Vioxx: More Debate, More Data

As doctors struggle to come to grips with what the withdrawal of Vioxx means for drug safety, the letters pages of the normally sedate New England Journal of Medicine have turned into a battleground.

... letter from Merck ... Vioxx increased the risk of heart attack. ..."significant" increase in heart attack and stroke in patients taking Vioxx ...Merck's scientists have publicly defended ... pulled it off the market. ... Merck wasn't aware of the possible risks to the heart posed by Vioxx, perhaps it should have been. ... the development of Vioxx, ... evaluating the cardiovascular profile of rofecoxib (Vioxx)... clinical evidence of a heart risk for Vioxx. Based on a theoretical risk alone, ... studies that could also assess any risk Vioxx caused to the heart. ... resulted in Vioxx being pulled from the market.

Merck's defense all along has been that Vioxx looked bad because naproxen, another pain killer that it was compared to, actually protected the heart. Naproxen is an older drug sold by Bayer (nyse: BAY - news - people ) as Aleve.

But in his response, Topol looks at data from a previous study that compared 390 patients taking Vioxx to 588 patients taking a placebo. ...patients taking Vioxx had heart attacks or strokes, ... The data he based his analysis on has previously been buried in FDA briefing documents. (See: "Eight Questions Merck Must Answer") Merck's Peter Kim has said in interviews that '090' was too small to be considered a strong result...

Forbes