Ethics

Lack of transparency and reliance on statistics alone make doctors vulnerable The Professional Services Review (PSR) was established to investigate and manage situations where the Medicare system was being used inappropriately by doctors. Undoubtedly, the PSR’s activities have identified and addressed instances of doctors knowingly exploiting Medicare. However, over the past 5 years, an initial general disquiet about the increased effect of the PSR’s investigative system and processes on general practice grew into widespread concern among broad sections of the medical profession and others. The PSR committees were disbanded because they were not ratified by the Australian Medical Association (AMA), 39 cases under review were dropped, and a senate inquiry into the entire running of the PSR scheme was conducted. The inquiry resulted in the publication of seven recommendations for improvements in the system,1 with a review with all relevant stakeholders planned for 12 months later. A common recurrent complaint was Medicare’s focus on statistics, with less emphasis on other information provided. Medicare targeted the right-hand end of the bell curve, assuming this was where inappropriate practice occurred. The “vanilla GP” who held four standard consultations an hour was the Medicare epitome of a gold standard practitioner and was safe from audit. However, the further GPs steered away from this “standard” practice, the more they were at risk of being investigated by the PSR. There is no substantial evidence that statistical outliers represent a high-risk group, and yet the PSR has intensified its auditing activities among such doctors, increasing auditing from 1% to 4%.2 Surveys of the medical profession have revealed deep concerns with the system and processes of the PSR. The AMA posed the question: “Do you think the Medicare audit process has become too heavy handed?”, to which 88% of respondents (307) voted yes.3 The Medical Observer ran a survey that attracted over 200 replies. It showed that over 80% of respondents felt that Medicare and the PSR had not replied adequately to queries on the Medicare Benefits Schedule and less than 15% felt confident they would pass an audit on the Enhanced Primary Care item numbers.4 The specific concerns held by us and others are numerous. In our view, the operational processes of the PSR and the Medicare audit system appear to be non-transparent, with too much power in the hands of the PSR Director. There is a denial of natural justice, with a high conviction rate and pressure to accept “negotiated agreements”, with no practical appeal process. Fines imposed are large, running to between five and six figures. Preserving patient confidentiality during an audit seems to disadvantage the case of the doctor being audited. The PSR does not appear to respond to concerns raised in these areas, and this undermines community confidence in primary care. A particular problem is that Medicare and the PSR give little or no guidance to GPs on the approved use of item numbers in the Medicare schedule. They have tried to refer complex requests back to the AMA and Royal Australian College of General Practitioners,5 and will not give binding interpretations on the use of Medicare items. Their past rulings do not provide useful guidance. This puts GPs in an extremely vulnerable situation, being unable to reliably check their interpretation of Medicare item numbers, yet able to be severely punished for actions judged to be misdemeanours at a later date. Some of the submissions to the Senate inquiry6 show the heavy-handedness of the PSR, particularly in relation to procedures performed by GPs. Examples include a rural GP being required to pay back a substantial sum because he had not personally documented the wound dressings and vaccinations performed (a nurse had done the documentation), and the rejection of independent assessment that disagreed with the PSR when investigating a rural GP for computed tomography scan orders. The PSR investigated 200 records associated with a procedural rural GP who had been in practice for 26 years because of “statistical anomaly” in the number of pre-anaesthetic checks ordered, even though the local hospital generated all these requests. On this basis, the GP was found guilty of incomplete record keeping and misinterpretations of item numbers 723 and 2713. He decided to accept the settlement after trying to sort through the issue over 2 years, although he did not feel at any stage that he had done anything wrong. Despite his previously clear record and full cooperation, he was subsequently fined a substantial five-figure sum and his patients were banned from claiming item 36 from Medicare. The particular case of Dr Tisdall,7 whose disqualification from Medicare was publicised by the PSR, and who fought for 10 years to clear his name, only to die soon after the federal court granted him the right to have his case reviewed by a new committee, is well known in the medical community and in Kyabram where he worked. The Full Federal Court was highly critical of the way the PSR went about making its findings. They described it as making a “speculative assumption” and decisions “simply based upon inferences drawn from statistics”,7 echoing criticisms from medical groups. The PSR is not only the concern of the various medical organisations that have queried its operation. The Australian community are the losers when government bodies fail. This inquiry has given us all the opportunity to improve a system for the benefit of patients, the government and doctors alike. The PSR needs to work hard with all medical and community groups to regain trust and respect.

C Scott Masters FRACGP, FAFMM, DipMusMed · Malcolm I Watt

To the Editor: Were the views expressed by Conway and Savulescu really opposing?1,2 I turned to those pages with much interest, only to find that it seemed as if they would have been in agreement, had you put the scenarios they each describe to both of them. Conway discussed the conflict between doctor and patient about acceptability of the recommended management (the “best interests” of a dying child). In contrast, Savulescu talked of irrational prejudices held by doctors on the grounds of race, sex and other factors. Indeed, unless I missed some subtle points, I could not see any opposition in their arguments. I was, therefore, stumped when your online poll asked me to vote on the question: “Do doctors have the right to refuse certain treatments on the grounds of personal conscience?” Is the question asking about Conway’s point about what the doctor sincerely, on medical grounds, considers to be in the patient’s best interests, or is the question asking about a doctor’s refusal to attend to a patient on the basis of some irrational prejudice? Horses of quite different colours — racing in different races.

Peter C Arnold

To the Editor: In 2006, the Cancer Institute NSW established a single ethics committee, in order to improve the efficiency of ethics reviews for multicentre cancer clinical trials. This predates the National Health and Medical Research Council (NHMRC) Harmonisation of Multi-centre Ethical Review (HoMER) but exemplifies what HoMER aims to encourage nationally. Previously, such trials were submitted to each institution’s ethics committee, resulting in replication of effort and cost and prolonged review times, potentially making sites uncompetitive in attracting clinical trials.1 Under the Cancer Institute’s model, with the agreement of individual institutions, multicentre projects are submitted directly to a single ethics committee. Governance issues, such as the capability of an institution to provide appropriate support, and insurance issues have remained local health unit responsibilities.2 Data were prospectively collected on applications received from 1 July 2007 to 30 June 2009, and their processing times. The Australian Research Ethics Database was used to track and manage multicentre research projects. The aim was to achieve a 60-calendar-day time period from submission (1 month before the ethics committee meeting) to approval. Submissions were made on the NHMRC National Ethics Application Form, along with a protocol and patient information form. We evaluated 89 studies from the 2-year period. Fourteen trials were reviewed from single sites before other sites were engaged or whose ethics committees lacked cancer expertise. The median time range for review was 61–70 days. Forty-four per cent of applications were reviewed within 60 days and 70% within 80 days, ranging from eight studies taking 31–40 days to the extreme of seven studies requiring 131–160 days. The median time for assessment improved as the committee streamlined its processes: from 89 days in 2007 to 68 days in 2008 and 59 days in 2009. There were 15 studies, predominantly in the first year, that had long assessment times because of multiple issues concerning research merit and inadequate information for participants. Of the studies evaluated, one was approved without revision, 48 required minor revisions that were approved between meetings, and 40 required review by the full committee. Eighteen studies were reviewed twice, and 22 were reviewed more than twice. Efficiencies introduced included disseminating all documentation electronically, empowering the chair and deputy chair to approve minor amendments or responses between meetings, and the website carrying standard wording for use in sections of the patient information forms that were proving to be recurrently problematic. To resolve difficult issues that correspondence had not resolved, investigators were invited to meet with the committee. We conclude that a single ethics review for multicentre trials may be able to deliver a rapid response and be efficient without compromising ethical rigour. However, to make a difference to researchers, the governance review process will need to become correspondingly efficient. Our experience parallels that internationally, where such ethics committees can demonstrate cost savings with faster response times, yet provide ethical reviews of similar quality.3,4,5

Ian N Olver · Sharon J P Falleiro · Marion L Marson · James F Bishop

To the Editor: The letter by Johnson and Mitchell,1 responding to the two published papers of Rosenwax2 and Lowthian3 and their colleagues, about hospital, ambulance and emergency department use in the last year of life, concluded with the statement: Also essential is an ongoing dialogue with the patient and family to enable a clear understanding of the goals of treatment and to proactively plan for likely adverse events . . . [this] will potentially reduce the use of acute services and encourage the provision of care in more appropriate environments. The most significant factor in facilitating this latter objective is the timely preparation by the patient of the appropriate form of instructions to medical staff and designated family members about end-of-life management. Unfortunately, there is no common, state-recognised instrument for this in Australia. Many people appear to believe that conferring a “power of attorney” on a family member is all that is required, but this is not the case. In most situations, this allows the designated member or members to administer financial and property matters but not to make medical decisions about end-of-life care. The requirements for a valid medical decision-making authority differ from state to state. The instruments are variously known as: “enduring power of attorney” in the Australian Capital Territory; “enduring power of attorney (medical treatment)” in Victoria; “medical power of attorney” in South Australia; “enduring guardianship” in New South Wales and Tasmania; “enduring power of guardianship” in Western Australia; “advance health directive” in Queensland; and “medical enduring power of attorney” in the Northern Territory. It would be a major advance in the rational use of health resources, and towards ensuring compliance with the wishes of people who are terminally ill, while minimising the stress and distress of their family members, if general practitioners were to encourage their chronically and terminally ill patients to complete the appropriate form early in their illness.

John D Paull

To the Editor: Faunce and colleagues wisely called for the introduction of legislation modelled on the United States False Claims Act (FCA) in the Australian health care setting.1 Indeed, whistleblowers require protection and reward.2 The authors stated that the “key strengths of the US qui tam anti-fraud regime ... lie in its recovery of large amounts of public monies, its encouragement of good corporate practice” and noted that it is “largely compensatory or remedial rather than punitive”.2 However, the non-punitive nature of the regime is problematic. Settlements in the US may appear substantial. In 2009, Pfizer paid US$2.3 billion to settle a false claims action against their marketing of Bextra (valdecoxib).1 However, this sum represents only a small proportion of Pfizer’s overall profits, given that Bextra was marketed from 2001 to 2005 and the company’s profit for the first quarter of 2011 was US$2.2 billion.3 Clearly, pharmaceutical companies in the US cope with the FCA — their huge profits largely compensate for the settlements. “While the defense industry used to be the biggest defrauder of the federal government under the FCA ... the pharmaceutical industry has greatly overtaken the defense industry in recent years.”4 Between 1991 and 2010, settlements for criminal and civil monetary penalties reached a total of US$20 billion. Three-quarters of these occurred between 2006 and 2010.4 The message from the US experience is that non-punitive anti-fraud laws do not stop pharmaceutical companies from engaging in fraudulent activities.

Alain Braillon

YES: Paediatrician Brian Conway believes freedom to practise in accordance with conscience enables healthy diversity and is the ultimate safeguard for patients The child lies in the hospital, defeated by cancer and on the edge of death. Clinicians advise that there is nothing more to do beyond keeping her comfortable. The parents disagree. Wanting absolutely everything done, they secure a court order to enforce their wishes. With every cardiac arrest, the treating team reluctantly sets to work. She has already arrested nearly 10 times through the day and staff dread the next code. The team feel distressed and angry — forced to deprive this child of a peaceful death. Their duty to her is violated. They feel the court order is forcing them to participate in child abuse. What should they do? Parents’ wishes are normally a good guide to their child’s needs and best interests, but in this case, the treating team may be best placed to identify better options. Experience and knowledge give insight into how resuscitative measures may feel for a dying child. Professional detachment assists good decision making. The parents, naturally, are far from detached and may be emotionally confused, perhaps in denial, and panicking. Better communication with the distressed couple is probably needed. Doctors should aim to build a partnership1 with patients based on trust and respect. The shared goal is to act in the best interests of the patient. Inevitable power imbalances must be managed and each party’s values and conscience acknowledged, avoiding paternalism or authoritarianism in the relationship. Doctors and patients may not always agree. A recommended treatment may be refused or poorly implemented. In this case, recommended palliative care is refused. But words like “recalcitrance” have no place here, or in the proper discourse of the doctor–patient relationship. A doctor must share with the patient the evaluation of the patient’s views, values and circumstances in considering appropriate medical responses. Conscience may guide the doctor to refuse a particular request, such as this resuscitation. The doctor ought, nonetheless, to continue to offer other care, to keep up their end of the partnership. The patient is free to seek the refused treatment elsewhere but should not coerce the doctor’s cooperation in something they believe will be harmful for the patient. For this dying girl, clinicians acting on conscience may be her only protection from harm. One prominent view, espoused by Savulescu,2 argues that conscience has no place in medicine, and doctors ought always to carry out the patient’s lawful, efficient and beneficial requests. Even though it is promoted as being anti-paternal, this model would still result in an unbalanced, authoritarian relationship, now with the patient holding all the power and the doctor reduced to mere technician, their autonomy refused. This model2 would hold no hope for the little girl burdened by the court order and panicked parents. Nor would it have held any reliable hope for the coopted subjects of the Tuskegee syphilis study,3 where dominant views, in government and the medical profession, argued that the broader social good justified the study’s continuance against repeated whistleblower conscientious objection. Medical schools and colleges must avoid any authoritarian selectivity regarding values, lest they weed out future whistleblowers or reduce needed diversity in the profession. Patients seek doctors who share their values, and sometimes because they refrain from certain procedures. Different values might be labelled “rigid” simply because they are held in the face of majority rigidity concerning contrary values. Conscience-based medicine is practised with a concern for patients’ wellbeing, recognising patients’ dignity and worth. Yet those who see little place for conscience2,4 insist that doctors who conscientiously refuse to cooperate in provision of controversial treatments that they regard as harmful should be punished like the recklessly negligent or boundary violators appearing before medical boards. Homogeneity under a majority, state or institutionally ordained value system or dictated rules has been shown in numerous historical cases to be disastrous for patient protection.3,5 The demand for lockstep adherence to required values and rules seeks to relegate conscientious objection to the realm of the unprofessional and illegal, and even the traitorous. The state legal mechanism fails the dying girl because it does not acknowledge her need for conscientious care by her clinicians. The profession and the health system failed her and her parents, because widespread confusion has been allowed to persist about the validity and desirability of attending to and following conscience, both in day-to-day practice and even in the face of court orders or administrative directives. Respect for doctors’ right to conscientiously object is the ultimate safeguard against abuses of power, error and exploitation in medicine. It is the key safeguard of the doctor–patient relationship.

Brian V Conway MB BS, BMedSc, FRACP

NO: Ethicist Julian Savulescu believes patient safety lies in objective moral standards CConscientious objection by doctors, as is commonly practised, is discriminatory medicine. Only a fully justified and publicly accepted set of objective values results in ethical medicine as a proper public service with agreed and justified moral and legal standards to which doctors should be held. Imagine that a doctor refused to examine a patient of the opposite sex on religious grounds. This is treating the patient unequally and unfairly on morally irrelevant grounds. It is sexism and therefore wrong, regardless of the doctor’s religious practice. Australian society does not and should not tolerate sexism, even if it is institutionalised by other countries or religions, or is part of the doctor’s values. Similarly, if a doctor refuses to treat a patient because they are black, or Jewish, or gay, or drunk, it is discrimination, even if conscientious discrimination. Yet some of the doctors of the future believe they are entitled to refuse to examine patients because they are of the opposite sex or drunk.1 Respect for current conscientious objection is grounded in a dangerous moral relativism: that morality and moral rightness are culture-specific, or equate to individuals’ own values and desires. This is false. Female infibulation is wrong, even in those countries and cultures that condone it. We must stand up for a non-relative morality and an objective account of interests. People should be free to live according to mistaken values or religious values. But they should not have the liberty to coerce, directly or indirectly, other people to live according to their own values, even if they are medical professionals. Freedom to practise religion does not imply freedom to impose religious values on others in a secular liberal society. The same applies to secular moral values. The place to decide what kinds of values should govern public institutions and practices is in a public forum, not by the bedside. For instance, a secular doctor might believe that people with advanced dementia or brain damage, who no longer recognise themselves or others, are not persons. She might believe it is right to kill such non-persons. However, this moral belief is not widely shared by the community at this point in time. Even though the doctor strongly believes it is morally justified, she should not kill or support the killing of specific individuals with advanced dementia but, instead, argue for legal reform in a public forum. Conscientious objection is often justified by a person saying that they are acting in a patient’s best interests. However, deciding what a patient’s best interests are requires input of the patient’s values, but is not determined entirely by them. It is partly, but importantly, an objective judgement.2 If a Jehovah’s Witness believes that a blood transfusion is not in his interests, it does not mean that a blood transfusion is against his interests. We should withhold blood transfusions from people who refuse them, to respect the objective principle of liberty, not because blood transfusion is against their personal interests. Similarly, one can, on the objective principle of distributive justice, deny further care to patients who are wasting limited medical resources through non-compliance or recalcitrance, but not because the patient offends the treating doctor’s individual values. The place of conscience is in dialogue with patients. Doctors argue for what they believe is right and engage patients in moral dialogue. This is what I call “rational non-interventional paternalism” or liberal rationalism.3,4 But in a liberal society that respects personal freedom, doctors should ultimately offer what are just, legal medical procedures. Conscientious objection will become more common because of increasing societal pluralism and treatments becoming more morally contentious. Such objection may be justified. For example, drugs developed by the use of slave labour or by the maltreatment of children in developing countries should not be used, even if licensed. Doctors should refuse to perform female genital mutilation. What distinguishes these justified objections from current refusal to perform abortions or deliver contraception? Justified conscientious objection is an objection to harming people. But harm and benefit are not in the eye of the beholder — they are grounded in a robust, morally justified concept of best interests and of moral status. Doctors should conscientiously object to female circumcision for this reason. But current conscientious objection is not morally justified because it is not grounded in a justified and agreed conception of interests. As a result, these forms of unjustified conscientious objection harm patients.

Julian Savulescu MB BS, BMedSci, PhD

It is never too late, or too early, to listen to patients about what they want How people die remains in the memories of those who live on. Cicely Saunders, Pain and impending death1 Isn’t it rather odd that, only a few decades ago, dying was a normal part of life? You would most likely be cared for and die at home, surrounded by family. While all the advances in medicine that treat disease and enable us to live much longer have been welcomed, what has been pushed off the agenda is that the mortality rate for all of us remains at 100%. It is in this context that advance care planning is beginning to be recognised as a pivotal part of end-of-life care. In the 19th century, when little was understood about disease processes and few effective treatments existed, Sir William Osler famously said, “It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has”. As modern medicine evolved, with rapid scientific discoveries and technological advances, the focus shifted profoundly to cure — to defeating disease and saving or prolonging life at all costs. Early in the 21st century, it has become increasingly apparent that one of these costs has often been the quality of the patient’s survival. Modern medicine has started to focus equally on the disease and the patient. There is much wisdom in the code of ethics for Catholic health and aged care services, which clearly states that if a treatment is overly burdensome or the burdens outweigh the benefits, the patient may legitimately forgo the treatment.2 To do everything possible just because it is possible, without regard to the patient’s goals, values and wishes, is ethically unsound and not good medical practice. Yet it is remarkable how often this occurs. How many times have doctors, both senior and junior, said that they were continuing or commencing treatment because the family wanted it, and not because they thought that it was right for the patient and was supported by evidence in the medical literature? Our common law duty of care as doctors is to always act in the patient’s best interests. One of the most practical ways to put this into action is to regularly ask ourselves, “Am I caring for this patient or family the way that I would want myself or my family to be cared for, by taking the time to identify their personal, spiritual or religious views and take these into account when I am making decisions?”. There are three opportunities to check whether the care we are providing is patient-centred. The first is with competent patients, by ensuring that their consent to treatment is fully informed, by understanding their goals and values that are relevant to their current or future treatment, and by identifying their wishes regarding treatment if they become seriously ill and can no longer decide or communicate what they want. This process of enquiry is called advance care planning. It may be as simple as identifying who the patient’s substitute decisionmaker would be and ensuring that this person is someone who has a clear idea about the patient’s goals, values and wishes. It may also include assisting patients to put their future wishes in writing. It is crucial to enquire what the patient would regard as an acceptable outcome, rather than make a shopping list of acceptable versus unacceptable treatments. Where is the patient’s line in the sand — his or her acceptable level of ability to communicate or of cognitive or physical function? The second opportunity is when caring for a patient who is no longer competent. At this time, we need to look for any documents, such as an advance care plan, that record the patient’s wishes, and speak to the family and the substitute decisionmaker, if appointed. We should ask them what the patient would want rather than what they want, with the focus on what the patient would regard as an acceptable outcome,3 through questions such as, “If your father could sit with us here, right now, what would he tell us to do?”. The third opportunity is when caring for a patient approaching the end of life. A study in which patients were interviewed identified five factors that patients regard as important to having a “good death”: avoiding suffering, avoiding the prolongation of dying, achieving a sense of control, relieving burdens placed on the family, and strengthening relationships with loved ones.4 Apart from providing good palliative care, the most effective way to achieve these goals is to know ahead of time what a person would want. More than half of us are not in a position to express these preferences at the end of life. In a randomised controlled trial published last year, we showed that advance care planning improved end-of-life care for elderly patients admitted to hospital, increased respect for the patients’ wishes at the end of life, improved patient and family satisfaction with regard to hospital care, and reduced the likelihood of anxiety, depression and post-traumatic stress in the surviving relatives of patients who died.5 The skills needed to effectively facilitate advance care planning are learnable. Through the Respecting Patient Choices Program, medical and non-medical health professionals can be trained to discuss these personal, intimate subjects with patients and their families in a sensitive, compassionate way.6 It is never too late, or too early, to listen to patients about what they want. The importance of involving patients in decisions about their care was acknowledged by a maxim in a recent white paper from the Department of Health in the United Kingdom: “no decision about me without me”.7

William Silvester MB BS, FRACP, FCICM · Karen Detering MB BS, FRACP, MHEth

Clinical guidelines are being increasingly produced to improve quality of care, but are vulnerable to bias. Only 15% of guidelines on the National Health and Medical Research Council portal from the most prolific developers have published conflict of interest statements, and fewer detail the processes used to manage conflicts. Comprehensive disclosure of conflicts is needed to safeguard the integrity of clinical guidelines and the medical profession. Peak bodies and clinicians should seek to promote an improvement to current poor practice.

Michael J Williams* BA(Hons), LLB(Hons) · Dev A S Kevat* MB BS, LLB(Hons), MPH(Oxon) · Bebe Loff LLB, MA(Lond), PhD

To the Editor: The commissioned article by Pirotta, dealing with the ethics of prescribing alternative complementary treatments that may lack an evidence base,1 contains a number of statements which, if the article had been subjected to peer review, might well have finished up on the cutting-room floor. For example, the statement “it is estimated that as little as a quarter of conventional medicine is based on level-1 evidence” is not backed up by the only monograph cited in support of it.2 Whatever relevance a lack of level-1 evidence may have to the practice of dermatology (for which it is claimed), it plays little part in either modern medicine or the revolutionary advances in surgery, few being the result of a systematic review of multiple well controlled randomised trials. Having said that, the reference to complementary or alternative treatments that lack any evidence base as “medicine” gives a misleading legitimacy to practices that may be — and frequently are — based on cultural, historical or spiritual beliefs, or even just plain wacky approaches to healing. Regrettably, Pirotta adds nothing new to the (uncited) definitive 2004 article by Kerridge and McPhee.3 How times have changed. Not only are doctors now expected to have sufficient knowledge of complementary and alternative medicine to be able to advise their patients of therapeutic alternatives, but we may well have reached the stage where a failure to alert patients of such alternative treatment options may constitute negligence at common law. The New South Wales case of McGroder v Maguire4 is instructive. In that case, the plaintiff, a truck driver, had suffered a neck injury in the course of his employment. Despite a lengthy period of treatment, he continued to suffer from tingling in his arm. The defendant, a general practitioner retained by the plaintiff’s employer, although not having examined the patient, nevertheless referred him to a chiropractor. This referral was held to have been negligent, not because of the referral per se, but because of the patient’s condition. This came to light in the evidence given by a neurosurgeon and orthopaedic surgeon at the trial of the action, both of whom agreed that this case was not one for chiropractic manipulation of the plaintiff’s neck and back. Despite subsequent neurosurgery, the plaintiff became totally incapacitated for work. In the result, both the referring GP and the chiropractor were held to be liable in negligence.

Paul Gerber

To the Editor: We read with interest the commentaries by Pirotta and Dwyer on complementary and alternative medicines (CAMs).1,2 This debate has a long history, spanning more than two decades,3 and the pessimism continues to ignore good science.2 Firstly, integrative medicine (IM), which combines alternative and conventional medical practices, is not and never has been synonymous with CAMs. IM is a global paradigm shift that expands the conventional model of medical care with evidence-based laboratory and clinical research. IM embraces the foundations of medicine, such as (i) the critical role of the doctor–patient relationship, (ii) the importance of lifestyle, and (iii) improving the wellbeing and promoting the natural healing potential of people afflicted with disease.4 Secondly, a thinly disguised commentary on the ineffectiveness of CAMs,2 while dismissing a large body of scientific clinical evidence, is broadly misleading. This is significantly remiss, failing to cite the value of prebiotics and probiotics in digestive diseases,5 the effect of omega-3 essential fatty acids on endothelial function,6 the efficacy of acupuncture for some forms of pain,4 mindfulness-based stress reduction and mindfulness-based cognitive therapy for mental health,7 and emerging modalities such as yoga for menopausal symptoms4 and tai chi for fibromyalgia,4 and many more.4 Moreover, such deliberate carelessness serves only to confuse researchers and clinicians, as well as the public. Evidence-based medicine is critical in expanding the medical model of care; of this there can be no doubt. Adhering to biologically plausible mechanisms of action is the key foundation that will always guide scientific evidence, including that for CAMs. As an example, we have recently scientifically challenged the validity of the antioxidant effect to abrogate free radicals that are purported to contribute to the development of chronic diseases.8 Therapies that deviate from the conventional medical model still elicit an unhealthy cynical response2 that hinders the progress of scientific and medical investigations. If Florey and Fleming had adopted such cynicism and dismissed the biologically far-fetched notion of an antimicrobial mould in a Petri dish (Penicillium notatum), they most probably would not have pursued and contributed to the discovery of the antibiotic penicillin. Thus there is no place in science and medicine for the imprimatur of distrust and scepticism that is levelled without respite at novel concepts, even those with scientific plausibility.

Luis Vitetta · Shoshannah L Beck · Samantha Coulson · Avni Sali

To the Editor: I am concerned that the viewpoints by Dwyer1 and Pirotta2 were published without establishing a clear definition of “complementary and alternative medicine” (CAM). The term CAM is not ideal as it groups many non-evidence-based therapies that have little in common, such as iridology and homoeopathy, with more evidence-based complementary therapies such as acupuncture, nutritional medicine, meditation and some herbal medicines that have demonstrated efficacy. To date there is a growing body of research, including Cochrane reviews, to support the use of some complementary therapies (Box). The fact that many complementary therapies have not been tested and subjected to high-quality research does not necessarily mean they do not work.3 For other complementary therapies, there are mixed findings (negative trials balanced by positive trials, as seen in Cochrane reviews), so one needs to ask why the differences in results? Were there differences in dosage, the quality of the substance or method of the therapy tested? Would you argue with patients who find symptomatic relief for troublesome symptoms of menopause from herbs when they are intolerant to hormone replacement therapy, or relief from osteoarthritic pain from complementary medicines and acupuncture if non-steroidal anti-inflammatory medications are contraindicated because of a peptic ulcer? Demand for complementary therapies in Australia is actually coming from consumers. If they found the therapies unhelpful, why would they continue with them? A better term for complementary and alternative medicine is integrative medicine (IM), defined as: the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing.4 The aim of IM is to find common ground and respect for the patients who choose to use complementary therapies and to understand their use. General practitioners have been shown to be very interested in learning about complementary therapies, with one study finding that about 30% of Australian GPs identified themselves as practising IM and most (more than 80%) requesting more education and research in complementary therapies.5 It is important that doctors balance clinical decisions between the risks associated with any therapy, the evidence and the therapeutic clinical outcome (effectiveness) to inform patients appropriately.

Vicki Kotsirilos

To the Editor: I would have thought that, in 2011, any debate pitting fee-for-service against salary models of remuneration was both stale and futile. These debates, such as the one entered into by Peat1 and Travis,2 have been around since Bismarck introduced health insurance for workers in Germany. Surely we have come to realise, after more than a century of varied health insurance schemes and health services around the world, that it is a matter of horses for courses. A single payment system, whatever it is, will be inappropriate if applied universally in any country. There is a place for fee-for-service delivery, accompanied by insurance; there is a place for salaried service; and there is even (heresy for some!) a place for that form of salary called “capitation”. Each system has its merits and its faults, which have been discussed ad nauseam by health economists too numerous to refer to (two publications serve as examples3,4); there is nothing new under the sun. Debates such as this generalise the behaviour of a few miscreants to all salaried or fee-for-service practitioners. This is clearly unfair to both groups. Australia is fortunate that, back in the 1970s, our profession was able to stave off a Canadian-style, single-payer system. Our graduates can choose their method of remuneration — and, however they have been paid, we have distinguished colleagues who have achieved much and, regrettably, a few rogues. In the latter respect, we are no different from any other profession or trade. Why not abandon the ideologies underlying both sides of the debate, face these facts and have both systems in place, where each is appropriate, rather than trying to apply a single solution everywhere? I am reminded of the wisdom of Anthony Ashley Cooper, third Earl of Shaftesbury; “The most ingenious way of becoming foolish is by a System”.5

Peter C Arnold

When a patient’s wishes conflict with “best practice” The question of whether a person has the capacity to make decisions for him- or herself is one that has increasing relevance throughout clinical practice. It is especially relevant in palliative medicine, where practitioners often pride themselves on offering patient choice, particularly when it comes to selecting a venue for receiving care. Patients seen by palliative care services frequently have impaired cognition, often due to delirium.1 Such cognitive impairment places patients at risk of not understanding the ramifications of the decisions that they make. This is likely to become an increasing problem, as palliative care services care for an ageing population, with a significant comorbid burden, who are more at risk of diminished capacity due to the prevalence of illnesses such as dementia. The four ethical principles of health care — non-maleficence (doing no harm), beneficence (doing good), respect for autonomy, and justice2 — remain the foundation for ethical clinical practice. However, in the course of our duties, these principles may come into conflict. Deciding to act in the patient’s best interestsAn 85-year-old man with metastatic rectal cancer, who received domiciliary palliative care support following an “unsafe discharge” from an inpatient palliative care unit, was readmitted against his express wishes and subsequently died in hospital. This article explores the resulting sense of unease among the responsible clinicians, arising from our decision to act with beneficence and, arguably, humanity, in overriding a patient’s dying wishes. The patient was diagnosed with a stenosing rectal cancer, with lung and bone metastases, following presentation with advanced cachexia and symptomatic anaemia. The diagnosis came as a shock to the patient, who denied any previous major health issues and had infrequent contact with his family doctor. He had been a lifetime smoker of 60 pack years, and smoking was one of the few passions of his now-isolated existence. The patient was a worldly man, born in Malta, who had travelled extensively in his youth before settling in metropolitan Melbourne and raising a family. Unfortunately, his wife’s death in 1989 heralded a slow withdrawal from his friends and family. By the time of his presentation, he was living a squalid existence and reluctantly came to hospital at the insistence of his adult children. Options for palliative surgery, chemotherapy and radiotherapy were discussed and declined by the patient. A brief period at home resulted in a further presentation with symptomatic anaemia due to ongoing rectal blood loss and faecal incontinence. He was referred and admitted to inpatient hospice care, but again asked to be discharged almost immediately following blood transfusion. His insistence on discharge and refusal to discuss options to improve his physical care and safety at home led his palliative care providers to organise an assessment of his decision-making capacity by a neuropsychologist and consultation liaison psychiatry team. He was found to have decision-making capacity during these assessments, although it was noted that he was an avoidant historian and lacked some insight into the ramifications of his decisions. Plans were made to support the patient at home, as was his wish, with extra community services, community palliative care and family involvement. Unfortunately, the situation unravelled quickly at home. He refused many of the services that had been organised. He was reluctant to let his family help him more and they felt powerless to compel him. The community palliative care team attempted to act as mediator but made little progress. During this time, he became progressively frail until no personal care or safe use of medications was deemed possible. He had a fall at home 6 weeks after discharge, and an ambulance was called when he was found on the floor, unable to rise. Despite his frail condition, he remained both vocally and physically resistant to paramedic attempts to transfer him to hospital, and he finally sent them away. He was also left alone by his family, who felt both unable to provide care for their father at home and powerless to compel him to go to hospital. He remained on the floor for several hours, until urgent re-review by the community palliative care physician. By this time, the sun had set, and his home was shrouded in darkness and cold. He told the physician that he was lying on the floor only because he wished to do so and that he wished to remain where he was, although he was intermittently not orientated to place or person. Under Victorian legislation, he was assessed by the palliative care physician as being incompetent due to delirium3 and was transferred to hospital as an involuntary patient. This required police attendance and the ambulance service to transport him safely. His involuntary status was upheld for a further 48 hours by subsequent independent psychiatric review. No reversible cause of delirium was found on investigation when he was hospitalised, although his cognition did improve. He deteriorated over a course of weeks and died comfortably in hospital without requesting discharge again. Weighing up the ethical issuesThe decision that led to the patient’s removal from his home against his wishes, and his subsequent death in hospital, continues to rest uneasily on the team, given that clinical decisions are usually made not only for the benefit of the patient, but are also informed by respect for patient autonomy, non-maleficence and justice. In this instance, less invasive interventions, including enlisting family support, appointing a guardian, or urgent review by community-based psychiatric services were considered but judged to be inadequate or not possible within the time frame required. Subsequent peer-review discussions raised the probability of similar situations of isolated people living and dying without support in poor conditions. While this is likely true, there is a clear distinction between knowing the detail of a specific unfolding clinical scenario and not intervening, and theoretical events outside our direct knowledge. In the end, the contention returns to the dilemma that this patient had decided not to comply with what we would regard as “a good death”. In doing this, the consequences of his actions were detrimental not only to his comfort and condition but to the physical and psychological wellbeing of his family and carers, who were placed in the unenviable situation of having to provide inadequate care in an inappropriate environment. The clinical decision was made that drastic action was necessary, even to the point of forcing his compliance against his will. At the time of the decision to compel his removal from his home, it became less about his competence to make decisions, and more about our recognition of his humanity. To leave him to die alone, cold and probably in pain, in the midst of one of our well resourced cities, with medical and health care professionals in full awareness of his predicament, without acting, would have been a betrayal of our responsibility as his medical carers. We would have been inappropriately allowing respect for his autonomy to outweigh all other ethical considerations, despite his changed circumstances and limited realistic choice to remain as he was. While this is a pragmatic principlist approach, other ethical theories, such as virtue ethics, accord with our decision, which was guided by compassionate interest in the patient’s wellbeing. Was this an act of excessive medical paternalism, resulting in the denial of a person’s last wish to die at home? Undoubtedly there are those who would argue on both sides. However, even with the passage of time, we remain comforted that, after acknowledging the patient’s autonomy, our intervention was carried out in his best interests.

Brian H Le MPH, FRACP, FAChPM · Michael D Chapman MB BS

Forensic medical practitioners urgently require credentials and national guidelines Across Australia, health professionals from differing disciplines provide health care for victims of suspected assault, which may include collection of samples for forensic analysis. Although some have been trained to collect forensic samples, few hold professional qualifications in forensic medicine. The current lack of standards and credentialled training for collection of forensic samples (in a manner that minimises the risk of contamination) poses an unacceptable risk to individual doctors and nurses, the profession and to the criminal justice system. During the past decade, several high profile cases involving DNA contamination of evidence have been reported in the medical, legal and popular media. These cases highlight the costs in economic terms and in terms of human suffering, injustice and loss of confidence in the criminal justice system when errors occur because of DNA contamination. A swab, and materials collected onto a swab, for forensic DNA identification might become contaminated at any time from the collection stage to the final stage of DNA identification. The process of DNA identification is a lengthy one that involves a number of people operating at different locations, at different times. There are many opportunities for a swab, or the genetic material obtained from the swab, to become contaminated with another person’s DNA. It could be argued that there are two levels at which we should consider the need to avoid DNA contamination of swabs. First, there is a need to avoid contamination of a swab with DNA from a member of the public who might be inculpated in a crime. These individuals cannot easily be excluded as suspects. Second, there is a need to avoid contamination of a swab by DNA shed from a professional who has handled the swab or worked in the environment in which the swab was collected. By virtue of their employment, these individuals have a valid reason for their DNA being in the proximity of the swab. They might more easily be excluded as suspects, and most would readily volunteer to donate a reference sample to enable their DNA to be identified for the purpose of excluding them from further consideration in a criminal investigation. The compelling reason to avoid contaminating a swab with DNA from a medical professional or laboratory scientist is that the presence of any extraneous DNA affects the DNA scientists’ ability to interpret electropherograms. When mixed profiles are obtained, confidence in the scientists’ interpretation of the results is reduced. Some laboratories will not provide an interpretation of DNA results when a mixed profile of four or more individuals is obtained. What are the consequences when DNA contamination of a forensic swab occurs?Wrongful convictions of innocent individuals have occurred because of DNA misidentification and other DNA-related errors in Australia and other countries — an outcome regarded as intolerable in a civilised society. Examples of wrongful convictions that appear to have resulted from DNA contamination are shown in Box 1. Wrongful convictions have far-reaching consequences. In regions of the world where the death penalty exists, the outcome can be lethal. How has the legal system responded?As new case law increases everyone’s awareness of the phenomenon of secondary transfer of DNA, and techniques such as low-copy-number DNA amplification increase the risk of amplification of traces of contaminating DNA,6 defence lawyers are demonstrating greater willingness to challenge DNA evidence in court. In the United Kingdom, at Terence and David Reed’s unsuccessful appeal ([2009] EWCA Crim 2698) against their 2006 conviction for the murder of Peter Hoe, the defence counsel argued that shards of plastic said to be from a knife handle and found near the victim were contaminated with the brothers’ DNA. Prosecutors argued that the DNA connected the brothers to the murder weapon. (The appeal was dismissed as there was sufficient evidence for conviction beyond the doubts over the DNA evidence.) In 2008, the UK police conducted a review of the use of low-copy-number DNA amplification techniques in light of the increased risk of erroneous interpretation of DNA identification results.7 In Australia, Canberra man Steven Hillier was acquitted of his ex-wife’s murder at a retrial in April 2010 (R v Hillier [2010] ACTSC 33). He had been convicted of murder in 2004. The conviction was quashed in 2006, and the Australian Capital Territory Director of Public Prosecutions subsequently challenged the appeal and sought a retrial. Hillier’s counsel successfully argued that a possibility existed that his DNA had been secondarily transferred onto his estranged wife’s clothing and doona.2 Prominent Australian lawyers8-10 have provided advice for barristers and judges on matters to consider during cross-examination and guidelines for determining admissibility of DNA evidence in Australian courts. How have forensic scientists responded?Quality assurance activities within laboratories minimise the risk of DNA contamination. National standards exist (National Association of Testing Authorities [NATA]) and DNA laboratory scientists must be credentialled. Most scientists remain alert to the possibility of DNA contamination and openly acknowledge when contamination within a laboratory occurs. On rare occasions, scientists have denied responsibility for contamination or error. For example, the Victoria Police Forensic Services Centre (VPFSC) scientist involved in the contamination of a murdered child’s bib with a rape victim’s DNA suggested that an adventitious DNA match, not laboratory error, was responsible (inquest into the death of Jaidyn Leskie, Coroner Graeme Johnstone, July 2006). At the trial of a man wrongfully convicted of rape, the testimony of a VPFSC scientist suggests that the scientist had limited understanding of the potential for contamination at a site other than the VPFSC laboratory.5 How have clinical forensic medical practitioners responded?Justice Frank Vincent’s conclusions5 about environmental contamination of the swab that led to the wrongful conviction of Farah Jama (Box 1) has been a powerful influence for change in the practice of clinical forensic medicine in relation to suspected sexual assault in Australia. There are a number of areas of improvement driven by the Victorian Institute of Forensic Medicine (VIFM), which has developed, in consultation with others, interim practice arrangements that act as guidelines for the collection of samples for forensic analysis.11 Key areas for improvement include the equipment and procedures used to collect samples and the environment in which samples are collected. Swabs and slides within sexual assault kits should be as free of contaminating DNA as possible. Irradiation of swabs has proven to be an inadequate process for denaturing DNA. An unknown female suspect, linked to several unsolved serious crimes in Germany and Austria between 1993 and 2009, was eventually shown to be a worker involved with the manufacture of the swabs.12 Forensic-supply companies continue to develop and supply swabs, slides and kits that are increasingly easy to use and are designed to minimise the risk that DNA might inadvertently be transferred onto a swab via a swab sheath or equipment used during the procedure. Disposable single-use instruments such as pencils, pens, speculae, forceps and scissors are recommended. Documents for recording samples collected and envelopes used for transporting samples to a laboratory are treated to denature DNA. Currently, there is significant variation between regions in Australia in relation to the design and suitability for purpose of some of the facilities where forensic samples are collected. Some facilities are clearly not “fit for purpose”. The structure of the facility should enable restricted access to a limited number of known individuals, adequate and documented cleaning to DNA elimination standards, furniture and surfaces that are maintained in a DNA-clean state, storage of equipment and supplies that prevents reuse or replacement of supplies that might have been contaminated and appropriate disposal of used supplies. Furniture and equipment within the examining room should be kept to a minimum and all surfaces should be able to tolerate cleaning with bleach. There should be a flow of patients from the entrance area into the examination room then shower facility. Suspects should not be examined in the area where victims are examined. These recommendations were set out in the VIFM submission to the Vincent inquiry. Gloves must be worn and changed regularly, particularly during the interval between collecting samples from different sites and when labelling and packaging samples. In some overseas jurisdictions, medical practitioners shower and change clothing between cases. No agreement has yet been reached about the need for forensic practitioners to wear gowns, masks or hairnets. The requirement to use gowns and masks is likely to meet with opposition from paediatric forensic practitioners who are likely to express concern about the negative emotional impact that this apparel might have on child victims. Cleaning procedures need to be at a standard that will denature DNA. Hypochlorite bleach has been demonstrated in DNA laboratories to denature DNA and is used for routine cleaning of floors and walls, as well as for cleaning work surfaces. Techniques used to collect samples must ensure that material from one site is not inadvertently transferred to another site. Tamper-proof seals are used in some jurisdictions. How have the regulators responded?Following the release of the Vincent report, the Victorian Department of Justice sought to rectify problems within the Victorian centres where sexual assault victims are examined. To date, changes to cleaning practices and modifications to a small number of units have occurred, primarily as a direct request to health services, where most facilities are located. Although it was a clear recommendation in the Vincent report, no reduction in the number of sites where sexual assault victims are examined has occurred. In July 2010, the UK Home Office published the second draft of the Codes of practice and conduct for forensic science providers and practitioners in the criminal justice system.13 The document was informed by a critical review of low-copy-number DNA amplification techniques and the use of this technology within courts. This comprehensive discussion document is regarded to be the first step in a process aimed at achieving better governance and higher standards throughout the sector. In Australia and New Zealand, standards are being developed in line with the strategy for 2009–2012 developed by the Australia New Zealand Policing Advisory Agency National Institute of Forensic Science.14 Forensic science centres are assessed according to explicit criteria that test quality and the reliability of results in order to achieve NATA accreditation. Within government in Australia, particularly Departments of Justice, there is an increasing awareness of the need for standards, monitoring and governance of those standards and the need for caution in relation to the use of DNA evidence in courts. The Public Defenders Office in New South Wales offered succinct advice to the legal profession in relation to the use of DNA evidence in court.15,16 In May 2011, the High Court, the highest court of appeal in Australia, dismissed convicted Canberra rapist Benjamin Forbes’ application for an appeal on the basis that he had been convicted on DNA evidence alone.17 This judgement indicates confidence in DNA technology and its use in the Australian criminal justice system. At present, there is no governing or regulatory body for clinical forensic medical practice. Doctors are accountable to their employer and to the Medical Board of Australia. Nurses are likewise accountable to their employer and the Nursing and Midwifery Board of Australia. Most forensic practitioners belong to professional colleges, such as the Royal Australasian College of Physicians, the Royal Australasian College of General Practitioners, and the Australasian College of Legal Medicine. There is no overarching collegiate body to certify successful completion of forensic medical training. The intercollegiate working group that developed guidelines for genital examinations of girls and young women did not provide explicit advice about the collection of samples for forensic analysis when sexual assault is suspected.18 The Australasian Association of Forensic Physicians has demonstrated an interest in developing standards and guidelines for collection of forensic samples, but this work is in its infancy. Where to now?It is unlikely that the medical profession will ever be able to exclude the possibility that a swab has become contaminated with DNA. The task before us is to minimise the risk, and to be seen to be minimising the risk, of DNA contamination. Forensic medical practitioners urgently require national guidelines and standards to guide and govern forensic medical practice (Box 2). We also need: a national collegiate body to certify that practitioners have met training requirements and have demonstrated required competencies; a national group to negotiate across state boundaries with employers and governments to ensure that we are enabled and supported to provide a high standard of forensic medical care and to maintain an effective workforce; police and forensic scientists to share with us the desire to safeguard the integrity of forensic samples and the results obtained from their analysis; a well informed public that has realistic expectations of forensic services; a legal system that challenges, questions and pushes us to consider our failings; and a health system that supports and encourages us to continue to improve. 1 DNA contamination resulting in wrongful identification of suspect Country Year Case Contamination site Criminal charge Consequences for wrongly accused New Zealand 1998 Profile N1 Laboratory Murder × 2 Financial records seized; intense police investigation; no conviction Canada 2001 Gregory Turner2 Laboratory Murder 27 months’ jail Australia 2004 Steven Hillier3 Before collection Murder Conviction; successful appeal Australia 2008 Russell Gesah4 Laboratory cold-case match Murder × 2 Charges dropped Australia 2008 Farah Jama5 Collection Rape 15 months’ jail 2 A multicomponent plan for national clinical practice standards regarding collection of forensic samples for DNA identification Task Responsible group Strategy Authorising body Determine clinical practice guidelines Forensic physicians, paediatricians and nurses Working group evaluation of evidence; consensus; recommendations Currently none; potentially AAFP Develop national standards for handling of forensic samples ANZPAA National Institute of Forensic Science Multidisciplinary working group evaluation of evidence; consensus ANZPAA National Institute of Forensic Science Determine professional training requirements College or university department of forensic medicine Curriculum development and implementation Currently none; potentially VIFM and/or Monash University Certification of competency College or university department of forensic medicine Successful completion of training program; demonstrated competency Currently none; potentially VIFM and/or Monash University or alternative Governance of professional practice clinical forensic medicine Employing organisations Organisational standards; monitoring practice Multiple, such as state centres providing clinical forensic medicine services Monitor and enforce clinical forensic medicine standards across Australia National body A new national college of forensic medicine Currently none; potentially RACP, Australasian College of Legal Medicine or new national college of forensic medicine AAFP = Australasian Association of Forensic Physicians. ANZPAA = Australia New Zealand Policing Advisory Agency. RACP = Royal Australasian College of Physicians. VIFM = Victorian Institute of Forensic Medicine.

J Anne S Smith MB BS, FRACP

Understanding and responding to pharmaceutical promotion. Mintzes B, Mangin D, Hayes L (editors). Amsterdam: Health Action International Global and World Health Organization, 2010 (online, free). THIS BOOK is a collaborative project by Health Action International Global — an organisation based in Amsterdam and committed to promoting the rational use of medicines — and to increasing access to essential medicines, and the World Health Organization. The editors (Barbara Mintzes, Assistant Professor in the Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Canada; Dee Mangin, Director of the Primary Care Research Unit at the University of Otago in New Zealand; and freelance scientific editor Lisa Waller-Hayes) all have a background in writing about pharmaceutical promotion. Information on the influence of promotion on medicine use is often lacking. This book is an attempt to remedy this by bringing together studies on various aspects of promotion, including medical journal advertisements, sales representatives, conference sponsorship, physician opinion leaders and direct consumer advertising. There are contributions from many countries including Australia, a world leader in promoting the rational use of medicines. Health professionals are the target of aggressive and sustained promotional pressure by the pharmaceutical industry but are often not sufficiently educated about understanding and responding to such promotion. This book is intended to fill this gap, and it does so admirably. It also teaches readers the importance of using unbiased sources of information. It has been designed as part of a student module on pharmaceutical promotion, but the easy-to-read style incorporating pictures, graphs and well designed boxes and logical organisation ensures that it can be read on its own. I am currently using it to conduct small-group activity-based teaching sessions for second-year students and consider it superior to other initiatives I have used. I especially liked the chapters dealing with pharmaceutical sales representatives and how to avoid the “pharmaceutical industry tango”. The references at the end of each chapter are comprehensive, and numerous web links are provided. However, it lacks an index. The book can be freely downloaded from the Health Action International website (www.haiweb.org) and is sure to be of interest to all health professionals.

P Ravi Shankar

Objective: To describe the frequency, characteristics, and outcomes of medicolegal disputes over informed consent.Design and setting: Retrospective review and analysis of negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Office of the Health Services Commissioner of Victoria that alleged failures in the informed consent process and were adjudicated between 1 January 2002 and 31 December 2008.Main outcome measures: Case frequency (by medical specialty), type of allegation, type of treatment.Results: A total of 481 cases alleged deficiencies in the informed consent process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons experienced dispute rates that were more than twice those of any other specialty or subspecialty group. 92% of cases (442/481) involved surgical procedures and 16% (77/481) involved cosmetic procedures. The primary allegation in 71% of cases was that the clinician failed to mention or properly explain risks of complications. Five treatment types — procedures on reproductive organs (12% of cases), procedures on facial features excluding eyes (12%), prescription medications (8%), eye surgery (7%) and breast surgery (7%) — accounted for 46% of all cases.Conclusions: The typical dispute over informed consent involves an operation, often cosmetic, and allegations that a particular complication was not properly disclosed. With Australian courts now looking to patient preferences in setting legal standards of care for risk disclosure, medicolegal disputes provide valuable insights for targeting both quality improvement efforts and risk management activities.

Andrew J Gogos MB BS · Richard B Clark DHSc · Marie M Bismark MB ChB, LLB · Russell L Gruen MB BS, PhD · David M Studdert LLB, ScD, MPH

Current practice in forensic medicine. John Gall, Jason Payne-James, editors. Oxford: Wiley-Blackwell, 2011 (327 pp, $120.00). ISBN 9780470744871. Recent times have seen a growing interest in forensic medicine among members of the public, although not necessarily among medical practitioners. An involvement in forensic medicine requires more than just a passing interest, and this publication examines aspects of the discipline that apply to both the living and the dead. The editors are both specialists in the field. John Gall is a forensic physician with the Victorian Paediatric Forensic Medical Service in Melbourne and Jason Payne-James is a forensic physician based in the United Kingdom and is editor-in-chief of the Journal of Forensic & Legal Medicine. In this book, they cover many areas of clinical forensic medicine and also touch on aviation disasters, but not toxicology. At least once in their careers doctors are likely to be called upon to give evidence in court. This book includes excellent instructions on how to prepare reports for medicolegal cases. For this alone it is a worthwhile reference text for a medical practitioner. For those who practise forensic medicine relating to the living, as in the case of sexual assault, this book should be required reading — it covers essential areas, such as how to assess, describe and interpret injuries, and how to collect specimens for biological or toxicological purposes. The book goes into some detail about the proper classification and description of wounds. However, it cautions against being too robust in attributing causes for wounds in medicolegal cases unless practitioners have the experience to back their judgement. The editors of this text have compiled an authoritative review of the topic, with contributions from leading international experts in the field. They provide enough detail about the forensic sciences to give practitioners some insight into these areas without attempting to turn them into experts.

Tony F Moynham

Asbestos manufacturers have never warned homeowners of the risks of renovation On the Australian mainland, there have only been two manufacturers of asbestos cement products used in home construction and renovation: James Hardie and Wunderlich, a subsidiary of CSR. Asbestos products were manufactured from the 1920s up until 1984, when Hardies ceased using asbestos in their building products (Wunderlich had been acquired by James Hardie in June 1977). In 1978, James Hardie boasted that their products were in most homes in Australia. The range of asbestos cement building products (once widely known as “fibro”) that were made in Australia include flat and striated walls, eaves and panels; corrugated panels (used primarily for fencing and roofing); flat sheets covered with crushed or artificial brick; flues for gas heaters; thick sheets for flooring or as tile underlay; and sheets covered with coloured or patterned vinyl used in bathrooms and other wet areas. As the country with the highest rate of mesothelioma in the world,1 Australia has lived through two “waves” of asbestos-related disease — the first from the mining of asbestos and the manufacturing of asbestos products, and the second from asbestos use in industry. In this issue of the Journal, Olsen and colleagues clearly reveal that the “third wave” of the asbestos disease epidemic in Australia comprises non-industrial users of asbestos products,2 and a significant contributor to this cohort are the non-professionals who cut and fixed asbestos cement products in home renovation or maintenance and other do-it-yourself activities, or who demolished asbestos cement products during renovations. Family members present during these activities are also part of this cohort. The most alarming feature of this third wave is its potential to continue to grow for many years to come. Neither James Hardie nor CSR have ever taken any steps to systematically warn people who have asbestos products in their homes — including products that contain the highly dangerous Wittenoom blue asbestos used by both manufacturers — of the potential for fatal consequences in 20–40 years if they demolish those products today. We contend that the manufacturers have a legal duty of care to these people (Box). Claims for compensation and damages for people with asbestos disease because a manufacturer breached a duty of care have been pursued for over 25 years. Many of the legal precedents derived from the early claims against CSR by workers at the Wittenoom mine, and against James Hardie by its employees, have been applied in these product-user claims. Most mesothelioma claims are now successfully resolved out of court without a trial. When this does not occur, the claims primarily involve one or two instances of construction or demolition. The major issues of controversy are (i) the claimant’s ability to prove that the manufacturer could, and should, have taken steps that would (before the time of exposure) have drawn the risk to the user’s attention; and (ii) proving, more probably than not, that the exposure in such limited circumstances was a cause of, or made a contribution to, the mesothelioma manifesting many years later. Almost from the first acceptance in 1960 of mesothelioma as a cancer uniquely related to asbestos, it has been recognised that this cancer could be caused by very low exposures.1 The argument is sometimes put that mesothelioma can occur without asbestos exposure at all, or can be caused by exposure to the very low “background” levels present in most urban environments and some non-urban environments. In reality, in an individual mesothelioma case, all cumulative asbestos exposure — “background”, unrecalled or unrecognised exposure, and specifically recalled exposure — must, on biological mechanistic grounds, be considered to be playing a part in causation.3 With acceptable evidence of specific exposure, no matter how slight, a claimant should succeed, as such exposure would add more than a minimal dose to any background exposure. No threshold for asbestos causation of mesothelioma has been demonstrated.4,5 The article by Olsen et al documents an upward trend in mesothelioma cases in home renovators.2 This trend was appearing in reports of the Australian Mesothelioma Register operated by the National Occupational Health and Safety Commission (NOHSC) up to 2001.6 However, until now, it has not been possible to statistically confirm the trend, because of incomplete coverage of the Register from 2001 onwards. This was a consequence of the drastic cutbacks in the scientific capacity of the NOHSC, and over-stringent privacy legislation preventing comparisons with state cancer registries and the collecting of data on exposure history. We hope that the newly reconstituted Australian Mesothelioma Registry collaboration, administered by the New South Wales Cancer Council, and covering all mesothelioma cases in Australia diagnosed after 1 July 2010, will enable continued monitoring across the whole of Australia of this tragic third wave of the mesothelioma epidemic. While the Western Australian Mesothelioma Register study2 and the new Australia-wide initiative will be of small comfort to those who already have or will develop mesothelioma, these initiatives may assist in maintaining an awareness of the risks of exposure during home maintenance, and of other possibly unrecognised exposures, and hasten regulatory and control activities both nationally and internationally. All asbestos use was banned in Australia in 2003, and it is also banned in 56 other countries. (There are a few very limited, technical exceptions to the ban; eg, for military use where no substitute is available.) However, there are a few countries where it is still being used in building products (eg, India, Thailand, Russia, China and Indonesia). Data from Australian registers serve a very important purpose in sending a global warning of the deadly nature of this substance and the need for a complete global ban on any future use.7 The legal duty of care A manufacturer of an asbestos cement building product owes a legal duty of care to users of the product. The duty obliges the manufacturer to take reasonable care that a person is not at risk of suffering a foreseeable injury from using the product. A foreseeable injury is one of which the manufacturer, knowing the way the product is used, and up to date with the literature concerning injury from use of such a product and any potentially dangerous components or ingredients of that product, is, or ought to be, aware. As asbestos cement building products were used in homes, people who used the new product in the construction or renovation of their homes were owed the duty, as will the people who later demolish and remove the product, as both uses should be contemplated by the product manufacturer. The steps required of the manufacturer to discharge this duty — ceasing manufacture, warning, and recall — will be proportionate to the likelihood, and the potential seriousness, of the injury. If a person is injured because of a breach of the duty of care, they are entitled to compensation commensurate with the loss and harm suffered.

John R C Gordon BJuris, LLB · James Leigh MD, FAFOEM, FAFPHM

To the Editor: Kelly and colleagues are to be applauded for their call for a no-fault compensation scheme.1 If only such a scheme had been available in the early 1960s, when my sister (who has approved this letter) developed encephalitis secondary to a vaccinia inoculation. Then she, and our parents, would have been spared decades of struggling with the sequelae of this acquired brain injury in a “fault averse” system. The few who have been seriously harmed should not be forgotten by the millions who have benefited.

Mark R Nelson

Doctors are accustomed to taking on clinically related tasks — including management, organisational redesign, quality improvement and teaching — despite a lack of formal training, funding or protected time. There is a great tradition in medicine of clinical teaching while providing patient care. Although doctors are encouraged to base practice on evidence, their teaching methods are often simply based on the methods by which they themselves were taught. There is considerable pressure on general practitioners to provide more medical student education (MJA 2007; 187: 124-128) and to take on more general practice trainees (MJA 2009; 191: 102-104). Renewed pressure to place interns and postgraduate year (PGY) 1 and 2 trainees in general practices adds to this load. Currently, academic departments of general practice are small and under-equipped to build teaching capacity in general practice. The high workload of general practice makes it hard to “squeeze teaching in”. The GP, who often works alone, lacks the advantage of the hierarchical structure of the teaching hospital, where medical students, interns, PGY1 and 2 trainees, junior and senior registrars and consultants are all available, and appropriately delegated teaching and supervision generally occur. GP supervisors also lack the ability to assess trainees’ progress in the graded manner that is possible in some other specialties. In procedural specialties, trainees’ progress toward independent practice is partly assessed by their performance of a specified number of procedures. In contrast, GPs deal with a seemingly infinite variety of patient presentations and, without direct supervision, it is very hard for GP supervisors to be sure that trainees will be able to cope on their own with the next patient who comes through the door. The Journal recently published on future GP-training models, including the proposal to vertically integrate vocational training with undergraduate education (MJA 2011; 194: S97-S100). In this issue, some fundamental concerns are raised. Sturman discusses the tension GPs feel about allowing medical students to play major roles in the care of patients whom the GPs will bill (page 231). There is a broader ethical issue too — the possibility that the patient’s needs may be marginalised in the teaching context. Wearne lists some problems with the current model of GP training (page 224). Of special note is the risk to patient safety when GP supervisors are interrupted in their own work with patients. Interruptions disrupt cognition (memory of the primary task begins to decay when a new task is taken on) and thus may contribute to medical errors (Qual Saf Health Care 2010; 19: 304-312). Our present system is unable to cope with the rapid increase in demand for practice-based medical education. Wearne suggests a new and expensive supervisory model for general practice training but, as she observes, this cost merely “reflects ... the true cost of quality supervision in general practice”. Both training and time are needed and will require funding. Creative approaches to solving this problem are clearly called for. Ultimately, it is most important that the placement experience is a positive one for patients, GPs and students. For students, it may otherwise mean they will not choose a career in general practice.

Annette Katelaris · Christine Jorm

To the Editor: A recent interview-based study of the experience of 60 general practitioner teachers in Brisbane1 found that private, fee-paying patients were perceived by a number of participants as being less accepting of active student involvement in teaching consultations than those in bulk-billing practices. Some examples of a perceived relationship between patient payment and patient attitudes — and perhaps obligations (although no participants explicitly related non-payment for health care with an increased patient obligation to assist with doctor training) — in relation to teaching are provided in the Box. Arguably, there is an implication that private fee-paying patients may be more inclined to be litigious in the event of an adverse outcome associated with teaching, and that these patients may choose to obtain their general practice care elsewhere if they are imposed on. These perceptions are likely to influence GPs’ decisions to seek patient consent for active student learning. The literature does not explore whether fee-paying GP patients have more or less positive views about teaching than those who are bulk billed or treated in public hospitals, although a United States emergency department study2 found no significant difference between patient income and patient consent rates. However, an “uncomfortable sense of obligation” to, and boundary blurring with, patients who assist with teaching has been reported by GPs in the United Kingdom,3 and it is interesting to hypothesise that this sense may be sharpened by patient payment, and relieved somewhat by reducing fees. In relation to any perceived obligation for (bulk-billed) patients to assist with teaching, for the “greater good” of securing ongoing health care for society, Waterbury4 argues against sacrificing patient autonomy and refutes several arguments for a patient’s obligation to assist. He also argues powerfully against placing any teaching burden disproportionately on community members who are both ill and impoverished. The extent of the “teaching burden” on patients is difficult to assess in the absence of evidence about patient health outcomes in relation to teaching, but both patients5 and doctors1 report that student presence in consultations may be inhibiting. An element of “marginalisation of the patient in the (teaching) doctor’s duties”4 is arguably inevitable. Further Australian general practice research into private patient attitudes might challenge these GP perceptions. If many of these patients are in fact willing for greater involvement than that anticipated by the GP, both patients and students may be frustrated by the loss of teaching opportunities. Quotes: patient payment and teaching “It’s not my job to teach Pap smears or procedures on private patients. That’s the role of the public health system.” “Rural practices may be able to offer students a different experience operating almost as a practice nurse, but patient expectations are different in a professional practice with patients paying top dollar.” “I’ll often bulk bill a patient if a student has taken a major role in the consultation.” “The majority of my patients accept students; I have a high-end professional practice, mostly lawyers, but they make it clear they don’t want students taking histories or doing examinations — they want me to do it.” “It’s much easier to give students a greater role in a bulk-billing practice with a high turnover — the patients don’t really have a choice — but I can’t offer this.”

Nancy J Sturman

A medical-legal companion to the AMA Guides Fifth. Guides to the evaluation of permanent impairment. Kenneth Kingdon, JD, LLM. California: American Medical Association, 2011 (xxi + 410 pp, $120.00). ISBN 9781603591980. This publication by the American Medical Association (AMA) provides a detailed review of the AMA guides to the evaluation of permanent impairment, 5th ed. (AMA5). These guides, which provide a systematic and highly descriptive methodology for rating impairment arising from illness or injury, have been adopted not only in many American states and other countries but also in many Australian compensation jurisdictions as a standard reference upon which state-specific guidelines have been designed. Medical practitioners are increasingly being requested to evaluate impairment for lawyers and insurance claims managers. This companion to the AMA guides is helpful to doctors as well as lawyers and claims managers in bridging the gap between medicine and the law. The text analyses each chapter of AMA5, and includes an overview of the salient points regarding the impairment-rating procedure. This is particularly useful as it picks the eyes out of the expansive AMA5 and highlights areas that need to be understood to ensure correct impairment-evaluating methodology. Included in the text are comments regarding contentious or ambiguous rating issues, with explanations and definitions of medical terms that make the information more comprehensible to the non-medical reader. Each chapter has numerous worked examples to help the reader understand the points being made and the correct application of methodology. This is followed by review questions that allow the reader to test whether he or she has completely understood the impairment evaluation principles being discussed. This book accurately and authoritatively interprets impairment-evaluating methodology (strictly according to AMA5) and addresses various issues in interpretation that are relevant to any user of AMA5 in Australia. For medical assessors who are already trained in using AMA5 (as modified regionally in Australia), this publication provides a useful review of definitions, procedures and methodology. For non-medical readers (eg, lawyers and claims managers), it is a relatively inexpensive and helpful tool for clarifying the sometimes overwhelming content of AMA5.

Dwight K Dowda

For all of us who have tried and failed to help obese patients lose weight, the viewpoint by Proietto in this issue of the Journal offers some explanation for our defeat. Overeating and low activity levels cause everyone to gain weight. However, the propensity to become obese is genetically predisposed, and expression of the genes involved may well be permanently up-regulated by early experience of overeating. When weight is lost, there are hormonal changes that favour weight regain. These factors make it very difficult for obese people to achieve significant and sustained weight loss with diet, exercise, medication or food replacement programs. For this reason (and because studies of bariatric surgery have repeatedly shown significant long-term weight loss), Proietto calls for bariatric surgery to be made more widely available in public hospitals. This view has widespread support from many sectors of the medical profession. Bariatric surgery has generally only been available at high financial cost to patients, and, indeed, a lucrative private bariatric surgery industry exists. However, in Australia, as in other developed countries, highly processed food with low nutritional value and high caloric density is often cheaper and easier to prepare than more nutritious food, so obesity is more commonly a disease of the poor, who would need public funding to make bariatric surgery accessible. Greater availability of gastric banding may well have some impact on the burden of chronic disease in our society. Proietto reminds us that significant weight loss is accompanied by a degree of reversibility of conditions that are common in obese people, such as diabetes, metabolic syndrome, obstructive sleep apnoea and infertility. Nonetheless, as a public health measure and in the long term, bariatric surgery is unlikely to be our most effective approach to the obesity epidemic. It is time to look seriously at primary prevention, and Proietto’s discussion of epigenetics explains why this must start with maternal diet in pregnancy and infant feeding. We have waited far too long for legislated public health measures that will improve the food intake of Australians. Clinical medicine doesn’t happen in a vacuum. Various legislative measures support the medical message to stop smoking and moderate alcohol intake. We need to be equally aggressive towards the obesity epidemic. This, of course, includes strategies to encourage regular daily exercise. There is good evidence that self-regulation by the food industry has been ineffective. In a previous issue of the Journal, Hebden et al (Med J Aust 2011;195: 20-24) reported that junk food advertising during children’s peak hours of television viewing actually increased after self-regulation was introduced. We have previously debated the problems inherent in the National Heart Foundation Tick program (Stanton, Med J Aust 2011; 194: 284-285). It is important for food labelling programs to be transparent and universal. Many experts argue that sugar and fats are far too cheap, and should be taxed. The government is already fighting the alcohol and tobacco industries. It is time to take on the processed food lobby as well.

Annette G Katelaris

To the Editor: Comparing Australian medical school policies regarding conflict of interest (COI) to their United States counterparts, Mason and Tattersall1 conclude that within Australia there is “a need for improved self-regulation”. The authors are applauded for highlighting this important aspect of medical education and organisational practice; however, the comparisons made fail to acknowledge a number of contextual differences that undermine the conclusions drawn. First, significant cultural differences exist between Australia and the US with respect to historical market practices and commercial sponsorship within the tertiary education sector.2 The persistent failure of self-regulation in the US recently culminated in the passing of the Physicians Payment Sunshine Provision, which now mandates transparent disclosure of all (> $10) payments, gifts and sponsorships, and imposes significant penalties for failure to report.3 Arguably, it is this changing legislative landscape that has encouraged US medical schools to develop more robust COI policies, rather than a proactive commitment to manage COI. Second, unlike in the US, most of Australia’s 20 medical schools sit within publicly funded universities, where central policy regulation of COI prevails. Mason and Tattersall’s1 suggestion that each school have its own COI policy without reference to the overarching university’s COI policy is flawed, particularly in a wider academic environment where industry sponsorship of education and commercialisation in research are increasingly encouraged as a desirable strategy to supplement falling levels of Commonwealth resourcing. Third, despite the lack of policies in Australian medical schools, positive performances with respect to COI in the curriculum were noted,1 demonstrating that lack of policy does not necessarily hinder appropriate curriculum content. Finally, on becoming doctors, medical students are bound by their professional codes of practice, codes of ethics, organisational policies and state and federal legislation, which outline the obligation to act within the recognised standards of the profession.4 While medical schools have a significant role to play in preparing future doctors to effectively recognise bias and appropriately manage COI,5 their ability to enforce more rigorous standards than those that apply within the professional community at large is doubtful. The adequacy of current professional codes is a matter for further debate. Medical schools exist within the wider context of the university, the community and the overarching political and legal landscape that governs their resourcing and practices. These factors must be taken into account when judging the actions of medical schools. To present Australian medical schools as lacking1 on the basis of a decontextualised comparison with US schools may be overly simplistic.

Eleanor Milligan · Allan W Cripps