Errors and Omissions

A big Vioxx "oops" from the New England Journal of Medicine

From the NEJM, released today (full text here):

Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial

Which reads, in part:

In the reported results, the test for proportionality of hazards used linear time rather than the logarithm of time that was specified in the Methods section. Analysis using the logarithm of time leads to the following changes: The first complete paragraph on page 1097 should have read, "In a post hoc assessment, visual inspection of Figure 2 suggested that the Kaplan-Meier curves separated 18 months after randomization. However, the results of an overall test of the proportional-hazards assumption for the entire 36-month observation period did not reach statistical significance (P = 0.07)."

Therefore, statements regarding an increase in risk after 18 months should be removed from the Abstract (the sentence "The increased relative risk became apparent after 18 months of treatment; during the first 18 months, the event rates were similar in the two groups" should be deleted, as should the sentence beginning "There was earlier separation . . . ") and from the Discussion section (the sentence "In post hoc analyses, the increased relative risk of adjudicated thrombotic events was first observed after approximately 18 months of treatment" should be deleted).

Meaning what, exactly? Well, here's how Reuters explains it (full text here):

The journal and the authors corrected the May 2005 study to show the risks do not, as originally shown, greatly increase after 18 months. In fact, it is not possible to tell when the risk of heart attack or stroke shoot up, Journal editor Dr. Jeffrey Drazen said."

That sound you hear is a thousand product-liability lawyers cursing.

newspapers, media, errors, medicine

posted by Unknown @ 6/26/2006 06:39:00 PM