• The extra data would not have changed the take-home message: See the earlier post
• They followed SOP for trials: The authors pointed out that there was a prespecified cutoff date to include events in the analysis. NEJM:
  

  This date, which the sponsor selected shortly before the trial ended, was one month earlier than the cutoff date for the reporting of adverse gastrointestinal events. This untenable feature of trial design, which inevitably skewed the results, was not disclosed to the editors or the academic authors⁵ of the study.
  

  The 3 cardiovascular events...and one more in the naproxen group...occurred only a couple of weeks after the cutoff date, while the paper was first submitted in May. The academic authors were not aware of the cutoff date, and there was an internal memo at Merck noting the events. Sounds bad? Not really. NEJM compounds the sin of their original statement of concern by continuing to add inuendo to their editorial content. The implication is that Merck was even trying to hide the cardiology data from their own coauthors. But the academic authors explain why they didn't know about the prespecified date:
  

  At a time approaching the completion of the study, the data safety and monitoring board (the independent committee [emph added] charged with overseeing any potential safety concerns) recommended to Merck that a data analysis plan be developed for serious cardiovascular events. The data safety and monitoring board stated that they did not feel it appropriate to bring this issue to members of the VIGOR steering committee since they were "not recommending a change to the trial conduct, simply that a prespecified plan be accomplished."³ As a result, a cardiovascular data analysis plan was developed by Merck. Merck indicated that they chose the study termination date of February 10, 2000, as the cutoff date for reporting cardiovascular events to allow sufficient time to adjudicate these events.⁴ Per the data safety and monitoring board recommendation, we were unaware of the cutoff date for reporting of cardiovascular events.
  

• NEJM also suggests that there is something untoward about setting the Feb 10 cutoff date during the study. From my reading of the above, the saftey and monitoring board decided during the study that cardiovascular effects should be added. So, lacking time travel, it seems that Merck could not have set a cutoff date before the study started. If Merck had argued that cardiovascular events should not be studied at all in VIGOR, saying this would introduce an "untenable feature of trial design"...imagine the uproar. The date was still prespecified. Is NEJM claiming that Merck knew before that additional cardiovascular events would make Vioxx look worse. This doesn't make sense, unless NEJM thinks that there was a trend in the timing of problems that Merck could extrapolate past Feb 10.

I lean toward the explanation that the editors of NEJM are simply statistically illiterate.