Is Australia's national medicines policy failing? The case of COX-2 inhibitors

Abstract

Australia has a National Medicines Policy with aims that include quality use of medicines, but policy stakeholders failed to protect Australia from the COX-2 (cyclo-oxygenase-2) inhibitor disaster. Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures on COX-2 inhibitors. Drug companies ran intense and misleading promotional campaigns on COX-2 inhibitors without adequate controls. Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising. Core elements of the National Medicines Policy—in particular the drug approval process, the post-marketing sur-veillance system, the control of drug promotion, and the quality of independent drug information—require major reappraisal if we want to avoid similar disasters in the future.