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Mountains out of molehills: New England Journal of Medicine and VIGOR



The NEJM editorial, which has received a lot of credulous press coverage, looks awfully fishy to me.

  • The "omitted" data in question was outside the pre-determined scope of the study and wasn't available until after NEJM had signed off on the original article. (Executive editor Dr. Gregory Curfman argues that data is routinely updated before publication—but "data is routinely updated" is different from "pre-determined scope of a study is routinely disregarded," which is the issue here. If the latter is true, Merck needs to have a better explanation than this one, or it would appear that data-mining is at issue. Curfman's defensive and non-responsive attack on the Merck response is curious.)
  • The "omitted" data was known to the FDA in 2000 and published in 2001, and the NEJM editorialists admit they knew about it then four years ago.
  • The "omitted" data doesn't materially change any of the conclusions of the study.
  • The "omitted" data were included in Merck press releases.
  • The "omitted" data was right there on the Vioxx insert when Merck added an FDA-approved statement about VIGOR to the labeling in April 2002.

Why make a press release the afternoon of the closing argument? This looks like an attempt to affect the federal trial—and the NEJM editorial writers say they got their information from a deposition.

Even assuming improper data mining (i.e., would Merck have disregarded the scope of the study to provide positive data?) where is the proximate causal harm from the chronological difference between the NEJM Bombardier publication and the release of the full study? The additional data doesn't make the statistically insignificant risk-ratios statistically significant; it doesn't even change the percentages used in the Bombardier article for non-aspirin-indicated MI risk (0.2% before; 0.2% after).

Update: Evan Schaeffer and Kevin MD comment. As Evan points out (though he wouldn't phrase it the same way), the perception of the story is more important than the reality with respect to one of Merck's star witnesses. Forbes has done follow-up reporting.

 

 


Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute
igorodetski@manhattan-institute.org

Katherine Lazarski
Press Officer,
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.