University issues statement on Vioxx study
On Dec. 8 the New England Journal of Medicine (NEJM) posted on its website an editorial article which calls into question certain data contained in the VIGOR (Vioxx gastrointestinal outcomes research) study published in the NEJM in 2000, whose lead investigator was a faculty member from U of T, Mount Sinai Hospital and the University Health Network. The study examined the gastrointestinal safety of the painkiller Vioxx.
The editorial alleges that at least two of the study's authors failed to disclose certain data that they had become aware of prior to publication. The university and Mount Sinai Hospital have discussed this issue with the lead investigator.
The lead investigator and her co-authors have begun a scientific evaluation of the scientific facts and data that the NEJM published this week. They will make every effort to complete this evaluation - in full accordance with applicable medical and scientific standards - as promptly as possible. Further comment on the data would be inappropriate until that scientific analysis is complete.
This evaluation of data published this week by the NEJM does not constitute or imply any investigation of the research by the university. The university will be closely monitoring further developments reported by the journal, the Food and Drug Administration in the U.S. and Merck & Co and the response of the authors. In the event that any information is brought to light that would require an official investigation by the university, due process would be initiated immediately.
The editorial alleges that at least two of the study's authors failed to disclose certain data that they had become aware of prior to publication. The university and Mount Sinai Hospital have discussed this issue with the lead investigator.
The lead investigator and her co-authors have begun a scientific evaluation of the scientific facts and data that the NEJM published this week. They will make every effort to complete this evaluation - in full accordance with applicable medical and scientific standards - as promptly as possible. Further comment on the data would be inappropriate until that scientific analysis is complete.
This evaluation of data published this week by the NEJM does not constitute or imply any investigation of the research by the university. The university will be closely monitoring further developments reported by the journal, the Food and Drug Administration in the U.S. and Merck & Co and the response of the authors. In the event that any information is brought to light that would require an official investigation by the university, due process would be initiated immediately.
posted by Chris Placitella at 6:27 AM
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