A report alleges that docs down under are concerned the drugmaker may have tried to cover up the dangers of Prexige just weeks before the government ordered the Cox-2 painkiller off the shelves over two deaths, two liver transplants and serious liver problems in eight patients. More than 60,000 Australians and 1000 Tasmanians had taken Prexige to treat osteoarthritis.

In June, Novartis abruptly withdrew the standard 200mg dose from the Pharmaceutical Benefits Scheme in favour of a 100mg dose, reports Mercury, The Voice of Tasmania. The lower dose wasn’t approved by the PBS, forcing the elderly to pay up to $30 more per script.

Some docs now question whether Novartis had concerns about the higher dose before the side effects became public. The two patients who died had been taking 200mg to 400mg doses. Just weeks before the recall, Novartis reps were talking up the 100mg dose to docs, saying recent studies had shown it was just as effective. And docs were given dozens of free samples.

Peter Meggyesy, chairman of the Mornington Division of General Practice in Victoria, says the transition from the higher to the lower dose was unusually abrupt. “The way it hastily withdrew the 200mg dose was really fishy,” he tells the news service. “I asked a company representative at the time whether the 200mg dose was safe and he said `yes’.”

A Novartis spokeswoman denied allegations of a cover-up. “The reason for changing from 200mg to 100mg was that our clinical trials had shown the 100 had the same effect as the 200,” she says, adding that the withdrawal of the 200mg dose wasn’t motivated by concerns about side-effects and began well before adverse health effects came to light.

The cluster of liver problems that alerted the TGA occurred between June and early July. Meggyesy believes Novartis could face a class action over the way it handled the recall. “Patients have a right to be angry and the medical profession has a right to be angry too,” he says.

Graeme Bleach, who is General Practitioner South chairman, says it would be worrisome if Novartis had concerns that weren’t immediately relayed to docs. “What was driving that (the change in dose) - whether it was genuine or ulterior motives, it is impossible to say,” says Bleach.

But AMA state president Haydn Walters says Novartis shouldn’t be demonized. “When tens of thousands of people are using a drug there needs to be very effective post-marketing surveillance and the good thing about this is it was pulled up and action was taken very quickly,” Walters says.

Last week, rheumatologist and Menzies Research Institute head Graeme Jones said the recall was an “over-reaction” and the side-effects occurred at low rates similar to other anti-inflammatory drugs.