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Drug surveillance system reform urged


The current drug surveillance system needs to be fixed, argues an editorial in this week’s BMJ.

The call follows a recent analysis of the diabetes drug rosiglitazone (Avandia®) which raised serious questions about the drug’s safety.

Rosiglitazone was approved by the FDA in 1999 and the EMEA in 2000. Its popularity has increased steadily, with more than one million prescriptions written in England alone in the year to March 2006.

But last month an analysis of 42 trials of rosiglitazone, published in the New England Journal of Medicine, found the drug was associated with an increased risk of heart attack and death from cardiovascular causes.

Now Dr Dhruv Kazi from the London School of Economics has argued that these emerging safety concerns highlight the need for a better system of drug evaluation both before and after approval.

Dr Kazi maintains that the current approach relies heavily on passive surveillance and is based on reports of unusual adverse events from consumers, practitioners, manufacturers and national regulatory authorities. Alternatively, the regulatory authorities may require further (phase IV) trials after approval, but he says these are often not completed in a timely manner.

This results in a fractured regulatory process, where postmarketing surveillance falls short of the standards the agencies set for themselves.

He says this is exemplified by the case of rosiglitazone, which comes from a family of drugs with well documented side-effects. However, postmarketing safety data seven years after regulatory approval consist of a patchwork of heterogeneous manufacturer-sponsored trials, many of them unpublished.

Dr Kazi says the system needs to be fixed. This will require systematic rethinking of the existing regulatory and funding processes, and expediting changes now in the pipeline.

BMJ 2007:334:1233-4


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