To the editor:

Merck is committed to the highest standards of scientific integrity and patient safety. Your editorial “Truth in Numbers” (January 2006) incorrectly characterizes how we disclosed information regarding the VIGOR study. I am writing to set the record straight.

As we have previously stated, Merck submitted cardiovascular data from the VIGOR study to the New England Journal of Medicine (NEJM) that were reported to Merck as of a prespecified cutoff date. One of the reasons for specifying a cutoff date in advance is precisely to avoid any later allegation that the data were manipulated.

Any suggestion that Merck improperly hid data from NEJM is simply false. The editorial states that “three additional heart attacks had been omitted from the published data” and that “relevant data were removed from the manuscript before its submission to the journal.” These statements are incorrect. As we have stated previously, these data were never included in the draft manuscript. During revision, the authors did change the format of presentation—from table to text—for the cardiovascular data. But, at all times, the data were those obtained as of the prespecified cutoff date.

The final data were provided to the US Food and Drug Administration (FDA) a month before publication of the article and were discussed at the public February 2001 meeting of the FDA Advisory Committee. In addition, the final data were widely disseminated and discussed in the scientific community at large and in the public media. Moreover, the small difference between the earlier and final data did not change the article's conclusion that there was a statistically significant difference in the rate of heart attacks between individuals taking Vioxx and individuals taking naproxen in the VIGOR study.

Merck has a long-standing tradition of providing innovative, safe drugs and vaccines that address unmet medical needs. We remain committed to this mission and to upholding the highest standards of scientific integrity.