Volume 195 Issue 10

Assisted reproductive technologies, including in-vitro fertilisation (IVF), are now mainstream treatments in Australia, strongly supported by public opinion and accessible to most patients via adequate Medicare funding. Over the past 30 years, the growth in uptake of IVF in this country has been remarkable, with nearly 4% of all live births resulting from this mode of conception.

Robert J Norman FRANZCOG, FRCPA, CREI

Stimulants increase the risks of psychosis and stroke Stimulant use disorders (rather than recreational use) account for most of the harms associated with illicit stimulant use, and are more likely to occur with frequent use and more efficient routes of administration (ie, injection and smoking rather than oral or intranasal use).1 A driving factor behind many of the problems associated with stimulant use in Australia is the long-standing history of methamphetamine injection.2 The majority of dependent methamphetamine users in Australia inject the drug and have been using for a decade or longer.1 In this issue of the Journal, Sara and colleagues highlight the substantial number of heavy stimulant users in Australia.3 They estimate that almost half the people who report taking stimulants on more than five occasions progress to problematic levels of use, meeting criteria for either misuse or dependence. This amounts to around 97 000 Australians in the past year. Such findings are a timely reminder that heavy stimulant use is an ongoing issue in Australia that cannot be ignored. Heavy stimulant use is associated with a number of public health concerns, the most salient of which is stimulant-induced psychosis. As Sara and colleagues point out, stimulant use disorders are concentrated among young men, who are the population subgroup at highest risk for developing psychosis, and the least likely to seek professional help for a mental disorder.4 Stimulants also exacerbate existing psychotic disorders and, in this context, they hinder the efficacy of antipsychotic drugs and increase the risk of violent behaviour.5 Heavy users are not only at increased risk of contracting HIV and other blood-borne viruses from injecting stimulants, but they are also at elevated risk of sexually transmitted diseases (including HIV) because stimulants increase libido.6 This situation creates a nexus for the spread of HIV between drug users and the broader population. Stimulants can further increase the risk of HIV transmission through immunopathological processes.6 As such, HIV prevention efforts for stimulant users need to focus on both safe injecting and safe sex practices. Stimulants increase the risk of cerebrovascular events,7 particularly young ischaemic stroke, as emphasised by Phillips and colleagues,8 also in this issue of the Journal. Stimulants increase the risk of stroke as a consequence of hypertension and other catecholamine-mediated vascular changes that occur during intoxication, while vascular abnormalities and cardiac pathology that occur with chronic use are also risk factors.7 Heavy tobacco and cannabis smoking, as well as the risk of infectious endocarditis as a result of intravenous use, compound the risk of cerebrovascular incidents in this population. Such public health concerns highlight the importance of early detection and intervention efforts. However, illicit stimulant use increasingly spans a broad segment of the population, including people who are well educated, employed and whose life situation would not otherwise point toward drug use. This “mainstreaming” of stimulant use, coupled with the community’s reluctance to disclose illegal drug consumption, can make stimulant use difficult to detect. Given that stimulant users commonly seek help from general practitioners for a range of health issues, offering a safe environment to talk about drugs, where confidentiality is assured and patients do not feel judged, is a critical first step in identifying harmful use. This can be done in a non-confronting way by discussing how stimulant use (both legal and illicit) might be a factor in the aetiology of certain conditions (eg, sleep problems, mood disturbances, hypertension), and whether such use is contraindicated for prescribed medications. Being proactive in this way, at the very least, imparts knowledge with which patients can self-manage their health. Once detected, it is important to appreciate that stimulant use disorders do not occur in isolation; they tend to co-occur with heavy use of cannabis, alcohol and tobacco, as well as with other mental disorders. Stimulant use can increase heavy drinking because it negates the sedating effects of alcohol intoxication. Cannabis and sedative drugs are often taken as a means of coping with the “come-down”, or after effects, of stimulant intoxication. Stimulants can also increase the risk of toxicity from medications prescribed to manage symptoms of depression that are almost ubiquitous among heavy stimulant users.9 The potential involvement of heavy stimulant use in physical and psychiatric problems seen within medical health care settings needs to be considered. Patients who desire treatment for stimulant use can be referred to generic drug and alcohol services (eg, counselling and residential rehabilitation), and specialised treatment programs have been established in some locations (eg, NSW Health’s stimulant treatment clinics10). There is little available in terms of evidence-based treatments. Intensive psychological interventions (eg, tailored cognitive behaviour therapy, contingency management) have shown some promise,6 although these interventions have not been widely implemented. More work is needed to develop and implement effective treatment options for heavy users of stimulants.

Rebecca McKetin BSc(Psychol)(Hons), PhD · Dan I Lubman PhD, FRANZCP, FAChAM

Time to find a systems-level model for a serious, undermanaged, but preventable problem For over 20 years, we have known that osteoporotic fractures predispose to further fractures and significant morbidity.1,2 We also understand that first and subsequent fragility fractures are associated with premature death.2-4 However, surprisingly little has happened over the past two decades to translate this knowledge into good clinical practice for our patients. Of course, anyone presenting with a low-trauma fracture to an Australian hospital will get it fixed in due time. But little happens after that. Nobody seems to ask why that person had a low-trauma fracture (or a second or third one) to begin with. Indeed, 75%–80% of patients who have had an osteoporotic fracture are neither being investigated nor treated for their underlying condition — osteoporosis.5,6 This systematic failure is all the more shocking as we have available to us not only one of the world’s best medical systems, but also subsidised pharmacotherapies with proven efficacy to reduce the risk of (re)fracture.7 Recent data from New South Wales reveal that 35% of patients admitted to hospital with an osteoporotic fracture were readmitted with another fragility fracture, often within 1–2 years of the initial event. This accounted for 16 225 essentially unnecessary admissions with a startling average length of stay of 22 days. Of those with refractures, 17% died during the period studied.8 These numbers represent a medical nightmare and a health care systems failure of huge and growing dimensions. Because the Australian population is ageing, the prevalence of osteoporosis has been steadily rising over the past few decades. Currently, 2.2 million Australians live with osteoporosis, and this number is projected to increase to 3 million by 2021.9 While 67 000 osteoporotic fractures were recorded in Australia in 2001, this figure had risen to more than 87 000 in 2007.9 In 2001, the annual total cost of osteoporosis to the Australian health system was estimated at $7.4 billion,10 and it does not require much imagination to anticipate that we will soon spend an even larger amount of our nation’s income on a medical problem that can be treated and, more importantly, effectively prevented. The reasons for such management failures are complex, and include inadequate awareness among doctors and patients of the health hazards related to osteoporosis, and the almost complete lack of effective medical postfracture care.6 While the fundamental need to improve osteoporosis recognition and management has been acknowledged worldwide, attempts to tackle this issue through simple educational campaigns have clearly not translated into improvements in treatment rates.11 In contrast, there is now high-quality evidence that the implementation of system-level models of care reduces refracture rates, morbidity and mortality, hospital bed days and other health system use. The most effective of these interventions are “fracture liaison services” that include targeted case-finding, systematic assessment, appropriate treatment and follow-up, and access to self-management education programs and support systems.12-15 While such programs have been developed by individual clinicians in Australia, most health services seem reluctant to meet the financial and logistical requirements for secondary fracture prevention services. Are we asking for too much? Would public funding for such services be justified? Let us look at the evidence. We recently reported on the clinical effectiveness of a fracture liaison service established in 2005 at Concord Repatriation General Hospital in Sydney.12 This outpatient service is available to all patients with osteoporotic fractures and, over 4 years, reduced the risk of refracture by 80% compared with standard care. Obviously, the service involves human resources and more use of bone densitometry, laboratory testing and medications. The question therefore was whether the benefits provided by the service would be cost-effective. A health-economic analysis published in the latest issue of Osteoporosis International shows that even though the service is comprehensive, it is also highly cost-effective.16 The economic model used for the analysis accounted for all major osteoporotic fractures (ie. hip, forearm, and humerus), their associated direct costs, changes in health utility and, in the case of hip fractures, increases in mortality. Fracture probabilities were calculated from the clinical data, and medical costs for the service and the control arm were derived from reported health resource consumption data. The (very conservative) analysis showed that reducing subsequent fractures through a fracture liaison service led to significant improvements in quality-adjusted life-years (QALYs). Despite higher treatment costs, the total cost of the intervention was only $1300 per patient over a 10-year period, that is, $130 per patient per year. The incremental cost-effectiveness ratio for the service (versus no intervention) was $20 210 per QALY gained, which means that the intervention represents excellent value for money. Indeed, when lower medication costs were introduced (as would be expected over time), the service was cost-saving; that is, the money saved by preventing fractures would be more than the cost of the service.16 The Concord fracture liaison service is one of various possible models, but conceptually can be implemented in any Australian health service. Its proven clinical and cost-effectiveness leave no excuses for not attempting to close the appalling gap in the postfracture care of patients at high risk of fracture.

Markus J Seibel MD, FRACP, PhD

The full content of this article is available by downloading the PDF.

The full content of this article is available by downloading the PDF.

The world of medicine is about to take an extraordinary leap forward in transparency. In the United States, from 1 January 2012, by law, every pharmaceutical and medical device manufacturer will have to start recording every payment to every doctor. From the following year, the companies will have to hand over all that information to the government annually, and this will then be published in full.

Ray Moynihan BA

Pregnant women and their health care providers deserve better drug labelling, so that risks and benefits of medications can be weighed up rationally Given that over 80% of women use at least one prescribed or over-the-counter medication (typically one to three) at some time during their pregnancy, most medical practitioners who treat women of reproductive age can expect frequent questions about the use of medications during pregnancy and breastfeeding.1 In addition, as the average age of women having babies increases, their likelihood of having medical disorders that complicate pregnancy (such as hypertension) or chronic conditions also increases. A recent Australian study found that 322 of 819 pregnant women (39.3%) reported a chronic health condition during pregnancy, the most common being asthma, blood-related disorders (eg, thrombosis, haemorrhage and/or anaemia) and diabetes.2 Of concern, 107 out of 181 of those who reported a chronic health condition and use of regular prescribed medication (59.1%) reported non-adherence to medication for a number of different reasons. Most of the participants had “some concerns” about using any medicine during pregnancy and almost one-third believed that natural remedies were safer than other medicines during pregnancy. Complementary medicines include nutritional supplements, vitamin and mineral preparations, and herbal, aromatherapy and homoeopathy products, and an estimated $1.3 billion was spent by Australians on such products in 2004.3 In an Australian study completed between 2005 and 2007, about one-third of pregnant women reported taking complementary and alternative therapies to treat common complaints during pregnancy (eg, vitamins and minerals to treat colds and leg cramps, yoga and aromatherapy).4 Complementary medicines are included on the Australian Register of Therapeutic Goods as listed (low-risk) or registered (higher-risk) medicines, but most complementary medicine products do not carry a pregnancy risk category, even though some may have significant effects on pregnancy or fetal development. Since the 1960s and the birth of babies in Australia and Europe with severe birth defects following early pregnancy exposure to thalidomide, there has been a general reluctance on the part of doctors to prescribe, and women to take, medications during pregnancy because of fears about potential teratogenic effects. In 1963, as a direct consequence of the thalidomide tragedy, the Commonwealth Department of Health established the Australian Drug Evaluation Committee (ADEC) as an independent committee to advise on the safety of new drugs being introduced into Australia and to monitor and evaluate potential adverse effects of drugs already in use. In 2010, ADEC was replaced by the Advisory Committee on Prescription Medicines. An ad hoc working party of ADEC published a unique Australian categorisation of the risk of drugs in pregnancy (Categories A, B1, B2, B3, C, D and X). In the United States, the Food and Drug Administration (FDA) adopted a labelling format for safety of drugs in human pregnancy in 1979, and other countries developed their own categorisations. The ADEC categorisation is similar to the Swedish system and, although it shares the same letters as the FDA categorisation, there are some notable differences (particularly the Australian B1, B2 and B3 categories). The first Australian Medicines in pregnancy booklet was published in 1989. The last hard copy (fourth) edition, retitled Prescribing medicines in pregnancy, was published by the Therapeutics Goods Administration (TGA) in 1999.5 This resource subsequently went online, and the currently available Prescribing medicines in pregnancy database was revamped in May 2011.6 Unfortunately, the content of the data on drug safety in pregnancy and reliance on the categories did not change. A recent audit of practice of 80 general practitioners and 50 pharmacists by MotherSafe (a counselling service for women and health care providers who are concerned about exposures during pregnancy and breastfeeding) found that both groups were generally very conservative regarding advice about medications during pregnancy and breastfeeding, relying heavily on the ADEC categorisation and company product information listed in MIMS (the Monthly Index of Medical Specialties).7 The survey found that 80% of pharmacists and GPs used MIMS (ie, the categorisations and product information, where pregnancy and lactation are almost without exception included under special precautions or contraindications) as their primary source of information on medication safety in pregnancy. While 25% of pharmacists used the Australian medicines handbook, only 4% of pharmacists and 2% of GPs used the TGA’s Prescribing medicines in pregnancy booklet. Almost half of Australian drugs fall into one of the B categories because of the paucity of available human pregnancy data. Undoubtedly the most problematic of the Australian categories is B3 — limited use by pregnant women and women of childbearing age, without an increase in the frequency of harmful effects on the fetus, but with animal data showing increased occurrence of fetal damage. If the definition of the B3 category were explained to an average pregnant woman, she would probably never take a B3 drug because of anxiety about what this could mean for her baby. However, the data regarding many B3 drugs (such as combinations of long-acting β-agonists plus inhaled corticosteroids) are limited but reassuring, and uncontrolled asthma in pregnancy is a significantly greater risk than the potential risks (derived from animal data) posed by these medications.8,9 The biggest problem of the ADEC system is its alphabetical nature, which implies (incorrectly) that there is a gradation of risk, with the B category being “worse” than the A category, and so on. Confusingly, some publications that list the categories alphabetically (eg, MIMS) add a note explaining that “allocation of a B category does not imply greater safety than the C category” — counterintuitive and distinctly unhelpful to say the least. Unfortunately, the apparent simplicity of the categories means that clinicians tend to use it as a “bible”, rather than as a guide, which can result in misinterpretation of risk. The ready availability of the categories means that practitioners would rarely critically assess the quality or content of the original studies on which the categorisation was based and, therefore, would not consider the complexities involved in balancing the risks and benefits of using or not using a particular drug for a specified indication at a certain stage in pregnancy. There is also an assumption that drugs in the same category carry a similar risk, which is often erroneous. For example, valproate and paroxetine are both in the D category, but the former is associated with a significantly increased risk of birth defects and neurodevelopmental sequelae following use in the first trimester, whereas there are conflicting data about paroxetine being associated with a slightly increased risk of cardiac and other defects. Also, the categories do not take the stage of pregnancy into account. For example, tetracyclines cause tooth discoloration in the fetus when taken after 14 weeks’ gestation, so being categorised D in the first trimester is misleading and unnecessarily worrying. In addition, the categories do not adequately differentiate between different pregnancy situations — planned versus unplanned pregnancy and essential versus non-essential medications. Furthermore, the categories rarely take the dose or route of exposure into account — topical and inhaled exposures are generally less concerning than oral or intravenous exposures as they result in less systemic absorption, lower maternal serum concentrations, and thus minimal transplacental passage and a negligible chance of affecting the embryo. The categories are assigned before drugs are marketed and are often based solely on the results of animal reproductive studies, owing to a general paucity of human pregnancy data. The categories are rarely changed despite new (and often reassuring) evidence because of a general reluctance to advocate the safety of drugs in pregnancy. Other limitations of the ADEC categorisation include the fact that it does not cover environmental agents, chemicals, infectious agents, illicit drugs or complementary medicines and that, contrary to the understanding of many medical practitioners, the categories are not applicable to breastfeeding. In general, recommendations given to women about medications in pregnancy are cautious at best and scaremongering and inappropriate at worst. Unfortunately, the advice given by health care providers is compounded by misleading information obtained from the internet and other lay sources. Misleading advice, often based largely on the ADEC categorisations, can result in significant consequences for both the mother and baby. Some women stop taking essential medication because of fears about fetal safety, thus putting themselves and their baby at risk of an untreated illness (which is often a higher risk than the potential risk posed by the medication). Other women have their medication switched, on misunderstood grounds of fetal safety, from those that are beneficial to those with unknown or less efficacy — for example, switching antidepressants from citalopram (C category) to mirtazapine (B3 category). Equally concerning is that, when pregnant women are told that they should stop their effective, prescribed medications (eg, antidepressants) because of their categorisation, some may self-medicate with complementary medicines (about which there are usually less pregnancy safety and efficacy data) or potentially more harmful substances such as alcohol, cigarettes or illicit drugs. Worse still, some women consider terminating otherwise wanted pregnancies because of perceived safety concerns based on a drug’s categorisation. In a group of 177 of callers to MotherSafe (from 2005 to 2007) who had been considering termination of a pregnancy because of a range of exposures (including drugs, radiation and vaccines), only 30% had been exposed to major teratogens such as retinoids and antiepileptic drugs. Most had received information from other sources (including health care providers and the internet), which had caused them such anxiety that they were considering terminating their pregnancy.10 For several years, concerns have been voiced about the appropriateness of the current system of labelling of drugs for safety in pregnancy in the US.11 In 2008, the FDA proposed major revisions to the labelling of prescription drugs because of these concerns. All labels would include a general statement about the background risk of birth defects for all pregnancies as well as information about whether there was an active pregnancy exposure registry for that particular agent and, if so, how to enrol in it. The new labelling would: remove the letter categorisations; present information regarding fetal risks in a more narrative style; put discussions about risk in the contexts of background risk of birth defects and drug indication; document how the risk was determined (eg, extrapolated from animal data or obtained from human data); and include information (if available) about drug dosing in pregnancy. New and relevant information would be incorporated as it became available.12 As of late 2011, the FDA’s final rule on pregnancy and lactation labelling was in the final writing and clearance process; this promises an exciting new era in the field of rational use of medicine in this important population group. Given that the FDA review has been ongoing for the past 3 years, and it will be several more years before any objective evaluation of the new US system can be made, it may be a long time before Australian regulatory authorities look at the issue of improved labelling of drugs for safety in pregnancy or implement change. I hope that this article will stimulate debate about the direction that Australian regulatory authorities should take to develop an improved, more rational approach to labelling of drugs for safety in pregnancy and breastfeeding in the near future.

Debra S Kennedy MB BS, FRACP, HGSA

As a condition of publication of phase III clinical trials, medical journals should insist on the release of all raw data and a written independent clinical audit Editorials and commentaries in some high-profile journals herald an upcoming revolution in personalised oncology.1 However, any new treatment can only be considered an advance if it: extends the life of the patient; improves quality of life; reduces the toxicity of the current best treatment; and/or reduces costs. Definitive proof of therapeutic benefit relies on freely accessible, high-quality data and their independent evaluation. Unfortunately, open access to de-identified patient data and statistical analyses remains unavailable, so only limited verification of claims emanating from commercially sponsored clinical trials is possible. This restriction reinforces concerns about reporting of trials in general, as “overestimation of the clinical benefit of a drug” is well documented.2 Further, reliance on progression-free survival (PFS) as a surrogate for the clinical benefit of a drug is a risky undertaking. PFS is subjective, as it is based on interpretation of radiological tumour size, whereas overall survival (OS) is objective and unambiguous. Despite the inherent subjectivity of PFS, Genentech requested its use as a basis for the approval of bevacizumab (Avastin) for first-line treatment of locally recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.3 However, the usefulness of PFS as a surrogate for OS, therapeutic benefit and accelerated drug approval is controversial.4-6 To understand why, it is prudent to carefully re-examine the original data, particularly as time-constrained clinicians may be unfamiliar with important details of bevacizumab’s accelerated approval. In 2007, the United States Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee evaluated data from a report of the E2100 trial,7 in which Genentech claimed an impressive 5.5-month increase in median PFS (mPFS) as a therapeutic benefit, but showed no improvement in median OS (mOS).3 Hence, the participating patients did not live longer with bevacizumab treatment. As no correlation existed between mPFS and mOS or quality of life, we asked: “What, then, are the benefits of this treatment?”8 The uncertainties regarding the strengths of Genentech’s claims were exposed by the Committee’s analysis,3 which listed many “significant protocol deviations”. These deviations were tabulated in the Committee’s analysis and included: stratification errors and treatment beyond progression (Table 3); absent radiographs for some participants (Table 5); discordance between the independent review facility and the trial investigators in PFS determination, with incorrect dates for disease progression, including a massive discordance rate of 51% of PFS date (Table 8); and more frequent dose modifications, omissions, delays and reductions in the bevacizumab arm (Tables 10 and 11).3 The Committee disagreed with Genentech’s cause-of-death attribution in several instances (Tables 15, 16 and 17) and documented a 20% increase in the incidence of grade 3–5 adverse events (including hypertension and neutropenia) in the bevacizumab arm (Tables 13 and 14).3 The Committee also analysed a precursor randomised phase III trial from Genentech (denoted AVF2119g),9 which compared bevacizumab plus capecitabine with capecitabine alone in patients with previously treated metastatic breast cancer.3 The increase in mPFS in AVF2119g was a non-significant 3 weeks, in striking contrast to the large 5.5 month value in the E2100 trial. The Committee took cognisance of the serious adverse events (Tables 19 and 20) and concluded that this trial “failed to demonstrate a statistically significant effect on PFS and overall survival”.3 Given these data, the Committee voted against approval of bevacizumab for first-line treatment of locally recurrent or metastatic HER2-negative breast cancer. Despite this recommendation, which was based on independent scientific, clinical and biostatistical analyses, bevacizumab received accelerated approval with the proviso that further confirmatory trials be conducted.4,5 Three years later, the confirmatory trials, AVADO10 and RIBBON-1 (Regimens in Bevacizumab for Breast Oncology),11 were completed. Bevacizumab plus docetaxel was compared with docetaxel plus placebo in AVADO, and capecitabine, anthracyclines or taxanes plus either bevacizumab or placebo were compared in RIBBON-1. The previous stunning 5.5-month improvement in mPFS was not seen. AVADO and RIBBON-1 yielded mPFS values of 0.8, 1.2, 1.9 and 2.9 months — again, with no improvement in mOS. Patients did not live longer and both trials confirmed “the serious risks associated with bevacizumab”.4 With this new evidence, the FDA initiated proceedings to withdraw approval for bevacizumab for metastatic breast cancer,5 a move endorsed in editorials in the Journal of Clinical Oncology and Nature Biotechnology, which concluded, respectively, that “the outcomes were arguably not clinically compelling”12 and that “if lack of [drug] efficacy in the face of toxicity is insufficient to reverse an accelerated approval, then what is?”.13 It is illuminating to compare the mPFS values from the four bevacizumab breast cancer trials (0.7, 0.8, 1.2 1.9, 2.9 and 5.5 months),7,9-11 with values from the randomised phase III trials of bevacizumab in prostate, ovarian, gastric, pancreatic and colorectal cancer (0.4, 0.6, 0.9, 0.9, 1.0, 1.4, 1.4, 1.7, 2.4, 3.8 and 4.4 months).6 First, the 5.5-month value on which bevacizumab received accelerated approval is the extreme outlier. Second, statistically significant increases in mOS occurred in only two of the above 17 patient sets.6 Clearly, statistically significant increases in mPFS were not reflected in mOS. Thus, irrespective of whether tumour size is increasing, decreasing, or remaining stable under drug treatment, tumour size changes are extremely poor predictors of how long a patient will live. The above data show that PFS is not a surrogate for OS. Evaluating the therapeutic benefit of other anti-cancer drugs requires similar in-depth data analyses. In the case of cetuximab for first-line treatment of metastatic colorectal cancer and the use of KRAS mutations as biomarkers in tumour samples, the increase in mPFS was only 0.9 months, with no increase in mOS.14 As with bevacizumab, some physicians with no ties to the study concluded that this small difference is “clinically irrelevant”.15 Similarly, claims of therapeutic benefit for rituximab in treatment of chronic lymphocytic leukaemia16 and chemotherapy-sensitive low-grade follicular lymphoma17 have been questioned, particularly as these claims were based on PFS, a largely clinically irrelevant end point in these usually indolent diseases.18-20 In breast cancer, claims for the superior efficacy and safety of anastrozole, an expensive, often toxic aromatase inhibitor, evaluated in postmenopausal women with early-stage breast cancer,21 have been challenged.22 The data failed to show a survival advantage over tamoxifen, which is cheaper and well tolerated.21 We further contend that claims of therapeutic benefit based on PFS — from the recent trials of sunitinib and everolimus in low-grade and indolent pancreatic neuroendocrine tumours,23,24 zalutumumab in recurrent or metastatic squamous cell carcinoma of the head and neck25 and vandetanib in advanced non-small cell lung cancer26 — all require additional trials before they can be considered therapeutically robust. Most of the above drugs, all with questionable therapeutic benefits, are very expensive. For example, approximate costs per month for an average patient for bevacizumab, everolimus, sunitinib or cetuximab are AUD $3400, $5700, $5800 and $7000, respectively.27 Some newer drugs, recently approved in the US and already in use in trials in Australia, are even costlier (ipilimumab for metastatic melanoma sells at US$120 000 wholesale for a four-dose course of treatment given over 3 months).28 In summary, many drugs will add a significant burden to the Australian health care system, and hence all claims based on PFS by authors of pharmaceutical-company- or academic-sponsored trials need to be carefully scrutinised by independent experts before regulatory approval. How can the evaluation of therapeutic benefit be improved? A pragmatic example has been set by the molecular, neurobiological and physical sciences communities. First, all de-identified raw data should be lodged in approved, publicly accessible databases where the data conform to minimum information standards and are in a form suitable for independent statistical scrutiny, as exemplified by the US National Center for Biotechnology Information Gene Expression Omnibus (http://www.ncbi.nlm.nih.gov/geo). Second, an independent evaluation of the data conducted by professionals with no ties to, or financial compensation from, the sponsor or its surrogates should accompany the published abstract in medical journals. This “accompanying abstract” constitutes an independent clinical audit. Public companies cannot audit their own financial returns, and it is even more important that companies whose activities involve billions of public dollars in health care expenditure should abide by standards of transparency that can be independently verified using the highest standards of scientific excellence. As a recent MJA commentary stated: Facilitating data sharing among researchers, allowing other researchers and peer reviewers to test published conclusions, testing of secondary hypotheses, simplifying data acquisition for meta-analyses, and preventing selective reporting are all important advantages.29 Medical journals and their editors have a choice — to be viewed as “an extension of the marketing arm of pharmaceutical companies”,30 or to be beacons of transparent data processes that inform clinicians, improve patient treatment, and provide high standards on which governments, health care providers and patients can have confidence. Medical journals should demonstrate strong leadership by mandating open access to detailed clinical trial protocols and de-identified raw study data. They should insist on independent audits of data, concomitant publication of an “accompanying abstract”, and lodgement of the data in independent databases; these three actions should be a precondition for publication.

Ian E Haines MB BS, FRACP, FAChPM · George L Gabor Miklos PhD

Should the recently published PCOS guidelines be revised? The recent supplement of the Journal titled “Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline” summarises the full Australian guideline document that was launched at the 2011 Endocrine Society of Australia Annual Scientific Meeting.1 The document is thorough and has been put together meticulously; it covers the major diagnostic and management issues encountered by health professionals looking after patients with this challenging condition. However, the recommendations for metabolic screening included a 2-yearly 75 g oral glucose tolerance test (OGTT) in all women with polycystic ovary syndrome (PCOS), and annual testing for those with an additional risk factor.1 I believe that this screening protocol is not based on evidence and should not be applied universally to women with PCOS. Insulin resistance is a common feature in PCOS, and many studies have shown that even lean women with PCOS are insulin resistant compared with weight-matched controls.2 However, although the major risk factors for abnormalities in glucose metabolism are amplified in these women, they are similar to those in the general population — namely age, obesity and family history of type 2 diabetes.3 Given the young age of many patients with PCOS, and the fact that a significant minority (34% in one United States study4) have a normal body mass index (BMI), the diagnostic yield of 2-yearly OGTTs in some subgroups of women with PCOS is very low. The recommendation was taken directly from a position statement that was published by the Androgen Excess Society in 2007, in which it was acknowledged that some members of the expert panel disagreed with the recommendation and suggested a more targeted approach to screening.5 In a study of 372 Australian women with PCOS, only one of 73 women who had been diagnosed with diabetes had a BMI of less than 25 kg/m2, but, in women in the cohort who were aged under 30 years (whose mean BMI was over 35 kg/m2), the prevalence of diabetes was less than 2%.3 Therefore 98% of women with PCOS under the age of 30 years could undergo an OGTT five times during their 20s with little chance of a clinical benefit. Should screening for impaired glucose tolerance, which is more common, be a sufficient reason to justify routine screening? In the same Australian study, the prevalence of impaired glucose tolerance in a very obese group was 13.4%.3 A more recent report from the US showed that only 3% of non-diabetic women with PCOS and a BMI of less than 25 kg/m2 had impaired glucose tolerance.6 Furthermore, among the principles of screening are (i) that there must be evidence that diagnosing the condition being screened for leads to treatment which is better at an earlier stage and (ii) that there should be an agreed policy on who to treat.7 Such evidence does not exist for impaired glucose tolerance screening in PCOS. Possible predictors of progression from normal glucose tolerance to abnormal glucose metabolism in PCOS have been examined. In a Canadian cohort of patients with PCOS, the best predictor of later abnormal glucose tolerance was a glucose excursion of more than 1.4 mmol/L in the initial OGTT (ie, that which returned a normal result).8 Confining future screening to those women who fulfilled this criterion would reduce the number of the OGTTs performed by 45%.8 Decision tree modelling is another technique that has been used to enable targeted screening of women with PCOS.9 Even a decision tree which uses clinical data alone (ie, age, BMI, waist circumference and waist-to-hip ratio) would reduce the number of OGTTs performed by 25%, without missing a single case of impaired glucose metabolism.9 While intuitively it would seem that delaying or preventing the diagnosis of diabetes would be good, in practice this just means a change in the glucose threshold at which intervention commences. Considering that recent large studies of type 2 diabetes have shown no evidence that aggressive glucose lowering improves macrovascular outcomes, and that it may increase mortality,10,11 we are far from a situation where earlier glucose lowering intervention in “prediabetes” is of proven benefit. The mainstay of treating patients with impaired glucose tolerance is lifestyle change and, in some cases, metformin therapy12 — established therapies for PCOS that are covered later in the guideline document.1 Some experts have stated that metformin should only be used to treat PCOS in the settings of diabetes and impaired glucose tolerance (and possibly in adolescence) and should not be used to manage infertility or hirsutism.13 This is a narrower opinion than expressed in the Australian guideline and ignores the beneficial effects that metformin may have in inducing ovulation in women with a BMI of less than 30 kg/m2 or when combined with clomiphene citrate.1 Diagnosing impaired glucose tolerance in PCOS may not lead to any particular change in management, with lifestyle change and/or metformin still the mainstay. The exception to this is women seeking to become pregnant, in whom early recognition of an abnormality in glucose metabolism enables earlier treatment and improved fetal and maternal outcomes. Predominantly though, the main diagnosis of importance from an intervention viewpoint is type 2 diabetes. My concern is that practitioners who choose to perform selective OGTT screening in patients with PCOS (based on age, BMI, waist circumference, family history of diabetes and a wish to become pregnant) will be seen as “not following the guidelines”. Patients do not find the OGTT a pleasant experience. Non-selective, frequent repetition of the OGTT in women with PCOS will create an unnecessary burden for many patients, with no proven benefit. Larger prospective studies are needed to examine whether the intensive screening protocols recommended in the Australian guideline and the intervention which arises from an abnormal result are superior to universal lifestyle advice and selective screening of women with PCOS who have a substantially increased risk of diabetes. I urge the authors of this otherwise excellent document to revise their recommendations to state that performing a 2-yearly OGTT in all women with PCOS has an extremely low yield of abnormality in certain subgroups and that no evidence of benefit exists in diagnosing impaired glucose tolerance over and above the usual treatment recommended for this common condition. Until such evidence is available, a more targeted approach to screening for glucose metabolism abnormalities in PCOS should be suggested.

Warrick J Inder MB ChB, MD, FRACP

To the Editor: We read with interest the case report by Guirgis and colleagues. Recently, we examined a 62-year-old man with a 20-day history of dysphagia with solids and odynophagia. He did not recall ingesting any foreign body, and his medical history and physical examination were unremarkable.

Athanasios Sioulas · Dimitrios Polymeros · Ioannis S Papanikolaou · Konstantinos Triantafyllou

To the Editor: Health data can have an important role in alerting product safety regulators to consumer product-related injuries. Such injuries are a significant public health concern, with an estimated 173 000 incidents occurring each year in Australia, many of which require medical treatment.1 The new Australian Consumer Law (ACL; http://www.consumerlaw. gov.au), enacted in January 2011, increases safety requirements and recognises that industry members have an important injury prevention role. The ACL requires suppliers to report to the Australian Government when they become aware of serious injuries, illnesses or deaths associated with products they supply.2,3 Monitoring product safety issues under the ACL therefore relies on systematic reporting of injuries by consumers to suppliers, and by suppliers to safety regulators, although the extent of compliance is unknown. Given that medical treatment is an indicator of injuries serious enough to warrant mandatory reporting, monitoring of products involved in injuries that require treatment in hospital emergency departments is a logical place to focus initial attention. Australia currently has an array of injury data, such as emergency department data, morbidity and mortality data and specialised injury surveillance collections, that could be used for this purpose, without the need for new, expensive data collections. We conducted a pilot study of product-related injuries in children in Queensland, which identified significant potential for using existing injury data more effectively in product safety surveillance.4 A comprehensive national evaluation of routinely collected health data would enable product safety regulators to better understand and use these data. With a lack of exposure to the ACL in the health sector, clinical staff and injured parties may not be aware of reasons for and mechanisms of reporting product-related injuries. It is important that medical professionals are made aware of the law and informed about actions they can take to support this system. Engaging emergency department staff could be a first step for product safety regulators. This could be as simple as a well publicised free-call number or a dedicated email address that clinicians can use to access information or report injuries quickly, without the need to complete large amounts of paperwork. There are substantial opportunities for strengthening product safety surveillance in Australia using existing routine health information systems and timely reporting of clinically significant incidents. This is critical for ensuring a more strategic approach to emerging product safety issues, prioritising efforts and evaluating the efficacy of product safety initiatives, to reduce preventable injuries and deaths related to unsafe consumer products.

Kirsten McKenzie · Ruth A Barker · Deborah A Scott · Dave A Strachan

To the Editor: MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis and stroke-like episodes) syndrome has not been reported previously in the Aboriginal Australian population. Here, we describe a patient with MELAS syndrome in this population. A 29-year-old Aboriginal Australian woman presented with a 3-day history of seizures and confusion and a background of cognitive impairment, sensorineural deafness, epilepsy and short stature. On admission, she weighed 29.9 kg and was 1.46 m tall (body mass index, 14 kg/m2). She had myopathic facies, generalised mild motor weakness (4/5) and brisk reflexes (3+). These neurological findings represented a stepwise deterioration from previous assessments. On admission, the patient’s blood count, liver function tests, and serum urea, electrolytes and creatinine levels were normal. Her plasma bicarbonate level, anion gap and thyroid function were also normal. The patient had elevated resting arterial lactate (2.7 mmol/L; reference interval [RI], 0.7–2.5 mmol/L) and pyruvate (98 μmol/L; RI, 30–90 μmol/L) levels. The cerebrospinal fluid (CSF) protein concentration was 820 mg/L (RI, 150–500 mg/L) and the CSF lactate level was 5.4 mmol/L (RI, 0.7–2.5 mmol/L). Magnetic resonance imaging of the patient’s brain demonstrated increased T2 signal involving grey and white matter throughout both cerebral hemispheres, most confluent in the right temporal and parietal lobes (Box 1, A). An electroencephalogram displayed a slow rhythm with epileptic activity in the temporal and centroparietal regions. Histological examination of a biopsy of the gastrocnemius muscle was consistent with MELAS syndrome (Box 1, B). Electron microscopy of a muscle biopsy sample revealed mitochondria with abnormally arranged cristae and abnormal electron densities. Mitochondrial respiratory chain enzyme studies on muscle samples were within normal limits, but the common m.3243A>G mutation in the MTTL1 gene was detected in about 70% of the mitochondrial DNA (mtDNA) in muscle tissue and in 10% of the mtDNA of the peripheral blood. MELAS syndrome is a maternally inherited multisystem disorder resulting from mutations in mtDNA.1 Mitochondrial dysfunction leads to the clinical phenotype and lactic acidosis. Cerebral ischaemia unrelated to vascular territories is suggestive of the diagnosis,2 which is confirmed by genetic studies, enzyme assays and histological examination of affected tissue.3 The patient’s family was of Aboriginal Australian descent and she was not aware of any European ancestry. Further inquiry revealed a family history of deafness, diabetes and epilepsy (Box 2). Consequently, the family were offered genetic counselling. A literature review prompted initiation of arginine and coenzyme Q10 therapy.3 Twelve months later, she had good seizure control and had not been re-hospitalised. The disproportionate differences in health between Indigenous and non-Indigenous Australians are often appropriately ascribed to environmental factors. However, potentially treatable causes should always be considered. 1 Magnetic resonance imaging (MRI) and muscle histological studies A. T1-weighted MRI of the brain showing atrophy and enhancing low attenuation lesions. B. Gomori trichrome stain showing a ragged red fibre (black arrow) and two severely atrophic denervated fibres (white arrow). 2 Pedigree of the family of the patient (arrow)

Luke J Conway · Thomas E Robertson · James J McGill · Josh P Hanson

To the Editor: The editorial by Newman and colleagues on suicide and self-harm in immigration detention1 was a timely reminder of a contemporary issue that has aroused clinical, sociological and political debate. However, in providing a list of dot points for investigation, there was one curious omission. Although perhaps not politically correct or indeed comfortable for the authors, the well recognised possibility that suicide and self-harming behaviour could be politically motivated2 should also be addressed. This is important, not only because we as health professionals could be seen to be naive to ignore this, but, more specifically, so that inappropriate medicalisation of readily understandable distress does not occur.

Robert D Goldney

In reply: We thank Goldney for his thought-provoking response. We recognise that self-harm has multiple determinants, including mental disorders, but that it also attempts to influence or communicate. Acknowledging the political context that has created and sustains this issue, we also note long traditions of politically motivated self-harm and suicide, for example, by self-immolation or hunger strike; and that political protests using these methods — lip-sewing, cutting and self-burial — have occurred in Australian immigration settings. Our belief, based on extensive clinical engagement, is that the motivation for most self-harm and suicide in Australian immigration detention is not primarily political, but anchored in detainees’ deep despair. Many say that by killing themselves, they will end their pain and no longer be a problem to themselves, the government or their loved ones. As clinicians, we experience a tension — we acknowledge, with Goldney, the importance of not medicalising an area where the environmental and contextual influences so overtly create and maintain distress, yet we have a duty of care to reduce the risk associated with such behaviour and distress, irrespective of their origins. A pre-eminent challenge for professionals working in such stressful environments is to remain open to these multiple influences. We remain open to what the data will tell us about political and other contributing factors.

Michael J Dudley · Nicholas G Procter · Louise K Newman

To the Editor: In 2006, the Cancer Institute NSW established a single ethics committee, in order to improve the efficiency of ethics reviews for multicentre cancer clinical trials. This predates the National Health and Medical Research Council (NHMRC) Harmonisation of Multi-centre Ethical Review (HoMER) but exemplifies what HoMER aims to encourage nationally. Previously, such trials were submitted to each institution’s ethics committee, resulting in replication of effort and cost and prolonged review times, potentially making sites uncompetitive in attracting clinical trials.1 Under the Cancer Institute’s model, with the agreement of individual institutions, multicentre projects are submitted directly to a single ethics committee. Governance issues, such as the capability of an institution to provide appropriate support, and insurance issues have remained local health unit responsibilities.2 Data were prospectively collected on applications received from 1 July 2007 to 30 June 2009, and their processing times. The Australian Research Ethics Database was used to track and manage multicentre research projects. The aim was to achieve a 60-calendar-day time period from submission (1 month before the ethics committee meeting) to approval. Submissions were made on the NHMRC National Ethics Application Form, along with a protocol and patient information form. We evaluated 89 studies from the 2-year period. Fourteen trials were reviewed from single sites before other sites were engaged or whose ethics committees lacked cancer expertise. The median time range for review was 61–70 days. Forty-four per cent of applications were reviewed within 60 days and 70% within 80 days, ranging from eight studies taking 31–40 days to the extreme of seven studies requiring 131–160 days. The median time for assessment improved as the committee streamlined its processes: from 89 days in 2007 to 68 days in 2008 and 59 days in 2009. There were 15 studies, predominantly in the first year, that had long assessment times because of multiple issues concerning research merit and inadequate information for participants. Of the studies evaluated, one was approved without revision, 48 required minor revisions that were approved between meetings, and 40 required review by the full committee. Eighteen studies were reviewed twice, and 22 were reviewed more than twice. Efficiencies introduced included disseminating all documentation electronically, empowering the chair and deputy chair to approve minor amendments or responses between meetings, and the website carrying standard wording for use in sections of the patient information forms that were proving to be recurrently problematic. To resolve difficult issues that correspondence had not resolved, investigators were invited to meet with the committee. We conclude that a single ethics review for multicentre trials may be able to deliver a rapid response and be efficient without compromising ethical rigour. However, to make a difference to researchers, the governance review process will need to become correspondingly efficient. Our experience parallels that internationally, where such ethics committees can demonstrate cost savings with faster response times, yet provide ethical reviews of similar quality.3,4,5

Ian N Olver · Sharon J P Falleiro · Marion L Marson · James F Bishop

To the Editor: I am responding to the letter from McIntyre and colleagues in which they strongly urged the National Health and Medical Research Council (NHMRC) to increase support for primary health care research.1 Primary health care research is essential to the future of the Australian health system. Unfortunately, few primary care researchers apply to the NHMRC for support. Reflecting our concern about the low application numbers, we held a workshop on primary health care research last year (see http://www.nhmrc.gov.au/media/events/2010). Our statistics show that from 2008 to 2010, just 1% of total applications to the NHMRC for project grant funding designated the field of research as primary health care. The overall success rate for these primary health care grants over the period 2008–2010 (24%) compares favourably with the overall success rate for all project grants (24%) and clinical research project grant success rates (20%) over the same period. It is notable that the annual number of primary health care grant applications peaked early in the decade and have plateaued since 2004 (Box). This possibly reflects the additional funding for primary health care research from other sources, notably the Australian Primary Health Care Research Institute (APHCRI), which has funded a number of research projects since 2001. In 2010, the APHCRI announced funding of more than $3 million in the form of three centres of research excellence,2 four project grants3 and four fellowships.4,5 Number of National Health and Medical Research Council project grant applications with the field of research as primary health care, 2000–2010 Application year No. of applications 2000 7 2001 5 2002 58 2003 42 2004 31 2005 27 2006 28 2007 20 2008 30 2009 30 2010 30

Warwick P Anderson

To the Editor: The letter by Johnson and Mitchell,1 responding to the two published papers of Rosenwax2 and Lowthian3 and their colleagues, about hospital, ambulance and emergency department use in the last year of life, concluded with the statement: Also essential is an ongoing dialogue with the patient and family to enable a clear understanding of the goals of treatment and to proactively plan for likely adverse events . . . [this] will potentially reduce the use of acute services and encourage the provision of care in more appropriate environments. The most significant factor in facilitating this latter objective is the timely preparation by the patient of the appropriate form of instructions to medical staff and designated family members about end-of-life management. Unfortunately, there is no common, state-recognised instrument for this in Australia. Many people appear to believe that conferring a “power of attorney” on a family member is all that is required, but this is not the case. In most situations, this allows the designated member or members to administer financial and property matters but not to make medical decisions about end-of-life care. The requirements for a valid medical decision-making authority differ from state to state. The instruments are variously known as: “enduring power of attorney” in the Australian Capital Territory; “enduring power of attorney (medical treatment)” in Victoria; “medical power of attorney” in South Australia; “enduring guardianship” in New South Wales and Tasmania; “enduring power of guardianship” in Western Australia; “advance health directive” in Queensland; and “medical enduring power of attorney” in the Northern Territory. It would be a major advance in the rational use of health resources, and towards ensuring compliance with the wishes of people who are terminally ill, while minimising the stress and distress of their family members, if general practitioners were to encourage their chronically and terminally ill patients to complete the appropriate form early in their illness.

John D Paull

To the Editor: In 1999, a new medical school was established at James Cook University in an underserved region with specific needs in rural, remote and Indigenous health.1 Early data suggest graduates are contributing to the local workforce,2 but medical student places have increased further as part of the continued expansion of Australian medical education. As a result, the capacity for medical students to experience high-quality clinical opportunities is under challenge. We explored teaching capacity through a cross-sectional survey of inpatient workload at a private and a public teaching hospital in Townsville. Both hospitals have been established as major teaching sites for the past decade. Ward audits were conducted for almost 400 inpatients, followed by content analysis of primary and additional diagnoses obtained from hospital records. We found that in both hospitals, only about half the total number of beds contained patients who were well enough for medical student interactions, and only around half of these patients were available to the students. Overall, the clinical casemix indicated students had reasonable access to patients with a wide range of medical problems. However, the data also showed poor exposure across both hospitals to certain subspecialties, and relatively low exposure in the private hospital to more chronic and complex medical problems. These findings suggest the potential numbers of meaningful learning opportunities per student may be fewer than expected. Growing student numbers have coincided with expansion in the emergency department, and same-day, early discharge and hospital-in-the-home services. Further, surrounding rural hospitals are being better utilised as step-down facilities for rural residents. These innovations have resulted in a decrease in the average length of stay in the main hospital wards.3,4 Although increased throughput of patients may theoretically increase teaching capacity, it is likely that higher turnover also results in students missing opportunities for holistic learning, such as practising routine history taking and examination skills, and developing a social understanding of a patient’s illness episode. About 300 inpatient beds are currently being added to the public hospital. Based on our findings, this could translate into about 75 additional patients on any given day. However, the number of medical students has now doubled to over 200 per year. The findings suggest that, at least in one regional area of Australia, hospitals face significant constraints in expanding their clinical teaching. This may have implications for medical schools in other regions. General practices and rural hospitals may also be close to capacity.5 Therefore, we recommend that Australian medical schools plan carefully and strategically to ensure students gain access to sufficient clinical experiences. With support from the Health Workforce Australia initiatives, opportunities to innovate and expand in non-traditional clinical settings may provide a partial solution, but will require evaluation.

Tarun Sen Gupta · Richard B Hays · Torres S Woolley · Isaac Seidl · Andrew Johnson

To the Editor: Faunce and colleagues wisely called for the introduction of legislation modelled on the United States False Claims Act (FCA) in the Australian health care setting.1 Indeed, whistleblowers require protection and reward.2 The authors stated that the “key strengths of the US qui tam anti-fraud regime ... lie in its recovery of large amounts of public monies, its encouragement of good corporate practice” and noted that it is “largely compensatory or remedial rather than punitive”.2 However, the non-punitive nature of the regime is problematic. Settlements in the US may appear substantial. In 2009, Pfizer paid US$2.3 billion to settle a false claims action against their marketing of Bextra (valdecoxib).1 However, this sum represents only a small proportion of Pfizer’s overall profits, given that Bextra was marketed from 2001 to 2005 and the company’s profit for the first quarter of 2011 was US$2.2 billion.3 Clearly, pharmaceutical companies in the US cope with the FCA — their huge profits largely compensate for the settlements. “While the defense industry used to be the biggest defrauder of the federal government under the FCA ... the pharmaceutical industry has greatly overtaken the defense industry in recent years.”4 Between 1991 and 2010, settlements for criminal and civil monetary penalties reached a total of US$20 billion. Three-quarters of these occurred between 2006 and 2010.4 The message from the US experience is that non-punitive anti-fraud laws do not stop pharmaceutical companies from engaging in fraudulent activities.

Alain Braillon

Janice’s story: Janice, who is 23 years old, presented to her general practitioner with a history of stereotyped episodes that her partner had observed every 1–2 weeks over the previous year. She described the episodes as starting with “butterflies in the stomach”(rising up to her throat and lasting about 20 seconds) and intense deja vu.

Melissa A DeGruyter BM BS, BA(Physio) · Mark J Cook MB BS, MD, FRACP

To calculate cost savings to the Australian federal and state governments from the reduction in twin and triplet birth rates for infants conceived by assisted reproductive technology (ART) since 2002, and to determine the number of ART treatment programs theoretically funded by means of these savings.

Georgina M Chambers BAppSci(MLS), MBA, PhD · Peter J Illingworth MD(Hons), FRANZCOG, CREI · Elizabeth A Sullivan MD, MPH, FAFPHM

To describe the clinical outcomes for all HIV-serodiscordant couples attending an assisted reproduction program.

on behalf of the CVI Study Group

Objective: To describe why, when and to whom general practitioners refer women with symptoms possibly attributable to cervical, endometrial or ovarian cancers, and to identify patient and GP factors that predict referral to either a gynaecologist or a gynaecological oncologist.Design and setting: A national survey of GPs between 1 April and 31 August 2009 using a randomised incomplete block design based on case vignettes, and using a self-completed postal or online questionnaire.Participants: A sample of GPs, stratified by location and randomly selected from a database of GPs maintained by the Australasian Medical Publishing Company.Main outcome measures: Proportion of vignettes that were deemed to reflect a high probability of cancer being referred; and the patient and clinician factors that were the strongest predictors of referral.Results: Of the 3082 GPs who were selected for participation, 1402 responded, giving a response rate of 45.5%. Overall, for vignettes identified as describing women with a high probability of cancer, 75% were referred by metropolitan GPs and 73% by rural practitioners. Metropolitan GPs were significantly more likely to refer women in scenarios indicative of endometrial cancer than rural GPs. For all three cancers, GPs were significantly more likely to refer a patient to a gynaecologist (between 70.8% and 95.4%) than a gynaecological oncologist. Metropolitan GPs had significantly greater access to both private and public gynaecological oncologists than their rural counterparts. Referral rates were higher for ovarian and cervical cancer (83% and 80%, respectively) and lower for endometrial cancer (68%). For all three cancers, patient factors were stronger predictors of referral than the demographic factors of participating GPs.Conclusion: There appears to be significant variation in referral practices among GPs and this variation is greater for endometrial cancer, for which there are currently no evidence-based clinical practice guidelines in Australia. There is a need for further research into understanding the basis of these differences, including a review of the existing guidelines for ovarian and cervical cancer and the development of guidelines for endometrial cancer.

Shanthi A Ramanathan BA, MHlthSci(Hons) · Genevieve Baratiny BSc(Hons), PhD · Nigel P Stocks MD, FRACGP, FAFPHM · Andrew M Searles BEc, MMedStats, PhD · Russell J Redford BSc, DipCompSc

Objectives: To describe the prevalence of lifetime and 12-month stimulant use disorders in the Australian population, and to compare the prevalence estimates from a population survey with prevalence estimates derived using indirect methods.Design and setting: Data were drawn from the 2007 National Survey of Mental Health and Wellbeing, which sampled 8841 residents of private dwellings in Australia in 2007. Interviews were conducted by lay interviewers using the Composite International Diagnostic Interview.Main outcome measures: Lifetime and 12-month rates of stimulant use and stimulant use disorders (abuse, dependence) diagnosed according to the Diagnostic and statistical manual of mental disorders, 4th edition.Results: Lifetime prevalence of stimulant use disorders was 3.3%, and 12-month prevalence was 0.6%, equating to more than 97 000 Australians. Nearly half of those who had used stimulants on more than five occasions met criteria for a lifetime disorder. More than 8% of men aged 16–29 years met criteria for a lifetime stimulant use disorder. Prevalence estimates were consistent with recent estimates using indirect methods.Conclusions: Stimulant use disorders affect a significant number of Australians, and are most common in the age groups at greatest risk for development of psychosis.

Grant E Sara MM, MM(Psychother), FRANZCP · Philip M Burgess MA, PhD · Meredith G Harris BA(Hons), MPASR, MPH · Gin S Malhi MD, FRCPsych, FRANZCP · Harvey A Whiteford MB BS, MPH, FRANZCP

Objectives: To report risk factors, aetiology and neuroimaging features among a large series of young Australian patients who were admitted to hospital for a first-ever occurrence of ischaemic stroke; to analyse the effect of age, sex and ethnicity on the presence of risk factors; and to compare Australian and overseas data.Design, setting and patients: Retrospective evaluation of data for all patients aged from 15 to 50 years who were admitted to a public hospital in Adelaide, South Australia, from January 2006 to June 2010 with a primary diagnosis of ischaemic stroke.Results: Among 326 patients (184 males), the most frequent stroke risk factors overall were dyslipidaemia (187), smoking (161), hypertension (105) and obesity (92). Fifty-one patients used illicit drugs, mostly comprising marijuana and amphetamines. The most frequent stroke aetiologies overall were cardioembolism (85), arterial dissection (49), and small-vessel occlusion (31). Cardioembolism was highly prevalent among our study population compared with patients in other countries. Neuroimaging showed that more patients in our study had strokes that involved both vascular territories concurrently (9%) compared with patients in other countries.Conclusions: Risk factors, aetiology and features of ischaemic stroke among young people in Adelaide differ significantly from published data for young patients around the world. Patients in Adelaide are more likely to be obese, to be misusing marijuana and amphetamines, to suffer a cardioembolic event and to have a stroke that concurrently affects both the anterior and posterior cerebral circulation.

Matthew C L Phillips MB BS · James M Leyden MB BS, FRACP · Woon K Chong MB BS, FRANZCR · Tim Kleinig MB BS(Hons), PhD, FRACP · Philippa Czapran MB BS · Andrew Lee MB BS, FRACP · Simon A Koblar BM BS, FRACP, PhD · Jim Jannes MB BS, FRACP, PhD

Objective: To report outcomes from the first 2 years of the National Hand Hygiene Initiative (NHHI), a hand hygiene (HH) culture-change program implemented in all Australian hospitals to improve health care workers’ HH compliance, increase use of alcohol-based hand rub and reduce the risk of health care-associated infections.

M Lindsay Grayson MD, FRACP, FAFPHM · Philip L Russo MClinEpid, BN · Marilyn Cruickshank RN, PhD, FRCNA · Jacqui L Bear BEc, MLitt, GradCertMgmt · Christine A Gee MBA · Clifford F Hughes AO, FRACS, FACS · Paul D R Johnson MB BS, PhD, FRACP · Rebecca McCann BSc(Nursing) · Alison J McMillan MBA, BEd, RN · Brett G Mitchell RN, MAdvPrac, DTN · Christine E Selvey MB BS, MSc · Robin E Smith MBA · Irene J Wilkinson BSc(Hons), MPH

Safe, legal abortions and comprehensive reproductive health care are crucial for women, but there is still a long way to go It was the first autopsy I attended and it left a lifelong impression. The year was 1970, and I was a medical student in Dublin. A young woman had come from the country to work in a bank. She became unwell and was cared for by her landlady, who diagnosed the flu. When her condition worsened, she refused a doctor until she was moribund. By the time an ambulance was called, she had developed septicaemia, and she died soon after reaching hospital. The autopsy revealed extensive peritonitis and infected placental tissue in the uterus, which showed signs of interference, although by whom, or where, or when was never established, as was often the case. As a junior doctor in Papua New Guinea in the 1970s I was to see more such deaths among women who had wanted to conceal their pregnancies, consuming toxic herbs or using sticks to try to induce an abortion. In particular, I remember a nursing student from a distant province. Top of her class in her home village, she had come to Port Moresby to train. Like the Irish bank-teller, she was too terrified to seek help until it was too late. Those experiences provided much of my motivation for advocating — with many others — reforms in women’s reproductive health care in Australia, in particular the introduction of mifepristone (RU486) for medical abortion and the decriminalisation of abortion in state legislation. Over 40 years, I have seen many advances in my chosen specialty of obstetrics and gynaecology. When I began training, the only use of ultrasound was to locate the placental site after antepartum haemorrhage. Now, sophisticated ultrasound techniques are used on a daily basis to assess both normal and abnormal pregnancies. Perinatal mortality rates have dropped to a fraction of what they were due to closer fetal surveillance, and we have better management of diabetes and pre-eclampsia, and better facilities for care of pre-term babies. In-vitro fertilisation now enables many women, who would have previously remained childless, to give birth. There has been great progress in hormonal contraception, and the progestogen intrauterine device has made a huge difference to management of menstrual disorders, so that hysterectomy, common 20 years ago, is much less needed. However, I believe that among all these advances, the most dramatic and beneficial development in the provision of women’s health care in this time has been the change from unsafe, clandestine abortion to safe, open practice. In Australia, as in most other developed countries, there has been abortion law reform. Of course, there is still a long way to go. Only some states and territories have reformed or decriminalised their quaintly worded 19th-century legislation. But even without reform, case law has made the provision of abortion less uncertain for doctors, and more accessible for women. Medical abortion using mifepristone remains available only in restricted circumstances in Australia, and generally only to urban women; hopefully, in the near future, the drug will be accessible to all Australian women. Abortion is now much more widely discussed in society generally, as well as in the medical literature. There is increasing recognition that abortion is an important health issue for Australian women. However, there are still many countries in the developing world, including Papua New Guinea, where women die or suffer chronic ill health from complications of unsafe abortion. Making abortion, in particular medical abortion, widely and safely available has the potential to prevent many maternal deaths. Like everybody else interested in improving women’s health, I would like to see abortion rates reduced in Australia and elsewhere. However, this needs to be achieved by reducing the rates of unplanned and unwanted pregnancies, rather than by forcing reluctant women to continue their pregnancies. In Australia, certainly, effective contraception is available, including a variety of hormonal preparations. There are intrauterine devices with minimal side effects and long life spans, and the morning-after pill can be bought over the counter in Australian pharmacies. Yet our abortion rates are still more than three times higher than those of Belgium, the Netherlands and Scandinavia, where there are very liberal abortion laws and accessible abortion services. Clearly, we are not providing effective sex education at a standard equal to these countries. Little attention is given to contraceptive information and services in the course of antenatal and postnatal care, especially in the public sector. A more integrated system of women’s reproductive health care is needed, in which sexual health care, contraceptive advice and provision, prepregnancy and pregnancy advice, and care during and after pregnancy and birth would complement one another. Such a system would also incorporate abortion provision into mainstream health care. All women should have access to appropriate information and care in pregnancy, regardless of whether or not they intend to continue that pregnancy. I look forward to working towards improvements in abortion provision, and in other aspects of women’s reproductive health care, for the rest of my professional life.

Caroline M de Costa PhD, FRANZCOG, FRCOG

Carl Wood was an outstanding Australian gynaecologist who pioneered in-vitro fertilisation (IVF) and is often referred to as “the father of IVF”.

Gabor T Kovacs · John F Leeton

Jim Macken was born in Sydney on 24 January 1924, the eldest child of Irish immigrants. He grew up in Greenwich, Sydney, and was educated at St Aloysius’ College, Milson’s Point. In his final year there he was a prefect and a member of the first XV (rugby) and first XI (cricket). After school, he joined the Commonwealth Bank, while successfully studying for his economics degree part-time. He switched careers in 1953, commencing his medical studies at the University of Sydney at the age of 29. At university, he was often referred to as “Senator” Macken, as he was a mature-aged undergraduate representative on the university senate. Jim was a medical student at Royal North Shore Hospital. After graduating in 1959, he undertook his residency at the Mater Hospital, Sydney, before entering general practice at North Bondi. This was a dedicated community practice, with the doctors doing house calls, nursing home visits and obstetrics. Jim remained there for almost 40 years. As a visiting GP Obstetrician at St Margaret’s Hospital, Darlinghurst, Jim delivered many babies over the years, and gained his Diploma of Obstetrics from the Royal College of Obstetricians and Gynaecologists in 1980. He became a Fellow of the Royal Australian College of General Practitioners in 1981 and was an examiner at the College exams for a number of years. His wide-ranging interest in history, politics, sport, cards and literature enabled him to discuss virtually any subject with his patients, whether young or old. Jim was always immaculately groomed and had a great sense of humour and charming bedside manner. He was a lifetime member of the Balmoral Beach Club and swam in the inaugural Jack Cox Memorial 1500 m swim in 1946. He enjoyed playing golf at the Royal Sydney Golf Club. For 50 years, Jim was married to Marie, who died from ovarian cancer 4 months before Jim died from cardiac and renal failure on 19 January 2010. Jim is survived by his children Philip, Peter, John, Marea, James and Rosie.

Peter L Macken · V John Roche

Professor Sir Graham Collingwood Liggins (24 June 1926 – 24 August 2010)Sir Graham Liggins, who died last year aged 84, made arguably the greatest contribution of any Australian or New Zealand practitioner to modern obstetric practice. Educated at the University of Otago, his work in the 1960s on causes of prematurity led to the publication of a landmark randomised controlled trial. This 1972 report demonstrated a two-thirds reduction in the incidence of respiratory distress syndrome in preterm neonates who had received antenatal corticosteroids. Although not immediately universally accepted, subsequent work substantiated the benefit of this simple, ground-breaking treatment. The administration of antenatal glucocorticoids, now standard obstetric practice, is widely acknowledged as the single most effective therapy in minimising mortality from prematurity. Image courtesy: Bruce Jarvis, Auckland, New Zealand. Professor Ian Frazer (6 January 1953 –)Named Australian of the Year in 2006, Professor Ian Frazer’s development of a vaccine against the human papillomavirus (HPV) is arguably the most significant advancement in the prevention of gynaecological cancer in modern times. After completing medical studies in his native Scotland, he emigrated to Melbourne. Initial research into HIV-related immunodeficiency led to work on HPV and subsequently the creation of virus-like particles, from which the HPV vaccine would eventually develop. The recipient of numerous scientific and medical accolades, including the 2009 Australian Medical Association Gold Medal, he is currently Director of the Diamantina Institute at the University of Queensland. Sir Albert William Liley (12 March 1929 – 15 June 1983) Born and educated in Auckland, the “Father of Fetology” was a pioneer in maternal and fetal physiology. Practising at a time when Rhesus isoimmunisation was a major disease, he developed a graph that enabled interpretation of amniotic bilirubin levels into prognostic “Liley’s zones”, allowing more accurate prediction of stillbirth risk. Over 4 years, Rhesus-associated perinatal mortality in Auckland fell from 22% to less than 9%. Liley is also credited with the first successful intrauterine fetal transfusion, in 1963. This case laid the foundation for the evolution of fetal therapy and the acceptance of the fetus as a person in his or her own right in the decades that followed. Ian Alexander McDonald (1 April 1922 – 4 September 1990)Ian McDonald was born in Perth, Western Australia, but throughout his career practised mostly at the Royal Melbourne Hospital. His most significant contribution to modern obstetric care is the cervical cerclage (suture) that bears his name. The concept of inserting a stitch to close an incompetent cervix was first introduced by Vithal Shirodkar in 1955. In 1957, McDonald published a technically easier approach: a simple purse-string suture involving circumferential bites around the cervix at the level of the internal os, without the need for bladder dissection. The McDonald cerclage now forms part of the standard surgical armamentarium of the contemporary obstetrician. Image courtesy: Archives of the Royal Melbourne Hospital. George Simpson (14 May 1899 – 24 November 1960)Born in Clifton, Victoria, the young George Simpson was introduced to a number of ministers from the Presbyterian Church, including Reverend John Flynn. This was the beginning of a collaboration from which the Aerial Medical Service (later known as the Royal Flying Doctor Service of Australia) would eventually emerge. Simpson graduated from the University of Melbourne and, in 1927, undertook a 3-month survey to assess the medical needs of the Australian outback. In that year, he undertook the first unofficial flight of the Service, evacuating a miner with a spinal fracture from Mount Isa. Later, he established Melbourne’s first family planning clinic. Appointed an Officer of the Order of the British Empire in 1957, he died 3 years later aged 61. Image courtesy: National Archives of Australia

Jennifer N Lees MB BS · Colin A Walsh MB BCh, BAO, MRCOG

Incorrect symbol: In the supplement to the 19 September 2011 issue of the Journal, “Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline” (Med J Aust 2011; 195: S65-S112), there was an error in Algorithm 5. Under Pharmacological management, the third evidence-based recommendation contained a ≥ symbol instead of a ≤ symbol. The recommendation should read: Metformin could be used alone to improve ovulation rate and pregnancy rate in women with PCOS who are anovulatory, have a BMI ≤ 30 kg/m2 and are infertile with no other infertility factors. The html and pdf versions of this article have been corrected.

Helena J Teede · Marie L Misso · Amanda A Deeks · Lisa J Moran · Bronwyn G A Stuckey · Jennifer L A Wong · Robert J Norman · Michael F Costello

Associate Professor John Svigos is an obstetrician-gynaecologist at Women’s Health Specialists in Adelaide and an associate professor in obstetrics and gynaecology at the University of Adelaide. Since completing his medical degree in 1970, he estimates that he has delivered between 12 000 and 13 000 babies. He was awarded a Member of the Order of Australia for his services to medicine in 2010. He received the highest award from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) — the President’s Medal — in 2008. “I had some wonderful experiences delivering babies as a 5th-year medical student, which is why I decided to enter obstetrics and gynaecology training. I really owe everything I’ve done in obstetrics and gynaecology to the trusting nature of the women in Woodville, Adelaide, who let a bumbling student deliver their baby. I still remember the first baby I delivered. It was the fourth baby for an Italian lady. She was screaming and crying — there were no epidurals in those days. After we delivered the placenta and washed the sheets, I was making a cup of tea for the mother and I had this wonderful experience of seeing her with her child in a very serene, Madonna and Child-type pose, having previously been screaming in all sorts of agony. There was this beautiful serenity and peace, and I thought, ‘This is magic, I’m very lucky to have been a part of this’. I still get that feeling every time. I’ve delivered three babies in the past 12 hours and each was terrific. Every time there’s something different. There’s nothing routine about it. That’s what is exciting about obstetrics. My practice is a bit biased towards obstetrics but, really, I’m a generalist. I do obstetrics and gynaecology, as well as teaching and working in both public and private practice. I deliver around 250 to 300 babies a year. I’ve also had the excitement of delivering babies for some of the girls I had delivered years ago. That adds another special layer for me. ‘‘ There was this beautiful serenity and peace, and I thought, ‘This is magic, I’m very lucky to have been a part of this’. ” I teach a whole array of people from 5th-year medical students to midwives and trainee O&Gs. I also act as a mentor to overseas institutions, principally in Bali, Indonesia. I have AusAid funding for three maternal–fetal medicine trainees to rotate through Adelaide for 2 months. I’ve also worked at Vellore in southern India as a visiting professor, and in Penang, Malaysia, as a mentor. I also worked in Cape Town, South Africa, in 1976–1977, which was an enormous challenge for my wife and our three children who were all under 5 years of age. There was outright warfare in the streets because of apartheid. The experience in obstetrics and gynaecology was awesome, while the sociopolitical experience gave us a long-lasting social maturity and a keen appreciation of the freedom we have in Australia. Working overseas has been one of the highlights of my career. I think mentoring is incredibly important, particularly because we’re becoming more isolated in our practice. As a mentor, you have different roles — you can be a coach, an adviser, a counsellor, a facilitator, or a confidant. You have to be committed and make time for it. You have to be patient and you need to try and take a neutral viewpoint rather than defend those you are mentoring to the hilt. You also need The specialty has changed considerably over the years. Some patients look up everything online before they come to see you, so you have to give very succinct explanations, almost in competition with Wikipedia and Google. The other thing that’s changed considerably is patient expectations. They’ve gone up, and rightly so. We try very hard to meet them. Technically, we’re required to do many more operations and procedures than ever before. When I first started in the specialty, there was no ultrasound, no laparoscopy — none of the tools that we now have and take for granted. I might be old but I don’t feel old, and I certainly don’t feel like I’m on top of everything. I’m learning every day. I learn a lot from the people I teach. I was an examiner with RANZCOG recently and I learnt a lot by discussing cases with my colleagues. It was a very rewarding experience. There’s nothing about the day- to-day activity I don’t like. I don’t mind getting up early in the morning. My dad was a newsagent so I used to get up early and roll the newspapers for him. Even with things like breaking bad news, I think that presents a challenge. Anyone can be a good doctor when everything’s going well; it’s when things are going bad that you develop as a doctor. That’s when patients are looking for that little extra, something to get them through that difficult time. That’s where you’ve got to pull out all stops and give them the benefit of everything you’ve got to try and help them.” Interview by Sophie McNamara

Sophie McNamara

For many obstetricians, it is the excitement of bringing new life into the world that first attracts them to the specialty. "There are still many situations where nature is not a good midwife" Dr Rupert Sherwood, president Dof the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), says one of his favourite parts of his job is seeing the first ultrasound images of a growing embryo. "After 25­26 years [as an obstetrician–gynaecologist] I still get a buzz when I see that first ultrasound image of an embryo at 8­9 weeks, with a heartbeat ... it's a story that you can watch together with the parents", he says. The excitement of delivering a baby is also something many obstetricians continue to find stimulating after many years of practice (eg, see Medical Mentor, page C5). Intrapartum care can range from a supervisory role to hands-on involvement, especially in complicated labour or caesarean deliveries. Before the pregnancy, obstetricians are also involved in pre-pregnancy medical care, and after the birth they provide postnatal care, which is defined as care up to around 6 weeks after the birth. Dr Sherwood says most specialist obstetricians also practise as gynaecologists. "Unlike some other fields where the degree of subspecialisation is quite high, we still have a fairly large generalist workforce and we aim to keep it that way, particularly in rural and regional Australia", he says. Dr Sherwood, who practises in Hobart, says that obstetrics allows doctors to use an appealing mix of medical and surgical skills. "I describe myself as an operating physician. [The specialty suits] people who don't want to do the technical thing all day, but enjoy consulting and medicine as well." Junior doctors who are considering a career in obstetrics need to be empathetic, with good communication skills."Because you are dealing with people at a difficult emotional time in their lives, you need to be supportive and have good interpersonal skills ... you can't survive on technical excellence only", says Dr Sherwood. "I still get a buzz when I see that first ultrasound image of an embryo at 8-­9 weeks" Professor Ian Fraser, professor of reproductive medicine at the University of Sydney, says would-be obstetricians also need to have a real enthusiasm for the field so they can handle the often antisocial working hours. "They need to find the wonder of reproduction and pregnancy and birth and new life something that excites them, because it's a demanding specialty in terms of time and commitment." Obstetricians also need to be able to project an air of confidence, which will inspire confidence in other staff, such as nurses and midwives, as well as their patients -- particularly when things go wrong. "There are still many situations where nature is not a good midwife", says Professor Fraser. "You need a personality which doesn't freak out when something unexpected happens. You have to have confidence in yourself, and a calmness in your personality that will extend to the people around you." Obstetricians, particularly those in the private sector, often have long-term relationships with their patients over many years, or even over generations. As well as the close care provided during a pregnancy, many obstetrician­gynaecologists will also provide gynaecological care between pregnancies. "Getting to know your patients and their children and their families over the years, and seeing the children of the women you delivered, or, when you get to my stage, the grandchildren -- that aspect can be particularly satisfying. We find that in few other specialties", says Professor Fraser.

Sophie McNamara

Dr William Milford is a 4th-year obstetrics and gynaecology (O&G) trainee currently based at Bundaberg Hospital, Queensland. Why did you decide to do O&G training? Factors which drew me to the specialty included its generality, with medicine, surgery, emergency medicine and imaging all part of the work. Every day is different. Along with this was the potential to pursue subspecialty areas as diverse as cancer surgery, minimally invasive surgery and maternal­fetal medicine. I also wished to care for mainly young, healthy patients and families during what were hopefully normal life events, rather than just caring for the sick. What do you like most about your training so far? I enjoy most of my training but the intellectual challenge of managing high-risk pregnancies, particularly in women with medical comorbidities, is something I enjoy greatly. I also get great pleasure from performing surgical procedures. The three main modalities of surgery -- vaginal, abdominal and laparoscopic -- require different techniques, which makes operating diverse and interesting. It sounds a bit nerdy, but I particularly enjoy the academic stimulation brought by research and teaching. What do you dislike or find challenging? There is no aspect that I truly dislike but challenges are aplenty. Managing patients who have poor outcomes, from miscarriage through to intrapartum complications, is always challenging and stressful, but can be satisfying when done well. Similarly, dealing with chronic conditions such as incontinence or pelvic pain brings its own challenges and frustrations, particularly once the limits of therapy are reached. What's next? I would ideally like to remain a generalist, practising both obstetrics and gynaecology with public, private and academic aspects to my practice. I would like to continue to participate in research and teaching and am currently studying for a masters in public health, which ties into this. In the short term, I'm hoping to find a job in Europe towards the end of next year, preferably in a specialised unit with a research role. Do you have any mentors or role models? Probably the biggest influence has been working with and for other trainees early in my career. These trainees provided valuable role models and created inspiration, while setting the standards by which I judge my own practice. Probably my first role model was my father, a practising GP, who used to do obstetrics as well. I remember as a child being taken up to the maternity ward or waiting in the car while he did his ward rounds on the weekend.

Cate Swannell

A practice manager can make or break a medical practice Formulating the job description when advertising for a practice manager isn’t a simple affair, because, in 2011, there’s a lot they need to know. “The complexities of running a medical practice are significant”, says Brett McPherson, the president of the Australian Association of Practice Managers (AAPM), who is the go-to person for the 2000 practice managers he represents. Mr McPherson says that while doctors are the qualified experts in practising medicine, practice managers are the experts in managing medical practices. “General practice is a business; it’s a small to medium business enterprise now and, as such, it requires professional management.” Mr McPherson says an effective practice manager will be a leader who develops the practice, facilitates change, communicates well and handles thorny issues with staff. They should understand business, basic finance and principles of management. “The position exists to support and work in consultation with the practice principals in ensuring that the business management of the practice is professional and allows all employees to achieve the business vision, values and objectives”, he says. When doctors are deciding who to employ as a practice manager, and how much to pay them, there are many different factors to consider, including the size, type and location of the practice. He says salaries start at $40 per hour, while some corporate practice managers will expect to be paid six figures (see box, left). Although practice managers need excellent people skills to manage staff, most have very little face-to-face contact with patients. “Receptionists are doing all the front- of-house work. The managers are really doing the behind-the-scenes running of the practice”, says Mr McPherson. Practice managers are responsible for financial management, governance and organisation, business and clinic operations, risk management, IT management, human resources management, and marketing and planning. “These days, as practitioners realise the value of their practice managers, a lot of the time it’s the practice manager that can be the practice’s competitive edge”, Mr McPherson says. “Doctors want to walk in and work in a well-run practice. They don’t want to be worrying about if their Medicare is being paid or if the equipment is right or the IT is working. It just all happens — that’s what they want.” Implementing legislation Mr McPherson says that the government has recognised that practice managers are “agents of change” when it comes to implementing new systems or legislative changes. “There are a lot of things like Medicare Locals, bulk-billing, electronic health ... practice mangers play a significant role in the practical implementation and success of Australia’s health reform”, he says. Mrs Elizabeth Stanick, practice manager for The Hobart Anaesthetic Group, agrees that it’s imperative for a manager to maintain knowledge of, and comply with, changes in legislation. Mrs Stanick says practice managers also need to keep in tune with political and economic changes, be aware of the contractual obligations of the practice and have clear financial reporting skills. The practice Mrs Stanick manages is large, with 29 anaesthetists and 11 staff. The group provides anaesthetic services to about 95 proceduralists at four private hospitals in Hobart. Although her work is challenging and often complex, Mrs Stanick says there are more highs than lows, and she enjoys the constant learning which is required to keep abreast of changes in the health system. Varied role Mrs Stanick trained as a nurse in Adelaide before moving into banking. She says practice management allows her to combine her financial and administrative skills with her medical knowledge. “A practice manager should be able to interact with and influence a range of contacts at all levels, internal and external to the practice”, says Mrs Stanick, who received a meritorious award for her services to the AAPM, which recognises a 20-year involvement. “It gives the most wonderful scope to use a multitude of management

Linda McSweeny