UK Watchdog System Needs Change 'Badly'

After gazing across the pond at the drug safety debate in the US, some UK politicians and docs would like to see the Medicines and Healthcare products Regulatory Agency ( MHRA) become more aggressive in reviewing drugs for safety signals. The concern is that, after such high-profile controversies as Vioxx and Avandia, the UK watchdog lacks initiative in encouraging doctors to file adverse event reports and most of its budget is earmarked for reviewing drugs (if this sounds familiar to American ears, well...).

"Just how many people in the UK are being affected by a drug is the key question that the system is just not able to answer at all well at the moment," Dhruv Kazi, an expert in medical statistics at the London School of Economics, tells The Daily Mail. "We badly need the kind of changes being proposed for the FDA. Drug agencies are largely funded by drug companies, so their main focus is getting drugs licensed as fast as possible. Checking up on what happens comes a very poor second."

And Paul Flynn, a member of Parliament, carps that public protection is inadequate. "For too long the British authorities have just followed the US lead in issuing warnings about drug safety," he tells the paper. "The system the MHRA uses to pick up the number of side-effects a drug is causing gave absolutely no indication of the scale of the problem. American safety experts reckoned that up to 100,000 people had been harmed by the drug over there.

"Do you know how many reports of problems with Vioxx the MHRA received on average every year? Six. If it hadn't been for the American action, we would still be taking that drug and suffering all the damage that went with it. As it is, we still have no idea of how many people were affected in the UK because there has never been any investigation."

Of course, the MHRA blames docs for not reporting more adverse events, and the ABPI industry trade group maintains the system is working just fine. But Roger Odd, a pharmacist and trustee of the Patients Association, isn't fooled. "For the sake of patient safety," he says, "there should be a review of how the reporting system can be improved."