Editorials

Can we solve a riddle by burying an illusion? Over the past 40 years, the prevalence of asthma appeared to rise inexorably in both the developed and the developing world. So the report by Robertson and colleagues in this issue of the Journal (page 273), showing a decline in reported symptoms in children since 1993,1 is to be warmly welcomed. It comes with supporting evidence, in the form of reduced hospital admissions for asthma in Victoria, but also with a catch. The prevalence of reported hay fever and eczema has increased over the same period. Why the prevalence of asthma increased and why it may now be stabilising or declining is baffling. Robertson et al suggest one possibility may be the increased use of daycare facilities. The “hygiene hypothesis” — the inverse relationship between microbial or infection exposure and allergic disease — was first suggested by Gerrard et al while studying allergic disease in the Metis Indian community in Canada.2 Strachan refined this observation from large UK cohorts, in which he found an inverse relation between the number of older siblings and the prevalence of hay fever, but not asthma.3 He emphasised that the link was through atopy to allergic disease. Several studies have subsequently shown reduced asthma prevalence in school-aged children with early daycare attendance. These children tend to show more early wheezing, but less asthma later on. The proposed explanation is that they contract more upper respiratory tract infections from close contact with children, and this leads them to have more early wheezing, but, in turn, protects them from later developing atopy and atopic disease. This explanation seems less likely in the study by Robertson et al, given that the prevalence of hay fever and eczema increased while asthma prevalence decreased. However, one would need to know the atopic status of the children to clarify the issue. The 26% reduction in current wheeze prevalence in Melbourne, while significant, is within the range found in Australia in phase 1 of the International Study of Asthma and Allergies in Childhood (ISAAC) study. For example, in the four Australian centres that took part, there was a 19% difference between the highest and lowest prevalence. For sleep disturbance and speech limitation, this was 40%.4 There is even greater variation in large cities. In Mumbai (Bombay), for example, reported current wheeze varied by more than 100% in different parts of the city. Large cities are not homogeneous, with large variations in many factors that may affect wheezing, such as housing conditions, smoking prevalence, diet and variable access to healthcare. Over time, with gentrification and changes in zoning, factors may vary even in the same narrow geographic location. Robertson et al also note that awareness of asthma in the community is a determinant of the prevalence of reported symptoms. The pool of individuals with a history of symptoms in any population will be larger than the proportion who report symptoms in a defined period. In a resurvey of 700 young adults, all of whom had 4 years previously responded positively to at least one of three asthma questions, only two-thirds reported symptoms. In the first survey, 28% had responded positively to all three questions, and in the second, 29%. However, only 60% were the same individuals.5 Just how large this pool is has recently been clarified, at least in New Zealand. In a 26-year follow-up of a birth cohort in Dunedin, 73% reported wheezing on at least one occasion and 51% on at least two.6 Given that there is likely to be some loss to recall, wheezing at some time between birth and adulthood appears virtually universal. Clearly, most of this wheezing is occasional, trivial, inconsequential, and a normal phenomenon. It is now easy to see how a change in diagnostic and hence societal emphasis on wheezing, as opposed to bronchitis, with attendant changes in treatment, can enhance recall for asthma in cross-sectional surveys. Perhaps this emphasis is now stabilising and the diagnostic label “asthma” is being applied slightly less frequently in Melbourne. The strengths of the ISAAC approach — simple questionnaires requiring minimal funding — allow large-scale international comparisons of children (in fact, this is the only way that such large population studies can be conducted), but interpreting relatively small changes over time in a very asthma-“savvy” environment like Australia is more difficult. Although the ISAAC approach clearly shows that reported asthma symptoms are far more frequent in Australia, New Zealand and the United Kingdom compared with, say, Albania or India (more than 10-fold), smaller differences over relatively short time intervals in individual countries are harder to interpret. In the past 30 years there have been many cross-sectional studies reporting an increase in the prevalence of asthma symptoms over time. In only two has this been accompanied by measures of airway hyperresponsiveness. In the first, in the United Kingdom, Burr et al showed that current asthma symptom reporting had doubled over a 15-year period, but exercise-induced fall in peak expiratory flow rate had not changed.7 In the second, Peat et al showed a doubling of current symptoms and airway hyperresponsiveness, predominantly among atopic children, suggesting an increase in asthma relating to greater allergen exposure.8 There is a real need for the measurement of objective markers over time in similar populations. The advent of easily obtainable markers of airway inflammation, such as exhaled nitric oxide or constituents of breath condensate, may allow population studies of airway inflammation to be quantified and tracked over time. Perhaps it is time to abandon our inconvenient population model of asthma as a disease, just as doctors did for essential hypertension in the 1950s.9 Nature provides no obvious support for asthma and we can neither define nor measure it accurately; indeed, it remains a mystery because it is largely an illusion. The late Geoffrey Rose (Professor of Epidemiology at the London School of Hygiene and Tropical Medicine) suggested that we should seek the answers to “disease” by exploring populations rather than atypical minorities.10 We need to consider applying this concept to airway inflammation. Now that appropriate tools are becoming available, we should measure airway inflammation and airway responses in large populations and explore the environmental and genetic factors that affect the airway at a population level. This might reveal that it is not just the upper end of the distribution of airway inflammation (which we arbitrarily and inconsistently call asthma) that varies by environment, and over time, but the whole distribution. In the meantime, Robertson and colleagues have shown that parent-reported asthma symptoms of young Melbourne children have declined in the past decade. This may or may not be an early signal for a real decline in asthma prevalence. What it does suggest is that asthma prevalence has not increased, which in itself is a welcome observation.

Julian Crane MB BS, FRCP, FRACP

GPs need a means to easily and accurately identify prescription shoppers The Health Insurance Commission (HIC) defines “doctor shoppers” as people who have 30 or more Medicare consultations a year or see more than 15 different general practitioners to obtain more Pharmaceutical Benefits Scheme (PBS) prescriptions than appear to be clinically necessary. In 1995–96, there were 13 240 Australians who met this definition, and in 1999–2000 this figure had fallen to 8780.1 The current system places the legal standing of prescription shoppers above that of the doctors who are trying to deal with them. Recently, the HIC introduced a new definition of “prescription shopper” as a person who has, in a 3-month period, been supplied prescription drugs by six or more different prescribers, or has been prescribed a total of 25 target pharmaceutical benefits or 50 or more pharmaceutical benefits in total. These broadened criteria have resulted in a new figure of 22 000 prescription shoppers.2,3 The agenda of doctor shoppers is to obtain benzodiazepines and opioid analgesic drugs, either for their own use or to swap or sell. The upper quartile of doctor shoppers work hard at their task, and will have seen up to two different GPs a day for every working day of the year.1 Doctor shoppers confront GPs with a confusion of our usual roles and trouble us in many ways. They are not like our usual patients and only want drugs, not help.4 Their dissembling destroys trust and, when unsuccessful in obtaining prescriptions, they can become aggressive and unsettle regular patients and reception staff. They are also quick to spread the word about any new doctor who has been a “soft touch”. Although many doctors have ethical and humanitarian concerns for the wellbeing of these patients, most do not want to get involved. Even reputable and dedicated doctors who espouse a philosophy of harm minimisation can face disciplinary proceedings if they are accused of prescribing excessive amounts of drugs of addiction.5 Strangely, prescription shopping is not illegal, and doctor shoppers are not subject to the same legal constraints as those who prescribe for them. For an experienced GP, making a diagnosis of “doctor shopper” can be easier than diagnosing the trickier presentations of cholecystitis. But for less-experienced doctors, used to giving patients the benefit of the doubt, it can be a problem, and requires educational input. Doctor shoppers are of either sex, and most are between 20 and 40 years old. They often present with fairly transparent stories involving severe pain of some description, stress, insomnia, or a request for benzodiazepines to help them withdraw from opiates or alcohol.4 They often claim to have recently arrived from interstate and present a letter, which may be forged on a stolen letterhead, attesting to their diagnosis and need for opiates and tranquillisers. They are usually much more medically sophisticated than the average patient and are quite explicit about the medication they want.4 They will tell the GP that tramadol is useless for their pain, which only responds to various derivatives of morphine. Similarly, temazepam tablets do not help them to sleep, but capsules do. Subsequent attempts at getting further prescriptions involve a variety of unlikely stories about the loss of previous prescriptions through various forms of theft, washing machine mishaps, and prescription-devouring dogs. In this issue of the Journal, Martyres et al (page 211) analyse the doctor-shopping behaviour of 202 people aged 15–24 years, who died between 1994 and 1999 after using heroin.6 Martyres et al found that the frequency of doctor shopping over a 4-year period increased threefold in the year before death. They see this rapid escalation of doctor shopping as both a cry for help and as an opportunity for GP intervention — even if this is only advice on the options available for help and treatment.6 They are also of the view that the government sees doctor shopping (which costs the PBS more than $30 million a year) as more of an economic than a medical problem. Indeed, the focus of the HIC’s Prescription Shopping Project has a large economic component aimed not only at doctor shoppers, but also at people who hoard drugs or send PBS drugs to relatives in other countries.7 Besides its economic cost, doctor shopping is a public health and ethical problem for the medical profession. Most GPs do not write prescriptions for doctor shoppers — half these prescriptions are written by 7.5% of Australian GPs, most of whom practise in one of 10 residential postcode areas.1 These GPs appear to have an irresponsible, laissez-faire approach to prescribing. The Prescription Shopping Project will provide feedback and educational intervention to excessive prescribers, with the aim of changing their prescribing practices.7 The Prescription Shopping Project also gives the HIC “special authority to contact the patient or to give drug information to their doctor without the patient’s consent”.7 However, if a young heroin user can see up to 613 GPs in a year,1 how will the HIC know which of the 613 GPs is that patient’s doctor? The Prescription Shopping Project legislation empowers the HIC to assist a “prescriber to make decisions about prescribing to the prescription shopper, if that prescription shopper is visiting that prescriber or is a patient of that prescriber”,3 but the immediate need of the busy GP is quick access to information. And the easiest and fastest technology to assist the busy GP is access to a dedicated prescription shoppers’ telephone line. Until August 2002, a doctor could quickly confirm, to a high level of probability, who was a known doctor shopper by using a dedicated telephone line, “The Doctor Shopping Line”. This was the diagnostic equivalent of the ultrasound in confirming the diagnosis of cholecystitis and the number and type of gallstones involved. Indeed, the HIC won a Government Technology Productivity Award for developing the software for generating the required doctor-shopping information within 30 seconds.8 Budgetary constraints, fears about privacy provisions, and a re-examination of the secrecy provisions of the National Health Act 1953 (Cwlth) led to a cancellation of this dedicated telephone line. Its replacement requires patients to sign a voluntary release-of-information form and it takes 7–10 days for the GP to receive the prescription-shopping history. The current system places the legal standing of prescription shoppers above that of the doctors who are trying to deal with them,9 and may have placed these individuals’ fragile lives at greater risk than is necessary.6 If Martyres et al are correct in seeing an escalation in prescription shopping as a cry for help, GPs must have the information on which to act. The success of the federal government’s Prescription Shopping Project also depends on GPs accessing quick and accurate prescription-shopping information. The necessary legislation and technology to reactivate the previously effective dedicated doctor-shopping line is already in place. 3,8 There is no logic in further governmental delay in its reintroduction. Doctors want it and need it, and will not in the least mind if the new politically correct term is “Prescription Shoppers’ Line”.

Max Kamien MD, FRACGP, RACP

Behavioural sciences can make a substantive contribution There is continuing evidence of the failure to translate clinical research findings into existing practice: it is thought that 30%–40% of patients do not receive treatments of proven effectiveness and, more disturbingly, 20%–25% of patients receive care that is not needed or is potentially harmful. 1,2 However, the mere existence of evidence is not sufficient to ensure the adoption of best practice into routine clinical care.3 It is not surprising, then, that there is a growing interest in making knowledge transfer from research into clinical practice more effective.4 Many approaches to changing clinical practice revolve around idiosyncratic beliefs and tradition rather than scientific evidence.5 Evidence is needed on which interventions are the most cost-effective for changing clinical practice and healthcare delivery. A recent systematic review of 235 evaluations of guideline dissemination and implementation strategies concluded that “the majority of interventions observed modest to moderate improvements in care”.4 However, the quality of reporting of important aspects of the studies reviewed (such as details of the study interventions and contextual factors) was poor, and often the rationale for the choice of intervention was obscure. Further, only 30% of studies provided any economic data. The results of this review should therefore be interpreted cautiously, as the methodological quality of many of the contributing studies, and of research in this area more generally, is poor.4 There is growing interest in developing strategies to encourage the adoption of best evidence into practice, including efforts to change behaviour. The effectiveness of these efforts is likely to depend on a complex interaction between the nature of the clinical activity to be changed and the costs and benefits of adopting the change for the healthcare professionals, patients and organisations involved. At a recent National Institute of Clinical Studies meeting, involving multidisciplinary experts in the field of promoting the uptake of research evidence,6 these issues were discussed. Delegates agreed that behavioural scientists, working within multidisciplinary teams of researchers, are important players in the process of understanding how change in healthcare providers’ behaviour may be achieved. Behavioural science refers to a broad range of disciplines, including psychology, sociology, management science and education. This disciplinary group may contribute in several ways to the scientific study of changing healthcare providers’ behaviour. Use of behavioural change theories. Behavioural scientists have developed a number of theoretical frameworks to explain how behavioural change is achieved. These include persuasive communication, diffusion of innovation,7 social influences, adult learning theory8 and social cognition.9 Such models can provide useful overviews of issues to be considered when attempting to change healthcare providers’ behaviour. The development of theoretical models for predicting when targeted individuals are likely to respond to different types of intervention would be of considerable benefit. The development of accurate and acceptable measures. Without adequate measurement of relevant clinical behaviour it is difficult to provide accurate feedback to health professionals and to evaluate the effectiveness of any interventions. Behavioural science has addressed issues about how human behaviour can be effectively, accurately and acceptably measured. Techniques include the use of direct observation, examination of the accuracy of self-report by healthcare providers and patients, as well as more controversial strategies such as the use of “simulated” patients. The discipline has also been involved in developing a wide range of other potentially relevant outcome measures, such as satisfaction scales, patients’ perceived needs, quality of life and other indices that may be used to measure the quality of healthcare delivery. Examination of the prevalence of certain behaviours, and the incentives and barriers to the adoption of best-evidence practice. Behavioural science has a long history of exploring variables that may explain why individuals and groups may or may not engage in specific behaviours. There has also been a substantive examination of variables correlated with the performance of behaviours of interest. Strategies to determine the potential prevalence of different behaviours include the use of qualitative group methods such as focus groups, self-completed questionnaires, open-structured interviews with key informants, and a wider representation of the target group. Behavioural science has also examined methodological strengths and weaknesses of the various approaches designed to determine barriers and incentives. Development, implementation and evaluation of interventions designed to change human behaviour. Strategies effective in changing human behaviour have been derived from educational research, health promotion, and other fields in behavioural science. Change strategies that have been evaluated include modifying individuals’ knowledge, attitudes and skills; the social environment surrounding the individual; and the organisational or sociopolitical structure in which individuals operate. The last includes changes in the financial costs and benefits, organisation structures, and more effective ways of communicating information. While the majority of this research has not focused specifically on healthcare providers, many of the principles are likely to be generalisable to healthcare providers. In essence, the behavioural sciences can make a substantive contribution to our understanding and implementation of behavioural change in healthcare providers. This is critical to the process of translating evidence into clinical practice. To achieve the potential that the behavioural sciences can offer to this process, we need to actively involve behavioural scientists in efforts to change provider behaviour and evaluate such interventions. As in other areas of healthcare research, the involvement of multidisciplinary teams working on a common problem is more likely to achieve positive results.

Robert W Sanson-Fisher PhD · Jeremy M Grimshaw PhD, MB ChB, FRCGP · Martin P Eccles MD, FMedSci, FRCGP

Specialist palliative care services and services involved in the pre-palliative phase of a patient’s disease must accept GPs as an integral part of the care team The number of Australians requiring palliative care is set to rise as the population ages. Although specialist palliative care services now cover most regions of Australia, rationing will be inevitable. Addressing the gaps and shortfalls to enable successful care of dying people will always require general practitioners to shoulder most of this clinical load. Unfortunately, specialist palliative care services report that some GPs are disinclined to continue to care for patients who need palliative care. They also report variability in the palliative care skills GPs possess, and struggle to work out how to support the GP colleagues whose care they perceive to be suboptimal. In 2002, the Commonwealth Department of Health and Ageing commissioned research to identify the barriers and propose solutions to this perceived problem. The outcome of this exercise provides a series of options for managing the engagement of GPs in palliative care.1 Most of the barriers to GP participation in palliative care are complex structural factors that will take some time to address (Box 1). GPs are increasingly opting for part-time work and there is a rising proportion of female GPs. In view of family responsibilities and safety issues, female GPs may have to consider their willingness to undertake home visits and after-hours work.2 For some GPs, regardless of gender, performing the time-consuming services involved in palliative care is becoming socially, financially and professionally non-viable.1 Practice costs, and the pressures arising from them, continue to increase. Several interim measures may improve GP participation in palliative care. Financial incentives (in the form of palliative-care-specific item numbers, or a substantial Special Incentives Program payment that recognises the intense work required in palliative care) may help. Items within the Enhanced Primary Care Program that encourage multidisciplinary care need to be simplified if they are to be used more often.3 For some GPs, exposure to only a small number of palliative care patients each year,4,5 combined with rapid advances in the evidence base for palliative care, undermines their confidence in managing patients appropriately. Given these disincentives, GPs may well ask, “Why should I be involved when there is a specialist palliative care unit in the district?”. Education providers, specialist palliative care services, governments and GPs themselves can all play a part in reinforcing the central role of GPs in palliative care. Defining a minimum set of palliative care skills to be taught to all doctors at undergraduate and intern level would ensure that all GPs have the knowledge and confidence to manage most common problems in palliative care. Medical schools should accept the challenge of embedding the national undergraduate palliative care curriculum6 into their programs. Currently, neither the national intern training curriculum7 nor the Royal Australian College of General Practitioners vocational training curriculum8 includes palliative care as a distinct entity. Many parts of both curricula could be covered by structured teaching of palliative care. Educational strategies aimed at established GPs should take into account the variable level of their skills and interest in palliative care. Such strategies include: reinforcing the core skill set, especially during vocational training; opportunistic case-based education, based on adult learning principles; accessible and available local teaching; financial support to attend educational sessions (including locum fee support); and funded longer-term placements for GPs interested in making palliative care a major part of their practice. Both specialist palliative care services and services involved in the pre-palliative phase of a patient’s disease (when the focus is on curative measures) must accept GPs as an integral part of the care team and work towards integrating GP input into patient care planning, patient review and management. Maintaining clear lines of communication between hospitals and GPs is important, but, unfortunately, not always done well.1 When patients are discharged from curative care, GPs need to be informed and their responsibilities delineated. Direct transfer of patients to palliative care units without keeping GPs informed and without giving them a defined role sends a message that they are not valued in this setting. Case conferences at the point of transfer can be useful. Furthermore, offering GPs responsibility during care planning and seeking their involvement in routine surveillance of patients during the pre-palliative phase (with clear protocols in place)9 might facilitate their involvement when patients enter the palliative phase of the illness. Specialist palliative care services should not take on the role of finding an alternative GP or acting as primary care provider for patients whose GP will not or can not accept this responsibility — rather, this role should be referred back to the GP.10 GPs, in turn, should accept this responsibility and embrace or initiate shared-care models (Box 2). Such models have been established successfully here and overseas.11-13 Divisions of General Practice could play a key role (not yet well exploited) in encouraging formal shared-care arrangements — only 9% of Divisions were involved in palliative care shared-care projects in 2002.14 A significant proportion of Australians are from minority ethnic backgrounds, including Indigenous Australians. Many GPs who care for people from minority cultural groups require cross-cultural training relating to issues of death and dying. Many GPs who care for people of their own cultural group, while understanding the barriers to care that different cultural beliefs may pose, nevertheless have difficulty reducing the impact of these beliefs. Some GPs and communities require assistance in participating in and benefiting from mainstream models of palliative care. Palliative care should be a rewarding part of general practice,15 and indeed the skills of good palliative care closely mirror those of good general practice care. It is essential that this core task is not diminished by, or lost in, the current rapid evolution of consumer needs, financial uncertainties, structural changes and increasing training imperatives. 1: Barriers to greater general practitioner participation in palliative care Structural barriers GP undersupply and uneven distribution Time constraints for adequate service provision Changing demographics (eg, increased proportion of female and part-time GPs) Safety fears around home visits Cost inefficiencies of providing quality palliative care Rising practice costs and related pressures Knowledge barriers Sporadic patient load Rapidly expanding knowledge base of palliative care Competing educational priorities Practical barriers to undertaking training (eg, time, cost, availability of locum support) Lack of structured basic training undergraduate curricula national intern training curricula culturally specific palliative care Service barriers Suboptimal planning of palliative care provision after attempted curative measures Lack of active GP involvement in care during curative phase or in transition from curative to palliative care “Specialisation” of palliative care Unclear role definition for GPs in specialist palliative care service environment or among multiple service providers with palliative care brief 2: Roles of general practitioners and specialist palliative care services in palliative care General practitioners Provision of contextual knowledge of patient, family dynamics, history of illness to team’s care plan Routine medical surveillance Early intervention to prevent or control symptoms Medical care of carers Specialist teams Provision of specialist advice on symptoms and treatment to team’s care plan Nursing and allied health services Pastoral care Access to inpatient admission Either GPs or specialist teams (by negotiation) Care coordination After-hours emergency care Bereavement surveillance of carers

Geoffrey K Mitchell FRACGP, FAChPM · Elizabeth J Reymond PhD, FRACGP, FAChPM · Barry P M McGrath MB BS, MPH, PhD

Have you got a paper burning a hole in your desk, waiting to be sent to your favourite journal? Or an idea for an article, needing just a little more inspiration to push it into print? Now could be your big chance! MJA theme issues 2004 17 May — Indigenous Health Closed to research manuscripts 5 July — MJA’s 90th Anniversary Closing date 19 April 19 July — General Practice Closing date 15 March 16 August — Doctors’ Health and Lifestyle Closing date 10 May 18 October — Adolescent Health Closing date 5 July Contact details: email editorialATampco.com.au phone (02) 9562 6666 This year, the MJA will be publishing five special theme issues, and we are inviting submissions in all categories of articles (Research, Viewpoints, For Debate, Clinical Updates, Snapshots, and even Editorials, although these last should be discussed with an editor first to check suitability). Last year’s big hits were Women’s Health (16 June 2003) and Chronic Illness (1 September 2003). This year’s special issues are shown in the Box and the closing dates for submissions. Please remember that a lot of work is involved in preparing a manuscript for publication, including editorial assessment, peer review, revision, editing and finally page layout — it doesn’t happen overnight, so the sooner you can submit your material, the better. July will be a very special month for us because it is our 90th birthday — we hope our readers will be able to help us celebrate in style. In the decade since our last anniversary issue, there have been major changes to the Journal and to how readers prefer to receive and use their medical information. We would like to know what you think of the Journal, how medical journals and the MJA have changed over your years of reading, and what kind of journal you would like the MJA to be on our 100th anniversary. We would also be very interested to know which MJA articles have made a difference to the way you practise medicine or have affected the way you treated a particular patient. Finally, we would be interested in your views on changes in medicine in the last decade. In all issues and all categories, we’re looking for originality, innovation, topicality and positivity, with a focus on “health” rather than disease. Do consult our Advice to authors for submission requirements and details of article categories (www.mja.com.au/public/information/instruc.html). We look forward to receiving your submissions.

Bronwyn Gaut

If we can learn from this, it will have made a contribution to the pursuit of integrity in research On beginning his recent sabbatical at the Mayo Clinic, Professor Michael O’Rourke, a renowned academic from the University of New South Wales, was handed a slim volume entitled Honor in science. First published in 1984, it is recommended reading for research trainees as a guide to ethics and the values of research. Significantly, there are now more than 50 000 copies in circulation.1 Activities such as the dissemination of this booklet are central to ensuring society’s trust in the integrity of research. More than 20 years ago, Al Gore Jr (then a United States congressman, and later Vice President in the Clinton administration), as chairman of the first congressional hearing into scientific misconduct, noted: “At the base of our involvement in research lies the trust of American people and the integrity of the scientific exercise.”2 There is no reason to believe that this would be any different in Australia. Allegations of research impropriety affect the careers of both the accused and the accusers and . . . can divide an institution and damage its reputation. But trust in our research enterprise has recently been shaken by the “Hall affair” at the University of New South Wales (UNSW). At the end of 2001, complaints of research misconduct were levelled at Professor Bruce Hall, a Professor of Medicine at UNSW, and an internationally acclaimed scientist in immunology. The complainants were members of Hall’s research laboratory and it has taken more than 2 years to resolve their allegations. During this time, there were four different inquiries and reports, which reached different conclusions (see Box). From the beginning of the affair, all the allegations have been vigorously denied by Hall. Sadly, as it unfolded, the Hall affair illustrated the reality that allegations of research impropriety affect the careers of both the accused and the accusers and, in the process, can divide an institution and damage its reputation.11 Most importantly, such allegations jeopardise public trust in the integrity of research. Further, they provide fuel for a media that feeds on human discord, and, dealing in perceptions and innuendo, accelerate this corrosion. The Hall affair was first publicly dramatically exposed on the Australian Broadcasting Corporation (ABC) Radio National’s Science Show,4 and then clinically dissected by ABC television’s Four Corners9 (see Box). The media also covered the investigation as it progressed and, on the release of the UNSW Vice-Chancellor’s Report on the affair,8 one journalist commented, “Let me get this straight. Plucking data from thin air, recycling old research in new papers and telling porkies in a grant application is OK. Funny, I thought such doings were serious no-nos, construed at best as scientific misconduct, or at worst scientific fraud. Apparently not . . .”12 Looking back over the Hall affair, we are forced to ask ourselves how we can move forward. Are there any lessons to be learned? Scientific misconduct and fraud may well be seen as an illness, requiring not only diagnosis but also treatment. The diagnosis involves a fast and fair inquiry which, at the same time, must assure the public of its propriety. Unhappily, the Hall affair dragged on for more than 2 years and involved at least four inquiries (see Box). The initial inquiry by the UNSW’s Dean of Medicine should not have moved beyond a prompt and preliminary process to establish whether there was a case to be answered. In any event, it went on, patently crippled by perceptions of conflicts of interest — including an institution investigating allegations of improprieties carried out in its own backyard! Herein lies lesson number one — once allegations of scientific misconduct and fraud have been made, these should be addressed from the beginning by an external and independent inquiry. The external inquiry must establish the evidence for misconduct. From the publicly available details of the Brennan Inquiry,7 it appears the inquiry had its hands tied in testing the evidence. Herein lies lesson number two — the external inquiry should have statutory power to investigate and inquire. Defining this power will not be straightforward, as the inquiry should not be hijacked by obfuscating and delaying legal tactics. The Brennan Inquiry was made up of legal and scientific experts, with the latter in the majority. Despite the fact that the framework of research conduct is generic, professional criticisms surfaced in the Four Corners program9 and elsewhere about the inquiry panel’s lack of expertise in immunology.10,13 To allay public concerns about the lack of relevant “expertness” — inquiries into allegations of scientific misconduct and fraud should consider having on the panel of inquiry at least one expert from the same scientific discipline as the scientists under investigation — lesson number three! In the 2002 Reith Lectures for the British Broadcasting Corporation, Onora O’Neill stated that “. . . ‘Loss of trust’ is, in short, a cliché of our times.”14 Mistrust of professionals, politicians and public servants and their institutions permeates our society. The antidotes to this “culture of suspicion” are supposedly higher standards of accountability and greater transparency.14 As it progressed, the Hall affair was not the epitome of transparency and, to date, the details of its four inquiries remain cloistered within academia. Herein lies lesson number four — to preserve public confidence, inquiries into scientific misconduct should aim for the highest degree of transparency and accessibility of final reports. Finally the Vice-Chancellor’s Report (see Box) makes judgements on the outcomes of the Brennan Inquiry, and also conveys opinions on the relative value of scientific abstracts and the nature of data in research-funding applications that are at odds with conventional scientific wisdom. Even more intriguing is the rationale behind the action of the Vice-Chancellor in judging the findings of the Brennan Inquiry, yet not consulting its panel. Why bother with an external inquiry if its outcomes are to be subsequently interpreted and judged by an individual calling on his own wisdom along with the views of another battery of experts? Such action may be in accordance with and required by the UNSW enterprise agreement, but surely the integrity of research transcends any industrial agreement! Herein lies lesson number five — universities, research institutions, research societies, societies and funding bodies need to collectively define uniform processes and procedures for addressing and adjudicating on scientific research and fraud.15 But what about treatment? The emphasis in healthcare today has shifted from the management of diseases to their prevention, and herein lies lesson number six — there is a need to shift the emphasis from managing scientific misconduct and fraud to preventing them. This shift is thoroughly summarised in the recent report of the United States Institute of Medicine (IOM), Integrity in scientific research: creating an environment that promotes responsible conduct.16 Its central theme is the need to foster responsible research conduct, and it identifies the individual scientist as the most unpredictable variable in the equation. But it also throws back to institutions the responsibility of creating a culture that values research integrity through comprehensive and effective education, self-assessment and self-improvement, aimed at both the individual and the institutional level. In short, the IOM report moves the prevention of research misconduct from focusing on what we should do in the conduct of research, as prescribed in guidelines, codes of conduct and other affirmations or declarations, to determining what we actually do through individual and institutional self-assessment, and moving to best practice through education and continuous improvement underpinned by a reward system. The IOM report lists desirable goals for both individuals and institutions in maintaining scientific integrity, but, ultimately, research is an intense and complex human exercise — one which sees young investigators and their mentors working in a “pressure-cooker” environment, where the only safety valves are open communication, mutual respect and mentors prepared to be actively involved. In his 1982 Presidential Address to the American Society for Clinical Investigation, Phillip Majerus (Professor of Medicine, Biochemistry, and Molecular Biophysics at Washington University, and past editor of the Journal of Clinical Investigation) describes this ideal environment: “Students, postdoctoral fellows and junior colleagues are the future of medical research. They are our most valuable resource and should be treated as such. Senior investigators have a solemn responsibility to guide trainees to allow them to express their full potential. If because of clinical, administrative or other constraints, an investigator does not have time to participate in the ongoing progress of an investigation on a day-to-day basis, then he should dissociate himself from it . . . Work in progress should be discussed openly and the data should be reviewed, frequently, not just by the laboratory chief but also by disinterested parties. Group meetings of large laboratories where there is evaluation of data of individuals are important. Even better are presentations to departmental or other groups, where investigators not directly connected with the work, evaluate the data. These exercises require heavy applications of skepticism, the most important ingredient in scientific creativity.”17 Good advice then and good advice now. The Hall affair has wreaked untold havoc, but, despite this, can be viewed in a detached, scientific sense as experiments in processes and procedures. The results of experiments need to be mulled over and interpreted to determine future directions. In this vein, the Hall affair should make a contribution to the pursuit of research integrity. Ultimately, integrity in research requires leadership. If, in the wake of the Hall affair, our universities cannot ensure an enlightened and responsible ethos in their research enterprises they risk a loss of public confidence. The ball is in their court. The “Hall affair” — investigations of complaints against Bruce Hall, Professor of Medicine at the University of New South Wales September 2001 – January 2002 Complaints received by the University of New South Wales (UNSW) from three members of Professor Hall’s laboratory, which, among other things, raised allegations of scientific misconduct and fraud, as well as deficiencies in workplace relationships and procedures.3 13 April 2002 Dr Norman Swan revealed details of the complaints against Professor Hall, and discussed these with the complainants on the Australian Broadcasting Commission Radio National’s Science Show.4 Hall, at all times, fiercely denied these allegations. 17 April 2003 The UNSW released the outcomes of two parallel internal inquiries by Professor Bruce Dowton, Dean of the Faculty of Medicine, who carried out the initial investigation of the complaints, and Professor Elspeth McLachlan, Pro-Vice-Chancellor (Research), who focused on complaints that had been raised with the National Health and Medical Research Council. Both inquiries found no overwhelming evidence to sustain the complaints. Both were unable to report conclusively on some matter of alleged scientific misconduct and fraud.3 As to the workplace complaints, the inquiries found there were unsatisfactory working relationships and an unsatisfactory working environment in Hall’s laboratory.3 UNSW Vice-Chancellor John Niland announced the setting up of an external inquiry to address the allegations of scientific misconduct and fraud as defined by the National Health and Medical Research Council and the Australian Vice-Chancellors Committee (NHMRC/AVCC) Joint Statement and Guidelines on Research Practice.5 June 2002 The UNSW announced the members of the external independent inquiry, who were: Sir Gerard Brennan, previous Chief Justice of the High Court (chair); Professor John Chalmers of the University of Sydney; Sir David Weatherall of Oxford University; and Professor Judith Whitworth of the Australian National University.6 Subsequently, it become known as the Brennan Inquiry. January 2003 The UNSW received the final report of the Brennan Inquiry, after which the Hall Affair proceeded along two pathways: (a) matters related to the release of the Brennan Inquiry report; and (b) processes required to comply with the University Enterprise Agreement in dealing with allegations of research misconduct. Events were as follows: (a) On 14 February 2003, the UNSW Council resolved not to release the Brennan Inquiry report, and also considered a submission by Professor Hall as to why its release should not occur. Ten days later, the Council reversed its position and sanctioned limited release. The following day (24 February), lawyers for Hall obtained a temporary injunction against its release. In August 2003, Justice McLennan lifted the injunction.7 (b) To satisfy the provisions of the UNSW Enterprise Agreement for pursuing alleged research misconduct, the Brennan Report was referred to Professor Stephen Deane, Professor of Surgery at Liverpool Hospital, acting as Hall’s academic supervisor at Liverpool Hospital. The UNSW Enterprise Agreement sets out a detailed process to be followed in cases of alleged research misconduct, so that the UNSW may only discipline an academic if the Enterprise Agreement process has been complied with. Professor Deane’s remit was to determine whether the Brennan Inquiry report gave rise to any allegations of misconduct or serious misconduct as defined by the Enterprise Agreement and, if so, whether such allegations could be “resolved through guidance, counselling, conciliation or other appropriate action.”8 Professor Deane provided a report (the Deane Report) on 17 March to UNSW Deputy Vice-Chancellor, Professor Mark Wainwright. Based on the Deane and the Brennan Inquiry reports, Professor Wainwright identified 12 outstanding allegations against Hall which warranted further investigation. Professor Hall was given the opportunity to respond to these allegations. Ultimately, Professor Wainwright determined that, in relation to six allegations, there was no misconduct or serious misconduct. However, for the remaining six he was unable to determine whether or not serious misconduct had occurred. Hall was notified of these allegations, which he denied, but he elected to have the matter referred directly to the Vice-Chancellor. 6 October 2003 An ABC Four Corners program presents the central concerns and provides real-life insights into the key players in the Hall Affair.9 23 December 2003 UNSW releases the report by the Vice Chancellor, Rory Hume, on findings of allegations of misconduct.8 In reaching his decision, Hume considered the Brennan Inquiry report and the views of two experts, along with a written response from Hall, which included reports by six experts in immunology. Professor Hume considered the allegations only in the terms of the Enterprise Agreement and, where indicated, the NHMRC/ACVV statement and guidelines.5 His findings are shown below. Allegation 1: A paper that was submitted or authorised to be submitted contained data and statements for which there were no supporting experiments. Finding: Professor Hall was not guilty under the Enterprise Agreement. Rather he had committed an error of omission reflecting the pressure of mitigating circumstances.* Allegation 2: A grant application by Professor Hall contained a figure with a conclusion “all differences are significant at P < 0.05”, but omitted relevant facts. Finding: Guilty of misconduct, but, given the mitigating circumstances* and the Vice-Chancellor’s belief that grant proposals are preliminary data yet to be validated and that there was no intention to deliberately deceive, he deemed the transgression to be minor and warranting no further action. Allegation 3: A grant application by Professor Hall contained a statement when no experiments to support the statement were ever done in Hall’s laboratory or in the laboratory of any other author of the grant application. Finding: Guilty of misconduct despite the mitigating circumstances.* Hall was censured. Allegation 4: Failure to notify the granting body of the details once the absence of the experiments outlined in Allegation 3 became apparent. Finding: Guilty of misconduct warranting censure. However, Professor Hall’s lack of action did not demonstrate an intention to deceive. Allegation 5: The publication of an abstract which contained a statement for which no experiments were performed in Hall’s laboratory. Finding: Guilty of misconduct in failing to take reasonable steps to ensure that the abstract was accurate, but, in view of mitigating circumstances,* including the Vice-Chancellor’s view that “abstracts have very little potential to damage the fabric of science,” along with the premise that individuals’ interpretations of the abstracts differ, no further action was taken. Allegation 6: That Professor Hall must accept the main responsibility for allowing a substantial degree of procedural laxity in his laboratory at Liverpool Hospital. Here, there were mitigating circumstances* against a background of a complex research laboratory and Hall’s need to supervise a busy clinical service and a teaching program. Finding: Guilty of misconduct. Hall was advised of his error of judgement, but, given the circumstances, no further action was taken. In summary, the Vice-Chancellor did not believe that Professor Hall was guilty of scientific misconduct. Rather, he committed errors of judgement sufficiently serious in two instances to warrant censure. None of the Vice-Chancellor’s findings warranted Hall’s dismissal. With the release of the Vice-Chancellor’s findings, one prominent immunologist was quoted as saying that the allegations against Hall were “much ado about nothing”.10 * During the period when some of the alleged misconduct occurred, Hall was afflicted by a debilitating illness, his laptop and disks containing grant proposals were stolen, and he was subject to the pressure of tight deadlines.

Martin B Van Der Weyden MD, FRACP, FRCPA

Improving global health requires foreign policy reform and more aid Health and foreign affairs are inextricably linked. No day goes by without news reports on health and its global dimensions, whether focused around HIV/AIDS, the rise of non-communicable diseases, the implications of ageing populations, bioterrorism, or other topics. While global population health indices have improved considerably, many countries — both rich and poor — are experiencing health crises, and, in a globalised world, proactive policies are essential in all regions to protect and promote public health. In a number of countries discussion is under way about how best to respond;1 Australia is adding its voice to these debates. What are the links between health and foreign policies? How consistent and coherent are they? What are the benefits or dangers of improving these links? In this special issue of the Journal, we present a selection of papers presented at a symposium entitled “Health and foreign policy: scope for Australian engagement”, held in Sydney in September 2003. The Symposium was a collaboration between the School of Public Health and Community Medicine (University of New South Wales), the Institute for International Health (University of Sydney) and the Nuffield Trust, a leading health charity and research organisation in the United Kingdom.2 What is Australia’s contribution to overseas aid?Australia’s geography provides a particular focus on the Asia–Pacific region. The total Australian aid program for 2003–04 is budgeted at $1.894 billion,3 representing 0.25% of gross national income (GNI). Although this is above the donor average in 2002 (0.23%), this proportion has declined from close to 0.5% in the early 1970s,3 and remains well below the target of 0.7% of GNI set internationally several years ago.4 AusAID, the agency charged with implementing Australia’s overseas aid policy and delivering the Government’s overseas aid program, has highlighted five key themes for its activities: governance — “promoting democratic and accountable government and effective public administration”; globalisation — “assisting developing countries to access and maximise the benefits from trade and new information technologies”; human capital — “supporting stability and government legitimacy through improved delivery of basic services”; security — “strengthening regional security by enhancing partner governments’ capacity to prevent conflict, enhance stability and manage trans-boundary challenges”; and sustainable resource management — “promoting sustainable approaches to the management of the environment and the use of scarce natural resources”.3 The overarching objective of AusAID’s program remains “to advance Australia’s national interest by assisting developing countries to reduce poverty and achieve sustainable development”,5 elements of which are the focus of ongoing debate and critique.6,7 A particularly fundamental challenge is to take account of the new focus on global security, terrorism and governance, while still addressing fundamental health and development concerns, as expressed, for example, in the Millennium Development Goals.8 Alexander Downer, the Australian Foreign Minister, also draws attention to the need for greater involvement of recipient countries in determining what is done with foreign assistance resources; greater emphasis on building developing country capacity to achieve development objectives; greater coordination among development partners; and less reliance on standalone projects.9 Within this broader context, AusAID itself is currently reviewing its health strategy and approach, although this process is at an early stage. Development assistance for health has increased globally from 3.8% of total overseas development assistance to 6.8% in 2002. AusAID anticipates devoting 13% of its 2003–04 budget allocation to health sector support.3 AusAID has previously directed such funding to health sector reform, mental health and non-communicable diseases, and promoting primary healthcare with a focus on the Asia–Pacific region. Australia has devoted particular attention to action on HIV/AIDS, one of the key success areas for the Millennium Development Goals, and HIV/AIDS consumes an ever-increasing share of the health aid budget. Moving beyond aidGlobal health inequality is mirrored by global patterns in health research — less than 10% of health research concerns the major health problems affecting 90% of the world’s population.10 This is now the focus of concerted international action, and Australian research contributions, many of which have great potential, could be greatly facilitated by more extensive support and engagement by AusAID, the National Health and Medical Research Council and the Australian Research Council. It is notable that increasing aid alone will not solve global health problems; reform of broader policies on trade, debt and globalisation are needed if global health is to be promoted and protected. Direct foreign investment is four times greater than the transfer of aid from wealthy to developing countries, and is likely to have a major impact on health.5 The complexity of global governance means that diverse international linkages and structures are needed. Australia’s active membership and involvement in a reforming United Nations, as well as in the Commonwealth of Nations, and regional Asia–Pacific structures, all present avenues for strengthening multilateral commitment to global health and ensuring that it endures as a global priority beyond the current window of opportunity. The debateThe global health and foreign policy articles presented here reflect concern with a number of the major issues of the debate. What is the nature of globalisation and who benefits from it (Lee, page 156)? How do changes in the global trade environment affect health (Labonte, page 159)? What are the challenges and impediments to ensuring that those responsible for forging our foreign policy include health issues on their agenda (Harris, page 171)? What are the dangers of seeking a closer relationship between health and foreign policy, given that security and national interest inevitably are higher on the agenda than concerns for development or poverty reduction (McInnes, page 168)? How does the growing acknowledgement of health as a human right affect health-related foreign and development policies (Reid, page 163). The debate in Australia is at an early stage. The articles that follow highlight many of the key challenges and constraints, but also the promise and potential, of fostering a more inclusive and humane globalisation. Promoting intercountry and intracountry equity, alongside tackling poverty, is consistent with Australian values of a “fair go” and should contribute to multiple desirable and integrally related objectives — promoting health, economic growth, development, poverty reduction, and regional stability (see workshop recommendations, page 166). Read on . . .

Anthony B Zwi MB BCh, P hD, FFPHM · John Wyn Owen CB, MA(Camb) · Alan Ingram MA, PhD

The problems of staff and funding shortages implicated in this affair may not be confined to the hospitals in question In December 2003, public confidence in New South Wales hospitals was severely shaken by the release of the Health Care Complaints Commission (HCCC) report on the “Cam affair”. 1,2 This had erupted from the allegations of four nurses who had voiced their concern, some 13 months earlier, over questionable patient care, disregard for quality and safety, and an indifferent administration at the Campbelltown and Camden hospitals of the Macarthur Health Service in Sydney’s southwest.3 The HCCC report detailed a raft of symptoms of a sick hospital and administration system, and outlined a blueprint to rid the health service of this sickness.4 It is hoped that something more substantial than yet another list of blameworthy individuals will emerge from the inquiry. The response by the NSW Minister for Health, Morris Iemma, was surgical and swift: two doctors were suspended and another nine were referred to the NSW Medical Board; disciplinary proceedings were commenced against four administrators; 19 deaths examined in the HCCC report were referred to the State Coroner; and the South West Area Health Board, ultimately responsible for the two hospitals, was dissolved.5 To this point, the minister’s actions had the right political resonance and were ostensibly defensible. But then came a decision at odds with the wisdom of focusing on the message, and not the messenger. The minister noted, “The report does detail in great length instances of clinical failure, deficiencies in management systems, and the failure to ensure appropriate supervision. But for an investigation that took 13 months to complete, the HCCC doesn’t go far enough in terms of finding anyone accountable for these failures [my emphasis].”5 He then dismissed the HCCC commissioner, Amanda Adrian. This baffling, and as yet unexplained, decision might reflect information to which the minister alone is privy, or simply poor advice from his minders. In any event, the commissioner went. To drive home the political focus on accountability, the minister announced yet another inquiry.5 Its brief is not only to retrace the HCCC investigation, but also to “make recommendations as to further actions against individuals, and to refer any matter or person for disciplinary action” and to “make recommendations on the regulatory and administrative arrangement of the HCCC.”5 It is hoped that something more substantial than yet another list of blameworthy individuals will emerge from the inquiry. To the casual observer, the Cam affair resembles the United Kingdom’s high profile Bristol case.6 Both were the result of whistleblowers’ altruism, and their frustration when their complaints about unacceptable patient care and safety fell on institutional deaf ears. In both, the whistleblowers (seven nurses in the Cam affair and an anaesthetist in the Bristol case) paid a high personal and professional price for their public stance. 4,7 In both, there were long initial investigations followed by other inquiries. 5,7 But there the similarity ends. The Bristol case revolved around issues of professional competence and self-regulation,6 whereas the Cam affair centres on, among other things, a mismatch between clinical capacity and clinical demand4 — a mismatch exacerbated by the chronic “poor country cousin” status of Sydney’s outer metropolitan hospitals compared with their “rich city cousins”, the established inner-city hospitals.8,9 But what to do? What are the pathways out of this situation? The HCCC remedial blueprint and the recommendations for change made by the Macarthur Expert Clinical Review Team led by Bruce Barraclough, Director of the NSW Institute of Clinical Excellence,10 have much in common. The Macarthur Expert Clinical Review Team, at the behest of the minister, examined the embattled hospitals in August 2003. Its recommendations include the need for: significant leadership in the clinical and administrative spheres; increased clinical service capacities in workforce and resources; involvement of academic institutions and clinical colleges to enhance the professional attractiveness of the hospitals for postgraduate training and senior staff; and an ethos that encourages open reporting, review and remediation of problems — an ethos that is patient and safety centred. These conventional approaches to troubled healthcare systems are laudable, but the Cam affair also provides opportunities to explore innovative approaches that might be transferable to our troubled hospitals in other jurisdictions. These include: confronting the “silo” mentality of our hospitals by appointing staff, not to specific hospitals, but to health areas, so that expertise and services are available area-wide according to need (there is a pressing need to develop more flexible service capacity within healthcare services); developing clinical services on the basis of area-wide need rather than political or academic opportunism; establishing a tertiary care teaching hospital at the hub of the health area, with real and transparent service or training links with the area’s other hospitals; and developing indicators, or clinical “Plimsoll lines”, which signal higher risks to proper patient care and required quality and safety. At a global level, politicians need to be made more individually aware of, and accountable for, health services. This may be achieved by: dismantling the highly centralised and adversarial HCCC and replacing it with local-area health ombudsmen, accountable to an independent panel comprising the area’s state and federal politicians along with community and health-discipline representatives (such a system would be far more responsive to local difficulties and more in tune with concepts of accountability and quality); and increasing the proportion of bipartisan local, state or federal politicians serving on area health boards, along with limited-tenure members selected for professional prowess rather than political patronage. But change and innovation alone will not allay a real anxiety about whether the Cam affair was an isolated incident or is destined to be replayed elsewhere. The unstoppable demand for hospital services during a medical and nursing workforce crisis, compounded by inadequate hospital funding,11 suggests that the latter is more likely. The community, through its politicians, has a confronting choice: either reinvigorate our hospital services by increasing the number of doctors and nurses and attend to our hospitals’ waning capacity and infrastructure through adequate funding, or await the next Cam affair. Ironically, the Macarthur Health Service’s quality policy statement throughout this affair outlined a commitment to the principles of customer focus, strong leadership, striving for best practice, evidence of outcomes, and a culture of improving.12 But the Cam affair illustrates that, for our hospitals, there is more to quality than rhetoric.

Martin B Van Der Weyden MD, FRACP, FRCPA

We need to provide appropriate, high-quality training in and for rural areas Australia’s medical workforce is distributed unevenly — in rural and remote areas, where people have the highest morbidity and mortality rates, there is reduced access to medical services. 1,2 Not only is there a maldistribution adversely affecting rural and remote areas, but the work of rural and remote general practitioners is more complex than that in metropolitan areas.3 Thus, we need to provide appropriate medical training for these environments, and strategies to increase the rural workforce. In recent years a suite of initiatives has been introduced to encourage more doctors to choose careers in the bush.4 These range from visits to rural high schools promoting medicine as a career, to undergraduate scholarship schemes, through to regionalised general practice training. Rural Australian Medical Undergraduate Scholarships are offered to students from rural areas, and the John Flynn Scholarships are open to all students who express an interest in future rural practice. Both of these foster relationships with rural areas and practitioners. All general practice registrars are now required to work for at least 6 months in a rural area, and there are financial incentives to train in rural areas. Finally, substantial academic infrastructure, in the form of university departments of rural health and rural clinical schools, has been funded.5 Will these initiatives have an impact on rural and remote workforce shortages? Current evidence suggests that rural doctors are more likely to have come from a rural background, to have a partner or spouse with a rural background, to have wanted a career as a general practitioner, and to have undertaken undergraduate and postgraduate training in rural areas. 6-8 Doctors who spend more than half their postgraduate training period in rural areas are over 10 times more likely to practise in a rural area.9 Most of the initiatives to encourage rural practice have been aimed at medical students, or at doctors after rather than before registration. Historically, most internships have been completed in metropolitan hospitals. The health system needs high technology centres, but are they an appropriate place to apprentice practitioners in their pre-differentiated stage? In this issue of the Journal, Peach et al (page 106)10 present the results of a study on the eventual place of work of doctors who completed their internships in a regional hospital in Victoria. These doctors were more likely to work as general practitioners in regional Victoria than their contemporaries who completed internships in metropolitan hospitals. Peach et al argue that more internships should be available in regional areas. This retrospective, case–controlled study shows an association between regional internships and regional careers, but, as the authors acknowledge, this does not prove causation. Were those who worked in regional Ballarat a self-selected group, already with an interest in life outside the city? Only a prospective study can explore why choices were made, and what aspect of the internship promoted the choice of a career in rural medicine. Was it the social network the doctor made? or the content of medicine in rural areas, with common acute presentations to hospital rather than rare conditions (providing confidence in diagnosis and reducing the “fear” factor of on-call in comparative isolation)? or was it the context, with close relationships with a community making the doctor feel involved and included? There has always been a tension in postgraduate medical education between providing workforce and furthering the education of doctors in training. Studies have shown that sending general practice registrars to areas of workforce need does not always guarantee a good learning experience, and may generate a desire to rush back to the city at the earliest opportunity. A study in central Australia suggests that, without adequate supervision, the significant learning opportunities available in rural areas are not fully utilised.11 Moreover, the National Female Rural General Practitioners Research Project12 noted that, while increasing numbers of women are choosing rural general practice, many female general practice registrars in rural areas planned to return to metropolitan areas once they had completed their training. To solve the rural and remote workforce shortages, we need to provide appropriate, high-quality training in rural areas and specifically for rural areas. The absolute numbers of medical students with a rural background are still low, so any mechanisms that encourage students from urban backgrounds to work in rural and remote areas are important. However, the intern year needs to provide, in a protected environment, the practical knowledge and skills necessary for a safe standard of medical practice. We need to be sure that regional areas can provide this environment — accredited education, support, assessment, and suitable working conditions.13-15 Do we need further evaluative research, as suggested by Peach et al? Yes, we need a prospective cohort study, taking into account the planned Committee of Deans of Australian Medical Schools (CDAMS) Rural Programs Evaluation Project, to examine the impact of both undergraduate and postgraduate rural initiatives on career directions.16 Should we wait for another 5 or 10 years for the results of this research? No, Australians in rural and remote areas cannot wait. We now have sufficient evidence to be confident that rural and remote training has an impact on subsequent choice of rural practice, and we know what constitutes an effective training post. Armed with these two pieces of information, we can proceed with increasing the numbers of regional internships. The distribution of internships should better reflect the health needs across Australia.

Susan M Wearne MMedSc, FRACGP, GCTEd · John Wakerman MTH, FAFPHM, FACRRM

Cyberdrugs will only take off if there is a significant price advantage over that on the black market The Wild West is a prominent metaphor for the new challenges and opportunities the Internet brings. The adventurous welcome the challenge, the cautious fear the hazards. The Internet has opened up a whole new area of information exchange and free trade. The information exchange makes it difficult for totalitarian regimes to easily control their citizens’ access to information, and Internet share trading makes governments more cautious about their fiscal policies. Free traders welcome the level playing field, for they see restricted markets opening up, and efficiencies based on market forces.1 The Internet cuts out the “middle man”. However, there are downsides, as anyone harassed by SPAM mail will know. Multinationals can more easily extend their sphere of influence, the pornography trade flourishes, as does the trade in music and illicit CDs, which boldly flouts copyright laws. Internet trading of pharmaceuticals challenges the tradition that pharmaceutical drugs should only be prescribed by health professionals and dispensed by pharmacists who have seen the person face-to-face. In June 1999, the American Medical Association formally adopted the position that appropriate medical care can only result from face-to-face consultations.2 Likewise, members of the US Food and Drug Administration are expressing a caveat emptor (“let the buyer beware”) about e-pharmaceuticals,3 because of problems with the quality of cyberpharmacies and the qualifications of cyberpharmacists.4 To what extent does society get involved in individuals’ free choice, especially in the context of drug use? Is free trade better than social control? Social safeguards are set both to protect the ignorant and to restrain the wilful, although critics will argue that the medical and pharmacy professions are simply protecting their eroding turf. With drugs of dependence, those involved in misuse would prefer to cut out the “middle man”, and make their own deals. In addition, they are quite prepared to use substances of poor quality and uncertain potency. Should the profession try to stop this? And, if so, how? Social controls of the supply of drugs of dependence vary for different drugs. Thus, society is tightening its control over tobacco advertising and distribution, relaxing controls over alcohol, and clamping down on illicit drugs. Decisions for each drug class are decided somewhat arbitrarily — partly they relate to the severity of the perceived problems arising from use of the drug and partly to the feasibility of control measures. The underlying assumption is that society should exercise some control over drug dealers who seek to exploit those vulnerable to drug addiction, but, in each case — whether tobacco, alcohol or illicit drugs — some uneasy compromises are necessary. These compromises change over time, depending in part on ideological and political forces, as well as on the science of drug-related harm. What is the size of the cyberpharmacy problem in relation to addictive drugs? Is the single case of online purchasing of drugs for misuse described by St George and colleagues in this issue of the Journal (page 118)5 an exception, or the start of a new and dangerous trend? We need more data, but we can make some observations. Licit drugs present a far greater problem than illicit drugs. Most drug-related deaths in our society are a result of diseases caused by tobacco. Tobacco accounts for over 80% of drug-related deaths and 79% of years of life lost. 6 When the cardioprotective effects of alcohol are factored into the equation, the impact of alcohol is on a par with those of the illicit drugs. Yet, alcohol as a licit drug is freely available in our local supermarkets. Are not tobacco and alcohol a higher priority? The illicit use of licit drugs — prescription opioids and benzodiazepines — is more difficult to study. In particular, the impact of sedatives, including benzodiazepines, is difficult to quantify, as their main impact is their contribution to opiate deaths in polydrug overdoses. How big a problem, compared with other sources, is the cybersourcing of licit drugs for illicit use? As general practitioners have become more aware of the need to restrict benzodiazepine prescribing, a black market has developed. There is also a growing market in black-market prescription opiates, like MS Contin (Mundipharma) and Kapenol (GlaxoSmithKline). Thus, there is a ready market for people keen to buy these drugs. Cyberdrugs will only take off if there is a significant price advantage over that on the black market. Data are hard to obtain, but we suspect that, until it becomes harder for users to obtain benzodiazepines from lax prescribers or on the black market, the purchase of cyberdrugs will be regarded as too slow and too expensive. What should we now do? We need more data, and cases like that described by St George et al help to alert health professionals in the field to this new drug source. The suggestions put forward by St George and colleagues have merit, but, without more data, their alarm may be premature. In the past, drug control on the supply side, especially of illicit drugs, has produced disappointing results.7 In the meantime, we believe more effort is needed to control the damage caused by tobacco, alcohol and opiates.

Alan J Gijsbers FRACP, FAChAM · Gregory Whelan MD, FRACP, FAFPHM, FAChAM

Five years after the completion of the study, some of its benefits have been maintained The United Kingdom Prospective Diabetes Study (UKPDS) provided definitive evidence for the benefit of intensive management of blood glucose level and blood pressure in people with type 2 diabetes.1,2 When the main findings of the UKPDS were published in 1998, a year after the study had closed, several questions arose. How much would the UKPDS findings influence usual care? Would the vascular benefits of intensive therapy be sustained? Would the status of borderline or unexpected results change with longer observation? 1: Key findings of 5-year post-study monitoring after the United Kingdom Prospective Diabetes Study1,2 Diabetes control (assessed by haemoglobin A1c levels) in patients treated either conventionally or with intensive pharmacotherapy converged The effect of intensive blood glucose control on diabetes end-points was maintained The reduced risk of a fatal or non-fatal myocardial infarction became statistically significant The benefit of metformin treatment in overweight people was maintained The increased risk of all-cause and diabetes-related mortality with combination sulfonylurea and metformin therapy was no longer evident Blood pressure levels converged in the conventionally and intensively treated groups, but the beneficial effects of aggressive antihypertensive therapy were only maintained for microvascular complications To answer these questions, post-study monitoring was initiated after completion of the UKPDS. All patients stopped protocol-driven management but were asked to participate in further regular assessment. The 5-year post-study monitoring period ran from September 1997 to September 2002. Some early results were presented at the International Diabetes Federation Scientific Meeting in Paris in August 2003. The Chief Investigator, Professor Rury Holman, stressed the preliminary nature of the data, and foreshadowed full peer-reviewed publication in 2004. Nevertheless, given the impact of the UKPDS since 1998, the data were of great interest to many delegates present. In the UKPDS, 3867 patients newly diagnosed with type 2 diabetes were randomly allocated to receive either conventional diet-based blood glucose control therapy or intensive pharmacotherapy, primarily with sulfonylurea or insulin (with a target fasting plasma glucose level of < 6.0 mmol/L). Of the original cohort, 489 died during the study period and 76 were lost to follow-up. Thus, 3302 patients (85.4%) entered post-study monitoring. Endpoint data were collected for all of these patients. More detailed results were available for the 1696 (51.4%) patients who were followed up in UKPDS clinics. Regardless of whether or not the patients elected to continue attending UKPDS clinics after the study had finished, management was left to the discretion of the treating physician. The median haemoglobin A1c (HbA1c) values in the two therapy groups were close to 7% at the start of the UKPDS; they diverged during the first year of the study, then rose in parallel, with a separation approaching 1%.1 After the end of the UKPDS, the median HbA1c levels in the conventional therapy group plateaued at about 8.5%, while those in the intensive therapy group continued to rise. By the end of 3 years of post-study monitoring, the curves had converged. Over the next 2 years, the median HbA1c level fell progressively in both groups by about 1%. Only a quarter of patients had achieved the target HbA1c level of < 7.0% by the end of post-study monitoring, even though most were receiving insulin treatment at the time. The post-UKPDS changes in median HbA1c level mirror those found after the end of the equivalent type 1 diabetes study, the Diabetes Control and Complications Trial.3 The convergence during the first 3 years of post-study monitoring probably reflects a combination of patient reluctance to maintain intensive therapy (in view of the risks of hypoglycaemia and weight gain), set against increasing acceptance of lower glycaemic targets by patients and their doctors in the conventionally managed group. The subsequent downward trend suggests that incorporation of UKPDS-based recommendations into usual care was increasing, but the availability of new therapies, including thiazolidinediones, may have contributed. When analysed on an intention-to-treat basis, post-study monitoring data confirmed that participation in the intensive blood glucose lowering policy group was associated with a significantly lower rate of any diabetes-related endpoint (eg, myocardial infarction, stroke, renal failure, retinopathy, death from hyper- or hypoglycaemia) and of microvascular complications 5 years after the UKPDS had finished. This sustained effect has been termed “metabolic imprinting”.3 Although there were no group-specific differences in all-cause mortality and diabetes-related deaths during the UKPDS, intensive therapy during the study period was associated with a lower risk of diabetes-related death during post-study monitoring. The benefit of intensive therapy on fatal or non-fatal myocardial infarction — borderline in the UKPDS — was still weak by the end of post-study monitoring, but had become statistically significant. During the UKPDS, metformin therapy in overweight patients substantially reduced the risk of any diabetes-related endpoint, all-cause mortality, diabetes-related deaths and myocardial infarction compared with conventional therapy.4 During post-study monitoring, these risk reductions were attenuated but remained significant. There were unexpected increases in all-cause mortality (relative risk, 1.60; 95% CI, 1.02–2.52) and diabetes-related deaths (relative risk, 1.96; 95% CI, 1.02–3.75) in patients taking combination sulfonylurea plus metformin compared with sulfonylurea monotherapy in the UKPDS.4 This was considered a chance finding resulting from the low number of deaths in the latter group. These differences were no longer evident at the end of post-study monitoring. In the UKPDS, a subset of 1148 hypertensive patients were randomly allocated to tight blood pressure control (target, < 150/85 mmHg) or less tight control (target, < 180/105 mmHg).2 Of these, 884 were available for post-study monitoring, of whom 522 continued to attend UKPDS clinics. The pattern of change in systolic and diastolic blood pressure was similar to the pattern of change in HbA1c levels during post-study monitoring, with convergence between groups during the first 3 years and progressive reduction over the next 2 years. Despite a doubling of the percentage of patients taking three or more antihypertensive medications during the post-study period, only one in six patients had achieved a systolic blood pressure of < 130 mmHg and a diastolic blood pressure of < 80 mmHg at the end of this time. Compared with event rates in the less tightly controlled patients at the end of the UKPDS, there were impressive reductions in any diabetes-related endpoint, diabetes-related deaths, stroke and microvascular disease among patients subject to tight blood pressure control.2 By the end of post-study monitoring, the relative risk reductions in the first three of these categories were no longer statistically significant. For microvascular disease, a significant but attenuated risk reduction remained in the tight-control group. The UKPDS design was complex, and analysis of post-study monitoring data will be further complicated by the fact that clinical management was non-uniform after completion of the UKPDS. Nevertheless, it appears that the microvascular benefit of tight glycaemic control is maintained after resumption of usual care. This was also seen in the Diabetes Control and Complications Trial,3 and argues for early and aggressive blood glucose management strategies. Concerns about the safety of combination metformin–sulfonylurea therapy appear to have been allayed, and the macrovascular benefits of metformin in overweight patients are supported by the data presented in Paris. Disappointingly, it appears that the effects of aggressive antihypertensive therapy may wane relatively quickly. Formal analysis of post-study monitoring data is eagerly awaited, but, until then, there is reason to believe that the legacy of the UKPDS continues.

Timothy M E Davis FRACP · Stephen Colagiuri FRACP

Adolescents and young adults fare worse than children, yet do not have the same access to clinical trial therapy In almost half a century of clinical trials in children with cancer, survival rates have increased from less than 20% to over 80%. The national and international cooperation for such results has been an enormous feat of organisation. However, older adolescents and young adults, while having a higher and increasing incidence of cancer, have not fared so well.1 As shown by Mitchell and colleagues in this issue of the Journal (page 59), few are recruited into clinical trials, and improvement in survival has lagged behind that in younger patients.2 Some cancers that affect adolescents have a good prognosis (eg, Hodgkin’s disease and gonadal tumours), and little difference in survival is seen between patients who are treated in trials and those who are not. Yet clinical trials are still necessary to find the least toxic therapy while maintaining excellent survival. On the other hand, other cancers common in adolescents, such as acute myeloid leukaemia, acute lymphoblastic leukaemia, rhabdomyosarcoma, osteogenic sarcoma and Ewing’s sarcoma, are associated with considerably lower 5-year disease-free survival rates in adolescents than in younger patients.3 With increasing intensity of therapy, the importance of supportive care and a multidisciplinary approach cannot be over-emphasised. Outcomes of adolescents with acute lymphoblastic leukaemia have been reported to be markedly better with paediatric-based, high-risk (intensive) therapy performed in large teaching hospitals with appropriate support and a commitment to multidisciplinary coordinated care. In Children’s Cancer Group trials between 1989 and 1995, older adolescents had a 6-year event-free survival of 64%, compared with 38% for similar patients on (adult) Cancer and Leukemia Group B trials.4 Cooperation between paediatric and adult groups is essential to encourage entry into clinical trials. In France in 1993 and 1994, 15–20-year-old patients with acute lymphoblastic leukaemia treated within the paediatric FRALLE-93 study had a 5-year event-free survival of 67%, compared with 41% for 15–20-year-olds treated within the adult LALA-94 study.5 How can the lessons learnt in the large, multi-institutional, national and international paediatric cooperative groups be translated into better outcomes for adolescents and young adults with cancer? The Children’s Oncology Group (United States, Canada, Australia, New Zealand) and adult cooperative groups sponsored by the National Cancer Institute have identified four initiatives to improve the accrual of adolescents and young adults with cancer into clinical trials:2 Improving access to care through understanding barriers to participation. These barriers remain largely unstudied, but might include the time, cost and effort of being involved in a clinical trial, which may deter both physician and patient. Oncologists in private practice may retain these patients rather than referring them to a tertiary-care facility or cooperative group member institution. Also, clinicians and patients may not be aware of opportunities for clinical trials, the age policies of hospitals may prevent access to clinical trials for eligible patients, eligibility criteria may exclude some adolescent and adult patients, or there may be no available clinical trial for a patient. Developing a cancer resource network to provide information about clinical trials to patients, families, healthcare professionals and the public. Enhancing adherence to protocol therapy among adolescents. Although compliance was not found to be poor in the study by Mitchell et al,1 adolescent and young adult patients are often perceived as having difficulty in complying with treatment while keeping up their normal lives. Ancillary medical, psychological and educational support should be directed towards their specific needs.6 Increasing adolescent and adult participation in sarcoma trials specifically designed for patients in this age group. Just as paediatric oncologists have little experience with epithelial tumours, some adult oncologists have limited experience managing rare sarcomas.7 Cooperation between paediatric and adult groups is essential to encourage entry into clinical trials. For example, many Children’s Oncology Group trials will admit patients up to 30 years of age. It is imperative that alliances are formed to enable haematologists and oncologists who treat adults to enrol their younger patients in these trials. Although institutions that are members of the Children’s Oncology Group undergo rigorous performance monitoring to maintain high quality of care and data, this should not be a hindrance to such associations. Managing cancer patients in clinical trials requires significant financial support for administration and data management, but the benefit in improved survival will prove to be highly cost effective. Current funding models for research in Australia may not be suitable for the funding of clinical research such as cancer trials. National Health and Medical Research Council funding is tied strongly to researchers’ previously published research. Clinical research as part of a large cooperative group will not lead to numerous publications for individual clinicians. Nevertheless, commitment to such trials must be acknowledged by funding groups so that appropriate financial support to treat patients in trials is forthcoming. Only in this way will Australians of all ages with cancer have the benefit of the best evidence-based treatment within randomised controlled clinical trials in centres of excellence.

Catherine H Cole FRACP, FRCPA

Attention to known contraindications and intercurrent illness can avoid life-threatening acidosis Metformin, a biguanide derivative, has been used in the treatment of type 2 diabetes for nearly 50 years. It acts as an insulin-sensitising agent, lowering fasting plasma insulin concentrations by inducing greater peripheral uptake of glucose, as well as decreasing hepatic glucose output. In 1998, the United Kingdom Prospective Diabetes Study reported that, in overweight patients with type 2 diabetes, treatment with metformin compared with diet alone resulted in statistically significant absolute risk reductions (ARRs) in all-cause mortality (ARR, 7%), diabetes-related deaths (ARR, 5%), any diabetes-related endpoint (ARR, 10%), and macrovascular disease (myocardial infarction, sudden death, angina, stroke, peripheral vascular disease).1 This was achieved without hypoglycaemia or weight gain. As a result, metformin is now regarded as the oral hypoglycaemic agent of choice in the treatment of overweight people with type 2 diabetes. More recently, the use of metformin has broadened, with evidence for its benefit in other insulin-resistant states. In polycystic ovary syndrome, metformin decreases insulin resistance, restores ovulatory menses, facilitates conception, and reduces the rate of first-trimester spontaneous abortion.2 Metformin also delays progression to type 2 diabetes in people with impaired glucose tolerance.3 It is currently being evaluated in the treatment of gestational diabetes mellitus, and has shown promising results in selected individuals with type 1 diabetes.4 But this increase in the use of metformin is not without risk. The manufacturer’s product information on metformin reminds prescribers that life-threatening lactic acidosis can occur, caused by accumulation of metformin, and that risk factors for this include renal impairment, old age and doses over 2 g per day. The estimated prevalence of life-threatening lactic acidosis is one to five cases per 100 000,5 with mortality in reported cases up to 50%.6 Traditionally, this complication has been thought of as secondary to an accumulation of the drug. Metformin is excreted unchanged in the urine, with the half-life prolonged and renal clearance decreased in proportion to any decrease in creatinine clearance.6 This may occur chronically in chronic renal impairment, or acutely with dehydration, shock, and intravascular administration of iodinated contrast agents, all of which have the potential to alter renal function. Tissue hypoxia also has a significant role, and acute or chronic conditions that may predispose to this condition, such as sepsis, acute myocardial infarction, pulmonary embolism, cardiac failure and chronic liver disease, may act as triggers. Between 1985 and 2001, 48 cases of lactic acidosis with metformin were reported to the Australian Adverse Drug Reactions Advisory Committee (ADRAC). In 15 of these cases, the complication was fatal. In 35 of the 48 cases, known risk factors were identified. Over the past 4 years, the average number of cases reported to ADRAC has been six per annum. In Australia in 2002–2003, about 200 000 patients were prescribed metformin, giving a reported frequency of lactic acidosis of one in 30 000. However the actual rate of occurrence is likely to be higher, given that under-reporting is an inherent problem with voluntary pharmacovigilance programs. At the Princess Alexandra Hospital in Brisbane, since January 2000, we have identified 13 patients with lactic acidosis thought to be related to use of metformin. Of these 13 patients, two died, while three require ongoing dialysis for renal failure; another was left with severe neurological disability requiring nursing-home care. The average age of the affected patients was 67 years (range, 47–79 years), and the baseline serum creatinine concentration (known in 10 patients) ranged from 0.12 mmol/L to 0.48 mmol/L, with a mean of 0.21 mmol/L (reference range, 0.05–0.11 mmol/L in women, and 0.06–0.12 mmol/L in men). Seven of the 13 patients were taking a metformin dose of 3 g per day, three were taking 2 g, while the remaining patients were taking between 500 mg and 1.7 g. How well do we currently comply with recommendations on prescribing metformin? A study at the University of Pittsburgh Medical Center in the United States reported on 263 hospital admissions involving 204 patients who were taking metformin. Patients had at least one absolute contraindication to metformin in 27% (71) of admissions. In 41% (29) of these, treatment with metformin continued despite the contraindication.7 A Scottish study of 1847 patients taking metformin found that 24.5% (452) had a contraindication.8 It follows that metformin must be prescribed appropriately to avoid potential adverse effects, while offering patients the best treatment possible. In well, ambulatory patients, renal function should be monitored regularly. A cut-off serum creatinine concentration above which metformin should be discontinued has been arbitrarily set at 0.15 mmol/L.9 Obviously, this needs to be individualised, and age, muscle mass, and protein turnover need to be considered. This can be achieved using the Cockcroft–Gault equation, which estimates creatinine clearance from age, weight and serum creatinine concentration. For example, with this equation, a 75-year-old woman, weighing 65 kg, with a serum creatinine concentration of 0.11 mmol/L, has an estimated creatinine clearance of 40 mL/min, which is significantly reduced. We propose: setting an absolute cut-off point (a creatinine clearance of 30 mL/min), below which metformin should be discontinued; and using metformin with extreme caution in patients with a creatinine clearance in the range 30–50 mL/min. No clear guidelines exist on reducing the dose of metformin as renal function declines, but reports of lactic acidosis have occurred with doses as low as 500 mg per day. Alternative strategies for managing diabetes in this situation include the use of insulin, thiazolidinediones and sulfonylureas. The second adverse situation to be considered is the previously well patient with a significant intercurrent illness. This includes illnesses with the potential to alter renal function, such as dehydration, shock, and sepsis. Metformin should be ceased completely while the patient is unwell, and recommenced when the illness has resolved, and renal function is shown to be normal. In addition, illnesses that increase the risk of tissue hypoxia and acidosis, such as acute myocardial infarction, pulmonary embolism, and cardiac failure, can trigger lactic acidosis, and the dose of metformin should be significantly reduced (or the drug discontinued altogether) under these circumstances. Patients need to be educated about these risks. Finally, a special situation is the use of iodinated contrast agents. The current recommendation is that metformin be withheld for 24–48 hours before the procedure and be recommenced 48 hours afterwards and only when renal function is shown to be normal.10 Without doubt, metformin remains the drug of choice for most patients with type 2 diabetes. Careful and thoughtful use of this drug has the potential to avoid life-threatening adverse events.

Janelle C Nisbet MB BS · Joanna M Sturtevant BPharm, BSc · Johannes B Prins PhD, FRACP

Radiotherapy should be an integral part of a comprehensive national cancer control plan In June 2002, the Radiation Oncology Inquiry (ROI), chaired by Peter Baume, delivered its report, A vision for radiotherapy.1 The inquiry was, some might say, a cynical attempt by the then Federal Minister for Health and Ageing to defuse the furore created by a series of questions-without-notice by the Federal Opposition. The questions arose from the 2001 National radiation oncology strategic plan of the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists (RANZCR).2 However, the strategic plan disclosed nothing that should have taken the Government by surprise. Over the past two decades, nearly 50 reports have delivered the same messages: that radiotherapy is a vital part of cancer treatment, that radiotherapy services have been chronically under-resourced, that this deficiency has been deteriorating rapidly, and that correction of the lack of resources and manpower is long overdue. In this article we review the progress over the past year, since the release of the ROI report. What, then, are the problems? There is strong evidence that about 50% of all patients with cancer should receive radiotherapy at some stage during their illness.3 Using that benchmark, a survey for the abovementioned strategic plan estimated that each year in Australia about 10 000 patients who might have benefited from radiotherapy did not receive it. The survey also revealed a catalogue of insufficient and antiquated treatment facilities and an inadequate supply of radiation oncologists, radiation therapists and medical physicists — the three professions that are central to radiation oncology. For example, in New South Wales alone, a third of the linear accelerators in public radiotherapy departments were closed because of a lack of radiation therapists, and the effects of closure were reflected in long waiting times for radiotherapy. In a report on 25 000 patients treated between 1999 and 2001,4 the Australian Council on Healthcare Standards found that, over that period, the proportion of patients who waited more than 21 days for treatment had doubled. A recent survey by the RANZCR Faculty of Radiation Oncology confirms that long waiting times persist.5 Delay in receiving radiotherapy results in higher cancer recurrence rates and lower survival rates.6,7 Underlying the problems in service delivery, the ROI noted, Radiation therapy has suffered most seriously from the fragmentation of responsibilities between different organisations and governments. In itself, this is not unusual in the health care industry, but its effect has also been serious, as this fragmentation of responsibilities is to blame for the lack of action in the past 20 years — even though all parties are in general agreement about what problems need to be addressed. (p 14) The ROI made 96 recommendations, of which the five key action items are summarised in Box 1. In response, the Australian Health Ministers’ Advisory Council established a Radiation Oncology Jurisdictional Implementation Group (ROJIG), with representatives of each state and territory government, in an attempt to get all jurisdictions together at the same table. Paradoxically, the professions are not directly represented in ROJIG. The group has met several times during 2003 and established subcommittees to address issues of patient access, workforce, funding and quality. Although these subcommittees have some professional representatives, committee members have to sign stringent confidentiality agreements, resulting in the perception that the professions are not adequately consulted. ROJIG reported to the Health Ministers in November 2003,8 and has already endorsed, accepted and completed 35 of the 96 ROI recommendations. A further 50 recommendations were endorsed. Due in large part to the representations of consumer groups as well as the professions, the need to improve radiotherapy services has become a political priority. At the time of the 2001 federal election, the Australian Government committed $72.7 million to improve regional access to radiotherapy, including the funding of new facilities.9 In 2002, the Victorian Government pledged $78 million to build a new radiotherapy department at the Latrobe Regional Hospital in Gippsland, expand facilities at Geelong and Moorabbin hospitals, and replace old linear accelerators at existing metropolitan facilities. The Australian Government is also contributing $12 million to these projects.10 In 2003, the New South Wales Government budgeted $85.2 million to build new facilities, replace old equipment and improve training in radiation therapy and physics.11 Projects under way to improve radiotherapy services in various states are summarised in Box 2. Because of the long lead times involved, no new facilities have been brought into service since the ROI report was released. Long waiting times persist and are worsening in many centres. In the private sector, which treats more than a third of all patients, patient out-of-pocket costs are escalating, because outdated Medicare Benefits Schedule rebates fall far short of the cost of delivering quality radiotherapy. Although increased government investment in capital equipment is now taking place in the public sector, operational funding constraints continue to limit the ability of departments to meet service requirements. To us the solutions are clear. Workforce planning is required both in the short and long term. The recent initiatives, while laudable, were a stopgap response rather than a step towards building a rational framework for expanding the workforce. Working the staff harder and longer is not cost-effective12 and leads to higher staff resignation rates.13 Radiotherapy needs a sustainable funding model that supports the real cost of quality radiotherapy and a strong, profession-led quality improvement program to ensure that quality is achieved. The outstanding problem for radiotherapy and, indeed, all cancer services in Australia is that there is no nationally coordinated cancer care policy. Australia needs to develop and implement a comprehensive cancer control plan that incorporates radiotherapy in the overall context of cancer management. Fortunately, there are signs that things may be changing. The Australian Government has embarked on developing a National Service Improvement Framework for cancer, driven by the National Cancer Control Initiative’s report, Optimising cancer care in Australia.14 Victoria has just completed a framework for cancer services,15 and New South Wales has published a framework16 and established a Cancer Institute with the task of developing a cancer control plan by June 2004. Western Australia and Queensland have also started to develop cancer plans. Cancer is a complex disease that requires a diverse range of specialist and generalist treatment services. There is no single government agency responsible or accountable for the outcomes of cancer management in Australia. Without an accountable nation-wide approach, the ROI report will become just another in the series of mirages that have promised, but not delivered, the access to quality care that Australians with cancer require and should expect. 1: Major recommendations of the Radiation Oncology Inquiry1 Establish an independent national body to oversee radiotherapy, reporting to the Ministers for Health, to address the fragmentation of healthcare delivery. The national body would be responsible for quality and productivity issues, such as facility accreditation, clinical protocols, benchmarking and coordinating data collection. Improve the availability of radiotherapy in rural and regional Australia. Ensure adequate workforce, especially in radiation therapy and medical physics. Ensure appropriate quality of services by accrediting facilities and having mandatory continuing professional development. Resolve the disputes over who should be paying for radiotherapy, and tensions between public and private providers, by pooling state, territory and Commonwealth funding. 2: Projects under way, in various government jurisdictions, to improve radiotherapy services in Australia Federal Increasing the number of undergraduate radiation therapy students by 50% Helping establish a national uniform training program in medical physics Introducing a postgraduate radiation therapy course at Monash University (VIC) Providing partial funding to replace outdated linear accelerators in all jurisdictions Funding a new radiotherapy centre in Toowoomba (QLD) Funding a skills mix and work analysis project New South Wales Employing more radiotherapy tutors Employing physics registrars for the first time in Australia Building new radiotherapy departments at hospitals in Port Macquarie and Coffs Harbour Victoria Building a new radiotherapy department at Latrobe Regional Hospital Providing a new linear accelerator at Moorabbin Hospital Replacing outdated linear accelerators at all public facilities Establishing a Ministerial Taskforce for Cancer South Australia Replacing three linear accelerators Western Australia Providing two new linear accelerators for hospitals in Perth Appointing a Chief Cancer Officer Northern Territory Conducting a feasibility study of local radiotherapy services

Michael B Barton MB BS, FRANZCR · Lester J Peters AM, MD, FRANZCR · Lizbeth M Kenny MB BS, FRANZCR

A missed opportunity for improvements to medical practice Medical practitioners in New Zealand are to be regulated by a new piece of legislation — the Health Practitioners Competence Assurance (HPCA) Act. The stated purpose of the Act — “to protect the health and safety of members of the public by providing for mechanisms to ensure that health practitioners are competent and fit to practise their professions” — while laudable, is ambitious and conceptually flawed. The resulting legislation is complicated and undermines professional functioning. Its effect may be exactly the opposite of its intention . . . The initial aims of the Bill, as proposed by the Minister of Health, were widely supported. It was to be an omnibus piece of legislation designed to bring 16 health practitioner groups (including dentists, nurses, chiropractors, midwives, pharmacists, psychologists and other allied health practitioners), regulated by 11 statutes, into line with the registration, competency and discipline provisions of the NZ Medical Practitioners Act 1995. The Medical Practitioners Act was modern, effective and cognisant of societal changes (such as the need for openness by having disciplinary hearings in public). There had been wide consultation and debate associated with its development, and it had the support of major medical professional groups, both in the development phase and in practice. During a long gestation period, however, the initial concept of the HPCA Bill became lost under the onslaught of multiple competing agendas. The resulting legislation is complicated and undermines professional functioning. Its effect may be exactly the opposite of its intention — to make the provision of health services safer and of higher quality. From initial tentative support, the leading medical professional organisation in New Zealand — the New Zealand Medical Association (NZMA) — along with the union representing senior hospital doctors (the Association of Salaried Medical Specialists), and the major medical colleges of surgery and general practice, ended up opposing the legislation in favour of retaining regulation under the Medical Practitioners Act. We were unsuccessful. So how did these changes come about? And how did the New Zealand Government come to pass a law that was actively opposed by organisations representing many of the people who would be bound by it? First of all, there was no doubting that much of the legislation covering other health practitioners was outdated and in need of modernising (eg, laws regulating occupational therapists and physiotherapists dated back to 1949). The advocacy of many of these other health practitioner groups, while publicly supportive of the concerns of the medical profession, was in the end more muted because of issues with their existing outdated legislation. Secondly, Ministry of Health consultation on the Bill was primarily with the statutory bodies that would be administering the new legislation (such as the Medical Council of New Zealand). These bodies do not and cannot represent practitioners, as their statutory role is to regulate them. Professional medical organisations received little consultation. Such consultation that did occur was late and completely inadequate, and despite strong and detailed responses, concerns raised were largely dismissed. Thirdly, there is a political perception that more political and external controls on the professions are what society wants. This runs counter to repeated polls that place professions such as medicine and nursing high in the public trust, with politicians scoring poorly in this regard. It also ignores the growing body of international opinion that competence, quality and safety are better assured through models structured on professionalism rather than state control.1 Consequently, as the legislation developed, it moved substantially away from the concepts and clarity of processes of the Medical Practitioners Act on which it was supposed to be based. The NZMA believes the new Act is a missed opportunity for improvements to medical practice and offers no assurance of further benefits to patients. It will increase political influence and bureaucratic involvement in the practice of medicine, with a consequent decrease in professional self-regulation, which has been at the core of the development of safe healthcare for New Zealanders.2 As Onora O’Neill, Cambridge Professor of Philosophy, as well as teacher, bioethicist and politician, said in her 2002 Reith lectures:3 Plants don’t flourish when we pull them up too often to check how their roots are growing: political institutional and professional life too may not go well if we constantly uproot them to demonstrate that everything is transparent and trustworthy. Perhaps the culture of accountability that we are relentlessly building for ourselves actually damages trust rather than supporting it. The Act, as passed (among other things): provides for additional Ministerial powers; introduces scopes of practice for all health practitioners; introduces restricted activities; and mandates regulatory authorities to set standards of ethical conduct. Along with cumbersome bureaucratic requirements, the HPCA Act significantly increases political control over doctors. The Minister of Health now has powers to resolve disputes over scopes of practice, to designate restricted activities, and to appoint all the members of regulatory authorities (eg, the Medical Council, which currently has four members elected by the profession). The Minister may also allow new health practitioner groups to become regulated under the Act. The introduction of legislation-based scopes of practice is an unproven concept and has the potential to bring about substantial change to the practice of medicine, particularly if scopes of practice are narrow and, as the NZMA fears, become highly codified and prescriptive. Practitioners will be limited in the activities they can practise by the details of their scope of practice, irrespective of possible wider competencies, and disciplined if they step outside that scope. The Minister of Health now has powers to resolve disputes between authorities over scopes of practice, which should be entirely a matter for the professions and not subject to bureaucratic influence or political decisions. Consequent changes in other statutes, the decisions of future authorities appointed by the Minister of Health, determinations by case law, and inclusion in employment contracts, with time, are likely to make scopes of practice more restrictive and task oriented. Restricted activities, which may be undertaken only by specified practitioners or disciplines, are another new and untested legislative concept, with uncertain outcomes. As the process is defined in the Act, the declaration of restricted activities may potentially be responsive less to professional and patient safety realities than to political pragmatism. Another major concern is the mandating of statutory regulatory authorities to set standards of ethical conduct. Effectively, this could mean people appointed by the government setting ethical standards for the profession. For the safety of patients, the independence of medical ethics must be protected from political agendas. William Sullivan, a prominent North American sociologist said: Neither economic incentives nor technology nor administrative control has proved an effective surrogate for the commitment to integrity evoked in the ideal of professionalism.4 Health legislation can actively promote professionalism — or it can discourage it. The NZMA believes that the HPCA Act is a backward step for the promotion of professionalism in medicine. We are establishing a monitoring process to assess the effects of the Act on both doctors and their patients so that we will be prepared for the planned review in 2006.2

Tricia A Briscoe MB ChB, BSc, DipObst

Improving safety is important, but in many regions antivenoms are not available Although snakebite has been a subject of medical interest since antiquity, and despite it continuing to affect millions of people annually,1,2 it remains one of the neglected health problems of the tropics.1-3 Today, almost lost amidst the preoccupation with shortages of vaccines and antiretroviral medication in the developing world, there is a crisis in antivenom availability in the very same nations.3 In response, the World Health Organization recently held its first antivenom workshop in more than 20 years, to discuss the global supply and quality of antivenoms.4 However, perhaps more importantly, a growing community of physicians from the regions with the greatest snakebite burden have become more active in seeking solutions to at least some part of this ancient problem. The study by Gawarammana and colleagues in Sri Lanka (page 20) is one example of such scholarship.5 It is a welcome addition to the relatively scant clinical trial literature examining the management of snakebite. In a well conducted but underpowered study, the authors document a reduction in mild-to-moderate acute reactions to antivenom with an antihistamine bolus in conjunction with a hydrocortisone infusion. However, in the clinically important endpoints of moderate and severe reactions, there was insufficient power to confirm a trend toward fewer reactions in the hydrocortisone-containing regimens. This study is in contrast to a previous study from Brazil that failed to demonstrate any difference in early antivenom reactions with prophylactic promethazine alone.6 Most notable in this and an earlier Sri Lankan study,7 which assessed subcutaneous adrenaline as prophylaxis against acute antivenom reactions, was the extremely high rate of such reactions — in this study, almost half the patients had moderate or severe reactions sufficient to require adrenaline. This differs considerably from the rates in Australia (reported as 10% in the absence of premedication8 and 4.6% with premedication9). Snake antivenom is derived from antibodies of immunised animals; the rates of reactions appear to vary with the species of antibody origin, the extent of pepsin digestion, the presence of molecular aggregates and the total protein content of the product.4,10 It has been presumed that most acute reactions relate to the extent of complement activation from Fc receptor binding,10,11 with improvements in quality having largely resulted from enhancements in antivenom processing.4 However, the recent WHO workshop called for a re-examination of old assumptions concerning such reactions and, consequently, what constitutes “best practice” for antivenom manufacture and administration.4 Although Sutherland attributed the low reaction rate to Australian snake antivenoms to a series of refinements in the recommendations from the former Commonwealth Serum Laboratories concerning antivenom administration, including the practice of prophylactic use of adrenaline and hydrocortisone,9 current national reaction rates and associated clinical practice remain unclear.12 It is intended that recently introduced refinements to the Australian coding standards for ICD-10-AM (third edition)13 will assist in closing this gap in the national toxinology evidence base. However, because of the inherent delays in the collation of national statistics, and as current methods are far from complete,12 it would seem appropriate to mandate reporting of adverse antivenom reactions to facilitate appropriate follow-up. Such a system is in place in Brazil.14 Meanwhile, there is a dichotomy in current premedication recommendations for reducing acute reactions to snake antivenoms in Australia. In Australia’s toxinology textbook,15 Sutherland and Tibballs considered the evidence available up to 2001 and concluded that “premedication with subcutaneous adrenaline is recommended (0.25 mg for an adult, 0.005 mg/kg for a child) before antivenom therapy”. By contrast, a recent review by Currie concluded: “with the very low rate of severe reactions to antivenom seen in Australia . . . and the ability of emergency medicine physicians to adequately manage reactions that may occur, a policy of withholding premedication but always having adrenaline drawn up and ready is now recommended by many authorities and is policy in the Northern Territory”.16 In the middle is Australia’s antivenom manufacturer, CSL Limited: “Some authorities have advocated premedication with subcutaneous adrenaline and intravenous antihistamine, particularly in those patients who are known to be at risk, but such use is controversial”.17 Readers should consult the references for further details of the respective arguments and the history and evolution of the manufacturer’s recommendations.8,9 Although it is likely that well staffed major hospitals can, if it is recognised early, readily and rapidly manage antivenom reactions, such events can be severe, progressive and are not necessarily remediable.18 Therefore, it is the small rural centres, with more limited staffing and facilities, that may benefit most from the apparent efficacy of adrenaline premedication.7,9,15 If premedication is to be given, currently the best evidence is that it should be subcutaneous adrenaline.7 However, it is notable that Sutherland himself was agreeable to some “alternative but equally effective replacement for adrenaline”.9 And so we return to the search in Sri Lanka for such a replacement (or adjunct). The apparent benefit from the combination of an H1 antagonist and hydrocortisone described here suggests that a combination of H1 and H2 blockers may bring additional benefit, as has been proven for the treatment of acute allergic syndromes.19 However, the applicability of this study, in which a poor-quality antivenom resulted in extreme reaction rates, to the situation in Australia (where low reaction rates are reported) is uncertain. Interestingly, the antivenom used (the Haffine polyvalent snake antivenom) appears to be an equine Fab2 product,20 the same as that used in Australia.17 The Indian antivenom that was used in Sri Lanka, however, is a lyophilised preparation5, whereas the Australian antivenom is a liquid product. Therefore, aside from the premedication issue, there are clearly opportunities to improve the reaction rate by improved processing of this Indian product.4 Unfortunately, these debates are irrelevant for most people affected by snakebite, predominantly in the rural tropics. For example, in Papua New Guinea the high cost of Australian antivenoms puts adequate supplies beyond the reach of the health budget.2 For people in countries where the available antivenoms are of poorer quality, studies such as these, even if they only demonstrate reductions in reaction rates from 80% to 50%, are applauded; more are sorely needed. But for most countries where antivenoms are unavailable or unaffordable, there is little to do but measure smoke from the burning house while praying for rain.

Allen C Cheng MB BS, FRACP, GradDipClinEpid · Ken D Winkel BMedSci, PhD, FACTM

compassion n. Pity inclining one to help or be merciful. (The Concise Oxford Dictionary). Doctors resigning and demoralised by forces ranging from heavy workloads to indemnity woes . . . A society conditioned to instant gratification, soaring expectations of modern medicine and technology, often fuelled by media hype (Ooi, page 639; Daniels, page 637) and increasingly cynical about doctors’ true priorities . . . A lucky country that’s materially better off than ever before . . . The latter observation comes from one of our foremost playwrights David Williamson (page 594), yet, as sociologist Hugh Mackay comments, we are “. . . neglecting the most vulnerable people in our society — the aged, the frail, the sick, the disadvantaged, the bewildered”.1 Meanwhile, internationally, the rift between rich and poor nations grows, and the lack of compassion of nations who “have” toward those who “have not” is seen as one of the antecedents to current international insecurity. Is compassion in its death throes two millennia after one man in Jerusalem advocated loving others as oneself, and another in Mecca described “a person’s true wealth [as] the good he or she does in the world”? A flock of white coats hovers above a young man in a hospital bed. The consultant tells the patient that he needs an urgent back operation and the flock moves on. It disperses after the ward round, and its most junior member returns to write up the young man’s medication chart. She is about to dash to her next task when the patient calls out, “Will the operation make me walk again?” The resident hesitates. “That’s unlikely, but it will stop things getting worse.” The patient nods and turns his head away. The resident hesitates again then leaves as her beeper goes off. Fifteen years later, I still wish I’d stayed to ask this man if he wanted to say or ask more. It would have cost me little, despite feeling ill-equipped to handle his pain and the eternal call of ward duties. It might have made no difference to him, but surely we are each responsible for becoming the change we wish to see. M Chew, Deputy Editor A qualified “no” is the answer to this question from contributors to the 2003 Christmas issue of the Journal. Perspectives by emergency physicians O’Reilly et al (page 649) and Fulde (page 651), who make space in their hearts and lives for homeless people visiting their emergency departments, and by Sutton (page 591) and Taylor (page 617), who have worked in developing nations, indicate that many doctors are still motivated by compassion. Furthermore, a recent forum on globalisation, aid and foreign policies, and their impact on health brought together diverse Australian and international experts (Zwi and Reid, page 573) and showed that many of us want to engage in compassionate “big picture” action. Yet all acknowledge the difficulties of practising compassion in an environment that does not seem conducive to it. Bleeding hearts?Certainly not. There are sound, even pragmatic, reasons for healthcare workers to act compassionately. Firstly, it benefits patients. While the benefits of a compassionate approach may be difficult to measure, a systematic review suggests that patients have less pain and recover faster if their doctors show empathy and reassurance.2 Furthermore, homeless patients presenting to a Canadian emergency department, and randomly allocated to receive “compassionate” care (a chat and a snack with a volunteer) re-presented less frequently than those receiving standard care.3 Secondly, doctors are well placed to join informed debate about sociopolitical issues that may impact on health. This is also crucial if our profession is to regain the trust of a sceptical community. The Royal Australasian College of Physicians (RACP) gives its rationale for taking physicians’ views on health and social policy to Canberra: “What doctors must do is show the community that medicine and consumers have overwhelmingly common imperatives and that doctors stand with the community before self interest. . . . lack of trust [that doctors act from concern for their patients] . . . most seriously threatens medicine’s continuance as a profession bound up in ethical values rather than commercial ones”.4 Thirdly, a modicum of compassion would not go astray in medical workforce planning. Part of the remedy for our workforce crises lies in regarding it as “more than a numbers game and . . . [with more] explicit attention to working conditions, incentives and rewards”.5 While compassion might begin at home, a global perspective is also vital. At the inescapable altar of evidence, even certain humanitarian medical interventions (such as vaccination, providing food and safe water) have gained sanction for efficacy, although alternative types of evidence and outcome measures should also be pursued.6 Smith’s editorial in this issue (page 571) argues that the impact of climate change on the health and economies of all in our global village offers rich countries ample incentive to act now for a win–win solution. Ultimately, however, to provide or enable healthcare of any ilk is a moral endeavour7 — we do so because we value human life. How do we regain compassion?Paradoxically, we believe that self-care (as opposed to self-centredness) is one of the keys. Reciprocity (or “getting something back”) is a motivation for altruism,5 and contributors to this issue of the Journal highlight their need for personal and external supports to prevent distress and the erosion of compassion (Smart, page 587; Edwards, page 647). Like it or not, role models are integral to medical training, and medical students and young doctors value attributes such as compassion in their role models, as eminent neurologist Lance attests (page 620). Yet good role models are not plentiful in our hospitals,8 and all of us need both to be and to emulate such models (see Box). Indeed, the World Health Organization has outlined the social accountability of medical schools, which have an obligation to direct their education, research and services toward the community’s priority health concerns.9 Medical schools must be responsive to, and proactive about, societal needs. Our initial and ongoing education should also seek to actively instil a recognition of the social determinants of health, and the place of humane values and ethics.10 The imposition of mechanistic guidelines, audits and regulations on clinical practice, with increasing commercialisation, have contributed not only to de-professionalism, but also to compassion fatigue. Our practice and research should embrace and refine such outcome measures as quality of life and the doctor–patient relationship. Compassionate action may also mean becoming advocates and agents of change for a variety of public health issues, such as more equitable healthcare access. We can do so as individuals by enthusing colleagues, engaging with others in the community and petitioning parliamentarians. We can do so as members of professional bodies (eg, the Australian Medical Association stance on Indigenous health [www.ama.com.au/web.nsf/doc/WEEN-5N5UHZ] and the joint statement by the RACP and the Royal Australian and New Zealand College of Psychiatrists on the health of children in immigration detention centres [www.racp.edu.au/hpu/policy/asylumseekers/detention.htm]). We can do so by supporting national and international coalitions of health, development, social justice and human rights, rather than coalitions of conflict or commercial interests. Examples of the former include Healthy Skepticism (Mansfield, page 644), the Medical Association for Prevention of War (www.mapw.org.au/about.html), and Médecins Sans Frontières. Surely medical involvement in some of these fields represents the ultimate preventive healthcare! . . . and what about a compassionate society?Hugh Mackay also observed in his commentary, “Who could have predicted that, at the turn of the century, Australia would become a less tolerant, less hospitable and less compassionate society?”1 This issue of the Journal celebrates the survival of compassion in medicine, in the face of bewildering societal changes. But we need much more. We need our policymakers to develop evidence-based, targeted strategies against health inequities. We need continued leadership and advocacy from our professional bodies. Above all, we need political leaders who champion compassion and unity rather than fear and division. If you want others to be happy, practise compassion. If you want to be happy, practise compassion — The Dalai Lama.

Mabel Chew FRACGP, FAChPM · Ruth M Armstrong BMed · Martin B Van Der Weyden MD, FRACP, FRCPA

Rich countries must lead the fight against climate change affecting rich and poor in our global village It is nearly a tautology to say that poor people and poor nations generally act with short time horizons or, in the jargon of economics, high discount rates. Anecdote and analysis confirm it. Those who realistically fear potentially severe consequences tomorrow are less concerned about next year. At the family level, these attitudes can be understood as the consequence of natural selection acting on the propagation of genes. High discount rates are necessary to ensure one’s genes survive under short-term stress; when the ground is treacherous and the tiger is following, raising one’s eyes to the horizon is risky to survival, let alone procreation. Although even poor societies and nations generally act with longer time perspectives than their individual members, they too must acknowledge the demands of short-term survival.1 However, many human reactions honed through natural selection no longer serve us well. We crave dietary fat for the nutritional security it once brought, but in modern excess it kills rather than saves us. Equally, the scale of our impact on the environment now has effects on time scales much longer than those of typical human time horizons. The archetypal example is perhaps global pollution leading to global climate change. We are now well into a planetary experiment on the effect of injecting a bolus of warming pollutants, three to four times natural levels, during an instant of geological time. Nothing much happens at first, but analysts say that much more is set to happen unless we mend our ways soon.2 Still, it may be decades before the really bad things happen. Should we care? How much? And should how much we care depend on how poor we are? This issue is illustrated starkly by a graph developed from calculations by Hughes at the University of Edinburgh3 (Box). It shows the ratio of the cost of health and economic damage from local energy-derived air pollution (household indoor pollution from use of poor quality fuels and urban outdoor air pollution) to the cost of damage from climate change.4 A standard low discount rate is applied (3% per year) to convert future costs into the equivalent cost today. The graph shows that, in poor countries, short-term local pollution typically causes three to four times more health and economic damage than climate change. This occurs even though poor countries are expected to experience much more health damage from climate change than rich countries. In contrast, in rich countries, long-term damage caused by climate change is greater, even after discounting, because short-term pollution has been greatly controlled. Many in the climate-change debate argue that, because of the huge stakes involved, developed countries should use lower-than-standard discount rates and act today to reduce the long-term damage. This could even be at the cost of spending less on today’s problems. After all, developed countries can afford longer time horizons and produce most of the climate-changing emissions through their use of fossil fuels. However, it is difficult to put this argument to poor countries, which have many other pressing problems and have benefited little from the burning of fossil fuels that has produced most climate-changing emissions to date.5 However, the graph also reveals potential solutions. It shows the attractiveness of rich countries investing in poor countries to simultaneously reduce both local and global pollution. These “win–win” activities could benefit both countries because of their different discount rates and local impacts. An example is investing in clean household fuels that simultaneously halve the local health impact of air pollution and reduce climate-changing emissions.6 Recognising these “win–win” opportunities helps us set current priorities.7 Unfortunately, the climate-change debate no longer encompasses the option of total prevention. It is nearly certain that, no matter what we do, we are already committed to significant change and, indeed, are already experiencing the first stages. We must start planning how to live with this change. The principal health impacts are expected to include an increase in environmentally related infectious and vector-borne diseases in poor countries.8 However, climate change enhances rather than creates these diseases,9 offering another means of prioritising competing public-health needs. For instance, if climate change will increase malaria, we would benefit from spending more now on reducing the baseline malaria rate before serious climate change begins. This is a practical way to consider the long term, while addressing today’s serious problems.10 Perhaps the most important long-term benefit of the climate-change debate is that it illustrates, more than any other issue, that we live in a global village. Although one can argue, on humanitarian and other grounds, that an easily preventable child death in India impoverishes everyone, everywhere, such arguments do not go far in most policy forums. However, it is incontrovertible that greenhouse gases released anywhere affect us all, everywhere. In addition, no matter how much greenhouse gas we ourselves release, we are all subject to the same global climate and its changes. Thus, we are hostage to each other and will have to find ways to make the necessary decisions together to protect us all, rich and poor. Health and economic damage to nations from energy use * Ratio of cost of damage to nations from local energy-derived air pollution over cost of damage to nations from global climate change.3 † Poor = South Asia and Sub-Saharan Africa. ‡ Middle-income = East Asia, Middle East and Latin America; § Rich = nations belonging to the OECD (Organisation for Economic Co-operation and Development), eastern Europe/former USSR.

Kirk R Smith

Most of the solutions lie beyond the emergency department Hospitals represent essential infrastructure. Engineers who run an essential community resource such as the water supply system at 100% of capacity might expect to lose their jobs the first time consumers had to queue to use a tap. In contrast, some hospital funding models include activity targets that reward administrators who run at 100% of capacity — a level that guarantees queuing in the emergency department for coronary care beds and other critical inpatient services. The community accepts the use of price and denial (eg, restrictions of hours or allowed uses) as a rationing mechanism for the water supply, but not for hospital beds — queuing is the only rationing method currently accepted in the hospital system. Rationing is an essential feature in modern medicine,1 and queuing has long been used to ration elective services. But queuing is fundamentally an inefficient means of rationing care for time-critical illness. Access block — the inability of patients in the emergency department (ED) to access hospital beds — is the major issue currently facing emergency medicine in Australasia2 and, indeed, the whole Western world. Given a fixed physical resource and a relatively fixed labour force, increased average total ED time,3 also called ED length of stay (EDLOS), will decrease the resources available for providing care to acutely ill patients. Access block decreases access to emergency care (eg, measured as waiting time),4 and the resultant overcrowding is associated with adverse outcomes for ED patients.5,6 It is certainly in the interests of ED staff and patients to decrease EDLOS. . . . restricting the access and quality of initial care because of inability to provide timely later care is ethically dubious . . . The article by Liew et al in this issue of the Journal 7 adds to the growing evidence for an association between EDLOS and outcomes beyond the ED.8 The authors used a multivariate approach to study the relationship between EDLOS, other confounding factors, and subsequent inpatient length of stay in three Melbourne metropolitan hospitals. They found a positive association between EDLOS and inpatient length of stay after adjusting for casemix, time of presentation, and patient age. Whether this relationship is causal is a subject for further study. The Australasian College for Emergency Medicine has committed resources to such research through the Emergency Medicine Research Foundation. From an administrative perspective, the underlying mechanism is less important than the result. Increased inpatient length of stay after correction for casemix is financially undesirable: it is in the interest of hospital management to reduce both EDLOS and inpatient length of stay. Emergency departments are specialist multidisciplinary units with expertise in managing acutely unwell patients for the first few hours in hospital. Neither the facilities (generally poor privacy, small trolleys, 24-hour lighting) nor the staff are appropriate for providing longer term inpatient care. Very few patients who require an inpatient bed benefit from staying in the ED longer than 4 hours, and no ED benefits by caring for patients beyond this time. If the 30% or so of patients who are admitted spend twice as long in the ED, this represents a 30% increase in workload for ED staff with no change in conventional measures of activity (presentations, admission rate). Steadily worsening delays in accessing inpatient beds have been documented in many EDs over the past decade,9 suggesting there might be an underlying incentive such as increased efficiency in a different part of the health system. This research demonstrates an association with increased opportunity costs rather than any benefits. There is a clear need to reduce EDLOS for patients, but most of the solutions lie beyond the ED.10 Changes within the ED can mitigate the effects of increased workload, but, because of access block, they cannot shorten EDLOS. Much can be done to improve our hospital systems, including use of protocols for common conditions, transparent bed-management processes, and a focus on efficient use of the available beds, particularly through admission and discharge planning. Clinicians must be willing to trial different methods of management, such as treatment in the home and accelerated discharge, and to evaluate the outcomes rigorously.10 The study by Liew et al identifies the elderly as a group with the greatest potential for effective intervention. There have been significant achievements and more can be expected, but process change will not completely address the underlying mismatch between demand for inpatient beds and resources available. The primary problem is the lack of acutely available beds.11,12 The scarcer those empty beds become, the more difficult they are to access. Queuing for care at the entrance to ED is managed by triage, which stratifies patients by urgency — the most time-critical cases have the shortest queues. Queuing for a bed at the exit of ED is managed by bed allocation, which tends to stratify patients by their nursing load — the least intensive cases generally have the shortest queues. Elementary queuing theory predicts the accumulation of patients, but the daily variation in emergency medical activity has for too long allowed both emergency staff and others to assume the ED has “rubber walls” and that the marginal cost of the ED absorbing additional care to inpatients is low. The study by Liew et al7 and other studies on the effects of overcrowding5,6,13 now provide clear evidence that this is not the case. Emergency departments are expert at triage to achieve “the greatest good for the greatest number”, but, when prioritising, even emergency physicians are reluctant to consider denying care to patients with whom they have begun a therapeutic relationship. EDs are faced with the ridiculous situation of providing many hours of care to patients whose conditions were urgent on arrival but stable after treatment, while potentially unstable patients of similar initial urgency languish in the waiting room or in an ambulance for want of an ED trolley and nurse. It is time that hospitals addressed this inequity: restricting the access and quality of initial care because of inability to provide timely later care is ethically dubious14 and is likely to lead to adverse outcomes and medicolegal exposure. These weighty issues cannot be addressed by EDs alone. Demand for emergency services has increased9 while bed numbers have decreased,15 and demographic projections indicate that these trends are unlikely to reverse. Unless practices change, our EDs will cease to function in their designated role, and will instead inappropriately spend most of their resources providing care to patients who should be in inpatient beds. Hospitals, communities, and government must debate and decide the allocation of resources to EDs and wards and agree on a sensible approach to providing appropriate care in both environments. The debate is no longer about the level of resources our EDs deserve, but rather about how to ensure that ED resources are directed to those who need them — the patients in the waiting room.

Drew B Richardson MB BS(Hons), FACEM

Even for a simple genetic condition, screening the general population is not straightforward Hereditary haemochromatosis has been touted as the “poster child” for public health genetics. Most cases of haemochromatosis are due to homozygosity for a single mutation leading to iron overload. It is considered to be an ideal candidate for population genetic screening because genetic susceptibility is common, testing is inexpensive, and iron studies can detect early stages of disease. Most importantly, venesection is a simple and effective way to both prevent and manage the potential sequelae of iron overload, which include severe fatigue, arthritis, impotence, cirrhosis, diabetes, and cardiomyopathy. However, even though most cases of haemochromatosis are due to a single mutation, it is still unclear how many people homozygous for this mutation will develop serious disease. Consequently, there is uncertainty as to the benefit of screening. Following characterisation of the HFE gene in 1996,1 genetic testing for hereditary haemochromatosis has become available. In Australia, Medicare claims for testing for genetic susceptibility to hereditary haemochromatosis have risen from 14 414 in 1999 to almost 30 000 in 2002.2 It is predicted that about one in 200 Australians are homozygous for the C282Y mutation, which accounts for about 90% of cases of hereditary haemochromatosis identified to date in high-risk families.3 A person carrying two copies of the C282Y mutation is at risk of developing iron overload and subsequent disease. However, like all diseases, haemochromatosis is defined by pathology, and a person does not have hereditary haemochromatosis unless body iron stores, as reflected by abnormal iron indices (serum ferritin and fasting transferrin saturation), are elevated. There is a wide spectrum of potential consequences of iron overload, and while about 60% of C282Y homozygotes will eventually develop iron overload,3,4 it is not known what proportion will progress to serious clinical disease. The answer is complicated by the long latency for development of disease (probably many years) and the possible modifying effects of sex, diet, environment and other genes. Recent population-based studies have shed light on disease expression in people genetically susceptible to hereditary haemochromatosis. In the Busselton study, 16 homozygotes were identified from a sample of 3011 adults (1 in 188) with a median age of 52.7 years (range, 20–79 years).3 Twelve were not previously aware of their genetic risk, and of these, seven had elevated serum ferritin levels and the four with normal iron studies were premenopausal women. Half of the original 16 had clinical features consistent with hereditary haemochromatosis, although the prevalence of symptoms in non-homozygotes of the same age was not presented for comparison.3 A recent study in California identified 152 homozygotes from a sample of 41 038 individuals (1 in 270) with mean age 57 years (SD, 14).4 Among these homozygotes, 76% of men and 54% of women had raised serum ferritin levels. Homozygotes were twice as likely as controls to report liver problems (8.1% versus 4.1%), but there was no evidence for a higher prevalence in homozygotes for any other symptom associated with hereditary haemochromatosis. The authors estimated only a small percentage of homozygotes would develop frank clinical haemochromatosis.4 However, exclusion of people with pre-existing disease may have biased this estimate downwards.5 Although it is possible that disease expression is greater in Australia, owing to our relatively higher meat and alcohol intake,6 the results of the Californian study indicate that further population-based studies are necessary. The key factors in considering population screening of asymptomatic people are whether it will do more benefit than harm and whether it is cost-effective.7 International expert opinion has been cautious about population genetic screening for hereditary haemochromatosis,8,9 given the limited population data and possible adverse effects of screening, such as the potential for insurance discrimination in the United States. In Australia, health insurance is population-rated and discrimination is illegal. For life insurance, an agreement has been reached with the insurance industry that considerably reduces the risk of discrimination.10 Because cost–benefit analyses depend upon the number of people for whom disease can be prevented, enthusiasm for population screening for hereditary haemochromatosis has been dampened by the Californian findings. Even if these results are confirmed in whole or in part, it could be argued that, in Australia, there is minimal “cost” to genetically susceptible individuals in becoming blood donors, which virtually eliminates their risk of disease.11 However, until it can be demonstrated that benefits or savings outweigh any potential harm or costs, population genetic screening programs — paid for by the public purse — are on the backburner. The current standard of care remains cascade screening (ie, testing the HFE mutation status of first-degree relatives of individuals who have developed iron-related disease), because it is reasonable to assume that familial homozygous individuals are more likely to express disease.12 Genetic testing for HFE mutations is also appropriate as a follow-up in people with abnormal iron studies (ie, elevated serum transferrin saturation and serum ferritin). Iron studies should be considered for patients with unexplained symptoms or conditions consistent with hereditary haemochromatosis, such as severe fatigue, liver disease and diabetes, although the predictive value of such testing is likely to be low. C282Y homozygotes found to have high serum ferritin levels, with or without increased transferrin saturation, should have regular therapeutic venesection. Those with normal iron studies should be monitored expectantly, but do not require venesection unless they develop persistent abnormalities in serum ferritin levels. The Human Genome Project has made a great step forward in mapping tens of thousands of genes, but it may be decades before we can predict which individuals are most likely to develop serious disease. Even for a condition as apparently straightforward as hereditary haemochromatosis, the path to general population genetic screening has proven more complicated than initially expected.

Dorota M Gertig MB BS, DSc, FAFPHM · John L Hopper MSc, PhD · Katrina J Allen MB BS, FRACP, PhD

Failure to provide public funding for clinical trials may come at a high cost to the community in the long term Large-scale morbidity–mortality trials have become fundamental to the evaluation of most new drugs intended for long-term administration. Such trials have the unique ability to determine the net balance of positive and negative outcomes from the long-term use of drugs and allow consumers to feel confident that long-term therapy is safe in otherwise healthy individuals. A randomised controlled trial is the only study design that can provide reliable and unbiased estimates of the moderate treatment effects of interventions for most chronic diseases. Smaller studies measure surrogate outcomes or are underpowered to answer important clinical questions. If underpowered, they may be unethical and also squander the community altruism that underpins trial participation. Large-scale trials are major logistical exercises. They involve several thousand people allocated randomly to different treatment groups and monitored for 4–6 years. Depending on the recruitment strategy and the mode of follow-up, the cost is typically $20–$50 million.1 Past attempts to interest Australian research organisations in funding such studies have floundered because of this cost. In spite of this, there are a number of groups in Australia with an excellent track record in initiating and running high-quality large-scale clinical trials (many of the “public good” variety), indicating local capacity to conduct this type of research. However, these trials have largely been the province of the pharmaceutical industry. Although industry-funded studies have yielded firm scientific foundations in many areas of clinical practice, they are almost all directed towards testing superiority or equivalence of specific products, or other aspects such as greater convenience of new agents or technologies over the existing ones. Indeed, it is naïve to believe that the interests of industry will align with broader societal interests in securing effective and affordable care.2 The failure of non-industry concerns, including governments, to fund large-scale clinical trials leaves some conspicuous gaps in evidence where the consequences may be forgone savings for the public purse. In other cases, the result may be prolonged community exposure to older agents whose long-term risks have not been adequately assessed. Some recent examples highlight the importance of this problem. Antihypertensive drugs make up a large component of the Australian pharmaceutical budget — $516 million for the Pharmaceutical Benefits Scheme (PBS) for the newer agents in the financial year 2002–03 alone.3 For many years, there has been a trend towards these newer, more expensive agents replacing older, cheaper drugs for first-line management of mild hypertension.4 The justification was provided by small trials involving surrogate endpoints, such as effects on blood pressure control, vascular changes, and other risk factors. However, clinical trials with surrogate endpoints do not provide an appropriate basis to underpin long-term drug therapy: they can not provide reassurance of the drug’s long-term safety or determine the balance of desirable and undesirable effects of new agents. When the necessary studies of antihypertensive drugs were finally undertaken, they demonstrated that the advantage of newer agents over diuretics was marginal, at best.5,6 In this instance, a lack of appropriate trial data on management of hypertension probably led to years of unnecessary expense to the PBS that greatly outweighed the cost of a large-scale trial. It is clearly in the public interest to ensure that PBS funds are not being spent on expensive therapies when much cheaper agents are just as effective. We recently estimated that the failure to provide funding for trials probably cost Australian taxpayers between $45 million and $108 million in 1998 alone.4 Another example of the false economy of failing to fund clinical trials is the recently reported Women’s Health Initiative study.7 Before the results of this trial were published, a generation of women was prescribed hormone replacement therapy (HRT), despite the lack of rigorous long-term safety data that could only have been obtained from a large-scale trial. There was little commercial imperative to fund such a long-term trial when large markets of regular users existed. Eventually the US National Institutes of Health (NIH) recognised the importance of funding such a study, as indeed they have funded a number of other “public good” studies. Release of the study results has led to a sharp drop in the use of combined HRT, except for short-term use to relieve significant perimenopausal symptoms. The “dividend” for the Australian government was $16 million less expenditure on HRT in the financial year 2002–03.3 A failure to learn from these experiences may cost the community in the future. For example, low-dose aspirin is an effective antiplatelet agent whose use has recently been advocated in the United States for people with a 10-year risk of coronary events and stroke of 10% or more.8 This recommendation may lead to widespread use of aspirin for primary cardiovascular prevention in the elderly, despite a lack of data to indicate that its benefits in this age group outweigh the risk of haemorrhage.9,10 There is little likelihood that commercial interests will supply the funding to overcome this lack of data. It is more likely that industry would fund a study using a newer, more expensive antithrombotic agent in the hope of establishing it as standard therapy. The means must be found to identify and target strategically important research questions that require public funding. A budget (in the order of $100 million) for national research funding of these large “public good” trials should be established and administered by the National Health and Medical Research Council (NHMRC). This sum, representing 12% of the NHMRC budget and 0.2% of the recurrent health expenditure of $60 billion, is commensurate with the importance of such trials to clinical medicine and public health. Using the NIH as a model, trials would involve a mix of requested and investigator-initiated research. Research groups, either alone or (more likely) collaboratively, would apply for competitive funding. Although this would be administered by the NHMRC, a number of other stakeholders would benefit, including federal and state governments and their agencies, departments of health, the Health Insurance Commission, and the PBS. New funds should be made available from these sources. States should contribute to this initiative as large-scale trials are usually multicentred, allowing research capacity building and employment in both metropolitan and rural areas throughout Australia. Failure to develop a policy that supports such strategic research may well lead to waste of public funds and a delayed recognition of unfavourable risk–benefit ratios.

John J McNeil PhD, FRACP · Mark R Nelson PhD, FRACGP, FAFPHM · Andrew M Tonkin MB BS, MD, FRACP

Pets probably do confer health benefits, but we don’t know precisely how In the current issue of the Journal (page 466), Parslow and Jorm1 reopen the debate about whether pets benefit human health. They give the results of a high quality Australian sample survey indicating that pet owners do not have lower blood pressure than non-owners, and, in this respect at least, are not at lower risk of heart disease. Their results run counter to an earlier Australian study,2 based on a large volunteer sample, in which pet owners were found to have lower blood pressure and cholesterol levels. . . . the benefits of pets appear linked to the human desire to be close to nature . . . Where are we up to in this debate — are we back to square one? The case I will present here is that we can be fairly confident that pets do confer health benefits, but we do not know exactly how. Several types of research by very different kinds of scientists — medical scientists and social scientists — have been conducted on this topic. These scientists have different understandings of causation (ie, of what it means to claim that pets cause their owners to have better health), and, because of this, it is difficult to have a meeting of minds. However, it can be argued that social science research forms a natural prelude to medical research, and that the social science evidence in favour of health benefits of pet ownership makes it worthwhile to mount a substantial medical research effort to discover how the benefits occur. Social science surveys in Australia,3 Britain,4 Germany5 and the United States6 during the 1990s have come pretty close (in social science terms) to establishing that pets produce health benefits. The first surveys were cross-sectional (ie, they provided snapshot evidence at one point in time). With some exceptions, they showed that pet ownership is associated with better self-reported physical and psychological health, and also fewer doctor visits. Controlling for the main demographic variables associated with health problems, including sex, age, marital status, education and income, did not change the results. Of course, social scientists recognised that causation might run the other way round, or even both ways. It was possible that people who were healthy and happy in the first place tended to acquire pets, rather than that having a pet caused better health. So, as a next step, efforts were made to design valid longitudinal studies (ie, studies following people over a period of time) to see whether owning a pet made a difference. The strongest positive evidence has come from the German Socio-Economic Panel Survey,5 which asked a sample of about 10 000 respondents about pet ownership in 1996 and again in 2001. Controlling for health status in 1996 (as well as for the usual demographic variables), it was found that people who continuously owned a pet reported the fewest doctor visits (in the 3 months before interview), and those who had acquired a pet during the 5-year period reported the next fewest number of visits. Both these groups went to the doctor about 10% less often than people who did not have a pet at either time, or who had ceased to have a pet. The German sample is very large and most of the questions are about income and work, so the respondents could not possibly have suspected that the researchers were looking for a link between pets and health. Similar results were found in a smaller Australian longitudinal study, although here the evidence was based on recall, not on repeated interviews.5 Because the German and Australian results came from national representative samples, it was possible to make preliminary estimates of savings in national health expenditure arising from lower use of medical services by pet owners. A second type of study is based on examining the effects of interventions (either natural or intentional), and thus takes the causal reasoning further. An American study of heart attack victims showed that those with pets at home were twice as likely to survive for a year.7 A British longitudinal study involved giving a pet to people who had not recently owned one and following their lives for 10 months.4 The new pet owners showed improvements in physical and mental health, and dog owners took more exercise. A control group who did not own pets showed no change. The study could perhaps be criticised on the grounds that the new pet owners might have known or suspected why they were given pets. The same cannot be said of an American longitudinal study of Medicare enrollees that measured the impact of adverse life events (eg, bereavement or marital separation) on mental health.6 Pet owners coped significantly better. But medical researchers want better evidence of causation than this. They want to know precisely which medical conditions, if any, are improved by pet ownership, and, ideally, they want to understand things at the molecular level. It has to be said that research along these lines has made only limited progress. The American heart attack study7 is relevant here, and, although criticised, has since been replicated.8 On the other hand, studies of blood pressure,1,2 and of the potentially anxiety-reducing effects of pets,9,10 have yielded contradictory results. Arguably then, the state of debate is that pets probably do confer health benefits, but we don’t know precisely how. Continuing medical research is needed to move things forward. At a fundamental level, the benefits of pets appear linked to the human desire to be close to nature and other living creatures. The famous zoologist Edward O Wilson has called the belief that humans need and benefit from closeness and companionship with other species “the biophilia hypothesis”.11 About 50% of adults and 70% of adolescents who own pets report that they confide in them.12 It is most unlikely that all this communication and companionship is wasted.

Bruce Headey PhD

The concept of “first-responder” defibrillation is not being embraced The article in this issue of the Journal by Finn and Jacobs (page 470)1 challenges our professions to find better ways of dealing with sudden unexpected cardiac arrest in the nation’s hospitals — that is, in those places which should be best able to deal with it. Nurses, with a nursing perspective, wrote the article. It underscores the important role played by nurses, and the problem that needs to be addressed by nurses through their influence within our hospitals. Australia played a major role in initiating coronary care wards for managing ventricular fibrillation (VF) in the early stage of myocardial infarction, through the work of Desmond Julian at Sydney Hospital2 and Graeme Sloman at Royal Melbourne Hospital3 during 1961 and 1962. While now taken for granted, one is apt to forget how controversial this development initially was, and how poor the initial results were until nurses were permitted to use defibrillators and so shorten the time from cardiac arrest to termination of VF. At the time, physicians claimed the high ground — defibrillators were too dangerous to be entrusted to nurses — ignoring the fact that the first article on successful use of external defibrillators was written in 1960 by two engineers and one surgeon.4 Fortunately, reason and logic triumphed, and defibrillation became the most important priority for coronary care unit and intensive care unit nurses, with a doctor being summoned concurrently, and usually arriving in time to document return of consciousness and plan ongoing management. Such pioneering work was followed by the development of automatic internal and external defibrillators (AIDs and AEDs, respectively). These are able to sense and interpret VF, and will operate and deliver a shock only if VF is present. They are small and ubiquitous. The US Vice-President, Dick Cheney, has an implanted AID. Indeed, the man who is “a heartbeat behind” the world’s most powerful man is himself “a heartbeat behind” (obviously a number of heartbeats behind) the scrutiny of an automatic implanted defibrillator. Implantation is one mode of use for defibrillators in people at high personal risk of VF. Another mode is public access defibrillation, where AEDs are placed in public places, like fire extinguishers, for use by minimally trained or untrained people, who apply chest pads to an unconscious person and respond to voice prompts delivered by the device. Providing such devices in Chicago’s airport complexes (Box) has resulted in long-term, neurologically intact survival of 56% of sudden cardiac arrest victims, compared with no cases of neurologically intact survival before the devices were made available.5 One of us (C S D) is responsible for a national program,6 in which nearly 700 defibrillators have been installed in airports, train stations, and other busy public places across England. Early results suggest that 29 people have survived to hospital discharge after sudden cardiac arrest. The downside has been minimal, with no injury from use, and virtually no theft, misuse or vandalism. Other highly favourable experiences involving police and the community have recently been reported.7,8 What relevance does the community experience have for Australian hospitals? Finn and Jacobs have identified a number of anomalies. Certainly, AEDs are now available in many Australian hospitals, so that training for nurses in their use is easier, less formidable, and less costly. But most Australian hospitals (57%) still do not have these devices. In hospitals with any kind of defibrillator, 16% in Australia do not permit nurses to defibrillate; in those with AEDs, this figure is 9%. This practice persists despite the knowledge that survival decreases by 10% for each minute that passes after onset of VF until defibrillation is achieved — automatically by an implanted defibrillator, or with manual intervention after placement of pads by doctor, nurse — by anyone. It matters not who places the pads and pushes the button, but hospital procedures are often based on the view that it does. The outcome, demonstrated by hospital, national and published data, is that cardiac arrest is more successfully treated in Chicago or Heathrow airport, on an American Airlines or Qantas jet, or in a Boston post office, than in the vestibules, corridors or general wards of Australia’s premier hospitals. An example of the existing problem is shown in the Box, which contrasts the well signed, alarmed, and easily accessible defibrillator at O’Hare Airport with the unsigned, unalarmed, padlocked defibrillator in the corridor of a major Australian hospital. Providing a defibrillator in such a way is a contemptuous gesture to modern knowledge, and to pronouncements of the Australian Resuscitation Council, as described by Finn and Jacobs. This “AED in a cage” symbolises the problems exposed by Finn and Jacobs,1 and illustrates the 1960s view — that defibrillation is the preserve of the enlightened few with access to the key. We are not overly concerned with the issue raised by Finn and Jacobs in relation to CPR training for medical staff. Their survey was sent to directors of nursing and the replies reflect the nursing perspective, which may not include full knowledge of medical staff activities. Medical practitioners usually prefer to train themselves in resuscitation, and there are surely few who cannot initiate CPR or use a defibrillator, so the number of hospitals identified as offering CPR training to doctors may not be important. We are delighted to see how many hospitals train lay staff in resuscitation. Hopefully, the future will see more communication between doctors, nurses and lay staff at hospitals where issues of “turf”, keys, and locked cages can be resolved, and where the chain of survival can be initiated expeditiously wherever and whenever the need arises. Forty years ago, the Australian hospital system was slow to pick up on the inspirational but logical initiative of Julian, Gaston Bauer (who recruited Julian to Sydney Hospital and encouraged subsequent developments) and Sloman. It remains slow in throwing off the shackles of officialdom. Finn and Jacobs are to be complimented on their fine work. Two approaches to providing automatic external defibrillators (AEDs) One of the many AEDs deployed along a concourse of Chicago’s O’Hare Airport. The device is clearly signposted (not seen in picture), alarmed, and connected by automatic phone to the emergency medical centre. AED in a corridor of a major Australian hospital. There is no signposting, the case is locked and no advice is given on the location of the key.

Michael F O’Rourke AM, MD, FRACP · C Siân Davies MBE, RN

We understand the molecular basis, and a cure may soon be possible The French neurologist Duchenne de Boulogne (1806–1875) originally described paralysie hypertrophique de l’enfance in 1861, outlining the key clinical features, including lordosis and calf hypertrophy.1,2 Although the English physician Edward Meryon had recognised similar cases 10 years earlier, Duchenne’s name became associated with this condition through a series of illustrated articles in which he described key features, including male predominance, progressive course, waddling gait, pseudohypertrophy of calf muscles, loss of ambulation by adolescence, and early death. Duchenne devised a muscle biopsy needle and established that hyperplasia of fibrous connective tissue and destruction of the muscle cytoarchitecture (arrangement of cells) are key abnormalities. By the 1880s, the English neurologist Sir William Gowers was able to identify 81 case reports confirming the clinical features established by Duchenne. Clinicians established the clinical heterogeneity of the muscular dystrophies, and various disorders were identified, including facioscapulohumeral muscular dystrophy, limb-girdle muscular dystrophy and myotonic dystrophy. Importantly, Becker muscular dystrophy (BMD) was identified as a much less severe condition with some similarity to Duchenne muscular dystrophy (DMD). Success in delineating the basis of the dystrophies awaited the molecular era. Kunkel and coworkers identified a patient with a cytologically recognisable deletion on the X chromosome (Xp21) and realised that, if they allowed this to hybridise (pair) with normal DNA, they could find the gene.3 By ingenious use of their novel techniques, they created probes containing part of the Duchenne gene and found that one detected submicroscopic deletions in some affected boys.3 This led to the identification of the gene and eventual delineation of its sequence. Boys with DMD were found to have mutations that produced non-functional dystrophin protein.4 BMD patients were identified as having mutations that produced dystrophin protein with some function.4 The structure of the functional protein was predicted from the genetic sequence,5 and immunocytochemical investigation revealed a close relationship to the sarcolemma.6 Dystrophin’s function as a key cytoskeletal protein was subsequently defined in elegant studies in many laboratories, but especially by Kevin Campbell and colleagues.7 Dystrophin links the actin filament of the contractile apparatus to a complex series of linking proteins in the cell membrane, and hence to the extracellular matrix (Box). It was found that the C-terminus of dystrophin, which binds it to the sarcolemma, is crucial, as is the actin-binding zone, but the helical zone can be shortened with some preservation of function, explaining the differences between BMD and DMD. Subsequently, defects in the dystrophin-associated glycoprotein complex were found to underlie many other types of muscular dystrophy, including the limb-girdle syndromes and the congenital muscular dystrophies. Indeed, it was through pursuit of the cause of DMD that an understanding of much of what we now know about the muscle cytoskeleton has been achieved.7,8 Much new knowledge, but what has been achieved of practical importance for the patients and their families? Diagnosis has improved a great deal. Established DMD is not difficult to diagnose, but molecular causation can now be defined in most cases, allowing accurate confirmation of female carrier status and, with in-vitro fertilisation techniques, selection of a healthy embryo for implantation.9 Advances in clinical management include the use of steroid therapy to improve muscle strength,10 orthopaedic techniques, especially Luque rods, to prevent kyphoscoliosis,11 and regular respiratory monitoring, including sleep studies, to maximise use of non-invasive ventilatory techniques to improve quality of life. Later, depending on patients’ wishes, tracheostomy-dependent ventilation can be used to prolong duration of life. What of new potential treatments? The aim is to develop curative treatments, and it is somewhat disappointing that, more than 20 years after Kunkel’s pioneering discoveries, this is yet to be achieved. Studies with cell therapy (myoblast transfer therapy) have not fulfilled initial promise, although they are still proceeding in several laboratories.12 Major effort in gene therapy has led to an understanding of the key parts of the dystrophin gene that must be incorporated to achieve reasonable function.8 New techniques of gene repair are under evaluation in several laboratories, including our own.8 Skeletal muscle has an enormous capacity for regeneration, and there is every chance that effective strategies to achieve functional muscle remodelling will be achieved, especially if applied before irreversible fibrosis has occurred. Indeed, skeletal muscle, by virtue of its relatively simple structure, enormous capacity for regeneration, and easy and safe accessibility, is an ideal tissue for many of the new therapies in the cell and gene area. Correction of causative mutations through gene repair in autologous mesenchymal stem cells derived from bone marrow, manipulation to a committed myogenic lineage, and systemic delivery, once a concept in the realm of science fiction, may be practical in the years ahead. However, even with the promise so close, there need to be further advances in several areas to achieve this. For example, we need better understanding of the factors that drive pluripotent stem cells into myogenic lineages, and of other factors, mainly immunological, that have limited stem cell survival in vivo. Gene vectors capable of encompassing the whole dystrophin gene are likely to be tested in human studies, and promising new techniques of gene repair are likely to reach clinical trials. It is important that various potential treatments be pursued in parallel, as it is not currently possible to determine which of the approaches available will enjoy most success. Equally important to the search for a cure is the maintenance of quality of life for people who currently have muscular dystrophy. This necessitates adequate funding for clinical care in key paramedical areas, including access to state of the art wheelchair and ventilatory equipment. The role of the Muscular Dystrophy Association in providing support for carers and families is especially important. The next decade is full of promise for robust advances in the management of the dystrophies, and there is real hope that by 2011, the 150th anniversary of Duchenne’s landmark description, a cure for DMD will have been found. Dystrophin: the key protein in Duchenne muscular dystrophy Dystrophin links actin filaments to a complex of transmembrane proteins and hence to the extracellular matrix. Mutations that affect the C-terminus or actin-binding region cause Duchenne muscular dystrophy. Mutations that shorten the a helix cause Becker muscular dystrophy. Other muscular dystrophies are caused by defects in the dystrophin-associated glycoprotein complex.

Edward Byrne DSc, MD, FRCP, FRACP · Andrew J Kornberg MB BS, FRACP · Robert Kapsa PhD

Burden-of-disease and cost-effectiveness studies will help us realise better population health Over the past decade or so, there has been increasing demand for greater clarity about the major causes of disease and injury, how these differentially affect populations, and how they are changing. In part, this demand has been motivated by resource constraints and a realisation that better health is possible with more informed allocation of resources. At the same time, there has been a change in the way population health and its determinants are quantified, with a much closer integration of the quantitative population sciences (such as epidemiology, demography and health economics) to strengthen and broaden the evidence base for healthcare policy. As demand for healthcare grows, decisions about resource allocation and priorities for the healthcare sector will fall under increasing scrutiny. The first coordinated efforts to provide more relevant and comprehensive data on the health (as opposed to survival) of populations and on specific strategies for disease control were led by the World Bank, culminating in two seminal reports in 1993 on the state of global health and priorities for improving it.1,2 These reports have subsequently had a great influence on debates about health sector priorities and healthcare research needs. A fundamental outcome of this World Bank research has been a change in the paradigm for health accounting, from measuring death to measuring population health, using a single summary index that simultaneously incorporates information about age at death and the incidence and prevalence of disease and injury. A time-based metric, the disability-adjusted life-year (DALY), was used to capture both fatal and non-fatal health outcomes affecting populations. DALYs for over 100 specific diseases and injuries have been assessed within a “burden-of-disease” framework which constrains individual estimates and preserves epidemiological plausibility.3,4 The burden-of-disease approach gives estimates of DALYs from risk factors (eg, smoking) as well as diseases caused by known risk factors (eg, ischaemic heart disease related to smoking) and from other, unrelated conditions (eg, road traffic accidents, which have nothing to do with smoking).5 Thus, a single metric (the DALY) can be used to compare disease burden across a range of diseases, injuries and risk factors. Certainly, the data and information requirements for adequate measurements of the burden of disease in a population are not inconsiderable. They need information on age at death and cause of death, the age-specific incidence of disease and injury, the typical duration of life lived with the sequelae of diseases and injuries, and some quantification of the severity of disability assessed according to a commonly agreed framework. The ethical, philosophical and conceptual issues involved in quantifying states of health other than perfect health are still very much a matter of debate, and rightly so.6 However, the reliability, and hence the utility, of burden-of-disease studies for public policy depend much more strongly on the quality and availability of the underlying epidemiological data. A principal advantage of the burden-of-disease approach is that it entails a data “audit”, whereby the completeness, reliability and consistency of routinely collected data are assessed, and critical gaps in health data collection are identified. One implication is that periodic quality assessments of, say, routine cause-of-death data ought to be carried out to ensure their continued relevance and reliability for public policy. Another might be the need for a more rational assessment of priority data for the healthcare sector, placing greater emphasis on data collection and data linkage to facilitate burden-of-disease studies, rather than on routine collection of statistics of limited public health relevance. The burden-of-disease framework, based on the estimated epidemiological path of incident cases, would benefit greatly from wider availability of linked data sets on health outcomes and further research into health-state transition probabilities (ie, the probability that patients with a given illness or disability will get better or worse, and the severity of their current compared with their previous health state) from longitudinal studies.7 In parallel with the increased emphasis on more reliable and comprehensive assessment of population health, there has been a rapid expansion in knowledge about the cost-effectiveness of interventions for reducing the burden of disease. Packages of interventions to optimise health in populations at different levels of development were among the major research outcomes of the World development report 1993.1 Subsequent work by the World Health Organization identified evidence of cost-effectiveness as a key health research priority worldwide.8 The findings of a large international study of the cost-effectiveness of 170 interventions, primarily to reduce health hazards from unsafe water and hygiene, childhood undernutrition, tobacco use, unsafe sex, and high blood pressure and blood lipid levels were recently reported by WHO.9 The evidence base for setting health priorities is thus rapidly expanding. Yet, as the WHO report points out, there is still a large potential for realising better health through more informed and systematic application of this knowledge.9 As demand for healthcare grows, decisions about resource allocation and priorities for the healthcare sector will fall under increasing scrutiny. This is likely to lead to demands for more reliable and useful evidence about population health problems, and for affordable and effective measures to address them. Australian researchers have been at the forefront of these international developments, and have carried out local burden-of-disease studies that have been used to support policy development by the federal and state governments, particularly in Victoria.10,11 Australia is also well placed to provide technical support to neighbouring countries that are undertaking burden-of-disease and cost-effectiveness research to improve the efficiency of their healthcare systems. More than 5 years have now passed since the first Australian burden-of-disease study was undertaken, and much could be gained from a renewed appraisal of Australian healthcare information based on the methodological advances in burden-of-disease measurement in the interim. The School of Population Health at the University of Queensland has established a Centre for Burden of Disease and Global Health Research which has a mission to provide the technical and strategic leadership for priority-setting research in Australia and the entire Asia–Pacific region. Strong links to WHO, the World Bank, the National Institutes of Health in the United States, and other leading health research institutions worldwide, will ensure that efforts to improve the evidence base for healthcare reflect global advances in health research and development.

Alan D Lopez PhD