy.”

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