Your Dec. 17 editorial “A sin of omission” incorrectly characterizes how Merck disclosed Vioxx information to the public. As we have previously stated to regulators, the scientific community and the public, Merck submitted cardiovascular data to The New England Journal of Medicine available as of a prespecified cutoff date established by the company.
One of the reasons for specifying a cutoff date in advance is precisely to avoid any later allegation that the data were manipulated.
The final data were provided to the Food and Drug Administration a month before publication of the article and to the agency’s advisory committee, widely disseminated and discussed in the scientific community at large and included in our own press releases. Moreover the small difference between the earlier and final data did not affect any of the conclusions in the article.
Any suggestion that Merck improperly hid data from The New England Journal of Medicine is simply false. When comparing the original draft submission of the manuscript to an earlier draft, the authors did not substitute data. Instead they streamlined the presentation of the same data–the data reported at the time of the prespecified cutoff date–from table to text.
They did not delete updated data reflecting cardiovascular events for patients on Vioxx from this original draft submission.
Moving forward, we remain committed to serving patients as the leading provider of innovative, safe and therapeutic medicines.
Our reputation in the industry, with patients and in our community is that of a company that puts patients first. We intend to keep it that way.
