Ethics

To the Editor: We support the conclusions reached by Parker and colleagues in their study on the attitudes of Australian medical practitioners to end-of-life decisions.1 They recommend the inclusion of decision-making theory and practice within medical ethics curricula, and highlight the need “to facilitate more discussion between specialties about medical decisions at the end of life”.1 An investigation commissioned to the Australian Institute for Suicide Research and Prevention by the Australian Government Department of Health and Ageing in 2006 aimed to verify receptivity towards, and possible ways of implementing, suicide prevention education in the medical curricula of Australian universities. This mandate also provided the opportunity to assess potential interest in and feasibility for education on end-of-life decisions.2 Our exploratory investigation included interviews of key academics in curriculum or accreditation committees of 10 out of 15 Australian medical schools, 24 general practitioners from six Australian states, and 373 medical students from the University of Queensland.2 Representatives of the medical schools considered it a “very high priority” to implement adequate education on end-of-life issues, including euthanasia, in medical curricula. Most of the interviewed GPs (21/24) and 80% of medical students agreed with this sentiment. Common themes that emerged from the study were the need for good preparedness in coping with difficult situations, and the desired capacity in competently handling decisions that are perceived to be requested with increasing frequency in clinical scenarios.2 End-of-life issues nearly always involve aspects that go beyond the treatment of somatic conditions. Moral convictions, religious beliefs, and self-identification processes (with the patient) all compound the challenge physicians face in their practice. The very complexity of the challenge should push towards more knowledge, and this should be obtained through modern medical curricula.

Diego De Leo · Jacinta L Hawgood

Potential conflicts of interest do not imply wrongdoing, but can create bias, distort decision making, and create a perception that practitioners are being “bought “or “bribed” by industry. Transparency alone may not be sufficient to erase the doubts created when authors of clinical practice guidelines or editorials declare potential conflicts of interest. Can the subconscious obligation for reciprocation that exists when gifts are offered and accepted be fully negated? Analyses of published clinical cancer research studies have found a positive association between pharmaceutical industry sponsorship and reporting of positive outcomes, manipulation of clinical trials, and hiding of “preliminary data sets”. More problematic is the issue of clinical researchers leaking preliminary results to the investment industry. Influential literature reviews and treatment guidelines have been associated with widespread declarations of conflict of interest. Some potential solutions are: regulating pharmaceutical companies to declare all gifts to clinicians, or ban such gifts; for clinicians to carefully declare potential conflicts of interest or to provide pro bono advice without accepting industry sponsorship; and for all gifts and payments from industry to academic physicians to be coordinated by an independent review committee. Journals should only allow reviews, editorials, guidelines and opinion pieces to be written by those without significant conflicts of interest.

Ian E Haines MB BS, FRACP, FAChPM · Ian N Olver MD, PhD, FRACP

Death investigation and the coroner’s inquest. Ian Freckleton, David Ranson. Melbourne: Oxford University Press, 2006 (iix + 929 pp). ISBN 978 0 195507003. Death investigation and the coroner’s inquest is an impressive text written by two highly qualified and acknowledged experts in their respective fields. International in scope, the book manages to bridge the gap between legal and standard forensic pathology texts, providing significant information about coronial systems in Australasia, and how forensic practice and the law interact in this forum. The text is set out in a number of well constructed and easily accessed chapters. One useful and quite fascinating section that sets the scene for the rest of the text deals with the history of the coronial system in England, and subsequently in the colonies, with examples of inquests dealing with the Kelly Gang and the Eureka Stockade. Particularly useful information is provided on the similarities of and differences between coronial systems among the states of Australia and also those of nearby Pacific neighbours, including New Zealand, Papua New Guinea and Fiji. Death-scene investigation is tackled from a number of perspectives, with cross-jurisdictional comparisons of systems in Europe, North America, Asia and the Pacific providing a useful overview not readily available in other texts. The various roles of forensic practitioners in evaluating death scenes are succinctly outlined, with an analysis of not only the medical aspects of postmortem examinations, but also a review of the legal and cultural issues associated with body and tissue retention and handling. A review is provided of the variety of techniques that may be used to identify human remains, with a clear demonstration of how computer-assisted photofit images may improve upon original material. The discussion of international disaster victim identification is comprehensive and timely. Helpful advice is given for doctors who may be called to give expert evidence, and the analysis of the process of inquests is extremely useful. Finally, the review of the strengths and weaknesses of the coronial system, and its likely future, provides a suitable end for the text. This excellent and reasonably priced book certainly fills a niche in the market and will be of use to all lawyers and doctors who are involved in the coronial process.

Roger W Byard

Objective: To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study.Design, setting and participants: Cross-sectional questionnaire administered to 324 participants in six clinical trials conducted at the Royal Melbourne Hospital in 1999–2000 and 2006 for non-acute conditions (asthma, chronic obstructive pulmonary disease, osteoporosis, rheumatoid arthritis, diabetes and influenza vaccine efficacy).Main outcome measures: Participants’ desire for information on study funding, investigators’ conflicts of interest, and use of accrued funds.Results: 259 participants (80%) completed the survey. Participants wanted to be informed about the identity of the project sponsor (148 participants; 57%), whether the investigators owned shares in the company (105; 41%) or received travel grants (83; 32%), how much funding was accrued at study completion (88; 34%), how accrued funds were used (98; 38%), and who approved their use (91; 35%). After adjusting for year of survey and level of education, younger subjects (aged ≤ 60 years) wished to be informed more often than older participants of who sponsored the project (odds ratio [OR], 2.35 [95% CI, 1.21–4.55]; P = 0.012), whether the investigators owned shares in the company (OR, 2.41 [95% CI, 1.27–4.60]; P = 0.007) and how much funding was available for other uses (OR, 1.79 [95% CI, 0.94–3.41]; P = 0.078).Conclusion: While most participants indicated that they would take part in clinical research again regardless of whether they received financial information, providing information on the sponsor, the investigators’ financial interest in the company, whether accrual of funds is expected, and how these funds will be spent should satisfy the interests of participants in company-sponsored clinical trials.

Anastasia Hutchinson BN, CCRN · Abe R Rubinfeld MB BS, MD, FRACP

Objectives: To explore general practitioners’ perceptions of their preparedness for an influenza pandemic, the changes they would make to their practice, and the ethical justifications for their planned actions.Design and setting: A qualitative study was performed among South Australian GPs between March and October 2007. A semi-structured interview was carried out with each participant in his or her practice, and the interviews were audio-recorded, transcribed and analysed thematically.Participants: 10 GPs were recruited: five from a metropolitan Division and five from a rural Division of General Practice.Results: Some participants felt they would not be able to cope with an influenza pandemic, while others felt it would simply mean an increase in their workloads. Most respondents considered creating separate waiting rooms, moving the reception desk outside of the practice and delaying all non-urgent consultations in order to deal with a pandemic more effectively. Respondents mentioned the conflict between their various roles and responsibilities as a primary source of tension when thinking about the way they would organise their work in the event of a pandemic. A number of GPs said they would not practise in the event of a pandemic, as they felt their responsibility to their families outweighed that to their patients.Conclusions: Professional codes of ethics should include guidance about the scope of the duty to treat during infectious disease outbreaks. The community has to uphold the value of reciprocity, and ensure that GPs and their families are provided with support during a pandemic and are given the opportunity to be actively involved in pandemic preparedness planning.

Olga Anikeeva BHlthSci(Hons) · Annette J Braunack-Mayer PhD, BMedSci(Hons) · Jackie M Street PhD, BSc(Hons), GradDipPrimaryHealthCare

Two children with advanced lung disease underwent successful cadaveric bilateral lobar lung transplantation, using lungs “cut down” from deceased adult donors — the first reported use of the technique in Australia. This approach, while it cannot address the lack of donor organs, may enable us to redress any size bias limiting paediatric lung transplantation. Clinical recordsPatient 1A previously healthy 9-year-old girl presented in early 2007 with an upper respiratory tract infection that progressed over 10 days to respiratory failure, requiring intubation and ventilation with high inspiratory pressures. Subsequent tracheal aspirates were positive for Mycoplasma (by polymerase chain reaction), with consistent serological results (antibody titres, 1 : 640). Computed tomography of the chest demonstrated widespread bronchiectasis (Box 1, A). Although she was extubated 6 weeks after initial presentation, she remained in hypercapnic respiratory failure (Pco2, 80 mmHg), requiring continuous oxygen supplementation (5 L/min) and bilevel non-invasive positive-pressure ventilation (BiPAP). She was listed for lung transplantation in May 2007, but, given the severity of her lung disease and in the absence of appropriately matched donor organs, the transplant team gave early consideration to cadaveric bilateral lobar transplantation using an adult “oversized” donor. This was performed in August 2007. Patient 2A 13-year-old girl with cystic fibrosis was referred for consideration of lung transplantation. She had been diagnosed with cystic fibrosis at birth (Δ508 homozygous, without liver, sinus or diabetic sequelae), and over the preceding 2 years developed progressive bronchiectasis (Box 1, B), necessitating supplemental oxygen and initiation of nocturnal BiPAP. She was initially listed for either lung transplantation or heart–lung transplantation; however, after 9 months of progressive respiratory failure (Pco2 increased to 46 mmHg; forced expiratory flow in 1 second [FEV1], 16%; forced vital capacity [FVC], 28% predicted), the transplant team considered cadaveric bilateral lobar transplantation, which was performed in September 2007. Surgical procedure and clinical courseBoth children underwent cadaveric bilateral lobar transplantation as described by Starnes and colleagues1 for living-related lung transplantation. Briefly, the donor right lower lobe was resected, and the right upper and middle lobes were implanted, the anastomosis being performed at the right main bronchus. On the left, the inferior pulmonary vein, interlobar artery distal to its lingular branch, and bronchus were transected, and the lower lobe removed. Size mismatch was compensated for by seating the donor bronchus inside the recipient bronchus, while pulmonary vessel mismatch was taken up in the suture lines. Neither patient required cardiopulmonary bypass, and resected lobes were not used further. Following surgery, both children were established on an internationally standardised immunosuppression regime, comprising prednisolone, tacrolimus and mycophenolate mofetil.2 Both patients made a good postoperative recovery, with short intensive care unit stays. Patient 1 required a longer inpatient stay for treatment of pneumonia. Neither patient developed allograft rejection, and lung function gradually improved (Box 2). Both patients were discharged to their respective tertiary hospitals for continuing follow-up. Both patients were well and without complication at follow-up 10 and 9 months postoperatively, respectively. DiscussionTo our knowledge, these are the first reported cases of cadaveric bilateral lobar transplantation in Australia. They demonstrate its efficacy as a means of reducing waiting-list mortality for paediatric lung transplantation recipients. Lung transplantation is now an established treatment for patients with severe end-stage lung or pulmonary vascular disease. Despite attempts to increase organ donation worldwide, the number of patients requiring lung transplantation far exceeds the availability of donor lungs. In Australia, this is of particular concern for children awaiting appropriate size-matched donor organs.3 Review of the Australian and New Zealand Organ Donation Registry between 2002 and 2006 revealed that very few lungs are retrieved from paediatric donors younger than 14 years (26/497 lung donors).4 The number of children with severe lung disease warranting consideration of lung transplantation, both globally and in Australia, is, fortunately, very small. The most recent data from the International Society for Heart and Lung Transplantation show that only 65 paediatric lung transplantations were performed worldwide in 2005.2 However, of concern is that waiting-list mortality is greater for children than for adults — a worrying trend as fewer paediatric lung transplantations have been performed per annum, while adult lung transplantation numbers have increased.5 In Australia during 2006, 181 donor lungs were offered for lung transplantation, with only seven paediatric donors contributing, all of whom were aged 6–14 years (Ross Pettersson, Australian and New Zealand Cardiothoracic Organ Transplant Registry and Heart Transplant Data Manager, St Vincent’s Hospital, Sydney, NSW, personal communication). Despite an active policy of utilising “extended” donor organs (eg, from older donors or donors with previous cancer, smoking or aspiration history) wherever possible, only 30%–50% of available lungs are actually suitable for transplantation,6 further diminishing the number of available donor lungs, which is low by international standards.7 In the absence of appropriately size-matched organs, children from our institution have died while on the waiting list (2/9 listed in 2000–2007); after reviewing the 2007 donor referrals, it became apparent that the children described here would most likely have died while waiting. Minimising paediatric waiting-list mortality requires consideration of non-traditional donor sources, such as live donors, who have been used in small numbers in the United States and Japan.8 The technique involves a bilateral lobar transplantation, typically taking one lobe from each of two larger, usually related, adult donors. Outcomes for living-donor bilateral lobar transplantation are similar to cadaveric lung transplantation, but there are significant ethical and technical issues with such an approach, and a potential 300% mortality rate. The number of these procedures being performed is declining.5 To our knowledge, no centre presently offers this service in Australia. In adults, cadaveric lungs have been cut down to facilitate lung transplantation where size mismatch between donor and recipient could prevent transplant.9 Typically, this involves non-anatomical “lung shaving” or anatomical lobar resection. Rarely is this a bilateral extensive procedure, given the potential complications, including persistent air leaks, airway stenoses and stump dehiscence. Lobar transplantation is not specific to lung transplantation and has become common practice in liver transplantation; lessons may be learned from these experiences.10 Paediatric lobar transplantation has not been widely performed outside of the living-related scenario, but despite the additional surgical complexity, outcomes have proven comparable to cadaveric lung transplantation.8,9 Starnes and colleagues’ work suggests our two patients can be expected to ultimately achieve near-normal lung function,11 and their total lung capacity will increase as they grow.12 Cutting down cadaveric adult donor lungs for use in paediatric recipients raises ethical and practical issues about removing donor lungs from an already insufficient adult pool. Should lungs that might “perfectly” match an adult be cut down for a paediatric patient? Is a child more deserving than an adult? Our approach to reducing waiting-list mortality is to perform transplantation on recipients with the most severe lung disease at the first opportunity, and both these children satisfied that criterion. In conclusion, our cases illustrate the difficulty experienced by many centres in acquiring an adequate number of donor lungs to service the needs of the paediatric lung transplantation waiting list. Using cut-down adult donor lungs had a good outcome in both our patients. Such an approach is likely to expand the donor pool available for children needing lung transplantation, thereby reducing the high waiting-list mortality experienced by this age group. 1 Computed tomography scans of the two patients’ lungs before transplantation A: Patient 1 had cysts and lung destruction after Mycoplasma infection (arrows). B: Patient 2 had severe cystic fibrosis-related bronchiectasis (arrows). 2 Clinical course after cadaveric bilateral lobar transplantation in two children Patient ICU days Hospital days Respiratory infection in first 3 months Biopsy (ISHLT grade) 30 days 90 days 180 days FEV1 (% pred) FVC (% pred) FEV1 (% pred) FVC (% pred) FEV1 (% pred) FVC (% pred) 1 2 27 Pseudomonas, Staphylococcus A0 0.89 (40%) 0.90 (37%) 1.02 (46%) 1.33 (54%) 1.26 (55%) 1.81 (78%) 2 2 11 Staphylococcus A0 1.12 (72%) 1.27 (71%) 1.17 (75%) 1.45 (81%) 1.11 (63%) 1.66 (94%) ICU = intensive care unit. ISHLT = International Society for Heart and Lung Transplantation. FEV1 = forced expiratory flow in 1 second. pred = predicted. FVC = forced vital capacity.

Dominic T Keating MD, MRCPI · Glen P Westall FRACP, PhD · Silvana F Marasco MS, FRACS · Jacquie H Burton DipAppSci(Nursing), BN, GradDipPaed · Mark R Buckland MB BS, FANZCA · Colin F Robertson MSc(Epi), MD, FRACP · Trevor J Williams MB BS, FRACP, MD · Gregory I Snell MB BS, FRACP, MD

To the Editor: I challenge the assertion made by Donohoo (Managing Editor of MIMS [the Monthly Index of Medical Specialities]) that “MIMS is held . . . in high regard” and that the “vast majority of MIMS subscribers recognise that the quality information provided by MIMS is essential in their daily encounters with their patients”.1 In fact, the most common MIMS annual to be seen around hospitals, in nursing homes and in doctors’ surgeries is an out-of-date one. Furthermore, as a general practitioner, when I do use MIMS, it is because it is packaged with our desktop software, rather than by choice or active decision. I have online access to the Australian medicines handbook (http://www.amh.net.au/), and various other references. I have no need to refer to MIMS, and I tire of the understandable bias MIMS has always had for proprietary prescribing.

Lilon G Bandler

Medico-legal radiology. William S C Hare. Sydney: Churchill Livingstone, 2007 (ix + 201 pp). ISBN 978 0 7295 3831 2. Emeritus Professor W S C (Bill) Hare had a long and distinguished career in clinical radiology, including a term as President of the Royal Australian and New Zealand College of Radiologists and Chair of Radiology at the University of Melbourne and the Royal Melbourne Hospital. In retirement, he has continued an active medicolegal practice as well as his writing. This latest book draws on both his personal experience and an extensive review of the extant literature. The first chapter, “Lawmakers and legal processes”, is as succinct a summary of the structure and practice of the law as I have seen. The second chapter, “Radiologists and the law”, examines how both statute and civil law can impinge on doctors in general and radiologists in particular, and the roles doctors can take in legal proceedings (ie, as defendant or as expert witness). The third chapter deals briefly with no-fault and fault-based systems of compensation for iatrogenic injuries, and looks at why patients sue, who they sue, the results of litigation and the impact of the cost of litigation on medical indemnity insurance premiums. Chapter four is a brief primer on how to interpret diagnostic images — a seven-page summary that would make valuable reading for any student or recent graduate, or indeed any doctor who needs to make sense of such images. The fifth chapter, on writing reports, is pure gold. When a defence organisation runs an expert witness seminar, attendees are desperate to learn how to manage themselves in court. But most will write dozens of reports for every time they actually go to court, and the quality of their report will have a great influence on whether they need to be called at all. Doctors generally write poor reports, because few seek instruction on how to write good ones. For radiologists, Professor Hare has now, in just nine pages, written the definitive primer. The remaining 10 chapters deal systematically with the major areas of medicolegal concern in radiology and conclude with a chapter on necroradiology (the title Hare adopts for radiological examination of the dead). Each chapter deals separately with litigation arising from diagnosis and litigation related to procedures. Each chapter ends with a series of dot-pointed “suggestions” which radiology registrars would be well advised to commit to memory! This is a relatively short, well written book. While written in an Australian context, the “suggestions” have application to any radiologist anywhere in the world.

Paul Nisselle

A cold never killed anyone ... did it? I went to work with a cold. My nasty sore throat woke me early, so I spent the time emailing our incoming clinical students: Get your influenza vaccinations before you start your clinical rotations — influenza kills people, vaccinating health care workers decreases mortality in nursing homes, and vaccination reduces other viral infections and days off work or school, and meets duty of care for oneself and others!1,2 Sincerely, your (vaccinated) Clinical Dean Sneezing and miserable, I considered staying home, abandoning the 20 complex, high-admission risk (general medicine) patients scheduled at the Aboriginal Health Centre and the hospital, many of whom had waited 2–3 months for an appointment. I thought of my mother — “Go to school, you’re not dying, you only have a cold!” Memories of my only previous sick day resurfaced: as an on-call intensive care unit senior registrar — feverish, achy, sneezing, nose running like a faucet, I had decided this wasn’t good for anyone. Caving at the prospect of working all night sick, I settled for guiltily calling in a fellow registrar. My “chief” had then rung — “How are you?” — Oh no, they think I’m skiving off! Peer pressure is strong stuff. So, this time, with patients waiting and my past lurking, I took some paracetamol, packed some tissues, and went to work. My first patient, recovering from a lung resection for bronchiectasis after last winter’s viruses almost killed him, is now surviving his first postoperative virus — not a drama. After warning him to stay far away and not shake my hand, I got through the rest of the day constantly apologising to my patients and colleagues, suppressing sneezes, washing my hands, and touching as few things as possible. After clinic, an email explained the coincidental absence of my medical students — “Sick with cough, unable to attend”. A colleague’s voice from the doorway wryly observed, “You’re sending the students mixed messages about getting vaccinated and duty of care while working with a cold yourself, potentially infecting everyone in sight”. I responded blithely, “I’m more dedicated to my work than the students are (different generation), and besides, a cold never killed anyone” ... but then, a moment of evidence-based-medicine horror hit me — That’s true, right? Although my work-despite-a-cold ethic hasn’t done me any harm (misery aside), I salved my skiving-off guilt with my greater desire to “do no harm”, collected kilos of paperwork and my laptop, and retreated home for a day in isolation. A hasty MEDLINE search for “common cold AND mortality” from 1997 to 2007 revealed 68 papers. Of these, the 13 highly relevant papers (gulp) fell into three categories: chronic obstructive pulmonary disease (COPD) or asthma complications (eight); childhood morbidity and deaths, largely related to cold medications (four); and HIV-related deaths (one). I quickly discovered that over 50% of COPD exacerbations are attributed to respiratory viruses — no big surprise.3 More concerningly, rhinoviruses are now well established culprits causing significant morbidity and even mortality.4-6 Indeed, only miniscule amounts of rhinovirus are needed to infect patients who then develop lung function changes typical of COPD exacerbations.7 If COPD causes 4% of all deaths per year in the United States (Australia should be similar)8 and viruses cause half of COPD exacerbations, then about 2% of mortality is potentially attributable to respiratory viruses. I began to worry about my patient with bronchiectasis. On the other hand, at least I hadn’t done any harm by prescribing over-the-counter cold medications with worrying potential for harm for any of my adult patients, let alone any children.9 Hmm ... non-steroidal anti-inflammatory medications seem to have evidence for relief (as long as I don’t have hypertension, stomach ulcer, heart failure, or kidney disease),6 so I think I’ll take some. What about vaccination? Reassuringly, at least for my reputation among my students and staff, several reviews supported influenza vaccination,10,11 especially since influenza viruses account for up to 10% of “common colds”.6 Distressingly, however, vaccination rates among health care workers are less than optimal — 82% of doctors and 40% of nurses had been vaccinated in one emergency department study (the best rates I could find).11 One dilemma remains. I, like 80% of doctors, worked with an illness for which I would have “sick-listed” my patients,12 but given that I care for under-served patients in a rural area with a shortage of doctors, is it worse to stay home and reschedule patients for appointments weeks to months later or to risk exposing them to my virus-laden self? Mortality rates for residents of rural and regional areas in Australia are 10% higher than for city-dwellers13 — largely due to health care access issues. My personal vaccination campaign should decrease the frequency of my own (and my students’ and staffs’) “colds” and, if I’m sick less often, this should increase access to me, thus decreasing my patients’ morbidity and mortality. Sadly, the evidence suggests that if I were working in an intensive care unit or a medical ward with high-risk COPD patients, I could justify staying home, but in my general medicine role and doctor-shortage situation, the mortality trade-offs suggest that I should probably go to work with a cold next time too (sigh). But as for you, dear health care providers: first, do what I say and what I do (get vaccinated against influenza); and second, do what I say and not what I did, and consider staying home with your own cold — because, you never know, it just might kill someone ...

Dawn E DeWitt MD, MSc, FRACP

To the Editor: The recent article by de Crespigny and Savulescu1 is nominally about the medical care of pregnant women, but its ramifications extend more widely into power relations, law and ethics, and matters of life and death. The article is entirely adult-centred: its authors never hint that a doctor who is treating a pregnant woman has not one but two patients. There is never the faintest suggestion that the fetus is a separate human being with his or her own medical interests. The “research” reported is a survey of 20 obstetricians, who all agree with the authors on abortion for fetal abnormality. Unsurprisingly, most said they would prefer fewer constraints on such abortions. Which abnormalities are grounds for termination? The authors never say, although terminations are performed in Victoria for conditions as readily treatable as cleft lip.2 The authors cite an estimate that where Down syndrome is identified in Victoria, 95% of pregnancies are terminated. Yet people with Down syndrome do not appear to find their lives intolerable: is the misery we want to put Down syndrome children out of their misery, or their parents’? The authors insist that in Victoria, “uncertain laws compromise good prenatal care”. The prenatal care they seem to have in mind can hardly be called care of the child: can it be called care of the mother? In one of the cases cited, a woman at Melbourne’s Royal Women’s Hospital was threatening suicide unless her pregnancy was terminated after a diagnosis of dwarfism at 31 weeks.1 Instead of providing her with urgent psychiatric care (had they never encountered a suicidal patient before?), the doctors terminated her pregnancy. If she had demanded the amputation of her left arm, would they have called in the surgeons? The surgical mutilation of an adult patient would not have been considered for a moment, but the surgical killing of a fetal patient was an available and practised routine. This woman was already not well, and the “prenatal care” she received put her further at risk. This case illustrates how true prenatal care is compromised, not by the few remaining legal limits on child destruction and abortion, but by their ready availability. Readers of the literature on post-abortion syndrome will have encountered many other illustrations of what should be obvious: that you are not likely to help a woman by destroying her child. Experienced and attentive general practitioners and psychiatrists will be able to give their own examples. Doctors need to pay close attention to the short paragraph on conscientious objection.1 The authors declare that “a doctor’s conscience should not be allowed to interfere with medical care” and that if “some individuals or institutions have moral objections ... those objections cannot compromise patient care”. If that does not mean that the authors want to exclude anyone who disagrees with them about what constitutes “medical care” from medical practice, what does it mean? There could hardly be a plainer threat to doctors’ personal professional judgement.

Edward D Watt

To the Editor: Superficially, de Crespigny and Savulescu make a compelling case for clarifying late-term abortion law.1 However, at a deeper level, it is disappointing that alternative points of view were not discussed in their article. The only solution offered in the case of a potentially imperfect child is to abort the pregnancy and try again. Unfortunately, this ignores several important issues. First, the consequences of abortion for the mother, both physical and psychological, are neglected.2 Our experience, as general practitioners, is that late-term abortions only lead to heartache and regret, even depression and anxiety, as the mother tries to deal with what has happened to her. Every time she sees either a “normal” or an “abnormal” child, her loss is re-lived. A patient of one of us (S B G) has developed Asherman syndrome as a result of a late-term abortion; she is now infertile. Second, without a definition of “child”, any discussion regarding abortion law is, at best, futile; at worst, it is emotionally charged and reliant on anecdotes. If a fetus is defined as a child, then that child has a right to live, whatever the disability. If not, then any disability up to the defined age could potentially justify “abortion” (ie, destruction). Third, the references given to support the assertion that women might “refuse to consider motherhood” without genetic testing described women who carry germline monogenic abnormalities (eg, thalassaemias, Huntington genotypes). These women would be eligible for earlier antenatal screening, such as pre-implantation genetic diagnosis, amniocentesis and chorionic villus sampling — all of which are available well before the current legal time frames in question. Fourth, de Crespigny and Savulescu’s premise for allowing late-term abortion is that there is a life-threatening fetal abnormality and the mother wishes to have children. However, a consequence of liberalising the law for the benefit of these women would be that women with non-life-threatening fetal abnormalities, and also those who simply did not want a child, could also access late-term abortion more easily. This is obviously a major concern. Finally, use of the term “child destruction” in the law is important when considering these situations. A helpful definition of the purpose of the law is to prevent injustice.3 As seen by the ability for women to access “legal” abortion before 20 weeks’ gestation, any law that protects children needs to stand. The pregnant woman clearly has a voice; unfortunately, the unborn child does not have the same ability to state his or her case before an ethics committee.

Simon B Gerber · John T Wenham

In reply: Watt seems to wish to return to the days of no prenatal testing; we believe today’s women reject this paternalistic view. However, Watt is correct in saying our article is “adult-centred” — it is not self-evident that the fetus is a patient, nor is this view consistent with those of most liberal legal jurisdictions. It has been found that 81% of Australians,1 including a majority in all major Australian religious groups,2 agree with a woman’s right to choose an abortion. Only 4% of Australians consider abortion wrong.3 We echo Amnesty International’s call for abortion to be decriminalised globally.4 Abortion laws should no longer discriminate against pregnant women with fetal abnormalities. Contrary to Watt’s claims, it is well documented that an experienced psychiatrist was central in managing the pregnant woman who had an abortion at 32 weeks at the Royal Women’s Hospital. In addition, we do not believe abortion has been demonstrated to cause psychiatric “post-abortion syndrome”,5,6 nor that abortion is analogous to amputating a healthy limb. We do not challenge doctors’ personal judgements. All individuals must be free to make their own value judgements for their own lives, including doctors. However, doctors have a duty to inform patients of all appropriate treatments. When a patient requests abortion and the doctor has a moral objection to providing it, the doctor must refer the patient to another practitioner.5 Contrary to Gerber and Wenham’s claims, we did not suggest that “to abort the pregnancy and try again” is the only option for fetal abnormality. Abortion — or continuing the pregnancy — must be the woman’s decision. One of us (L J d C) has 30 years’ experience of prenatal testing, including treating many women after terminations for fetal abnormality. Such women are sad about the diagnosis and outcome, extremely worried during subsequent pregnancies, and regret having had to make an awful decision. However, none have said that they made the wrong decision. Regarding Gerber and Wenham’s comments about the definition of “child”, our position is that (before birth) the fetus does not have the rights of a child.7 The data we cited show that prenatal testing for Huntington disease “allows” at-risk women, who might otherwise choose not to conceive, to have children. Personal experience (of L J d C) shows that women with a past history of other serious fetal disorders are no different. We did not suggest that late abortion should be available only in cases of life-threatening fetal abnormality. Indeed, our article clearly related to “pregnant women with fetal abnormalities” (not necessarily life-threatening). The claim that women would request late abortion simply because they don’t want a child demeans women’s integrity. We need clear abortion laws so that pregnant women and their doctors can know when abortion is lawful. Developing clear laws necessitates removing the crime of child destruction.8

Lachlan J de Crespigny · Julian Savulescu

Scientific evidence and the relationship between the medical profession, politics and the public are dynamic and inter-related In 1848, Rudolf Virchow asserted that “medicine is a social science, and politics nothing but medicine on a grand scale”.1 Regarded by many to be the father of modern pathology, Virchow saw clear responsibilities for doctors to engage with the broader social concerns that cause illness and harm. A century and a half later, human health faces threats ranging in scale from terrorism and climate change to the consequences of violence, substance misuse, poverty and environmental hazards that we deal with every day in our emergency departments and our clinics. On a handful of issues, such as smoking, health care professionals have been instrumental in changing public policy. But, with many ongoing social ills, is civic action a duty of modern clinicians? Following the September 11 terrorist attacks in the United States, the world’s leading medical journals expressed opposing views on this question. The editors of the New England Journal of Medicine implored doctors not to react directly to terrorism, but instead to treat injured patients, continue with medical research and ensure that the medical community is prepared for future terrorist attacks.2 In response, the Lancet’s Richard Horton argued that anyone working in the health professions is concerned with prevention as well as healing, that medicine cannot escape politics, and to reduce the burden of harm caused by violence, doctors must address how the political determines the clinical.3 Putting aside legitimate practical concerns — after all, few doctors think they have the time or skills to be effective political agents — the real question is whether or not we should nurture interest in addressing the health of communities among health care professionals, arming them with appropriate skills and promoting opportunities for engagement. If we examine the dual historical trajectories of scientific medicine and the place of professionals in society, we realise that this is not just a question of individual political or moral persuasion. Instead, it is one that depends on prevailing culture and circumstances of the time. In the 19th century, for example, doctors found professional distinction difficult to attain, largely because the scientific basis of medical practice was rudimentary and their treatments were often harmful. Public health activism was one way in which doctors could achieve status and authority. While not all doctors embraced it, public health was at least deemed to be complementary to the work of medicine.4 This changed rapidly early in the 20th century as scientific and clinical evidence evolved, and, in mastering this body of evidence, doctors became valuable to the public.5 Based on new understanding of bacteriology, germ theory and specific disease-based treatments, the biomedical model of disease triumphed. The new medical schools focused on diseases more than on people or populations, and on cures rather than on the social, behavioural and environmental forces that maintain health or produce disease. Unlike efforts to change social conditions, which were seen to be tainted by politics, advocacy and social diversity, the reductionism, objectivity and certainty of the biomedical model had great appeal. By the 1950s, the income, professional status and authority of doctors far exceeded that of public health professionals, and deep antipathies had evolved between them. In the most recent 50 years, this relationship has become less polarised, due especially to three scientific and sociological developments. The first was the birth of modern epidemiology and multivariate analysis. They demonstrated that most major illnesses were not random occurrences and that peoples’ overall health status was not only a consequence of the care they received. We now know that they are influenced by a range of social factors, including income and social status, social support networks, education and literacy, employment and working conditions, and social and physical environments.6,7 Second, business and government replaced the individual as the principal purchasers of health care, and have been increasingly interested in research that reveals disparities in health status, unequal access to treatment and variable quality of care. Managers and policymakers have challenged the view that entrenched health problems can be solved simply by more doctors, more medicines or faster discharge times. Third, fuelled by the repercussions of high-profile cases such as the Bristol Royal Infirmary8 and Bundaberg Hospital9 cases, cynicism grew about the medical profession’s ability to put aside its own interests and to self-regulate standards of performance. In light of such developments, it is no accident that doctors have been concerned with issues of professionalism. In February 2002, a transatlantic team of physicians published a Charter of Medical Professionalism, which was a bold restatement of the responsibilities of doctors as professionals — a sort of modern Hippocratic Oath.10,11 From July 2003, the American Council of Graduate Medical Education and the American Board of Medical Specialties required that all American medical and specialist training programs teach and assess “professionalism” as a core competency. The concept of professionalism rapidly gained traction, and the Charter provided a road map. It offered three fundamental principles: primacy of patient welfare, patient autonomy and social justice. The first two were uncontroversial. Social justice, however, with its implied responsibilities for public roles that redress social inequalities, was greeted with some ambivalence and much confusion, and needed clarification. With colleagues at Harvard I developed a conceptual and operational model based on our qualitative research with a range of professionals, academics, consumers and social commentators.12 Finding the label “social justice” generally unhelpful, we preferred the term “public roles”, which we defined as advocacy for and participation in improving the aspects of communities that affect the health of individual patients. We justified doctors’ public roles on the premise that doctors and the public expect discipline-based expertise to encompass all aspects of diagnosis, prevention and treatment; patients expect the medical profession to do what it can to promote their health; and doctors can be effective advocates for societal change through changes in legislation, advertising, public awareness and so on. We set reasonable limits on these obligations, based on the strength of evidence and the feasibility of doctor-promoted change. We identified three strategies for action by busy clinicians: community participation, individual political involvement, and collective advocacy through professional organisations. We made the case that individuals could choose activities — small or large — that suit their own situation and disposition. In the US the model generated considerable debate, became required reading for many medical training programs, and has been used in a variety of policy documents. In a survey of 1662 American doctors in six specialties, over 90% rated each of community participation, political involvement and collective advocacy as important roles, although fewer than half reported being involved in such activities in the previous 3 years.13 Dr John Furler and his team from the University of Melbourne Department of General Practice then explored the usefulness of the model for the Royal Australian College of General Practitioners’ policy on health inequalities. They conducted 80 interviews and two focus groups with a range of internal and external stakeholders.14 To some degree, Australian responses echoed the ambivalence to the concept of social justice observed in the US — public roles were supported when expressed within a familiar framework centred on care and compassion, but contested when expressed as matters of justice and fairness, particularly if any personal sacrifice was perceived. Their findings highlighted the tensions between the dual responsibilities of professional bodies to the public and to their members, and the importance of leadership from professional organisations in promoting public engagement. So what can we conclude? First, that both scientific evidence and the relationship between the medical profession, politics and the public are dynamic and inter-related. Second, most doctors now seem to accept that their expertise should include knowledge about social determinants of illness and access to care and that, even when they are not personally involved, it is important that the profession provides a responsible expert voice on such determinants in public debate. Third, public roles are most likely to gain traction among doctors when conceptualised as issues of care and compassion rather than as actions of justice and redistribution. Clinicians want their expertise put to good use in the public sphere in a way that complements rather than detracts from their core responsibility of being expert in the traditional doctor–patient relationship, and the rewards reaped from it. Fourth, a double challenge lies ahead because, while contemporary professional standing may partly depend on public engagement, the effectiveness of such engagement depends, in turn, on how convinced the public is that the profession has its own house in order.15 And finally, conceptual clarity, realistic expectations and good role models are needed if clinicians are to engage effectively with important public concerns. Teaching about social determinants of health alone is insufficient. To use this information and be effective political agents, future health care professionals will need skills in advocacy and public participation. Virchow led an extraordinarily civic-oriented life, as a participant in the 1848 Berlin uprisings and later as a Berlin city counsellor, cofounder of the German Progressive Radical Party, and member of parliament. With public-spiritedness and the right tools, modern health care professionals could be both active clinicians and evidence-based advocates on important health-related matters in their communities. Virchow would be pleased — medicine would once again be a social science.

Russell L Gruen MB BS, PhD, FRACS

Who owns our health? Medical professionalism, law and leadership beyond the age of the market state. Thomas Faunce. Sydney: UNSW Press, 2007 (xi + 298 pp). ISBN 978 086840 821 7. Global warming, unsustainable global demands for fossil fuel as China and India come on line, threats to biodiversity, obesity, 1.1 billion people in extreme poverty, wars and rumours of wars — it’s enough to make you sick. How, in a world like this, can we find the strength to be a doctor? Faced with this mess, you might choose to retreat into silence, keep your own council, look after your family and plan for retirement. Not prepared to retreat or be silent, Thomas Faunce — doctor, lawyer, philosopher and ethicist at the Australian National University — writes passionately in pursuit of a future for medical professionalism. He is deeply worried about how market fundamentalism has come to dominate everything, including politics, and explores what might be a satisfactory foundational ethic, or basic moral commitment, for tomorrow’s doctor. He considers the market state will not last, but in the meantime, we need to keep the flame of professionalism alight. Of the market state, which Faunce finds so objectionable, he writes: Governments are controlled by the will not of the people, but of . . . corporate executives [who] espouse . . . socially and environmentally damaging, profit-laden values . . . creating a world where . . . individualistic consumers grow increasingly apathetic about the erosion of their rights and responsibilities as citizens. Faunce sees the progressive privatisation of health care as a manifestation of the growing dominance in politics, without a popular mandate, of the private health insurance funds, large pharmaceutical and device manufacturers, and those seeking to make huge profits on behalf of shareholders from the care of the sick. Here is market fundamentalism on full display. After extended excursions into philosophy and ethics, and multiple literary allusions, Faunce proposes that the foundational value — the base plate — for medical practice should be “loyalty to the relief of patient suffering”. He does not think that medicine should primarily be promoting communal welfare, nor promoting and maintaining health. These are worthy actions, but they lack the voltage to power the engine of dedicated medical practice. If we cut medicine off from a strong connection to individual human suffering, then we cut it off at the knees. The relief of patient suffering, Faunce argues, is a strong moral force that generates action that is externally and publicly focused. There are many good things that come from being a doctor, such as status, job satisfaction and money, that motivate us, but none of these internally directed, individualistic ambitions provides all the strength for medical practice that responds to the need of individual patients who come seeking help. This requires us to put suffering patients always ahead of ourselves. A primary moral commitment to the relief of patient suffering then allows us, Faunce argues, to build a structure of other ethical action that constitutes truly professional practice.

Stephen R Leeder

Ethical issues are constantly changing as clinical research and practice push out the boundaries of what we know and do The beginnings of ethical and regulatory oversight of the human research enterprise are customarily traced to the Nuremberg Code, a set of principles and standards for medical experiments outlined by the Nuremberg war crimes tribunal in 1947 following revelations of the infamous Nazi experiments conducted during World War II.1 Ironically, Germany was the first Western country to officially require informed consent for non-therapeutic research. In 1900, the Prussian minister for religious, educational and medical affairs issued a directive after it came to light that Albert Neisser had injected syphilitic serum into prostitutes without their knowledge or consent;2 and in 1931, the Reich Minister of the Interior introduced Guidelines on innovative therapy and scientific experimentation following an inquiry into the Lübeck disaster, in which 75 infants died and 168 others developed tuberculosis after receiving a contaminated batch of oral BCG vaccine.3,4 In 1964, after more than a decade of drafting, the World Medical Association (WMA) issued the Declaration of Helsinki, elaborating on the basic principles in the Nuremberg Code.5 This was ratified in Australia the following year, and in 1966 the National Health and Medical Research Council (NHMRC) issued its first Statement on human experimentation.6 The requirement for ethical approval of NHMRC grant applications in 1973 and the addition of Supplementary Note 1 in 1976, defining the role and functioning of human research ethics committees (HRECs),6 marked the beginning of the current ethics oversight system in Australia. The devolution of responsibility for evaluation and approval of clinical trials from the Therapeutic Goods Administration (TGA) to local HRECs and the rapid growth of multicentre trials during the 1990s highlighted a number of weaknesses in the system, particularly the requirement for each HREC to give separate consideration to projects involving research in more than one institution.7 Recognising these issues, as well as the importance of applying ethical principles to all types of human research, the NHMRC released a significantly revised National statement on ethical conduct in research involving humans in 1999.8 Subsequently, concern that HRECs have become overburdened with management and regulatory functions that are primarily the responsibility of research institutions has generated discussion of the notion of “research governance”, defined as an organisational framework through which institutions are held accountable for maintaining standards of quality, safety, privacy, risk management and financial management of research, in addition to ensuring its ethical acceptability.9,10 Despite concerns about the risk of creating a massive new bureaucracy,11 the concept has been enthusiastically embraced12 and the 2007 revision of the NHMRC national statement has an entire section devoted to governance.13 The publication in this issue of the Journal of a survey of current knowledge of research governance by Babl and Sharwood14 is thus particularly timely (→ Research governance: current knowledge among clinical researchers). Researchers, students and clinicians were asked about their familiarity with “the essential national and international documents guiding GCRP” (good clinical research practice), namely the Declaration of Helsinki,5 the NHMRC national statement13 and Australian code for the responsible conduct of research.15 The results appear to show a worrying lack of familiarity with the content of some of these “key” documents, and Babl and Sharwood conclude that institutions are failing in their responsibility to provide adequate training for those engaged in research. Few would disagree that more resources should be devoted to training; however, the study probably overestimates the depth of ignorance. Babl and Sharwood seem unaware that formal guidelines for GCRP were originally published by the TGA in 1991 and superseded in 200016 by the Note for guidance on good clinical practice, a quality standard agreed to by the International Conference on Harmonization for the design, conduct, recording and reporting of clinical trials.17,18 While it is essential that principal investigators running clinical trials are familiar with its contents, it is of little relevance to students, researchers and clinicians not directly engaged in drug trials. As for the Declaration of Helsinki,5 this is no longer considered a key document. The sixth edition released in 2000 created a worldwide furore centred on two paragraphs, one concerning use of placebos in clinical trials, and the other asserting participants’ right of access to the best-proven treatment identified by the trial. Influential American and European regulatory bodies refused to accept the revisions, forcing the WMA to water down the offending paragraphs.19 As a consequence, the Declaration of Helsinki has declined in moral force and influence. Whereas in 1999, the NHMRC national statement listed it as a relevant publication,8 in the 2007 revision, it is relegated to a historical reference in the preamble.13 Also in this issue of the Journal, Ballantyne and Rogers report their survey of chairs of Australian HRECs on the fair inclusion of men and women in clinical research (→ Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs ).20 They correctly point out that, historically, women have been excluded from clinical trials, resulting in inadequate data on safety and efficacy of marketed drugs, and their findings suggest a lack of awareness, concern and action on the part of HREC chairs. Following the thalidomide tragedy in the 1960s, there was major strengthening of the drug regulatory agencies in the United States, United Kingdom, Europe and Australia. At that time, in the absence of widespread use of effective means of contraception, there were justifiable ethical concerns about enrolling women of childbearing potential in clinical trials. Exclusion was commonplace until the late 1980s, when the increasingly powerful HIV/AIDS lobby pressured the US Food and Drug Administration into reviewing its drug approval policies.21 By 1990, the US National Institutes of Health (NIH) had introduced guidelines covering the inclusion of women in clinical trials, strengthened by legislation in 1993, and the most recent policy update in 2000 stated: “NIH experience has indicated that inclusion has been accomplished”.22 In Australia, a Women and Clinical Trials Working Party was established in 1995 to advise on changes to NHMRC guidelines,23 and its recommendations were incorporated into the 1999 National Statement,8 albeit in rather general terms. Ballantyne and Rogers are critical of this, believing that “HRECs require further instruction from the NHMRC about how to interpret and apply the generic principle of fair inclusion.” However, detailed instructions were, in fact, provided in the Human research ethics handbook, issued by the NHMRC in 2002.24 The fact that chairs of HRECs may not be aware of them probably indicates that unfair sex discrimination in clinical trials is no longer a significant issue. So, where to next in the field of human research ethics? Times have changed. With the increase in off-label prescribing in paediatric practice, our challenge now lies in ensuring that children are adequately represented in clinical trials — with responsibility shared by researchers, sponsors, HRECs and regulators. Human research ethics is a work in progress, and will remain so for the foreseeable future.

Robert H Loblay PhD, FRACP

Research in Aboriginal health may be hampered by a lack of experience with the process of collaboration with Aboriginal communities, and additional ethics approval requirements. Awareness of resources and advice from Aboriginal mentors with in-depth knowledge of clinical and research issues can greatly assist researchers. A collaborative approach between researchers and Aboriginal communities is pivotal to developing a research project consistent with Indigenous cultural values and health concepts, with the potential to improve services and outcomes for Aboriginal peoples. Planning and broad consultation can ensure that research is feasible, ethical, culturally sensitive and beneficial. This article outlines lessons learned from personal experience of developing a project in Aboriginal health, which we hope may serve as a practical guide for others.

Anne P F Wand B(Sc)Med(Hons), MB BS(Hons) · Sandra J Eades BMed, PhD

The main objectives of medical negligence law relate to substandard care — the direction the law will take when new treatment approaches come along is not always clear If two heads are better than one, then four should be much better, and six should be truly formidable. The axiom is especially likely to hold true when the problem at hand is multifaceted, and each head carries knowledge that is relevant, different, and complementary. Therein lies the allure of multidis-ciplinary care (MDC) teams in cancer care. An age has passed since any surgeon, radiologist, pathologist, radiation oncologist, medical oncologist, or general practitioner could legitimately claim to be working both in splendid isolation and safely. Consultation among clinicians is integral to modern medical care. But the physical meeting of so large and diverse a group of busy clinicians, together with their allied health colleagues, for purposes of devising treatment plans for individual patients is a relatively recent phenomenon. Twenty years ago, the notion would surely have been met with disbelief in many hospitals. Today, the growing complexity of cancer treatment, coupled with new knowledge about the promise of team-based management in health care,1,2 are quickly establishing MDC teams as a standard feature of high-quality cancer care. Evidence of the effect of MDC on quality of care is still emerging. Recent studies suggest that cancer patients managed through MDC teams may have better decisions made about their care,3 live longer,4 enjoy better quality of life during treatment,5 and receive services more efficiently.6 However, substantial gaps remain in understanding the impact of MDC.7-9 From a medicolegal perspective, the salient aspect of MDC is that it shifts aspects of clinical decision making away from single actors and toward groups. How will courts handle allegations of substandard decision making levelled at all members of the team, or the team itself? Will team members with second-hand know-ledge of the patient’s condition assume less responsibility for faulty plans than those directly involved in the patient’s care? What of members who opposed the care path chosen? And what obligations do hospitals have to ensure MDC teams are established and that they play a meaningful role in clinical decision making? The short answer to these questions is that we don’t know yet. The absence of negligence claims targeting MDC in Australian courts and Anglo-American jurisdictions abroad means that we must speculate (although it is surely just a matter of time before litigation on point materialises). A threshold question in any negligence claim is whether the wrongdoer owed a duty of care to the person wronged. In medical negligence claims, the defendant’s duty is rarely disputed. In fact, tort law textbooks present the patient–doctor relationship as a paradigmatic example of a dutiful relationship. Occasionally, however, the assumption is challenged. Telemedicine10 and supervision of trainees by senior doctors at a distance11 are two recent examples of circumstances that force close consideration of the contours of the patient–doctor relationship. In both situations, duties may be imposed, even when the defendant clinician works at a considerable remove from the injured patient. The wise course is for each member of an MDC team to assume that, by virtue of their involvement in a team meeting, they assume certain responsibilities to the patient. (Indeed, responsibilities arise in virtually any setting in which doctors turn their mind to a particular patient and give advice.) Fulfilling those responsibilities requires sound judgement and informed input, commensurate with what would be expected of a team member’s professional peers were one of them seated at the same table and presented with the same information. If the first step in a medicolegal analysis of MDC is to recognise that the team and its members may be exposed to liability for their activities, the second step is sober assessment of how large that exposure is, and what can be done to minimise it. In this vein, the article by Evans and colleagues in this issue of the Journal (→ Medicolegal implications of a multidisciplinary approach to cancer care: consensus recommendations from a national workshop)12 is a welcome addition to the literature. The authors outline consensus recommendations developed at a workshop of experts. Their suggestions are clear and useful, particularly the need for attention to MDC activities in the informed consent process and careful documentation of team membership and resolutions. To these, I would add a simple exhortation to participants in MDC team meetings. Speak up! Your professional responsibilities entail weighing in wherever your expertise is relevant. If information is insufficient to render an informed opinion, say so. Group consensus is helpful, and learned clinical colleagues acting in good faith will often arrive at it, but, as Sidhom and Poulsen point out, MDC meetings should not be regarded as a strictly democratic process in which majorities rule.13 Disgruntled wallflower is the wrong part to play in an MDC team. Standards of care in medical negligence law are fluid and progressive. Today’s cutting-edge treatment may become a routine and expected treatment in the future, as it diffuses through clinical practice and evidence of its efficacy mounts. A curious aspect of negligence law is that novel treatments or approaches to care tend to raise heightened liability risks in their innovation phase, but once they gain currency, the risk profile flips: failure not to employ them becomes the greater liability risk. Recognition of this legal reality brings special resonance to the investigation of the uptake of MDC approaches among breast surgeons by Marsh and colleagues in this issue of the Journal (→ National Breast Cancer Audit: the use of multidisciplinary care teams by breast surgeons in Australia and New Zealand).14 Standards of care are not defined purely by reference to the prevalence of particular practices in the medical community; nor are recommendations and guidelines from august professional bodies, such as the National Breast Cancer Centre, accepted as definitive proof as to whether a particular practice has become an accepted standard. On the other hand, both factors are highly relevant considerations in determining the applicable standard of care. In Australia today, at least in some settings, MDC has probably become the standard of care for treatment of some cancers, particularly breast cancer. For other cancers, it likely stands on the cusp of becoming so. Thus, Marsh and colleagues’ findings14 should grab the attention of administrators and practitioners working in hospitals that have not adopted MDC practices. Rural and private facilities appear particularly likely to be in this situation. Many rural and private hospitals will face barriers to MDC that their counterparts in urban and public settings do not, as the article’s authors point out.14 Standards of care can bend to accommodate unavoidable resource and manpower constraints. However, in institutions where an MDC approach is feasible but is not being pursued, hospital leaders should carefully review their position. It is conceivable that a claimant may allege that the appropriate approach for breast cancer treatment was not followed and that, had it been, the harm in question would not have occurred. Such accusations would be likely to fall particularly heavily on the institution itself for failing to organise for effective MDC. Success for the plaintiff in this type of claim will not be easy. The evidence that MDC systematically improves quality of cancer care remains quite thin,7-9 which makes proving that it would have done so in an individual case an uphill climb. Nonetheless, it is quite possible that litigation along these lines may be brought. In that event, defendant institutions will no doubt find the attendant publicity unsavoury, whatever the claim’s outcome. The law aims to promote high-quality care, not retard it. Legal doctrine is neither static nor vacuum-sealed. As practices change, and promising initiatives like MDC emerge, the law must evolve to accommodate them, without abandoning its commitment to holding providers accountable for substandard care. Timely scholarship, like the articles in this issue of the Journal,12,14 can help guide that evolution at the right pace and in the right direction.

David M Studdert LLB, ScD, MPH

Treating clinicians need to make and own decisions about withholding futile treatment, instead of delegating them to patients’ families who are usually ill equipped to do so As a specialist physician for more than 20 years and, more recently, as a senior health manager, it has become apparent to me that staff at all levels across the hospital sector believe that they are actively treating a proportion of patients for whom such treatment is clearly futile. In providing this treatment, clinical leaders are on some level aware that they are doing a disservice to these patients, their families and the community, but seem ill equipped or unwilling to deal with the psychological, social and perceived legal challenges encountered in withholding futile treatment. Futile treatmentThe definition of futile treatment is complex and has been discussed in detail by others.1 One simple definition is treatment that gives no, or an extremely small, chance of meaningful prolongation of survival and, at best, can only briefly delay the inevitable death of the patient. It is helpful to use an example to illustrate: in my former clinical practice as a nephrologist, cases similar to that in the Box were becoming increasingly frequent. There are, of course, a variety of other clinical circumstances where treatment might not be strictly futile (in terms of prolonging survival) but in which complex quality-of-life issues are an important part of the decision-making process. For example, antibiotic treatment of curable pneumonia in a patient with advanced dementia who might then live some years would not be regarded as futile therapy but might still legitimately be questioned. In such situations, early consultation with patients, advanced care directives, and legal next-of-kin consent for incompetent patients are required. While there may be good arguments to not pursue active treatment in some of these cases, the context is quite different from that of futile treatment and requires a different approach to that proposed here. Futile treatment and the lawClinicians are under no moral or legal obligation to provide futile treatment2 and, indeed, I would contend that their obligation is to withhold treatment that keeps patients from their families and is invasive and unpleasant, in the absence of any likely survival benefit. Why, then, do clinicians pursue this course of action in the knowledge of its folly? Usually, when questioned, the response from clinicians in the common situation of an incompetent patient is: “Because the patient’s family or next of kin want us to do everything”. This is poor practice on two grounds: because futile treatment should not be continued even if apparently desired by the next of kin; and because, in my experience, most next of kin will accept a decision to withhold futile treatment, as long as they are not being asked (as is commonly the case) to personally make what they see as a life-ending decision. The legal situation is quite clear in all jurisdictions. Competent patients, or those holding authority to act on behalf of incompetent patients, cannot demand treatment that clinicians believe to be futile.2 This includes such treatment as cardiopulmonary resuscitation (CPR), dialysis, ventilation and, in some circumstances, even enteral or intravenous nutrition. It is quite surprising how little awareness of this legal situation there is among medical staff. Junior doctors often believe that consent of the next of kin is required to withhold CPR, when, in fact, even if the next of kin desires the patient to have CPR, they have no legal right to demand it if the treating clinicians consider it futile. Futile treatment and decision makingIn part, the current problem with clinical leadership in futile treatment relates to a misperception of the role of inclusiveness in decision making. Twenty-five years ago, medical leaders in hospitals were seen as decisive, but not in an inclusive way. Decisions would be made at the end of the bed, and the patient, his or her family, and the rest of the clinical team would, hopefully, be informed of the decision but not included in the decision-making process. Rightly, the educational and ethical framework has changed, such that it is now the norm to have multidisciplinary decision-making processes and to fully inform patients and their families about all aspects of care and clinical decisions. Unfortunately, some clinicians have interpreted this involvement of families in the clinical decision-making process for incompetent patients as a reason to delegate some of the clinical team’s decisions to the family, who, at the time, are ill equipped to deal with them. To illustrate this point, consider the case outlined in the Box. My approach to the family of this incompetent patient was to say that dialysis was not going to offer meaningful prolongation of survival and would be very unpleasant, and therefore that “the clinical team has decided not to offer this treatment and we will instead offer palliative care”. The more recent approach, with the misguided view of inclusive decision making, would be to give the family the gloomy prognosis but then leave them with the terrible question: “Do you want us to provide dialysis (which might be life-sustaining for a short period of time) or do you want us to not perform dialysis and instead provide palliative care?” In effect, the family hear this question as: “Do you want to make the decision to end the life of your loved one or do you want us to keep trying with a life-prolonging treatment?” While some spouses, children or other relatives may have sufficient psycho-emotional strength to deal appropriately with this scenario, many do not and will revert to the base position of “do everything, including dialysis”, in the mistaken belief that seeing their relative suffer and die despite treatment is better than living with the terrible responsibility of their (incorrect) belief that they consented to the death. Compare this with my approach, where the family are left with the view that the clinical team could do no more and decided that palliative care was best. In my experience, most families took comfort from this approach. A more common example is the decision to withhold CPR, which is usually made in the context of the treatment being considered futile for an incompetent patient. Modern practice would dictate, appropriately, that such a decision should not be made without full consultation with the family or next of kin. This is commonly misinterpreted by clinicians as a requirement for formal consent from the family to withhold CPR which, when asked for, is often refused for the same reason as given above. Few people are emotionally equipped to deal with a decision that they misinterpret to mean they let their relative die when his or her heart stopped. It is much better for them to know that the decision not to perform CPR was made and owned by the treating clinicians who have judged that they can do no more for the patient and that CPR would serve no purpose. Futile treatment and leadershipDiscussion with families about withholding futile treatment will always take considerable time, which must be allowed for, to ensure a full and complete picture is provided and their many inevitable questions can be answered. Families may request additional time to come to terms with a decision or even to gain another opinion on the prognosis and the futility of treatment. These requests should be granted, but with the understanding that it is the province of the clinicians to make these decisions. Very occasionally, some families will refuse to accept the clinical decision and will seek support from the legal system. Health services should support and welcome these rare legal challenges as an objective endorsement of actions to support the primary duty of care to the patient. There has not been a case where a court in Australia or the United Kingdom has overturned a carefully considered decision by a doctor to withhold treatment that is considered futile.3 While I have referred to clinicians and the clinical team, and strongly believe that treatment decisions are the province of the whole team, it is clear that the community looks to the (senior) medical practitioners for the security they need to accept decisions of great moment, such as withholding futile treatment. It is most important that the senior medical members of a hospital team be prepared to play a leadership role in these discussions and, based on their clinical experience, be prepared to make statements and communicate decisions in a way that inspires confidence in others. This leadership issue is therefore largely a problem of the medical profession. Indeed, junior medical staff and nursing and allied health staff in hospitals are often left with the consequences of poor or absent decision making by senior staff and will likely welcome the rebirth of leadership. Withholding futile care is not about saving money for the health system. The primary reason for clinicians to withhold futile care is to enable them to do their best by their patient. Certainly, some resources might be freed up, but only to be used by the many other patients with treatable conditions who are waiting for hospital care and may, indeed, cost more to treat. I strongly encourage medical leadership groups within and outside of health services to raise and debate this issue and call for a re-evaluation of the relevant parts of undergraduate and postgraduate medical education curricula. This is not an issue that requires legislative change or widespread community debate; it is merely implementing good practice in the best interests of patients and is within the existing power of medical clinicians to effect change today. An 88-year-old man is admitted with advanced renal failure for consideration of maintenance dialysis treatment. He is bed-bound, with longstanding type 2 diabetes, dementia, widespread macrovascular and microvascular disease, amputations, poor vision and advanced ischaemic cardiomyopathy. From clinical experience and registry data, nephrologists know that, while dialysis in the short term might provide some prolongation of life (perhaps weeks or months), it will be at the price of a long-term inpatient stay (probably until death), frequent vascular access surgery and a high risk of even earlier death from the complications of treatment. Maintenance dialysis treatment is therefore reasonably seen as futile in this clinical context.

Brendan F Murphy MB BS, PhD, FRACP

In 2007, the National Health and Medical Research Council (NHMRC) released a revised National statement on ethical conduct in human research. Public submissions in the review process leading to the 2007 statement highlighted four main areas of concern: children’s competence to consent, mature minors and the requirement for parental consent, whether children can refuse to participate, and the provision of information to children. A useful addition to the statement is the concept of levels of maturity, which help determine whether a child or young person’s consent is necessary and/or sufficient for participation in research. Changes in terminology (“capacity” instead of “competence” and introduction of the term “vulnerability”) have the potential to create confusion, as the new terms are not clearly defined, and capacity is used in several senses.

Merle P Spriggs PhD · Lynn H Gillam PhD

Suffering and healing in America: an American doctor’s view from outside. Raymond Downing. Oxford: Radcliffe Publishing, 2007 (xii + 126 pp). ISBN 978 1 84619 130 5. In an age of increasing disparity between the health systems of rich and poor countries, Suffering and healing in America offers an analysis of how America’s health system can learn from the achievements of those in more poorly funded settings. The author argues that health care in America risks the charge of hubris as it increasingly fails to address the needs of poorer members of the community. Furthermore, Western medicine has so raised the expectations of cure that it has contributed to the loss of capacity to cope with suffering when cure is not possible. He discusses the comparative notions of cure and healing and the evolving role of family medicine within the health care system. While many of the questions the author raises are undoubtedly serious challenges facing health care and therefore worthy of discussion, his subjective analysis rarely penetrates far below the surface of the more complex issues. The author makes heavy going of his cure versus healing discussion but never really mounts a clear argument. The way he uses anecdotes to illustrate certain points is reminiscent of parables, and too often they shed little light on the labyrinthine world of modern health care. The chapter on culture offers perhaps the most pertinent example of this, leaving the reader frustrated by the simplicity of the analysis. The title of the book is itself a curious example of the false trails the author follows: he spends more of the book discussing his experiences as a medical practitioner in Africa than America, and not all the comparisons he makes are relevant given the cultural, social and economic disparities between the two worlds. The repeated pattern of raising topical issues but then not really addressing them undermines the value of the book as anything more than a mildly interesting narrative.

Damien W Morgan

To the Editor: In the recent article by Richards and Rogers, the ethical and legal arguments made to justify antemortem interventions for organ donation after cardiac death (DCD) raise some questions.1 First, do antemortem interventions harm the patient? Anticoagulants (eg, heparin) expand intracranial haemorrhage and hasten the death of potential donors with acute ischaemic or haemorrhagic strokes. Large volumes of crystalloid fluids are infused to maintain organ perfusion, while exacerbating cerebral oedema and accelerating the onset of brain stem herniation and infarction in potential donors. Vasodilators are infused for organ preservation, causing hypotension and early onset of cardiorespiratory arrest after discontinuation of mechanical ventilation. While it may be debatable whether these interventions can cause harm to a person destined to die, they certainly shorten the dying process and hasten death.2 Many cultures and societies worldwide consider the performance of interventions to shorten the dying process ethically unacceptable.3 In the United States, the intent to administer — for the sole purpose of organ viability — a medication that expedites death and shortens the warm ischaemia time in DCD is a criminally liable action.4 Regardless of the lack of evidence that dying in an operating theatre is not worse than dying in an intensive care unit, if dying in the operating theatre results in the denial of death with dignity and peace, it can result in long-lasting traumatic experiences and memories for families and relatives.5 Second, is consenting to appendicectomy the same as consenting to organ donation? The only similarity between appendicectomy and removal of organs from a donor is that both are surgical procedures performed in the operating theatre. However, consent to the former is intended to “heal and preserve life” while the latter has no such intent and can imply to “shorten life”. To draw a conclusion that consent to DCD could be viewed as consent to take all reasonable steps to ensure that the operation is successful and results in the procurement of viable organs for transplantation is only justifiable if society has decided to abandon the “dead donor rule” and sanction “physician-assisted suicide”.2

Mohamed Y Rady · Joseph L Verheijde · Joan L McGregor

To the Editor: Richards and Rogers1 claim that antemortem interventions on an organ donor to improve organ viability for donation after cardiac death (DCD), such as administration of heparin and femoral vessel cannulation, are ethically and legally justified. Their reasoning is flawed. Their ethical argument is twofold. First, they argue that, just as consent for appendicectomy is broad and does not encompass details of the operation, so too the consent for organ donation is broad and does not exclude antemortem procedures. This is drawing a long bow. While details of appendicectomy are in the patient’s best interests while alive, interventions performed on a potential donor while alive for organ procurement after his or her death are not. It would be clear to potential donors signing a consent form giving permission for organs to be harvested after they die that they are not also giving permission for procedures to be performed while still alive. If potential donors discover that interventions which may hasten or contribute to their death could be done on them without their express consent, adverse publicity would reduce organ donation. Not only is the proposal disingenuous, it would be challenging indeed to find a potential donor willing to be harmed by treatment in order to be the donor of better organs! The authors’ second ethical argument, which relies on a conference report,2 is: There is no evidence that, in the absence of active bleeding, administration of heparin would cause sufficient bleeding to contribute to death.1 The underlying assumption is that full heparinisation carries no risk. This is wrong — major haemorrhagic complications of even therapeutic heparinisation have long been recognised.3 Moreover, the conference report also stated: The appropriate timing for administration of anticoagulants and vasodilators during the DCD process is unresolved. Flushing organs with anticoagulants/vasodilators after procurement may be as effective as pre-procurement administration.2 Thus, their argument is based on a statement taken out of context and against evidence. Ethical guidelines on the subject conflict. The National Health and Medical Research Council (NHMRC) guidelines state that: Where the law permits, it is ethical to proceed with these [antemortem] interventions if: ... interventions will not contribute to the cause of death or compromise the continuing care of the patient.4 In contrast, section 2(6)(h)(i) of the New South Wales Health guidelines5 advises against the use of antemortem interventions, because they would unlawfully contravene section 46(2)(b) of the Guardianship Act 1987 (NSW), which restricts guardians to consenting to treatments with the purpose of “promoting or maintaining the health and well-being” of the person involved. Whether one agrees or disagrees with either guideline, they do not constitute law.6 Richards and Rogers’ legal argument relies merely on fulfilment of a donor’s desire to be an organ donor as justification under the various Guardianship Acts. However, this argument can only apply when the antemortem interventions are not harmful to the potential donor; heparinisation is potentially harmful, and femoral vessel cannulation is clearly harmful. The NSW guidelines are criticised for interpreting the patient’s best interests requirement of the Guardianship Act too narrowly, and therefore do not constitute a reason to not perform antemortem interventions. But I consider this argument to be hoisted on its own petard: it is equally too narrow to focus on the wishes of the patient to be a donor as justification to perform antemortem interventions. The legal requirement is clearly illustrated in the Guardianship and Administration Act 1986 (Vic), which stipulates that a guardian must take account of all of several factors in determining if a treatment is in the patient’s best interests (Box). Lastly, an attempt is made to buttress the legal argument by reference to Airedale NHS Trust v Bland, in which the House of Lords permitted withdrawal of life-sustaining treatment to allow a man in a persistent vegetative state to die. Since the Lords considered best interests to include wider interests than continuance of futile treatment, Richards and Rogers, by analogy, believe that this concept is sufficient to justify performance of antemortem interventions on potential donors. In fact, the House of Lords did not base their decision on best interests, but rather on “the futility of the treatment which justifies its termination”.7 Comments by the Lords about other best interests did not form part of the court’s decision and so do not constitute law, cannot be invoked in other circumstances, and in any case, do not apply to Australian jurisdictions. There is neither ethical nor legal justification to perform antemortem interventions on a potential donor for the benefit of a recipient. Noble as the proposal may first appear, it is a Rubicon not to be crossed. Guardianship and Administration Act 1986 (Vic), section 38(1) To determine a patient’s best interests, a guardian must consider: (a) the wishes of the patient, so far as they can be ascertained; and (b) the wishes of any nearest relative or any other family members of the patient; and (c) the consequences to the patient if the treatment is not carried out; and (d) any alternative treatment available; and (e) the nature and degree of any significant risks associated with the treatment or any alternative treatment; and (f) whether the treatment to be carried out is only to promote and maintain the health and well-being of the patient; and (g) any other matters prescribed by the regulations.

James Tibballs

To the Editor: In their recent article,1 Richards and Rogers connect some ideas about patient autonomy, non-maleficence and laws relating to consent with specific antemortem activities, but their main “justification” for these activities is a practice termed donation after cardiac death (DCD). This practice has been introduced in the hope of increasing the availability of organs for transplant. It involves removing cardiorespiratory support and withholding resuscitation, then harvesting organs when cardiac death occurs.2,3 As illustrated by the New South Wales Health DCD guidelines (Box), DCD represents a significant shift in practice — from maintaining cardiorespiratory support for the purpose of organ preservation after an acutely injured patient has died (the brain death scenario), to removing life support with the explicit intention of allowing expeditious death and organ removal (the cardiac death scenario).3 There are two facts of clinical practice that I suggest should be taken into account in the ethical or legal justification of any DCD-related activity and also before the “re-introduction of expanded use of DCD” and “introduction of a NSW DCD program” mentioned in the NSW guidelines.3 The first is medical: the earlier a prognostic call is made in relation to catastrophic injury, the greater the chance it could be wrong. The second is psychological: doctors treating severely injured patients are aware of the need for organs in good condition and the importance of opportunity, and generally appreciate that organ transplant programs are one way that good can come out of tragedy. These simple facts are ethically and legally problematic because they could increase the probability of overcalling the extent and permanency of injury in an acutely injured patient, which in turn increases the probability of the patient being denied his or her chance to survive. Accordingly, any ethical or legal justification for submitting an injured patient to any antemortem activity relating to harvesting their organs after death — including withdrawing cardiorespiratory support and withholding resuscitative efforts — requires safeguards that protect the treatment paradigm for the patient. This requires two things: demonstrating that the care of the patient is not being compromised by his or her donor status; and making consent (in the full sense of the term) inviolate. I would argue that the former is impossible in the acute severe injury scenario of DCD, and the latter requires a legal step between end-of-life decisions and end-of-life action of the kind referred to by Justice O’Keefe in Northridge v Central Sydney Area Health Service, with respect to withdrawal of life-sustaining treatment and medical support from patients in a persistent vegetative state.4 As O’Keefe noted of such cases in the United Kingdom, where there are clear guidelines regarding lawful withdrawal of treatment: [T]he requirement that termination of treatment, artificial feeding and hydration be only with the prior sanction of a High Court judge, is a clear recognition of the right of unconscious patients to have their right to life protected by the full power of the law.4 Extract from the New South Wales Health guidelines3 Donor Category 3 Waiting cardiac death after planned treatment withdrawal – Known and limited warm ischaemic time: “Controlled” Donor selection criteria, point 3 Catastrophic, irreversible cardiorespiratory or neurological injury, not fulfilling brain death criteria, where withdrawal of life sustaining treatment is considered appropriate and following which rapid progression to death is anticipated.

Judith R Kennedy

In reply: The issues raised by Rady and colleagues, Tibballs, and Kennedy include claims that antemortem interventions for organ donation after cardiac death (DCD) are harmful, involve inadequate consent procedures, and require abandoning the “dead donor rule”. To clarify, we advocate the use of antemortem heparin in people with a known desire to be organ donors; we do not advocate potentially harmful or disruptive interventions such as femoral vessel cannulation. Rady and colleagues cite their recent article1 to support the claim that antemortem interventions are harmful. However, that article makes no reference to antemortem interventions such as heparin hastening death. In contrast, Bernat et al clearly state: The use of heparin is considered controversial on the basis of theoretic concerns that it may hasten the death of the donor. Nevertheless, there is no evidence that heparin causes sufficient bleeding after withdrawal of treatment and thus, causes death.2 (emphasis added) This position is supported by international evidence-based protocols that advocate the use of antemortem heparin, such as those from Britain3 and Canada.4 Rady and colleagues’ claim that antemortem interventions are criminal in the United States seems to relate to a US surgeon who was charged with murder after allegedly administering 200 mg of morphine and 80 mg of lorazepam to hasten patient death in a failed DCD case.5 These drugs are standardly used in therapeutic doses for end-of-life care. Our proposal supports best practice end-of-life care; we do not suggest this care should be delivered by the transplant surgeon. The example of one apparent rogue practitioner is not evidence that antemortem interventions are unethical. We agree with Tibballs that the wishes of the patient constitute only one of many elements listed in the various Guardianship Acts that should be taken into account when determining best interests. However, we are aiming at the spirit of the law rather than the narrower “black letter” view, as this ignores the situation of dying patients whose physical interests are extremely limited, leaving their wishes as the final expression of their humanity. With respect to Tibballs’ assertion that Airedale NHS Trust v Bland is not law in Australia, we acknowledge that it is not binding, but the persuasiveness of the judicial reasoning of the House of Lords has been well recognised and has provided guidance and been cited with approval in numerous decisions in Australia. Recent examples include Harriton v Stevens6 and Application of Herrington, re King.7 In relation to Kennedy’s comments about Northridge v Central Sydney Area Health Service, this difficult case (in which there was disagreement between hospital doctors and the patient’s family about treatment withdrawal) can be distinguished from our argument. We do not advocate acting contrary to the wishes of a patient’s family members. With DCD, the decision to withdraw treatment is made by the family and treating doctors independently of and before any discussions about donation. We recognise the potential psychological stresses involved in caring for patients in this situation. Clarity about what is legally and ethically acceptable, and clear separation of decisions to withdraw treatment from discussions about donation may help to alleviate some of this stress. We do not advocate hastening or redefining death, nor do we suggest abandoning informed consent. We believe, for the reasons given in our article, that non-harmful antemortem interventions are legally and ethically justifiable.8

Wendy A Rogers · Bernadette J Richards

Abortion law reform focuses on early abortion. Women wanting to have a family who have a fetal abnormality detected later in pregnancy are neglected in the debate and harmed by the consequences of current legal uncertainty. Unclear abortion laws compromise: the quality of prenatal testing; management when an abnormality is found; and patient care, through obstetricians’ fears of legal repercussions. Women carrying a fetus with an abnormality are being denied abortion, even when the abnormality is so severe that non-treatment would be an option if the baby were born. Many women are likely to refuse to consider motherhood if they are denied appropriate prenatal testing and access to abortion if serious abnormalities are detected. Current abortion laws result in discriminatory and inconsistent practices, where access to prenatal testing and termination of pregnancy depends on location, the values of the treating doctor or hospital ethics committee, and a woman’s personal resources. Legal certainty is needed to reduce the suffering of couples wanting to have a family.

Lachlan J de Crespigny MD, BS, FRANZCOG · Julian Savulescu MB BS, BMedSci, PhD