Agencies "failed miserably" over COX-2 inhibitor

doi:10.1136/bmj.330.7483.113-a

BMJ 2005;330:113 (15 January), doi:10.1136/bmj.330.7483.113-a

News roundup

Agencies "failed miserably" over COX-2 inhibitor

Ottawa Barbara Kermode-Scott

North America�s regulatory agencies have "failed miserably" in an important aspect of their public mandate, and new national agencies are needed to monitor drug safety, according to the Canadian Medical Association.

If the US Food and Drug Administration and Canada�s regulatory agency, Health Canada, had used an active surveillance system that targeted serious adverse events, then the alarm over the cyclo-oxygenase-2 inhibitor rofecoxib (Vioxx) would have been sounded much earlier, says the association.

Both regulatory agencies put their emphasis and resources into assessing drug benefits, not harmful effects, states an editorial in the CMAJ (2005;172:5, 4 Jan). "The bar for approval is low, requiring only that the agent be more effective than placebo. Pre-marketing approval trials are too small to flush out all of the risks of a drug," it says.

"The built-in bias toward approving drugs without adequate assurance of their safety, and with only . . . [Full text of this article]

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