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NEJM expression of concern on the VIGOR trial, 2005

Editors' notice of 29 December 2005 about missing heart attack data in the 2000 report of a Vioxx trial.

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Dates
29 Dec 2005
The debate

What it found

Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal.1

Who disputes it

  • Merck Dec 2005

    The additional events referred to in the editorial were events that were reported after the pre-specified cut-off date2

Each side is quoted in its own words. Whether a finding holds is not decided here.

Connections 2

finding disputed by

author

Timeline 3 dates
  1. Dec 2005 Merck disputes a finding of NEJM expression of concern on the VIGOR trial, 2005 According to Merck
  2. 29 Dec 2005 NEJM expression of concern on the VIGOR trial, 2005
  3. 29 Dec 2005 The New England Journal of Medicine authored NEJM expression of concern on the VIGOR trial, 2005
Proof 2 sources
  1. Expression of Concern: Bombardier et al., "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis," N Engl J Med 2000;343:1520-8, The New England Journal of Medicine, 29 Dec 2005. Scholarship & press
    Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal.
  2. Vioxx study questioned by medical journal, Manufacturing Chemist, 12 Dec 2005. Scholarship & press
    The additional events referred to in the editorial were events that were reported after the pre-specified cut-off date
    additional events did not materially change any of the conclusions in the article
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