Healthy Skepticism Library item: 968

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Publication type: news

Pollard R.
Lax system means killer drugs slip through
Sydney Morning Herald 2005 Apr 16

Full text:

Australia has no early warning system to detect the harm that drugs such as Vioxx could do to an unsuspecting public, say experts who predict more people will die needlessly from adverse reactions to medication.

Even well-run, randomised trials examining a drug’s safety and effectiveness could not pick up the long-term harm it could cause in a much larger population, said Fiona Stanley, the director of the Telethon Institute for Child Health Research at the University of Western Australia.

Only that state had a sophisticated system that linked depersonalised information from the Medical and Pharmaceutical Benefits Scheme with the health outcomes of a population, said Professor Stanley, who is a former Australian of the Year.

That way, the impact of a drug such as Vioxx, which is thought to increase the risk of strokes and heart attacks, could be measured by looking at both prescribing levels and the incidence of cardiovascular disease.

“If we had this capacity in Australia we could have picked this up more quickly and avoided so many deaths,” she said.

Vioxx was just one example of the harm prescription drugs could cause, Professor Stanley said.

The anti-inflammatory drug was withdrawn from the market by its manufacturer, Merck & Co, on September 30 last year because of evidence it increased the risk of cardiovascular disease.

At the time 250,000 to 300,000 Australians were taking the drug to treat the symptoms of arthritis; there are concerns up to 300 people may have died because of the drug’s side-effects.

As further concerns emerged about the safety of the entire Cox-2 Inhibitor class of drugs, the limitations of the Therapeutic Goods Administration came into sharp focus.

“These questions are not easily addressed by just doing another clinical trial,” said David Henry, a professor of public health at the University of Newcastle.

“The TGA should have the capacity of rapid response to urgently commission studies to investigate this safety issue …”

But Professor Henry, a specialist in clinical pharmacology, said Australia had fallen way behind other countries in this area, and the TGA this week complained that it lacked the power to order a large-scale study.

Meanwhile, an Australian law firm confirmed it was close to making a decision on whether to pursue a class action against Merck on behalf of more than 300 people who suffered heart attacks or strokes from Vioxx.

Despite clear signs in March 2000 that taking the drug increased the risk of cardiovascular disease, Merck failed to warn doctors or patients for another two years, said Richard Meeran, of Slater & Gordon.

However, a spokeswoman for Merck said the first indication the company had of an increased risk of cardiovascular disease was just before it voluntarily withdrew Vioxx on September 30 last year.

James Parry, 64, of Quakers Hill, had a massive heart attack in June last year after taking Vioxx for about two years to cope with arthritis.
“There was nothing wrong with me before I started taking those tablets,”
he said, confirming he is one of the those involved in the possible class action.