![]() Bombardier, who holds a Canada Research Chair in her field and who has been a Merck consultant on Vioxx since 1997, said in an e-mail to The Globe and Mail last night: "I believe that the VIGOR paper appropriately disclosed the data as per the pre-specified plan of analysis."ĭr. ![]() "We have asked the authors to submit a correction to the Journal."ĭr. "Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article," Dr. What is more, the editors wrote, "We determined from a computer diskette that some of these data were deleted from the VIGOR manuscript two days before it was initially submitted to the Journal on May 18, 2000." If those data had been included, the editors feel the heart safety of the drug could have been viewed differently. "Given this memorandum, it appears that there was ample time to include the data on these three additional (heart attacks) in the article." They went on to note the authors appeared to have had the information "at least two weeks before" they submitted revisions and four and a half months before publication of the article. "Until the end of November 2005, we believed that these were late events that were not known to the authors in time to be included in the article," the editors wrote. The memo shows at least two of the three authors, whom it does not name, knew before the study was published that there had been three more heart attacks among patients taking Vioxx than had been reported. In the on-line editorial, the editors wrote that court documents connected to a Vioxx lawsuit that were obtained in November revealed a memo dated July 5, 2000. Bombardier was the lead author, hers, as is customary when citing medical-journal reports, is the main name mentioned. The journal report does not specifically identify which authors it believes withheld data from the 2000 VIGOR article. ![]() ![]() But in an "expression of concern" published on-line yesterday, journal executive editor Gregory Curfman and colleagues said the VIGOR study understated the risk of heart attacks attributed to Vioxx and that "certain calculations and conclusions" were both incorrect and misleading. ![]()
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