Arthritis drug's death toll 'four times higher'

by JENNY HOPE

Up to four times as many arthritis patients as previously estimated may have died or been harmed by the painkiller Vioxx, it has been claimed.

The drug regulator at the centre of a dispute over its safety has vowed to fight attempts to suppress claims that many thousands have died or been seriously injured as a result of taking the drug.

Vioxx was removed from the market by U.S. manufacturer Merck in September when research found that patients had more than twice the risk of cardiovascular problems after 18 months compared with those taking a "dummy" pill.

British patient action

The research by Dr David Graham, an official at the U.S. Food and Drug Administration, has sparked a debate over the entire class of painkillers known as Cox-2 inhibitors. European regulators have ordered a safety review into four similar drugs.

At the height of their popularity, Cox-2s were taken by around 1.4million Britons.

The research will also spur legal action over Vioxx - taken by 400,000 British patients - with around 100 Britons preparing to launch a group action in the High Court within weeks.

Dr Graham raised the alarm over Vioxx in August, despite warnings from his FDA bosses to "downplay" the risks.

He originally estimated that 28,000 Americans had died or suffered heart attacks or strokes as a result of using the drug since it was launched there in 1999.

But a re-analysis of data suggests that that figure is between 89,000 and 139,000.

Dr Graham hopes his updated assessment will be published in The Lancet medical journal, even though he has been threatened with dismissal by the FDA for publishing any paper on the issue.

"The FDA has suppressed the paper and maligned me in the media," he said.

Potential claims

Around 20 class actions have started in the U.S. and analysts estimate the drug company faces a $ 15billion (£7.8billion) bill from U.S. claims alone. So far 100 Britons have approached lawyers with potential claims, including the families of three patients who died, said Martyn Day, one of the solicitors advising them.

The success of the action would depend on proving that the extra risk of harm posed by the drug had emerged before it was withdrawn, said Mr Day.

A spokesman for Merck said it had "meritorious" defences to any lawsuits and had acted in the "best interests of patient safety' throughout the period in which the drug was available.

She said: "Merck conducted well-controlled randomised clinical trials.

"Merck analysed the data from those studies, discussed them with the FDA and regulatory agencies around the world, and disclosed them to the medical and scientific community."