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Review
. 2007 Jan 20;334(7585):120-3.
doi: 10.1136/bmj.39024.487720.68.

What have we learnt from Vioxx?

Harlan M Krumholz  1 , Joseph S Ross, Amos H Presler, David S Egilman
Affiliations
Review

What have we learnt from Vioxx?

Harlan M Krumholz et al. BMJ. .

Abstract

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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Conflict of interest statement

Competing interests: HMK has research contracts with the American College of Cardiology and the Colorado Foundation for Medical Care; serves on the advisory boards of Amgen, Alere, and UnitedHealthcare; is a subject expert for VHA; and is editor in chief of Journal Watch Cardiology. All authors have been consultants at the request of plaintiffs for recent suits against Merck related to rofecoxib.

References

    1. United States Securities and Exchange Commission. Form 10-Q: quarterly report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 Note 7 to consolidated financial statements (http://phx.corporate-ir.net/phoenix.zhtml?c=73184&p=irol-SECText&TEXT=aH...=
    1. Merck. Vioxx (rofecoxib): frequently asked questions. www.vioxx.com/rofecoxib/vioxx/consumer/faq.jsp
    1. Morrison BW. Memo to Alan Nies, Barry Gertz, Beth Seidenberg. Letter to Ken Lasseter; manuscript draft for protocol 023. 18 Feb, 1998. Merck. Bates Nos MRK-NJ0017794 to MRK-NJ0017822. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Morrison1998.pdf
    1. Food and Drug Administration, Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products. HFD-550, medical officer review. Vioxx (rofecoxib), NDA 21-042/052. Washington, DC: FDA, 1999.
    1. Food and Drug Administration. FDA advisory committee briefing document NDA 21-042, s007: VIOXX gastrointestinal safety. Washington, DC: 2001.

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