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

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.

The secret things belong unto the Lord our God: secrecy in the pharmaceutical arena.

Secrecy in the pharmaceutical arena has taken on more importance in the recent past as the pharmaceutical industry has assumed greater prominence in the funding of clinical research and has also become a funder of the agencies that are charged with regulating it. Governments have adopted a neo-liberal agenda that prioritizes private profit over public health and are therefore willing to let industry set the research agenda. As a result, secrecy, to protect intellectual property rights, is a major feature of clinical research.

Physician awareness of drug cost: a systematic review.

Background: Pharmaceutical costs are the fastest-growing health-care expense in most developed countries. Higher drug costs have been shown to negatively impact patient outcomes. Studies suggest that doctors have a poor understanding of pharmaceutical costs, but the data are variable and there is no consistent pattern in awareness.

'Linkage' pharmaceutical evergreening in Canada and Australia.

'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases.

Notice of compliance with conditions: a policy in limbo.

Since 1998, the Therapeutic Products Directorate (TPD) has had a policy termed the Notice of Compliance with conditions (NOC/c) in order to allow earlier marketing of promising drugs for serious conditions before the drugs have definitively demonstrated clinical efficacy. Drugs approved under the NOC/c must undergo post-marketing trials to show clinical benefits. The reasons that some drugs receive a NOC/c are not always apparent, and the TPD releases only general information regarding the conditions that need to be fulfilled.

A systematic review of studies comparing health outcomes in Canada and the United States.

Background: Differences in medical care in the United States compared with Canada, including greater reliance on private funding and for-profit delivery, as well as markedly higher expenditures, may result in different health outcomes.

Objectives: To systematically review studies comparing health outcomes in the United States and Canada among patients treated for similar underlying medical conditions.

Methods: We identified studies comparing health outcomes of patients in Canada and the United States by searching multiple bibliographic databases and resources.

Introduction of direct-to-consumer advertising of prescription drugs in Canada: an opinion survey on regulatory policy.

Background: Canada is strongly influenced by US cross-border direct-to-consumer advertising (DTCA) and has held consultations to discuss introduction of DTCA since 1996. This article describes a survey of Canadian drug policy experts carried out in 2001, during one such legislative review. The survey results are compared to more recent DTCA policy developments.

Relationship between pharmaceutical company user fees and drug approvals in Canada and Australia: a hypothesis-generating study.

Background: Since the early- to mid-1990s, drug companies have paid fees for a variety of activities carried out by the Therapeutic Products Directorate in Canada and the Therapeutic Goods Administration in Australia.

Objective: To explore whether changes in approval times for new active substances and in the percentage of new drug submissions receiving positive decisions coincided with the level of user fees.

Methods: Data were collected from a range of Canadian and Australian government publications on the following topics: total funding for and workload of the regulatory agencies, the percentage of income that came from tax revenue and user fees, the percentage of new drug submissions that received a positive decision, and-for Canada only-the percent of submissions that were approved on first review.

Educating health professionals about drug and device promotion: advocates' recommendations.

Mansfield and colleagues outline the recommendations from four advocacy groups for improving the education of health professionals on promotion of drugs and devices.

Commercial influence and the content of medical journals.

How confident should we be in the objectivity of medical journals? Do commercial biases play a part in determining what appears in print?

Bigger and better: how Pfizer redefined erectile dysfunction.

Lexchin examines how Pfizer transformed sildenafil from an effective product for erectile dysfunction due to illness or injury into a drug that healthy men can use to enhance their erections.

A comparison of new drug availability in Canada and the United States and potential therapeutic implications of differences.

Background: Claims are made that new valuable drugs are not available in Canada at the time that they are marketed in the United States. This study uses a convenience sample of new drugs marketed in the United States and determines how many of these products are initially unavailable in Canada and their therapeutic value.

Methods: Issues of the Canadian edition of The Medical Letter from May 12, 2003 to June 21, 2004 were hand searched for evaluations of new drugs and the following information was recorded: indication, availability in Canada and conclusions about therapeutic value.