This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (11)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Health Policy  • Neurology  • Stroke  • Cardiovascular System  • Cardiovascular Disease/ Myocardial Infarction  • Adverse Effects  • Alert me on articles by topic  Social Bookmarking   What's this?

Arch Intern Med. 2005;165:158-160.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Merck & Co (West Point, Pa) withdrew rofecoxib (Vioxx) from the market on September 30, 2004, based on unpublished data from their own APPROVe trial (2004), a randomized placebo-controlled study of 2600 patients (mean age, 60 years) with a history of adenomatous polyps who were taking 25 mg of rofecoxib daily. Only a minority of these patients had a known history of coronary artery disease. In fact, those with ischemic events in the prior year were excluded from the study. Patients randomized to rofecoxib were found to have an approximately 2-fold increase in the rate of cardiovascular events compared with those randomized to placebo. Merck reported that this difference did not become statistically significant until 18 months after study inception.

The dramatic withdrawal of such a widely used and widely promoted drug 5 years after it was introduced to the market raises many questions concerning drug policy, scientific evidence, and . . . [Full Text of this Article]

DRUG POLICY: WHAT ROLE FOR POSTMARKETING SURVEILLANCE?


SCIENTIFIC EVIDENCE: WHAT ROLE FOR OBSERVATIONAL STUDIES OF DRUG SAFETY?

CLINICAL ISSUES: ARE OTHER COXIBS SAFE?

CONCLUSIONS: HOW CAN THE PUBLIC’S TRUST BE REGAINED?

AUTHOR INFORMATION
Daniel H. Solomon, MD, MPH; Jerry Avorn, MD

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence
DeAngelis and Fontanarosa
JAMA 2008;299:1833-1835.
FULL TEXT  

Inconsistency in the Editorial Process in Archives of Internal Medicine?
Bjarnason
Arch Intern Med 2005;165:1439-1440.
FULL TEXT  

Inconsistency in the Editorial Process in Archives of Internal Medicine?--Reply
Greenland
Arch Intern Med 2005;165:1440-1440.
FULL TEXT  

Safety in Numbers -- Monitoring Risk in Approved Drugs
Okie
NEJM 2005;352:1173-1176.
FULL TEXT