ADVANTAGE: Merck Does Say No
Authors: Harold C. Sox, Drummond Rennie
Journal: Annals of Internal Medicine (2008)

LettersNovember 18, 2008ADVANTAGE: Merck Does Say NoHarold C. Sox, MD, Editor and Drummond Rennie, MDHarold C. Sox, MD, EditorFrom Annals of Internal Medicine, Philadelphia, PA 19106, and JAMA, Chicago, IL 60610.Search for more papers by this author and Drummond Rennie, MDFrom Annals of Internal Medicine, Philadelphia, PA 19106, and JAMA, Chicago, IL 60610.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-149-10-200811180-00028 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Dr. Edelman writes that ADVANTAGE could not have been a seeding trial because the Annals editors decided to publish it, which would imply that the trial had scientific value. We knew about the VIGOR (Vioxx Gastrointestinal Outcomes Research) trial (1), which was published in 2000 and compared Vioxx with naproxen in patients with rheumatoid arthritis. VIGOR showed that Vioxx had significantly fewer gastrointestinal side effects than naproxen. We published the ADVANTAGE trial (2) because it framed the same findings in a different way: It showed that the margin between the new drug and the comparatoralso naproxenwas narrow (5.9% ...References1. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, et al. VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000;343:1520-8, 2 p following 1528. [PMID: 11087881] Google Scholar2. Lisse JR, Perlman M, Johansson G, Shoemaker JR, Schechtman J, and Skalky CS; ADVANTAGE Study Group. Gastrointestinal tolerability and effectiveness of rofecoxib versus naproxen in the treatment of osteoarthritis: a randomized, controlled trial. Ann Intern Med. 2003;139:539-46 LinkGoogle Scholar3. Proceedings of the ADVANTAGE Study Investigators Meeting, Los Angeles, California, 25 March 1999. Bates Nos. MRK-APU0025051 to MRK-APU0025303. Accessed at dida.library.ucsf.edu/tid/vio29x10 on 23 September 2008. Google Scholar4. Sugarman J, Kass NE, Goodman SN, Perentesis P, Fernandes P, and Faden RR. What patients say about medical research. IRB. 1998;20:1-7. [PMID: 11657084] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Harold C. Sox, MD, Editor; Drummond Rennie, MDAffiliations: From Annals of Internal Medicine, Philadelphia, PA 19106, and JAMA, Chicago, IL 60610.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoGastrointestinal Tolerability and Effectiveness of Rofecoxib versus Naproxen in the Treatment of Osteoarthritis Jeffrey R. Lisse , Monica Perlman , Gunnar Johansson , James R. Shoemaker , Joy Schechtman , Carol S. Skalky , Mary E. Dixon , Adam B. Polis , Arthur J. Mollen , Gregory P. Geba , and The ADVANTAGE Seeding Trial: A Review of Internal Documents Kevin P. Hill , Joseph S. Ross , David S. Egilman , and Harlan M. Krumholz Seeding Trials: Just Say “No” Harold C. Sox and Drummond Rennie ADVANTAGE: Merck Does Say No Alexander Rabin ADVANTAGE: Merck Does Say No Jonathan M. Edelman Metrics November 18, 2008Volume 149, Issue 10Page: 775KeywordsDrugsMotivationOsteoarthritisRheumatoid arthritis ePublished: 18 November 2008 Issue Published: November 18, 2008 Copyright & PermissionsCopyright © 2008 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...