Issues
Volume 187 Issue 4
From the editor’s desk
The health care happiness factor
Health and general wellbeing are high priorities in our society. We are regularly regaled with a surfeit of reports, including the many published each year by the Australian Institute of Health and Welfare, and its comprehensive biennial tome — Australia’s health. Our state and territory health departments also publish annual reports on the health of their residents and the performance of their health care systems. Not to be outdone, the World Health Organization has its own World health reports. There is also an international group of health care observers supported by the New York-based Commonwealth Fund, which regularly reports on a series of quality indicators reflecting medical care in Australia, Canada, the United Kingdom, New Zealand, Germany and the United States. These reports are reminiscent of a horse race, as each country vies for top billing in the categories of quality of care, access, efficiency, equity, and healthy lives, and the prestigious overall ranking. However, in all these reports there is one vital item missing: the happiness factor — an indicator measuring the overall happiness of doctors and other professionals working in our health care systems. To some this may seem frivolous. But surely the happiness of workers is a crucial determinant of quality outcomes? Indeed, as Edward C Rosenow III, an American physician, notes in The art of living ... the art of medicine: Happy people are flexible, unassuming, able to feel deeply; they have a passion and move through life with a grace, an elegance, a warmth. And most have a sense of purpose in life. Sadly, some would say that happiness in health care has now reached rock bottom, and it is baffling that this state of affairs does not command attention in the discourse on health care quality and safety. Surely it’s time that the importance of health care happiness is acknowledged, and the happiness fact or measured and regularly reported.
Martin B Van Der Weyden
In This Issue
Work with us Over the past few months the federal government has implemented a range of strategies, including deploying military personnel and doctors, aimed at eliminating the abuse of children in Indigenous communities. While this focus, and the promise of an ongoing commitment to the welfare of Indigenous children, is welcome, some Indigenous leaders and groups such as the National Sorry Day Committee have expressed dismay at the lack of consultation reflected in the government’s approach. In “Interventions to halt child abuse in Aboriginal communities”, Ring and Wenitong add their voices to the calls for the government to work with, rather than for, Aboriginal people to address the many factors that lead to Indigenous child disadvantage. Skin turf wars With reportedly burgeoning numbers of skin lesion excisions and overuse of flap repairs to close wounds, the management of skin cancer by general practitioners, particularly those working in skin clinics, has come under scrutiny of late. Askew et al add some data to this interesting debate with a national study that shows GPs are treating over half of all non-melanoma skin cancers and over a third of all melanomas, with flap repairs increasing between 2001 and 2005 as a proportion of all excisions (→ Skin cancer surgery in Australia 2001-2005: the changing role of the general practitioner). Meanwhile, Queensland researchers Youl et al found the diagnostic accuracy of regular GPs to be similar to those working in skin cancer clinics (→ Diagnosing skin cancer in primary care: how do mainstream general practitioners compare with primary care skin cancer clinic doctors?). Summing up some of the current controversy, Commens advocates for strengthening medical education in skin cancer management so that all patients have access to competent treatment (→ Skin cancer: changing paradigms of practice and medical education). Unregulated and untested — naturally Bioidentical hormone replacement therapy (HRT) regimens, tailor-made by compounding chemists, administered as lozenges or troches and generally more expensive than traditional prescription HRT, are marketed to women as being a natural and gentle HRT alternative. However, in “Three cases of endometrial cancer associated with “bioidentical” hormone replacement therapy” Eden et al warn (with three illustrative cases) that some bioidentical preparations may not contain enough available progesterone to protect the endometrium from the carcinogenic effects of unopposed oestrogen. Mile-high ketoacidosis Thought you’d heard all the possible travel nightmare stories? Diabetic patients requiring insulin need to travel with good documentation of their medication requirements and all supplies carried in a clear plastic bag ready to declare to security staff. So says Skowronski, whose insulin-dependent patient ended up in intensive care after being prohibited from carrying his insulin and syringes onboard a flight home from Norway (→ Airline security and diabetes). Monitor PBS changes You’ve probably heard about some changes to the Pharmaceutical Benefits Scheme that will save the PBS money by promoting the use, and reducing the price, of generic medications. However, the wisdom of the National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007 has been questioned by some experts, and the Bill was recently the subject of a Senate Committee inquiry. Articles outlining some of the concerns were published on the eMJA while the inquiry was running, and now appear in print. Faunce warns that the creation of two formularies, in which single brand F1 drugs are effectively protected from reference pricing against drugs in the multiple brand F2 category, will lead to a rise in the prices paid for patented drugs and may reflect an ongoing United States agenda to undermine reference pricing in Australia (→ Reference pricing for pharmaceuticals: is the Australia-United States Free Trade Agreement affecting Australia’s Pharmaceutical Benefits Scheme?). Searles et al believe that categorising drugs in this way may lead to a less evidence-based PBS, and that the cost of generic drugs will continue to be overpriced by international standards (→ Reference pricing, generic drugs and proposed changes to the Pharmaceutical Benefits Scheme). Harvey et al sum up the concerns in a linked editorial, pointing to a way forward that might increase the affordability of medications for both patients and the community (→ The National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007: reform or fracture?). The inquiry recommended that the Bill be passed but that the Minister report to the Senate on the impact of the reforms in 1 year’s time. Another time . . . another place Since I have seen three diabetics in the course of a year die, with remarkably similar symptoms in which there was a peculiar comatose condition preceded and accompanied by dyspnoea, I believe that it . . . has to do with a form of death which . . . bears the closest relationship to the disturbances in the metabolism in diabetes . . . [Kussmaul breathing] Adolf Kussmaul, 1874
Ruth Armstrong
Editorials
Interventions to halt child abuse in Aboriginal communities
A chance to make real gains in eliminating child abuse and the health, social, and economic problems associated with it The vigorous involvement of the Australian Government in addressing issues of child abuse in Aboriginal communities in the Northern Territory has been widely welcomed. The discussion that followed the Howard Government’s announcement (Box 1)1 has not been about whether there is a need to act — some of these interventions, in particular increased policing and better health services, have been called for by these NT communities for many years — but there has been debate about the way in which action should be taken. The intervention is attempting to confront a real and acute problem of child sexual abuse, using a legalistic and “tough love” policy approach. However, as well as an urgent response, sustainable solutions are needed to deal with the broader health and social issues that underpin child abuse, and it is important that these articulate with the longer-term aspirations of Aboriginal and Torres Strait Islander peoples and communities. These aspirations are much more comprehensive than a law and order approach delivering an “absence of fear”. A complex set of factors are associated with the occurrence of child abuse. A review of child abuse in the United States found poverty to be the most frequently and consistently noted risk factor.2 Community-related risk factors included a high crime rate, lack of social services, and a high unemployment rate. Parental-related factors included a history of physical or sexual abuse, being teenage or single parents, poor coping skills, low self-esteem, substance misuse, lack of parenting skills, mental health problems, and having multiple young children. Although there is far from an exact parallel between the situation in the US and that in the NT, there are some factors in common. Strategies recommended for preventing child abuse in the US included: increasing economic self-sufficiency; discouraging all forms of violence against children, including corporal punishment; making health care more accessible; expanding and improving the coordination of social services; improving treatment for psychological problems, and for substance misuse and spouse abuse; providing affordable child care; and educating parents about child behaviour, discipline, safety and development.2 The recent report from the Australian Productivity Commission entitled Overcoming Indigenous disadvantage3 provides contemporary information on many of these risk factors in the Aboriginal population. The report shows that rates of substantiated notifications of child abuse have increased. However, unemployment rates are down, there is more home ownership, basic education levels are improving, and there have been increases in native title determinations. While some aspects of child health are improving (although there is still a considerable way to go), a lack of progress or even deterioration in some health indicators point to continuing inadequacies in health services for Indigenous Australians. The problem of overcrowding in houses has not been solved, and risky alcohol consumption has not abated for men and has increased for women. Imprisonment rates for adults have increased, and the gap between Indigenous and non-Indigenous juvenile detention rates has widened. In announcing the measures that the government would take to deal with child sexual abuse, the Prime Minister drew attention to the comprehensive report into child sexual abuse in the NT by Pat Anderson and Rex Wild entitled Little children are sacred. However, the government’s response, at least as regards the initial strategies, has been in direct contrast to the recommendations of this report,4 in both content and philosophy.5 The government measures involve considerable reliance on uniformed services and coercive interventions, and limited consultation with the Aboriginal communities and leaders concerned. Evidence for the effectiveness of some of the Howard Government’s strategies does not appear to exist; nor does this seem to have been a dominant consideration. The relationship of land tenure to child sexual abuse is very poorly defined in the intervention, and detailed clarification of this aspect by the government would help to instil some trust in this aspect of the government’s response in the relevant communities. The same applies to the removal of the permit system: the need for permits would logically appear to be a deterrent to predators entering Aboriginal communities. Finally, it is not clear whether alcohol prohibition really works in the long-term. No one would say it was a spectacular success in the US or Russia, and in Indigenous communities in the Cape York Peninsula and in Canadian Indigenous communities the results of this measure have been mixed. In Native American communities in the US, it has been counterproductive,6 but it has provided some benefits in the particular circumstances of Alaska.6 A majority of remote NT Aboriginal communities are already “dry” by choice, and any such action should be negotiated with individual communities, and must include planning for the withdrawal of alcohol, as well as counselling. On the positive side, the government’s intervention will focus much more attention on the issues associated with child abuse, and give voice and opportunity to attempts to say much louder that the unacceptable really is unacceptable. So, at least, some short-term gains may be made, and there is some prospect of a residual shift in attitudes to child abuse and domestic violence. More importantly, the intervention engages the government and a committed Minister in efforts to tackle these vitally important issues. Nevertheless, the abuse of children cannot be dealt with effectively as a separate issue without also addressing the related health, social, education, and economic issues — and it will not occur without the full engagement of Aboriginal communities. Attempts to confront this emergency will immediately come up against longstanding problems, not just of the welfare system and exposure to alcohol and pornography, but of environmental and housing issues; and deficiencies in mental and other health services, in the law enforcement system, and in social services; and, finally, the manifest weaknesses of the criminal justice system. There are also problems related to workforce, training and accommodation for staff working in Aboriginal communities. Most importantly, there is the lack of self-esteem, the need for cultural strengthening, and the paucity of meaningful activities for individuals and communities. The record of those initiatives in Australia, no matter how well intentioned, which have been largely driven by the non-Indigenous community and lacked full Indigenous partnership, is pretty bleak. Disempowerment of Aboriginal people is a significant factor in the complex set of problems, and measures that lead to further disempowerment have, at best, doubtful prospects. We urge that, at the earliest possible stage, the government consider enlisting the support and involvement of Indigenous leaders in the health field, and give much more serious consideration to the community-engagement strategies and the more comprehensive approach outlined in the Anderson Wild report (Box 2).4 Child sexual abuse is not restricted to the NT, and the proper vehicle for addressing this issue at a national level is the Council of Australian Governments. The starting point ought to include those strategies that have been found to be effective in dealing with the abuse of children in Australia and other countries. Intervention trials, such as the initiative led by Noel Pearson in the communities of the Cape York Peninsula, should provide valuable information. The solution lies in taking action with Aboriginal people and communities rather than for them. With the Prime Minister’s promise7 that whatever resources are needed will be provided by the federal government, there is a tremendous opportunity for innovation, as well as effective implementation of the many strategies that have appeared in numerous government reports over many years in both health and other fields. It is a chance to make real gains in eliminating child abuse and the health, social, economic and other problems that are associated with it, but this requires bipartisan commitment for sustained, long-term interventions. The worst that could happen is that these communities are promised real, positive changes and the promise is again not fulfilled. We must do whatever it takes to save these children from sexual abuse today, but we must also ensure safe, healthy communities and a meaningful life for the children born into these communities in the years to come. 1 Measures announced by the Australian Government to halt child abuse in Indigenous communities of the Northern Territory On 21 June 2007, the Australian Prime Minister, John Howard, announced the following measures to combat child abuse in Indigenous communities in the NT:1 Widespread alcohol restrictions on NT Aboriginal land for 6 months Medical examinations of all Indigenous children in the NT under the age of 16 years Quarantining of 50% of the welfare payments to parents of children in the affected areas for the purchase of food and other essentials Enforcing school attendance by linking income support and family assistance payments to school attendance for all people living on Aboriginal land Taking control of townships through 5-year leases to ensure that property and public housing are improved Requiring an intensive clean-up of communities to make them safer and healthier, by marshalling local workforces through Work for the Dole arrangements Scrapping the permit system for common areas and road corridors on Aboriginal lands Banning the possession of x-rated pornography in the proscribed areas Increasing policing levels, and making law and order a central focus of the measures announced Amending NT land rights legislation 2 The Anderson Wild report4 The 97 recommendations covered: Leadership by the federal and Northern Territory governments in consultation with Aboriginal people, government responses to ensure child safety, the role of the Family and Children’s Services program in the NT, and family support services; Health aspects, both crisis intervention and prevention through primary health care; Policing, police education, cooperation with the Family and Children’s Services program, support for victims, bail applications (when the alleged offence is sexual abuse of a child), and offender rehabilitation; School attendance, the role of communities, community education and awareness, and housing; Alcohol and other substance abuse, pornography, and gambling; Community justice; Cross-cultural training of staff; and Implementation of the report.
Ian T Ring MB BS, MSc(StatsEpid), FAFPHM · Mark Wenitong BMed
The National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007: reform or fracture?
Reform is needed, but will the current Bill enact the best options? Two articles in this issue of the Journal1,2 comment on a complex but important piece of legislation put forward by the Minister for Health and Ageing — the National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007 (the Bill).3 The Bill splits the Pharmaceutical Benefits Schedule into two formularies: “one part for single brand drugs [F1], the other part for drugs that have multiple brands or that are interchangeable at the patient level with drugs with multiple brands [F2]”.3 The Bill allows reference pricing of drugs within each formulary but disallows an ongoing link in the price of drugs between formularies. The Bill institutes progressive mandatory price reduction and price disclosure by the sponsors of multiple brand (generic) medicines for drugs on F2. The aim of this is to ensure that the price the government pays for Pharmaceutical Benefits Scheme (PBS) medicines more closely reflects discounted prices paid by pharmacists and international prices for generic medicines. A support package will be provided to help community pharmacists adjust to the new arrangements. Authority approvals will be streamlined, a public awareness campaign is promised to promote the use of generic medicines, and a working group will be established to consider issues of continued access to innovative medicines through the PBS. The government argued in the Bill that dual delinked formularies were required to tackle a problem caused by reference pricing: price reductions imposed on multiple brand generic medicines that were being discounted to pharmacies would, in many cases, flow directly on through price linking to single brand patented medicines that were not being discounted. This was said to cause difficulties for the innovative pharmaceutical industry and to place patients at risk of losing subsidised access to many worthwhile medicines.4 The government believes patients will not be disadvantaged by the proposed changes, as out-of-pocket costs to patients would remain unchanged. In some cases, patients should pay less. It is estimated that the mandatory price reductions for drugs in the F2 formulary will result in patients paying between 20 cents and $4.65 less for about 400 drugs that will fall below the current copayment amount of $30.70 (for general patients), or that were already below this amount. The articles by Searles et al1 and Faunce2 raise three concerns about the Bill. First, eliminating global reference pricing could result in Australia paying more for a new medicine in F1 that is no better than those already available in F2. Second, these changes appear to reflect ongoing pressure from the United States through the Medicines Working Group established by the Australia–US Free Trade Agreement to weaken the PBS system of evidence-based reference pricing. Third, mandatory price reductions and price disclosure for drugs on the F2 formulary, while saving the government money, provide little financial relief to patients and are unlikely to stimulate the Australian generic medicine industry. Reference pricing is a means of negotiating a lower price by tying the subsidy to the differential effectiveness of the drug — its comparative clinical outcome rather than its cost of production. This principle applies both at the time of initial subsidy and later, when new competitors arrive on the scene. The proposed changes may not change the initial pricing mechanism, which will continue to use comparative effectiveness as a criterion for pricing. What they will do is lessen the “downward pressure” on single brand (patented) drug prices over time. With the new dual formulary system, there will no longer be an automatic price reduction when different drugs of similar effectiveness for the same condition are listed on the PBS at a lower price. The problem with the current system, as Searles et al make clear, is that we are paying too much for drugs that are out of patent, where the company has already made its profit on the initial investment. We need a means to reduce the price of generic drugs in a system where fixed out-of-pocket costs to consumers and historic negotiated prices with suppliers provide no incentive to switch to generics, and where there are no competitive forces to reduce prices to government. The Bill does provide one mechanism to do so. It will mandate price reductions to government for out-of-patent medicines over time. This will lower the cost of generic drugs in Australia — a much needed reform. The problem is that it relies on annual administrative rule changes that do little to encourage the generic medicine industry and may have the effect of maintaining high prices for patented medicines, even when similar non-patented drugs are falling in price. The unforeseen result might be that we will pay more for the health gains from many new expensive medicines over time. Searles et al suggest one alternative — maintain a single formulary, but have closed-bid, competitively tendered contracts with generic medicine suppliers to provide key drugs outside of the PBS. Another option would be to increase competition for generic drugs (within a single or dual formulary) by allowing generic drug manufacturers to discount to government rather than wholesalers or pharmacies. A generic-brand price discount to consumers could be seen as an extension of the current brand price premium scheme — instead of consumers paying more than the regular copayment for a particular brand, they could pay a lower price if they choose a particular generic. Using a market price signal of a copayment reduction for consumers is likely to be more effective in stimulating generic medicine use than the proposed government advertising campaign, possibly a lot cheaper, and is consistent with the aim of the National Medicines Policy to provide timely access to the medicines that Australians need, at a cost patients and the community can afford. Fine-tuning such a system so that the expected increase in market share would be enough to encourage a local industry, or to ensure the kind of continuous price reductions that the Bill imposes, is something that the government could experiment with — without serious disruption to the system. A Senate Committee inquiry into the Bill held a public hearing on Friday 15 June 2007, and was required to report the following Monday. The Committee recorded that this provided insufficient time to analyse specific concerns raised in evidence, especially in relation to possible long-term impact of these reforms. The Senate Committee recommended that the Minister report to the Senate 12 months after implementation of the reforms on their impact, par-ticularly on the cost of medicines to consumers.5 The Bill was amended accordingly.
Ken J Harvey MB BS, FRCPA · Anthony H Harris MA, MSc · Liliana Bulfone BPharm, MBA, GradCertHealthEco
Skin cancer: changing paradigms of practice and medical education
As practice continues to evolve, there will need to be concurrent changes in undergraduate and postgraduate medical education on skin cancer Over the past two decades, preventive health programs about the need for sun protection have alerted patients to the significance of increased rates of skin cancer in white Australians. Skin checks of both affected people and the “worried well” have become daily medical practice. This public demand has resulted in changes to medical practice and an increase in associated health costs, as touched on in two other articles in this issue.1,2 In this editorial, I argue that, as practice continues to evolve, there will be a need for concurrent changes in undergraduate and postgraduate medical education on skin cancer. Each year over 300 000 Australians are diagnosed with melanoma or non-melanoma skin cancer.3 However, on clinical examination, it is not always easy to tell the difference between benign lesions and skin cancer, even with specialist training. Both patients and medical practitioners feel the pressure to excise lesions if there is doubt about their malignancy. In this issue of the Journal, Youl et al report that a quarter of the number of lesions removed were as a result of patient insistence.1 For every melanoma excised, about 20–25 benign pigmented lesions are excised,1,4 amplifying surgical and pathology costs — nearly 300 000 benign naevi were excised over the period July 2005 to June 2006.5 Further, Askew et al demonstrate that skin cancer excisions are increasingly associated with complex and expensive surgical repairs.2 Medicare Australia statistics show that procedural cryotherapy for 10 or more solar keratoses was performed 595 568 times between July 2005 and June 2006.5 Skin cancer has been reported as the costliest of all cancers to treat.6 Traditionally, actinic lesions were initially managed by general practitioners, with appropriate referral to dermatologists, surgeons and radiotherapists. If GPs were uncertain about skin cancer diagnoses, they would refer patients to specialist dermatologists, who often had long waiting lists, were variably accessible, and charged higher fees. The Australasian College of Dermatologists (ACD) has long recognised the skin cancer “epidemic” in Australia, but has had difficulty meeting patient demand for dermatologists’ services, even with a trebling of the number of trainees from 20 in 1976 to 65 in 2006 (ACD, unpublished data). With a minimum 4-year training scheme, the number of practising Australian dermatologists has only risen from 136 in 1976 to about 350 in 2006 (ACD, unpublished data). Most people in metropolitan areas will have to wait for weeks or months to see a dermatologist, while access to dermatologists in rural and regional Australia is variable. The College’s state facilities have created regional outreach clinics with rostered dermatologists, but services still need to be improved. The two-tier relationship between GPs and specialists has been challenged recently by the rapid growth of skin cancer clinics that bulk-bill patients and are staffed by non-specialist medical practitioners.7 There are no regulations about who can set up these clinics — some are part of large commercial corporations. Nor are there any particular requirements for training of the clinicians who work there. Thus, an under-regulated three-tiered system of skin cancer management has developed. From the patient’s point of view, the convenience, accessibility and billing arrangement of these clinics may be appreciated. But, patients may also be incorrectly assuming that the attending medical practitioners have had “specialist training” and be unaware that their usual GP may be just as competent.1 From a professional perspective, some skin cancer clinicians, realising that they may have a “credibility” issue with their colleagues, have started to form liaisons with universities to establish accreditation courses. These clinicians are the “standard bearers”, but we need to know the competence of all clinicians in all skin cancer clinics, which should be open to examination by the public and professional peers. In my view, the rise of skin cancer clinics and the partial “sidelining” of GPs in skin cancer management is due not only to the relative shortage of specialist dermatologists but also to a failure in undergraduate and postgraduate education on skin cancer. In the 1980s and 1990s, I believe there was a profound, long-term underinvestment in the number of Australian medical schools, accompanied by variability in the breadth and quality of teaching on skin cancer. Over the next few years, owing to the development of new medical schools, the number of medical students graduating each year will almost double.8 Ensuring that skin cancer education is adequate will be an enormous challenge. Given the high prevalence of skin cancer in Australia, the Australian Medical Council should ensure that universities can sign off their graduates as competent in clinical recognition of skin cancers, as all interns will need this skill. This education needs to be significantly patient-based, to ensure that medical students have the chance to develop an appreciation of subtle clinical features. Available resources, including teachers as well as patients, are limited. New paradigms, educational technologies and collaborations will need to be established quickly.9,10 Going beyond basic recognition of lesions, skin cancer management is a complex issue, involving both procedural and pharmaceutical interventions. This requires supervised training, which should be undertaken by postgraduate clinicians who want to manage skin cancer. At the moment, further training for non-dermatologists who wish to increase their skills in this area is extremely ad hoc. Some universities have recently capitalised on the interest in skin cancer management by establishing skin cancer courses for medical postgraduates.7 These vary from weekend diagnostic certificate courses to year-long masters degrees, but, critically, may lack a significant component of face-to-face clinical contact with patients. While such courses may form an important part of future postgraduate skin cancer education, I believe the first priority of universities must remain the provision of undergraduate education. A different approach would be to look at more “hands-on” clinical training to achieve clinical competence in skin cancer management. The Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine, and the ACD are working on a unique training and education scheme that will provide supervised clinical attachments and assess competence, but this program will take years to provide enough certified GPs. In the meantime, other GPs are establishing and publishing their credentials to manage skin cancer.2,3 There may be little difference in outcomes between competent experienced GPs and skin cancer clinicians.1 Public health studies have ensured that we are now aware that skin cancers are five times more common than all other cancers combined.6 Now the public needs to be assured that new medical graduates are able to recognise skin cancers and that postgraduate education institutes will ensure that clinicians who choose to treat skin cancer are appropriately trained and competent.
Christopher A Commens MB BS, FACD
Research
Skin cancer surgery in Australia 2001–2005: the changing role of the general practitioner
Objective: To describe changing patterns of skin cancer surgery by Australian general practitioners and make comparisons with specialists.Design and setting: Analysis of Medicare Australia item number reports for skin cancer excisions and for flap and graft repairs between 2001 and 2005.Main outcome measures: GPs’ and specialists’ rates of non-melanoma skin cancer (NMSC) excisions, melanoma excisions, flap repairs and graft repairs; excision to flap ratios.Results: NMSC excisions in Australia increased from 338 712 (2001) to 451 628 (2005), a mean annual increase of 1.11/1000 population (P = 0.04); GPs did 51.1% of excisions in 2001, increasing to 54.4% in 2005, representing a higher mean annual rate increase than in specialists (P = 0.003). Nationally, melanoma excisions increased from 20 414 (2001) to 25 580 (2005); GPs did 34.3% of excisions in 2001, increasing to 35.8% in 2005 — a similar mean annual rate increase to that in specialists (P = 0.25). Total flap repairs increased from 58 550 (2001) to 80 742 (2005); GPs did 21.3% of flap repairs in 2001, increasing to 26.9% in 2005 — a similar mean annual rate increase to that in specialists (P = 0.83). Nationally, the excision to flap ratio for GPs fell from 14 : 1 (2001) to 12 : 1 (2005); in Queensland the ratio fell from 14 : 1 to 9 : 1 over the same period.Conclusion: GPs excise the majority of skin cancers, and the proportion excised by GPs is increasing. GPs are increasingly using skin flaps for repair, suggesting substantial changes to patterns of treatment, especially in Queensland.
Deborah A Askew PhD · David Wilkinson MB ChB, DSc, FRACGP · Philip J Schluter BSc(Hons) MSc, PhD · Kerena Eckert MPH
Diagnosing skin cancer in primary care: how do mainstream general practitioners compare with primary care skin cancer clinic doctors?
Objective: To measure and compare the casemix and diagnostic accuracy of excised or biopsied skin lesions managed by mainstream general practitioners and doctors within primary care skin cancer clinics.Design, setting and participants: Prospective comparative study of 104 GPs and 50 skin cancer clinic doctors in south-eastern Queensland, involving 28 755 patient encounters. The study was conducted in 2005.Main outcome measures: Prevalence of each type of skin lesion; sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the clinical diagnosis against histology; number needed to excise or biopsy (NNE) for a diagnosis of skin cancer.Results: GPs excised or biopsied 3175 skin lesions (mean 2.5/week) including 743 basal cell carcinomas (BCCs) (23.4%), 704 squamous cell carcinomas (SCCs) (22.2%) and 49 melanomas (1.5%). Skin cancer clinic doctors excised or biopsied 7941 skin lesions (mean 34/week), including 2701 BCCs (34.0%), 1274 SCCs (16.0%) and 103 melanomas (1.3%). Overall, sensitivity for diagnosing any skin cancer was similar for skin cancer clinic doctors (0.94) and GPs (0.91), although higher for skin cancer clinic doctors for BCC (0.89 v 0.79; P < 0.01) and melanoma (0.60 v 0.29; P < 0.01). The overall NNE was similar for skin cancer clinic doctors (1.9; 95% CI, 1.8%–2.1%) and GPs (2.1; 95% CI, 1.9%–2.3%). This did not change after adjusting for years of clinical experience.Conclusions: GPs and skin cancer clinic doctors in Queensland treat large numbers of skin cancers and diagnose these with overall high sensitivity. The two groups diagnosed skin cancer with similar accuracy.
Philippa H Youl MPH · Peter D Baade PhD · Monika Janda PhD · Christopher B Del Mar MD · David C Whiteman PhD · Joanne F Aitken PhD
Asthma among school children in the Barwon region of Victoria
Objectives: To determine (i) the relationship between asthma management and socioeconomic status; (ii) whether recent estimates from the International Study of Asthma and Allergies in Childhood (ISAAC) conducted in Melbourne apply to a broader cross-section of Victorian children; and (iii) age-related trends in asthma prevalence.Design: A questionnaire survey, based on the ISAAC protocol.Participants and setting: Subjects were children aged 4–13 years from a random sample of primary schools in the Barwon region of Victoria. The survey was conducted between March and September 2005.Main outcome measures: Parent-reported wheeze and wheeze-related use of health resources during the preceding 12 months.Results: Questionnaires were returned by 7813/9258 students (84%). Lower socioeconomic status was associated with increased frequency of regular asthma reviews (P < 0.01 for trend), but not of emergency department visits (P = 0.19). The prevalence of wheeze among 6- and 7-year-old children in the Barwon region was similar to that in Melbourne children (20.2% v 20.0%, respectively).There was an age-related increase in the proportion of children with ≥ 12 episodes of wheeze (P = 0.01); but an age-related decrease in emergency department visits (P = 0.02).Conclusions: Disadvantaged children have good access to regular asthma reviews and are no more likely to attend an emergency department with an episode of acute wheeze. Asthma prevalence in 6- and 7-year-old children in the Barwon region is similar to that in Melbourne. The prevalence of children with very frequent wheeze increases with age, but their use of health resources decreases.
Peter J Vuillermin FRACP · Mike South MD · John B Carlin PhD · Maree I Biscan Mstrs · Sharon L Brennan Mstrs · Colin F Robertson MD
Review
Issues for clinicians training international medical graduates: a systematic review
Objective: To ascertain the specialised communication issues clinicians need to understand when preparing international medical graduates (IMGs) for clinical practice in Australia.Study design: Systematic review.Data sources: A series of searches using MEDLINE (1990–2006) was conducted with relevant keywords. Literature from countries with experience in the integration of IMGs into their medical workforces was included. All except four articles were published between 1997 and 2006.Study selection: The initial search identified 748 articles, which reduced to 234 evidence-based English language articles for review. Of these, only articles relating to postgraduate medical training and overseas trained doctors were selected for inclusion.Data extraction: Titles and abstracts were independently reviewed by two reviewers, with a concordance rate of 0.9. Articles were included if they addressed communication needs of IMGs in training. Any disparities between reviewers about which articles to include were discussed and resolved by consensus.Data synthesis: Key issues that emerged were the need for IMGs to adjust to a change in status; the need for clinicians to understand the high level of English language proficiency required by IMGs; the need for clinicians to develop IMGs’ skills in communicating with patients; the need for clinicians to understand IMGs’ expectations about teaching and learning; and the need for IMGs to be able to interact effectively with a range of people.Conclusion: Training organisations need to ensure that clinicians are aware of the communication issues facing IMGs and equip them with the skills and tools to deal with the problems that may arise.
Louis S Pilotto PhD, FRACGP, FAFPHM · Geraldine F Duncan MB BS, FRACGP, DipRANZCOG · Jane Anderson-Wurf BAppSc(Speech Pathol), GradDipEd(TESOL), BEd
Obituary
John Charles Proctor Cone MBBS, MD, FRANZCP
John Cone was born on 6 December 1925 in Hawthorn, Victoria. He matriculated from Camberwell Grammar School and entered the medical school of the University of Melbourne in 1944. Graduating in 1949, he joined a general practice in the then outer Melbourne suburb of Ringwood, while retaining a sessional appointment in the medical outpatients clinic at the Royal Melbourne Hospital (RMH). He obtained a clinical doctorate of medicine from the University of Melbourne in 1954. Years later, when recounting his experiences in general practice, he described how his curiosity had been aroused by those often-frustrating patients whose problems could not be neatly categorised as either mental or physical, and he was drawn to psychiatry. In the 1960s, the most prestigious centre for the clinical study of such patients was the Department of Psychiatry of the Strong Memorial Hospital at the University of Rochester in New York State. There, the psychiatrist John Romano and the psychoanalytically-trained Professor of Medicine, George Engel, had pioneered the discipline of consultation–liaison psychiatry, based on the application of psychoanalytical ideas to clinical medicine. In 1964, John took his young family to Rochester to pursue state-of-the-art training in psychiatry. Returning to Melbourne in 1967, John established a private practice in psychiatry and became the senior Honorary Psychiatrist at the RMH in 1971, a position he held for 15 years. He was a foundation member of the Royal Australian and New Zealand College of Psychiatrists, serving on committees at both state and federal levels. He was also a founding member and chairman of the Melbourne Clinic, the city’s largest private psychiatric hospital. John was a connoisseur of fine food and wines, and, together with his wife, Margaret, a generous and welcoming host. He had an encyclopaedic knowledge of Australian and foreign flora and was a passionate gardener. He was diagnosed with cancer in 1994. During the period of terminal illness, he conducted himself with the same quiet dignity, resolve and thoughtfulness that had made him such an excellent doctor and teacher. He died on 16 January 2007. He is survived by Margaret and daughters Andrea, Felicity and Gair Amina.
Edwin Harari
Clinical update
Preventing suicide after traumatic brain injury: implications for general practice
People with traumatic brain injury (TBI) have an increased risk of suicide, suicide attempts and suicide ideation compared with the general population. Most suicide deaths and attempts involve self-poisoning. General practitioners are strategically placed to make a significant contribution to preventing suicide in this group. Assessment approaches need to take into account the chronic nature of suicide risk in people with TBI. The assessment of post-TBI depression is complicated by the confounding effect of post-TBI motor–sensory and cognitive impairments, but psychological symptoms (feelings of hopelessness, worthlessness, and anhedonia, in particular) suggest the diagnosis of depression after TBI. Management includes close attention to how medications are prescribed, dispensed and administered. Family and community brain injury agencies can be enlisted to provide emotional support and monitoring of people with TBI. GPs can facilitate access to needed mental health services for people with TBI during times of suicidal crisis. Clinical practice guidelines for the care of people living with traumatic brain injury in the community, recently published for general practice, may be of use in managing people with TBI (http://www.maa.nsw.gov.au/default.aspx?MenuID=188).
Grahame K Simpson PhD · Robyn L Tate PhD
Medicine and the law
Loss of chance: a new development in medical negligence law
The concept of “loss of chance” as an alternative cause of action in cases of medical negligence has succeeded in recent cases where actions based on causation have failed. The plaintiff must prove negligence and loss of a chance of a better outcome. The quantity of loss of chance must be more than “speculative” (1%). Damages are awarded as a proportion of the total injury commensurate with the loss of chance. More claims may be expected, although damages will generally be less than those awarded under causation. Doctors’ insurance premiums may rise.
James Tibballs MD, MHlth
For debate
Reference pricing, generic drugs and proposed changes to the Pharmaceutical Benefits Scheme
Draft legislation introduced to Parliament on 24 May 2007 proposes changes to the Pharmaceutical Benefits Scheme (PBS), including the creation of two formularies. The F1 formulary will contain single brand drugs that are not considered “interchangeable on an individual patient basis”, while the F2 formulary will contain mainly older drugs (many of them generic) for which there is at least one alternative product considered to be clinically interchangeable. Drugs in F1 will not be compared with those in F2 for pricing purposes, even if clinical trial data show them to be equivalent (or even inferior) for the same clinical indication. This undermines the evidence-based approach to reference pricing currently used in the PBS. Other changes require compulsory price disclosures and price cuts for generic medicines. While positive, these amendments are unlikely to deliver generic medicine prices as low as those in other developed countries. This is important, in view of growing evidence of the unaffordability of prescription medicines in the Australian community.
Andrew Searles BEc, DipEd, MMedStat · Susannah Jefferys BA LLB(Hons) · Evan Doran BA, GradDipHealthSocSci, PhD · David A Henry MB ChB, MRCP, FRCP
Viewpoint
Reference pricing for pharmaceuticals: is the Australia–United States Free Trade Agreement affecting Australia’s Pharmaceutical Benefits Scheme?
Unless the federal government changes the course of our medicines policy with intention, Australia’s pricing of patented pharmaceuticals is likely to follow inequitable US trends Proposed amendments to the National Health Act 1953 (Cwlth) are currently being considered by the Australian federal government. The National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007 (the Bill) includes several changes that will limit reference pricing under the Australian Pharmaceutical Benefits Scheme (PBS). Here, I argue that these amendments have been influenced by the Australia–United States Free Trade Agreement (AUSFTA) and, further, that if US influence on Australian medicines policy continues, there are likely to be adverse consequences for all Australians, involving the erosion of scientific objectivity and equity in PBS processes and, eventually, the end of public-funded medicines. What is reference pricing?The PBS is an internationally respected system under which the federal government uses public funds to reimburse pharmacists (and thence manufacturers) the “health innovation” value of listed medications, as proven by scientific evidence assessed by pharmacoeconomic experts on the Pharmaceutical Benefits Advisory Committee (PBAC). This allows Australian patients to generally pay a relatively low standardised copayment (currently $30.70 for non-concessional patients) for all PBS medicines, patented and generic alike. Under the current PBS system, once expert assessment has established that a new patented drug has better efficacy or safety than a different off-patent comparator for the same clinical indication, it is recommended by the PBAC for listing. The submission price is then further negotiated by the Pharmaceutical Benefits Pricing Authority (PBPA). If the PBAC’s analysis merely establishes equal effectiveness, then, in a fundamental cost-minimisation process, the newly listed drug’s initial reimbursement price is linked to the lowest in the relevant price reference group. Reference pricing, in its most fundamental sense however, applies post-listing when new competitors (with lower prices) enter six groups presently established under the Therapeutic Group Premium (TGP) Policy. In this TGP system, the unusual criterion of “individual interchangeability” assists patients wishing to obtain an alternative to a drug in one of these groups whose price has a high additional premium. Readily expanding categories of TGP reference pricing are a fundamental institutional manifestation of the evidence-based distributional justice — seeking a fair balance between price and proven community benefit — required to underpin public expenditure on medicines under section 101(3B[a]) of the National Health Act, as well as the principle of equity of access under the Australian National Medicines Policy.1 What are the amendments influencing reference pricing? The Bill proposes amendments (new sections 85AB, 85AC) to the National Health Act that will divide the current PBS formulary into two. Medicines will be listed on the F1 formulary if there are no “bioequivalent” brands or drugs in reference pricing groups subject to the TGP Policy — these will mostly be patented or “innovative” medicines. The F2 formulary will cover generic medicines. Once adopted, specific price cuts and disclosures will be imposed only on F2 generic medicines. New reference pricing groups subject to the TGP (in addition to the existing six) will have to meet the additional high standard (undefined in legislation) that they are “interchangeable on an individual patient basis” (proposed sections 84AG and 101[3BA]). Reference pricing — as it now operates after PBS listing to produce “flow-on” price drops — will be problematic when the trigger drug is in the F2 formulary (although the latter’s existence may cause the F1 comparator to be redefined as an F2). What lies behind these changes?I am concerned that at least some of the impetus for this alteration of PBS fundamentals may have come from multinational patented-pharmaceutical companies through mechanisms established by the AUSFTA. Annex 2C of the AUSFTA,2 which focuses on the PBS and pharmaceuticals, has led to some positive changes, including public summary documents of PBS drug-listing decisions.3 However, it also produced a new review mechanism that is triggered after PBAC rejection decisions,4 with increased opportunities for industry pre-hearings and consultations with technical staff, as well as a Medicines Working Group (MWG) comprising high-level officials on medicines policy from both Australia and the US.5 Further, in the past few months policies have been produced for full PBS cost-recovery from industry6 — despite such “user fees” and increased liaison mechanisms being criticised as creating conflicts of interest for the US Food and Drug Administration that significantly endanger public safety.7 Perhaps most significantly with respect to the Bill, Annex 2C.1 of the AUSFTA emphasises the principle of valuing pharmaceutical innovation through either the operation of “competitive markets” (the US position) or by “adopting or maintaining procedures that appropriately value the objectively demonstrated therapeutic significance of a pharmaceutical” (the Australian position).8 The potential importance to Australian medicines policy of this ambiguous definition of innovation has been highlighted in this Journal9 and elsewhere.10 We should not forget that the US negotiators to the AUSFTA, who previously worked very closely with senior members of the US patented-pharmaceutical industry on the Industry Functional Advisory Committee on Intellectual Property Rights for Trade Policy Matters, had an explicit legislative mandate to seek the “elimination” of PBS reference pricing (see Box).11 The same legislation also required the US Department of Commerce to investigate the possible future dismantling of reference pricing in OECD (Organisation for Economic Co-operation and Development) countries.12 In December 2005, in Paris, the US sought to implement this agenda through the OECD Project on Pharmaceutical Pricing Policies and Innovation.13 Australian AUSFTA negotiators provided reassurances about the Annex 2C.1 innovation principle before a Senate Select Committee on 21 June 2004: ... we went into these negotiations with an absolutely clear mandate to protect and preserve the fundamentals of the PBS. That is what this agreement does ... there is nothing in the commitments that we have entered into in Annex 2C or the exchange of letters on the PBS that requires legislative change.14 However, when the AUSFTA MWG met for the first time in Washington, DC on 13 January 2006, Australia’s Minister for Trade, Mark Vaile, stated that: . . . the core principle that we both agree on in this area . . . is recognising the value of innovation . . .15 To my way of thinking, this represents a restatement of Australia’s position on objective, evidence-based assessment of health innovation, in accord with the National Medicines Policy. Documents obtained under a Freedom of Information application (organised by Pat Ranald, Australian Fair Trade and Investment Network, 2007) reveal almost nothing of what was said at the first AUSFTA MWG meeting. One disclosed document, presumably discussed, was an opinion editorial in The Australian, which argued that: “Truly innovative cures should be referenced against innovation in other classes, rather than against generics”16 — an approach that seems to reflect the US “competitive markets” method of valuing innovation. The second meeting of the MWG on 30 April 2007 discussed the new F1 category, which had now been structured along the same lines proposed in the editorial the MWG had discussed at their previous meeting (International Trade Law Symposium, Canberra, 4 May 2007, personal communication). The official Australian Government website only disclosed that the MWG “discussions were constructive and informative”.17 I believe this evidence suggesting a possible, non-transparent link between the definition of innovation in AUSFTA Annex 2C.1, the MWG, and the new F1 PBS category, with its sequestration from post-listing reference pricing against generic medicines, has disturbing implications for sovereignty over Australian public health policy. The PBS beyond AustraliaIn its recent free trade negotiations with the US, the South Korean Government demanded a process similar to Australia’s current system of evidence-based cost-effectiveness and reference pricing.18 Article 5.2 of the Republic of Korea–United States Free Trade Agreement, after recognising each nation’s differing approach to medicines policy, indicates that if South Korea establishes a reimbursement system for pharmaceuticals or medical devices where the amount paid is not based on “competitive market-derived prices”, then it has to “appropriately recognize the value of patented pharmaceutical products” (Article 5.2 [b][i]). Article 5.1 (c) and (e) respectively mention PBS-type “sound economic incentives” as a method of facilitating access to patented medicines and PBAC-style “transparent and accountable” procedures as a means of promoting health innovation. However, Article 5.7 creates a Medicines and Medical Devices Committee, similar to the AUSFTA MWG. Will the parallels continue? The end of public-funded medicines?In Australia, it is likely that creating an F1 PBS category where patented drugs are insulated from post-listing reference pricing against generics and required price drops may, in the short term, tempt governments to increase the extent of patient cost-sharing (perhaps through differential means-tested copayments) for high-cost patented medicines. If the proposed amendments are adopted, the incentives for pharmaceutical products to remain within the price-protected F1 class are likely to lead to much more aggressive pharmaceutical patent battles in Australia (taking advantage of intellectual property changes introduced by Chapter 17 of the AUSFTA) that could delay the introduction of cheaper generic medicines.19 The consequent widening discrepancy between initial listing prices for patented medicines and their therapeutically equivalent generic comparators may become unconscionable. The evolving higher prices for F1 patented medicines could also provide additional arguments for patented-pharmaceutical industry lobbyists to claim that the PBS is “unsustainable” and that we need to move to a privately financed prepaid insurance system, such as medical savings accounts (a form of medicines superannuation).20 If, however, a future Australian government wants to retain public funding of patented medicines and contain PBS expenditure, it could remove, or rigorously define according to established PBAC records, the criteria of “interchangeable on an individual patient basis”. It also needs to be clarified that this concept will not interfere with the initial choice of cost-effectiveness comparator, initial cost-minimisation, or the creation of therapeutic relativity sheets that are used by the PBPA to assess post-listing industry requests for price rises. Without such clarification, and a robust mechanism for shifting F1 drugs to the F2, the proposed changes to the PBS threaten a shift away from the fundamentally evidence-based method of valuing the health innovation of a patented pharmaceutical after listing. They may, instead, push it more towards valuing F1 products through the operation of markets that are nominally competitive, but readily distorted by collusion and advertising. Much will depend on whether the government protects and supports the independence of officials involved in pharmacoeconomic analysis and vigorous price negotiations with patented pharmaceutical manufacturers (both at first listing and over time), in the MWG and, if necessary, in AUSFTA Chapter 21 dispute resolution procedures. My concern is that the haste with which this legislation is progressing might lead to this policy choice being delegated to technical experts in finance, or working groups with private interests, rather than being made part of a systematic public debate about the kind of health care system all Australians want to have, and the trade-offs they are prepared to make against strategic objectives of trade or international public policy. If the Australian regulatory and policy environment for medicines continues to further resemble the inequitable US system, we will similarly have unaffordable innovative products and worse health outcomes (despite low-cost generics) for citizens lacking private insurance with extensive coverage. United States AUSFTA negotiators’ instructions on Pharmaceutical Benefits Scheme reference pricing The US Trade Representative, the Secretary of Commerce, and the Secretary of Health and Human Services were obliged to: Bear in mind the negotiating objective set forth in the Bipartisan Trade Promotion Authority Act of 2002 to achieve the elimination of government measures such as price controls and reference pricing which deny full market access for United States products. In so doing, the agencies shall provide periodic and timely briefings for the Committees of the House and Senate listed above, with an interim briefing no later than 90 days after enactment to address negotiations to establish a US–Australia Free Trade Agreement and, as appropriate, other current negotiations.11 [emphasis added] AUSFTA = Australia–United States Free Trade Agreement.
Thomas A Faunce BA LLB, BMed, PhD
Notable cases
Three cases of endometrial cancer associated with “bioidentical” hormone replacement therapy
We describe three women who developed endometrial cancer after taking “bioidentical” hormone replacement therapy (HRT) to relieve menopausal symptoms. Although pharmaceutical HRT is a well established and tested therapy, little is known about the quality control, safety and efficacy of bioidentical HRT. Women should be advised to avoid bioidentical HRT, and those who continue to use it should receive regular endometrial surveillance. Clinical recordsPatient 1A 71-year-old non-diabetic woman had been on some form of hormone replacement therapy (HRT) since the age of 49 years. She took oral oestrone sulfate 1.25 mg daily and medroxyprogesterone acetate 10 mg for at least 10 days a month for 8 years. For the next 2 years, she used a 3.2% compounded topical progesterone cream (at a daily dose of “one level spoonful”). In December 1997, she had some irregular vaginal bleeding, which was investigated by diagnostic hysteroscopy and curettage. The tissue diagnosis was atrophic endometritis. Between June 1998 and July 2002, she used “bioidentical” HRT as troches. Each troche contained: oestradiol, 1.75 mg; progesterone, 300 mg; testosterone, 4.5 mg; and dehydroepiandrosterone (DHEA), 5 mg. The initial dose was half a troche per day, dissolved in the mouth. Between July 2002 and December 2004, she used one-eighth of a troche in the morning and one-quarter in the evening. Each troche contained: trieste (oestrone, oestradiol, oestriol), 3.0 mg; progesterone, 400 mg; testosterone, 1.5 mg; and DHEA, 5 mg. Early in 2004, she presented with several episodes of vaginal bleeding, and an ultrasonic scan revealed a thickened endometrial lining (combined thickness, 18 mm; normal for a postmenopausal woman is < 5 mm). Hysteroscopy confirmed a grossly abnormal endometrium with abnormal vascularisation. Curettage revealed a grade 2 endometrioid carcinoma. She underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy. The final diagnosis was stage IA, grade 2 endometrial cancer. Patient 2A 59-year-old non-diabetic woman, who had been menopausal from age 51 years, used “bioidentical” HRT as troches containing oestradiol, progesterone, testosterone and DHEA (doses unknown) from November 2001. From May 2003, she had noted continuous vaginal bleeding. An ultrasonic scan showed that the endometrial thickness was 19 mm. Diagnostic curettage in July 2003 confirmed a diagnosis of complex endometrial hyperplasia with atypia. She was referred to the Gynaecological Cancer Centre at the Royal Hospital for Women in September 2003, and underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy. The final diagnosis was stage IB, grade 2 endometrial cancer. Patient 3A 54-year-old non-diabetic woman presented with irregular vaginal bleeding. She had been using troches made by a compounding chemist for several years (precise time unknown). This treatment had been commenced while she was still menstruating. The troches had contained varying doses of DHEA, oestrone, oestradiol, oestriol and progesterone (doses unknown). The troches were posted to her by mail and she was monitored by telephone conversations with a nurse. A pelvic ultrasound revealed a thickened endometrium; hysteroscopy and curettage showed a polypoid lesion at the fundus. Histopathology revealed grade 2 endometrial cancer. She underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy, and the final diagnosis was stage IA, grade 2 endometrial cancer. DiscussionPharmaceutical HRT is a well established and tested therapy for the relief of menopausal symptoms such as hot flushes.1 The risks, benefits and adverse effects of pharmaceutical HRT have been established in large randomised controlled trials such as the Women’s Health Initiative study.2 For example, unopposed oestrogen is known to be associated with an increased risk of endometrial carcinoma,3 so a progestin is added to prevent this complication. Pharmaceutical progestins, when used appropriately, are very effective in preventing endometrial carcinoma.3 Pharmaceutical medications undergo rigorous quality control, safety and efficacy testing. In Australia, pharmaceutical medicines are regulated by the Therapeutic Goods Administration. In contrast to this, compounding chemists can “hand make” pharmaceuticals in novel delivery systems. Currently, these compounds are not directly regulated by the Therapeutic Goods Administration. Thus, little is known about the quality control, pharmacokinetics, safety and efficacy of these treatments. Compounded hormone replacement therapy is often termed “bioidentical” HRT. Typically, bioidentical HRT contains three oestrogens (oestrone, oestradiol and oestriol), progesterone, and androgens such as testosterone and DHEA, and is usually given either as cream rubbed onto the skin or as troches. Often, bioidentical HRT is monitored using blood or salivary levels of sex hormones. If the dose of progesterone is insufficient to prevent oestrogen-induced endometrial hyperplasia, then these treatments might cause endometrial carcinoma. When testing new HRT regimens, endometrial assessment is one of the most important safety endpoints. The usual method used for evaluating the endometrium in HRT trials is endometrial biopsy (usually performed every 6–12 months). In its guidelines to the pharmaceutical industry, the United States Food and Drug Administration recommends endometrial biopsies at the beginning and end of an HRT trial.4 Sometimes ultrasound can give additional useful information (endometrial thickness, polyps, fibroids etc). The current “gold standard” test for endometrial assessment is hysteroscopy and curettage. The three cases reported here raise the possibility that the oestrogen component of the troche was significantly absorbed but the dose of progesterone was inadequate, thereby causing endometrial hyperplasia. The North American Menopause Society has produced a useful discussion paper on bioidentical HRT,5 and it should be noted that the Australasian Menopause Society does not recommend the use of bioidentical HRT.6,7 Until this therapy has been properly tested, it may be prudent not to advocate bioidentical HRT and to perform endometrial surveillance (eg, annual transvaginal ultrasound and endometrial biopsies) on women who, despite counselling, continue to use bioidentical HRT.
John A Eden FRANZCOG, FRCOG, CREI · Neville F Hacker FACOG, FACS, CGO · Michael Fortune MB BChir, FRCOG, FRANZCOG
Snapshot
A giant splenic artery aneurysm
A 70-year-old man had a 1-year history of intermittent abdominal distension. Abdominal ultrasound examination showed a cystic lesion near the pancreas. Contrast computed tomography scans showed a large aneurysm (Figure A, arrows) about 80 × 70 mm in size. Angiography of the coeliac and splenic arteries confirmed the diagnosis of a giant splenic artery aneurysm (Figure B, arrow). The aneurysm was surgically ligated and excised, and the spleen was removed. The postoperative course was uneventful. Splenic artery aneurysms larger than 80 mm are rare.1 Open ligation or embolisation should be considered for symptomatic aneurysms, aneurysms ≥ 2 0 mm in size, or any splenic artery aneurysm in a woman of childbearing age.2
Chih-Chen Lai · Liang-Wen Ding · Tung-Wei Chu
Correction
Use of thoracic computed tomography by general practitioners
Re: “Use of thoracic computed tomography by general practitioners”, by Graham Simpson and Garry S Hartrick, in the 2 July issue of the Journal (Med J Aust 2007; 187: 43-46). A university affiliation of one of the authors was omitted. Graham Simpson’s affiliations are Director, Thoracic Medicine and Regional TB Control Unit, Cairns Base Hospital, Cairns, QLD, and Clinical Associate Professor, Department of Medicine, James Cook University, Cairns, QLD. The html and pdf versions of this article have been corrected.
Graham Simpson · Garry S Hartrick
Letters
Airline security and diabetes
To the Editor: Security requirements for air travel have recently become very strict and include limitations on the carriage of medication and medical equipment. International flights to and from Australia are often lengthy, and patients needing regular medication can suffer serious complications without it. Diabetic patients are particularly vulnerable, as illustrated by this case. A 54-year-old engineer was returning to Australia after a 4-month placement in Norway. He had a history of type 2 diabetes, which had become insulin dependent 5 years previously. His diabetes was well controlled with 40 units of insulin twice daily, and he had no other major medical problems. At a Norwegian airport, his insulin, needles and syringes were detected on security screening of his cabin baggage. Security staff told him that he was not permitted to carry his insulin or equipment in the cabin without a letter from his doctor and a current valid prescription. The man’s protests were to no avail, and he boarded without his insulin. During the 25-hour journey to Sydney, he developed vomiting, polyuria, sweating and dyspnoea. Despite making cabin staff aware of the underlying problem, he was offered no assistance apart from a steady supply of airsickness bags. On arrival in Sydney, he was very ill and was taken by ambulance to St George Hospital, where he required admission to the intensive care unit. His pulse rate was 130 beats/min and respiratory rate 30 breaths/min. His urine was strongly positive for ketones and his blood glucose level was 51 mmol/L. Arterial blood gas analysis showed very severe metabolic acidosis with a pH of 6.9, Pco2 18 mmHg, and Hco3 4 mmol/L. His diabetic ketoacidosis was treated conventionally, with aggressive extracellular volume and electrolyte replacement, and insulin by infusion. His condition improved rapidly, and he was discharged home the next day. Australian doctors and their diabetic patients should be reminded that airline security requirements are now very strict in most countries, and that life-threatening ketoacidosis can readily develop over the course of a flight between Australia and the northern hemisphere. Insulin-dependent patients must continue to take their insulin during these flights and should not board without their supplies. In Australia, the Department of Transport and Regional Services stipulates that people with medical requirements may carry “prohibited items” such as hypodermic needles, but must also carry a doctor’s letter, a medical certificate, or a current National Diabetes Services Scheme card.1 Supplies should be clearly labelled, carried in a clear plastic bag and declared to security staff before being screened. The United Kingdom Department of Transport2 and the United States Transportation Security Administration3 have broadly similar requirements.
George Skowronski
Colonoscopy capacity in selected New South Wales hospitals
To the Editor: The recent editorial by Macrae1 outlined the potential issues facing the rollout of the National Bowel Cancer Screening Program. It is estimated there will be about 5000 additional colonoscopies performed in New South Wales in the first year.2 To ascertain how the NSW public health system might absorb this increased demand, the Greater Metropolitan Clinical Taskforce (GMCT) Gastroenterology Network conducted a survey in 2006, featuring structured interviews with clinicians. Our aims were to estimate the current capacity of NSW public hospitals to perform colonoscopies and to identify perceived impediments to meeting future demand. From a total of 113 public hospitals where colonoscopies had been performed in the period 2001–2004,3 we selected a purposive sample of 32 where there had been at least 500 procedures, or which were regarded as major providers in their area health service. Responses were received from 26 hospitals, which represented 54% of colonoscopies performed in all public hospitals in NSW in 2001–20043 and included both metropolitan and rural hospitals. No information was collected from the private sector. Fifteen hospitals had dedicated endoscopy suites, 10 used operating theatres, and one unit used a day surgery centre. We found that for the majority of these hospitals (23/26), colonoscopy activity is currently at or near maximal capacity, with limited potential for expansion of services. The additional number of colonoscopies that could be accommodated ranged from one to four per week in six hospitals, up to a maximum of eight per week in a single hospital. Reasons for unbooked hours included insufficient funds, and a lack of nurses and anaesthetists. The Box summarises other key findings, which emphasise that the three major factors limiting activity are insufficient endoscopy nurses, insufficient nursing applicants, and the need for more equipment. Importantly, an absolute shortage of proceduralists was not found to be a restricting factor. Rather, insufficient available colonoscopy time for existing proceduralists was identified as a limitation. While our survey was successful in clarifying factors that impede optimal performance, the small number of participating hospitals is a relative limitation. Nevertheless, the survey suggests a requirement for additional nursing staff and equipment, and for the establishment of uniform data collection and reporting systems. Areas requiring further exploration include greater unit efficiency, opportunities for workplace redesign, and consideration of inequities in access to anaesthetic cover for patients in public hospitals. The GMCT Gastroenterology Network is currently working on these issues in collaboration with the NSW Department of Health. Factors affecting colonoscopy capacity in selected New South Wales public hospitals* Most responding units (22/26) regarded additional nursing staff as a medium to high priority requirement Increasing time available to existing proceduralists (18/25) and allocating time for new proceduralists (16/25) were regarded as medium to high priorities 11/15 hospitals with dedicated endoscopy suites had an unused endoscopy room. Most common reasons were: insufficient funds (5); lack of nurses (5); insufficient equipment, including anaesthetic machines (3); and lack of anaesthetists (2) No unit cited a shortage of proceduralists as a reason for the unit not running at full capacity “For” (11/24) and “against” (13/24) responses for the addition of procedure rooms were evenly spread across responding facilities Prioritisation of colonoscopies over other procedures was not favoured (14/24 ranked this of low importance, 5 as neither low nor high, 5 as medium to high) Most important factors impeding capacity were: Lack of approval to recruit nursing staff (18/23) Shortage of nursing staff applicants (16/25) Budgetary limitations (19/25) Insufficient endoscopy time for existing proceduralists (17/25) Insufficient budget to recruit new proceduralists (16/23) Only 2/26 units (both using operating theatres) had a data manager recording data and compiling statistics; others (13/26) in dedicated endoscopy suites used commercial reporting systems, such as Endoscribe, however the survey did not determine how systematically and completely data were compiled and reported from these systems * Some respondents did not answer all questions.
Shelanah A Fernando · Anne E Duggan · Owen F Dent · Maeve C Eikli
Comparing survival outcomes for patients with colorectal cancer treated in public and private hospitals
To the Editor: I note with interest the results of the study by Morris and colleagues comparing survival outcomes for patients with colorectal cancer treated in public and private hospitals.1 Stage of disease is a major determinant of survival in colorectal cancer, yet, as stated in their article, stage of disease was derived solely from pathology reports. I believe that this method would have very limited accuracy in diagnosing stage IV disease. Determining stage IV disease requires additional investigations such as computed tomography, which may either not have been performed before surgery, or the results of which may not have been noted on the pathology request form. Underdiagnosis of stage IV disease appears likely, as the incidence of stage IV disease of about 10% noted in this study is substantially less than the 20%–25% incidence observed in other epidemiological studies.2 Moreover, the limitations associated with the use of pathology reports to determine stage IV disease have been observed by other investigators.3 Although this study evaluates an interesting question in relation to the management of colorectal cancer, the significant possibility of an imbalance of important prognostic factors (such as tumour stage) between public and private patients creates major doubt about its conclusions.
Niall C Tebbutt
Comparing survival outcomes for patients with colorectal cancer treated in public and private hospitals
To the Editor: We suggest that marked differences in comorbidities could be one explanation for the superior outcomes for patients with colorectal cancer treated in private hospitals as reported in the study by Morris et al.1 We also have concerns about the quality of the data used in their study. We used a comprehensive prospective database to examine a cohort of Victorian patients treated at the Royal Melbourne Hospital (n = 260) and the adjacent Melbourne Private Hospital (n = 118) between 2003 and 2006. Specifically, we included data on important patient variables that were not considered in the Western Australian series (Box). These data showed a clear bias towards improved postoperative and long-term survival outcomes for patients in the private system, independent of cancer treatment. Significantly, diabetes, which affected a much larger proportion of public than private hospital patients, is also associated with inferior cancer-specific outcomes.2 Together, these results could explain the differences reported by Morris et al. In support of this, the 5-year cancer-specific survival rates they report for stage I cancer in the two hospital groups is similar (89% public versus 92% private), but the overall survival rates are markedly different (74% public versus 85% private) — consistent, we contend, with an excess of non-cancer deaths in public patients. Morris et al also report an imbalance in the receipt of adjuvant chemotherapy between public and private patients, possibly a marker of inequality of care. We analysed prospectively collected data for our patients with stage III colon cancer, where adjuvant chemotherapy has a proven impact on survival. As shown in the Box, a similar percentage were offered, accepted and completed adjuvant chemotherapy, suggesting, in Victoria at least, similar access to care and support for public and private patients. The pathology-based staging used by Morris et al may also be inaccurate, as recording of stage IV disease relies on the surgeon noting this on the pathology request form and patients having been fully evaluated before surgery (we contend that preoperative computed tomography scanning would not have been routine). This may explain the relatively low percentage of patients recorded as having stage IV disease (12% public; 9% private) compared with 17% in our combined series in which prospective clinicopathological staging was used. Finally, inaccurate data are suggested by the reported 5-year overall survival figures for patients with stage IV cancer (17% in private care).1 That this is superior to figures reported in recent clinical trials is an unexpected finding, particularly as clinical trials enrol only a select subset of patients and provide access to novel combination chemotherapy, and presentation with metastatic disease is an adverse prognostic factor. Comparison of public and private hospital patients with colorectal cancer Public hospital Private hospital P Number of patients 277 122 Smoker 141 (51%) 16 (13%) < 0.001 Diabetes 57 (21%) 8 (7%) 0.002 Emergency presentation 22 (8%) 2 (2%) 0.02 ASA score* 1 28 (10%) 36 (30%) 2 131 (47%) 32 (26%) 3 89 (32%) 22 (18%) 4 15 (5%) 0 Unknown 14 (5%) 32 (26%) Stage III colon cancer 64 38 Chemotherapy advised 50 (78%) 30 (79%) 0.22 Patient followed advice 44 (88%) 29 (97%) 0.12 Chemotherapy completed 28 (64%) 21 (72%) Chemotherapy not completed 16 (36%) 8 (28%) Toxicity 7 (44%) 3 (38%) Patient request 4 (25%) 0 Ongoing computed tomography 3 (19%) 4 (50%) Other 2 (12%) 1 (12%) * American Society of Anesthesiologists physical status score.
Suzanne Kosmider · Ian T Jones · Ian P Hayes · Peter Gibbs
Comparing survival outcomes for patients with colorectal cancer treated in public and private hospitals
In reply: The first issue is whether we accurately identified patients with stage IV disease, as the incidence in our study was only 11% and the anticipated incidence is normally 20%–25%. We agree that simply reviewing pathology reports would tend to underdiagnose stage IV disease. However, all patients were crosschecked to the linked database to see if they had had a computed tomography scan or ultrasound image showing metastatic disease. In addition, we only reviewed patients whose primary cancer was resected. This excluded about a third of all the patients with stage IV disease. In my (C P) own surgical prospective colorectal cancer database of 781 patients, (1996 to 2007), 24% of the 185 referred with colorectal cancer had stage IV disease (private hospital patients, 21% v public hospital patients, 25%). Resection of the primary cancer was only undertaken in 126 of the 185 patients with stage IV disease (68%). Therefore, only 16% of all patients with colorectal cancer who had resections had stage IV disease (126/781). Tebbutt argues that there could be a possibility of some imbalance between public and private patients based on this observation. We argue that the difficulty in diagnosing stage IV disease applies equally to public and private patients. Similarly, my own database does not show a significant difference in the incidence of stage IV disease between public and private hospital patients. Kosmider et al report that, at their own institution, completion rates for chemotherapy for stage III colon cancers are the same for public and private patients, “. . . suggesting, in Victoria at least, similar access to care and support for public and private patients”. These results are hardly comparable with our study. Their observations are limited to a select subgroup and only relevant to a small section of the Victorian population, where there is a collocated public and private hospital. In contrast, our study included the entire population of Western Australia, and all public and private hospital patients. Interestingly, we noted wide variations in the rates at which chemotherapy was used, not only between public and private hospitals, but also between individual hospitals. We also noted that there are few collocated public and private hospitals within WA. The fact remains that, at a population level, public hospital patients in WA were less likely to receive chemotherapy. Finally, Kosmider et al raise the issue that comorbidities can influence overall and cancer-specific survival (especially in relation to diabetes). We recognise this as a weakness of our study, and highlighted it in the discussion. Nonetheless, we did include a number of measures of social disadvantage in the analysis. Such measures can act as surrogate markers of common comorbidities. For example, there is a fairly clear association between type 2 diabetes and disadvantage.1 We therefore do not believe that comorbidities can account for all of the observations seen in our study. Our conclusion therefore remains — that patients with colon and rectal cancer treated in private hospitals in WA had superior outcomes. In reality, given the inequities between the two systems, is this really so surprising?
Cameron Platell · Melinda Morris · Barry Iacopetta
Use of dermoscopy in Australia
To the Editor: Menzies’ recent editorial1 highlights the clear benefits of dermoscopy in the assessment of pigmented lesions. This is well appreciated by anyone who uses this inexpensive handheld tool on a day-to-day basis (its retail price ranges from A$380 to A$1840). Although the potential value of the device has been documented in both specialist and general practice settings, it would seem that most Australian general practitioners aren’t using this valuable technology. We recently surveyed 223 predominantly Victorian GPs (at a dermatology symposium for GPs, Melbourne, August 2006) and a cross-section of 179 Australian dermatologists (at the 39th Annual Scientific Meeting of the Australasian College of Dermatologists, Melbourne, May 2006) on their use and perceptions of the value of dermoscopy (Box). The surveys were conducted at the end of dermoscopy seminars using electronic keypads that generated live feedback to questions posed. The sample of dermatologists represented about 56% of all practising fellows of the Australasian College of Dermatologists and should thus be reasonably representative. On the other hand, we acknowledge that the sample of GPs may have been biased towards those with a particular interest (and more experience) in the area of skin cancer and dermatology — or, alternatively, biased towards novice GPs seeking more experience in the area. Participation rates in each survey were over 90%. The majority of both groups of clinicians who reported using dermoscopy felt that it influenced their clinical diagnosis. However, only a third of GPs reported using dermoscopy as a diagnostic aid, in contrast with the vast majority of dermatologists (95%), who were regular users. While there was a difference between the instrument preferred by GPs (the Welch Allyn EpiScope [Welch Allyn Inc, Skaneateles Falls, NY, USA]) and by dermatologists (the Heine Delta 20 Dermatoscope [Heine Optotechnik, Herrsching, Germany]), any one of the commercially available dermoscopes would be suitable for the novice user. The popularity of the Heine system is mostly due to its brighter light-emitting-diode illumination and adaptability to compact digital cameras. Although there is a general perception that non-polarised immersion contact dermoscopes offer superior imaging (this was reflected in the most popular choices from our survey), newer polarised non-contact dermoscopes are increasingly popular, and some of the earlier models are inexpensive. Polarised dermoscopes, such as the DermLite range of instruments (3Gen, LLC [San Juan Capistrano, Calif, USA]), offer the advantages of creating less mess (immersion fluid is not required) and better resolution of vascular structures. However, certain features critical for diagnosis of melanoma may be harder to appreciate with polarised systems (eg, the presence of regression structures or blue–white veil).2 The use of dermoscopy is fairly mainstream among dermatologists in continental Europe (Giuseppe Argenziano, Assistant Professor, Department of Dermatology, Second University of Naples, personal communication), where the technology was first established in the 1980s. However, dermatologists in the United States have been slow to embrace the technology: only 17% of dermatologists surveyed in a 2001 study were using the tool.3 In our personal experience, there is an increasing demand from Australian GPs for dermoscopic educational seminars. Given the high incidence of skin cancer in Australia, and the important role that Australian GPs play in managing the disease, we support Menzies’ assertion that training and familiarity with dermoscopy should be a priority.1 Survey of use and value of dermoscopy among Australian general practitioners and dermatologists GPs (n = 223) Dermatologists (n = 179) Never use dermoscopy 66% 5% Favoured instrument Welch Allyn EpiScope (41%) Heine Delta 20 Dermatoscope (32%) Use computer-assisted dermoscopy 5% 3% Claim that dermoscopy influences diagnosis 75% 97%
Alex J Chamberlain MB BS(Hons), FACD · John W Kelly MD, FACD
Potential link between HMG-CoA reductase inhibitor (statin) use and interstitial lung disease
To the Editor: Walker and colleagues recently reported a series of patients with interstitial pneumonitis following use of statin cholesterol-lowering drugs.1 They state that other investigators have previously reported biopsy findings resembling amiodarone-induced pulmonary toxicity in pneumonitis associated with statin therapy. We believe this observation is pivotal to understanding the authors’ findings. Amiodarone produces mitochondrial toxicity, which is recognised to be a potential initiating event in amiodarone-induced pulmonary toxicity.2 Statins also produce mitochondrial toxicity in vulnerable individuals. Adverse effects of statins on muscle have been linked to mitochondrial abnormalities,3 and other clinical manifestations of statin mitochondrial toxicity have been reported. Mitochondrial respiratory chain disease is famously protean in its manifestations, but most classically produces a mitochondrial encephalomyopathy — with muscle, brain, or both affected. Consistent with this, muscle and cognitive symptoms are the most widely reported adverse effects in our reporting database of statin adverse effects (comprising 2478 patients to date), and these symptoms frequently occur together, consistent with a common mechanism. Statin–amiodarone combinations have produced heightened toxicity relative to each agent alone. Interference with cytochrome P450 metabolism has been the presumed mechanism,4 but additive or synergistic mitochondrial toxicity may also be a factor. The occurrence of amiodarone-like interstitial pulmonary disease in statin users adds to concerns that a range of clinical presentations of mitochondrial toxicity may ultimately be reported with statins in susceptible individuals, with mitochondrial heteroplasmy and threshold effects determining the specific manifestations.5
Beatrice A Golomb · Marcella A Evans
The effects of oxygen therapy in patients presenting to an emergency department with exacerbation of chronic obstructive pulmonary disease
To the Editor: While Joosten et al highlight the uncommon but serious problem of potential carbon dioxide (CO2) narcosis after emergency management of respiratory illness,1 it is important that their findings are kept in perspective and do not lead to inadequate administration of oxygen to patients with acute dyspnoea. Their findings are based on a retrospective chart review. The main claim that the administration of oxygen causes increased length of hospital stay and possibly death for those presenting to emergency departments with exacerbation of chronic obstructive pulmonary disease (COPD) can be challenged by selection bias, sample size, assessment of severity of illness, and the definition of clinically significant hypercapnia. Ninety per cent of their study patients arrived by ambulance, presumably indicating the relatively sudden onset of acute distressing symptoms — a call for urgent help, not the “killing me slowly” drowsiness and confusion of CO2 retention. Of those who received more than 4 litres of oxygen (O2) per minute, 57% (16 of 28) were in triage category 1 and 2, but only 31% (4 of 13) of those who received O2 at a lower flow rate were in triage category 1 and 2. Sixty per cent (12 of 20) of those with a high partial pressure of arterial oxygen (Pao2), when measured after arrival and treatment were in triage category 1 or 2, but only 14% (3 of 21) of those with a lower Pao2 were in triage category 1 or 2 (P = 0.002; Fisher’s exact test). Clearly the first group was a sicker group on arrival, and the increased length of stay of these patients was more likely to be the result of this, rather than of O2 therapy supervised by emergency specialists in an emergency room of a teaching hospital. The contention that oxygen therapy in emergency departments is “often uncontrolled” is not supported by any data supplied. Critical care staff, including ambulance and emergency personnel, are acutely aware of the challenges posed by patients with chronic respiratory disease. However, they are also aware of the need to achieve adequate oxygenation in patients with acute dyspnoea. Patients are observed closely for signs of clinically significant hypercapnia and respiratory support is adjusted accordingly. Some patients may require a higher fraction of inspired oxygen (Fio2), particularly in the initial phases of care, to achieve this. As the patient’s condition improves, the Fio2 is often reduced. The methods in the study by Joosten et al fail to account for this. Respiratory rate, for example, was not reported. Treating the patient, not the chart, is of most importance. It would be a pity if the article by Joosten et al resulted in the withholding of oxygen from acutely dyspnoeic patients with a rapid respiratory rate and adequate respiratory drive because of some fear that they could be retaining CO2. We agree that a better and seamless patient-centred information system with cooperation between sectors of the health system, the patient, the patient’s general practitioner, and ambulance, emergency and in-hospital services, would assist in identifying those at risk of CO2 narcosis and improve patient care.
Andrew W Dent · George A Jelinek · Sandra L Neate · Tracey J Weiland · Ann-Maree Kelly
The effects of oxygen therapy in patients presenting to an emergency department with exacerbation of chronic obstructive pulmonary disease
In reply: We performed a retrospective audit as part of a quality improvement program following a number of serious adverse events in various areas of our hospital. Our article showed that carbon dioxide retention in acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is common (41 of 65 patients admitted with chronic obstructive pulmonary disease [COPD] over 4 months), and that guidelines on blood gas measurement and oxygen use were not being followed. Dent and colleagues state that more patients in our study who received more than 4 litres of oxygen per minute were in a triage category that indicated a more serious condition. However, the multivariate analysis showed that triage category did not predict length of stay. In contrast, partial pressure of arterial oxygen (Pao2) did, and patients with a Pao2 of less than 74.5 mmHg (range, 36.7–74.0 mmHg) had a shorter length of stay than those with a Pao2 of 74.5 mmHg or higher (range, 74.5–452.0 mmHg). Many patients had a Pao2 much higher than neccessary to achieve a haemoglobin saturation of about 90%. Dent and colleagues state that our data did not support the claim that oxygen therapy is often uncontrolled in the emergency setting. In fact, only 68% of the patients receiving more than 4 litres of oxygen per minute had arterial blood gas measurements performed. We agree with Dent et al that the management of AECOPD may not be as simple as following guidelines. However, we hope to raise awareness of the fact that hypercapnia in COPD is common, requires careful assessment, and that oxygen therapy should be titrated to physiological endpoints.
Simon A Joosten · David Smallwood · Mariko S Koh · Louis B Irving · Xiaoning Bu
Attitudes towards cosmetic surgery among university students
To the Editor: Cosmetic surgery has grown in appeal over the past few years, and more and more procedures are being performed. However, the literature on attitudes towards cosmetic surgery is scant. Here, we report the results of a cross-sectional study that assessed Australian university students’ attitudes towards, and experiences of, cosmetic surgery. Preclinical students from the faculty of medicine at the University of Melbourne were chosen to participate, as they formed a fairly homogeneous group and were considered at a higher risk of experiencing appearance concerns than the general population.1,2 Students from clinical years were excluded, as their greater exposure to clinical medicine could have impacted on their attitudes towards cosmetic surgery. Participants completed a questionnaire that covered their experience of and familiarity with a range of cosmetic procedures, as well as attitudes towards cosmetic procedures. About 320 students were approached for this study, and 284 agreed to participate (45% male; age [mean ± SD], 20.8 ± 3.4 years; body mass index [mean ± SD], 21.9 ± 2.7 kg/m2). Respondents noted a high degree of familiarity with cosmetic enhancement procedures (Box); only 8% were not familiar with any procedures. Thirty-six per cent knew someone who had had cosmetic surgery and 11% knew at least one person in their family who had had cosmetic surgery. Only four respondents (1%) had themselves had cosmetic surgery. Many respondents were fearful of undergoing surgical procedures (53% “agreed” or “strongly agreed”). Over a third disapproved of people surgically altering their appearance for reasons of self-esteem (36%) or to feel better about themselves (35%), and 38% thought cosmetic surgery was a waste of money. Most respondents (63%) indicated they would be embarrassed to let others know if they had had such surgery, although 52% believed that appearance was an important facet of a person. The majority (70%) would not consider cosmetic surgery in later years, even if their partner wished them to (79%). These findings are in stark contrast to a United States study of female college students, which found that about 5% of participants had undergone cosmetic surgery, 67% knew someone who had received a cosmetic surgical intervention, and around 33% had a family member who had undergone cosmetic surgery.3 Overall, their attitudes to cosmetic procedures were much more favourable, which might reflect a greater acceptance, availability and prevalence of cosmetic surgery in the US. Our findings have relevance for the future Australian medical workforce, and suggest that broader issues relating to body image should be covered in the medical curriculum. Proportion of students familiar with cosmetic enhancement procedures Procedure Proportion of students Lipoplasty 83% Botox injections 82% Facelifts 78% Breast augmentation 78% Rhinoplasty 73% Breast reduction 71% Abdominoplasty 69% Cellulite treatment 48% Chemical peels 47% Blepharoplasty 41%
David J Castle · Riteesh Bookun
Entry tests for graduate medical programs: is it time to re-think?
To the Editor: We are concerned about aspects of the study of selection predictors of medical school performance in Australian medical schools by Groves et al,1 and how they may be interpreted. A “voluntary” response rate of 13.6% is very small and unlikely to be representative, and selection or response bias is likely. Although noted by the authors, this fundamental flaw may be overlooked in interpreting the results. This aside, of what value is the outcome measure of clinical reasoning skills among students, some of whom are only in second year, and whom we would not expect to have developed substantial expertise in clinical reasoning at this early stage? More significantly, we consider that the research question itself may be flawed, as we are not at all convinced that selection scores are intended to predict relative performance in programs. Groves et al, of course, show that, in fact, they do not. Selection serves two purposes, one obvious and the other questionable. The first is to reduce the large pool of well qualified students to the available number of places. The second is the Holy Grail of selection: attempting to select those best suited to success in medicine. The key problem is that nobody can fully define, let alone measure, such success, other than in the negative terms of professional misconduct after graduation.2 Moreover, medicine offers a wide range of careers requiring different attributes, making a broad range of entry characteristics beneficial to the profession and the community at large, and putting in question the pursuit of a profile of critical criteria. Further research is needed, involving large, representative samples to confirm or discount putative outcome measures, but most medical students succeed in medical school and do not create problems as doctors, indicating that we are currently getting more of this right than wrong. If the predictive value of entry attributes for (often questionable) outcomes is modest at best, and if we teach and assess communication skills, clinical reasoning and professionalism during the programs, does it not make sense to focus our energies and resources more effectively there, and relinquish our continuing anxiety over selection? We should remember what motivated the flurry of activity towards more complex selection processes in the first place: concern over communication by doctors, failure in aspects of professionalism, and to a much lesser extent, clinical competence.
Malcolm H Parker · David Wilkinson · Ray G Peterson · Ieva Z Ozolins · Haida Luke · Jenny Zhang · Gerard J A Byrne
Entry tests for graduate medical programs: is it time to re-think?
In reply: The limitations of our study have been acknowledged, and we agree with Parker and colleagues that further research is needed. However, their proposition that selection scores may not be intended to predict relative performance in programs seems at odds with their recommendation to select principally on the basis of academic performance. If selection scores do not provide predictability, why bother establishing any criteria at all? Why not simply use a lottery system, as they have been claimed to be equally effective?1 Although our study did not set out to evaluate the relative merits of cognitive versus non-cognitive criteria for selecting medical students, surely the first question to be decided is whether non-cognitive characteristics, including interpersonal skills, attitudes and behaviour, are important in medical practice and should be considered in selecting future doctors. If so, then the next question is how best to select students with these characteristics or, at least, the capacity to develop them during their medical training. The selection processes of most medical schools indicate that the answer to the first question is “yes”. In answering the second question, not only the validity of the chosen method, but its feasibility in terms of cost and effectiveness need to be considered.
Michele A Groves · Jill Gordon · Greg Ryan
Words, words, words
To the Editor: Could I use a tiny fragment of a recent article as springboard to a plea for a change in terminology? Wilcken et al refer to two observations on the use of tamoxifen changing clinical practice, “and thousands of lives were potentially saved”.1 Are we fooling ourselves? Surely it is more accurate to say, in the situation of breast cancer in lives already well advanced, that thousands of deaths were postponed? “Humankind cannot bear very much reality.”2 Could we leave “lives saved” to the populist sensationalist media, and only use it in medicine for interventions in trauma, and possibly infection, in young people whose life expectancy is otherwise so good that their life has been truly “saved”? “. . . speech impelled us to purify the dialogue of the tribe and urge the mind to aftersight and foresight . . .”3
Warwick H Ruse
Words, words, words
In reply: We agree that attention to terminology is important, and that claims about potential medical advances are often exaggerated. On the other hand, on the rare occasions when things go really well, we should not hide our light under a bushel. In the overview cited in our article, the risk of death 15 years after diagnosis was about 35% for the controls and about 25% for those who were given tamoxifen for 5 years1 — a reduction in the death rate of about a third. Another example is the finding from the earliest chemotherapy trials that significantly more women in the treatment arms were alive nearly 30 years later,2 showing that postoperative systemic therapy can have very long-lasting effects on the chances of being alive or dead. Over the years, this adds up to a lot of women not dead from breast cancer. However, whether these are really “lives saved” may be more a philosophical than a medical question. It is true that, despite decades of research and billions of dollars spent, the mortality rate remains at 1.0 per person, and death still consumes much of our thoughts.3 Rather than “lives were potentially saved”, perhaps a compromise could have been the less poetic “breast cancer deaths were avoided”.
Nicholas R Wilcken · Val J Gebski · Anthony C Keech · Rhana Pike
Book reviews
Health care professionals’ guide to religions
Religions, culture and healthcare Susan Hollins. Oxford: Radcliffe Publishing, 2006 (ix + 115 pp). ISBN 1 85775 755 6 Written by the lead chaplain of the UK National Health Service’s National Chaplaincy Strategy, this handbook is designed to serve as an accessible reference for health care professionals seeking to understand various practices and beliefs associated with a range of faiths. As the book was produced in the United Kingdom, it focuses on faiths which are most widely practised there (Christianity, Judaism, Hinduism, Sikhism, and Islam), but also includes less familiar traditions such as Jainism, Zoroastrianism, Mormonism, Baha’i, and even paganism. The bulk of the book is devoted to detailed examinations of each religious tradition, presented in an easy-to-use format. Sections provide basic information on the history of the faith and core tenets, and outline beliefs associated with key areas related to care, including attitudes toward illness; gender and privacy; naming, diet, and hygiene; birth, dying, and death; contraception and assisted reproductive technologies; and organ/tissue donation. The author is careful to note the diversity of beliefs within faiths where relevant (for instance, within Islam, Judaism, and Zoroastrianism there are debates over the permissibility of organ donation). The book includes a thoughtful set of introductory chapters that explore cultural and religious diversity in health care, as well as spiritual care for patients. They promote the idea that health care professionals must maintain open minds with regard to patients, and to avoid stereotyping on the basis of religion or culture, in order to provide sensitive and appropriate care. Hollins notes in her preface that this book should be placed at nursing stations and other places where it can be easily accessed for quick answers. It must be noted that there are some local differences in belief systems between the UK and Australia, but as a preliminary guide to religious beliefs in health care, this is an excellent resource.
Rachel A Ankeny
Pepping up tired patients
Why am I so tired? How to put the fuel back in your tank Ginni Mansberg, Anne Thomson. Melbourne: Michelle Anderson Publishing, 2006 (vi + 151 pp). ISBN 085572 369 6 This book is written for patients who experience tiredness. Most general practitioners appreciate this is a common complaint they see and agree it can be quite challenging to treat, especially within consultation time constraints. There are a number of aspects of this book that I love. It is easy to read. It is written as though the authors are having a friendly, chatty conversation with the reader. The authors encourage patients to attend their GP by making a longer consultation time with them. They also discuss what diseases need to be excluded and why certain tests (such as iron levels and thyroid function) are performed by the GP. The role of depression in fatigue is also given due respect. Mansberg and Thomson focus on lifestyle factors that are known to impact on health and energy. These include improving diet, exercise, sleep, stress management, and avoidance of smoking and alcohol. They also cover the possible role of nutritional supplements and herbs for the treatment of fatigue, but do quite rightly emphasise the lack of research in this area. Tiredness can be a difficult condition to treat and is often confused with chronic fatigue syndrome. The book provides some nice, easy practical lifestyle solutions. It motivates the patient to take control of and responsibility for their health; to be more proactive, taking simple steps to help restore their energy and vitality. So when a GP is next confronted with a tired patient, this would be a useful book to suggest, to reinforce their advice on the importance of lifestyle changes. I have already started recommending this book to my patients. At $19.95, the book is great value for money.
Vicki Kotsirilos
Found poetry
Search for Oz Richard Bronson. New York: Padishah Press, 2006 (102 pp). ISBN 0 9776405 2 3 A 12-year-old girl is playing the violin. The poet asks if she hears the tunes in her head. “No”, she replies, “My fingers know the way, and I follow them”. It’s a measure of how much meaning Richard Bronson’s poems can sustain that this glorious, insouciant piece of “found poetry” (the girl presumably said just this) reads as a brief image of the link between body and mind, the physical and the inspirational. Bronson is an endocrinologist, and this is his first collection of poetry. Some of his work draws directly and successfully on his medical experiences, but most does not. There is a cool intelligence and compassion throughout which one can think of as exemplifying the ideal doctor, but little which fits easily with lazier notions of “medical humanities”. Rather, the driving force is an awareness of cultural heritage. Music and literature are everywhere. The girl, the poet, his late father are all musical, and we learn that Bronson’s library includes Rilke’s magnificent (and fiercely difficult) Duino Elegies and the like. Indeed, two poems are addressed to Hypatia, murdered by Christian fanatics in 5th century Alexandria and one of the first women of learning whose name we know. The destruction of a civilisation which this event symbolises is at the heart of some bleak meditations for a post 9/11 world: The world has come to this no heat, no water, no food, but boxes of books in my basement. The half-dozen love poems with which the volume concludes are serious but occasionally awkward (“a chamber of rules/ where carnal love reigned”), and there are a couple of pieces of whimsy; but Bronson at his best is very much worth reading. (A video log of Bronson reading four of his poems — rather well — is at http://www.poetryvlog.com/rbronson.html, and one of Bronson’s poems was published in the 2 July issue of the Journal [Med J Aust 2007; 187: 46].)
John R Skelton
Indigenous health: reaching beyond rhetoric
Social determinants of Indigenous health Bronwyn Carson, Terry Dunbar, Richard D Chenhall, Ross Bailie, editors. Sydney: Allen & Unwin, 2007 (xxviii + 306 pp). ISBN 978 1 74175 1420 Forty years have passed since the 1967 referendum on whether Aborigines should be counted in the census. This anniversary led, yet again, to demands for greater effort and tangible improvement in Aboriginal and Torres Strait Islander health. Then, suddenly, a report on the neglect of children in the Northern Territory provoked action by the federal government. Whether this will help is hard to predict, but the matter certainly has national attention. Right now, at least, some politicians have joined the new President of the Australian Medical Association in making Indigenous health priority number one. Is a text on the social determinants of Indigenous health relevant to this election-year drama? The book is based on a series of courses funded by the Public Health Education and Research Program (an initiative of the Australian Government Department of Health and Ageing). It provides introductory material that belongs to the cultural curriculum of modern Australia in general, and medical education specifically. The authors first explain social models of health and epidemiology, and then move on to topics of more or less immediate importance to health status, including racism, poverty, education, employment, welfare, housing, and human rights. These issues were never more relevant than now. A second question applies more to the average reader of the Journal, concerned with the provision of medical care. What does this book add to the coverage of Indigenous health topics needed by clinicians? These readers will probably turn to the last chapter, on interventions and sustainable programs. Three examples cover “healthy lifestyle”, with a focus on diet, exercise, and smoking cessation; injury prevention and safety promotion; and the measurement of the impact of alcohol and drug treatment programs. The key elements identified are not surprising, including governance, accountability, and appropriate staffing. Any clinician can get involved by contributing to the provision of health services. These examples show that it is possible to reach beyond the current rhetoric of disgrace.
Charles Guest
Columns
In Other Journals
Treating depression in teens Adding cognitive behaviour therapy (CBT) to a treatment regime of selective serotonin reuptake inhibitors (SSRIs) and routine clinical care does not appear to contribute to an improved outcome for depressed teenagers.1 A British randomised controlled trial assigned 208 adolescents suffering from moderate to severe major depression to one of two groups. Half received an SSRI and routine care alone, while the remaining participants also underwent weekly CBT for 12 weeks, then fortnightly for 12 weeks. Researchers used several rating scales of depression to assess the outcome at 6, 12 and 28 weeks. A similar proportion of teenagers across the groups showed significant improvement in their depressive symptoms over time, with almost 60% showing improvement by 28 weeks. There was no difference in the incidence of side effects between the treatment arms. An accompanying editorial comments that the evidence suggests monotherapy with an SSRI is reasonable as a treatment for teenagers with moderate to severe depression, but that therapy needs to be of adequate dosage, for a sufficient length of time, and under proper supervision.2 1 BMJ 2007; 335: 142 2 BMJ 2007; 335: 106-107 Eat less, live longer A gene acting in the central nervous system neurones of the nematode worm Caenorhabditis elegans may mediate the effect of dietary restriction on longevity. In a US study, worms were cultivated with different concentrations of a bacterial food source until a maximum life span was reached with a prescribed level of dietary restriction. The transcription factor gene skn-1 was found to be activated by a restricted diet. This gene signals peripheral tissues to increase metabolic activity and is critical in controlling the oxidative stress response. Organisms with a mutation of skn-1 were unable to maintain longevity with dietary restriction. The researchers propose that, as in the mammalian hypothalamus, levels of key intracellular metabolites act as signals of energy availability to control food intake and metabolism. They suggest a hormonal signal is released on dietary restriction which promotes metabolic activity, increases respiration, and prolongs life span. Nature 2007; 447: 545-549 Dual therapy for hypertension An antihypertensive medication, aliskiren, newly approved in the US, appears to have an additive effect in reducing blood pressure when used in combination with an angiotensin converting enzyme (ACE) inhibitor. Aliskiren is an angiotensin receptor blocker (ARB). Both ACE inhibitors and ARBs work by inhibiting the production or action of angiotensin II, resulting in increased plasma renin activity. In a randomised, double-blind placebo-controlled trial, 1797 patients with essential hypertension were assigned to four groups. The treatment groups received valsartan (an ACE inhibitor) alone, aliskiren alone, or a combination of both drugs for 8 weeks. Both drugs were administered at the maximum therapeutic dose. The placebo group received no active therapy. The combination of the ACE inhibitor and ARB resulted in a lowering of mean systolic blood pressure from baseline by 12.2 mmHg. This result was significantly greater than that achieved by either monotherapy or placebo. The combination of drugs showed a similar rate of adverse effects and biochemical abnormalities to the other treatment regimes —a result inconsistent with another large trial. The researchers comment that this may have been due to the inclusion of patients with impaired cardiovascular and renal function in the earlier study. Lancet 2007; 370: 221-229 Diet and breast cancer A diet very high in vegetables, fruit and fibre, and low in fat, does not appear to reduce recurrences or mortality in women who have survived early stage breast cancer, according to a US study. The randomised controlled trial followed over 3 000 women who had been previously treated for early breast cancer. The intervention group received regular telephone counselling and monthly newsletters promoting intake of fruit and vegetables and low fat meals. This group also attended cooking classes covering aspects of healthy eating. The control group were provided with printed materials outlining a diet high in fruit and vegetables and low in fat, and attended an average of one cooking class as opposed to four in the intervention group. The dietary pattern was shown to change significantly in the intervention group compared with the control group. The change in diet appeared to be maintained for the 6 years of the study. Researchers found there was no evidence for an intervention effect of dietary change on breast cancer recurrence or mortality in this group of women with breast cancer. The authors comment that the findings do not rule out a longer-term effect on survival of dietary alteration. JAMA 2007; 298: 289-298 Even CAD is in the genes Recent research analysing data from two large genome-wide association studies of coronary artery disease (CAD) and myocardial infarction has found several new genetic loci which individually and together have a significant effect on the risk of CAD. Of particular interest were loci on chromosome 9 (9p21.3), which were able to be identified by using recently developed high-density genotyping arrays. The authors comment on the usefulness of the genome-wide approach, whereby previously unsuspected loci which increase susceptibility to complex diseases can now be identified. N Engl J Med 2007; Jul 18 [Epub ahead of print]
Tanya Grassi
The people’s hospital
Martin B Van Der Weyden
In This Issue
Ruth Armstrong
Lung transplantation: does age make a difference?
Gregory I Snell MB BS, FRACP, MD · Glen P Westall MB BS, FRACP · Trevor J Williams MB BS, FRACP, MD
Health technology assessment in Australia: challenges ahead
Terri J Jackson PhD
Australians deserve better than this
Martin B Van Der Weyden
In This Issue
Ann Gregory
Human embryonic stem cells leap the barrier
David G Penington AC · Graham F Mitchell AO
How should stable coronary artery disease be managed in the modern era?
Keith V Woollard MRCP, FRACP · Mark A J Newman DS, FRACS