What have we learnt from Vioxx?
Open accessAbstract
In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation. But researchers and journals can still benefit from this case if they learn from the mistakes, write Harlan Krumholz and colleagues
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Although the analysis is secondary, reanalyses of clinical trial data have led to the detection of adverse events well after the market entry of major drugs such as rofecoxib and rosiglitazone.
“Although our analysis is secondary, reanalyses of clinical trial data have led to the detection of adverse events well after the market entry of major drugs such as rofecoxib and rosiglitazone. [36,37]”
From Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults (2022) · cites this paper as [36]
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Boutron, I. (2010) · JAMA · doi:10.1001/jama.2010.651 · Cited by 842 · see citing works
Antman, E. M., Bennett, J. S., Daugherty, A., Furberg, C., Roberts, H., & Taubert, K. A. (2007) · Circulation · doi:10.1161/circulationaha.106.181424 · Cited by 804 · see citing works
Reporting bias in medical research - a narrative review
McGauran, N., Wieseler, B., Kreis, J., Schüler, Y.-B., Kölsch, H., & Kaiser, T. (2010) · Trials · doi:10.1186/1745-6215-11-37 · Cited by 452 · see citing works
Reporting of Safety Results in Published Reports of Randomized Controlled Trials
(2009) · Archives of Internal Medicine · doi:10.1001/archinternmed.2009.306 · Cited by 287 · see citing works
Fraiman, J., Erviti, J., Jones, M., Greenland, S., Whelan, P., Kaplan, R. M., & Doshi, P. (2022) · Vaccine · doi:10.1016/j.vaccine.2022.08.036 · Cited by 228 · see citing works
“[36,37] Our analysis has an advantage over postmarketing observational studies in that the data are from blinded, placebo-controlled randomized trials vetted by the FDA, which were matched against a list of adverse events created before the availability of the clinical-trial results and designed…”
MethodMapping conflict of interests: scoping review
Chimonas, S., Mamoor, M., Zimbalist, S. A., Barrow, B., Bach, P. B., & Korenstein, D. (2021) · BMJ · doi:10.1136/bmj-2021-066576 · Cited by 54 · see citing works
- Authors
- Krumholz, H. M., Ross, J. S., Presler, A. H., & Egilman, D. S.
- Affiliations
- Yale University (US)
- Icahn School of Medicine at Mount Sinai (US)
- Never Again Consulting, Attleboro, MA, USA
- Brown University (US)
- Corresponding author
- Krumholz, Harlan M
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2007-01-18
- Volume
- 334
- Issue
- 7585
- Pages
- 120-123
- ISSN
- 1756-1833 (ISSN-L)
- 0959-8138
- PMC
- PMC1779871
- OpenAlex
- W2011949050
- Cited by
- 267
- References
- 0
- Citations by year
- 2026: 6 · 2025: 25 · 2024: 15 · 2023: 15 · 2022: 5 · 2021: 15 · 2020: 15 · 2019: 12 · 2018: 17 · 2017: 13 · 2016: 10 · 2015: 12 · 2014: 9 · 2013: 9 · 2012: 12
- FWCI
- 14.47
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Inflammatory mediators and NSAID effects
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- rofecoxib, Merck, drug safety, cardiovascular events, litigation, pharmaceutical industry
- MeSH terms
- Cardiovascular Diseases, Drug Industry, United Kingdom, Humans, Interprofessional Relations, Lactones, Risk Factors, Sulfones, Time Factors, United States, Scientific Misconduct, Compensation and Redress, Cyclooxygenase 2 Inhibitors
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