BMJ  2004;329:1342 (4 December), doi:10.1136/bmj.329.7478.1342

Letter

Lessons from the withdrawal of rofecoxib

Observational studies should not be forgotten

The first 150 words of the full text of this article appear below.

EDITOR—In their editorial Dieppe et al describe the lessons from the withdrawal of rofecoxib.¹

Randomised controlled trials are not the usual way in which serious, uncommon adverse effects of a new drug are discovered. They are usually discovered in observational studies, often case-control studies. Using randomised controlled trials to find adverse effects is dangerous. It would feed on the current vogue from trialists that the only data that count are those from randomised controlled trials. By this standard, we would not have concluded that cigarette smoking causes lung cancer. We should not exclude observational studies but rather continue to do them well, in a timely fashion.

As I understand the rofecoxib story, the cardiovascular effect is strong enough to see in a randomised controlled trial in 2000, although according to some creative interpretation of the data a protective effect of control drug could have explained the result. The . . . [Full text of this article]

Rollins School of Public Health of Emory University Rollins School of Public Health, 1518 Clifton Rd, NE, Atlanta, GA 30322 gpoakley@mindspring.com

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