Ethics

In reply: The medical community in Australia regulates itself through various non-binding codes and guidelines, but these have not been shown to reduce industry influence on doctors or medical students. In contrast, the existence of institutional policies can limit the influence of industry, resulting in medical students and doctors who are less influenced by industry marketing.1,2 University conflict-of-interest (COI) policies must reflect the context in which they exist, but it is unlikely that a general university policy covering all faculties could address the specific challenges presented by medical student education. Policy development, while difficult, is possible, and the University of Melbourne is scheduled to complete a policy framework covering staff and students in health-related degrees this year. Arguably, it was the failure of the medical profession in the United States to self-regulate that led to the legislative changes that stimulated the recent COI policy advances in US medical schools. This could also occur in Australia. Despite the logistical difficulties of developing effective self-regulation within medical schools, there are increasing societal expectations that COI be dealt with effectively. If we ignore this sentiment, we risk the imposition of perhaps excessive and punitive legislation. Medical schools should embrace their influential position, and act now to demonstrate their leadership.

Paul R Mason · Martin Tattersall

Deaths in custody rightly receive significant attention in the media, but the far higher rate of deaths among ex-prisoners during their first year after release from prison is not widely reported. A high risk of death after release from custody seems counterintuitive, but the phenomenon has been reported in overseas literature. In this issue of the Journal (Kinner), we present the first Australian evidence. Kinner and colleagues found that, in 2007–08, more than 400 ex-prisoners died in their first year after release — up to 30% of these in the first month. While their analysis had methodological limitations, it is likely that their estimates understate the mortality rate. The Australian prison population is about 30 000, a figure that had increased by 39% over the decade to 2009. Approximately 50 000 prisoners are released each year, and there are about 385 000 ex-prisoners living in the community (http://www.aihw.gov.au/publication-detail/?id=6442468371). This represents 1.8% of the Australian population, so ex-prisoner health has significant repercussions, and the load on our health services is likely to increase. It is now clear that this population is extremely vulnerable. Almost half of all deaths were drug-related, involving mostly non-Indigenous ex-prisoners. While Indigenous Australians comprise more than a quarter of the total prisoner population, they are less likely to be injecting drug users. As Kinner et al discuss, there are evidence-based programs available that may reduce drug-related deaths, yet they are not being widely implemented. Reducing deaths from non-drug-related causes is more complex. Interventions that target mental illness, chronic disease and injury prevention will be required as part of the solution. Sadly, a United States man with chronic health problems recently resorted to stealing $1 from his bank with the aim of being arrested to gain access to prison health services. If we are to look for answers overseas, there is probably more to be learnt from the German penal system, which aims to resocialise and rehabilitate prisoners. It endeavours to “normalise” living conditions so that they resemble life in the community (http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhaff/193/19304.htm). Presumably, this makes the transition to freedom less stressful. The Australian penal system, with a 2-year recidivism rate of about 40%, and about half of prisoners having been previously imprisoned, is failing. Prisoner health must be seen to encompass both inmates and those recently released. It should be seen to include justice issues that influence health: is the quantum of punishment appropriate; are there alternatives to incarceration; are rehabilitation and education programs available? Programs that smooth the reintegration of prisoners into society are urgently required. Better data are needed to understand what is happening to prisoners after release, but the results of the study by Kinner et al leave no doubt that the health care system must flag ex-prisoners as a high-risk group, and move to meet its needs.

The difficulties of knowing when, and to whom, to refer patients with a mental disorder Recognising one’s clinical limitations and the need for them to be augmented by others’ specialised knowledge and experience is a key component of professional reflectiveness and humility. Referring a patient to a specialist should never be experienced as a reflection of inadequacy or as a slight upon the quality of one’s care. It is an opportunity to provide enhanced treatment and to draw collaboratively upon the specialisation and wisdom of a respected colleague.1 It is also an important ethical obligation.2 By contrast, a failure to be conscious of one’s limitations can lead to insensitivity to the repercussions of patients’ symptoms, erroneous diagnoses and treatment, and a failure to attend adequately to risk factors. There are many possible reasons for this, which have been described in some instances as potentially including narcissism, grandiosity or a sense of omniscience,3 or therapeutic nihilism.4 Depending on the clinical outcome, non-referral can result in actions for negligence and disciplinary consequences. Mental illness is, by nature, episodic, with symptoms waxing and waning at different periods of a patient’s life and in response to different triggers and vulnerabilities. This highlights the need for a longitudinal perspective on the course of a mental disorder to identify improvement, deterioration or the existence of cycles of symptoms, all of which can give rise to therapeutic opportunities. Continuing evaluation of the need for pharmacotherapy, psychotherapy or any other modality is important. Matters can be complicated by patients resorting to unorthodox forms of intervention, such as “vitamin therapies”, past-life therapy and counselling from unqualified practitioners, all of which have the potential to exacerbate or briefly camouflage symptoms and warning signs.5 Practitioners’ perspectives of their patients’ mental states are inevitably snapshots taken at times that might not be representative of the course or trajectory of the illness. This is especially so in relation to bipolar disorder. Bipolar II disorder poses particular clinical challenges because of the risk that a practitioner seeing a patient irregularly will fail to identify hypomanic episodes and misdiagnose by reference only to observed or reported depression or anxiety. This risk is graphically illustrated in this issue of the Journal by Parker, in the context of the coronial inquest into the death of Charmaine Dragun.6 It is incumbent upon practitioners to be alert to dangerously labile moods suggestive of bipolar I or II disorder. Where signs of bipolar disorder are identified, there is frequently a need to refer the patient to a psychiatrist to manage and to titrate medication. Such referrals must be informed and suitably selective. Indiscriminate referrals run the risk of using the services of a psychologist or a counsellor in cases where such practitioners may not be the most suitable providers of treatment. This can be a particular issue in the era of mental health care plans, in which there can be pressures on general practitioners, driven by financial considerations, to refer to non-medically qualified practitioners who may not be the best equipped to deal with psychiatric illness. A survey of psychiatrists in the United Kingdom and the United States identified early referral to appropriate specialist care as being one of the “highest priority needs” in the effective management of patients diagnosed with bipolar disorder.7 Such patients are at real and foreseeable danger of lifestyle harm (such as severe embarrassment and financial loss), of taking risks that might endanger their own or others’ safety, and of suicide. These dangers can be avoided by timely referral to specialists with experience in the diagnosis and treatment of patients with bipolar disorders. However, the advantages of suitable and timely referral go beyond the practice of prudent and defensive medicine. Such referral enables focused and intensive provision of treatment for patients who might have limited insight into their illness and the need for treatment, as well as ambivalence about seeking assistance for their symptoms. In the legal context, the scenarios in which failures to refer have most commonly been litigated have been in relation to cancer investigations, when malignant tumours have been misdiagnosed as benign or have not been identified at all,8 and when there has been the potential for, or reality of, a boundary blurring or transgression. An example of the latter is when moves have commenced toward the creation of an unethical romantic or sexual relationship between practitioner and patient, and the doctor has not referred the patient to another practitioner. The principle underlying the obligation to refer in both scenarios is the same — that another practitioner is better positioned to advance the patient’s interests and that non-referral will disadvantage the wellbeing of the patient, breaching the obligation to exercise reasonable care and skill in the provision of professional advice and treatment.9,10 However, the referral must be clinically appropriate. In a New South Wales case, this was illustrated by a GP being found civilly liable to his patient for referring him to a chiropractor from whom he received treatment that was foreseeably clinically contraindicated because the patient had degenerative cervical changes and neurological symptoms from a disc injury.11 The same issue arises in respect of patients who might have bipolar disorder. This is not to say that a suitably experienced GP might not be able to treat such patients adequately; rather, that it can be negligent not to take active steps to enable patients to avail themselves of the specialist care that might be able to manage their illness most intensively at the time. Such a referral is also a significant protection for the practitioner, should allegations of insufficient or inadequately informed care be made later by the patient or the patient’s dependants.

Ian R Freckelton SC, LLB, PhD · George Mendelson MD, FRANZCP, FFPMANZCA

A coronial inquest into the suicide of television newsreader Charmaine Dragun identified that a likely contributory factor to her death was the failure of many health practitioners to diagnose a bipolar II disorder and to provide more specific treatment for her condition. Lack of awareness about bipolar II disorder among practitioners and the public, as well as screening and detection problems, may have contributed to the failure to diagnose this disorder over the course of a decade. Detection and management of bipolar II disorder generally differs from that for a unipolar disorder, in that mood stabilisers rather than antidepressants are more often a priority. The diagnosis therefore has distinctive implications for management and course of the illness. The Coroner recommended “increased awareness by health professionals of the need to exclude a bipolar disorder in all patients presenting with signs and symptoms of depression” and highlighted the need for “readily available” screening tools.

Gordon B Parker AO, MD, PhD, FRANZCP

To the Editor: In their report on the findings in Hope v Hunter and New England Area Health Service,1 Mahar and Burke suggest that some of the judge’s reasoning “may reasonably cause apprehension for clinicians relying on the peer professional practice defence”.2 In her Editor’s Choice, Katelaris mirrors this apprehension.3 But the judge’s findings are not nearly so troubling. Mahar and Burke state that “the court considered ... that because the defendant had completed much of his training in the United Kingdom and the United States, the evidence that he gave was not necessarily indicative of professional practice in Australia”. However, the judge had said: Without at all intending any criticism of Associate Professor Haertsch [expert witness for the defendant] ... his practice was in accordance with what he had learnt in his training in Edinburgh, Scotland and in Michigan, USA which was not, of itself, evidence as to peer practice in this country.1 The judge’s point was not about the defendant having trained overseas — the judge made no mention of where the defendant had trained. The judge was concerned about the expert witness who was testifying as to what extent the technique used by the defendant was peer practice in Australia. In doing this, the expert witness described how he conducted this sort of procedure, drawing on his overseas training. Quite reasonably, the judge regarded this as “not, of itself, evidence as to peer practice in this country”. Also, Mahar and Burke state that because the same expert witness had consulted a colleague about her practice concerning ganglion excision, the “court noted that this witness ... was in sufficient doubt to consult another practitioner” and “this may have partly informed the court’s decision to reject the expert’s evidence for the purposes of the defence”. However, the judge had said: I also consider it telling that Associate Professor Haertsch appeared to be in sufficient doubt about the matter that he thought it was necessary to consult Dr Gschwind for her views and for details of her practice concerning ganglion excision. I infer from the fact of such consultation, together with the fact that Associate Professor Haertsch has only operated on little rice grain sized ganglia ... that he has not had the same breadth of experience as Associate Professor Connolly [expert witness for the plaintiff] as to what constituted widely accepted professional practice ... concerning the excision of a half centimetre sized ganglia of the type that the plaintiff had presented for removal. In this regard I prefer the evidence of Associate Professor Connolly to that of Associate Professor Haertsch.1 Seen in context, it is hard to draw the conclusion that the testimony of the expert witness “was discounted because ... he consulted a colleague about her views on the case”.3 If the consultation with a colleague discounted the testimony, it was a very minor factor.

Christopher J Ryan

To the Editor: The Journal recently drew attention to circumstances in which courts have not accepted professional opinions on standard of care required in negligence cases.1,2 These include opinions formed after consulting colleagues, from doctors trained overseas or unrepresentative of national peer professional practice. In a veterans’ entitlements case in 2004 (Linton and Repatriation Commission3), in which I was an expert witness for the Department of Veterans’ Affairs, the Administrative Appeals Tribunal did not accept an opinion on appropriate clinical management in the past from an expert whose memory of peer professional practice was contradicted by documents that were in use at the time in question, preferring the latter. However, contrary to the circumstances described by Mahar and Burke, the Tribunal did accept opinions from a doctor who consulted others and from me, even though I trained overseas. The Repatriation Medical Authority produces “statements of principles” that enumerate factors which connect veterans’ health to service under the Veterans’ Entitlements Act 1986 [Cwlth].4 Inability to obtain appropriate clinical management is a factor in many of these statements. Tribunals have relied on professional opinion to determine the appropriateness of clinical management received by veterans. In Linton and Repatriation Commission, a veteran claimed in 2004 that withholding corticosteroids during the 1970s constituted inappropriate management of asymptomatic hilar lymphadenopathy due to sarcoidosis.3 There was disagreement between expert witnesses. One expert, a graduate of 12 years and a newly qualified Fellow of the Royal Australasian College of Physicians (FRACP) in the early 1970s, believed that the veteran should have been offered corticosteroids. Another FRACP, who was 15 years younger and graduated in the mid 1970s, after consulting colleagues who had practised at the time in question, believed corticosteroids would reasonably have been withheld. Despite being trained in the United Kingdom, the Tribunal accepted evidence from me on three important issues.3 First, the Tribunal accepted that textbooks used in the 1970s may contain statements of what should have been done at that time to manage sarcoidosis. Second, the Tribunal accepted that, based on the textbook on which Australian physicians probably relied during the 1970s, patients with the veteran’s condition were unlikely to have been treated with corticosteroids owing to an expectation that the condition would resolve spontaneously. Third, the Tribunal accepted that early clinical trials of corticosteroids in the treatment of pulmonary sarcoidosis between 1967 and 1976 were inconclusive and gave doctors no reason to believe that steroids would alter the long-term outcome of the condition. In addition, a 2000 Cochrane review found that the long-term effect of steroids was still unclear.5 The Tribunal, therefore, found that the veteran’s condition was managed appropriately. Comparing the circumstances under which civil courts and the Administrative Appeals Tribunal have not accepted opinions on standard of care would reveal any systematic differences between the jurisdictions.

Hedley G Peach

It has long been known that poverty has a negative impact on health. In this issue of the Journal, Heeley and colleagues show that people living in socioeconomically deprived areas in Australia and New Zealand experience higher rates of stroke. They tend to be younger, more likely to have hypertension and diabetes and, not surprisingly, are more likely to smoke. The magnitude of the difference was startling. When comparing the most deprived with the least deprived groups, the age standardised incidence rate for stroke per 100 000 person years was 70% higher. After adjusting for age, they found that almost one in five strokes could be attributed to living in the most socioeconomically deprived areas compared with the least deprived areas. In developed countries, stroke is the second most common cause of death after heart disease, and it is predicted that by 2020 this will be the case worldwide. Stroke is a leading cause of disability and results in the loss of at least 49 million disability-adjusted life-years annually throughout the world. Stroke in later life has been linked to socioeconomic deprivation in early life, and even to prenatal factors that have socioeconomic determinants, such as low birthweight and short birth length (Lancet Neurol 2006; 5: 181-188). The effect of socioeconomic status on health is multifactorial. Income, environment, education level and social support are important, as are lifestyle factors such as diet, exercise and smoking. Service provision and access also matter. The Marmot Review (http://www.marmotreview.org/reviews/english-review-of-hi) was undertaken to put forward evidence-based strategies for reducing health inequalities in England from 2010. Its key message was that health inequalities result from social inequalities and that the reduction of inequality is a matter of fairness and social justice. The Review also identified a “social gradient” for health in England: people living in the poorest neighbourhoods have a life expectancy that is 7 years less than those living in the richest neighbourhoods. In addition to the health benefits for an individual, the Marmot Review also points out the economic benefits of alleviating health inequalities. These include reduced productivity losses and forgone tax revenue, and reduced treatment costs and welfare payments — all especially relevant to stroke. In Australia, belatedly, we are aware of the survival difference between Indigenous and non-Indigenous people and there are now calls to “close the gap”. There is less awareness of the difference in survival rates across socioeconomic groups. As a profession, we have a responsibility to the community as well as our individual patients to ensure that the treatments we employ are cost-effective. By extrapolating the message of Heeley et al and Marmot, it’s also part of our role to promote health by advocating for policy that diminishes socioeconomic inequality. The “debate” of the moment is about plain packaging of cigarettes. Smoking has a strong inverse relationship with socioeconomic status and is a major risk factor for stroke. We should continue to advocate for any measure that will reduce it — not nanny state, but Nanny knows best.

Martin Van Der Weyden

No-fault compensation, based on the ethical principle of redistributive justice, should form a cornerstone of Australia’s immunisation strategy Australia has an enviable reputation for its publicly funded vaccine program — a program that has benefited Australian children and adults over many years. In 2010, the National Immunisation Program funded 12 vaccines, twice as many as a decade previously. To monitor outcomes from this program, the Australian Childhood Immunisation Register, which commenced data collection in 1996, provides a detailed record of vaccine uptake by children.1 Funding for the register and for incentives to general practitioners to improve vaccine uptake are part of the total budget for Australia’s vaccine program, estimated to exceed $400 million annually.2,3 One area for improvement in the vaccine program is monitoring of adverse events following immunisation (AEFI). Another would be the introduction of a no-fault compensation scheme for serious adverse events which can be confidently attributed to vaccination. An investigation into the unexpectedly high number of febrile convulsions in children aged less than 5 years after they had received the influenza vaccine in 2010 — in some cases, with devastating consequences4 — provided a forceful reminder that timely vaccine safety monitoring is needed in Australia.5 More active adverse event surveillance is certain to uncover more AEFI but many of these will only be coincidental, while others will be of a transient or relatively trivial nature. On rare occasions, a serious AEFI with long-term sequelae will be recognised. A decision will then need to be made on whether the vaccine was responsible for that serious event. The World Health Organization defines four categories of serious AEFI: hospital admission or prolongation of an existing hospital admission; permanent disability; any event that is life threatening; or death.6 Using these criteria, 8% (193/2396) of the AEFI reported by passive surveillance in Australia in 2009 were judged to be serious.7 However, unlike many countries where compensation schemes exist for adverse events attributed to a vaccine, Australia has no routine approach to making the assessment of attribution. Parents of children or adults who believe they deserve compensation for a serious adverse event that they attribute to a vaccine are therefore required to make their case through the adversarial legal system. This requires the demonstration that an individual or an organisation was at fault. However, fault is often difficult to demonstrate and an adverse event may be caused by vaccination through no fault of the vaccine manufacturer, the regulator or the person who administered the vaccine. We have previously argued that a Queensland child who developed transverse myelitis after receiving oral polio vaccine was an example of an adverse event following vaccination where no fault was attributable to any party.8,9 Despite detailed epidemiological evidence that was consistent in this case with the causal criteria for an AEFI promulgated by the Institute of Medicine of the National Academies in the United States,8 and despite laboratory evidence showing that the polio virus recovered from this child was similarly pathogenic to a polio virus that has been accepted as causing vaccine-associated paralytic polio,9 the polio expert committee concluded that the evidence was insufficient to support a causal relationship between the oral polio vaccine and transverse myelitis. As causality has not been accepted, this child has received no compensation. The general principles associated with this case raise a number of pertinent questions for Australia. First, should a child who may have been injured by a vaccine, which was endorsed and paid for by the community, be compensated by the community when the serious adverse event may be attributed to the vaccine? Second, what are the criteria for accepting an attributable relationship between receipt of the vaccine and a subsequent adverse event? Third, what is the best method for financing a compensation scheme? Each question may highlight a potential barrier to the implementation of a no-fault AEFI compensation scheme in Australia. By 2010, 19 countries around the world had implemented no-fault AEFI compensation, implicitly answering “yes” to the question of whether the community owes a duty of care to an individual injured by a vaccine.10 There is also a strong ethical argument for this position, based on the concept of redistributive justice. Any person who is injured while helping to protect the community — for instance, by contributing to herd immunity, such that there are sufficiently many people immunised to prevent widespread disease transmission within the community — should not bear the consequences of injury alone. In essence, the community owes a debt of gratitude to that person. Temporal association of an adverse event with receipt of a vaccine does not establish causality and the underlying notion of causation used in most compensation schemes is similar to that used in epidemiology.10 The World Health Organization has published guidelines on causality for an AEFI.11 An adverse event considered to be very likely or certainly due to a vaccine would comprise a “Clinical event with a plausible time relationship to vaccine administration, and which cannot be explained by concurrent disease or other drugs or chemicals”.11 To simplify and expedite determinations of causality in the US, a vaccine injury table is used to predetermine causality if a vaccine injury is included in the table.10 However, determining causation is a complex issue. Recognising this, most countries have a designated committee, comprising medical and legal members, which deliberates on the attributable relationship between receipt of the vaccine and subsequent adverse event.10 Concerns about funding a no-fault compensation scheme is another of the probable barriers to its implementation in Australia. Schemes are currently funded by one of four methods: a vaccine levy; compensation for AEFI as part of a much broader injury compensation scheme; specific AEFI compensation funded through general tax revenue; and funding in association with industry.10 Funding through a vaccine levy has been self-sustaining in the US. Despite compensation payments having been made to 2580 claimants since 1989, the compensation fund there has a surplus of about US$3 billion.12,13 No-fault vaccine-injury compensation programs are based on the premise that any adverse event attributable to vaccination is not due to the fault of a specific individual or organisation, but due to an unavoidable risk that is acknowledged as being associated with vaccines. Germany has been operating a no-fault AEFI compensation scheme for 50 years.10 France restricts its compensation to serious AEFI, since these are likely to have long-term implications for the injured party.10 Restricting compensation to events with long-term consequences, above a nominated clinical threshold, may be an acceptable model for Australia. We have previously argued that Australia should follow the lead of other advanced countries and implement a no-fault compensation scheme.14 We continue to argue that such a scheme, based on the ethical principle of redistributive justice, should form a cornerstone of Australia’s immunisation strategy. Disclaimer The views expressed are those of the authors and have not been endorsed by any institution or organisation with which the authors are affiliated or by any committees of which the authors are members.

Heath A Kelly BSc, MB BS, MPH · Clare Looker MB BS, MPH · David Isaacs MD, FRACP, FRCPCH

Objective: To identify characteristics of doctors who are repeated subjects of complaints by patients.Design and setting: Case–control study of doctors about whom patients had complained to the Victorian Health Services Commissioner between 1 January 2000 and 31 December 2009.Participants: 384 doctors in private practice; cases comprised 96 doctors who were the subject of four or more separate complaints; and the control group comprised 288 doctors who were the subject of a single complaint over the study period.Results: Among doctors in private practice in Victoria, 20.5% (95% CI, 19.7%–21.3%) experienced at least one complaint over the decade. Among doctors who were the subject of a complaint, 4.5% (95% CI, 3.6%–5.4%) had four or more complaints, and this group accounted for 17.6% (95% CI, 16.3%–19.0%) of all complaints to the Victorian Health Services Commissioner. Multivariate analyses showed that surgeons (odds ratio [OR], 8.90; 95% CI, 3.69–21.50) and psychiatrists (OR, 4.59; 95% CI, 1.46–14.43) had higher odds of being in the complaint-prone group than general practitioners. Doctors trained overseas had lower odds of being complaint-prone than those trained in Australia (OR, 0.31; 95% CI, 0.13–0.72).Conclusions: A small group of doctors in private practice in Victoria account for nearly 18% of complaints. Interventions to improve patient satisfaction and public confidence in health services should target complaint-prone subgroups of practitioners.

Marie M Bismark MB ChB, LLB, MBHL · Matthew J Spittal BSc(Hon), PhD · David M Studdert LLB, ScD, MPH

To the Editor: The Health Practitioner Regulation National Law Act 2009 (Part 8, Sections 140 and 141) enshrines mandatory notification in the new national registration framework. As registered health practitioners, clinician-researchers are bound by the notification requirements. This raises the question of whether mandatory notification has implications for observational research in health services that is conducted by clinician-researchers. In particular, how likely is it that these requirements will lead to reclassification of one’s observations from “research data” to “notification evidence”? Three initial considerations are important here. First, the Act was designed to make health care safer for patients. Its intent is to limit incidents by ensuring clinicians are more open about and address inappropriate care. Second, serious incidents are rarely isolated, instantaneous and therefore easily observable disasters. When something goes seriously wrong, problems tend to be inherent in how teams practise, communicate and support one another over time. Third, observers may encounter instances of substandard care, but these become notifiable only when the threshold of unsafety is surpassed. This threshold is pegged to relatively high levels of severity, frequency and risk.1 In all, observational research can help clinicians to identify existing risks, but it is unlikely to become a source of notification. Human research ethics committees may also feel obliged to acknowledge and consider the possibility of incident notifications arising from observational research. However, it would not be wise to regard the risk of such notification as detracting from a study’s potential for obtaining ethics approval. The situation calls for specification of: how the observers will deal with incidents if and when observed the observers’ understanding of the definition and threshold of notification how the definition of notification is likely to bear on the study how the design of the study affects the likelihood of notification (eg, does the researcher seek to identify care irregularities or track these irregularities over time?) a projection of the relevant service’s vulnerabilities to notification, and plans for addressing and resolving existing vulnerabilities. In addition, mandatory notification does not mean that observational research will be more difficult to “sell” to ethics committees and frontline clinicians. The aim is generally to stimulate learning and raise awareness of problems. Our experience is that if the research is designed with frontline clinicians, and they contribute to its implementation, analysis and publication,2 it attracts considerable interest and support.3 Frontline staff know that the best way to understand the complexities inherent in their everyday work is through observation. Such research takes seriously their specific and unique circumstances, enabling them to actively participate as analysts and improvers of their own practice. Observation encourages reflection, and this means they become aware of and can proactively resolve their own vulnerabilities. Ultimately, the priority for clinician-researchers involved in observational research in health services, as for patients, is to reduce risks and prevent incidents.

Rick A M Iedema · Donella A Piper

To the Editor: Katelaris recently asserted: In our society the response to medical error is typically legal, rather than investigative and remedial. This should be deplored by both the profession and the public.1 This polarised orientation seems more political than objective. It acknowledges neither the reticence of medical professionals regarding investigative reviews, nor the costs to patients’ families. Katelaris notes that defensive approaches encourage the concealment of errors. I have long advocated clinical reviews of critical incidents. Having personally set up Queensland Health’s original Suicide Register, I released statewide patient suicide data to health services. Reactions from service providers were decidedly underwhelming, despite the gravity of the outcomes. Katelaris did not explain how clinical reviews can address the problem of income replacement or other major costs associated with catastrophic outcomes for patients’ families. In the 1990s, I reviewed all Australian litigation for failure to prevent suicidal behaviour in care, through a survey of insurers and defendant solicitors.2 Of the 13 non-fatal cases identified, paraplegia occurred in seven patients, with other serious injuries in the remaining six. These were not trivial complaints. I also reviewed what might be learnt from the international literature3 and made known my availability to assist with clinical reviews of patient suicides. Despite having been an expert witness at the Royal Commission into Aboriginal Deaths in Custody and a Royal Australian Navy inquiry into the loss of a sailor who disappeared overboard in 2002, among others, no medical services have sought my assistance over more than 20 years! I understand, from personal experience, how distressing trivial and vexatious complaints against doctors are. I have even received a complaint for providing a report to a plaintiff’s solicitor, in relation to failure to prevent suicidal behaviour, in which I asserted that reasonable care had been provided. I now run a personal-injury psychiatric practice, with alleged medical negligence featuring in about 3% of cases. Mostly I am called by the plaintiff’s side, often following devastating surgical outcomes. Referral bias operates, in that negative surgical outcomes with psychiatric consequences are likely to have been more serious than those without. The outcomes have often been both emotionally and financially devastating to those affected. I long to see a medically mature culture develop with respect to clinical reviews of critical incidents, but my experience suggests we still have a way to go. But even when or if such a medical utopia is achieved, how will the financial disadvantages to patients’ families be overcome?

Christopher H Cantor

CorrectionsIncorrect statement: In “Fraud in fluid resuscitation research” in the 20 June 2011 issue of the Journal (Med J Aust 2011; 194: 621-622), there was an error in the second-last paragraph (page 622). The second sentence of this paragraph should have read “This code was established by the National Health and Medical Research Council and the Australian Research Council to bolster responsibilities of research organisations.11” The html and pdf versions of this article were corrected when published online on 20 June 2011.

John A Myburgh

Given the nexus between published research, medical practice and public health policy, the veracity of published medical research is vital. Melbourne newspaper The Age recently reported on an “explosion of medical research fraud” (12 May 2011), and Myburgh’s editorial in this issue of the Journal (→ Fraud in fluid resuscitation research) examines a specific incident of fraud. Trust in the ethical behaviour of researchers is the cornerstone of medical science and publication. The Guideline for Good Clinical Practice, to which Australia adheres, provides some regulation but not enough to protect against fraud. It is up to medical journals to take a primary role in the prevention of research fraud, and many already have policies in place. These include requirements for ethics approval and registration of all trials before publication will even be considered. Authors should state their contribution to the study and manuscript and must declare all financial conflicts of interest. Finally, articles must be skilfully peer reviewed before publication. Despite all this, as described in Myburgh’s editorial, it is clear that current policies are inadequate and we must ask — what else can be done? The role of thorough audits is well established to improve regulation by funding bodies and ethics committees. There is a push to make raw trial data available to reviewers and readers. Already, some agencies such as the United States Food and Drug Administration mandate that raw data be made available to them for their own independent analysis. In principle, making raw datasets available at or before the time of publication has many potential advantages, with deterrence of fraud being only one important benefit. Facilitating data sharing among researchers, allowing other researchers and peer reviewers to test published conclusions, testing of secondary hypotheses, simplifying data acquisition for meta-analyses, and preventing selective reporting are all important advantages. It may even reduce unnecessary research duplication and facilitate research progress. In comparison, the case against the publication of raw datasets seems flimsy. Issues of confidentiality are easily overcome, and issues of data dredging and invalid analyses are no different to those already confronted by ethics committees and the peer-review process. However, the practical difficulties of data sharing cannot be understated. The vast quantity of data collected in large clinical trials would require the provision of the data dictionary and statistical code to make the data intelligible. Further, it is unlikely that peer reviewers would be able to make sense of the data in a timely way. But practical issues are not the only obstacle. Clearly, there is resistance to the publication of raw data; researchers have a natural tendency to view the collected data as their own. However, there is a compelling argument to maximise the utility of data collected when research has been funded by the public purse. The Wellcome Trust has already stated its aspiration to share data (BMJ 2011; 342: d2323). For now, however, to prevent research fraud, we need to ensure that we seek out smart, proactive peer reviewers, and the research community needs to ensure that audits are carried out so that history does not repeat itself and researchers are called to account early in their careers. Change is inevitable, but what shape it takes is yet to be defined.

Annette Katelaris MB BS, MPH, FRACGP

Research fraud is an unacceptable breach of trust Few issues in medicine provoke the wrath of the profession more than research fraud. In an era when evidence-based medicine has become the cornerstone of information about the safest and most effective way to practise medicine, fraudulent or unethical medical research represents an unacceptable breach of trust for clinicians, health policymakers and the general public. Research fraud takes many forms, including plagiarism, duplicate publication and fabrication by falsifying or omitting data to create “positive” results. When the latter occurs, the damage to the reputation of investigators, institutions, specialties and the broader profession is often permanent. An article published in Anesthesia and Analgesia in December 2009 by Joachim Boldt compared the effects of two colloid cardiopulmonary bypass pump-priming solutions — albumin and hydroxyethyl starch (HES) — on physiological variables in 50 patients undergoing cardiac surgery.1 It was retracted in October 2010.2 Following concerns about the validity of some of the results, raised in letters from readers, an enquiry to the institution where the study was conducted confirmed that no institutional review board approval had been obtained. A formal inquiry by the state medical authority of Rheinland-Pfalz, Germany, confirmed that the study had been entirely fabricated on the basis that there were no original patient or laboratory data to support the findings. Furthermore, Boldt had confessed to forging the signatures of the coauthors, who denied participating in the fabrication.3 Boldt had been a prolific author and the retraction of this report immediately cast doubt on the scientific and ethical validity of his previous and subsequent publications. This suspicion was confirmed in two open letters published by the editors-in-chief of 18 journals that retracted a further 87 reports. While these publications concern a range of topics in anaesthesia and perioperative care, 11 were reports on the safety and efficacy of a relatively new HES preparation used for fluid resuscitation, 6% HES 130/0.4. These reports constitute a substantive body of literature that has been used in manufacturers’ product information sheets and submissions to regulatory authorities, including the Therapeutic Goods Administration (TGA). Although HES preparations have been used as resuscitation fluid for over 40 years, particularly in Europe, 6% HES 130/0.4 was the first HES approved by the TGA (in November 2006). Since 2008, the use of 6% HES 130/0.4 in Australia has increased, which is consistent with reports that show that it is the most commonly used resuscitation fluid on a global basis, although there is marked variability in selection and use of resuscitation fluids from country to country.4 Before confirmation of the first retraction, two updated Cochrane systematic reviews on resuscitation fluids — comparing colloids with crystalloids5 and comparing different colloid solutions6 — included a sensitivity analysis excluding studies published by Boldt. Both reviews concluded that excluding these reports did not change the conclusions that there was no evidence from randomised controlled trials that (a) resuscitation with colloids reduced the risk of death compared with crystalloids or (b) any one colloid was more effective or safer than any other. The reviews highlighted the urgent need to conduct large-scale high-quality trials of fluid therapy. The Crystalloid Versus Hydroxyethyl Starch Trials, being conducted by the Australian and New Zealand Intensive Care Society Clinical Trials Group and the George Institute for Global Health, are underway. These trials will compare the effects of 6% HES 130/0.4 and saline for resuscitation in intensive care units, using patient-centred outcomes — specifically, mortality and the incidence of acute renal injury. The magnitude of the Boldt case is unprecedented in intensive care medicine. It ranks with the fraudulent research conducted by Wakefield (measles–mumps–rubella vaccine),7 Sudbo (non-steroidal anti-inflammatory drugs and the risk of oral cancer)8 and Hwang (embryonic stem cell cloning).9 That these cases of major research fraud have occurred within the past decade, despite increases in ethics governance and regulatory processes within the jurisdictions involved, highlights the determination of fraudulent researchers to publish their reports. The reasons driving this are complex and include career pressure, financial incentives, the ease of fabricating data, and the proliferation of electronic media.10 Researchers and institutional human research ethics committees are expected to act in accordance with the Australian Code for the Responsible Conduct of Research. This code was established by the National Health and Medical Research Council and the Australian Research Council to bolster responsibilities of research organisations.11 Equally, journals have a key role in verifying that appropriate ethics review processes have been completed and ensuring that only studies of the highest levels of internal and external scientific validity are published. While the protection of patients who participate in clinical trials is the ultimate consideration of ethics governance processes, it is imperative that high-quality research conducted with the highest levels of ethical integrity and scientific validity continues to provide the best information for clinicians.

John A Myburgh MB BCh, PhD, FCICM

To the Editor: Suthers and colleagues raise a number of significant ethical issues regarding patients’ right to privacy and the passing of genetic information to relatives.1 Although the National Health and Medical Research Council guidelines relate specifically to private practice and living patients,2 similar dilemmas arise during medicolegal autopsies. Forensic pathologists regularly encounter conditions in deceased individuals that may have implications for surviving family members. Examples include advanced coronary artery atherosclerosis in a young individual, raising the possibility of a familial dyslipidaemic syndrome; pulmonary thromboembolism, suggesting a hereditary thrombophilia;3 and haemochromatosis. However, there are no national guidelines, let alone nationally consistent laws, for the appropriate handling of such information. It would seem obvious that a deceased person’s relatives should have access to information of possible significance to their health. If a family wishes to receive such information, then mechanisms to pass it on should exist. These might range from contact with the forensic pathology service itself, to referring the family to a general practitioner or physician who has been briefed by the service. Whoever takes on this responsibility should be aware of the subtleties and pitfalls of genetic counselling. For example, the relevant condition may be an incidental finding rather than what caused the death (eg, haemochromatosis in a person killed in a road accident). The issues concerning the identification of, and appropriate medical response to, serious familial conditions at autopsy involve: accurately establishing the potential significance of postmortem findings;4 determining whether the family wish to be made aware of this information; disclosing the information to family members when a patient is deceased and not able to give consent; and deciding on the mechanisms by which this should be done. A complicating factor is the role of the coroner, as autopsies and subsequent reports are performed and written under coronial, not medical, authority. However, the authors of these reports are first and foremost doctors, and many feel a therapeutic obligation to the families of those whose autopsies they have performed. Many of these pathologists feel that the autopsy is indeed for the family — even if it is formally for the coroner and the public interest. However, it is no part of the coroner’s legislated responsibility to look after the health of surviving family members. It would therefore be a useful service to accommodate these issues in future iterations of the national guidelines.2

Roger W Byard · Stephen M Cordner

Objectives: To describe professional discipline cases in Australia and New Zealand in which doctors were found guilty of professional misconduct, and to develop a typology for describing the misconduct.Design and setting: A retrospective analysis of disciplinary cases adjudicated in five jurisdictions (New South Wales, Victoria, Queensland, Western Australia and New Zealand) in 2000–2009.Main outcome measures: Characteristics of the cases (setting, misconduct type, patient outcomes, disciplinary measure imposed), characteristics of the doctors involved (sex, specialty, years since qualification) and population-level case rates (by doctor characteristics).Results: The tribunals studied disciplined 485 doctors. Male doctors were disciplined for misconduct at four times the rate of their female colleagues (91 versus 22 cases per 100 000 doctor-years). Obstetrics and gynaecology and psychiatry were the specialties with the highest rates (224 and 178 cases per 100 000 doctor-years). The mean age of disciplined doctors did not differ from that of the general doctor population. The most common types of offences considered as the primary issue were sexual misconduct (24% of cases), illegal or unethical prescribing (21%) and inappropriate medical care (20%). In 78% of cases, the tribunal made no mention of any patient having experienced physical or mental harm as a result of the misconduct. Penalties were severe, with 43% of cases resulting in removal from practice and 37% in restrictions on practice.Conclusions: Disciplinary cases in Australia and New Zealand have features distinct from those studied internationally. The recent nationalisation of Australia’s medical boards offers new possibilities for tracking and analysing disciplinary cases to improve the safety and quality of health care.

Katie J Elkin LLB(Hons), BSc, GDipMedHlthLaw · Matthew J Spittal PhD, BSc(Hons) · David J Elkin MA, BSc(Hons), BA · David M Studdert ScD, MPH, LLB

This article critically analyses the prospects for introducing United States anti-fraud (or anti-false claims) laws in the Australian health care setting. Australian governments spend billions of dollars each year on medicines and health care. A recent report estimates that the money lost to corporate fraud in Australia is growing at an annual rate of 7%, but that only a third of the losses are currently being detected. In the US, qui tam provisions — the component of anti-fraud or anti-false claims laws involving payments to whistleblowers — have been particularly successful in providing critical evidence allowing public prosecutors to recover damages for fraud and false claims made by corporations in relation to federal and state health care programs. The US continues to strengthen such anti-fraud measures and to successfully apply them to a widening range of areas involving large public investment. Australia still suffers from the absence of any comprehensive scheme that not only allows treble damages recovery for fraud on the public purse, but crucially supports such actions by providing financial encouragement for whistleblowing corporate insiders to expose evidence of fraud. Potential areas of application could include direct and indirect government expenditure on health care service provision, pharmaceuticals, medical devices, defence, carbon emissions compensation and tobacco-related illness. The creation in Australia of an equivalent to US anti-false claims legislation should be a policy priority, particularly in a period of financial stringency.

Thomas A Faunce LLB(Hons), BMed, PhD · Gregor Urbas BA, LLB (Hons), PhD · Lesley Skillen BA(Hons), LLB(Hons), LLM

Guidelines for private sector practitioners implementing the new provisions in the Privacy Act Every health care practitioner must respect confidentiality. Patients reasonably expect that private information offered or identified during an episode of care will not be divulged without their consent. The fundamental importance of confidentiality finds formal expression in the National Privacy Principles. Practitioners in the private sector must comply with the National Privacy Principles, which are embodied in the Privacy Act 1988 (Cwlth).1 Public sector employees are obliged to comply with the relevant legislation in each jurisdiction. Knowledge of a history of disease in relatives can be crucial for making a diagnosis in a patient. Similarly, medical care of relatives may be affected by the patient’s diagnosis. For example, a family history of colorectal cancer may assist in identifying the cause of a patient’s abdominal pain, and the diagnosis of colorectal cancer in the patient would then place his or her close relatives at increased risk of the same condition. In general, a practitioner is not obliged to inform relatives about the diagnosis of a familial disorder. There are some situations in which a practitioner may be required to advise a third party about a patient’s non-genetic diagnosis because of an immediate threat to the safety of others, as is the case with certain infections such as hepatitis A.2 These legally sanctioned breaches of confidentiality do not apply to the risk of a relative developing a familial disorder at some unspecified time in the future. Nonetheless, a practitioner cannot ignore the medical implications of a familial diagnosis for the patient’s relatives, and must inform the patient (or the patient’s authorised representative) of these implications and recommend that they seek medical advice in their own right.3 It is unusual for a patient to refuse to share such information with relatives,4 but such situations do arise and present the practitioner with a challenging dilemma.5 On the one hand, the patient has a right to make an autonomous decision about the use of personal information. On the other hand, this information has a direct bearing on the future health of relatives who may welcome the opportunity to make strategic decisions regarding their health. Whose rights should prevail? Before 2006, the privacy legislation in Australia was unequivocal: in the absence of an immediate threat to the health or wellbeing of a third party, the patient’s right to privacy prevailed and relatives could not be informed without the patient’s consent. This situation has since changed. In response to a recommendation from the Australian Law Reform Commission,6 the federal government amended the Privacy Act in 2006 to make specific provision for this situation.7 The Privacy Legislation Amendment Act 2006 (Cwlth) allows for the disclosure and use of information without consent, provided that such disclosure is necessary to lessen or prevent a serious threat to the life, health or safety (whether or not the threat is imminent) of an individual who is a genetic relative of the individual to whom the genetic information relates ... The significant provision is that the threat need not be imminent and may occur at an unspecified time in the future. There are some important features of this amendment that must be borne in mind. First, the amendment applies only in the setting of managing a familial disorder in a health care setting. A medical practitioner must authorise disclosure, and there must be consultation with appropriate colleagues. Second, the amendment does not require the practitioner to notify relatives about a familial disorder. The amendment provides a potential legal mechanism for doing so but does not create an obligation. Third, the amendment only applies to the disclosure and use of genetic information that is necessary to lessen the risk of a familial disorder for a genetic relative. There is no provision to release other information about the patient (including the patient’s identity), or to release information to a non-genetic relative (other than the authorised representative of a genetic relative). Finally, the Privacy Act currently applies only to practitioners in the private sector. The amendment does not apply to health care practitioners in the public sector. It is anticipated that similar provisions and processes will be developed in the local legislation of the states and territories, which would apply to practitioners in the public sector. The potential to disclose a patient’s confidential information to a relative against the patient’s wishes represents a major departure from longstanding views on confidentiality in health care. It is appropriate that such an action be taken rarely and with great circumspection. Furthermore, the process for disclosure must recognise that many relatives do not use the genetic information provided to them.8 The National Health and Medical Research Council (NHMRC) has developed guidelines for practitioners who might use this amendment;1 the principles that form the heart of the document are summarised in the Box. Readers should refer to the full guidelines for details, and to a more general NHMRC discussion paper on genetic testing in health care.9 It is important to note that the guidelines1 are not simply recommendations regarding best practice — they are the formal mechanism for implementation of this federal legislation, and practitioners who wish to use the provisions of the Privacy Legislation Amendment Act must comply with the guidelines and requirements of the Privacy Commissioner.10 There is another important sense in which the guidelines do not reflect “best practice”. With careful and considerate communication, especially before embarking on genetic tests that might diagnose a familial disorder, it is usually possible to resolve issues of concern that a patient may have about sharing this personal, confronting, and potentially useful information with relatives. Best practice is represented by striving to avoid the need to use the provisions of this amendment. With a combination of professionalism and patience, most apparent conflicts can be resolved without recourse to disclosing private information without consent. NHMRC guidelines for the use or disclosure of genetic information to a patient’s genetic relatives1 The guidelines developed by the NHMRC* for implementing the new provisions of the Privacy Act 1988 (Cwlth) are as follows: 1. Use or disclosure of genetic information without consent may proceed only when the authorising medical practitioner has a reasonable belief that this is necessary to lessen or prevent a serious threat to the life, health or safety of a genetic relative. 2. Specific ethical considerations must be taken into account when making a decision about whether or not to use or disclose genetic information without consent. 3. Reasonable steps must be taken to obtain the consent of the patient or his or her authorised representative to use or disclose genetic information. 4. The authorising medical practitioner should have a significant role in the care of the patient and sufficient knowledge of the patient’s condition and its genetic basis to take responsibility for decision making about use or disclosure. 5. Prior to any decision concerning use or disclosure, the authorising medical practitioner must discuss the case with other health practitioners with appropriate expertise to fully assess the specific situation. 6. Where practicable, the identity of the patient should not be apparent or readily ascertainable in the course of interprofessional communication. 7. Disclosure to genetic relatives should be limited to genetic information that is necessary for communicating the increased risk and should avoid identifying the patient or conveying that there was no consent for the disclosure. 8. Disclosure of genetic information without consent should generally be limited to relatives no further removed than third-degree relatives. 9. All stages of the process must be fully documented, including how the decision to use or disclose without consent was made. NHMRC = National Health and Medical Research Council. * NHMRC’s Working Committee (Dr Sandra Hacker, Ms Sharon Caris, Dr Elizabeth McCusker, Dr Graeme Suthers and Dr Samantha Wake) developed the guidelines in collaboration with the NHMRC’s Australian Health Ethics Committee and Human Genetics Advisory Committee.

Graeme K Suthers PhD, FRACP, FRCPA · Elizabeth A McCusker MB BS, FRACP · Samantha A Wake BSc(Hons), PhD, FHGSA

Legislative changes made without public discussion allow disclosure without patient consent Of all the ethical principles underlying medical practice, confidentiality is so fundamental that its breach is an illegal, high-order betrayal of responsibility. Disclosing personal medical information without consent profoundly violates the autonomy, beneficence and privacy that patients have always rightly expected.1 Although disclosure without consent has only rarely been necessitated by an urgent threat to life or health, two recent legal erosions of doctor–patient confidentiality illustrate how privacy-invading legislation can so easily and silently harm individuals who do not form sufficiently clamorous rights-demanding groups. In one, a state government directs that private medical records be lodged in an Orwellian sounding “Central Register” without regard for the individual’s knowledge, and risking privacy breaches by seeking consent for disclosure to third parties. The other permits disclosures of a patient’s medical information against their wishes even without any urgent threat to the life or health of another person. Both represent unreasonable intrusions on privacy and erosion of personal liberty. Recently, the New South Wales Government made a legislative amendment, without parliamentary debate or public discussion, in the last days of their current term. This amendment to the Assisted Reproductive Technology Act 2007 (NSW)2 forces doctors to provide the identity of anonymous sperm donors to a central register when their genetic offspring submit a request for information to the Director-General of NSW Health. This transfer of identifying information can occur regardless of the sperm donor’s consent, and overrides any prior condition of strict confidentiality guaranteed at the time of sperm donation. Although it is argued that identifying information cannot be released without the donor’s consent, the Director-General’s possession of donor contact details creates a situation where a stranger to the donor might try to contact him to seek consent for disclosure. The donor, however, did not ever consent to such an approach from a government instrumentality which, in itself, is virtually certain to breach the donor’s strict confidentiality. Inevitably, once the Director-General possesses identifying information and this contact and consent process proves unworkable, the logical next step is eliminating the troublesome consent requirement. This retroactive legislation is starkly at variance with the recent Australian Senate’s report of its inquiry into donor conception in Australia,3 which recognised that all states’ legislation on donor conception respected the time-honoured principle of rejecting legislative retrospectivity. Sperm donors have often long forgotten their altruistic act, two decades previously, motivated by a wish to help infertile couples and thought of as akin to blood donation; certainly they would not have provided sperm without the guarantee of enduring and strict confidentiality. Now, merely expecting undisturbed privacy, they do not constitute any sort of group to oppose the persistent, vocal donor-conception lobby groups demanding involuntary disclosure that overrides donors’ legal and moral rights. Sperm donors’ lives over the decades since donation could have changed in every imaginable way so that forced disclosure may be unwelcome, and damaging to some. It denies natural justice to disregard the usual requirement for their consent. We hope that a new NSW Government will show regard for consent and amend the retrospectivity of this assault on the privacy and personal liberty of well intentioned individuals. The other legal assault on privacy is highlighted in a recent update of the National Health and Medical Research Council (NHMRC) guidelines on medical genetic testing.4 These guidelines endorse a recent amendment to Commonwealth privacy legislation that widens the legal exemption allowing disclosure of patients’ genetic information to others, even against a patient’s wishes. Rarely, the situation arises where a patient is unwilling to inform relatives of a genetic test result that, in a doctor’s opinion, should be disclosed. Such disclosure was previously only permitted to resolve an imminent danger to another person’s health. After the previous exemption for imminent medical danger created a precedent, a recent amendment has removed the requirement altogether. In effect, this now creates genetic testing without consent by proxy — a situation where the relative may be informed, against the patient’s wishes, of the patient’s genetic status without the relative soliciting the information and possibly without wishing to know. The arbitrary nature of this new standard is illustrated by its vague boundaries — only a “serious threat to life, health or safety” extending to “third-degree relatives” is required to override the patient’s denial of consent. The NHMRC guidelines even encourage not disclosing that the original genetic testing occurred, piling dishonesty upon breach of faith. The widened loophole creates an elastic legal excuse for the well meaning (but impatient) to breach individuals’ privacy. This disavowal of patient confidentiality at a doctor’s sole discretion has the net effect of allowing one individual’s subjective, value-laden judgement, triggered by any remote threat to health or welfare, to override a patient’s refusal of consent. Inevitably, unintended perverse outcomes should be expected — bringing to mind the legal maxim “hard cases make bad law”. In practice, this loophole will encourage the taking of the lazy path of legal coercion rather than gradual persuasion and ultimate acceptance of a patient’s decision. If forced disclosure is really required, such a momentous breach of a patient’s expressed wishes in the absence of genuine life-threatening circumstances should require approval from an independent legal tribunal, a standard well established for surgery on children whose parents refuse consent, or for sterilisation operations or other major elective procedures for those unable to consent. Both these legislative assaults on privacy reflect the fashionable belief in genetic determinism prevailing over any ethical, moral and legal constraints of everyday life. But ditching the trusted confidentiality of medical information for doctors’ convenience or to satisfy lobby groups permits arbitrary and damaging intrusion on personal liberty — the price of which remains eternal vigilance.

David J Handelsman MB BS, FRACP, PhD · Leo A Turner RN, MSc Med · Ann J Conway MB BS, FRACP

Multidose vials (MDVs) for injectable therapeutic agents, including vaccines, pose a risk of infection to injected patients as a result of contamination of the vials. The Australian Government Department of Health and Ageing (DoHA) distributed the vaccine against pandemic (H1N1) 2009 influenza in MDVs. The distribution was accompanied by consent forms. The consent forms provided an inadequate basis for a discussion with patients about the risks associated with the use of MDVs. The High Court of Australia has previously held that medical practitioners who fail to explain the material risks of medical procedures to their patients might be held liable in negligence for any adverse sequelae of the procedures, even if the risks are very low. Medical practitioners, nurses, medical indemnity insurers and the DoHA should prepare now for the probable future use of MDVs by developing a consent form that would provide a solid foundation for a discussion of material risks with patients seeking vaccination.

Mark R Diamond PhD · Angela O’Brien-Malone PhD

Issues relating to voluntary euthanasia that are currently being debated by Australian society are distinctly different from those encountered by battlefield doctors. Doctors in war undertake to treat those affected by conflict; their participation in euthanasia challenges the profession’s definition of “duty of care”. Euthanasia must be distinguished from “triage” and medical withdrawal of care (which are decided within a medical facility where, although resources may be limited, comfort care can be provided in the face of treatment futility). Battlefield euthanasia is a decision made, often immediately after hostile action, in the face of apparently overwhelming injuries; there is often limited availability of pain relief, support systems or palliation that would be available in a civilian environment. The battlefield situation is further complicated by issues of personal danger, the immediacy of decision making and difficulties with distinguishing civilians from combatants. Regardless of the circumstances on a battlefield, doctors, whether they are civilians or members of a defence force, are subject to the laws of armed conflict, the special provisions of the Geneva Conventions and the ethical codes of the medical profession.

Susan J Neuhaus CSC, PhD, FRACS

Clinical research is an area of increasing activity for hospitals, universities and research institutions, which requires formal governance and oversight to manage risks. Monitoring research practice should be a part of research governance activities. However, formal audits have proved time consuming for researchers and auditors. To increase attention to good research practice and screen for poor practice, the Department of Epidemiology and Preventive Medicine at Monash University and the Alfred Research and Ethics Unit in Melbourne have developed a brief self-audit tool for researchers. We evaluated the self-audit using a questionnaire for researchers. The results were positive, with most respondents believing that it promoted good research practice.

Bradley R Crammond BA LLB, LLM · Anna V Parker BA(Hons), MA, MBioeth · Megan Brooks BAppSci, GradCert(ClinRes), PhD · Marina Skiba BEd(Sec)Sci · John J McNeil PhD, FRACP, FAFPHM

Newborn screening (NBS) programs are a well established and cost-effective method for early identification of genetic disorders. However, a raft of legal questions surrounds the collection, storage, ownership and secondary use of NBS cards. The absence of clear legal rules governing NBS programs in Australia means that there are few straightforward answers to these questions. A series of controversial incidents have exposed this uncertainty in Australia, and remarkably similar controversies have occurred in the United States and European Union. We review the situation, using Victoria as a case study. We also make the case for a dedicated regulatory regime for NBS programs, arguing that the lack of such a regime threatens public trust and the robust operation of NBS programs in Australia. New rules would likely introduce stricter requirements for informed consent at the point of blood collection than has been the norm to date. However, the scope for use of cards in research could expand rather than contract, and it may be possible to reduce the risk that vast card archives will need to be destroyed in response to future public outcries.

Diana M Bowman BSc, LLB, PhD · David M Studdert LLB, ScD, MPH

To the Editor: Nash and colleagues have produced another report on medicolegal matters and Australian doctors.1 This report, and one that preceded it in 2009,2 are derived from responses to a questionnaire from nearly 3000 doctors. The survey showed that 65% of respondents had been involved in “medicolegal matters”. From a mass of data, the authors conclude that medicolegal concerns impact on doctors’ practice of medicine. As potential benefits of medicolegal matters, they list improved communication of risk to patients, disclosure of diagnostic uncertainty, and better methods to track test results and non-attenders. Negative impacts included increased referral to specialists, ordering more tests, and seeing fewer patients. The authors recommend targeted training in patient safety and medicolegal aspects of practice to help doctors to be “better informed”. However, as 65% of the group had been involved in medicolegal matters, it seems unlikely they need to be better informed about them. In the title and throughout the article, there is much emphasis on the word “perceived”. With this heavy emphasis on perception, it might be thought that the key finding was that fear of a medicolegal matter was greater than the reality. In fact, the reverse was found. Of those who had experienced medicolegal matters, 46% had considered retiring early, 39% considered giving up medicine and 38% considered reducing hours of work. The respective figures for those who had not experienced medicolegal matters were 29%, 22% and 21%. The difference was highly significant. An inescapable conclusion is that medicolegal matters result in large numbers of demoralised doctors. The reality is worse than the perception. Unfortunately, the obvious question — What was the outcome of the medicolegal matter? — was not included in the survey. Given the numbers involved, it seems likely that for many doctors, although the outcome was favourable, the process had a profoundly negative effect on their work. Forty-one per cent now regard every patient as a potential litigant. A logical response to these data might have been to ask: (1) Could there be a problem with the way medicolegal matters are conducted? and (2) Is the demoralisation of a large percentage of the medical workforce good for society? Neither question was asked here. This is perhaps not surprising as, in their previous article, the authors questioned, without embarrassment and on the basis of a questionnaire, whether “psychiatric morbidity in doctors is a cause or effect of the medicolegal process”.2 This study is “one of the largest [of its kind] in the world”. Sadly, the authors’ negativity towards doctors and their unquestioning allegiance to current medicolegal practice have greatly diminished its value.

Padraic J Grattan-Smith

In reply: I agree with Grattan-Smith that current medicolegal processes have profoundly negative effects on doctors. I do not agree that my coauthors and I have “negativity” towards doctors and an allegiance to current medicolegal practice. Our aim was to investigate the impact of medicolegal matters on Australian doctors — their emotional response and their practice changes.1,2 We have shown that doctors who have a current medicolegal matter have higher levels of psychiatric morbidity,2 and that most doctors believe they change how they practise due to medicolegal concerns — more so in the case of doctors who have experienced a medicolegal matter.1 Justice Ipp and colleagues,3 when reviewing the law of negligence for the Commonwealth of Australia in 2002 with the objective of limiting liability and damages arising from personal injury or death, made note of the lack of empirical evidence in the submissions they received. We have now provided some empirical evidence of medicolegal matters from the doctors’ perspective. If such a review were conducted now, I would suggest the current medicolegal systems are not good for patients, for doctors, or for the health system in general. The evidence from our studies1,2 now allows a more informed conversation on this issue to take place.

Louise M Nash