Drug Surveillance System Needs To Be Fixed
The current drug surveillance system needs to be fixed, argues an editorial in this week's British Medical Journal. 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 US Food and Drug Administration (FDA) in 1999 and by the European Medicines Agency (EMEA) in 2000. Its popularity has increased steadily, with more than one million prescriptions written in the one year period ending March 2006 in England alone. Emerging safety concerns highlight the need for a better system of drug evaluation both before and after approval, says Dr Dhruv Kazi from the London School of Economics. He argues 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 these are often not completed in a timely manner, he says. This results in a fractured regulatory process, where postmarketing surveillance falls short of the standards the agencies set for themselves. For the system to be fixed, it will require systematic rethinking of the existing regulatory and funding processes and expediting changes currently in the pipeline. In the meantime, doctors will need to revisit the indication for the drug on a case by case basis, bearing in mind that several alternatives are cheaper, supported by robust evidence and now perhaps safer.
