Expression of Concern Reaffirmed

Curfman, Gregory D.; Morrissey, Stephen; Drazen, Jeffrey M.

doi:10.1056/nejme068054

Cited by 109Pharmaceutical industry and healthcareInflammatory mediators and NSAID effectsPharmacovigilance and Adverse Drug Reactions

Expression of Concern Reaffirmed

Curfman, Gregory D., Morrissey, Stephen, Drazen, Jeffrey M.·2006·New England Journal of Medicine

DOI 10.1056/nejme068054

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Abstract

On December 8, 2005, we published an expression of concern1 regarding an article by Bombardier et al. on the Vioxx Gastrointestinal Outcomes Research (VIGOR) study that was published in the Journal on November 23, 2000.2 Our expression of concern was prompted by evidence that the VIGOR article did not accurately represent the safety data available to the authors when the article was being reviewed for publication. More than four months before the article was published, at least two of its authors were aware of critical data on an array of adverse cardiovascular events that were not included in the VIGOR . . .

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How harms outcomes are assessed will affect the results obtained.
“How harms outcomes are assessed will affect the results obtained.276 277 278 279”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [278]

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COMPARISON OF UPPER GASTROINTESTINAL TOXICITY OF ROFECOXIB AND NAPROXEN IN PATIENTS WITH RHEUMATOID ARTHRITIS
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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.
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Self-citation
Response to Expression of Concern Regarding VIGOR Study
Bombardier, C., Laine, L., Burgos‐Vargas, R., Davis, B. R., Day, R. O., Ferraz, M. B., Hawkey, C. J., Hochberg, M. C., Kvien, T. K., Schnitzer, T. J., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmc066096 · Cited by 29 · see citing works

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Authors: Curfman, G. D., Morrissey, S., & Drazen, J. M.
ORCID: Curfman, Gregory D.
Morrissey, Stephen
Drazen, Jeffrey M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2006-03-16
Volume: 354
Issue: 11
Pages: 1193-1193
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejme068054
OpenAlex: W1998613929
Cited by: 109
References: 4
Citations by year: 2025: 14 · 2023: 1 · 2022: 3 · 2021: 2 · 2020: 1 · 2019: 1 · 2018: 2 · 2017: 1 · 2016: 4 · 2015: 3 · 2014: 5 · 2013: 6 · 2012: 6
Type: journal article
Language: en
Open access: closed
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Health Sciences › Medicine › Pharmacology › Inflammatory mediators and NSAID effects
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: rofecoxib, VIGOR trial, cardiovascular adverse events, drug safety, publication integrity, expression of concern
MeSH terms: Arthritis, Rheumatoid, Cardiovascular Diseases, Gastrointestinal Diseases, Humans, Lactones, Myocardial Infarction, Naproxen, Research Design, Sulfones, Thromboembolism

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