Letters

Lessons from the withdrawal of rofecoxib: Observational studies should not be forgotten

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7478.1342 (Published 02 December 2004) Cite this as: BMJ 2004;329:1342
  1. Godfrey Oakley Jr (gpoakley@mindspring.com), research professor of epidemiology
  1. Rollins School of Public Health of Emory University Rollins School of Public Health, 1518 Clifton Rd, NE, Atlanta, GA 30322

    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 …

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