February 22, 2006

Both the non-Merck and Merck authors of VIGOR defend their study to the NEJM. (See also Dec. 15 Merck press release.) As previously discussed here, (1) the cardiovascular events were excluded from the publication because of a predetermined cut-off date, and were submitted to the FDA and doctors; and (2) the omission of the three cardiovascular events changes none of the conclusions of the study. Most interestingly is the revelation that (3) the "deleted" table was not deleted at all, but revised to be presented as part of the text, with no loss of information in the article. This last fact is especially damning, as it shows that NEJM's allegations of wrongdoing (which highlighted the deletion as evidence of sinister intent) are especially disingenuous. It's encouraging that plaintiffs' first attempt to use the NEJM editorial as a weapon didn't unfairly prejudice Merck in the Plunkett Vioxx trial. Previous coverage: Feb. 14; Jan. 8; Dec. 16; Dec. 10; Dec. 8.