Issues

Volume 180 Issue 11

7 June 2004

From the editor’s desk

7 June 2004 Free

Leisure and the 4 Cs

Despite its love affair with high technology, modern medicine is still defined by the patient-doctor relationship and its 4 Cs: competence (that is sustained by lifelong learning), communication (that is clear and two-way), care (that is caring), and choice (the patient’s freedom to choose). But in the hurly-burly of modern life, the 4 Cs are frequently tested. At times, the patient’s choice may seem odd. At other times, professional competence may be wrongly questioned or patients’ expectations become unduly burdensome. William Carlos Williams, the US author and physician, details such an experience in A face of stone, in which he describes how a particular couple provoked his anger. In desperation, Williams had made repeated requests that he not be disturbed every time “the kid gets a belly ache”. “... And sure enough, on a Sunday night, about nine o'clock, with the thermometer at six below and the roads like a skating rink, they would call me. Nothing doing, I said. But Doc, you said you'd come. I'm not going out there tonight, I insisted. I won’t do it. I'll ask my associate to make the call or some good younger man that lives in that neighborhood but I won’t go over there tonight. But we need you Doc, the baby’s very sick. Can’t help it. I tell you I'm not going. And I slammed up the receiver.” Williams recognised that incessant intrusion into a doctor’s private life sorely tests the patient–doctor relationship. Time away from patients is crucial to the health of that relationship — a need for leisure, simply echoed in the words: “A poor life this if, full of care, We have no time to stand and stare.”* *William H Davies. Leisure.

Martin B Van Der Weyden

7 June 2004 Free

In This Issue

Danger: new MJA series Don’t read our new series on complementary and alternative medicine (CAM) if you'd like a polite chronicle of the different therapies (that’s been done already). Don’t read it if you expect a CAM-bashing critique or even a feel-good acceptance of all things complementary. (Life’s a bit more complex than that.) But, if controversy and debate are up your alley, you're in the right place! In “Complementary and alternative medicine — with a difference”, series editors Lewith and Bensoussan give the rationale for the series, while Coulter and Willis speculate on why people are willing to spend more on CAM than on "ordinary" medicine (→ The rise and rise of complementary and alternative medicine: a sociological perspective). Finding "Pneumo" In good time for the next school holidays, we present the tale of Australia’s largest outbreak of Legionnaire’s disease, which occurred at the Melbourne Aquarium. Greig and colleagues describe how the source was rapidly traced, and what the ensuing detective work revealed (→ An outbreak of Legionnaires' disease at the Melbourne Aquarium, April 2000: investigation and case–control studies). Playground arm harm Speaking of fun pastimes that can be dangerous, Australian safety standards for children’s playgrounds are aimed at preventing serious head injuries, but upper-limb fractures are still common. Sherker and Ozanne-Smith visited playgrounds where children had broken an arm to determine whether our standards need to change if we wish to protect little limbs from harm (→ Are current playground safety standards adequate for preventing arm fractures?). The uses of research If you still believe that the purpose of medical research is to improve healthcare, two short articles in this issue should set you straight in time for Medical Research Week (June 5–12). Ernst has had a few disturbed nights dreaming up the "ten commandments of pseudoscience", which are aimed at advancing the cause of the researcher (→ My pseudoscientific nightmare). Meanwhile, a Postcard from the UK finds our Aussie spies puzzling over the Research Assessment Exercise, a real-life nightmare (involving, among other things, a "star" rating for research) being lived out in UK universities (→ Research assessment: there must be an easier way). Rays raise reservations A recent article published in The Lancet used available data to calculate that, in Australia, about 431 cancers per year may be attributable to diagnostic x-rays. Although this estimate is far from exact, Dickie and Fitchew explain why we should take it seriously (→ Medical radiation and the risk of cancer). A beat-up We've all grown accustomed to worried-looking politicians regaling us with the horrors of “Our Ageing Population”. In the face of some impressive rhetoric on the subject, Coory went looking for evidence that elderly populations cause health budget blowouts (→ Ageing and healthcare costs in Australia: a case of policy-based evidence?). Another current favourite is that emergency department overcrowding can be attributed to the decline in general practice bulk billing rates. Hanson et al and Knox (Letters) are in agreement with the recent statement from the College of Emergency Medicine in overturning this old chestnut (→ Bulk-billing GP clinics did not significantly reduce emergency department caseload in Mackay, Queensland). The people’s choice Judging from the newspapers that cross our desks here at the MJA’s headquarters in Sydney, public interest in medical error is at an all-time high. Some commentators have suggested that an anonymous system for reporting errors will encourage disclosure, but, according to the study by Evans et al, the general public may beg to differ (→ Anonymity or transparency in reporting of medical error: a community-based survey in South Australia). Burton and Sanders also went straight to the source to find out how Western Australian couples would feel about donating stored embryos for medical research (→ Patient attitudes to donation of embryos for research in Western Australia). Rats rejoice . . . Warfarin for the treatment of atrial fibrillation may soon be redundant, say Eikelboom and Hankey (→ The beginning of the end of warfarin?). A new drug, ximelagatran, seems to be “non-inferior” in preventing stroke and to have a better side effect profile, but there are still some unanswered questions. In the public interest For those of you who think enforcing playground safety standards is a threat to autonomy, try locking sick people up! It’s rarely done, but legal under certain circumstances, say Senanayake and Ferson (→ Detention for tuberculosis: public health and the law). Their discussion of two recent public health orders issued to patients with tuberculosis explains when and why. Sustaining our species World Environment Day falls on 5 June. Last year, a cross-section of concerned Australians, including doctors, participated in a 9-month internet-based conference on sustainability. In “In search of sustainability”, Towle provides a report. Another time ... another place... I’ve always been a quack. I’ve always been an excellent quack. The only difference between me and the quacks I don’t like is that I don’t try to get rich off my quackery, and I try to be honest about it. Eugene A Stead, Jr. 1997

Editorials

Medical practices 7 June 2004 Free

Medical radiation and the risk of cancer

Although the risk from medical radiation is small, we should not become complacent Ionising radiation is one of the most extensively researched agents in our society. Indeed, more is known about its effects than the effects of most other things in our environment. High doses are known to be harmful, with the main long-term adverse effect being cancer induction. The best evidence for this comes from survivors of the atomic bomb explosions in Japan, where models have been developed relating increased cancer induction to the dose of radiation received. Although the magnitude of the effect is small, the link is well established. When people are exposed to radiation, its use must be justified by ensuring that it does more good than harm. Diagnostic x-rays are the largest man-made source of exposure of the general population to radiation. Even if the risk from radiation to an individual is very small, exposure of a large number of people over time could translate into a considerable number of cancer cases. A recent report in The Lancet attempts to quantify the risk of cancer induction from diagnostic x-ray procedures, averaged over the population.1 From surveys of medical radiation use in a number of countries, the authors obtained information on the average annual frequency of various x-ray procedures and estimated the doses to various organs from those procedures. They then applied a model of radiation-induced cancer cumulative risk to the doses received by the various organs to derive an estimate of the attributable risk of developing cancer. Their analysis suggests that in Australia about 431 cancers per year (1.3% of all cancers) could be attributable to diagnostic x-rays. The corresponding percentages for 14 other countries considered ranged from 0.6% in the United Kingdom and Poland to 3.2% in Japan. Their study does not provide any new evidence that radiation from diagnostic medical procedures causes cancer. Rather, the researchers rigorously applied an existing model to medical diagnostic radiation exposure of the population to derive the best estimate to date of the magnitude of the risk of cancer induction. They acknowledge that there is considerable uncertainty attached to this estimate and that a number of assumptions had to be made in performing the analysis. There is uncertainty about the number and types of radiological procedures, the derivation from these data of doses to individual organs, and the applicability of the cancer induction model at the low doses used in diagnostic radiology. Nevertheless, it is probable that medical radiation procedures do lead to a small increase in cancer incidence in the population. The lowest dose of x-radiation for which there is epidemiological evidence of increased cancer risk is 10–50 mSv for an acute whole-body exposure.2 Some of the higher-dose diagnostic radiological procedures such as computed tomography (CT) produce effective doses at the lower end of this range.3 At lower radiation dose levels, in the absence of epidemiological evidence, there is some uncertainty as to whether there is any effect. However, a linear relationship between risk and dose with no threshold is commonly accepted and is supported by some laboratory data.2 Radiation protection agencies have adopted this linear-no-threshold hypothesis in their approach to risk management.4 The total population dose of radiation from medical diagnostic procedures is increasing worldwide, mainly due to the increase in CT scanning. CT entails the use of higher radiation doses than other common radiological procedures.3 In Australia, Medicare data indicate that CT use has increased 140% over the decade 1992–2002. The reason for the increased use of CT is that it is now able to provide much better and more valuable clinical information, and to do so more easily, than in the past. As the technology has improved, the image quality has improved and scanning times have been reduced to just a few seconds. CT can now image fine detail, even in mobile organs, and hence the indications for its use have expanded. It is easy to overlook the possible side effects of radiation, particularly if the risk is very low and the effect may not become apparent for years. Cancer may not develop until 20 to 30 years after radiation exposure, and so the group most at risk are people with a long life expectancy. Children are also more susceptible to the carcinogenic effects of radiation than adults. When people are exposed to radiation, its use must be justified by ensuring that it does more good than harm. If radiological investigations are done for a specific clinical problem, the potential benefit significantly outweighs the very small risk. However, if there is no valid clinical reason for a procedure, the risk is still present for no tangible benefit. One area in which risk is considered to outweigh benefit is whole-body CT screening of healthy asymptomatic people. The Royal Australian and New Zealand College of Radiologists has produced imaging guidelines on the appropriate use of diagnostic radiological procedures.5 The Australian Radiation Protection and Nuclear Safety Agency is in the process of drafting guidelines on radiation safety in medicine.6 Modern radiological equipment has the potential to reduce the radiation dose compared with older equipment. Radiologists also need to optimise their procedures to obtain the required diagnostic information using the lowest radiation dose.7 The Lancet article serves as a reminder that the potential dangers of radiation need to be respected.

Graeme J Dickie FRANZCR, FRACP, MBA · Robert S Fitchew MSc, MACPSEM, MAIP

Hematologic diseases 7 June 2004 Free

The beginning of the end of warfarin?

Randomised trials suggest that ximelagatran is “non-inferior” to warfarin for preventing stroke in patients with non-valvular atrial fibrillation, but important questions remain Atrial fibrillation is a strong and independent risk factor for stroke because it predisposes to thrombus formation in the left atrial appendage, and subsequent embolism to the brain.1 Each year, at least 6000 cardioembolic ischaemic strokes occur among an estimated 150 000 Australians with atrial fibrillation,2,3 and these numbers are expected to rise substantially with the ageing of the Australian population and associated increase in the prevalence of atrial fibrillation. The only two treatments proven to reduce the risk of stroke among patients with atrial fibrillation are aspirin and adjusted-dose warfarin.4 However, both have limitations. Aspirin is only modestly effective, reducing the risk of stroke by about a fifth compared with placebo (absolute risk reduction [ARR], 1.7% per year; number of patients needed to treat for one year to prevent one stroke [NNT], 59). Warfarin reduces the risk of stroke by about two-thirds compared with placebo (ARR, 3.1% per year; NNT, 32) and by about a third compared with aspirin (ARR, 0.8% per year; NNT, 125), but causes at least twice as many intracranial and extracranial bleeds as aspirin, particularly in patients at increased risk of bleeding (eg, those aged over 75 years, those with a history of bleeding; see Box 1).4 Warfarin is also inconvenient to use because it has a narrow therapeutic index, interacts with numerous drugs and food, and requires close laboratory monitoring (Box 2).5 Consequently, only a third to a half of patients with atrial fibrillation who are appropriate candidates for warfarin therapy actually receive it.6 Reducing the intensity of warfarin therapy to an international normalised ratio (INR) of less than 2.0 lowers the risk of bleeding, but is associated with an increased incidence of ischaemic stroke and worse stroke outcomes compared with standard-intensity warfarin therapy (INR ≥ 2.0).7 Direct thrombin inhibitors are a new class of anticoagulant drugs that bind directly to thrombin and block its interaction with substrates, thus inhibiting fibrin formation, thrombin-mediated activation of coagulation, and thrombin-induced platelet aggregation. Hirudin is the only direct thrombin inhibitor currently available for use in Australia, but must be given parenterally and is approved only for the treatment of heparin-induced thrombocytopenia. Ximelagatran, a pro-drug of melagatran, is an orally administered direct thrombin inhibitor and the newest drug in this class. It is rapidly absorbed from the gut and converted to its active form, melagatran. Melagatran is not metabolised or bound to plasma proteins. It is cleared predominantly (about 80%) by the kidneys, and has a half-life of 4–5 hours, which means ximelagatran needs to be administered twice daily (Box 2). Two large phase III randomised trials have recently evaluated ximelagatran as a replacement for warfarin to prevent thrombotic complications in patients with non-valvular atrial fibrillation.8,9 The primary objective of the Stroke Prevention using the ORal direct Thrombin Inhibitor ximelagatran in patients with non-valvular atrial Fibrillation (SPORTIF) III and V trials was to determine whether ximelagatran given in a fixed dose of 36 mg twice daily without laboratory monitoring was non-inferior to adjusted-dose warfarin (INR, 2.0–3.0) for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation and at least one additional major risk factor for stroke. The prespecified criterion for non-inferiority required that the lower confidence interval for the difference in the rate of stroke or systemic embolism between ximelagatran and warfarin did not exceed the prespecified threshold of 2% per year.10 Establishment of non-inferiority would imply that ximelagatran has either equivalent or superior effectiveness to warfarin and would allow clinicians to select ximelagatran over warfarin for convenience or safety. The design of the two SPORTIF trials was identical, except that SPORTIF III (3407 patients) was conducted in Europe, Asia, Australia and New Zealand and treatment allocation was open label, while SPORTIF V (3922 patients) was conducted in North America and treatment allocation was double blinded. The pooled results of the SPORTIF III and V trials (which had mean follow-up periods of 17 or 20 months, respectively) showed no significant difference in the risk of stroke or systemic embolism between ximelagatran (2.5%) and warfarin (2.5%; Box 1). In both trials, findings for ximelagatran fulfilled the criterion for non-inferiority. However, the pooled results of the SPORTIF trials also showed that ximelagatran significantly reduced the risk of major bleeding compared with warfarin (2.5% for ximelagatran; 3.4% for warfarin; estimated annualised ARR, 0.6%; NNT for 1 year to avoid one major bleed, 167) and increased the risk of transiently elevated levels of liver alanine aminotransferase (ALT) enzymes (6.1% for ximelagatran; 0.8% for warfarin; absolute risk increase [ARI], 5.3%; number of patients needed to treat with ximelagatran to harm [NNH] with increased ALT, 19). Raised ALT levels typically occurred 2–6 months after initiation of ximelagatran therapy, but produced no symptoms, were transient (returning to baseline spontaneously or after cessation of treatment), and without sequelae in all cases reported in the SPORTIF trials. These results suggest the beginning of the end of warfarin, because ximelagatran is not only associated with less major bleeding than warfarin, but it also has a predictable pharmacokinetic profile (uninfluenced by the patient’s age, sex, weight, ethnicity or diet). Therefore, it is not necessary to monitor anticoagulation activity or adjust the dose of ximelagatran (except in patients with renal dysfunction, in whom a decrease in dose or longer dosing interval is likely to be required). Furthermore, ximelagatran has a wider therapeutic margin than warfarin, and a low potential for drug interactions (Box 2). Although the cost of ximelagatran is likely to be substantially higher than the cost of warfarin, it may prove to be more cost effective because of its lower risk of bleeding and superior convenience (eg, no laboratory monitoring). Yet, important questions remain. First, there was significant heterogeneity between the two SPORTIF trials (P = 0.02). In the SPORTIF III trial, random allocation to open-label ximelagatran was associated with an absolute reduction in stroke or systemic embolism of 0.7% per year compared with warfarin, whereas in the SPORTIF V trial allocation to double-blinded ximelagatran was associated with an absolute increase in stroke or systemic embolism of 0.4% per year compared with warfarin. The cause of this heterogeneity remains uncertain, but might, at least in part, be accounted for by diagnostic suspicion or reporting bias in the open-label SPORTIF III trial. Second, the 2% per year threshold that was chosen as the criterion for non-inferiority does not reliably exclude even a near doubling of risk of stroke or systemic embolism with ximelagatran compared with warfarin. Third, unexpected hepatic side-effects of ximelagatran are an important concern given their high incidence in the short-term (6%), the large population potentially eligible for ximelagatran, and the likely long-term exposures to ximelagatran (and possibility of other long-term adverse effects). Monitoring of liver function is likely to be required during the first 6 months of treatment, and additional long term outcome data are required. The SPORTIF data signal the emergence of ximelagatran as an effective, safe and more convenient long-term alternative to warfarin for preventing stroke in patients with non-valvular atrial fibrillation. Safety concerns and cost issues are likely to delay its approval and eventual uptake by clinicians in Australia. In the meantime a range of other new antithrombotic drugs are also being evaluated for this indication. Both idraparinux (a selective clotting factor Xa inhibitor administered by once-weekly subcutaneous injection) and the combination of aspirin and clopidogrel are being tested in clinical trials, and novel oral preparations of direct-thrombin inhibitor and factor Xa inhibitors are in clinical development. This is heartening news for patients with atrial fibrillation, their doctors, and also public health professionals and governments faced with a looming epidemic of morbidity caused by atrial fibrillation in the ageing Australian community. 1: Estimated benefits and risks of treating a typical cohort of 1000 patients with non-valvular atrial fibrillation with aspirin, adjusted-dose warfarin, or ximelagatran* Aspirin (v placebo) Warfarin (v placebo) Warfarin (v aspirin) Ximelagatran (v warfarin)† Stroke‡ ARR ↓ 17 NNT 59 ARR ↓ 31 NNT 32 ARR ↓ 8 NNT 125 ARR§ 0 NNT§ — Major extracranial bleeds¶ ARI ↑ 1 NNH 1000 ARI ↑ 3 NNH 333 ARI ↑ 2 NNH 500 ARR ↓ 6 NNT 167 ALT ≥ 3 times upper limit of normal — — — — — — ARI ↑ 53 NNH 19 ARR =absolute risk reduction. ARI = absolute risk increase. NNT = number of patients needed to treat for one year to prevent or avoid one event. NNH = number of patients needed to treat for one year to harm by causing one event. ALT = alanine aminotransferase. * Data for aspirin v placebo, warfarin v placebo, and warfarin v aspirin are adapted from Hart et al.4 † ARR and NNT in the SPORTIF trials were calculated by dividing the pooled event rate by the mean duration of follow-up in years (approximately 1.5 years). ‡ Includes haemorrhagic stroke. § Includes stroke and systemic embolism. ¶ Event rates are likely to be substantially higher outside clinical trial settings, in the elderly, and in those with major comorbid conditions. 2: Comparison of the pharmacology and costs of aspirin, adjusted-dose warfarin and ximelagatran to prevent stroke in patients with non-valvular atrial fibrillation Aspirin Warfarin Ximelagatran Route Oral Oral Oral Dose 150–325 mg Variable* 36 mg Frequency Once daily Once daily Twice daily Half-life 20 minutes 40 hours 4–5 hours Clearance Systemic Hepatic Renal† Laboratory monitoring Not required INR Liver function tests‡ Antidote No Yes — Vitamin K No Reversal of antithrombotic effect Platelet transfusion Vitamin K Fresh frozen plasma Prothrombinex Discontinue ximelagatran Maintain diuresis Haemodialysis Food interactions Nil Multiple Nil known Drug interactions Uncommon Multiple Nil known Major side-effects Gastrointestinal bleeding Bleeding Bleeding Abnormal liver function test results Precautions and contraindications Bleeding diathesis Peptic ulcer Allergy Bleeding diathesis Alcoholism Dementia Impaired liver function Bleeding diathesis Impaired renal function Impaired liver function Approximate costs $2 per month§ $10 per month§ Unknown¶ INR = international normalised ratio. * Dose adjusted according to the results of the INR. † Trials of ximelagatran in atrial fibrillation have been restricted to patients with a creatinine clearance rate of ≥ 30 mL/min. ‡ Monitoring of liver function is likely to be required for the first 6 months. § Pharmaceutical Benefits Scheme November 2003: aspirin, $6.13 for 112 100 mg enteric-coated tablets; warfarin, $8.40 for 50 5 mg tablets (does not include the cost of laboratory monitoring). ¶ Cost of ximelagatran is not known but is likely to be at least $100 per month for a private prescription.

John W Eikelboom MSc, FRACP, FRCPA · Graeme J Hankey MD, FRCP, FRACP

Postcard from the UK

Research assessment: there must be an easier way

Understanding the rules of the game appears to be as important as the quality of the research “The role of the good civil servant,” said Sir Humphrey Appleby, “is to find a problem with every solution.”1 In mainstream British life, this appears to translate into a paralysing fascination with complexity. . . .“reseach-led” universities are afraid to show too much interest in teaching, as it will not gain RAE points. The greatest of all sources of complexity of current academic life in the UK is undoubtedly the Research Assessment Exercise (RAE), introduced by the Higher Education Funding Councils in 1992. Ratings in the RAE feed directly into the funding formula for higher-education institutions. Run episodically at unpredictable intervals of between 5 and 7 years, the RAE takes into account an eclectic mixture of indicators: papers published (up to four per academic in the 2001 cycle); grants awarded; research students, staff and strategies; and “measures of esteem” (which are not defined on the principal RAE website). Higher-education institutions in the UK devote millions of pounds’ worth of senior academics’ time to preparing their submissions to the RAE, choosing which members of staff to include in their shop window, and weighing every syllable that goes into a document of a precisely prescribed size. In parallel with this, academe temporarily becomes a giant intellectual meat-market as higher-education institutions vie with each other to buy in staff with impressive CVs in time for them to be included on their RAE return, while experienced individuals whose special skills and vocation lie in university teaching are simultaneously in grave danger of “going under the cleaver”. All this because the key principle of success in the RAE, at least in 2001 (the most recent RAE), was to enter for judgement the maximum possible proportion of academic staff with the highest possible average level of performance in research. And who are the judges? Panels of one’s peers in individual disciplines are the judges, and their task is to pore over research inputs and outputs that have already been through the peer-review process. Many more hours of academic time are devoted to this rereview of research and to the determination of criteria by which each particular specialty is to judge itself. Moreover, the rulebook changes each time the RAE is run. In 2001, academics were considered in cognate groups called “units of assessment”, and the maximum possible score was five star (all individuals entered for consideration four published papers of undisputed international quality), as opposed to five (on average, half of the papers entered for consideration were of international quality and the other half were nationally significant). In the end, many higher-education institutions increased their ratings, but the government declined to expand the overall funding cake. Thus, the big fish now consume an even larger share and the little fish are given even less. The rulebook for the next RAE, in 2008, is still being written by a committee chaired by Sir Gareth Roberts, President of Wolfson College, Oxford, but it seems likely that the unit of assessment will be the individual and the highest possible score six stars. Going into the RAE is like entering a football World Cup, but not knowing the number of players, the shape of the ball, the field or the goalposts, or whether there is an offside rule. Worst of all, university life is dominated by the exercise. While papers of international relevance are required to achieve a five-star rating, work of local relevance, such as most health services or policy research, cannot achieve this standard. Nor can most studies on the impact of new discoveries and implementing new methods in health services or other industries. Methods, rather than their application, are favoured. Particular study designs are deemed creditable in a somewhat arbitrary way, depending on the composition of the discipline panel. Those of us who work in “research-led” universities are afraid to show too much interest in teaching, as it will not gain RAE points. Thus, the whole direction of university life is affected, with the emphasis on research — or, at least, on certain types of research — rather than teaching. Although this is a research assessment, the implications flow on to teaching, both through the funding available to departments and the interests of people recruited to academic posts. In a recent meeting with the higher-education minister of a Middle Eastern country, one of us was told that this country now sends its students only to university departments with an RAE rating of at least four. Understanding the rules of the game appears to be as important as the quality of the research. Should your submission favour breadth or depth? Who should be “returned” (ie, put forward by the institution for scrutiny)? Since the result of the process is directly translated into funding, making the right decisions is crucial. Of course, there are benefits. There is a much smaller possibility for non-productive academics to hide; there is greater transparency about what are the values governing academic success; and there is a real need for individuals, departments, faculties and universities to define their goals and to measure performance. But the price paid for these gains is increasing disgruntlement in the academic workforce and direct lobbying of parliamentarians for a better, less disruptive system to be devised and imposed. For the record, the Australian equivalent of the RAE, which also affects university funding, combines routinely available data on various kinds of publications with information on grants awarded and PhDs completed. Publications are weighted by “impact factors”, a rating method with many shortcomings, but at least it is in the public realm and known in advance. The system is cheap, because most of the data are already available; it is unselective, because all academics and all of their outputs are considered; and it is simple, transparent and fast — fast enough to be run annually, so that the lag between effort and reward is relatively short, and fast enough to avoid causing a mass moonlight flit of university staff! Doubtless, some British civil servant found a problem with this “colonial” solution.

Konrad Jamrozik DPhil, FAFPHM, MFPH · David P Weller PhD, FRACGP, FAFPHM · Richard F Heller MD, FRACP, FAFPHM

Conference report

Environmental health 7 June 2004 Free

In search of sustainability

The ultimate consequence of failing to live sustainably is that we push our own species to extinction “In search of sustainability” was predominantly an Internet conference held over 9 months. Each month was dedicated to a particular theme, and a keynote paper and several related discussion papers formed the basis for an Internet debate on each theme (www.isosconference.org.au). The nine themes were water, human health and wellbeing, land use and natural ecosystems, energy, equity and peace, economic systems, climate, labour force and work, and transportation and urban design. The Internet conference culminated in a one-day face-to-face meeting at the Shine Dome in Canberra on 14 November 2003, which was attended by 190 delegates from around Australia. Twenty-four eminent Australian scientists and researchers presented papers summarising the nine core themes, with an emphasis on defining a path towards sustainability. I attended as a self-funded delegate, motivated by my passion and engagement in a spectrum of environmental issues. In this report, I have chosen to concentrate on the themes of greatest relevance to health and sustainability, and have given preference to contributions from the medical profession. Doctors, because of their credibility in public debate and their knowledge of the devastating health effects of environmental degradation and pollution, have an important role to play in community discussion about sustainability. Several of the speakers were members of the newly established Doctors for the Environment (www.dea.org.au), which has been established to provide an educational role for colleagues and a forum for the profession to add its voice to the sustainability debate. The term “sustainability” was defined very broadly in the opening session as the capacity of human systems to provide for the full range of human concerns over the long term. Human health and wellbeingTony McMichael (Director, National Centre for Epidemiology and Population Health, The Australian National University [ANU], Canberra) proposed that human health be embraced as a key indicator for sustainability, emphasising that current measures of national “wellbeing”, such as gross national product, do not correlate with a population’s health or wellbeing. He stated that gains in longevity and population numbers have come at the cost of depleting the world’s natural capital and degrading the ecosystems on which our survival ultimately depends. He offered several examples of how the impact of human activity on our biosphere is having increasingly detrimental effects on human health: damage to the stratospheric ozone layer, widespread degradation of productive land, the depletion of fresh water supplies, and overfishing and exhaustion of many of the ocean’s fish stocks. Modelling of human-induced global climate change indicates that, at present, 45% of the world’s population are exposed to the Anopheles mosquito, and at risk of contracting malaria. A rise in global temperature of merely 3°C would lead to an expansion of the range of the Anopheles mosquito, increasing the at-risk population world-wide to 60%. Other vector-borne diseases, such as Ross River virus, could be similarly affected. Tord Kjellstrom (National Centre for Epidemiology and Population Health, ANU) stated that “sustainability is the health promotion challenge of the 21st century”, adding that many of the changes needed at an individual level to improve our personal health are synonymous with the changes that will lead to a more sustainable way of living. Examples included taking the opportunity to walk or cycle in preference to burning fossil fuels in personal motor vehicles, and eating fresh local produce in preference to imported processed foods. He concluded that all members of society have a role to play in making “sustainability-based behaviours” the social norm — just as non-smoking has become the norm. Colin Butler (National Centre for Epidemiology and Population Health, ANU) pointed out that many factors may disrupt health, including environmental influences (floods, earthquakes, and climate change) and human activities (war and terrorism). “. . . denial of our increasingly unsustainable lifestyles will simply deepen the crisis we are in.” The goal to live more sustainably needs to become the primary objective of human endeavour. Transportation and urban designChris Johnson (NSW Government Architect) alluded to studies in the UK comparing “battery-raised kids” (those driven to school in a four-wheel-drive and bundled through the gates) with “free-range kids”, who were allowed to walk or cycle to school. The findings showed that free-range kids had better psychological development and school performance. He explained the concept of the “ecological footprint”,1 a scientific approximation of the area of land that each individual requires to meet his or her material needs and assimilate waste. “While this is an increasingly useful tool to assess the impact of our consumption patterns, we need to incorporate the element of liveability when we look at how we might design the cities of the future.” A proposed model of future city design included multiple-storey apartments with rooftop gardens and urban greenbelts. This greater density of living would allow more land for agriculture and biodiversity conservation. Economic systemsRichard Denniss (The Australia Institute, Canberra) argued that “economic growth is not only the target of economic policy and treasury but has become the priority for all areas of government policy”. But gross domestic product (GDP), as a measure of economic growth, does not correlate with a healthy, sustainable society. Paradoxically, loss of human life through trauma or natural disaster contributes a gain in GDP, whereas if members of society were to choose more leisure time and to engage in healthy activity this would be reflected as a downturn in GDP. Denniss urged the adoption of measures such as the genuine progress indicator2 as an alternative to GDP, and proposed that sustainability, encompassing human wellbeing and environmental integrity, should be mandated in all government policy and decision making. Equity and peaceSue Wareham (President of the Medical Association for the Prevention of War [Australia]) emphasised the waste of resources in war and preparations for war. As the sophistication and cost of weaponry increase, there is an increasing potential for even wealthy nations to overstep their capacity to support their own people. Expenditure on basic services, including health and education, are often the hidden casualties of war. The changing nature of weaponry is also having a devastating impact on human health. The contamination of both urban and rural environments in Iraq by the use of depleted uranium munitions will leave a legacy for the health system that will last long after the US-led occupation. The debateThe day concluded with a panel discussion. General agreement was reached that the Australian population, and most populations of the “developed” world, are no longer living within the Earth’s ecological limits. The ultimate consequence of failing to live sustainably is that we push our own species to extinction. While this seems fertile ground for pessimism, the core focus of the debate was how we might transform this situation. Some promoted technological and market-based solutions, working essentially within the existing frameworks established by industry and government. This generated considerable controversy, as others were seeking a more radical departure from our current societal norms, with the view that we already have much of the required knowledge and technology to bring about effective change. Here the emphasis was on generating cultural change through empowering individuals to take personal action, complemented by the development of positive role models. Jenny Goldie (National Director of Sustainable Population Australia) expressed concern that the issue of population size had been neglected throughout the conference. To highlight the population issue, she pointed out that, on the basis of our current consumption patterns, our population would need to be halved if we are to live within the ecological limits of our country. Our current consumption patterns are sustained by exploiting the resources of other countries. Bryan Furnass, a retired physician, gave his perspective on the issues surrounding sustainability: “The problem lies in the three P’s: population, pollution and poverty; the solution lies in three E’s: ecology, education and ethics”. In his conference summary, Ian Lowe (Griffith University, Queensland) suggested that further debate and action towards sustainability would not occur until more people understood the true meaning of sustainability. “If you look at the Earth from space, where’s the economy? The reality is that you see a ball of blue and green surrounded by a thin atmosphere of gases; you see the environment that sustains us. If you look closely you can make out borders of continents, some landmarks which roughly define country boundaries; this is the society that we have established, and then you have the economy which is a creation of our society.” Any human endeavour that leads to a compromise of ecosystem integrity will not be sustainable in the long term. OutcomesThe context of the debate and recommendations from the conference were summarised in a communiqué.3 In addition, the conference organisers are producing a book (expected to be available this year), with contributions from 14 of the conference speakers, which will reflect the breadth, urgency and relevance to national and international human health of the sustainability debate.

Nick J Towle MB BS(Hons), BMedSc

Research

Women's health 7 June 2004 Free

Patient attitudes to donation of embryos for research in Western Australia

Objective: To ascertain patients’ attitudes to embryo donation for research purposes.Design: Anonymous questionnaire survey.Participants and setting: 235 couples who had embryos in storage at Concept Fertility Centre on 30 March 2003 that had been cryopreserved between 1 January 2000 and 30 June 2002.Main outcome measures: Participants’ choices with regard to donating embryos to another couple, to research to improve in-vitro fertilisation (IVF) techniques or to stem-cell research, and the likelihood of couples choosing to use a range of sources to help them with their decision.Results: The response rate was 57%. Twenty-nine per cent of respondents (36/126) reported they would donate their embryos to research that would improve IVF techniques and 27% (34/126) reported they would donate their embryos to stem-cell research. Fifteen per cent (19/126) would donate their embryos to another infertile couple. Willingness to donate to research was not influenced by whether the couple had previous children, or age. Women and men with moderate to strong religious beliefs were less likely to donate to research. Over 90% of respondents indicated they would seek outside help to decide the fate of their embryos.Conclusion: This study suggests that about 30% of couples would donate their embryos to research, and highlights the need to provide support and information to help couples through their decision-making process.

Peter J Burton PGDip(Sci), PhD · Katherine Sanders BSc(Hons), PhD

Public health

Child health 7 June 2004 Free

Are current playground safety standards adequate for preventing arm fractures?

Objective: To assess compliance with current standards of playgrounds where children have sustained a fall-related arm fracture.Design, setting and participants: Between October 2000 and December 2002, a consecutive prospective series of 402 children aged under 13 years who fell from playground equipment and sustained an arm fracture was identified by emergency department staff in five Victorian hospitals. Trained field testers measured playground equipment height, surface type and depth, and surface impact attenuation factors to determine compliance with safety standards.Main outcome measures: Playground compliance with current Australian safety standards.Results: Ninety-eight percent of playgrounds had a recommended type of surface material. The mean surface depth was 11.1 cm (SD, 5.0 cm) and the mean equipment height was 2.04 m (SD, 0.43 m). Although over 85% of playgrounds complied with recommended maximum equipment height and surface impact attenuation characteristics, only 4.7% complied with recommended surface depth.Conclusion: Playgrounds where children have sustained an arm fracture generally comply with all important safety recommendations except surface depth. Playground fall-related arm fracture requires specific countermeasures for prevention, distinct from head injury prevention guidelines.

Shauna Sherker PhD, MSc, BSc · Joan Ozanne-Smith MD, FAFPHM, MPH

Infectious diseases 7 June 2004 Free

An outbreak of Legionnaires’ disease at the Melbourne Aquarium, April 2000: investigation and case–control studies

Objective: To investigate the source and risk factors associated with Australia’s largest outbreak of Legionnaires’ disease.Design and setting: Epidemiological and environmental investigation of cases of Legionnaires’ disease associated with visits to the Melbourne Aquarium; two case–control studies to confirm the outbreak source and to investigate risk factors for infection, respectively.Participants: Patients with confirmed Legionnaires’ disease who visited the Melbourne Aquarium between 11 and 27 April 2000 were compared (i) with control participants from the community, and (ii) with control participants selected from other visitors to the Aquarium during this period.Main outcome measures: Risk factors for acquiring Legionnaires’ disease.Results: There were 125 confirmed cases of Legionnaires’ disease caused by Legionella pneumophila serogroup 1 associated with the Aquarium; 76% of patients were hospitalised, and four (3.2%) died. The Aquarium cooling towers were contaminated with this organism. Visiting the Aquarium was significantly associated with disease (odds ratio [OR], 207; 95% CI, 73–630). The case–control study indicated that current smoking was a dose-dependent risk (multivariable OR for currently smoking > 70 cigarettes/week, 13.5; 95% CI, 5–36), but chronic illness and duration of exposure at the site were not significant risks.Conclusions: This study showed an association between poorly disinfected cooling towers at the Aquarium and Legionnaires’ disease in visitors, and confirmed current smoking as a critical risk factor. The rapid response, publicity, and widespread urinary antigen testing may have resulted in detection of milder cases and contributed to the relatively low apparent morbidity and mortality rates. The urinary antigen test allows rapid identification of cases and may be changing the severity of illness recognised as Legionnaires’ disease and altering who is considered at risk.

Jane E Greig PhD, MAppEpid · John A Carnie FAFPHM, MPH · Graham F Tallis FAFPHM, MPH · Bernard Zwolak MAppSc, BEd · William G Hart MB BS(Hons), FAFPHM · Charles S Guest PhD, FAFPHM · Norbert J Ryan PhD, BAgrSc · Jennie A Leydon BAppSc · Agnes G Tan BTech(Food)Hons, MHlthAdmin · Ian R Gordon PhD, AStat

Environmental health 7 June 2004 Free

Detention for tuberculosis: public health and the law

Non-compliance with treatment of pulmonary tuberculosis (TB) by an individual can put the community at risk of transmission of TB. Public health (detention) orders can be issued to detain non-compliant individuals, but this is a last resort and rarely used. Two recent cases in New South Wales illustrate the process of issuing a public health order in NSW, and some of the issues that may arise. The NSW law can also be applied to patients with severe acute respiratory syndrome (SARS) or HIV/AIDS. The other states and territories have similar laws, which often apply to a broader range of diseases and have fewer limits on issuing and extending orders.

Sanjaya N Senanayake FRACP, MB BS(Hons), BSc(Med) · Mark J Ferson MD, FRACP, FAFPHM

Medicine and the community

Anonymity or transparency in reporting of medical error: a community-based survey in South Australia

Objectives: To seek public opinion on the reporting of medical errors and the anonymity of healthcare workers who report medical errors.Design and participants: A random, representative survey of 2005 South Australians in April 2002, using telephone interviews based on a vignette provided.Main outcome measures: When a medical error occurs (i) whether the incident should be reported, and (ii) whether the report should disclose the healthcare worker’s identity.Results: (i) Most respondents (94.2%; 95% CI, 93.0%–95.2%) believed healthcare workers should report medical errors. (ii) 68.0% (95% CI, 65.5%–70.5%) of those in favour of reporting believed the healthcare worker should be identified on the report, while 29.2% (95% CI, 26.7%–31.7%) favoured anonymous reporting.Conclusions: Most respondents believed that, when a healthcare worker makes an error, an incident report should be written and the individual should be identified on the report. Respondents were reluctant to accept healthcare worker anonymity, even though this may encourage reporting.

Sue M Evans BN, GradDipClinEpi · Jesia G Berry BHSc(Hons), GradDipPublicHealth · Brian J Smith FRACP, PhD, DipClinEpiBiostat · Adrian J Esterman MSc, PhD, AStat

For debate

Statistics 7 June 2004 Free

Ageing and healthcare costs in Australia: a case of policy-based evidence?

There have been dire predictions that population ageing will result in skyrocketing health costs. However, numerous studies have shown that the effect of population ageing on health expenditure is likely to be small and manageable. Pessimism about population ageing is popular in policy debates because it fits with ideological positions that favour growth in the private sector and seek to contain health expenditure in the public sector. It might also distract attention from the need to evaluate the appropriateness and effectiveness of current patterns of care. Pessimistic scenarios have stifled debate and limited the number of policy options considered. Policy making in Australia would be improved if we took a more realistic view of the effect of population ageing on health expenditure.

Michael D Coory MB BS, PhD, FAFPHM

Snapshot

Cardiovascular diseases 7 June 2004 Free

Aortic dissection in Turner syndrome

Cardiovascular malformations occur in up to 47% of women with Turner syndrome. Aortic dissection, a devastating and often fatal condition, occurs more frequently in women with Turner syndrome than in the general population (0.8% v 0.00001%), particularly in women with 45XO monosomy. There have been many reported cases of Stanford type A aortic dissection (involving the ascending aorta or aortic arch, with variable distal extension) in women with Turner syndrome, but type B dissections (involving only the aorta distal to the arch) are relatively uncommon. We recently successfully treated a 38-year-old woman with Turner syndrome (45XO) who had a Stanford type B thoraco-abdominal aortic dissection. A computed tomography scan (Box) demonstrated contrast within the larger true lumen of the aorta and the smaller false lumen of the dissection, separated by intima. Clinicians treating a patient with Turner syndrome should be aware of their patient’s genotype and investigate for the presence of cardiovascular malformations to help stratify the risk. It is important to remain alert to the possibility of aortic dissection in patients with Turner syndrome who complain of chest pain, abdominal pain or dyspnoea, as early detection may save a life. Ao = aorta (true lumen). D = diaphragm. Ht = heart. IVC = inferior vena cava. Lg = lung. Lr = liver. Arrow indicates false lumen of aortic dissection.

Colin I Clement MB BS, PhD · John Brereton FRACS · Phillip Clifton-Bligh FRACP

Complementary and alternative medicine

Complementary therapies 7 June 2004 Free

Complementary and alternative medicine — with a difference

Understanding change in the 21st century will help us in the CAM debate Medical revolutions are often led by unique biological discoveries, like penicillin, or by technical advances, like microsurgery. Evidence-based medicine (EBM) is a more recent example of a movement led by clinicians seeking greater certainty in outcomes for patients; the Human Genome Project is a movement led by benchtop scientists driven by the vision for more tailored and effective medicines. Not so with complementary and alternative medicine (CAM), where the patient heads the revolution, in the vanguard of an apparently insatiable demand for therapies that may vary from the acceptable face of acupuncture to the more extraordinary claims of crystal therapy. In Australia, each year, we spend more on CAM products than our out-of-pocket contributions to pharmaceuticals.1 In the United States, there are now more CAM consultations than conventional consultations in primary care, while demand for and expenditure on CAM has doubled over the decade of the 1990s.2 A similar situation exists in the United Kingdom.3 In this issue of the Journal we begin a special series on CAM. Rather than dissecting its various diagnostic and therapeutic modalities, the series aims to take a look behind the scenes at CAM’s place in healthcare, in our ethical and legal frameworks and in society generally. We hope to initiate proper debate on CAM, and to promote better understanding of its current and potential roles in healthcare. Coulter and Willis (page 587) start this series with a comprehensive review of the background to the growth of CAM, and propose that the reasons for this growth relate to general societal changes rather than intrinsic concerns with medicine.4 They argue that this change within society might be interpreted as part of the ascendancy of patient self-empowerment, and describe approaches that conventional medicine can take to respond to this growth. It is strange that, at a time when we can do so much more with conventional medicine than we could 50 years ago, increasing numbers of individuals seek CAM for illnesses (such as asthma) which can be effectively and safely managed with conventional approaches. This can place doctors in a very difficult position. What do they do when confronted with a patient who seems to know more about herbal medicine or acupuncture than they do? How do they assess and evaluate an article that claims herbal medicine is effective in the management of inflammatory bowel disease, and to whom do they refer? How should we counsel our graduates to manage these demands, and how should we prepare them for a process of lifelong learning with respect to CAM? These are issues not generally dealt with in most Australian medical schools, and which will be tackled in the series. The emphasis on EBM has at its foundation a desire for improved patient safety, appropriate healthcare expenditure and better disease management. While it is no longer appropriate to dismiss CAM as an evidence-free zone, nor to dismiss educated consumers as misguided individuals, an accelerated research effort remains essential to determine clearly the effectiveness and safety of many CAM products and services. The high (and growing) levels of CAM use indicate that patients, at least, perceive that CAM interventions are effective. Among the issues that will form the focus of debate in the series are questions like: Do many conventional physicians assume patients seek CAM because they believe it to be a more, or equally, effective treatment? On what basis should we integrate CAM into conventional medical care and do we need evidence before integration? Are we, as physicians, medicalising the CAM model when perhaps our patients are trying to escape that model through their use of a particular mind–body therapy? These issues reflect directly on conventional healthcare delivery and the therapeutic relationship between doctor and patient. Almost all doctors in clinical practice will at some point “share care” with a complementary medicine practitioner. This may, of course, not be disclosed to them by their patients! However, if a doctor refers patients to a CAM practitioner, or vice versa, what is the professional relationship and what are the legal and ethical considerations within that relationship? Above all else, we have a duty of care to our patients — “primum non nocere”. With this in mind, it is essential that we establish the professional competence and safety of CAM practitioners and the products they prescribe. The following terms have been variously applied to the relationship between CAM and conventional medicine: Pluralism — a positive outcome of multiculturalism, attempts to encourage mutual respect for contrasting systems; Harmonisation — the diplomatic approach of the World Health Organization, where conventional and traditional (indigenous) medicines work together with no predetermined outcomes or biases; and Integration — the selective incorporation of elements of CAM and conventional medicine. However, true integration will only be possible if CAM commits to appropriate scientific scrutiny and if treatment guidelines are developed that clearly dictate when one option should be selected over (or alongside) another (based on effectiveness, safety, cost, convenience, etc). CAM raises a number of very important issues for medical practice, not least the sanctity, integrity and power of the therapeutic relationship. As our patients become more educated, vocal and vociferous, the medical profession can no longer just be the “possessor of knowledge” but must also provide interpretation and wise counsel. The debates around CAM bring this to the fore and highlight the need for more research, not only on efficacy, but also the cultural and political changes demanded of medicine in the 21st century. The sooner we can understand and manage the change, the more comfortable our role will be as caring physicians. Yet the growth in the use of CAM may have outpaced the development of government policy and the capacity for healthcare professions, insurers and industry to manage emerging issues effectively. It is therefore essential that we sustain, support and develop a coherent research strategy for CAM, and this series will generate suggestions as to how this might be best developed within an Australian context. Medical science holds no unique handle on truth. Much of what is taught now will be unlikely to be practised in 20 years’ time, bearing in mind recent examples such as changes in the evidence for use of HRT (in pharmacotherapy). We hope you enjoy the series, and we look forward to reader participation in the discussion and debate of the issues it raises.

George T Lewith DM, FRCP · Alan Bensoussan PhD

Complementary therapies 7 June 2004 Free

The rise and rise of complementary and alternative medicine: a sociological perspective

Major reasons for the growth in the use of complementary and alternative medicine (CAM), in Australia and elsewhere, are general societal changes rather than specific reasons internal to medicine. There are problems of definition of CAM, as well as the extent to which CAM modalities can be considered a unified paradigm. The general changes examined include the consumer and green movements, as well as postmodernism. The movement surrounding evidence-based healthcare may provide some answers, but will not settle the issue of compatibility. CAM is here to stay and will continue to present challenges for conventional medicine on how to respond.

Ian D Coulter PhD · Evan M Willis PhD

Film review

Metabolic diseases 7 June 2004 Free

A counterweight to fast-food advertising

“Patient is embarking on one-month McDonald’s binge”, writes pragmatic GP Daryl Isaacs in his medical record for a fighting-fit Morgan Spurlock. The young American filmmaker has decided that he is going to eat nothing but McDonald’s food, for three meals of every day for a whole month. He will try everything on the menu, and if asked to “super size”, he will accept the challenge. It seems this intriguing n-of-1 trial, documented on film in the tragi-comic Super size me, was the brainchild of a creative man. Or maybe it was a “gut response” to the judgment handed down in failed US legal action against fast food giant McDonald’s. The legal team for the plaintiffs (two very overweight teenagers) had failed to establish that McDonald’s should be liable for their clients’ obesity, in part because we all know (don’t we?) that fast food may be harmful and that it isn’t meant to be eaten for three meals a day. At the start of Spurlock’s McTrial, his GP and other professional advisers — a gastroenterologist, a cardiologist, a dietitian and an exercise physiologist — were expecting to see relatively minor changes as a result of his “Mac attack”, among them a rise in serum lipid levels and an increase in weight. None of the team seemed particularly worried. But fairly early on they start advising him to stop, or at least modify, what he is doing. A little later they are trying to convince him, in no uncertain terms, to stop the experiment altogether. His dietitian worried about weight gain and poor nutrition; the doctors were concerned about his rising liver enzyme levels; and his mother offered him a portion of her liver should he need a transplant! His girlfriend Alex — who just happens to be a vegan chef — stood by her man despite her fears for his health. Everyone can see where Spurlock is heading, and the trial doesn’t end a moment too soon for this young man’s peace of mind. Throughout, Morgan’s ever-present, ironic humour keeps the viewer entertained and engaged — for example, after his baseline physical, which included a per-rectal examination, he quipped: “I like my doctor to be thorough”, and after his first super size meal he reports symptoms of “McGas”, “McSweats” and McTwitches”, as well as “feeling a little McCrazy”. The film travels well beyond the filmmaker’s personal experiences. Although McDonald’s has received special attention in the film because, as one interviewee said, it “lures in young children”, Spurlock also takes us to schools, professorial offices and boardrooms around America, showing us how fast foods in general and their supporters have conquered not only neighbourhoods but also school canteens and government legislators. Former US Surgeon General David Satcher and Professor Kelly Brownell, Director of the Yale Center for Weight and Eating Disorders, are among the many experts interviewed. Spurlock’s film explains how fast food can conquer us as individuals (and whole nations?), with its cocktails of addictive constituents and why it has a starring role in the current epidemic of obesity and obesity-related diseases. It is no surprise that this documentary is already winning major awards, including for Best Director at this year’s Sundance Film Festival. Super size me exhibits a wonderful balance: as funny as it is informative, as intimate and personal as it is professional, and as affectionate about McDonald’s as it is castigating. If only all fast food was as balanced nutritionally.

Ann T Gregory

The Research Enterprise

Ethics 7 June 2004 Free

My pseudoscientific nightmare

Everyone knows medical research is about improving healthcare Recently I had some trouble with people one might call “pseudoscientists”. These individuals are often technically quite competent; they seem to know their craft and they produce seemingly good work. But there is something amiss. It took me a long time to find out what that might be. Now I think I have identified it — the pseudoscientist has entered the field of science for the wrong reason: to advance not medicine, but himself. This theme must have been on my mind the other night, when I had the most vivid dream. The dream took me to the “Annual Festival of Pseudoscience”, where a panel of the most distinguished pseudoscientists reached consensus on how to become a fellow pseudoscientist. Here are the 10 commandments of pseudoscience that they dictated to their audience. Ensure that passionate belief rather than reason is the force that drives you. In science, one tests (more accurately, falsifies) hypotheses. In pseudoscience you want to “prove” what you already “know”. Only the biased researcher can mislead the world effectively. Avoid scientific training. Pseudoscience needs enthusiastic amateurs who have picked up the rules of science while busy doing other things. The worst that could happen to pseudoscience is for properly trained career scientists to join its arena. Maintain your bias. Bias usually originates from interests that create financial, personal or emotional conflicts. Nurture those interests and never disclose these conflicts to anyone, particularly not when publishing. Use publicity to obtain funding. Research funds are becoming scarcer by the minute. Lack of funds can seriously delay your endeavours. If you find it difficult to compete, the time-tested approach is to make more noise than anyone else. Hire a PR firm, for instance. Once the daily papers regularly sing your praises, your pseudoscience will thrive. Do not lose sight of what you intend to prove. Some people say that good research can never be “negative” — even showing that therapy X is not effective would yield the positive result of enabling patients to choose something that does work. Make sure your goals are not obscured by such old-fashioned nonsense — your aim as a pseudoscientist is to assist your friends, the manufacturers or promoters of therapy X. Let your goals drive your data analysis. Even with safeguards in place, you might one day generate a result that does not fit your preconceived ideas (or those of your sponsors). Subanalyse and subanalyse until you have what you were fishing for — a significant result showing what you want. Suppress unwelcome results. If things should go disastrously wrong and even extensive data dredging does not yield the desired outcome, the professional pseudoscientist must resort to the last, desperate, but usually effective, measure. Make the unwelcome finding disappear — don’t ever publish anything that does not confirm your beliefs or that might upset your friends. Overinterpret. More often than not, you will create data that you and your sponsors like. Now you must ruthlessly overinterpret these findings to ensure that everyone knows about your work. Publish your results as often as you possibly can. Journal editors don’t like duplicate publications, so it would be foolish to tell them. Attack opposing scientists. There is always a danger that scientists will publish papers that upset pseudoscientists. In such cases, initiate a campaign of defamation against your opponent — this will decrease their credibility and increase yours, and all will be fine again. At this point, I woke up feeling sick and anxious. Where does the dream end and reality begin? Did I have a nightmare or a vision? And, horror of horrors, did I not recognise some of the faces of the panellists? But it must have been a nightmare! These 10 commandments are just a guide on “how not to conduct medical research”. Surely, medical research is not abused as a career springboard? This would result in chaos and lead us badly astray without a compass for orientation. Surely, any responsible researcher knows that medical research is about improving healthcare? If not, how could we continue with the progress medicine has made so far? Surely, medical research has not been taken over by pseudoscientists. Or has it?

Edzard Ernst MD, PhD, FRCP

Letters

Bulk-billing GP clinics did not significantly reduce emergency department caseload in Mackay, Queensland

Dale W Hanson,* Herbert R Sadlier,† Reinhold Muller‡ * Tom and Dorothy Cook Research Fellow, James Cook University; † Director, Emergency Department, Mackay Base Hospital, PO Box 5580, Mackay Mail Centre, Mackay, QLD 4741; ‡ Associate Professor, School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD. dwhansonATmackay.matilda.net.au To the Editor: It has been argued that reduced levels of bulk billing have resulted in emergency department (ED) overcrowding due to an increase in non-emergency, primary care ED presentations.1 In the 2001–02 financial year, Queensland EDs experienced a 7.1% growth in caseload compared with 2000–01 (Mr D Searle, Surgical Access Team, Queensland Health, personal communication, Nov 2002). During the same period, there was a 1.5% decline in the proportion of general practice services bulk billed in Queensland. Before December 2000, no dedicated general practice bulk-billing clinics existed in Mackay. The opening of two bulk-billing clinics, one within 1 km of Mackay Base Hospital, provided an opportunity to assess the effect of the increased availability of bulk-billing services on ED presentations. The Mackay region had a full-time-equivalent GP : patient ratio of 1 : 1648 in 2002, compared with a Queensland average of 1 : 1143.2 In the September quarter of 2000, 58.4% of GP consultations were bulk billed in Mackay, compared with 85.7% in Brisbane (Ms D-A Kelly, Federal Member for Dawson, personal communication, Jun 2003). The Mackay Base Hospital ED provides 24-hour, 365-day emergency medical services to the Mackay region, and managed 34 558 presentations in the 1999–00 financial year, admitting 15% of its caseload. On the Australasian Triage Score (ATS) classification, 0.2% of presentations were category 1, 4% category 2, 20% category 3, 54% category 4, and 21% category 5. Since the bulk-billing clinics were established, there has been an average of 237 extra bulk-billing consultations per day, with a resultant 7.3% increase in the proportion of GP consultations bulk billed in the federal electorate of Dawson (Ms D-A Kelly, Federal Member for Dawson, personal communication, Jun 2003) (91% of the electorate lives in the Mackay region). However, ED presentations have remained stable, with a median 93 presentations per day (Box). Changes in the proportion of ATS 3, 4 and 5 presentations were observed (25%, 55% and 14%, respectively), but were associated with internal organisational changes (shifting surgical and orthopaedic dressing clinics out of the ED and into the outpatient department, and a review of triage policy), and cannot be reliably attributed to the influence of the bulk-billing clinics. In Mackay, the implementation of two bulk-billing GP clinics did not result in a measurable reduction in the absolute number of ED presentations. These results are consistent with previous studies that suggest that non-emergency, primary care ED presentations are not a major determinant of ED overcrowding.3 Effect of general practice bulk-billing presentations on average daily emergency department presentations, Dawson electorate, Queensland

Dale W Hanson · Herbert R Sadlier · Reinhold Muller

Bulk-billing GP clinics did not significantly reduce emergency department caseload in Mackay, Queensland

Ian F Knox President, Australasian College for Emergency Medicine, 34 Jeffcott Street, West Melbourne, VIC 3003. iknoxATgil.com.au Comment: The report by Hanson et al1 comes at an important time in the debate regarding emergency departments, especially at the onset of winter, a time of high demand and stretched resources. The authors describe the effect of the opening of two bulk-billing clinics on attendances at the emergency department (ED) of a provincial Queensland hospital. Despite the clinics seeing 2.5 times the number of patients seen at the emergency department each day, this resulted in no reduction in ED attendances. This should give pause for thought to those who maintain there is a simple and direct relation between the level of bulk billing of general practitioner services and ED workloads. The nature of the relation between GP services and ED attendances has never been clearly defined, but it is likely to be complex. Similarly, the nature of ED workloads is also complex, and more than just a matter of the total attendances.2 In the Journal last year, Cameron and Campbell cited the major causes of access block and overcrowding as being the reduction in hospital beds and aged care facilities, along with changes in workforce and community attitudes.3 In that issue, the Journal published a series of articles that essentially represented a national audit of responses to ED overcrowding. Only one article described the opening of a GP clinic as a response; the authors noted that this was unsuccessful in reducing access block.4 Thus, the findings of Hanson and colleagues are neither new nor surprising. Overcrowding is the single most important barrier to quality in ED care. It is a symptom of a serious and growing mismatch between demand and supply for acute healthcare services. Solutions require a whole-of-systems approach. Efforts to improve the flow of patients through acute-care hospital beds are needed, as are strategies to divert some current inpatient flow to community-based subacute services. There is an important role to be played by GPs in coordinating the management of patients with chronic and complex health problems, to reduce the demand for acute-care admissions to hospital, and in working in partnership with the acute-care sector in coordinating community-based subacute alternatives to hospital care. Such initiatives will only come about if state and Commonwealth governments and health departments work together.

Ian F Knox

Statistics 7 June 2004 Free

What explains falling asthma mortality?

Elizabeth J Comino Senior Research Fellow, School of Public Health and Community Medicine, University of New South Wales, Liverpool Hospital, Liverpool, NSW. E. CominoATunsw.edu.au To the Editor: The Australian Bureau of Statistics recently released details of asthma mortality for 2002. These figures indicate that asthma mortality has continued to decline in 2002 and that deaths in young people aged 5–34 years are at their lowest level since the early 1950s (Box). In this age group, the number of deaths fell from 43 in 2001 to 33 in 2002 (a 23.3% drop), and for all ages the number of deaths fell from 422 in 2001 to 397 in 2002 (a 5.9% drop). This suggests that the various asthma awareness activities, spearheaded by the National Asthma Council and other interest groups, have been successful in raising awareness of asthma and its management. Or does it? Emerging evidence suggests other changes in the epidemiology of asthma in Australia. Robertson recently reported a 26% decrease in the prevalence of asthma in Melbourne school children between 1993 and 2002, but increased reporting of rhinitis and eczema over the same period.1 The significance of these findings is difficult to interpret without measures of airway function. A second study supported these results and also observed a small decline in the prevalence of parent-reported asthma, but found little change in atopy or airway hyperresponsiveness.2 Age-adjusted hospital separation rates for asthma decreased by 31.1% in young people and 31.4% in all ages between 1989–90 and 1999–00.3 There is little evidence of improved management of asthma in the general practice setting. Data published from the BEACH (Bettering the Evaluation and Care of Health) survey of general practice activity indicates a significant reduction in rates of presentation for asthma among children but not adults, with no changes in indicators of severity over time.4 Our recent research in south-western Sydney, examining uptake of the “asthma 3+ visit plan”5,6 by general practitioners and their patients, is disappointing. It suggests reluctance on the part of both GPs and patients to participate in the plan. Clearly, there remains much that we do not understand about the natural history of asthma.7 We need to continue to monitor asthma through regular surveys and routine data collection in order to understand more about fluctuations in asthma prevalence, the relationship to changing child-rearing practices (such as use of childcare facilities) and the impact of management practices. Asthma mortality in Australians aged 5–34 years, 1920–2002* * Points on the graph represent 3-year “moving” averages — for example, the 2001 value is the average of 2000, 2001 and 2002 data; the 2000 value is the average of 1999, 2000 and 2001 data, etc. This technique is used to smooth annual fluctuations that occur in data of this kind.

Elizabeth J Comino

Infectious diseases 7 June 2004 Free

Central venous catheters: optimal patient care or convenience?

John R Gowardman,* Maria Brosnan,† Joy Whiting,‡ Peter Collignon§ * Intensive Care Physician, † Medical Student, ‡ Data Manager, Intensive Care Unit, § Director, Infectious Diseases Unit and Microbiology Department, The Canberra Hospital, PO Box 11, Woden, ACT 2607. peter.collignonATact.gov.au To the Editor: In most serious infections associated with intravascular devices, the device is a central venous catheter (CVC).1,2 Good clinical practice dictates that these devices should be removed when no longer needed.3 Our intensive care unit maintains a clinical practice of prompt removal of CVCs once they are no longer required. In addition, CVCs are to be removed before patients are discharged from the unit (for “general” patients) or within 24 hours (for cardiothoracic surgical patients). We conducted an audit to determine how often this practice was followed and whether it had unintended adverse clinical consequences (eg, need to reinsert a CVC). The audit was conducted over 8 weeks in 2001 and included 126 CVCs in 103 patients. Fifty-eight CVCs (46%) were removed by the predetermined time, and 68 (53%) were retained past this time (Box). The data demonstrated: Low removal rates, with 31% (23/74) of CVCs removed in general patients, but higher rates in cardiothoracic surgical patients (67%; 35/52). APACHE II scores, ventilation times and lengths of stay in the intensive care unit were similar in the group who had the CVC removed and the group who retained the CVC, implying that severity of illness was not a factor biasing retention. Among patients who had a CVC removed, none had another CVC reinserted; cannulation rates with short peripheral catheters were low and acceptable. Retention of the CVC past the predetermined time resulted in significant prolongation of CVC in-situ time (eg, general patients 7.0 v 3.2 days). The reason given for CVC retention in general patients was antibiotic administration for 37/40 (93%) (vancomycin, 6; β-lactams, 20; aminoglycosides, 9; and quinolones, 2), while total parenteral nutrition and poor peripheral access were factors in only seven (18%). In the 13 cardiothoracic surgical patients, the reason given was inotrope infusion in four (30%) and amiodarone infusion in four; no reason could be ascertained in the other five. Two issues emerge from this audit. Firstly, there did not appear to be good reasons for retaining many of these CVCs. Drug therapy was most often quoted, but many of these drugs (antibiotics and amiodarone) could have been safely administered via a short peripheral intravenous cannula, with markedly lower risk of infection.2-5 We believe that when a patient left the intensive care unit with a CVC, it most likely remained in place as a “convenience” factor for busy nursing and junior medical staff on the wards. However, this was at the cost of a significant increase in CVC in-situ times, increasing the risk of both mechanical and infectious complications. Secondly, implementation of predetermined CVC removal appears safe in our hospital. Although removal rates were lower than expected, nearly half of all CVCs inserted over the 8-week study period were removed as per “clinical practice”, without any need for CVC reinsertions. We have now further refined our clinical practice and introduced a formal written policy that: All CVCs should be removed and replaced with a suitable alternative before patient discharge from the intensive care unit, unless there is a specific indication for retention. Retention of a CVC should be based on simple guidelines, such as need for total parenteral nutrition, poor peripheral venous access, or use of drugs that require central access. We recommend implementation of this simple policy in other intensive care units. Characteristics of patients and central venous catheters (CVCs) in the audit General ICU patients Cardiothoracic patients CVC removed CVC retained P CVC removed CVC retained P Number of patients 20 40 30 13 Number of CVCs 23 51 35 17 APACHE II score (mean [SD]) 14 (3) 16 (6) 0.13 13 (4) 13 (2) 1.00 Length of ICU stay (d) (mean [SD]) 3.9 (5.4) 2.4 (3.5) 0.2 1 (0) 2.1 (3.7) 0.1 Ventilation time (h) (mean [SD]) 61 (86) 47 (51) 0.5 17 (3.5) 20 (15.6) 0.3 % Of patients ventilated* 60% 41% 100%‡ 100%‡ CVC in-situ time (d) (mean [SD]) 3.2 (3.2) 7.0 (5.6) 0.003 2.1 (0.25) 4.5 (3.8) 0.001 Number of peripheral IV catheters† (mean [SD]) 1.8 (1) 0.6 (0.6) < 0.001 0 0.07‡ Number of CVCs reinserted 0 na 0 na ICU = intensive care unit. IV = intravenous. na = not applicable. * Mechanically ventilated in the intensive care unit. † At 7-day follow up. ‡ Only one peripheral catheter was inserted in one patient.

John R Gowardman · Maria Brosnan · Joy Whiting · Peter Collignon

Infectious diseases 7 June 2004 Free

Q fever in children: an emerging public health issue in Queensland

Jennifer H Barralet,* Neil R Parker† * Epidemiologist, Communicable Diseases Unit, † Public Health Physician, Darling Downs Public Health Unit, Queensland Health, GPO Box 48, Brisbane, QLD 4001. Neil_ParkerAThealth.qld.gov.au To the Editor: Queensland has a small but increasing number of Q fever notifications in children. This is of concern to public health services in the Darling Downs and south-west Queensland where most Q fever notifications originate (Box). Little is known about Q fever in children, especially in Australia, as the disease is primarily diagnosed in adults following occupational exposure to Coxiella burnetii. Here we report a case series examining clinical presentation, exposure to risk factors and disease outcomes in children. Twenty-one children aged 3–14 years notified with Q fever from the Darling Downs and south-west Queensland in 2001 and 2002 were followed up. In acute cases the febrile illness was similar to that in adults from the same region. The one child with chronic Q fever had no known acute illness and presented with osteomyelitis of the wrist. All the children recovered, although relapsing symptoms were reported in two children and three reported persisting fatigue for 3 months or more after diagnosis. All but one patient reported contact with cattle, sheep or goats (13 lived on a farm and 7 had visited a farm). The single exception reported contact with kangaroos and feral pigs through hunting. Prolonged exposure to animals or the farm environment was not necessary for infection. Twelve of the children had high risk exposure to C. burnetii (contact with animal births, newborn animals, or animal carcasses). With increasing age, exposure of children from rural properties approaches that of their parents as they participate in the same activities. An effective vaccine is available,1 but use in people younger than 15 years is not recommended because of the lack of safety and efficacy data. Although avoidance of high risk situations such as shearing, animal births or on-farm butchering will decrease the chance of infection, these measures may be impractical for rural children. Realising this, some practitioners choose to vaccinate younger children who assist with animal births and butchering. Increasing notifications in children may reflect increased awareness that Q fever is not confined to adults with occupational exposures. Increased awareness leading to recognition of infection would give children access to effective treatment and may contribute to prevention of chronic disease. However, much remains unknown about Q fever in children, including how often the infection is asymptomatic, the spectrum and outcome of disease, and if there are effective preventive strategies. As many rural children cannot avoid potential exposure to Q fever, our study highlights the need for a safe and effective vaccine for children. Q fever notifications in children aged 0–14 years, 1997–2002

Jennifer H Barralet · Neil R Parker

Environmental health 7 June 2004 Free

Border screening for SARS

Nicola Petrosillo,* Vincenzo Puro,† Giuseppe Ippolito‡ * Clinical Director, † Epidemiologist, ‡ Scientific Director, National Institute for Infectious Diseases “L. Spallanzani”, Rome, 00149, Italy. petrosilloATinmi.it To the Editor: In their article describing the Australian experience of border screening for severe acute respiratory syndrome (SARS), Samaan and coworkers add new insights about the low efficacy of this measure in identifying SARS cases at entry into a country.1 To our knowledge, this is the first report on this issue from a low-risk area for SARS.2 Indeed, as summarised by Samaan et al, other available data derive from countries where people with SARS, entering at the early stage of the epidemic, generated a sustained local transmission of SARS-associated coronavirus (SARS-CoV) disease. Among the reasons for a low sensitivity of entry screening, Samaan suggests that subjects may evade screening by making false declarations or by taking anti-pyretic drugs, or by simply being in the incubation period with no symptoms or only mild symptoms. To contribute to this debate, we report the experience of our Institute, which was designated as a referring centre for SARS by the Italian Ministry of Health. In Italy, where only four imported probable cases of SARS were identified and no local transmission occurred,3 entry screening was implemented at the two international airports of Milan and Rome. In particular, travellers and crews arriving from World Health Organization SARS-designated areas, directly or after transiting in other EU countries, were provided with health alert cards and screened for body temperature.4 Suspected SARS cases identified at Rome airport were to be referred to our institute. However, of the 72 subjects attending our admission unit for clinical evaluation for possible SARS, none was referred by the airport authorities. Among these patients was one of the four people with SARS arriving in Italy: an airline flight crew member coming from a SARS-designated area who passed both exit and entry screening, despite complaining of mild fever before his departure. He was admitted 6 days after arrival, at which time the clinical picture had evolved into full-blown SARS. He was discharged after 2 weeks. Among the measures recommended by WHO to reduce SARS-CoV spread, the identification of symptomatic subjects at border departure screening was the only measure with some evidence of efficacy, although this only reduced on-flight transmission.5 Conversely, evidence from several sources, including Samaan et al, showed that screening travellers (visual inspection and screening for fever) as they disembark identifies very few SARS cases and is of questionable value.1 We agree with the conclusions of Samaan et al that, in the light of a possible resurgence of SARS or similar diseases (avian flu), entry screening should, at least, be more focused, and needs further evaluation, including cost-effectiveness analysis.

Nicola Petrosillo · Vincenzo Puro · Giuseppe Ippolito

Using AUDIT to classify patients into Australian Alcohol Guideline categories

Julia E Fawcett,* Anthony P Shakeshaft,† Mark F Harris,‡ Alex Wodak,§ Richard P Mattick,¶ Robyn L Richmond** * PhD Candidate, † NHMRC Research Fellow, ¶ Director, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW 2052; ‡,** Professors, School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW; § Director, Alcohol and Drug Service, St Vincent's Hospital, Sydney, NSW. A. ShakeshaftATunsw.edu.au To the Editor: Revised Australian Alcohol Guidelines1 were released in 2001. Although general practitioners (GPs) can be influential in initiating and supporting behaviour change to reduce levels of alcohol misuse among their patients,2,3 the extent to which their advice remains relevant and effective depends largely on the extent to which screening tools can be modified to take account of revised versions of such guidelines. The Alcohol Use Disorders Identification Test (AUDIT)4 is a clinical instrument used widely to screen patients for problematic alcohol use. The aims of our study were to examine the ability of AUDIT to classify general practice patients’ alcohol consumption into the categories specified in the revised Australian guidelines, and to identify any additional information needed for such classification. Patients aged at least 16 years attending a general practice surgery in western Sydney were asked by receptionists to complete a health-related survey by means of a hand-held computer while waiting for their consultation. Items covered a number of domains, including demographics, the AUDIT, and two additional questions about consumption of specified quantities of alcohol. The use of computers ensured patients were only asked questions relevant to them. Risk of harm in the long term: Respondents’ average number of standard drinks per week was calculated from the first two AUDIT questions, using a previously devised method.5 Risk of harm in the short term: AUDIT question 3 is not specific enough to distinguish short-term risk of harm, so additional, sex-specific questions on how many occasions in the previous 30 days the patient had consumed “7–10” and “11 or more” (men) or “5–6” and “7 or more” (women) standard drinks were asked. Of the 115 patients who completed the survey, 62% were female; their mean age was 42 years; 10% were unemployed; 34% had had tertiary education; 65% were married or in a de facto relationship; and 80% were born in Australia. Their alcohol consumption patterns are shown in the Box. AUDIT is a reliable and valid instrument, and is widely used as a clinical tool. However, as national guidelines are updated, clinical tools such as AUDIT need to remain consistent with them. Ideally, revisions would build on the benefits of existing tools rather than rendering them obsolete. For example, a major advantage of AUDIT is that it measures a number of drinking dimensions within the one, brief, validated instrument. This multidimensionality could be preserved while promoting AUDIT’s consistency with new guidelines by adding two items, with high face validity, to more accurately assess risk of harm in the short term. Incorp-orating the two additional consumption items we used in this study with AUDIT allows drinkers to be classified according to the guidelines as “low-risk”, “risky” or “high-risk” both in the long term and short term, with minimal additional response time. Alcohol consumption patterns in one general practice in western Sydney, as defined by the recently revised Australian Alcohol Guidelines1 Characteristic Males (%) Females (%) Total (%) Abstinent 18.2 29.6 25.2 Long-term harm Low-risk 68.2 67.6 67.8 Risky 11.4 1.4 5.2 High-risk 2.3 1.4 1.7 Short-term harm Low-risk 61.4 52.1 55.7 Risky 9.1 8.5 8.7 High-risk 11.4 9.9 10.4 Bold text represents categories that cannot be distinguished using AUDIT alone.

Julia E Fawcett · Anthony P Shakeshaft · Mark F Harris · Alex Wodak · Richard P Mattick · Robyn L Richmond

Complementary therapies 7 June 2004 Free

Acute liver failure associated with the use of herbal preparations containing black cohosh

Michael Thomsen,* Luis Vitetta,† Avni Sali,‡ Matthias Schmidt§ * Research Associate, † Deputy Head, and Director of Research, ‡ Head, Graduate School of Integrative Medicine, Swinburne University, 9 Frederick Street, Hawthorn, VIC 3122; § Research Head of Toxicology, Society of Nutritional Medicine and Dietetics, Harsewinkel, Germany. LVitettaATmedicine.swin.edu.au To the Editor: We wish to comment on the case report by Lontos and colleagues on the proposed causal relationship between the herb black cohosh (Cimicifuga racemosa) and acute hepatic failure.1 One other case has been reported in Australia,2 and the evidence linking black cohosh to liver toxicity was weak and contested.3 The medication in the case report presented by Lontos and colleagues1 included a herb (ground ivy) containing a known liver toxin (pulegone). Pulegone is considered a strong hepatotoxin and should not be dismissed, even though it was reported that there was less pulegone in ground ivy than in pennyroyal. The authors do not indicate the daily dose of the pulegone ingested. The Therapeutic Goods Administration (TGA) made only qualitative analyses of three of the five herbs in the mixture. In our opinion the most suspect ingredient was ground ivy, and it was not assayed. The argument that the TGA could not find a standard for pulegone or ground ivy is untenable given the level of expertise and the capacity of the TGA and its laboratories. Was the supply company asked to provide analytical evidence of the contents of the herbal extracts? Ground ivy is not known to be hepatotoxic, but it is possible that the extract could have contained ground ivy with pennyroyal, which might explain the hepatoxicity of the mixture. Although uncertain without thoroughly investigating all ingredients in the herbal mixture, this alternative is a possibility. Without thorough investigation of herbal preparations, adverse events attributed to certain herbs remain dubious at best. Black cohosh has a very good safety record. There is a large body of clinical evidence and research which suggests that this herb has no hepatotoxic effects. Indeed, a German manufacturer has sold more than 350 million daily doses of black cohosh preparations worldwide since the pharmacovigilance system was introduced, and no comparable cases have been reported until these two reports in Australia. An Ames test (salmonella microsomal assay) showed no in-vitro evidence of mutagenic potential of an extract of black cohosh,4 and no chemical or organ toxicities were observed in Wistar rats given up to 5000 mg of a Cimicifuga racemosa extract granulate per kilogram body weight for 26 weeks.5 What may also be of concern is that the TGA may not have the full capabilities to test ingredients used in Australian herbal products. That substitution of herbs with potentially toxic herbs may be a common event, and that neither the TGA nor the manufacturers may have the expertise to prevent deleterious contaminants, is of even greater concern.

Michael Thomsen · Luis Vitetta · Avni Sali · Matthias Schmidt

Complementary therapies 7 June 2004 Free

Acute liver failure associated with the use of herbal preparations containing black cohosh

Fiona J Cumming,* Larry Kelly† * Director, Office of Complementary Medicines; † Acting Director, TGA Laboratories; Therapeutic Goods Administration, PO Box 100, Woden, ACT 2606. fiona.cummingAThealth.gov.au Comment: Thomsen and colleagues have pointed to what they believe were uncertainties in the case described by Lontos et al, associating the use of a herbal preparation containing black cohosh with acute liver failure.1 They assert that on the basis of these uncertainties, and other evidence, black cohosh was unlikely to have been the cause of the liver failure. There are indeed uncertainties about the cause of the illness. The first, and quite critical one, is that we cannot be certain that the patient was given the same herbal materials as those supplied to the Therapeutic Goods Administration (TGA) for analysis. The pharmacist who dispensed the herbal formula for the patient provided the TGA with samples for analysis of each of the five individual extracts in the formula. Documentary evidence supporting the correct identity of the five herbs was supplied in the form of certificates of analysis from the manufacturers of the individual herbal extracts. However, it was not possible to ascertain whether the exact batch of the exact formulation taken by the patient was that which was tested by the TGA. While the title of the article by Lontos et al suggests a “problem” with black cohosh, the body of the article makes clear that the causative agent(s) are unknown,1 which is in agreement with the letter by Thomsen et al.1 Thomsen and colleagues claim that the TGA did not test the ground ivy extract supplied by Lontos et al, and said that this was because the TGA did not have a standard for pulegone or ground ivy. This is not the case, and the letter by Lontos et al1 does not state that either. The reason the TGA did not test initially for pulegone was because it is a minor constituent of the essential oil of ground ivy. We did not expect there to be any significant levels of this compound. In fact, we have subsequently confirmed that pulegone was not detectable (limit of detection 5 ppm) in the sample of ground ivy extract provided by Lontos et al. Thomsen and colleagues refer to the good safety record of black cohosh in Australia and internationally, and claim there has been only one other case in Australia where black cohosh was linked to liver toxicity. Some caution is needed in drawing broad conclusions about the safety of herbal medicines. Most countries do not have adverse reaction reporting systems which include herbal remedies. In Australia, where we have a well-developed reporting system, there have been several reports of liver problems in patients taking various preparations containing black cohosh. However, causality has not been established beyond doubt in these cases. The TGA has state-of-the-art testing facilities and a team of internationally recognised scientific staff. The formulation supplied to the patient was extemporaneously dispensed by a pharmacist. Such medicines are not subject to the regulatory controls of the TGA and would not normally be included in the TGA’s testing program. However, the TGA offered to test the herbal formulation supplied by the pharmacist to assist the clinical team. The results of the TGA’s testing confirmed the absence of undeclared pharmaceuticals in the samples of herbal extracts provided. In view of these uncertainties, it is not possible to conclusively identify the cause of the patient’s liver failure. On the evidence available it cannot be concluded that black cohosh was a cause. It is simply not possible to rule in or rule out black cohosh, or indeed any of the other herbal extracts in the formulation taken by the patient, as a cause. Where practitioners suspect a complementary medicine is involved in an adverse reaction, providing the exact product and batch taken by the patient is essential if laboratory testing is to help in confirming causality.

Fiona J Cumming · Larry Kelly

Book reviews

Ethics 7 June 2004 Free

Antidote to depersonalised medicine

Restoring humane values to medicine. A Miles Little reader. Ian Kerridge, Christopher Jordens, Emma-Jane Sayers (editors). Sydney: Desert Pea Press, 2003 (x + 307 pp). ISBN 1 87686 108 8. Miles Little’s distinguished credentials and past experience as a surgeon, poet, philosopher and humanist make him particularly qualified to address the restoration of humane values to medicine. The origin of threats to values in medicine today is addressed in depth and in an analytic and reflective way. His essays are well chosen to accomplish this, but are difficult to read, as the language at times seems purposefully abstruse. Nonetheless, the importance of the topics covered makes the effort worthwhile. The technique of adding commentaries by thoughtful people in the field is helpful in putting Little’s views in perspective and in a contemporary context. One of the unique contributions to the book is Little’s discussion of the ethics of surgery and the analysis of its five moral domains. These follow the progression of the surgeon–patient relationship through the process of surgery and the patient’s response to each stage. As Russell Gruen points out in his associated commentary, they “help us to understand why surgery cannot be practised as a purely technical exercise.” In medicine, which is increasingly technology-dependent, the promotion of humanism in physicians and surgeons must be a strong antidote to the impersonalisation and deprofessionalisation which technology can bring. The other essays address the conflicts and dilemmas facing the practitioner in contemporary medicine. As one reads each essay there is an opportunity to reflect and gain a better understanding of the issues, whether the subject is euthanasia, death, the place of evidence-based medicine and epidemiology, the real issues of consent and whether it can be informed, the impact of resource restraints, or the demand for accounting logic in medicine leading to “ethonomics.” Physicians need to reflect on these issues if they are to bring care, compassion, and integrity to their practices. These essays are particularly useful to those in academic medicine where the teaching of the physician as healer and professional require humanism and reflection if these qualities are to be imparted. Sylvia R CruessAssociate Professor of Medicine McGill University, Montreal, Canada

Sylvia R Cruess

History and humanities 7 June 2004 Free

Colourful definitions

Dorland’s illustrated medical dictionary. 30th ed. Philadelphia: Saunders, 2003 (xxvii + 2190 pp + CD-ROM). ISBN 0 7216 0146 4. When you’re lost for words or in search of medical meanings, you may find what you’re looking for in Dorland’s illustrated medical dictionary. Now in her thirtieth edition, this oracle — in print for over 100 years — must have decided that a double celebration was in order. She has reinvented herself, not only in technicolour, but also by gaining a web presence, as book purchasers are granted full on-line access to the dictionary at www.dorlands.com, as well as given a CD-ROM with the Dorland’s pocket dictionary in personal digital assistant format and a spellchecker. The colouring of Dorland’s is not for show, but to facilitate ease of use. Headings are in red type, with the definition(s) following in black. Tables and appendices, and groupings like the syndromes and systems, are readily located within boxes with red borders and a pale yellow background. The word “illustrated” is more applicable than ever before, with the dictionary’s artwork undergoing a complete revamp. There are now 600 colour photographs and nearly 500 line drawings, all in colour. Dorland’s “designers” (lexicographers), with the aid of 22 consultants from North America, have also reviewed her entire wardrobe of words. Obsolete items have been removed, definitions have been updated and expanded, and new words have been added. In fact, the book has gained nearly a kilo in two editions, now tipping the scales at a little over 4 kg. The weight gain is partly due to the decision that she should embrace hundreds of terms from the increasingly popular fields of complementary and alternative medicine. Also contributing to the increase in size are new, updated and reorganised appendices, for example for cancer staging and symbols (such as the “shorthand” often used in clinical note-taking). Those who remember this old girl with fondness need not be alarmed. She has retained her classic, signature style — an attention to accuracy and clarity and an authoritative tone. And, although her accent is North American, Australians should have little difficulty in understanding her. In her class, Dorland’s illustrated medical dictionary remains a firm favourite with the Medical Journal of Australia editorial team. Or, in other words, the old girl’s still got it. Ann T GregoryDeputy Editor, Medical Journal of Australia Pyrmont, NSW

Ann T Gregory

Columns

7 June 2004 Free

In Other Journals

Exchanging kidneys A living-donor exchange of kidneys has occurred between members of a Palestinian and an Israeli family in the Middle East, defying political and social constraints, according to an article reporting advances in living-donor transplantation. The exchange involves two donors, incompatible with their intended recipient, donating to each other’s recipient, with whom they are compatible. In this exchange, a 45-year-old Arab truck driver received a kidney from a 38-year-old Jewish donor, and the Jewish donor’s 10-year-old son received a kidney from the truck driver’s wife. Programs of living-donor exchange are in operation in several locations around the world. N Engl J Med 2004; 350: 1812-1814 Tea-tree v MRSA Tea-tree (Melaleuca alternifolia) preparations may have a role in eradicating MRSA in colonised patients, say UK researchers. They compared two topical regimens in a randomised controlled trial involving 224 hospital patients. The researchers found that tea-tree treatment (5% body wash, 10% cream) was more effective than chlorhexidine or silver sulfadiazine at clearing superficial skin sites, including skin lesions (10% cream). Although tea-tree (10% cream) was less effective than mupirocin (2% nasal ointment) in clearing nasal carriage, it may still be useful in areas of high mupirocin resistance. J Hosp Infect 2004; 56: 283-286 Smoking homes Living with people who smoke is probably risky for non-smokers, according to New Zealand researchers. In two 3-year cohort studies (1981–1984, and 1996–1999), Hill and colleagues calculated that adult never-smokers living in households with at least one current smoker had about a 15% higher mortality than never-smokers living in smoke-free households. The study results support steps to reduce exposure to other people’s smoke — in the home and in other settings. BMJ 2004; 328: 988-989 Bright riders Wearing reflective or fluorescent clothing and a white or light helmet can help motorcyclists reduce their risk of crash-related injuries, say Australasian authors. They also identified day-time headlight use as another effective way to reduce this risk in a case-control study involving over 1500 motorcyclists riding in Auckland, New Zealand. All these measures make the rider more conspicuous on the road — fluorescence is more advantageous at twilight, reflective material at night. BMJ 2004; 328: 857-860 Is there a clot or not? A negative result for D-dimer — if assessed using an enzyme-linked immunosorbent assay (ELISA) — can help doctors exclude a diagnosis of deep venous thrombosis or pulmonary embolism, according to North American researchers.1 Their systematic review of the literature relating to the many available D-dimer assays found that the ELISAs, in general, ranked best in terms of sensitivity and negative likelihood ratio. However, a postive D-dimer result is not useful for confirming the diagnosis. An accompanying commentary2 cautioned doctors to keep a patient’s clinical picture in mind at all times — in a patient with many clinical findings of thromboembolic disease, even if an appropriate D-dimer assay is negative, most diagnostic algorithms would still call for further testing. 1. Ann Intern Med 2004; 140: 589-602 2. Ann Intern Med 2004; 140: 602 What the doctor ordered? Paracetamol prescribing by doctors and its administration by nurses can be very idiosyncratic, according to a detailed audit of 100 patients admitted to a children’s hospital in Sydney. Whereas doctors were often very specific when it came to prescribing other medication (eg, salbutamol), their paracetamol prescriptions were usually vague (ie, "prn" only). On contacting the doctor and nurse involved in each case for further information, the auditors found there was often discordance between what the physician had intended (eg, "for pain" or "for high fever only") and what the nurse had understood (eg, "for a mild fever"). Further, there were variations of opinion not only between but also within the groups of doctors and nurses. In response to the audit, the hospital’s guidelines for paracetamol use have been made much more specific. However, the auditors say the problem they reported is unlikely to be unique to a single hospital. J Paediatr Child Health 2004; 40: 213-216 — Dr Ann Gregory, MJA

Ann Gregory

Next Issue Volume 180 Issue 12

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From the editor’s desk 21 June 2004 Free

Medical education and hard science

Martin B Van Der Weyden

From the editor’s desk 21 June 2004 Free

In This Issue

Editorials 21 June 2004 Free

Web and telecounselling in Australia

Helen Christensen PhD · Barbara M Hocking BSc (Hons), DipEd, Dip H Eed, GAICD · Dawn Smith MBA

Editorials 21 June 2004 Free

Assessing bronchodilator reversibility: agreed standards are urgently needed

Christine Jenkins MB BS, MD, FRACP · Iven Young MB BS, PhD, FRACP

Previous Issue Volume 180 Issue 10

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From the editor’s desk 17 May 2004 Free

Burdensome bureaucratic style

Martin B Van Der Weyden

From the editor’s desk 17 May 2004 Free

In This Issue

Editorials 17 May 2004 Free

Indigenous health: tell us your story

Ruth M Armstrong BMed · Martin B Van Der Weyden MD, FRACP, FRCPA

Editorials 17 May 2004 Free

Screening sigmoidoscopy for colorectal cancer: further pieces in the jigsaw

Charlie H Viiala MB BS, FRACP · John K Olynyk MB BS, FRACP, MD

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