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Thursday, May 18th 2006

More From APPROVe

I wish Reuters and NPR wouldn’t print this as fact.

A 107-page report provided to the Food and Drug Administration by Merck last week included data from a four-year study suggesting the risk started much earlier, NPR said.

“Experts who have reviewed (the data) for NPR say it shows that patients were at higher risk of heart problems and strokes almost as soon as they started taking Vioxx,” NPR said.

Merck, which is facing thousands of lawsuits alleging harm from Vioxx, disagreed with NPR’s description of the report.

The Reuters headline states matter of factly that, “Vioxx risk seen with short-term use”. In reality, the risk is statistically insignificant and while that doesn’t play well in court rooms the best way to think about it in lay terms is like the +/- 3 percentage points on a political poll. The poll isn’t completely accurate, and neither is the statistical analysis of this data. The increased risk of cardiovascular events with short term Vioxx consumption in this data falls within that range of “error”.

Still, In the Pipeline is concerned about it.

Which is fine, as far as it goes. A more objective look at the data, though, show that they didn’t miss statistical significance by all that much. The numbers seem to be all against Vioxx, which is enough to make you wonder if the lights would have truly flashed red in a more statistically appropriate study. As it is, Merck is in the position of saying that a study which wasn’t expected to show a statistical difference between Vioxx and placebo heart safety didn’t show a difference – and that that’s good news.

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