Letters

To the Editor: Although Kerridge and McPhee stress the need to find an evidence base (if there is any) for CAM, they nevertheless claim “medical practitioners and students no longer have any choice but to gain some knowledge about CAM and the interface between conventional and complementary medicine.”1 I suppose that archaeologists, geologists, palaeontologists and biologists now need to gain some knowledge about the interface between Darwinism and Creation Science. And our astronomers need some knowledge about the interface between astronomy and astrology. Science, including effective medical care, is not advanced by pandering to unscientific consumerism about unproven theories, especially if it manages to get the law on its side. Galileo was persecuted for “his heretical view” that the earth revolved around the sun. Have we learnt nothing from his experience?

In reply: We agree with Kotsirilos and Hassed that there are many examples of successful integration of “proven” CAM into conventional medical practice. Our question, however, is whether it is possible to integrate CAM where its theoretical maxims and practices are incommensurate with allopathic medicine (eg, homoeopathy) and whether “integrative medicine” will ulti-mately fragment and diminish CAM, further isolate “non-evidence-based” CAM practi-tioners and make less visible those views of health and disease that are not consistent with modern medicine.1 It is misleading for Arnold to imply that there may be no evidence base for complementary and alternative medicines (CAMs). We suggest that medical practitioners should ask themselves not whether an “evidence base” exists, but what the existing evidence shows. The picture that emerges from a review of the literature is one of variable clinical efficacy. Thus, there is no evidence to support the use of chiropractic for childhood asthma,2 but there is good evidence that phytomedicines may reduce crises in sickle-cell disease,3 that cranberry juice may reduce the frequency of symptomatic urinary tract infections in women,4 and that horse chestnut seed extract is an efficacious treatment for chronic venous insufficiency.5 There is also clinically important evidence about harmful interactions, for example that St John’s Wort, garlic and ginseng may lower blood levels of warfarin.6 Medical practitioners should be critical and sceptical of all untested claims of therapeutic benefit. We suggest they acquaint themselves with evidence about risks and benefits of CAMs, particularly in their own area of practice. This is not pandering to anything. It is evidence-based practice. By the same token, use of CAM may reflect evidence-based decision-making by doctors and patients. It is simply divisive to dismiss it as “unscientific consumerism about unproven theories”, and it is foolish in any case to dismiss the latter. Medicine and science must compete with non-scientific perspectives in the public sphere, for the contest of ideas is never over in human history. Ideological positions are black and white. Science prefers shades of grey. We have indeed learnt much from Galileo’s experience.

To the Editor: I read with interest the article by Byles and colleagues that shows the minimal impact of health assessments in a section of the older Australian community.1 While these assessments may not be identical to the assessments covered by Enhanced Primary Care (EPC) items on the Medicare Benefits Schedule, my experience performing the latter in older people leads me to believe that they also have limited impact. I am now in part-time clinical practice, with a reasonably well-defined practice population, comprising mostly older patients with complex problems. My practice philosophy is closer to the (perhaps old-fashioned) notion of continuing, comprehensive care, which means I have not been afraid to spend the time needed to understand those patients and to document their health information. So far, I am not sure I have learned anything new in any of the EPC health assessments in which I have participated, although they have been useful for initial assessments of newer patients, as at least they remunerate practices better for the time-consuming task of doing this well. However, EPC assessments may be performed every 12 months. Is this really necessary, unless patient circumstances change? In my practice the answer is probably no, although they may be more useful in practices with less stable doctor–patient relationships. Would it not be a more effective use of resources to instead allow for better-funded initial assessments and assessments when a patient’s condition changes, irrespective of the timing?

Richard B Hays

To the Editor: Telemedicine in eye care (teleophthalmology) is one of the established technologies in medicine, providing the means for undertaking sophisticated eye care and for maintaining contact with patients in rural and remote areas.1 Telemedicine in Australia has been primarily facilitated by government, against a background of complex funding arrangements and interwoven healthcare responsibilities (it is funded mostly by project grants and state government telehealth initiatives).2 This funding mechanism impedes the efficient use and integration of telemedicine services.2 The current healthcare environment demands a detailed economic evaluation to justify continuous funding for teleophthalmology. However, some of the economic benefits of teleophthalmology may not be directly visible in the healthcare system itself. Significant benefit may be obtained by, for example, savings in time and travel expenses, thereby contributing to society indirectly. Furthermore, the cost-effectiveness of a telemedicine service improves considerably when it is integrated with existing routine healthcare services.3 But organisational and attitudinal barriers and lack of funding have delayed such integration.4 These barriers relate to human resource allocation issues in an already overstressed healthcare system and the mindset of some critics who view telemedicine as a peripheral activity and a “novelty” area for technological enthusiasts. The cost-effectiveness of telemedicine will not be improved unless the perception that it is an “add on” is changed.4 The question of whether teleophthalmology should be integrated into routine services, with Medicare reimbursement, can be judged by four criteria:5 Is the technology sound? (ie, does it fulfil its purpose?) Is the program effective compared with existing care? Is the program cost-effective? Is the program practical? (ie, are there any significant problems associated with it?). On the basis of our own comprehensive evaluation of teleophthalmology in Western Australia,6 we believe that all four questions can be answered affirmatively, and that teleophthalmology would be most efficiently provided if integrated into existing healthcare services. Its inclusion in the Medicare Benefits Schedule would benefit many patients in remote and rural areas in Australia.

Sajeesh K R Kumar · Yogesan Kanagasingam · Ian J Constable

To the Editor: The Postcard from Heller, Weller and Jamrozik1 may reflect a nostalgic and unrealistic view of how good things are back home. They suggest that, in New South Wales, the health chances of both advantaged and disadvantaged populations are improving, and, in relative terms, social inequalities in health may also be showing “some improvement”. In fact, despite impressive overall declines in mortality, there remain important differences in health status between NSW populations. Figures for the mid-1990s show that life expectancy at birth for both Aboriginal males and females is markedly less (by 20 years and 18 years, respectively). Similarly, socioeconomic disadvantage shortens life expectancy for both rural men and women (by 14 and 10 years, respectively) and urban men and women (by 10 and 7 years, respectively).2 The relative gap is also widening for some important health indices. For example, from 1980 to 2000, the percentage difference in premature death rates (< 70 years of age) between high and low socioeconomic groups has increased from 30% to 52% for men and from 24% to 32% for women, and for potentially avoidable mortality from 34% to 63% for men and from 27% to 40% for women.3 How should one respond to such inequalities? Heller et al suggest universal rather than targeted programs, as they are based on sound population health principles. To construct this as a simple choice is not helpful. Unless we recognise and address the barriers facing people in adverse social circumstances, universal programs may unintentionally widen health inequalities. For example, universal access to healthcare in the UK and Australia has not equally benefited those from the most disadvantaged circumstances compared with wealthier and better-educated populations.4 The Postcard authors suggest that Australia is saved from class divisions by the established “fair go” tradition, where shared values overcome structural inequalities in “socioeconomic status”. In fact, social class continues to be a powerful but complex and changing influence in Australia.5 It is important to acknowledge the evidence that structural inequalities are significant and worsening in Australia,6 and that the most disadvantaged experience continued social exclusion.7 We need to shift from a “trickle down” perspective that sees the greatest health gains accruing to the most advantaged — with a hope that these benefits will eventually be achieved by everyone — to a more explicit social justice perspective that ensures that resources for health are allocated in ways that produce fair outcomes. This may help address “socially entrenched self-denial of the chance for better health”.

John Furler · Elizabeth Harris · Don Nutbeam · Mark Harris

To the Editor: Pseudoephedrine is no longer a banned substance in sport.1 It was originally banned to protect athletes from overuse and its dangers. Has it become harmless or are athletes more intelligent? This highlights much of the confusion in drug testing. Athletes with diabetes are permitted to use insulin for therapy, but those with hypertension are not allowed to take β-blockers. Both drugs are popularly believed in athletic circles to improve performance. What is to stop an athlete with diabetes from taking extra insulin for performance enhancement? Why do we discriminate against those with hypertension? There is a ban on oxygen-transport drugs and on physical environment enhancers such as hypobaric chambers. Both are alleged to produce the same result, but only use of the drug can be tested. The penalty for the drug user is disqualification, but for the hypobaric enthusiast a rousing cheer for a drug-free effort. The crime is the same, so why vary the penalty? There is never likely to be a level playing field under the present system, in which one reads of positive test results being swept under the table. How will drug testing eliminate the genetic inequalities between athletes? How will testing improve the availability of top-level coaches and training facilities to all? How can it eliminate the inequality in financial incentives, allowing some athletes to train for 6 hours daily while others have to work to enable them to train for even 2 hours daily? We have swimming costumes that decrease drag in the water,1 resulting in faster times. These are not universally available, giving their owners an advantage. A level playing field will never exist in our present system. It is incongruous that in all this mess, only drugs are available to all. The current frenzy to test blood has ethical problems which have not been addressed.2 What is to happen to an athlete who develops an infection from a dirty needle? Who is responsible for the tester who has a needlestick injury from an HIV-positive athlete? It is worth remembering that this diagnosis will only be made 3 months after the Games, when everyone has dispersed. The whole area needs to be reviewed by an outside body with no vested interest in the outcome.

Anthony P Millar

Janine M Smith,* Edwin P E Kirk† * Senior Fellow in Clinical Genetics, Department of Clinical Genetics, The Children’s Hospital at Westmead, Westmead, NSW; † Clinical Geneticist, Department of Medical Genetics, Sydney Children’s Hospital, Randwick, NSW. kirkedATsesahs.nsw.gov.au To the Editor: The original understanding of cystic fibrosis (CF) as a well-defined, severe disorder has changed dramatically with the recent description of a wide range of clinical presentations. Correlations between genotype and phenotype have been reported, although the genotype–phenotype relationship is not a simple one.1 We report on a patient, now a 39-year-old woman, who had a single episode of distal intestinal obstruction (meconium ileus equivalent) at the age of 5 years, leading to a diagnosis of CF. She had a lower respiratory tract infection (caused by Klebsiella species) at the age of 10 years, but has otherwise been well, and is now asymptomatic, despite not being treated for CF since her teenage years. Her two pregnancies have been uncomplicated. She presented wishing to clarify the previous diagnosis of CF and to determine the health implications for her, if any. Her sweat chloride level was 93 mmol/L. Levels above 70 mmol/L are abnormal in adults, and this cutoff value reliably distinguishes people with CF from controls.2 Lung function testing and a chest x-ray were normal. Genetic testing revealed a genotype consistent with a diagnosis of CF. CF is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on chromosome 7. The most common mutation is ΔF508, which produces misfolding of the CFTR protein. The polythymidine tract is a region in the CFTR gene that varies in size depending on the number of thymidine bases present — most commonly 5, 7 or 9. The 5T variant causes a reduction in functional CFTR protein, but is not of itself associated with classic CF. In this case, testing for 30 CFTR mutations showed heterozygosity for ΔF508. Testing for the poly-T polymorphism showed the presence of 9T and 5T alleles. As ΔF508 is essentially always found in cis (on the same chromosome) with 9T,3 we conclude that the patient’s genotype is ΔF508(9T)/5T. The symptoms a patient develops and their severity are thought to be related to the amount of functional CFTR protein produced. If this is above 10% of normal, an abnormal phenotype is unlikely. Levels < 10% are associated with congenital bilateral absence of the vas deferens (CBAVD), levels < 4.5% with progressive pulmonary disease, and levels < 1% with pancreatic exocrine deficiency.4 Homozygosity for ΔF508 is associated with a severe phenotype, whereas the genotype ΔF508(9T)/5T has been associated with a range of clinical phenotypes, including CBAVD, atypical CF, or no clinical features.5 Currently, our patient has no symptoms attributable to CF. She is presumably at increased risk of chronic lung disease, and has been advised to have her lung function monitored. Giving a long-term prognosis for individuals with mild variants of CF is challenging, and a normal outcome should be considered. In future, it may be possible to predict which patients with ΔF508(9T)/5T are likely to develop symptoms. CF and its variants need to be considered in an increasingly wide range of clinical presentations. Testing for CF mutations is available from a number of Australian laboratories (listed on the Human Genetics Society of Australasia website, www.hgsa.com.au) and should be conducted in the setting of appropriate genetic counselling.

Janine M Smith · Edwin P E Kirk

Emma J Glasson,* John Wray† * Research Fellow, University of Western Australia, Telethon Institute for Child Health Research, West Perth, WA, and WA Register for Autism Spectrum Disorders; † Paediatrician, State Child Development Centre, West Perth, WA, and WA Register for Autism Spectrum Disorders Emma. GlassonAThealth.wa.gov.au To the Editor: There is growing international awareness about the realities and difficulties of obtaining written informed consent from patients to compile and use data recorded in population-based registries. In some cases, such data could be of substantial benefit to the community, while posing relatively low risk of infringing patients’ privacy.1-3 The Canadian Stroke Registry achieved only a 39% participation rate from 4285 eligible patients when applying a policy of written informed consent to their data collection, resulting in significant representation bias.1 The issues and consequences are mirrored in our own endeavour, since 1999, to maintain a prospective register of people diagnosed with autism spectrum disorders in Western Australia.4 As protocol, diagnosing clinicians in Western Australia ask parents for written consent to allow their autistic child’s name, date of birth and postcode to be forwarded to the register. However, for many reasons, parents are not always asked and diagnostic information is not always forwarded. Missed cases are collected annually from the major diagnostic and service provision centres, but only the sex and year of birth are recorded for the child. Between January 1999 and December 2002, 757 new cases of autism were registered in WA, but only 35% of parents gave written consent to include identifying details. Forty-three per cent of the 757 cases were identified by cross-referencing to diagnostic centres. When clinicians remember to notify new cases to the register, 56% of parents give consent, either at the time of diagnosis, or by sending the forms directly to the register, indicating that clinicians are instrumental in encouraging patient participation. Sometimes clinicians send anonymous diagnostic information without giving parents information about the register, and sometimes parents forget to send permission forms to the register. Various characteristics of the child or the child’s family have a bearing on whether consent is given. For example, consent is received for only 31% of children living in rural areas, 25% of children with no intellectual disability, 23% of children not Australian-born, and 16% of children from families whose primary language is not English. Without consent for every case, the register cannot accurately reflect the age or geographic distribution of children with autism. If the register only collected information on consenting cases, there would be severe under-ascertainment and the output would be notably biased. Perhaps more importantly, unidentifiable records cannot be linked to other datasets. Other WA population databases include information on hospitalisations, genetic testing, genealogical links, midwife notifications, birth defects, pharmaceutical history, and people with cerebral palsy. Linkage to these datasets would enormously facilitate population-based autism research to investigate the aetiology, associations and natural progression of autism disorders. The WA autism register is an internationally unique population-based resource, but its application is limited without the inclusion of identifying information. This remains the reality at a time when the research community and affected families desperately seek information about the condition and solutions for their children.

Emma J Glasson · John Wray

Patrick G P Charles,* Michelle Ananda-Rajah,† Paul D R Johnson,‡ M Lindsay Grayson§ Infectious Diseases Physician, † Infectious Diseases Registrar, ‡ Deputy Director, § Director, Infectious Diseases, Austin Health, PO Box 5555, Heidelberg, VIC 3084. Patrick. CharlesATaustin.org.au To the Editor: We agree with Buising and colleagues1 that, in terms of predicting clinical outcomes, the Pneumonia Severity Index (PSI) developed by Fine and colleagues2 is heavily weighted towards age and pre-existing comorbidities. However, we disagree with both their proposed “solution” and the concept on which it appears to be based. Although the current Australian antibiotic guidelines suggest that admission to the intensive care unit should be considered mainly for patients with class V community-acquired pneumonia (CAP),3 a review of the data of Fine and colleagues suggests that patients in both class IV and class V are most likely to need this type of care. In the PSI’s validation cohort of 38 039 patients, 73% of those requiring intensive care fitted these classes.2 Thus, by simply modifying the current antibiotic guidelines to include patients with CAP in either class IV or V as being at greatest risk of needing intensive-care admission, the recommendations would be accurate. By comparison, Buising and colleagues advocate using the modified British Thoracic Society (BTS) rule, which was validated in only 244 patients.4 While this approach may have some future merit, we believe there are insufficient data to advocate its use at present. A comparison of the PSI and original BTS criteria found that PSI classes IV and V were more sensitive at predicting need for intensive-care admission.5 Secondly, we are concerned about the suggestion by Buising and colleagues that young patients with severe CAP who are not in PSI class V could have worse outcomes if they do not receive broad-spectrum antibiotics.1 This implies that severe CAP is more likely to be due to unusual or resistant pathogens. This is not supported by available evidence. Instead, early clinical consideration of the likely pathogens and the potential use of new diagnostic “point of care” tests (eg, pneumococcal and Legionella urinary antigen assays and analysis of throat swabs by polymerase chain reaction for respiratory viruses and “atypical” pathogens) are likely to be of greatest benefit in empirical antibiotic prescribing. Although CAP is a common admission diagnosis, there are very few published Australian studies defining its aetiology, optimal treatment and clinical outcomes. We are currently undertaking a large prospective study (the Australian Community-Acquired Pneumonia Study) at six major hospitals in three states to address these issues. Results should be available in late 2005.

Patrick G P Charles · Michelle Ananda-Rajah · Paul D R Johnson · M Lindsay Grayson

Kirsty L Buising,* Karin A Thursky,† James F Black,‡ Graham V Brown§ * Clinical Research Fellow, † Physician, ‡ Head of Epidemiology, § Head, Victorian Infectious Diseases Service, Royal Melbourne Hospital, Grattan Street, Parkville, Melbourne, VIC 3050. Kirsty.buisingATmh.org.au In reply: We thank Charles and colleagues for their comments. The modified British Thoracic Society (mBTS) severity score for patients with community-acquired pneumonia (CAP) has been validated in more than one study (the largest involving 1068 patients from three countries1) and is recommended by the British and American thoracic societies. It predicts requirement for intensive care with comparable sensitivity to the Pneumonia Severity Index (PSI) score (using classes IV and V)2 (unpublished data), and is easy to use, requiring four variables rather than 21. The study cited by Charles and colleagues showing that the BTS severity score was less sensitive used an older version of the tool. We believe the mBTS score represents a reasonable, simple alternative tool to identify severe pneumonia, although neither score should replace clinical judgement. Caution is needed when relying on a scoring system that may give false reassurance about patients not recognised to be at risk. Early recognition of severe illness enables early intensive-care intervention, which is associated with better outcome.3 The major guidelines for management of CAP recognise the entity of severe pneumonia and recommend broader-spectrum antibiotic therapy.4-6 Whether the spectrum of pathogens in severe pneumonia differs from that in mild pneumonia is not yet clear, as data are conflicting.7,8 However, a percentage of patients with severe pneumonia will have more resistant or unusual pathogens. Inadequate antibiotic therapy for patients with severe pneumonia is associated with higher mortality. For intensive-care patients, where there is less perceived “room for error”, a strategy of broad empirical antibiotic therapy and early narrowing to directed therapy is usually promoted.

Kirsty L Buising · Karin A Thursky · James F Black · Graham V Brown

Kevin L Forbes Head, Years 3 and 4 MB BS Program, University of Queensland, Mayne Medical School, Herston, QLD 4006. k.forbesATuq.edu.au To the Editor: In response to the recent column on medical education,1 I would like to point out that many of the medical schools in Australia have broadened the content of their curricula to reflect the expected demands of professional practice and to satisfy the objectives of the accrediting body.2 Medical schools involved in curriculum change have tended to favour a broad education that emphasised learning across four domains (basic and clinical sciences, clinical skills, population health and ethics, and professional development). Another principle influencing changes to curricula was the need to ensure that the students were competent to enter supervised practice as an intern and be equipped with the desire to pursue life-long learning. Remarkably, medical schools have tended to deliver similar curricula in response to these and other issues (eg, emphasis on communication skills, critique and clinical application of evidence, exposure to rural health issues). Medical educators see a need to prepare medical students to cope with continuing changes in healthcare. Some of us would argue that many of the principles of such ongoing learning are fundamental to problem-based learning programs, and expect that graduates of such programs will be able to adapt to new continuing professional development programs. However, there is as yet no hard evidence that incorporating self-directed and problem-based learning techniques into medical curricula has any beneficial effect. Although it is not yet possible to measure the long-term effects of the changes in medical curricula, in the short term objective measures are encouraging. Today’s Australian medical school graduates function well as interns and residents.3 However, many in the profession are concerned about the level of knowledge of current graduates, particularly (but not exclusively) about anatomy. Although knowledge of anatomy needed by doctors varies considerably between disciplines, the basic sciences, including anatomy, do need to be included in college training programs. Clearly, the profession needs to measure the outcome of changes to medical school curricula.4 Ideally, as you say in your column, the outcome measures would be generally agreed by the profession.1 A debate in the Journal about the most appropriate outcome measures for medical schools would ensure that the concerns of many medical practitioners could be considered. Meanwhile, those involved in medical education need to develop and publish the outcomes that are measured in the medical schools.

Kevin L Forbes

Paul G McMenamin Associate Dean (Teaching and Learning), Faculty of Medicine and Dentistry, University of Western Australia, 35 Stirling Highway, Crawley, WA 6009. mcmenaminATanhb.uwa.edu.au To the Editor: In the lead-up to the description of events at a recent Royal Australasian College of Surgeons (RACS) conference,1 it appears that you do not fully agree with the changes in medical education in Australia and overseas in recent years. Firstly, it should be pointed out that problem-based learning has not “all but displaced didactic teaching”1 in Australian medical schools. Many schools have hybrid courses and a wide variety of teaching methods are used. Secondly, including outcomes such as “communication skills and compassion!”1 in the curricula can hardly be less than desirable. The desired outcomes of medical schools are driven by Australian Medical Council guidelines on the requirements for the safe and competent practice of clinical medicine by a generalised doctor in the intern setting before specialist training. Individual surgeons, the RACS, and their United Kingdom counterparts2 have lamented the decline in medical students’ anatomical knowledge for generations, even when students were taught 500–700 hours or more of anatomy.3 There is nothing new in this call-cry. A generalised doctor prepared for internship does not require much of the knowledge that some are lamenting has been lost from medical curricula. The “old” curricula were crowded with excessive amounts of topographical anatomy that was of questionable relevance and seldom taught within a clinical or medical context. The optimal time and context for students to learn detailed topographical anatomy is surely when the knowledge is most relevant and valuable. This is surely during basic and advanced surgical training programs, both administered through the RACS. There is good evidence that detailed teaching of topographical anatomy in targeted postgraduate surgical training courses is of measurable benefit and greatly appreciated.4,5 Indeed, is it really very suprising that, for example, urological and gynaecological surgeons have a greater interest in the nine branches of the anterior division of the internal iliac artery and the detailed relations of the ureter in the pelvis than 18-year-old first-year or second-year medical students? It is now the responsibility of surgeons and anatomists to deliver postgraduate programs that address the desired outcomes for RACS training (and the UK equivalent2). We at the University of Western Australia have launched a Graduate Diploma in Surgical Anatomy. A similar course has been in place in Melbourne for some years. Other states can only be encouraged to follow.

Paul G McMenamin

Martin B Van Der Weyden Editor, The Medical Journal of Australia, Locked Bag 3030, Strawberry Hills, NSW 2012. medjaustATampco.com.au In reply: McMenamin reiterates the importance of the educational components of current medical curricula: problem-based and self-directed learning, along with the enhancement of students’ capacities for communication and compassion. Forbes agrees and advances that these changes are to prepare future doctors for life-long learning. There are two issues at the centre of this discourse — what do medical students think of the curricular changes, and are these changes informed by scientific evidence? Anecdotal reports suggest that some medical students in the United Kingdom1 and Australia2 have concerns “that basic science does not get the priority that it once did”. Similar concerns have been raised in the popular press.3 Furthermore, UK academics fear that the dilution of basic sciences in current curricula may, in the long term, adversely affect medical graduates entering into research.1 Forbes concedes that the evidence underpinning these changes to medical education is wanting. And herein lies the rub. Despite continued calls for educational research that matters4,5 (and perhaps in keeping with opinions as to how difficult performing such research might be),6,7 the medical education community has yet to report solid evidence to support the intentions of these resource-intensive changes.8 The profession, hardened by the evidence-based movement, expects no less. This, I believe, was an undercurrent of the audience disquiet at the plenary session of the meeting of the Royal Australasian College of Surgeons in May this year. As to McMenamin’s robust defence of the pruning of anatomy in medical curricula, this debate is more than 2 centuries old. An 18th-century guide to the training of apothecaries (the forerunners of general practitioners) stated that “he” should be “tolerably well acquainted” with Latin, be competent in “his” own language and “acquainted with botany chemistry, and pharmacy; and have studied anatomy and physiology”. But “the minutiae of anatomy are not necessary”9 [my italics].

Martin B Van Der Weyden

Lionel L Wilson Principal, Qual-Med, 34B Kangaloon Road, Bowral, NSW 2576. Lwilson10ATbigpond.com To the Editor: Nisselle’s recent editorial on managing medical indemnity raises important issues.1 I would like to comment on some points. The quality movement, in the form of a system of hospital accreditation, actually began via the New South Wales Branch of the Australian Medical Association in the late 1960s. However, credentialling and the delineation of clinical privileges for medical staff are far from the norm that Nisselle claims. In fact, although some hospitals claim to be credentialling medical staff, in most instances this is little more than an exercise in tokenism and is quite incapable of contributing either to quality or to minimising risk. Nisselle also refers to the “safety movement”. While recognising current common usage, to talk of safety as separate from quality in healthcare is tautological. It is not credible to visualise a hospital that claims to provide quality care but tolerates unsafe practices of any description. Similarly, unsafe practices in a facility mean that quality care is not being achieved. In attempting to untangle the semantic problems occasioned by the term “risk management”, Nisselle merely compounds the problem that bedevils this subject. Of course, he is far from alone, and the medical literature further aggravates this confusion. I suggest the following definitions in the hope of introducing some clarity: Quality management: The management of all these issues, as Nisselle points out, is a big task. While the term “clinical governance” is currently in vogue, it means little, I believe, to most doctors. Managing quality is a complex task (as illustrated by Nisselle’s appropriate elephant analogy). So why not call it what it is? Managing quality is largely about avoiding patient harm. Risk management: The same definition should be used whether we are talking about an insurance company or a medical service. It is the minimisation of financial loss. In the case of healthcare, the risk is malpractice litigation directed at both doctors and hospitals. The techniques of risk management are very similar to those of quality management, and risk management is an intrinsic component of quality management.2 Risk management in healthcare is not simply about reducing error, any more than is quality management. It is this focus that leads to so much confusion. Quality assurance: This is the deliberate activity of ensuring that what was done and achieved is what should have been done and should have been achieved. It is another facet of the broader activity of quality management. The management of quality and avoidance of the risk of litigation is difficult enough. It would help if we did not all use the terminology to mean whatever we want it to mean.

Lionel L Wilson

Paul Nisselle Senior Advisor, Risk Management, Medical Defence Association of Victoria, PO Box 1059, Carlton, VIC 3053. nisselpATozemail.com.au In reply: Wilson highlights the confusing taxonomy of quality/risk in healthcare. My editorial distinguished prudential risk management (ensuring insurer solvency) from clinical risk management (reducing medical error).1 The term “clinical governance” combines quality improvement (ie, getting it right more often) and risk management (ie, getting it wrong less often). Wilson writes that “Managing quality is largely about avoiding patient harm”. But quality management is as much about finding more effective ways of doing things as it is about finding safer ones. Quality and safety are separate, albeit overlapping, concepts. Similarly, risk management is more than just “minimisation of financial loss”. Reducing the rate of head injuries by using seat belts has a human benefit, not just a financial one. One trade-off for the “Abbott reforms” to medical indemnity is a demand by government for a real commitment by both medical indemnity insurers and those insured to clinical risk management. Although we may disagree on the language, Wilson and I are in heated agreement on the need for a concerted, systemic approach to quality management. The medical indemnity insurers have a role to play that goes beyond just remaining solvent and keeping indemnity costs down!

Paul Nisselle

Kevin B Orr Surgeon, 3/22 Belgrave Street, Kogarah, NSW 2217. stgeorgedermATbigpond.com To the Editor: I report the case of an unexpected complication of a common cardiothoracic procedure which deserves the attention of the general medical community. An 82-year-old general practitioner required coronary artery bypass surgery. Although retired, he was fit enough to continue visiting patients in a number of nursing homes, and occasionally assisted at operations. His condition after the surgery was good for a few days, but deteriorated, with the development of dyspnoea, shortly before he was due to be transferred to a rehabilitation unit. Whether it was realised that his haemoblobin level had fallen from 150 g/L to 90 g/L over the days before surgery is not known. A blood count several days after surgery revealed a haemoglobin level of 100 g/L. This low level was attributed to insufficient transfusion during surgery. The patient was given two units of blood, which raised the haemoglobin level to 120 g/L. Although a repeat test on the day he was discharged to a rehabilitation unit showed the level was again 100 g/L, this result was not seen by a clinician before the transfer. On arrival at the rehabilitation unit, the patient was unable to complete the scheduled activities. He was breathless, returned to his room, almost fainted and had to be helped back into bed. Later that night, he had massive melaena and died. For some weeks leading up to the bypass surgery, the patient had suffered from dyspepsia and was “living on” antacid. He mentioned this to his general practitioner, who did not initiate any investigations or treatment. On the patient’s admission to hospital, the medical officer prescribed omeprazole, presumably in response to the history of dyspepsia. Whether this doctor was aware of a preoperative drop in haemoglobin level is not known. The most likely cause of this man’s death was a bleeding duodenal ulcer exacerbated by coagulation defects associated with major surgery (no autopsy was performed). Bleeding was initially slow but culminated in a fatal haemorrhage. The lesson from this case is that any suggestion of a serious concurrent illness should be thoroughly investigated before major surgery. In this case, a simple gastroscopy before the bypass surgery might have been lifesaving.

Kevin B Orr

Christine Y Lu,* Kenneth M Williams,† Lyn March,‡ James V Bertouch,§ Richard O Day¶ * PhD Candidate, † Deputy Director, ¶ Director, Therapeutics Centre, St Vincent’s Hospital, University of New South Wales, Victoria St, Darlinghurst, Sydney, NSW 2010. ‡ Rheumatologist, Royal North Shore Hospital, The University of Sydney, St Leonards, NSW. § Head, Department of Rheumatology, Prince of Wales Hospital, Randwick, NSW. christine.luATstudent.unsw.edu.au To the Editor: The tumour necrosis factor (TNFα) inhibitors etanercept, infliximab and adalimumab are new treatments for rheumatoid arthritis (RA) subsidised by the Pharmaceutical Benefits Scheme (PBS) under strict criteria. These are based on data supplied by the sponsors and protracted discussions between the stakeholders: the Pharmaceutical Benefits Advisory Committee (PBAC), the sponsors, rheumatologists and consumer representatives.1 One eligibility criterion is that adult patients must be or have been rheumatoid-factor positive. This requirement raises particular concerns. Rheumatoid factor is not exclusively associated with RA. It is found in a number of other autoimmune and infectious diseases, and has been detected in healthy people. Rheumatoid factor is a serological criterion in the American College of Rheumatology classification for RA. However, its presence is not definitive for a clinical diagnosis of RA, with rheumatoid factor being absent in about 30% of patients with RA. Studies suggest that patients who test positive for rheumatoid factor at baseline are more susceptible to relatively severe expression of RA, with development of erosions and functional disability.2 As the PBS already limits access to TNFα inhibitors to patients with severe active RA, the predictive value of rheumatoid factor for severity is redundant. We systematically reviewed 23 clinical trials of TNFα inhibitors available in the public domain (references available on request). The review showed that only the Early Rheumatoid Arthritis trial restricted recruitment to patients who tested positive for rheumatoid factor.3 The aim of this study was to examine the effect of etanercept on the rate of development of erosions in patients with early RA, not whether rheumatoid-factor status affected response. We conclude that the evidence for an association between rheumatoid-factor status and response to TNFα inhibitors in patients with severe RA is inadequate to justify rheumatoid-factor status as a criterion for PBS subsidisation. Similarly, no evidence for an association between rheumatoid factor and response to disease-modifying anti-rheumatic drugs has been reported.4 Nevertheless, potential predictors of response to TNFα inhibitors and such drugs are emerging (eg, polymorphisms of HLA-DRB1, TNFα, and interleukin-10).5 Further analysis of the unpublished individual patient data held by the sponsors is needed to shed light on this question. Clinical studies specifically designed to evaluate the influence of rheumatoid-factor status on response would be helpful. The PBAC may have been provided with these data, but patients and clinicians operating in the public domain have not. This gives rise to an ethical dilemma whereby prescribers cannot provide a plausible explanation for why rheumatoid-factor status is an access criterion. For example, if rheumatoid-factor-positive status was selected to exclude patients with rheumatoid-factor-negative psoriatic arthritis, then the rationale would not appear to be ethically sound. Greater transparency with respect to the rationale and the evidence for the criteria selected for targeting subsidised access to important high-cost pharmaceuticals will enhance confidence in the PBS process.

Christine Y Lu · Kenneth M Williams · Lyn March · James V Bertouch · Richard O Day

Lloyd N Sansom Chair, Australian Pharmaceutical Benefits Advisory Committee, School of Pharmacy, University of South Australia, Adelaide, SA 5000. Lloyd. SansomATunisa.edu.au Comment: I am grateful for the opportunity to put the perspective of the Pharmaceutical Benefits Advisory Committee (PBAC) on this important issue for patients and prescribers using TNFα inhibitors for rheumatoid arthritis. I can confirm that the PBAC based its recommendation to exclude patients who test rheumatoid-factor negative on a meta-analysis of the data presented to it in the sponsor’s reports of two published randomised trials.1,2 The sponsor of etanercept requested a restriction that limited use to patients with rheumatoid-factor-positive status — a proposition that was queried by the PBAC in its evaluation. The sponsor indicated in its response that rheumatoid-factor status was a treatment-effect modifier. As anticipated by Lu and colleagues, the reason for the recommendation was neither to confirm the diagnosis of rheumatoid arthritis nor an attempt to identify patients with more severe disease. The main reason is that there was some statistical support for the contention that, in patients with rheumatoid arthritis, being rheumatoid-factor positive is associated with a better response to treatment with these drugs. Unfortunately, my request to the sponsor to be able to release in this letter the information on which the decision was based was refused. The statistical analysis relied on by the PBAC was based on individual patient data, stratifying trial participants into two groups (rheumatoid-factor positive and rheumatoid-factor negative), and then formally applying a test for interaction against the reported treatment effect compared with placebo. Although a post-hoc analysis, this approach has the advantage of relying on the entire trial dataset rather than increasing the likelihood of detecting spurious differences by conducting a series of post-hoc sub-group analyses. It also differs from the systematic review reported by Lu and colleagues, which sought to examine the question based on the reported eligibility criteria of the trials, and therefore could only be conducted at the level of the overall trial, not the level of the individual patient in the trials. The interpretation of the data available to the PBAC at the time was supported by rheumatologists advising the PBAC about actual restrictions for the subsidy of these expensive agents. It is perhaps noteworthy that many decisions that guide treatment are made purely on the basis of biological plausibility. On this occasion, there was some statistical support, albeit from a post-hoc analysis, to support any biological arguments. There is inevitably an element of judgement about these decisions, as is clear in the letter from Lu et al, who describe “accumulating evidence” in relation to whether gene polymorphisms “may be predictive of clinical responsiveness”. The current situation, as exemplified in this letter, in which the PBAC is unable to give detailed reasons for its decisions, clearly demonstrates the urgent and critical need for greater transparency of the PBAC processes, and underscores the fundamental right of Australian consumers and prescribers to information relevant to decisions about the subsidy of medicines in this country. The PBAC is willing to examine any new evidence relating to the influence of rheumatoid-factor status on health outcomes and the cost-effectiveness of these agents. If there is additional evidence supporting a review of the current listing, the PBAC would encourage the sponsors of these drugs to prepare appropriate submissions to enable us to evaluate these data. As Chair of the PBAC, I intend to continue to work towards the goal of greater transparency, whereby the outcome of any such new evaluation, and its basis, could be made available to Australian consumers and prescribers.

Lloyd N Sansom

Tim Woodruff President, Doctors Reform Society, Suite 207, 320 Victoria Parade, East Melbourne, VIC 3002 twoodruffATbigpond.com To the Editor: It is encouraging to see the Journal continuing its tradition of taking on contentious issues in publishing articles about the negative influence of the pharmaceutical industry.1 With respect to the practical suggestions to address this issue, I suggest that reliance on our profession to substantially improve the situation, although laudable and appropriate, is too optimistic given the gross denial by our colleagues that there is an issue. Our professional bodies simply do not have the support to enforce codes of conduct. The Royal Australasian College of Physicians (RACP) has published guidelines on this issue,2 but I doubt most of its members have read them. I fully support Breen’s comments relating to funding of educational activities, but I suggest that the pharmaceutical pseudo-educational dollar be bypassed by a major expansion in government funding.3 The provision of regularly updated, easily accessible treatment guidelines integrated into prescribing software (which most general practitioners use daily) would go a long way to decreasing our reliance on the drug dollar for information on appropriate treatment. This requires government investment and professional college cooperation, but would lead to recurrent savings to the Pharmaceutical Benefits Scheme and better treatment. Currently, the federal government spends $21 million on drug information to doctors,4 while the drug industry spends $1 billion on marketing.5 To partially redress this imbalance would, however, require both political will and pressure from the profession.

Tim Woodruff

Linda V Graudins Senior Pharmacist (projects), Prince of Wales Hospital, High Street, Randwick, NSW 2031 graudinslvATsesahs.nsw.gov.au To the Editor: Thank you for publishing the Viewpoint by Breen regarding pharmaceutical industry relationships with the medical profession1 — but please do not coin the word “pharmaproof”. This word unintentionally casts aspersions on fellow clinicians — pharmacists — who share the dilemma of aggressive pharmaceutical marketing influencing professional decisions. The relationship between the industry and pharmacists is actually more complicated, as we are not only advocates for patients and advisers to doctors on the safe and evidence-based use of medicines, but also the buyers of the pharmaceutical products. This last function means that most pharmacists cannot be removed from the business side of medicine supply and must work with the manufacturers to obtain supplies in a timely fashion and at the best price. In my work as a hospital pharmacist, the pharmaceutical industry helps in planning financial aspects of medicine supply, sponsoring various activities that the public health system and universities are unable to, and providing specific product information — be it for marketed, unregistered or trial medicines. Most pharmacists cannot choose to not see industry representatives. The formation of such relationships can indeed insidiously affect our clinical decision-making, as outlined by Breen. Unfortunately, the issue of industry’s influence on pharmacists’ decision-making has only rarely been discussed in the pharmacy literature.2-4 Both medical and pharmacy clinicians must be aware of this influence and act accordingly. Peter Mansfield’s Healthy Skepticism (www.healthyskepticism.org) is a good starting point to increase this awareness. However, the movement must include physicians and pharmacists on the same side. I have often been told that we must have the latest new drug on the hospital’s formulary because . . . and have been given a hefty manufacturer-prepared dossier as the sole reason for the request. I urge physicians to work with pharmacists and be “pharma(cist)friendly”, yet also “industryaware”.

Linda V Graudins

Scott Masters General practitioner, Musculoskeletal Medicine, Caloundra Spinal and Sports Medicine Centre, 39 Minchinton St, Caloundra, QLD 4551 cfmpATozemail.com.au To the Editor: The Journal recently published three interesting articles on the relationship between the medical profession and the pharmaceutical industry.1-3 With Medicines Australia (the pharmaceutical manufacturers’ association) setting up a strict code of conduct (tighter than for any other industry I know), a better balance seems to be on the horizon. Breen reminded us of our responsibilities to protect ourselves and our patients from slick marketing by pharmaceutical companies.1 One technique our surgery has found useful is to have a personal code of conduct. Our surgery has a guide for pharmaceutical reps (copies available from the author). It advises reps that we are not interested in seeing their promotional material, especially those useless coloured graphs. However, we are very happy to look at published trials regarding their product and associated diseases. Personally, I have found the resources available from many reps useful and time-saving. Breen is concerned about our professional leaders being in denial about the influence of the pharmaceutical industry on doctors’ prescribing habits. If this is so, then the same leaders have complete amnesia and catatonia about another influence that potentially threatens to engulf us. The sale of supplements and complementary medicines in Australia is a billion-dollar business now. Every month I receive more requests to use supplements for conditions varying from heart disease, cancer and fatigue to non-specific therapies such as detoxification, immune support, metabolic enhancer and anti-ageing. I can sell all these products directly to consumers (patients) at a mark-up I consider reasonable. Alternatively, I can recruit patients to become sellers in a multilevel marketing scheme (similar to pyramid selling). One doctor who practises nutritional medicine full-time has told me he buys $10 000 worth of vitamin E at the start of the year and manages to sell it over the ensuing 12 months for $100 000. I imagine most of that doctor’s patients are recommended vitamin E for their health complaints or health maintenance. This is entirely legal, although there are major ethical concerns about conflict of interest. To date, there has been little debate among our leaders regarding proper guidelines and regulation of this behaviour. With the enormous potential of the complementary industry to be a useful partner in health management, this needs to be sorted out sooner rather than later.

Scott Masters

Rosanna Capolingua Chair, Ethics and Medico-Legal Subcommittee, Australian Medical Association, PO Box 6090, Kingston, ACT 2604 Comment: I commend Masters on his personal code of conduct in dealing with the pharmaceutical industry. I also share his concerns about the ethical minefield that lurks in the interface between complementary and conventional medicine. Some of the issues involved have recently been explored in the Journal’s series on Complementary and Alternative Medicine.1 However, his scenario of a doctor selling vitamin E to patients raises specific concerns, and the Australian Medical Association’s Code of Ethics2 provides some ethical principles in this regard. Specifically, it states that a doctor should: “make sure that you do not exploit your patient for any reason” “exercise caution in publicly endorsing any particular commercial product or service not covered by the Therapeutic Goods Advertising Code”3 and “when referring your patient to institutions or services in which you have a direct financial interest, provide full disclosure of such interests”. Translating these principles into daily professional conduct means the practitioner must at all times declare pecuniary interest in the sale of products and be aware of the evidence base of the commercial recommendation so as to not mislead the patient. This involves clear communication of potential benefit, adverse effects, and possible drug–drug interactions of whatever product is promoted. But, above all, the whole thrust of the AMA Code of Ethics is to ensure that perverse incentives remain foreign to the patient–doctor relationship. Ultimately, it is an individual doctor’s choice.

Rosanna Capolingua

Hugh G Dickson Chair, Human Research Ethics Committee, South Western Sydney Area Health Service, Locked Bag 7103, Liverpool BC, NSW 1871. Hugh. DicksonATswsahs.nsw.gov.au To the Editor: Roberts et al1 state that the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans2 clearly outlines that, once approval has been gained from one human research ethics committee (HREC), other sites should accept that approval. Nowhere does the national statement state this. What Roberts et al appear not to appreciate is that research projects may consume resources within a health service. The HREC might also have the responsibility of ensuring that the tasks required for successful completion of research can be performed without compromising the standard of care of the health facilities in which the research is to be performed. The project in question required the extraction of medical records — someone has to do this and be paid for the task. While centralisation of human research ethics approval might make the task of approval of research faster, each administrative unit has to be able to decide whether to allow participation in a project given its current level of service demand. Approval for multicentre research will therefore still take time whether or not central ethics approval is obtained, and researchers will not find an easy solution to this.

Hugh G Dickson

Kerry J Breen Chair, Australian Health Ethics Committee, National Health and Medical Research Council, PO Box 9848, Canberra, ACT 2601. kerrybreenATaccess.net.au Comment: It is correct that the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans1 (paragraph 3.4) does not say that other sites should accept ethics review of a research proposal from another human research ethics committee (HREC). However, the national statement is written to permit and encourage this, but not to enforce it. Dickson’s letter also raises the issue of the terms of reference of HRECs. He alludes to an additional role — as gatekeeper of an institution’s resources — which some may feel is beyond the domain of HRECs. The national statement provides the framework for the composition and role of HRECs in their work of ethical review, but does not prevent an institution from asking its committee to also be the steward of access to resources regularly used (eg, medical records, pathology laboratories). The national statement requires an institution to set out the terms of reference for its HREC, “including the scope of its responsibilities” (paragraph 2.2). The prime function of HRECs is to make recommendations about whether a research proposal is ethical, but the final approval about whether the research can proceed rests with each individual institution. Thus, there is more to getting approval for a research proposal than just the ethical review.

Kerry J Breen

David J Maxwell,* Karen I Kaye† * Project Officer, † Executive Officer, New South Wales Therapeutic Advisory Group, PO Box 766, Darlinghurst, NSW 2010. tagprojectATstvincents.com.au To the Editor: We are currently coordinating the New South Wales arm of a national quality assurance (QA) project to improve the management of community-acquired pneumonia in Australian hospital emergency departments (CAPTION project: Community-Acquired Pneumonia: Towards Improving Outcomes Nationally, funded by the National Prescribing Service). In the project drug usage evaluation methods are used, and it involves an audit (retrospective review of patient medical records) as well as feedback and targeted education of healthcare professionals about national management guidelines for community-acquired pneumonia.1 There is no direct patient contact at any stage. Because this is a QA project, we did not request that participating NSW hospitals seek human research ethics committee (HREC) review. However, we did request that the project proposal be supported by HRECs as a QA activity. Further endorsement from the Chief Executive Officer, Director of Emergency, Director of Pharmacy and other key people and groups was also required. According to the National Health and Medical Research Council (NHMRC),2 an appropriately planned QA activity can proceed without HREC review and patient consent if: there is consistency with National Privacy Principle 2.1(a); and all people involved in the activity are unlikely to suffer burden or harm. To assist hospitals reviewing this QA project proposal, we developed a number of tools that explicitly outlined the nature of the project and provided answers to the questions in the NHMRC document. 2 These tools were provided to emphasise that this QA project was consistent with NHMRC requirements. The NHMRC further describes the establishment of hospital policies to allow efficient review of QA proposals that involve minimal risk, burden, alteration of care or invasion of privacy. It is recommended that a member of the HREC be appointed to review such proposals. Despite the NHMRC recommendations and the provision of tools as described above, full HREC submissions have still been required by four out of eight hospitals to date (recruitment still ongoing). After receipt of an initial expression of interest, completing the HREC submission and obtaining approval in three of these hospitals has taken an average of 5 months. The HREC review has not yet been completed in the fourth hospital. As the project is only funded for a 2-year period, this has resulted in a significant delay in the progress of the project. We do not challenge the vital role of HRECs, and we value the importance of ensuring the safety and privacy of all involved in human research. If QA coordinators and HRECs work together within the NHMRC recommendations, valuable time and resources could be saved, for both parties. In doing so, the Australian Research Ethics Committees’ belief that “quality assurance activities are an essential and integral part of health care delivery that should be encouraged and facilitated” would be one step closer to becoming a reality.

David J Maxwell · Karen I Kaye