Ethics

Cracking the Code The Human Genome Project in the Dock Michael Kirby From a scientific viewpoint, the Human Genome Project is actually not in the dock, nor even under reasonable suspicion of wrongdoing. Overwhelmingly, it will prove of benefit to humanity. However, from legal, ethical and other societal points of view, there are many problems already being considered by bioethicists, philosophers, religious experts, lawyers and others in dialogue with scientists. MJA 2000; 173: 599-600 Manageable problems - More difficult problems - The big ones - Public debate - References - Authors' details - - More articles on Genetics I have just returned from meetings of the Ethics Committee of the Human Genome Organisation (HUGO) -- established by leading genome scientists in 1989 to promote international collaboration in the Human Genome Project (HGP)1 -- in London, and of the International Bioethics Committee (IBC) of the United Nations Educational, Scientific and Cultural Organisation (UNESCO) in Quito, Ecuador. At international meetings such as these, in national bodies, in lawmaking institutions and universities, a lot of minds are identifying the chief problems of the HGP. Some of these problems are comparatively straightforward. Others are complex and fundamental. Manageable problems Privacy and confidentiality: Patient confidentiality has long been fundamental to the healthcare professions, having its roots in rules even older than the Hippocratic Oath. However, when a disorder is the result of a genetic characteristic, is the "patient" solely the individual, or does the entire family have rights? Are there circumstances in which family members should be entitled, by law, to override an individual's desire for privacy to obtain information relevant to genetic conditions that may also affect them? Should a patient have a right not to know the genetic determinants of likely future medical problems? How do we reconcile the rights of the individual with the fact that genetic data may be very important for others, and how do we prevent discrimination based on such data? Third-party interests: The previous questions lead naturally to the legal rights of third parties. Should an employer have a right to require employees to submit to genetic testing to establish their likely future health status? If a blanket right is unacceptable, are there some kinds of employment for which such a right should exist by law? Are there other, less intrusive means for such employers to monitor relevant health conditions? And what of insurance companies, which traditionally have had to share largely unknown risks in sickness and life insurance with their clients? Now, would the use of newly available, near-perfect genetic tests not shift the scales unfairly to the insurers' advantage? Would it be feasible to deny the use of such tests, given that insurers can already require prospective clients to undergo other tests that may suggest genetic predispositions? Intellectual property: One of the key issues in genetic research is the desirability of permitting patenting of genetic sequences on the basis of their future therapeutic utility.2,3 In every country, legal rights in such research will depend on laws such as local intellectual property law, governing patents and copyrights. Such laws are usually influenced by international treaties. Opinions differ about patent protection for plant varieties and in respect of the genomes of humans and animals. One view is that the human genome is part of the common heritage of humanity -- like the open sea, outer space and the environment. Others argue that it belongs to God, and should not be subject to the profit motives of multinationals or the pretensions of passing generations. On the other hand, pharmaceutical corporations point to the costs of developing successful drugs and therapies. Such companies may not invest the large funds necessary to maximise the practical use of scientific discoveries if they are not given the advantage of temporary monopolies. All of the above questions can ultimately be answered in the traditional way. Parliaments can set up committees or refer questions to law-reform or similar bodies. Nations can consult with each other and answers will eventually be found. But beyond these problems are others which are more vexing. More difficult problems Criminal responsibility: The discovery of a genetic basis for many disorders raises the possibility of identifying genes associated with various forms of antisocial behaviour. Criminal law is normally based on the premise that it is necessary for the State to prove both that accused people acted as they did and that they had the necessary intention (mens rea) to do so. But what are the implications of discovering that an individual's actions may be caused, or profoundly influenced, by a pre-existing genetic characteristic?4 The law accommodates some genetic impairments in determining criminal responsibility. Proved and relevant impairment may be taken into account in sentencing, but will genetic discoveries present an even more profound challenge for our whole notion of criminal liability? Is it back to the drawing boards for assumptions about crime being the product of deliberate wrong-doing? Benefit-sharing: Much genetic research will be devoted to identifying the genetic characteristics that confer resistance or susceptibility to life-threatening or disabling conditions. Should a donor of genetic material that yields data useful for the development of drugs or therapies receive some share of the huge profits that may result? Or should the donation be put down to philanthropy for the benefit of humanity? Should something be paid to the donor's village, tribe or country if a sample proves valuable? How does the international community ensure that immediate research on the human genome focuses on problems like combating malaria and river blindness and not just wrinkles in the ageing rich? How can we promote distributive justice for humanity rather than selfish use of the HGP overwhelmingly for the illnesses of patients in the wealthy countries? The big ones As if the foregoing list did not present us with enough questions to cause headaches, there are two really big dilemmas presented by the advance of the HGP. Decision-making: It is important to realise that not to do anything, legally, about the HGP is to make a decision. It is to accept that science and technology may take our societies where they will. That may be a good thing. For example, there has been a great rush to legislate and regulate reproductive cloning of the human species based on intuitive objections to the very idea. Later thoughts have suggested that we may need to give the subject more consideration before we rush into total prohibition.5 In the past, there were similar responses, at first, to AIH (artificial insemination husband), AID (artificial insemination donor), IVF (in-vitro fertilisation) and reproductive cloning. Yet, apart from a few legislators, most politicians avoid the complex issues of the genome. The international community has the IBC and HUGO has its ethics committee. However, effective, well-resourced national and international advisory bodies are thin on the ground. Getting agreement at a national level is hard enough given the competing perspectives. Securing international agreement is almost impossible. Yet, without international rules, in genomic regulation, as with nuclear fission and Internet regulation, national laws can never be fully effective. Faced with local legal prohibition, scientists may simply move their laboratories to a less troublesome country. Genetic alteration: Fundamental questions are also raised by the long term effects of genetic alteration of the human species. For example, we have identified the genes that express themselves in Huntington's disease. Should the law permit, encourage or forbid the elimination of a fetus which manifests these genes? Elimination of a fetus with likely intellectual impairment is now not uncommon, but how far do we go down that track in the quest for the "perfect" child? Should we eliminate obesity, baldness, heart disease, homosexuality (if that turns out to be, at least in part, genetic)? Not to regulate these characteristics is, effectively, to permit them all. Already, in less well developed countries, crude steps are taken to eliminate one of the most common genetic conditions of all: the female sex. Should the law step in, or should we go with the flow? When it becomes possible to eliminate particular genes and transplant others, what will prevent the attempted creation of a superspecies? Or an under-species? Or an altered human species? We must be ready with our answers to these questions. It should not be assumed that sermons, political press releases and the solemn resolutions of corporate ethics committees will have the power to prevent developments deemed undesirable by most of humanity. Public debate Unless all of the foregoing questions are debated publicly, it is probable that legal responses, when they come, will be (as they were with reproductive human cloning) peremptory, emotional, intuitive. They may not be informed by knowledge of the best specific data. It is therefore the responsibility of the scientific community to inform their fellow citizens of exactly what is happening. It is the responsibility of politicians, lawyers and ethicists to engage in the public debate and to found their decisions or recommendations on the best available scientific information. These are not questions to be answered by the headlines of tabloids or the deadlines of politics or corporations. They require careful interdisciplinary dialogue. They should involve the community. It has begun, but it is not well funded. Its dilemmas are often very complex. It is far easier for most decision-makers to switch off. The neglect of the ethical issues raised by the race to produce the atomic bomb in the Manhattan Project ultimately caught up with humanity, and the puzzles of regulating the Internet are now with us. However, there is no more profound puzzle than the future of the human species. This is why the questions I have asked are of such importance to Australia and the world. I offer no clear answers, but the realisation that the questions must be answered, and soon, is the beginning of wisdom. References The Human Genome Organisation <http://www.hugo-international.org/hugo/ mission.html> (accessed November 2000). Chalmers DRC, Otlowski MFA, Nicol D, Skene L. Current research: project on the legal and ethical aspects of genetic research in Australia. J Law Med 1995; 3: 30-35. Oman R. Legal and ethical issues in intellectual property protection of human genome research. In: Hansen HC, editor. International intellectual property law and policy. Yonkers, NY: Juris Publications, 2000. Hodgson D. Guilty mind or guilty brain? Criminal responsibility in the age of neuroscience. Aust Law J 2000; 74; 661. Stem cell research: medical progress with responsibility. A report from the Chief Medical Officer's Expert Group reviewing the potential of developments in stem cell research and cell nuclear replacement to benefit human health. Department of Health, June 2000. <http://www.doh.gov.uk/cegc/stemcellreport.pdf> (accessed November 2000). Authors' details High Court of Australia, Canberra, ACT. The Hon. Michael Kirby, AC, CMG, Justice of the High Court of Australia, and member of the International Ethics Committee of UNESCO and the Ethics Committee of the Human Genome Organisation. Reprints will not be available from the author. Correspondence: Justice M Kirby, High Court of Australia, Parkes Place, Canberra, ACT, 2600. kirbyjAThcourt.gov.au Make a comment

Michael Kirby

Cracking the Code Social consequences of manufactured longevity Riaz Hassan The signs are that advances in biomedical sciences will add more years of "manufactured time" to life expectancy in industrialised countries, resulting in unprecedented rates of survival into older ages. Increasing longevity will force economic and social changes and the 20th-century revolution in social roles looks set to continue into the 21st century. MJA 2000; 173: 601-603 Life expectancy in rich and poor countries - Economic effects of longevity - Longevity and social structure - References - Authors' details - - More articles on Genetics In 1825, a British actuary, Benjamin Gompertz, discovered a distinctive pattern in human mortality statistics. He found that the probability of dying was high at birth, and then continued declining until sexual maturity, after which it increased at an exponential rate. He and other demographers speculated that the exponential rise in the risk of death following sexual maturity was the result of a natural law of mortality.1,2Ever since, scientists have been looking for evidence of a "universal" law of mortality that applies to all living things. Now there is evidence which suggests not only that a law of mortality may exist, but that the life span of human populations may have already exceeded the limits implied by such a law -- "a product of the survival time manufactured by medical technology and lifestyles modifications".3 For much of human history, life expectancy was around 25 to 30 years. The mean human life expectancy in industrialised countries has changed from 25 years in the 18th century to 50 years in 1900, and to about 75 years now.4 Over two-thirds of the improvements in longevity in the entire world, from prehistoric times until the present, has taken place since 1900.5 These changes in human populations raise a paradox: if evolutionary theories of senescence are correct and survival into the post-reproductive period serves no useful purpose, why is the human life span so much greater than the age when reproduction ceases?3 If, however, senescence is in fact the product of evolutionary neglect rather than evolutionary intent, then there is good reason to be optimistic that the process is modifiable, either through direct manipulation of crucial genes or, more indirectly, by controlling or manipulating the products of gene expression. Both of these interventions are a major focus of current biomedical research, boosted by the Human Genome Project. There may be a price to pay when only the progression or expression of senescent disease is modified. Such interventions may simply shift the burden of senescence to other forms of lethal or debilitating senescent diseases.3 Life expectancy in rich and poor countries The distribution of the "manufactured time" being added to human life expectancy as a result of advances in biomedical sciences is highly skewed in favour of industrialised countries. In poor countries, most deaths occur in the young, and result from infectious and parasitic diseases, wars and starvation.4 In rich countries, most deaths occur as a result of the diseases of old age, such as cancer, strokes and heart disease.4,6 The populations of the rich countries will be the major beneficiaries of the new biomedical advances. Overpopulation will once again become the concern of the wealthy countries, rather than just the poor countries with high fertility rates.4,7,8 Economic effects of longevity In the first half of the 20th century, when mortality began to fall, survival rates improved not only at the oldest ages but also in childhood and during the working years. Under these circumstances mortality decline is less costly for the State as it does not require major public welfare transfers. Greater mortality decline in the early years of life substantially increases the labour force, which helps to pay the aged pension costs and healthcare of the elderly. In the second half of the century, mortality decline slowed in the working ages, and accelerated in older ages. This is the pattern which now characterises the industrial countries.9 This change (which may be further boosted by the Human Genome Project) is likely to have major economic implications for the industrialised countries and will change their economies drastically over the next three to five decades. For example, in Australia, if present trends continue, the proportion of people aged from 20 to 39 years will increase by only 2% between 2001 and 2051. In the same period, proportions of populations aged 60 to 79 years and 80 and over will increase by 122% and 307%, respectively. By 2051, one in three Australians will be aged 60 and over. Never before have such proportions been reached in large human populations.10 The developed countries will have difficulty meeting the costs of supporting an increasingly larger proportion of elderly. Under these conditions, according to a World Bank study of the macroeconomic effects of aging populations, the industrial economies should see higher aggregate consumption relative to income and higher real interest rates.11 To avoid a fall in people's standards of living, economic productivity would need to be increased, and new tax policies would be needed to aid the process of capital formation. If the tax rates remain unchanged, government debt will increase substantially, resulting in higher real interest rates. Under these conditions, the real gross national product per capita in most industrialised countries will decline significantly.11,12 Healthcare costs will be increased by the addition of more years of life in the older age groups. Some healthcare workers argue that healthcare for the elderly places an unsustainable economic burden on national budgets, and one method of control would be rationing healthcare for older people, and even denying it to those who are 80 years of age or older. These arguments are supported by data from the United States -- 28% of Medicare bills are paid to only 6% of those Medicare-eligible, who die within a year.13 An intriguing aspect of healthcare spending in industrialised countries is that, in general, healthcare costs as a percentage of gross domestic product (GDP) appear not to be associated with population aging. Spending on healthcare is highest in the US, constituting about 14% of its GDP. However, the US has the lowest percentage of elderly (12.6%) people among the 12 most industrialised countries. In comparison, Sweden, with 17.8% of the population older than 65 years, spends 7.5% of its GDP on healthcare. Furthermore, healthcare spending does not necessarily rise with an increase in the percentage of elderly persons in the population. In Japan, the elderly population increased by more than 30% between 1980 and 1990, yet only a 1.6% increase in the proportion of its GDP during this period went to healthcare. In the US, where the proportion of those aged 65 and older increased by about 10% in the same period, healthcare spending went up by 31.5%.4,13 This means that more egalitarian industrialised countries like Sweden and Japan have not only longer life expectancies compared with the less egalitarian countries like the United States, but they are also more likely to be successful in coping with further increases in life expectancy in the future. The problems of high costs of healthcare arising from longer life expectancies are likely to be serious public issues in countries with greater social and economic inequalities. In this respect Australia is well situated to cope with the economic and social costs of increasing longevity of its population.4 Longevity and social structure As human life expectancy began to increase in the 20th century, it also began a revolution in shaping social roles at different stages of life-cycle. Life course began to become age-graded and differentiated. One consequence was the reduction in labour force participation among both the old and the young. The trend has been towards concentration of education in youth, work in early to middle adult years, and recreation in the post-retirement years. Human society became increasingly age-segregated. Although this had had many beneficial effects, such as expansion of education, greater economic productivity and innovation, it has also transformed industrial societies into rigidly age-segregated societies. The social patterns of modern life are now testing the usefulness of this structure of life course.14-16In countries like Australia, growing numbers of elderly people are rejecting the age constraints on paid work and biases against active participation of older people in society. Similarly, many young people are seeking "adult" roles in work, family and entertainment. These changes are increasing pressures for the development of age-integrated social structures. Unlike age-segregated structures, age-integrated structures do not use chronological age as a criterion for entrance, exit or participation. Sociologists have proposed an alternative model of life course that would allow learning, work and leisure to be integrated in the lives of individuals throughout the entire life course (Box).17 This life-course model is much more suited to the conditions of our society, which is adding more "manufactured time" to human life, producing unprecedented longevity. The evidence from Australian universities' enrolment statistics shows that education is becoming increasingly age-integrated and is now widely defined as "life-long". Barriers to work are also being relaxed, as evidenced by the increasing proportion of high school and university students who are in paid work. There is growing evidence that repudiates widely held beliefs about the inevitable and universal intellectual decline with aging, and ways to prevent the decline that does occur are being suggested.18,19 The most visible challenge to the age-segregated life course has come from women. Women have introduced a number of innovations which have made their life course flexible and age-integrated. Increasing proportions of women are combining work, education and family. If this transformation in sex-role attitudes and behaviours continues, it will affect every facet of modern life. Many middle-aged women today are performing more roles than men and will reach old age with greater role flexibility.19 An age-integrated society, with its accompanying cross-age interaction and flexible life course, will be conducive to promoting deeper understanding among people and reduce intergenerational conflict. It may lead to the development of more civil society. New social values will evolve when people from different age groups get accustomed to sharing work and family responsibilities, leisure time and cultural pursuits. These values may produce a greater sense of connectedness in the community and thus reduce loneliness, excessive individualism and materialism. Utopia may or may not result, but, of all the available futures, this appears the most promising for all ages. Whether we fear it or welcome it, this manufactured longevity will change our lives and human culture pervasively. References Gompertz B. On the nature of the function expressive of the law of human mortality and on a new mode of determining life contingencies. Philos Trans R Soc Lond 1825; 115: 513-585. Carnes BA, Olshansky SJ, Grahn D. Continuing the search for a law of mortality. Popul Dev Rev 1996; 22: 221-264. Olshansky SJ, Carnes BA, Grahn D. Confronting the boundaries of human longevity. Am Scientist 1998; 86: 52-61. Fossil M. Reversing human aging: it's time to consider the consequences. Futurist 1997; 31: 25-28. Preston SH. Mortality patterns in national populations. New York: Academic Press, 1976. Najman JM. The demography of death: Patterns of Australian Mortality. In: Kellehear A, editor. Death and dying in Australia. Melbourne: Oxford University Press, 2000. Roush W. Live long and prosper. Science 1996; 273: 42-46. Wilmoth JR. The future of human longevity: a demographer's perspective. Science 1998; 280: 395-397. Lee R. Long-term population projections and the US social security system. Popul Dev Rev 2000; 26: 137-143. Australian Bureau of Statistics. Australian demographic statistics. Canberra: ABS, 1999. (Catalogue no. 3101.0.) Mason PR. Long-term macroeconomic effects of aging. Finance Dev 1990; 27: 6-9. Mason PR, Tryon RW. Macroeconomic effects of projected populations aging in industrial countries. IMF Working Paper WP/90/5. Washington DC, 1990. Marwick C. Longevity requires policy revolution. JAMA 1995; 273: 1319-1320. Uhlenberg P. Introduction: why study age integration? Gerontologist 2000; 40: 261-265. Kohli MR. Social organization and subjective construction of the life-course. In: Sorensen AB, Weiner FE, Sherrod LR, editors. Human Development and the life cycle. Hiilsdale NJ: Erlbaum, 1988. Riley MW, Foner A, Riley JW. The aging and society paradigm. In: Bergtson VL, Schaie KW, editors. Handbook of theories of aging. New York: Springer, 1999. Riley MW, Riley JW Jr. Age integration: conceptual and historical background. Gerontologist 2000; 40: 266-270. Schaie WK, editor. Longitudinal studies of adult psychological development. New York: Guilford Press, 1983. Riley MW, Riley JW Jr. Longevity and social structure: the added years. Daedalus 1988; 115: 51-74. Authors' details Flinders University, Adelaide, SA. Riaz Hassan, PhD, FASSA, Professor, Department of Sociology. Reprints: Professor R Hassan, Department of Sociology, Flinders University, GPO Box 2100, Adelaide, SA 5001. Riaz. HassanATflinders.edu.au Make a comment Social structures Our current society is age-segregated -- we receive our education when we are young, we work until we are 60 or so, and then retire and spend our time in leisure. With increasing longevity, a better social structure would be age-integrated, in which education, work and leisure are all life-long activities. Back to text

Riaz Hassan

Medicine and the Media Medicine, the media and monetary interests: the need for transparency and professionalism Ray Moynihan and Melissa Sweet MJA 2000; 173: 631-634 Abstract - Breakthroughs and boosterism - The news business - Cosy relationships - The buck stops...where? - Cash for comment - Evidence-based journalism - References - Authors' Details - - More articles on Social issues Abstract Emerging evidence suggests that media coverage of medicine is increasingly promotional in nature. Recent Australian examples include misleading newspaper articles on an experimental cancer vaccine and a high profile television current affairs segment on a new influenza drug, which failed to disclose the industry ties of a key expert featured in the report. There are widening concerns that this problem in medical journalism may be exacerbated by the growing commercialisation of medical and scientific research, and the increasing ties between researchers, doctors and pharmaceutical or biotechnology companies. Closer links between industry and medicine are being explicitly encouraged both in academia and the health care sector for the mutual benefits they bring. However, these partnerships are the cause of growing unease within medicine. In the United States, rigorous legislation governing research protocols is being proposed, and in Australia new ethical guidelines covering industry-profession relationships are being promulgated. If one of the media's roles is informing the community about the business of health and medicine in a fair and accurate way, a cultural change in medical journalism is required. In November 1999, one of Australia's high circulation newspapers published a prominent story about a new cancer vaccine that had "tripled life expectancy in trials".1 In May 2000 the Australian Press Council upheld a complaint from a leading cancer expert that this report, versions of which were published in sister newspapers across the country, was both misleading and inaccurate.2 While the Australian Press Council made no judgement about the scientific evidence supporting the new vaccine, the finding served as a timely reminder of the need for more scepticism in medical journalism. Yet just two months later, in July 2000, the same vaccine received another round of positive publicity in the nation's leading newspapers, publicity echoing promotional material from the vaccine's proponents.3If one of the media's roles is to inform the community in a fair and accurate way, the reporting of medicine or medical research too often falls short of the mark. A recent study of newspaper and television coverage of medications over a five-year period found many stories tended to overstate therapy benefits, played down potential harms and failed to disclose the relevant industry ties of cited experts (Box).4 The misleading nature of much medical reporting requires urgent attention from both journalists and health professionals. Concern about media reporting raising false hopes, undue anxiety or unnecessary alarm is not new.5 However, the increasing commercialisation of scientific research, and the expanding role of the stockmarket in medicine, are creating powerful new forces. Like many new therapeutic advances, the experimental cancer vaccine featured in the Australian media is promoted by a biotechnology company listed on the stock-exchange: for these companies positive stories may boost share prices and negative stories may send them plummeting. Closer involvement between industry and science, which is being explicitly encouraged in a bipartisan way in Australia,6 may well carry the clear benefits of increased research funding or enhanced commercial opportunities for effective new treatments -- but at what cost? Within medical circles, and in the wider community, there is growing unease that overly cosy relationships may be affecting research integrity and professional independence.7,8 It may be time for the media to offer more critical analysis of the business of medicine, and less thinly disguised promotion of the latest "breakthroughs". Breakthroughs and boosterism At the international Berzelius Symposium, Medicine and the Media, convened in Stockholm in September this year by the Swedish Society of Medicine, many contributions focused on the increasing commercialisation of medical and scientific research. While some conference participants expressed optimism about a growing sophistication in media coverage of medicine, others expressed concern about promotional "boosterism", particularly in media coverage of genetics and biotechnology.9At the conference, Lars Holmgren, from the Karolinska Institute, Sweden, focused on the now-infamous front-page story in the New York Times on Sunday, 3 May 1998. It began with the paragraph: "Within a year, if all goes well, the first cancer patient will be injected with two new drugs that can eradicate any type of cancer, with no obvious side effects and no drug resistance -- in mice."10 The article referred to two agents, endostatin and angiostatin, which have shown significant promise in treating cancer in mice by blocking angiogenesis. It had an international impact, provoking widespread follow-up in other media outlets, and leading to many inquiries from anxious cancer patients about a treatment that had not yet been trialled in humans. As Holmgren explained, the front-page story also had a dramatic impact on the shares of the company developing the agent, which increased in value severalfold the next day. An investigation by the Los Angeles Times11 later showed that the shares in this and other biotechnology companies have since risen and fallen in response to continuing public relations activities and media stories, both positive and negative.12 In a provocative conclusion, Holmgren suggested that the trend towards researchers seeking to attract investors through publicity in the mass media -- often ahead of publication in scientific journals -- had become so prevalent that the high-tech stock index, the Nasdaq, had become a more reliable indicator of scientific developments than journals themselves! The news business If "good news" medical stories are valuable for listed companies, they are also big business for commercial media and increasingly entrepreneurial public broadcasters. Television news and current affairs programs routinely broadcast formulaic "breakthrough" medical stories, and often heavily promote them. As the southern hemisphere flu season got under way this year, a top-rating television current affairs program broadcast an item about Glaxo Wellcome's new influenza product Relenza (zanamivir), described as a "wonder drug" with "miraculous results".13 While brief mentions were made of concerns about cost-effectiveness and a paucity of sufficient trial data in high-risk patients, the presenter's voiceover was upbeat, and reinforced by comments that the drug had been hailed as "the greatest breakthrough ever" in the treatment of influenza. During the day of the broadcast and the following day's trading, the price of shares in Glaxo's Australian partner, Biota, jumped almost 15%. While the television segment was extremely good news for company investors, it serves as another stark example of the malaise affecting much of medical reporting. Like many previous items about zanamivir, the drug's modest benefits were not mentioned.14 Similarly, the evidence of rare but potential serious harm associated with the new drug for those with pre-existing illnesses like asthma were ignored.15 Perhaps most importantly, the television program failed to inform its audience of the links between Glaxo Wellcome and one of the key experts who repeatedly appeared in the segment, despite the company's support for the expert's research on zanamivir being clearly disclosed in the scientific literature.16 Instead, the program chose to describe the specialist as an "independent professor" from an academic institution. This clear failure to reveal the relevant industry ties of a key source is not an isolated instance.4 Cosy relationships While many media stories are failing to report on the potential conflicts of interest of their "experts", the growing ties between industry and academic medicine are generating considerable disquiet. In an editorial in the New England Journal of Medicine in May this year, Marcia Angell, the journal's editor, detailed the dangers of the increasingly "cosy relations" between medical scientists and the drug and device manufacturers providing funds for research, consultancies for advice, and free trips to speak at international conferences.7As an example of the problem, Angell cited the difficulties in finding independent reviewers to write about the treatment of depression, because so many US psychiatrists have links to companies selling antidepressants. "The problem is by no means unique to psychiatry," she wrote. Nor is the problem unique to the United States. Two years ago a leading Australian academic complained publicly of the difficulty in finding independent specialists to sit on regulatory committees, because so many were consultants to drug companies.17 The reason for concerns about the increasingly intricate ties between researchers and industry is not simply academic. Evidence suggests that a range of physician-company interactions (like attending company-sponsored education, or accepting sponsored trips) can carry negative impacts on behaviour.18 As Angell pointed out, "there is now considerable evidence that researchers with ties to drug companies are indeed more likely to report results that are favourable to the products of those companies than researchers without such ties."7 An obvious concern is that corporate funding may sometimes cause bias. More subtly, according to Angell, ties may influence scientific judgements in ways that are difficult to identify. The bottom line is that companies are seen to be buying the goodwill of researchers, "which is a very valuable commodity for drug and device manufacturers".7 The buck stops . . . where? The goodwill of researchers and opinion leaders is a particularly valuable commodity precisely because it can be exploited by a company using the media to promote a new product direct to the public. Having a new product endorsed in newspapers or on television by a purportedly independent authority figure is invaluable. Clearly, the mainstream media must urgently institute routine disclosure of the potential conflicts of medical and health experts, just as medical journals have required for some time. Amendments to journalist codes of ethics may be one route towards this outcome. Similarly, it may be appropriate for media to disclose when a public relations company or another vested interest has been responsible for orchestrating a story.19Community concerns about the ties between doctors and the pharmaceutical industry led the Royal Australasian College of Physicians this year to disseminate new ethical guidelines that cover these relationships.20 Largely accepting the benefits of close commercial relationships, including company funding of research, paid consultancies and sponsored travel, the guidelines recognise the possibility that these relationships may cause conflicts between physicians' responsibilities to their patients, and their own personal gain. Essentially endorsing the multiplicity of industry-professional ties, the guidelines argue that openness to public scrutiny is a sufficient safeguard. But self-regulatory professional guidelines that carry no real penalties are not considered enough in some quarters. Responding to Angell's editorial, the United States Secretary for Health and Human Services, Donna Shalala, recently announced a list of wide-ranging measures to improve ethical conduct in research.21 Included is the possibility of new legislation which would impose fines of up to $US250 000 per clinical investigator and up to $1 million per research institution for violations of ethical research conduct -- such as failing to obtain proper informed consent from research participants. Shalala argued that several recent incidents in the United States, including the much-publicised death of a subject in a gene therapy trial,22 had shaken public confidence in research ethics. One of the reasons that protection for human subjects needed to be strengthened was, according to her editorial, that academic investigators increasingly have commercial links with trial sponsors or personally hold patents over the therapies being trialled, creating potential conflicts of interest and major ethical dilemmas. Cash for comment The recent Australian Broadcasting Authority inquiry into commercial radio, known as the "cash for comment" inquiry, has helped raise awareness of the extent of hidden corporate payments to broadcasters and the way in which those payments can undermine and distort public debate. In a similar distortion of public debate, overly promotional media coverage of healthcare products may help foster false public expectations of benefits, encourage unnecessary or potentially harmful use, and add to healthcare costs. As well, there are concerns such coverage may promote overmedicalisation and discourage the use of effective non-medical interventions. In light of the revelations which emerged from the "cash for comment" inquiry,23 a rigorous and wide-ranging investigation of the nature and extent of commercial links between the medical profession and the pharmaceutical, biotechnology and medical technology companies may now be timely in Australia. In a spirit of openness and disclosure, such an inquiry could also examine the ties between journalists and the medical companies whose products they are charged with reporting on. Evidence-based journalism Enhanced transparency about industry ties is only one strategy for improving the way the media covers medicine. In our view, journalists and media managers could benefit greatly from a heightened understanding of the move towards an evidence-based approach in healthcare. As a recent article in the Australian journalists' professional magazine, The Walkley, noted,24 the media could learn from the questions which are being asked by proponents of evidence-based medicine (eg: What is the evidence to support the claim being made? How strong is the evidence? How does it fit with the existing body of evidence? Are there other, valid conclusions which could be drawn? Have the results been published in a reputable peer-reviewed journal? What interest might the doctor/researcher have in promoting this view?). Strategies for quality improvement will require debates within media organisations, journalist professional bodies and the wider research community. Valuable assistance in those debates may soon come from a group of researchers who are now conducting a randomised controlled trial of various educational interventions for journalists covering health and medicine.25 Similarly, many researchers and journalists, as well as the Australasian Medical Writers Association, are working on educational and other resources designed to improve medical reporting.26,27 In Sweden, for example, medical journalists are encouraged to follow a number of ethical guidelines, including do not arouse false hopes and fears; try to present risks and benefits together; emphasise the uncertain and temporal nature of knowledge.28 Critical, informed and independent journalism will become even more crucial in light of increasing commercialisation, combined with the major, complex changes arising from the new biotechnologies. Media organisations currently face a fundamental choice about how they cover the issue of human health: to act as "cheer squads" for the new products, or to seek out truly independent evaluation of promotional claims in order to better inform the public about the limitations, uncertainties, dangers and costs, as well as the genuine health benefits, of new medical therapies and technologies. References Busfield W. Melanoma vaccine next year. The Daily 1Telegraph, 19 November 1999: 3. The Australian Press Council. Adjudication No. 1081. Re: The Daily Telegraph, 19 November, 1999. Greenblat A. Cancer drug fires up AVT. The Age 20 July 2000: B3; and The Sydney Morning Herald, 20 July 2000: 23. Moynihan R, Bero L, Ross-Degnan D, et al. Coverage by the news media of the benefits and risks of medications. N Engl J Med 2000; 342: 1645-1650. Leask J, Chapman S. An attempt to swindle nature: press anti-immunisation reportage 1993-1997. Aust N Z J Public Health 1998; 22: 17-26. Wills PJ (Chairman). Health and Medical Research Strategic Review. The virtuous cycle -- working together for health and medical research. Canberra: Department of Health and Aged Care, 1999. Angell M. Is academic medicine for sale? [editorial]. N Engl J Med 2000; 342: 1516-1518. Weatherall D. Academia and industry: increasingly uneasy bedfellows. Lancet 2000; 355: 1574. Swedish Society of Medicine. Berzelius Symposium 54 -- Medicine and the Media. 31 August-1 September 2000. Stockholm. Kolata G. Hope in the lab -- A special report: A cautious awe greets drugs that eradicate tumors in mice. New York Times, 3 May 1998. Jacobs P. Biotech stocks ride roller coaster of publicity. Los Angeles Times 21 March 1999. Ashraf H. British Medical Journal apologises to biotech company [news]. Lancet 2000; 355: 2139. A Current Affair, June 14, 2000. Summary of evidence about effectiveness of zanamivir. National Institute for Clinical Excellence, UK, 1999. <http://www.nice.org.uk/nice-web/Article.asp?a=427> Accessed 14 November 2000. Relenza [US Food and Drug Administration consumer drug information]. <http://www.fda.gov/cder/ consumerinfo/druginfo/relenza.htm> Accessed 14 November 2000. The MIST (Management of Influenza in the Southern Hemisphere Trialists) Study Group. Randomised trial of efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections. Lancet 1998; 352: 1877-1881. Moynihan R. Too much medicine? Sydney: ABC Books, 1998: 8. Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283: 373-380. Sweet M. Medicines and the media; a journalist's view. Aust Prescriber 2000; 23: 70-71. The Royal Australasian College of Physicians. Ethical guidelines in the relationship between physicians and the pharmaceutical industry. Sydney: RACP, 2000. Shalala D. Protecting research subjects: what must be done? N Engl J Med 2000; 343: 808-810. Greenberg DS. Stricter regulation proposed for US gene therapy trials [news]. Lancet 2000; 355: 1977. Commercial Radio Inquiry. Report of the Australian Broadcasting Authority hearing into Radio 2UE Sydney Pty Limited, Sydney: ABA, 2000. Sweet M. Journalist, heal thyself. Walkley Magazine, August 1999: 15. Oxman A. Evidence-based medicine and medical journalism. Presentation to Berzelius Symposium 54 -- Medicine and the Media. 31 August-1 September 2000. Stockholm. Irwig L. University of Sydney continuing education courses on evaluating health studies. Levi R. Medical journalism: exposing fact, fiction, fraud. Studentlitteratur 2000 Stockholm. <www.studentlitteratur.se> Accessed 14 November 2000. Bengtsson H. The roles of the Medical Journalist. Presentation to Berzelius Symposium 54 -- Medicine and the Media. 31 August-1 September 2000. Stockholm. Authors' Details Ray Moynihan, BA, Journalist, Australian Financial Review, Harkness Fellow in Health Policy, 1998-1999. Melissa Sweet, BA, MA, Journalist, The Bulletin and Australian Doctor. Reprints will not be available from the authors. Correspondence: Mr R Moynihan, 76 Francis Street, Bondi, NSW 2026. ray_128AThotmail.com Make a comment What the media didn't say The relative-risk "gee-whizz" effect A retrospective analysis of 207 United States newspaper (n = 180) and television (n = 37) stories in the period 1994-1998 about three preventive medications (pravastatin, a cholesterol-lowering drug; alendronate, a bisphosphonate for treatment and prevention of osteoporosis; and aspirin, as used to prevent cardiovascular disease) revealed that: 53% of 207 stories did not mention potential harms. 70% of 207 stories did not mention drug costs. 83% of 124 stories which quantified benefits used a "relative" frame only -- an approach that is potentially misleading. 60% of 85 stories that cited at least one expert or study with a relevant "industry tie" failed to disclose that tie. A story reported a randomised controlled trial of alendronate as producing an "almost miraculous" 50% reduction in the incidence of fractured hip. Sounds good? The story did not report the actual rate of fractured hip in untreated patients (2%) or treated patients (1%). The relative-risk reduction of 50% sounds much more impressive than the absolute-risk reduction of 1% -- and, of course, both figures must be weighed against other information, such as the costs and side effects of treatment.4 Back to text

Ray Moynihan · Melissa Sweet

Medicine And The Law Determining the validity of advance directives Paul Biegler, Cameron Stewart, Julian Savulescu and Loane Skene MJA 2000; 172: 545-548 Abstract - Ethics - Legislation - Common law - Duties of treating physicians in determining legal validity of advance directives - Conclusions - References - Authors' details - - More articles on Ethics Abstract We examine the ethical principles underpinning advance directives (ADs) and the legal duties of doctors in determining their validity. A physician attending an incompetent patient with an acute life-threatening illness, and an AD refusing treatment, should ensure that the AD is legally valid before making the treatment decision. Treatment against a patient's wishes, as expressed in a valid AD, compromises patient autonomy and may constitute battery. Conversely, withholding treatment in accordance with an AD that is not legally valid risks substantial harm to the patient and may constitute breach of the duty of care and negligence. Legally valid directives should be respected. If an AD is not legally valid, the patient should be treated in his or her best interests. If uncertain, the physician should treat according to the patient's best interests while seeking legal advice. An advance directive (AD) is a statement by a competent person expressing the intention to refuse medical treatment in the future, at a time when he or she may no longer be competent to make a treatment decision.1 ADs have arisen in the context of an increasing need to respect and promote patient autonomy.2 They have received widespread international support and, in the United States, ADs now have a statutory basis in all 50 States.3 Three Australian States (Victoria, South Australia and Queensland) and two Territories (the Northern Territory and the Australian Capital Territory) now have legislation which provides for ADs (Box 1). Although New South Wales, Tasmania and Western Australia do not have similar legislation, ADs may still be valid under common (judge-made) law in these States. Despite their prevalence in the United States, ADs have, in many instances, failed to guide clinical decision-making, and their utility has been questioned.4 Of particular concern is the dilemma facing clinicians when the AD rules out treatment which the doctor believes is in the patient's best interests.5 Treatment in the presence of a valid AD compromises patient autonomy and may constitute battery.6 However, withholding treatment in accordance with a legally invalid AD risks substantial harm to the patient and may constitute breach of the duty of care and negligence.7 We contend that being equipped with a clear process for determining the legal validity of an AD can reduce the uncertainty of physicians in such situations. Legally valid ADs should be respected. If the AD is not legally valid, or if the physician is uncertain, treatment decisions should be based on an assessment of the patient's best interests.8 We look at the ethical foundations and the Australian law pertaining to ADs and offer recommendations to medical practitioners seeking to ascertain the legal validity of ADs. Ethics "Autonomy" comes from the Greek autos-nomos, meaning "self-rule" or "self-determination". The concept of respect for autonomy was enunciated by John Stuart Mill, who said that the sole justification for interfering in another person's action is if that action will harm others -- "His own good, either physical or moral, is not a sufficient warrant".9 This principle, known as Mill's "harm principle", is the grounds for the moral right of a patient to refuse medical treatment, even if such treatment is life-saving, and for a doctor not to interfere in this action. Mill did have one caveat to his stance. He felt that it was acceptable to restrain a person from causing self-harm if that person's action was not fully informed. Take the example of a person crossing a burning bridge without knowing it is burning. Intervening here would be acceptable and this has been labelled "weak or soft paternalism". Intervening if the person was fully informed about the consequences of his or her actions has been labelled "strong or hard paternalism" and is unacceptable.10 Modern theorists have elaborated the notion of autonomy and concluded that an autonomous decision is one that is freely made, by a competent person, based on his or her most recent set of values. It should also be applicable to the circumstances in question, with a full understanding of the relevant facts.11,12 The relevance to ADs is that, unless a directive expresses an autonomous decision, acting upon it may in fact violate patient autonomy and result in serious harm. An example is a patient with HIV who signs a directive refusing resuscitation or admission to an intensive care unit. The patient has a life-threatening allergic reaction to a drug early in the course of the disease, when the prognosis suggests many good years of life. If the patient did not intend the AD to apply in this circumstance, then to allow this patient to die would be to fail to respect his or her autonomy. Treatment here would be weak paternalism (see also Box 3). The law provides a framework for safeguarding patient autonomy in such situations. Legislation The Australian legislation covering ADs is outlined in Box 1. Common law The validity of ADs at common law is yet to be tested in an Australian court. The case law from other jurisdictions suggests the following factors should be considered. The competence of the decision-maker The patient must have been competent to refuse treatment when the AD was drafted. The test for competence rests on the question of whether the patient understood the nature and purpose of the treatment when he or she made the decision to refuse it.13,14 The true scope and basis for the decision The AD must cover the circumstances that have arisen. The evidence must confirm the true scope and basis of the decision; that is, that the anticipatory decision was based on an informed opinion and was intended to apply to the circumstances which have arisen.6,15 Evidence of a decision which consists of remote, general, spontaneous or casual comments will not support the claim of anticipatory decision-making.16 However, evidence of cogent and serious decision-making which consists of written evidence or eye-witness accounts is usually strong enough to support the veracity of an anticipatory decision.17 Evidence of oral directions can, by itself, support the finding of a valid anticipatory decision.18-20 Undue influence The decision to refuse treatment must be free from the undue influence of others. Undue influence may impair the decision-making process and invalidate the directive. Enquiries must be made as to both the strength of will of the patient and the relationship of the patient with the persuader. If the patient was in pain or under the influence of drugs when the decision was made, or was persuaded by someone with close familial ties, the decision may not have been the result of the patient's free will. Such decisions are not legally binding on doctors.15 Duties of treating physicians in determining legal validity of advance directives In the case of directives completed under a statutory scheme, a physician treating an incompetent patient is not required to investigate whether the patient's decision was voluntary, reasonably informed or that the patient was 18 years or over when the directive was signed. The witnesses to the directive attest to those matters. In Victoria, South Australia and Queensland, the witnesses also attest to the patient's capacity to refuse treatment at the time of completing the AD. The obligations of the treating physician are more onerous in relation to common law directives and legal advice may be required in this setting. A schema for determining the validity of ADs from both the legislative and the common law perspective is outlined in Box 2, and an example is given in Box 3. Conclusions In order to respect patient autonomy, avoid harm to patients and reduce the risk to doctors of civil or criminal liability, physicians need to determine the legal validity of advance directives before making their treatment decision. In cases of uncertainty treatment decisions should be made in the patient's best interests while legal advice is sought as to the validity of the directive. References Robertson GS. Making an advance directive. BMJ 1995; 310: 236-238. Kerridge IH, McPhee J, Lowe M, Flynn B. Advance directives. In: Freckelton I, Petersen K, editors. Controversies in health law. Sydney: The Federation Press; 1999: 302. Tonelli MR. Pulling the plug on living wills. A critical analysis of advance directives. Chest 1996; 110: 816-822. Teno JM, Licks S, Lynn J, et al. Do advance directives provide instructions that direct care? SUPPORT Investigators. Study to understand prognoses and preferences for outcomes and risks of treatment. J Am Geriatr Soc 1997; 45: 508-512. Danis M, Southerland LI, Garrett JM, et al. A prospective study of advance directives for life-sustaining care. N Engl J Med 1991; 324: 882-888. Skene L. When can doctors treat patients who cannot or will not consent? Monash University Law Review 1997; 23 (1): 77. Dix A. Law for the medical profession in Australia. Melbourne: Butterworth-Heinemann, 1996: 563. Luttrell S. Making decisions about medical treatment for mentally incapable adults in the UK. Lancet 1997; 350: 950-953. Mill JS. Utilitarianism, on liberty and considerations on representative government. Everyman library. London: J M Dent and Sons, 1910. Ten CL. Paternalism and levels of knowledge: a comment on Rainbolt. Bioethics 1989; 3: 135-139. Dworkin G. The theory and practice of autonomy. Cambridge: Cambridge University Press, 1988. Savulescu J. Good reasons to die [doctoral dissertation]. Melbourne: Monash University, June 1994. Lord Brandon in Re F (Sterilisation Mental Patient) [1989] 2 Fam 376, 419-420. Gillick v West Norfolk and Wisbech AHA [1986] AC 112. Re T [1992] 2 Fam 458, 473 (Lord Donaldson). Matter of Jobes 529 A 2d 434, 443 (NJ, 1987). Matter of Peter 529 A 2d 419 (NJ, 1987). Re Chad Swan 569 A 2d 1202 (Me, 1990). Leach v Akron General Medical Center 426 NE 2d 809 (Ohio Comm Pl, 1980). Matter of Eichner 420 NE 2d 64 (NY, 1981). Authors' details Emergency Department, Monash Medical Centre, Melbourne, VIC. Paul Biegler, MB BS, FACEM, Staff Specialist. Department of Law and Justice, Division of Law, Macquarie University, Sydney, NSW. Cameron Stewart, BEc, LLB(Hons), GradDipJur, Associate Lecturer. The Murdoch Institute, Royal Children's Hospital, and Centre for the Study of Health and Society, University of Melbourne, Melbourne, VIC. Julian Savulescu, MB BS, PhD, Associate Professor, and Director, Ethics Program. Law School, University of Melbourne, Melbourne, VIC. Loane Skene, LLM (Mon), LLB (Hons), Associate Professor and Reader. Reprints will not be available from the authors. Correspondence: Dr P Biegler, Emergency Department, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168. pbieglerATnetlink.com.au Make a comment 1: Legislation in Australia providing for advance directives Victoria Act: Medical Treatment Act 1988 (Vic). Type of advance directive: Refusal of treatment certificate (RTC). Treatment refused must relate to a current condition ("current condition" is not defined by the Act but presumably refers to a condition that the person has at the time of completing the RTC). The document must be in the form prescribed by the Act ("in the form" is also not defined, but presumably means in language consistent with that used in the Act). Legally valid if completed voluntarily by a person of sound mind over 18 years who is informed about their condition. Must be signed by a registered medical practitioner and another person who attest to these matters. The patient does not need to sign. Revoked by patient clearly indicating this wish to another person. Palliative care: The RTC does not cover refusal of palliative care, which is defined as "the provision of reasonable medical procedures for the relief of pain, suffering and discomfort; or the reasonable provision of food and water". Physicians’ liability: Under the Act, a doctor who treats a patient despite a valid certificate may commit the statutory offence of medical trespass. This offence would arise in addition to common law claims of battery. Doctors who comply with an RTC are granted immunity from civil claims, criminal charges or professional misconduct proceedings, provided the doctor acts in good faith and with reasonable care. South Australia Act: Consent to Medical Treatment and Palliative Care Act 1995 (SA). Type of advance directive: An "anticipatory grant" refusing consent to medical treatment. The directive is only effective for patients in the terminal stages of a terminal illness or in a persistent vegetative state, who are not competent to make treatment decisions. "Terminal illness" is defined as "an illness or condition that is likely to result in death" and terminal stage as "the phase of the illness reached when there is no real prospect of recovery or remission of symptoms". Legally valid if made by a patient of sound mind over the age of 18 years. Must be in the prescribed form, signed by the patient and witnessed by one person, who need not be a medical practitioner. Revoked by patient orally or in writing (not stipulated in the Act). Physicians’ liability: Physicians honouring directives under the Act are granted immunity from civil and criminal liability if they act in good faith, without negligence and in accordance with proper standards of professional practice. Australian Capital Territory Act: Medical Treatment Act 1994 (ACT), based on the Medical Treatment Act 1988 (Vic). Type of advance directive: "Direction" refusing treatment generally or treatment of a particular kind. Treatment does not have to relate to a current condition, as it does in Victoria. Legally valid if patients are of sound mind over 18 years. Direction must be in the prescribed form and witnessed by two people, neither of whom needs to be a medical practitioner. It can be signed by the patient or by another person at the patient’s direction, but it does not have to be signed to be valid. Revoked by patient clearly indicating his or her wish to another person. Palliative care: Does not cover refusal of palliative care. Physicians’ liability: A physician honouring a certificate in good faith is protected from civil and criminal liability, as well as claims of professional misconduct. Queensland Act: Powers of Attorney Act 1998 (Qld) Type of advance directive: "Advance health directives." Directions to withhold or withdraw life-sustaining measures cannot operate unless: the patient has a terminal illness or an incurable condition and is not expected to live more than a year, or is in a persistent vegetative state, or is permanently unconscious, or has a severe illness with no reasonable prospect of being able to live without the continued application of life-sustaining measures; and (if the direction concerns artificial hydration or nutrition) the life-sustaining measure would be contrary to good medical practice; and the patient has no reasonable prospect of regaining capacity for health matters. Legally valid if the directive is in the prescribed form, signed by the patient or another person at the patient’s direction and witnessed by two people, one of whom must be a medical practitioner. The witnesses must certify that the patient had the capacity to make the treatment decision at the time of completing the directive. Revoked by patient indicating his or her wish in writing. Physicians’ liability: Physicians are protected from criminal and civil liability if they honour the directive in good faith. Northern Territory Act: Natural Death Act 1988 (NT). Type of advance directive: "Directives" refusing treatment are only effective in the case of terminal illness, which is defined as "Such an illness, injury or degeneration of mental or physical faculties that death would, if extraordinary measures were not undertaken, be imminent; and from which there is no reasonable prospect of a temporary or permanent recovery, even if extraordinary measures were undertaken". Extraordinary measures are defined in the Act as "medical or surgical measures that prolong life, or are intended to prolong life, by supplanting or maintaining the operation of bodily functions that are temporarily or permanently incapable of independent operation". Legally valid if made by patients of sound mind who are over 18 years. Must be in the prescribed form, signed by the patient and witnessed by two people, who need not be medical practitioners. The treating doctor cannot be a witness. Revoked by patient orally or in writing (not stipulated by the Act). Palliative care: Does not cover refusal of palliative care. Physicians’ liability: Physicians complying with directives in good faith are protected from criminal and civil liability. Back to text 2: Schema of obligations of treating physicians Incompetent patient presents with acute life-threatening illness and an advance directive (AD) refusing treatment Step 1: Physician determines whether the AD conforms with State legislative requirements The form of the AD is correct The AD has the required signatures There is no evidence that the AD has been revoked (check with relatives, friends and the patient's GP) Victoria - the presenting condition for which treatment is now required is the same as, or has been caused by, the "current condition" as specified on the refusal of treatment certificate (RTC); Australian Capital Territory - treatment generally or treatment of a particular kind has been refused. There is no evidence that the patient was incompetent at the time of making the directive (witnesses are not required to attest to competence); South Australia - the patient is in the terminal phase of a terminal illness or in a persistent vegetative state; Northern Territory - the patient has a terminal illness. There is no evidence that the patient was incompetent at the time of making the directive (witnesses are not required to attest to competence); Queensland - the patient is suffering from one of the conditions outlined in Box 1, and the directive is not uncertain or contrary to good medical practice (section 106 of the Powers of Attorney Act 1998). If ALL of the criteria for Step 1 are satisfied Step 2: Comply with the AD (if uncertain proceed to Step 6). If ANY of the criteria for Step 1 are not satisfied Step 3: Determine common law validity of the AD. No evidence that the person was incompetent when they made the AD. AD covers the proposed treatment and the circumstances that have arisen. (i) It should not be ambiguous about the nature of the treatment being refused; and (ii) It should have been expressed to refuse treatment in the circumstances that have arisen. No evidence that the AD was procured by undue influence. If ALL of the criteria for Step 3 are satisfied Step 4: Comply with the AD (the difficulty of a physician's rapidly ascertaining these data in the acute setting is acknowledged) (if uncertain proceed to Step 6). If ANY of the criteria for Step 3 are not satisfied Step 5: Set aside the AD and treat according to the patient's best interests. Step 6: Legal advice should be sought if uncertainty exists about Steps 2-5. Faced with a delay in determining the validity of the AD, the physician should commence and continue any treatment deemed to be in the patient's best interests until such time as the AD is determined to be legally valid. Back to text 3: Example of an advance directive (AD) and physicians' decision-making A patient with HIV signs an AD refusing resuscitation or admission to an intensive care unit. The patient has an anaphylactic reaction to a drug early in the disease. Ethics If the AD was not intended to apply in this circumstance, withholding treatment would be to fail to respect this person's autonomy and would constitute a serious harm. Legislation Victoria The directive would be invalid because the presenting condition of anaphylaxis differs from the current condition of HIV as specified on the certificate. South Australia, Northern Territory, Queensland The directive would be invalid because the patient is not in the terminal phase of a terminal illness (SA, NT, QLD); in a persistent vegetative state (SA, QLD); and is not permanently unconscious with no reasonable prospect of regaining capacity for health matters (QLD). Australian Capital Territory The situation in the ACT is more complex. It seems that if the patient's AD was executed under the Medical Treatment Act 1994 (ACT) it may, in fact, be legally valid. However, we have argued that it would be ethically wrong to allow this person to die, and the directive would not be valid under other States' legislation or common law (see below). What should the doctor do? The uncertainty raised by the ACT situation should lead the doctor to act in the patient's best interests, which, in this case, probably favour resuscitation, while seeking legal advice. If in doubt, the patient's best interests must be the foremost consideration. Common Law The directive is unlikely to be valid at common law because the scope of the decision does not cover the circumstances that have arisen. Treatment decisions in these jurisdictions should thus be based on an assessment of the patient's best interests, which, in this case, as mentioned, probably favours treatment. Back to text

Paul Biegler · Cameron Stewart · Julian Savulescu · Loane Skene

A recent draft proposal for revising the Declaration has provoked heated controversy The World Medical Association (WMA) Declaration of Helsinki1 is regarded internationally as the pillar of ethical standards for biomedical research involving humans. In 1997, the American Medical Association presented a draft proposal to the WMA to update the Declaration to bring it more into line with contemporary ethical thinking,2-4 whereupon the WMA began the current process of revising the Declaration. Since 1964, the Declaration has evolved from a relatively broad set of ethical principles to a more defined, prescriptive set of guidelines, but it is extremely difficult to obtain global consensus on the Declaration because perceptions and ethical standards are not universal. ... we must determine just how the Declaration can remain relevant in the current biomedical research environment... Ethical standards are a product of cultural, linguistic, moral, religious, and social considerations; hence, many nations develop their own ethical guidelines for biomedical research -- for example, the National statement on ethical conduct in research involving humans,5 released recently by Australia's National Health and Medical Research Council. In June 1999, the WMA circulated a draft Proposed Revision of the Declaration of Helsinki6 to all National Medical Associations (NMAs). An international outcry ensued over the proposed amendments to issues such as informed consent, access to healthcare, placebo use, and publications (see Box).8-10 Some argued that the Proposed Revision established a model for human biomedical research ethics that encouraged utility and efficiency at the expense of patient autonomy and wellbeing.9 Those who defended the amendments said they were more in line with contemporary ethical thinking and did not impose unnecessarily stringent standards of practice.11 In this issue of the Journal, Loff and Black discuss some of the complexities associated with this debate and raise further questions.13 As a result of the lack of consensus between NMAs on the Proposed Revision, the WMA decided, at its General Assembly in October 1999, to develop a new draft revised Declaration in consultation with the public and WMA members.14 The difficulties imposed by the Declaration's prescriptive model are exemplified in the proposed amendments to placebo use (see Box). Robert Levine, Professor of Internal Medicine at Yale University School of Medicine, argues that the current Declaration's restrictions on placebo use, if taken literally, not only rule out the development of all new treatments other than for those diseases without a proven therapeutic treatment, but also forbid the use of a placebo when a standard therapy exists.11 Levine asserts that the current Declaration incorporates overly stringent ethical standards that needlessly impede biomedical research. However, a literal interpretation of the Proposed Revision's approach to placebo use gives cause for alarm. It proposed to change the standard from not allowing placebo use where a proven therapy exists to freely allowing placebo use as long as participants do not die or become disabled as a result.8 In so doing, it failed to recognise other adverse health effects that could arise from placebo use, such as pain, discomfort, or psychological stress, which might constitute unacceptable risks of the treatment. Indeed, even the perception of an "acceptable risk" in biomedical research finds little uniformity.8,15 The WMA should take heart from the fact that the Declaration of Helsinki can still provoke such strong passion and emotion almost 40 years after its adoption. The recent controversy is a true testament to just how important the Declaration is to those with a vested interest in biomedical research. As we head into the new century, we must determine just how the Declaration can remain relevant in the current biomedical research environment while not diminishing the fundamental ethical principles surrounding patient autonomy and wellbeing. Alternatives do exist to following the prescriptive model. A recent workshop on revising the Declaration of Helsinki, held by the Royal Society of Medicine, London,16,17 presented a reasonable alternative to pursuing the prescriptive approach: The Declaration should not be rewritten; The Declaration should remain a slim set of principles, not regulations, that could remain unchanged for a long time; and Guidance on such issues as informed consent could be addressed in accompanying commentaries which could easily be revised while leaving the Declaration intact.17 By using this or a similar alternative, the Declaration of Helsinki will not be further denigrated in the way it has been over the past year, and will continue to prevail as the definitive statement of ethical principles in human biomedical research. Kate Stockhausen Senior Research Officer, Health Services Australian Medical Association Federal Secretariat Canberra, ACT World Medical Association Declaration of Helsinki as adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. American Medical Association. Proposed Revision of the World Medical Association Declaration of Helsinki. Ferney-Voltaire, France: World Medical Association, 1997. (WMA document 17. CRev/97/A). American Medical Association. Background comments and text comparison aid for the proposed draft of the World Medical Association Declaration of Helsinki - recommendations guiding physicians and other investigators in biomedical research involving human subjects. Ferney-Voltaire, France: World Medical Association, 1997. (WMA document 17. CRev/97/B). Crawley F, Hoet J. Ethics and law: the Declaration of Helsinki under discussion. Bull Med Ethics Aug 1999: 9-12. National Health and Medical Research Council. National statement on ethical conduct in research involving humans. Canberra: Commonwealth of Australia, 1999. (Available from AusInfo government bookshops.) Medical Ethics Committee of the World Medical Association. Proposed Revision of the World Medical Association Declaration of Helsinki. Ferney-Voltaire, France: World Medical Association, 1999. (WMA document 17. C/Rev1/99). World Medical Association Declaration of Helsinki as amended by the 48th General Assembly, Somerset West, Republic of South Africa, October 1996. Australian Medical Association. AMA submission on the Proposed Revision of the World Medical Association Declaration of Helsinki (WMA document 17. C/Rev1/99). Canberra: Australian Medical Association, 1999. (Available from AMA, PO Box E115, Kingston, ACT 2604.) Brennan TA. Proposed revisions to the Declaration of Helsinki - will they weaken the ethical principles underlying human research? N Engl J Med 1999; 341: 527-531. Lurie P, Wolfe SM. Letter to Dr Delon Human, World Medical Association, on Helsinki Principles. Distributed by Public Citizen, Washington DC, March 1999. Levine RJ. The need to revise the Declaration of Helsinki. N Engl J Med 1999; 341: 531-534. Stockhausen K. Ethical hazards in new Declaration of Helsinki. Aust Med Aug 1999; 11: 10-11. Loff B, Black J. The Declaration of Helsinki and research in vulnerable populations. Med J Aust 2000; 172: 292-295. Summary minutes of the 51st WMA General Assembly, Tel Aviv, Israel, October 1999. Woodward B. Challenges to human subject protections in US medical research. JAMA 1999; 282: 1947-1952. Bulletin of Medical Ethics, European Forum for Good Clinical Practice. The 150th issue devoted to a workshop on revising the Declaration of Helsinki: a fresh start. Bull Med Ethics Aug 1999; 150. Report of a Workshop held at the Royal Society of Medicine, London. Revising the Declaration of Helsinki: a fresh start. Bull Med Ethics Oct 1999; 151: 13-17. Some controversial issues raised by the draft Proposed Revision of the Declaration of Helsinki (17. C/Rev1/99)6 Documentation of informed consent Article I.9 of the current Declaration states that a physician should "obtain a patient's freely-given informed consent, preferably in writing".7 Article 24 of the Proposed Revision introduces a waiver of written consent "when the research involves only slight risk or when the procedures to be used are customarily used in the practice of medicine without documentation of consent".6 Benefit of the amendment The amendment could reduce the time and effort needed to obtain written documentation of consent from every research participant. Objection to the amendment It allows a great deal of leeway to waive written consent based on subjective standards such as risk.8-10 It also fails to recognise that research is inherently different from clinical practice and research participants require specific protection that may not be required in clinical practice.10 Access to health care Article II.3 of the current Declaration states that "every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method".7 Article 18 of the Proposed Revision states that "every patient should be assured of the best proven diagnostic, prophylactic or therapeutic method that would otherwise be available to him or her" (emphasis added).6 Benefit of the amendment It may be economically and logistically unfeasible for a researcher to provide the same standard of health care found in an industrialised nation to participants in a developing nation (as required by the current Declaration). The amendment would allow research sponsors in industrialised countries to help developing countries establish affordable treatments and preventive interventions for debilitating diseases, eg HIV/AIDS. 11 Objection to the amendment It diminishes the researcher's moral and ethical commitment to protecting the patient's well-being.8-10 For economically disadvantaged individuals, the local standard of health care may be nothing; thus, providing an economic incentive to conduct biomedical research in economically disadvantaged areas and exploiting particular groups of research participants for commercial benefit.8-10,12 Placebo use and risk Article II.3 of the current Declaration states that "in any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists."7 Article 19 of the Proposed Revision states that "when the outcome measures are neither death nor disability, placebo or other no-treatment controls may be justified on the basis of their efficiency".6 Benefit of the amendment In certain circumstances, it permits placebo use even when a standard therapy already exists. This allows researchers to trial new and improved treatments in a more efficient, cost-effective manner.11 Objection to the amendment In freely allowing placebo use as long as participants do not die or become disabled, it fails to recognise other adverse health effects that could arise from placebo use, such as pain, discomfort or psychological stress.8

Kate Stockhausen

Mooted changes to the Declaration on the agenda of the World Medical Association have sparked a vigorous debate on international research issues. The medical, research and ethics communities in Australia need to participate more broadly in this debate. Introduction The Nuremberg Code, which was formulated to prevent a recurrence of the horrific medical experiments carried out on humans during World War II, is unwavering in its commitment to the primacy of the human subject. It states that any person who is a research participant "should be so situated as to be able to exercise free power of choice" and that "(t)he experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature."1 The Declaration of Helsinki2was the World Medical Association's (WMA's) response to the Nuremberg Code and its goal was to safeguard research subjects. However, in declaring the need to weigh the importance of the research objective against the risk to the subject (Article I.4), the Declaration was seen as a subtle retreat from the Code.3 Some fear that changes to the Declaration currently under consideration by the WMA would substantially "water down" the basic principles of ethical human research. The Declaration does not specifically deal with international collaborations. In 1993, the Council for International Organizations of Medical Sciences (CIOMS) developed the International ethical guidelines for biomedical research involving human subjects,4 which address issues pertinent to the conduct of research in developing countries. Despite the existence of the Declaration and other documents, it is apparent that the application of safeguards to protect research subjects is far from uniform, especially among impoverished or marginalised people.5,6 Proposed revisions to the Declaration of Helsinki A number of revisions are currently proposed to the Declaration to make it more relevant to researchers (some of whom, it has been suggested, commonly breach its provisions).7 Those who oppose the amendments fear that research participants will be made more vulnerable to harm in order to make research more efficient and perhaps expedient (see Box).8Two proposals have generated a great deal of discussion and controversy. One concerns the abolition of the distinction between "therapeutic" and "non-therapeutic" research. The other (the main focus of this article) relates to provision of the best proven treatment and to use of placebo-controlled trials. "Therapeutic" v "non-therapeutic" research The introduction to the Declaration requires that "a fundamental distinction . . . be recognised between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research". Article II.6 states that in "therapeutic" research "The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient." Article III.2 states that in "non-therapeutic" research "The subjects should be volunteers -- either healthy persons, or patients for whom the experimental design is not related to the patient's illness." Robert Levine, Professor of Internal Medicine at Yale University School of Medicine, argues that these Articles together rule out "all rational research on the causes of diseases or on their pathogenesis or pathophysiology".7 He notes that clinical trials may include both therapeutic and non-therapeutic agents.7 Others believe the division between therapeutic and non-therapeutic research to be firmly entrenched in research guidelines developed since and influenced by the Declaration and to be well understood in practice.9 "Best proven treatment" v "highest attainable treatment" The changes proposed to Article II.3 (see Box) have generated extensive debate. Opinions are polarised between those in favour of the "best proven treatment or method" and those for the "highest attainable and sustainable treatment or method". The problem with the "best proven treatment" approach is that it may prevent valuable research being done, as treatments and services will not be readily available in resource-poor settings and may not be provided by researchers and their sponsors. The problem with the "highest attainable treatment" goal is that it may lead to a marked decline in care -- there are no clear criteria for establishing what level of treatment is acceptable or firm safeguards for applying it. The problem in resource-poor countries Perhaps the real issues to be debated are how best to enable people to make meaningful choices and how to ensure that they are not treated poorly and without respect because of their circumstances. What should be examined are the problems created in some societies by a lack of fundamental civil and economic rights, and whether this advantages proposed research projects. To assume that all would like to be treated as people in affluent countries would, and to rely on this judgement as a basis for formulating an encompassing ethical ideal, is, to some extent, misguided. Classic egalitarian premises, upon which comparable rights documents, such as the Universal Declaration of Human Rights,10 are based fail to take account of subcultures and their priorities. Indeed, issues like gender and race are still inadequately addressed in these documents, in which the tacitly assumed "universal person" is the European white heterosexual male.11 This difficulty is accentuated when privileged cultures interact with others. Is it true to say that standards appropriate for industrialised countries are equally relevant to others? If not, what are we left with? Ruth Macklin, Professor of Bioethics at the Albert Einstein College of Medicine in New York, has analysed ethical concerns in international research according to the concept of justice.12 She states that a prominent feature of justice is that no one group should "receive disproportionate benefits or bear disproportionate burdens",12 a corollary being that like cases should be treated alike. One side argues that if the study is unethical in one place it is unethical in both. The other argues that risk-benefit ratios are different in resource-poor countries and therefore require a different response and, further, that if the benefit is actually to accrue and only to accrue to the developing country, this is ethically significant.12 Her conclusion in this debate is that both sides can claim that their arguments observe the ethical requirement of justice. Advocates of placebo-controlled trials in resource-poor countries cite local support and participation in defence of their views. Thus, in the case of trials of less expensive regimens to prevent vertical transmission of HIV, Edward Mbidde, a Ugandan physician, said in a now oft-cited statement, "(t)hese are Ugandan studies, conducted by Ugandan investigators, on Ugandans ... for the good of their people".13 It would be too simple a response to discount this comment entirely as being no answer to a breach of ethical standards.14 Yet, even when a host country agrees to allow drug trials, substantial ethical difficulties remain. One of us (J B), after working for 10 years as a clinician in Mozambique (where the local provincial health service budget was about $US3 per capita per year), believes that the basic rights of potential trial participants in some parts of Africa may be so compromised that refusal to participate is not an option: "This is the sort of health service where every clinician finds him or herself from time to time looking at the pharmacy cupboard and wondering how to divide the remaining three vials of penicillin between the five patients in the ward who need it. (Whether to give starting doses to everyone in the hope that the promised new supplies will arrive, or just give it to one seriously ill child, for whom at least it represents a curative course.) From that perspective, enrolling patients in a clinical trial will always look attractive, no matter how unethical that research may turn out to be."15 Almost any reward, even bars of soap or transistor radio batteries, is likely to ensure trial participation. Perhaps international collaborations, particularly those involving complex drug trials, should not be conducted where there is this degree of poverty. Speaking at the same symposium,15 Pascale Allotey, Lecturer in International Programs at the Key Centre for Women's Health, Melbourne University, made the point that the possibility of enhanced services or cashflow to a community will mean that community leaders will very likely agree to trials taking place, as, ostensibly, will community members. However, they may resent doing so. Fears of a diminished standard of care as a result of withdrawal from a trial are quite real in these circumstances. Where to from here? Are genuinely consensual relations possible between the research community and participants who otherwise have little or no access to healthcare or other basic rights and liberties? Can structures and criteria be implemented that promote dialogue and recognise diversity of approach, but discourage abuse of trial participants? The following suggestions were offered to the participants in the aforementioned symposium15 for consideration, and most agreed that more discussion was required to flesh out what these ideas might mean in practice (the suggestions are not entirely new and are broadly consistent with the CIOMS guidelines and draft UNAIDS guidelines16): (a) Where a population does not possess basic economic or social rights it should be regarded, prima facie, as one whose members' capacity to freely consent is gravely impaired. Research studies in such populations, especially those involving randomised trials, require special justification. An exception might be where the research goal is to work out how to apply a proven technology: for example, an assessment of whether open or covered buckets are more suitable water containers in a refugee camp (Associate Professor Michael Toole, Macfarlane Burnet Centre for Medical Research, personal communication). UNAIDS guidelines16 state that, in international collaborative programs, strategies should aim to balance inequalities by involving members of affected communities from very early on in the design and development stage, and by imposing a number of safeguards around the process of informed consent. (b) A research protocol should describe the conditions that might make a research population vulnerable to exploitation and the steps that will be taken to overcome them.16 The UNAIDS guidelines impose this requirement on research protocols. We further propose that these steps should be described in publications derived from the research, in order to give the issues greater prominence and to further this discussion. (c) In planning research in populations severely deprived of civil and political rights, agreements with governments and ethics committees are insufficient. This is especially the case when governments have demonstrated grossly repressive or corrupt behaviour, or where ethical review systems can not be regarded as independent. Research should not take place in these circumstances. This recommendation should be distinguished from ethical guidelines applying to research in emergency or refugee settings. (d) Thorough community-based consultation is required to determine local views, needs and priorities. Researchers need to establish what local research priorities exist (although, in many deprived populations, any problem area could be seen as a priority). This includes, in particular, consultation with people who have little power or are ostracised for whatever reason. Ethnographic studies could be conducted in advance of a proposed project to determine actual rather than supposed local attitudes, and debriefing could be required after completion of a trial (Deborah Zion, Centre for Human Bioethics, Monash University, personal communication). Including nationals on committees, or agreement by host governments and ethics committees, are not substitutes for community consultation. (e) An analysis should be made, in advance of a project, of the long-term consequences of the intervention. Long-term considerations should certainly include, but not be limited to, sustained access to a trial drug. One of the possible adverse consequences to consider would be the diversion of local researchers and healthcare providers into projects that are not local initiatives. Consistent with current ethical standards, if there is no prospect of benefit to the community in its terms the research should not be undertaken. At the very least, a memorandum of understanding should be prepared before the commencement of any international collaboration, indicating what each party -- community, government, research institution and sponsor -- expects prior to, during and as a consequence of the trial. Conclusion Angela Harris, Professor of Law at the University of California, Berkeley, has stated that modern human rights standards are at once indispensable and inadequate.17 The same may be said for ethical guidelines on medical research. The solutions are not clearcut. The WMA meeting in Tel Aviv, Israel, in October 1999, at which the Declaration of Helsinki was reconsidered, issued the following brief statement: "The meeting heard of widespread support for retaining the existing structure of the Declaration of Helsinki. It was agreed that the working group set up to consider amendments to the Declaration should report back with a proposed revision at next year's annual General Assembly meeting in Edinburgh, Scotland (3 October 2000)." It is to be hoped that the Australian medical research community and other interested groups will debate the issues and arrive at a consensus. Acknowledgements The authors warmly thank the following for their valuable contributions to "The Declaration of Helsinki: a symposium to review current proposals for change", held at the Victorian Institute of Forensic Medicine, Melbourne, on August 30 1999, and for their contributions to the discussion: Stephen Cordner and Helen McKelvie (Victorian Institute of Forensic Medicine), Norman Swan (Radio National), Sandra Hacker (Australian Medical Association), Louis Waller (Faculty of Law, Monash University), Pascale Allotey (Key Centre for Women's Health, Melbourne University), Deborah Zion and Justin Oakely (Centre for Human Bioethics, Monash University), Lyn Gillam (Centre for the Study of Health and Society, Melbourne University) and Ian Kerridge (Faculty of Medicine, Newcastle University). The views expressed in this article are those of the authors. References The Nuremberg Code. From: Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, Oct 1946-Apr 1949. Washington, DC: US Government Printing Office, 1949. World Medical Association. Recommendations guiding physicians in biomedical research involving human subjects. As adopted by the 18th World Medical Assembly, Helsinki, June 1964 (the "Declaration of Helsinki"). Katz J. The consent principle in the Nuremberg Code: its significance then and now. In: Annas G, Grodin M. The Nazi doctors and the Nuremberg Code: human rights in human experimentation. New York: Oxford University Press, 1992: 227-239. Council of International Organizations of Medical Sciences, in collaboration with the World Health Organization. International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS, WHO, 1993. French H. AIDS research in Africa: juggling risks and hopes. New York Times October 9, 1997: A1, A14. Allotey P. Clinical trials in developing countries: bringing people into the debate. Monash Bioethics Review 1999; 18: 18-23. Levine R. The need to revise the Declaration of Helsinki. N Engl J Med 1999; 341: 531-534. Brennan T. Proposed revisions to the Declaration of Helsinki -- will they weaken the ethical principles underlying human research? N Engl J Med 1999; 341: 527-531. British Medical Association. BMA response to the proposed revision of the WMA Declaration of Helsinki. London: BMA, August 1999. Universal Declaration of Human Rights. Adopted and proclaimed by the United Nations General Assembly on December 10, 1948. Geneva: Office of the United Nations High Commissioner for Human Rights. Otto D. Rethinking the "universality" of human rights law. Columbia Human Rights Law Rev 1997; 29: 1-46. Macklin R. Justice in international research. In: Kahn J, Mastroianni A, Sugarman J, editors. Beyond consent: seeking justice in international research. New York: Oxford University Press, 1998: 131-146. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997; 337: 1003-1005. Bayer R. The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and the Caribbean: racist exploitation or exploitation of racism? Am J Public Health 1998; 88: 567-570. Proceedings of a symposium. The Declaration of Helsinki: a symposium to review current proposals for change. Victorian Institute of Forensic Medicine; 1999 Aug 30; Monash University, Melbourne, VIC. Joint United Nations Programme on HIV/AIDS. Ethical considerations in HIV preventive vaccine research: UNAIDS guidance document. Geneva: UNAIDS, February 2000. Harris A. Foreword: the jurisprudence of reconstruction. California Law Rev 1994; 82: 741-785. Authors' details Department of Epidemiology and Preventive Medicine, Monash University Medical School, Alfred Hospital, Melbourne, VIC. Bebe Loff, MA, LLB, NHMRC Public Health Scholar. Jim Black, MB BS, MCommH, DTM&H, NHMRC Medical Scholar. Reprints will not be available from the authors. Correspondence: Ms B Loff, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC. Bebe. LoffATmed.monash.edu.au Some proposed revisions to the Declaration of HelsinkiCurrent statement I.8: Reports of experimentation not in accordance with principles laid down in this Declaration should not be accepted for publication. Proposed revision: Variances from these principles should be explained and justified in the report. Editors are obligated to consider carefully the justification for any variances from these principles in deciding whether to accept or reject the report for publication. Current statement I.10: ...the informed consent should be obtained by a physician who is not engaged in this investigation and who is completely independent of this official relationship. Proposed revision: In some cases of this type, it may be preferable if the informed consent were to be obtained by a qualified person who is not engaged in the investigation, independent of the dependent relationship, or both. Current statement II.3: In every medical study, every patient, including those of a control group, if any, should be assured of the best proven diagnostic and therapeutic method. Proposed revision: In any biomedical research protocol every patient-subject, including those of a control group, if any, should be assured that he or she will not be denied access to the best proven diagnostic, prophylactic or therapeutic method that would otherwise be available to him or her. Current statement II.3: This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists. Proposed revision: This principle does not exclude the use of placebo or no-treatment control groups if such are justified by a scientifically and ethically sound research protocol. When outcome measures are neither death nor disability, placebo or other no-treatment controls may be justified on the basis of their efficiency. Current statement II.5: If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee. Proposed revision: When permitted by applicable law, the requirement for informed consent may be waived by the independent research ethics committee. Such a waiver may be appropriate in research that presents little or no threat to the rights and welfare of research subjects as exemplified by use of anonymous tissue samples for research purposes and in certain other types of research in such fields as epidemiology and policy evaluation. It may be justified in research in emergency situations in which patient-subjects have temporary or enduring loss of decisional capacity and interventions or procedures must be initiated before informed consent can be obtained from patient-subjects or their legally authorised representatives. In the latter case the research ethics committee may require special procedures to protect the rights and welfare of subjects.

Bebe Loff · Jim Black

Editorial Genetically modified food: consternation, confusion, and crack-up The controversy over genetically modified food exposes larger issues about public trust in science and the role of science in policymaking MJA 2000; 172: 148-149 "The great pioneers of our subject were tormented by crises of belief and uncertainty, which we need to understand in facing our own problems today. It is only today, after 70 years, that such understanding is coming within our reach -- and may soon slip out of our reach."1 Did this desperate plea come recently from a scientist in defensive retreat? A scientist, perhaps, embroiled in the debate about genetically modified food, who flinched on reading that Stanley Ewen and Arpad Pusztai had found an "unexpected proliferative effect" of genetically modified potatoes on rat gut?2Not, thankfully, on this occasion. These were the opening remarks of a respected senior botanist, C D Darlington, in an issue of the Philosophical Transactions of the Royal Society of London devoted entirely to the manipulation of genetic systems in plant breeding. He was writing over 20 years ago. Interference with our systems of food production has always aroused public alarm, occasionally with justification. From soaking crops with pesticides to taking short cuts in the feeding of cattle (bovine revenge being wreaked on Britain with variant Creutzfeldt-Jakob disease), food is a lightning-rod for public fears about scientists' allegedly reckless indifference to safety. But, even by these high standards of public sensitivity, the debate surrounding genetically modified organisms became the scientific controversy of 1999,3 a debate that is summarised in this issue of the Journal, with restrained good temper, by Huppatz and Fitzgerald on one side 4 and Leeder on the other.5 Four larger issues have been exposed by these kinds of exchange in the last months of the 20th century, and the arguments they incite threaten the fragile remnant of trust that remains between the public and scientists. First, how can two (reasonably) well-regarded organisations peer review the same work -- Ewen and Pusztai's research on the effects of feeding genetically modified potatoes to rats -- and yet come to such radically opposite conclusions about its validity, as did the Royal Society and The Lancet? All six Royal Society reviewers pronounced the research "flawed", while five out of six of The Lancet's reviewers judged that Ewen and Pusztai's work should be published.6 Peer review as a reliable technique for assessing the validity of scientific data is surely discredited. The mistake, of course, is to have thought that peer review was any more than a crude means of discovering the acceptability -- not the validity -- of a new finding. Editors and scientists alike insist on the pivotal importance of peer review. We portray peer review to the public as a quasi-sacred process that helps to make science our most objective truth teller. But we know that the system of peer review is biased, unjust, unaccountable, incomplete, easily fixed, often insulting, usually ignorant, occasionally foolish, and frequently wrong. A recent editorial in Nature was right to conclude that an over-reliance on peer-reviewed publication "has disadvantages that should be countered by adequate provision of time and resources for independent assessment and, in the midst of controversies, publicly funded agencies providing comprehensive, reliable and prompt complementary information".7 Second, given each outrageously overblown claim and counterclaim about the safety of genetically modified foods, how can the public ever begin to reach a balanced opinion about this important new technology? British -- but hopefully not Australian -- doctors, scientists, politicians, and even journalists, treat the public with little more than patronising contempt when a compelling scientific issue surfaces. According to research published by the United Kingdom's Economic and Science Research Council,8 "the public are not stupid and ignorant about their approach to [genetically modified food] risks but have a sophisticated grasp of the main issues". In the United States, the culture is, as so often, entirely different. Faced with growing public anxiety about genetically modified foods, the Food and Drug Administration (FDA) called three open meetings to discuss the widespread concerns. The FDA plans to channel this public point of view into its own food-labelling and safety policies. Here is a model that other countries might adopt to their advantage. Third, after the latest storm has calmed, how much more do we really know about the safety of genetically modified foods? Regrettably, very little. Considered opinions have been traded,9,10 but few new insights have been gained. The insipid but correct conclusion is that more research -- notably to confirm or refute Ewen and Pusztai's preliminary findings -- is needed. But perhaps the terms of the debate could be refined. Mark Tester, for example, has argued against discussing genetically modified plants as a homogeneous group. Instead, he proposes a classification of such foods based on the type of gene transfer used -- between kingdoms, between plant species, or between genes in a single type of plant genome.11 Each category of transfer carries a diminishing theoretical risk. Careful thinking, and not brutish restatements of old positions, is now required. Finally, this and other recent public health scares have focused attention on the validity of the precautionary principle. This principle states that, where there are significant risks of damage to the public health, we should be prepared to take action to limit those risks, even when scientific knowledge is not conclusive, if the balance of likely costs and benefits justifies it. I have argued that the precautionary principle "offers one useful means to inform decision making".12 By contrast, Aaron Klug, President of the Royal Society, noted in his 1999 anniversary address that the precautionary principle "is no way to deal with uncertainty -- it is a recipe for [scientific] stagnation".13 Therefore, the question remains unresolved: how do policymakers make policy on controversial matters of public health when the scientific evidence is inconclusive? In some ways, this bitter debate is spurious. Huppatz and Fitzgerald repeat a familiar argument -- namely, that "gene technology offers enormous potential for world agriculture". The Royal Society went further, claiming that "we cannot assume that current practices will feed the population of 8 billion expected by 2020";7 hence, genetically modified food offers one solution to a projected global famine. Is this the problem we are trying to solve with genetic modification? If not, then what is? And if so, we may be missing a simpler, but far more profound, answer. The little research that has been conducted about the origins of famine reveals that the solution of "more food" may be no solution at all. There is no direct relation, Amartya Sen concludes in his study of poverty and famine,14 between food availability and starvation. Access to food depends far more on a complex mix of economic, social and political factors -- eg, without an income and a stable environment to exchange money for food, a person may starve in the face of plenty. If Sen's argument is correct, and the evidence he cites is persuasive, seeking a technological food fix for world hunger may be not only the biggest scientific controversy of 1999, but also the most commercially malevolent wild goose chase of the new century. Richard Horton Editor, The Lancet London, UK Reprints: Dr R Horton, The Lancet, 84 Theobald's Road, London, WCIX 8RR, UK. Darlington CD. Genetics and plant breeding, 1910-80. Philos Trans R Soc Lond 1981; B 292: 401-405. Ewen SWB, Pusztai A. Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Lancet 1999; 354: 1353-1354. Controversy of the year: GM foods under attack. Science 1999; 280: 2243. Huppatz JL, Fitzgerald PA. Genetically modified foods -- safety and regulatory issues. Med J Aust 2000; 172: 170-173. Leeder SR. Genetically modified food -- food for thought. Med J Aust 2000; 172: 173-174. Horton R. Genetically modified foods: "absurd" concern or welcome dialogue? Lancet 1999; 354: 1314-1315. Dangers of over-dependence on peer-reviewed publication [editorial]. Nature 1999; 401: 727. The politics of GM food: risk, science, and public trust. London: Economic and Science Research Council, 1999. The Royal Society Statement, 1998. Genetically modified plants for food use. London: The Royal Society, 1998. Millstone E, Brunner E, Mayer S. Beyond "substantial equivalence". Nature 1999; 401: 525-526. Tester M. Seeking clarity in the debate over the safety of GM foods. Nature 1999; 402: 575. Horton R. The new new public health of risk and radical engagement. Lancet 1998; 352: 251-252. Klug A. Anniversary address 1999. London: The Royal Society, 1999. Sen A. Poverty and famines. Oxford: Oxford University Press, 1981. Make a comment

Richard Horton

For Debate Risk management: how doctors, hospitals and MDOs can limit the costs of malpractice litigation Lionel L Wilson and Max Fulton MJA 2000; 172: 77-80 Introduction - What is risk management? - Current litigation environment - Medical defence organisations - Hospitals - What is effective risk management? - Conclusion - References - Authors' details - - More articles on Administration and health services Synopsis The concerns of doctors regarding their risk of malpractice litigation and the costs of indemnity premiums are resulting in calls for legal reforms to limit their liability. We do not believe these returns will be successful either practically or politically. Medical defence organisations often attempt to vindicate the doctor rather than settle the dispute -- a strategy that might be morally satisfying to doctors but which is also more expensive than the approach taken by commercial insurers. Risk management -- the activities required to minimise financial loss for hospitals and the doctors who work in them -- is disorganised or absent in most hospitals. Hospital managers lack incentives for risk management because the costs of litigation do not come out of their budgets. The five mainstays of effective risk management are credentialling of medical staff, incident monitoring and tracking, complaints monitoring and tracking, infection control, and documentation in the medical record. The implementation of risk management activities in hospitals is the immediate responsibility of hospital management, not doctors. IntroductionTypically, the response of the medical profession and the medical defence industry to what appears to be an ever-increasing problem with malpractice litigation and the consequent rise of indemnity premiums is to call for "tort reform" -- that is, changes in the legal system to limit the legal or financial exposure of doctors to tortious actions (in law, a "tort" is a breach of duty leading to a liability for damages). We believe that efforts to achieve limited liability are unlikely to succeed politically or in practice. Unless liability is capped at a level that would be unacceptable to the general public, capping will have little impact on indemnity funding, or insurance costs. For example, given that the value of over 99% of awards and settlements in medical cases is less than one million dollars, a cap of $5 million (which we believe would be the likely minimum rate anyone would consider as "fair") would be unlikely to have any substantive effect. We briefly describe the current professional indemnity environment and suggest actions that doctors, hospitals and mutual funds should consider if they wish to contain the escalating cost of professional negligence indemnity cover. What is risk management? We define risk management as the activities required to minimise financial loss for hospitals and the doctors who work in them.1In the literature there is much confusion between risk management and quality management.2 For our purposes, risk management is only concerned with avoiding patient harm as a means of minimising financial loss and not as an end in itself (unlike quality management). Other authors who recognise the commonality between risk management and quality management spend some time trying to clarify the relationship.3-5 Even if all adverse events (however defined) could be avoided, not all the costs of malpractice litigation would be eliminated. The Harvard Medical Practice Study6-8 found that while less than 2% of negligent injuries led to claims, over 80% of negligence claims were brought in cases in which there was no injury and no negligence.9 This means that, if the right risk management processes and systems are in place, hospitals and doctors should be able to rebut allegations of negligence in 80% of cases and successfully argue that no compensation payment should be made. Current litigation environment Anecdotal evidence suggests a rising tide of anxiety among doctors concerning their exposure to litigation and its costs, both financial and emotional. Many doctors perceive this increased risk as beyond their control and in the hands of others, in particular the judicial system and lawyers. As an example of the rise in compensation payouts, the current high water mark for awards in neurological damage cases is the Black v Lipovac case,10 in which the plaintiff was awarded over $7 million. When costs are added, the medical defence organisation concerned is estimated to have paid out over $10 million.11 In 1994 the highest amount awarded to a child with brain damage was only $2 million (Loo v Harbord Administration Pty Ltd). As for the rate of claims, statistics are very difficult to obtain, resulting in a debate as to whether it is actually increasing. In financial terms, hospitals are in an even more serious situation than doctors, although here again obtaining factual analysis of claims and judgements is extremely difficult, both for the public and private sectors. Australia is not alone in having these problems. Poor clinical risk management is estimated to cost the NHS in the UK some £100 million per annum and, with an increasingly litigious population, this figure is expected to rise sharply in coming years.12 Medical defence organisations (MDOs) Most doctors indemnify themselves against malpractice claims through membership of one of the MDOs. The remaining doctors either go without any indemnity cover or take professional indemnity insurance with a commercial insurer. The MDOs are "doctor organisations": non-profit societies governed by boards consisting mainly of medical practitioners. MDOs are underfunded Only in recent years have MDOs started to adopt the disciplines normally associated with commercial insurance companies, moving to establish wholly owned, authorised insurance companies and to introduce non-doctor, independent directors onto their boards. One sign of this has been the trend away from "discretionary cover" towards legally enforceable insurance contracts. There is still a way to go, and the way is further for some than for others. The MDOs' wholly owned, authorised insurance companies are fully funded and meet the prudential and solvency requirements laid down by Government for insurance companies. However, the MDOs themselves, which have historically provided discretionary cover, are underfunded. Ms Fiona Tito, in her Review of Professional Indemnity Arrangements for Health Care Professionals (commissioned by the Commonwealth Department of Health and published in 1994), assessed the (then) total underfunding at between $300 million and $400 million.13 Claims management Apart from the way MDOs report financially, nowhere is the difference between MDOs and insurance companies more apparent than in the way MDOs manage their members' claims. It seems that the underlying philosophy driving the dispute-settling process of MDOs is an implicit belief that:only doctors can truly understand medical issues, and if plaintiffs and their lawyers could only be made to understand what the doctors reviewing the claim understood about it they would drop the claim; the reason for most adverse events is not negligence by the doctor but the inherent complexities of medicine; as no doctor embarks upon a procedure with the purpose of harming a patient, in fact the very opposite, patients should be grateful for their efforts and not sue if something should go wrong. From this position on the moral high ground, MDOs have a tendency to be far more fixated on maintaining the "innocence" of the doctor (and the profession generally) than on opportunities for early settlement. In contrast, insurance companies are much more likely to be disinterested and pragmatic. More MDO cases are litigated, with settlements being left until later in the dispute resolution process. Often this means that MDOs pay out higher settlements than commercial insurance companies. Many doctors would see the approach taken by MDOs as laudable and correct. MDOs are, after all, non-profit mutual societies. We disagree. Irrespective of the stance taken at the beginning, the vast majority of cases ultimately settle, so why not settle as early as practicable? There is empirical evidence that insurers' legal costs and the average compensation payment are significantly higher in those organisations that are most ready to seek a litigated solution to disputes.14 Yet we are not aware of any MDO which has established an ongoing dispute-mediation program. If mediation is used at all, it is reactive, court-directed mediation, which is a case of "too little, too late". If an MDO pursues a high litigation strategy based on the premise that it is necessary to show plaintiff lawyers that the MDO is "not an easy touch", that strategy will generally be ineffective and will cost its members money. Medical input remains important in claims management, but it is not supreme. The processing and resolution of medical malpractice claims is a highly professional endeavour that should belong as much to the insurance and business world as it does to doctors. Failure to recognise this will only lead to a further escalation of costs and premiums. Hospitals The Tito Report highlighted the absence of effective risk management programs in hospitals (reference 13, page 295). In the past few years, efforts to improve risk management have been made by some public hospital authorities and by private sector groups, but this has not resulted in significant change at the individual hospital level. In the light of the level of claims against hospitals, it is difficult to explain why this is so, but we think the following reasons apply to most hospitals: hospital managers simply do not know what has to be done; or they know what to do but are not prepared to spend time and effort on implementation; or they know what to do but fear the political consequences of doing it; or they fear that the political price they will pay exceeds the costs of paying claims. Unfortunately, the lack of data on claims and judgements is still a serious barrier to analysing hospital and medical claims (reference 13, pages 13, 21). Using data provided by NSW Health, Wilson and Goldschmidt estimated that from 1981 to 1994 there was an average of more than one claim per year for every NSW public hospital (reference 1, pages 25-27). Data from the private sector are even more difficult to acquire. Most evidence is anecdotal, but points to a situation similar to that in public hospitals. For example, one large Australian insurer is refusing to renew any professional indemnity policies for private hospitals. Lack of drivers for change A "driver" is the term applied to incentives and sanctions built into any system. In most States, public hospitals have most of the costs of litigation met by State Treasury funds. As they do not have to meet these costs directly out of their own budgets, at least in the first instance, there is no incentive for public hospital managers to implement effective risk management and no sanctions if they do not. As far as risk management goes, the system in most States is devoid of effective drivers. Many hospitals in the private sector seem to be so fearful of offending their medical staff that they would sooner meet the cost of malpractice litigation or the rising cost of premiums than take steps to reduce risk. While this may be acceptable for some private hospitals, this attitude contributes to the overall increase of doctors' premiums for indemnity insurance. Most claims are settled out of court and generally a higher compensation burden falls on medical practitioners than on hospitals. In our view, when no formal risk management program is in place, the hospital should carry a greater proportion of the financial risk. Hospitals, not doctors, carry prime responsibility for risk management initiatives. Once public hospitals are faced with the full consequences of malpractice litigation, we believe a start will be made to implement effective risk management (reference 13, page 294). Both public and private hospitals should be compelled (by legislation if necessary) to make their statistics on malpractice claims available to the community (in a non-identifiable way) and to their medical staff. What is effective risk management? Five activities are the mainstay of effective risk management: Credentialling of medical staff Incident monitoring and tracking Complaints monitoring and tracking Infection control Documentation in the medical record. Credentialling of medical staff Credentialling, or delineation of clinical privileges of medical staff, is a formal process whereby the medical staff demonstrate competency in procedures, for which they are then given credentials by the hospital's governing body permitting them to perform those procedures in the hospital.15Credentialling should be separate from the appointment process and, if it is to be effective, it must be conducted annually and must be procedure-specific. Although many Australian hospitals claim to be conducting credentialling, we are unaware of any that do so to the level where it becomes an effective risk management tool. If conducted properly, credentialling is a complex undertaking, because it not only must be credible but also must be fair and free from bias or apparent bias. Achieving these ends demands a significant program, which must be planned and managed. To be effective and to prevent, or at least minimise, the possibility of a successful legal action against medical staff or the hospital as a result of the credentialling program, certain basic rules and proper process must be adhered to (see Box) (reference 1, pages 545-563). In spite of the concerns by many doctors about their legal privilege while conducting quality management activity, credentialling is the only aspect of quality management or risk management activity that, if not conducted in strict accordance with the principles listed in the Box, carries the risk of exposing doctors to legal consequences. The need for absolute observance of the terms of reference and the need for a formally structured process are paramount. Even in North America, where credentialling of medical staff has been an intrinsic element in hospital practice for most of this century, there is a recognised need to render credentialling more robust and effective.16,17 The Tito Report, and published material in the US, UK and Australia, strongly support detailed, robust credentialling.13,18-21 Incident monitoring Most Australian hospitals claim to engage in incident monitoring, and NSW Health, for example, collates incident reports from its hospitals. However, incident monitoring and analysis must be conducted as close to the workface as possible if activities to correct identified problems are to have any chance of being implemented. Several factors tend to diminish the practical benefit of incident monitoring as it is currently practised in Australian hospitals. There is no aggregation of incidents (which might be reported to the nursing, medical or hospital administration) within hospitals, and no pattern analysis (tracking). Finally, it is of no use monitoring incidents and conducting a pattern analysis if there is no internal hospital mechanism to correct problems that are identified. The reporting of incidents requires a non-judgemental and non-punitive attitude on the part of hospitals. Nursing staff, for example, will simply not report medication errors if they know that some punishment will follow.19,20 Complaints monitoring For the purposes of quality and risk management in hospitals, complaints must be handled promptly and effectively at the hospital level. In recent years, efforts have been made in several States to change the hospital culture and processes in handling complaints. Nevertheless, it is still all too common for complaints to hospitals to be met by a wall of silence and obstruction. It is still unusual for the hospital manager to become directly involved at an early stage. The patient and family readily see that they are being put off, and this increases the risk that they will become angry, aggrieved and litigious. Hospitals should have a complaints mechanism and a complaints-resolution procedure in place and the hospital manager should play a prominent and early role in this process. Hospitals should have a policy and a mechanism to advise all patients how to make a complaint and such information should be prominently displayed. The recent innovation of patient advocates is a positive step. The monitoring and analysis of complaints becomes a valuable risk management tool. Infection control Infection control is an example of surveillance, the monitoring of one aspect of care. In today's hospital environment, it becomes a vital piece of the risk management strategy. Infection control in most Australian hospitals is generally considered to be well developed. However, like credentialling, it is often not sufficiently rigorous to be an effective risk management tool. Documentation of the medical record Nothing causes doctors and hospitals more medicolegal angst than inadequacies in the medical record. Every case that has to be settled out of court because inadequate documentation precluded an effective defence means a rise in doctors' indemnity premiums. Anecdotal accounts all confirm that the adequacy of medical records in Australia varies widely within the same hospital and from hospital to hospital. In a case that may have far-reaching implications for doctors and hospitals alike, Australian Capital Territory Health Authority v Moorby (unreported, NSW Court of Appeal, 25 June 1997 -- CLS 1997 NSWCA 94), the court applied the doctrine of res ipsa loquitur ("the fact speaks for itself") for the first time in an Australian medical negligence case, finding negligence in the absence of any persuasive explanation for the adverse result which left a healthy 17-year-old severely brain damaged. One of the reasons why the court was able to find as it did was the absence of adequate medical notes. Hospitals should train interns, residents and, if necessary, even visiting medical officers in the requirements for good documentation to reduce the risk of litigation, even if not for the sake of quality of care. The expenditure involved would be returned many times. If hospitals are serious about limiting their risk, they must insist to all medical staff that their continuing appointment depends on maintaining an adequate standard of medical record. Doctors, in their own interest, should support such a move. A medical record review should be conducted every six months in all hospitals. A preliminary analysis of the results of a survey by the Australian Council on Healthcare Standards confirms that a significant proportion of hospital medical records are inadequate (Dr Denis Smith, Australian Council on Healthcare Standards, personal communication). Integration, organisation and problem resolution While doctors and other hospital staff must play an important part in risk management activities, it is hospital management that must make policy decisions and allocate sufficient resources to ensure implementation. Implementing and conducting these activities requires planning, organisation and management. Effective credentialling of medical staff alone is a complex undertaking requiring management resources. Furthermore, it is little use conducting incident monitoring, complaints monitoring or infection control if there is no organisational arrangement in the hospital with the authority and the capacity to correct problems that these initiatives reveal. The absence of problem-resolution mechanisms in hospitals is a major cause of poor quality and unnecessary risk. Conclusion Both hospital managements and MDOs have a role to play in containing the rising cost of professional indemnity. More effective efforts by hospitals to manage the risk of claims against them and their medical staff is the first essential. Effective credentialling of medical staff and a serious effort to improve medical records alone would result in a significant reduction in claims and hence in premiums. Doctors alone do not have the authority to implement effective risk management in hospitals, but they can certainly bring their considerable influence to bear on hospitals to implement the range of activities we have described. Doctors should also be reassuring their hospitals that risk management initiatives have their full collective support. Better claims management is the other essential requirement and this lies in the hands of the MDOs. These organisations have to continue the process of internal reform that they have already started or they will have reform forced upon them by commercial competition. Without these changes, the current escalation of indemnity premiums for doctors is unlikely to be effectively addressed. References Wilson LL, Goldschmidt PG. Quality management in healthcare. Sydney: McGraw-Hill; 1995. Quality and Outcomes Branch, Commonwealth Department of Health and Aged Care. Clinical Risk Management in Rural Victoria. Better Health Outcomes (A newsletter for the Health Service). 1998; December: 16. Bennett B. Quality care through risk management. Orthopaedic Nursing 1993; 12(3): 54-55. Atkins P. Reducing risks through quality improvement, infection control and risk management. Crit Care Nurs Clin North Am 1995; 7: 733-741. Murphy D. The development of a risk management program in response to the spread of bloodborne pathogen illnesses. J Intravenous Nurs 1995; 18 Suppl 6: S43-S47. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324: 370-376. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalised patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324: 377-384. Localio AR, Lawthers AG, Brennan TA, et al. Relation between malpractice claims and adverse events due to negligence. Special article. N Engl J Med 1991; 325: 245-251. Brennan TA. Medical injuries: international perspectives. Med J Aust 1995; 163: 475-476. Black v Lipovac [1998] 699 FCA (4 June 1998). Hirsch D. Lessons from Lipovac Aust Health Law Bull 1998; 6: 85-87. Knowles D. Clinical risk management. Br J Hosp Med 1995; 53: 291-292. Tito F, Chairman. Compensation and Professional Indemnity in Health Care. Review of Professional Indemnity Arrangements for Health Care Professionals. Canberra: Commonwealth Department of Human Services and Health, 1994. Wright T, Eyland A, Cox J. Claiming under the Motor Accidents Scheme. Sydney: Justice Research Centre. August 1998. Wilson LL. Credentialling of hospital medical staff. J Qual Clin Prac Dec 1997; 17: 187-194. Weagly S. Making the case for robust provider credentialling. Health Care Innovations May/June 1996: 29-39. Suarez CA. Training, credentialing, economics and risk management in operative surgery. Int Surg 1994; 79: 268-272. United States General Accounting Office. Health care: initiatives in hospital risk management. Washington: USGAO, 1989: 17. Elnitsky C, Nichols B, Palmer K. Are hospital incidents being reported? J Nurs Admin 1997; 27(11): 40-46. Mant J, Gatherer A. Managing clinical risk. BMJ 1994; 308: 1522-1523. NHS Management Executive. Risk management in the NHS. London: Department of Health, 1993. Authors' Details Health Systems Sciences, School of Public Health, La Trobe University, Melbourne, VIC. Lionel L Wilson, AM, FRACGP, Member of Faculty; Director of Qual-Med Pty Ltd, Sydney. Claims & Liability Management Services Pty Limited, Sydney and London. Max Fulton, LLM, MBA, Director; previously General Manager of United Medical Defence. Reprints will not be available from the authors. Correspondence: Dr L L Wilson, 134 Queens Road, Connells Point, NSW 2221. lwilson10ATCompuserve.com Requirements of the credentialling process Properly constituted credentials committee with terms of reference Carefully prepared minutes Absolute confidentiality Observe the rules of natural justice (ie, a reasonable decision made after giving the affected parties a right to be heard) Highly structured formalised process All medical staff subjected to the same process All decisions in the form of recommendations to the board Procedure-specific decisions to be given in writing to each medical staff member Back to text

Lionel L Wilson · Max Fulton

The Weight Debate Obesity and virtue. Is staying lean a matter of ethics? Self-control of one's own weight might be described as a form of bioethics John N Burry MJA 1999; 171: 609-610 Article - References - Authors' details - - More articles on Ethics

John N Burry

The Weight Debate Why staying lean is not a matter of ethics Joseph Proietto MJA 1999; 171: 611-613 Introduction - What is obesity? - Is obesity a risk to health? - Are obese people entirely responsible for their excess weight? - Are the obese abused in our society? - What should be the consequences of our new knowledge of the aetiology of obesity? - Acknowledgement - References - Authors' details - - More articles on Ethics

Joseph Proietto

Sex, Science & Society Reproductive technology, efficiency and equality Our challenge is to ensure everyone can share the benefits of reproductive technologies Julian Savulescu MJA 1999; 171: 668-670 Introduction - The radical possibility - Sex and reproduction - Should we fear the radical possibility? - Acknowledgements - References - Authors' details - - More articles on Ethics Introduction As epitomised by the Clinton sex scandal, "having sex" can be an elusive concept to define. For this article, I will define "having sex" broadly as any intentional physical touching between at least two persons which results in sexual feelings in at least one of them. What I will argue is that one possibility -- the Radical Possibility -- is that many people may not be having sex in 2099. The interesting question is not "Will we be having sex in the year 2099?" but "Who will be having sex in 2099?". Having sex has two primary purposes: pleasure and reproduction. Some would add intimacy and expression of love. There are also secondary purposes, such as providing employment, or to obtain physical protection. The radical possibility Sex for pleasure and Nozick's Experience Machine In 1974, the philosopher Robert Nozick asked us to imagine what life would be like in the "Experience Machine", a machine with electrodes that can be implanted into our brains to provide any set of experiences which we dial up, including "writing a great novel, or making a friend, or reading an interesting book. All the time you would be floating in a tank, with electrodes attached to your brain". Nozick is sceptical that we would plug in to such a machine. What does matter to us in addition to our experiences? First, we want to do certain things, it is only because we want to do the actions that we want the experiences of doing them or thinking that we've done them . . . A second reason for not plugging in is that we want to be a certain way, to be a certain sort of person. Someone floating in a tank is an indeterminate blob . . . Is he courageous, kind, intelligent, witty, loving? It's not merely that it's difficult to tell; there's no way he is . . . Thirdly, plugging into an experience machine limits us to a man-made world, to a world no deeper or more important than that which people can construct. There is no actual contact with any deeper reality, though the experience of it can be simulated.1 Nozick makes two claims. The first, that we should not connect to such a machine, I will address later. His second claim is that we would not connect. This has not been borne out by history. We have enthusiastically embraced various "experience machines". Television and other electronic fantasy worlds have replaced the real world of games and play for many children. Sometime next century, "sensual machines" will deliver a complete visual-auditory-tactile environment.2 "Virtual sex" may well become more pleasurable, more available, less risky, and cheaper than what some people find to be a rather ordinary, painful or disappointing physical alternative compared with the glamorous "reality" offered to them by the advertising and other industries. By 2099, Nozick's Experience Machine may be a reality. Moore's Law states computational power is roughly doubling every 18 months. Bill Gates has claimed that in 20 years a US$10 000 computer will have the same power as the human brain.2 If artificial intelligence replaces or supplants human intelligence, and human minds "upload" into machines3 or are replaced by them, "sex" between artificial minds may become a reality. The intimacy and love aspects of sex would presumably be as important to artificial persons as they are to us, and sex between artificial persons could mimic or improve all aspects of physical sex. Sex and reproduction Many will regard the possibility of virtual sex replacing physical sex for pleasure as unlikely. What is more likely is that many people in 2099 will no longer reproduce by sexual intercourse. Already 1.2% of births in Australia are the result of artificial reproduction (AR),4 defined as reproduction by any means not employing sexual intercourse. At present, AR is almost entirely confined to the treatment of infertility and prevention of genetic disease. The use of AR may expand considerably in the near future for two reasons: the introduction of preimplantation genetic diagnosis (PGD) and the identification of new genetic information. When the Human Genome Project is complete, the potential of PGD will be enormous. Couples may be able to select embryos less likely to develop heart disease, cancer, dementia, and so on. As genes for more complex characteristics like intelligence,5 personality and behaviour are identified, there will be pressure to select certain desired traits. PGD is now used for sex selection,6 and may in the future play a greater role in family planning. The next step might be to remove any genetic predisposition to disease. Still more controversially, we may modify non-medical characteristics (eg, creating darker-skinned children to protect against UV radiation as the ozone layer disappears). We may soon see the use of AR beyond treating infertility or preventing genetic disease. Postmenopausal women have produced children using AR with donor eggs, and men have "donated" sperm after death and fathered children.7,8 A 32-year-old investment banker recently had embryos frozen in England to allow her the option of having a child after she had established her career.9 Freezing eggs is more experimental and not readily available. However, the technology is rapidly advancing and births have been reported.10-13 Although freezing embryos is a well developed technique, is readily available, and has good success rates, it requires sperm -- freezing eggs does not. Freezing eggs and embryos has a number of attractions (Box 1). Reproduction may change more radically. Cloning in non-human animals is already a reality.14 In some States same-sex couples and single people can use AR to reproduce with donor gametes; in future, parthenogenesis (the production of an individual from an egg) and induced meiosis (causing a somatic cell to change to a sex cell) may enable them to have a child with genetic material from only themselves. Should we fear the radical possibility? I have raised the above as mere possibilities. I have not endorsed or rejected them. The radical possibility, then, is the possibility that many people will not have sex -- as physical touching -- either for pleasure or for reproduction. Nozick claimed that we should not connect to the Experience Machine. In part, his claims were based on the limits of artificiality and the man-made world. But it remains an open question what "pleasure machines" and artificial intelligence would be able to do, and what we would be able to do with them. Non-carbon-based life may be better, more productive and part of a "deeper reality". Ethical concerns Many concerns about the radical possibility will be raised. The most valid concern about any new technology is its safety, as the National Bioethics Advisory Commission concluded in its inquiry into cloning.15 Harm to others is also an important concern. For example, sex selection is alleged to have harmful effects on children of the opposite sex in the family and for the status of women in society. Another concern is that the use of technology to select children will place great expectations on the child. In the cloning debate, this is called the "living in the shadow" objection. It is argued that parents, in choosing a child with defined characteristics, may fail to love that child "unconditionally" and use (or commodify) it for their own ends. There are also worries that the use of these technologies will change the structure of families. For example, the offspring produced by cloning will have only one immediate genetic parent, and in AR, offspring may not know their genetic parents, and half- or full-siblings may not know of their relationship. Victoria and South Australia now require that details of gamete donors be kept and released to offspring. Concerns have been raised by UNESCO that cloning is an "affront to human dignity".16 However, there are over 5000 clones living in Australia today who have happy, normal existences. Indeed, one in every 300 births produces new clones (as identical twins). "Slippery slope" arguments claim that the expanded use of AR is the thin end of the wedge, the beginning of a return to Nazi eugenics and euthanasia.17,18All these objections have been critically addressed in the ethics literature.9,19-20 There are two major arguments for allowing access to these new technologies. The first is respect for "procreative autonomy", the liberty of couples to decide when and how to have children, and indeed which children to have, according to what they judge is best.10 Parents know best their own circumstances and ultimately it is parents who must live with and make sacrifices for their children. The second argument is that there can be good reasons in individual circumstances to choose certain characteristics in the children we bear. Consider the Ayala case (Box 2). In similar cases, AR has been used to produce children to serve as bone marrow donors.24 There was only a one-in-four chance that the child the Ayalas conceived would be compatible with Anissa. Use of AR (cloning Anissa or PGD and HLA typing of embryos) could have made it certain that the child would be compatible with Anissa. While Marissa's parents "used her" to save the life of Anissa, they also appear capable of loving her as a person in her own right. And her sister's life was saved. Should Marissa regret the fact that her parents decided to have her to provide bone marrow for her sister? She could, if her life has been so bad that she wishes she had never been brought into existence, but her life is not that bad. This raises a general point about reproductive technologies: if the intervention determines which unique sperm and egg unite, that particular child would not have existed without the technological intervention. Even if the child is disadvantaged psychologically, it is only wrong to employ the technology from the child's perspective if its life is so bad that it is not worth living. Efficiency and equality There is, however, at least one thing wrong with the radical possibility. There is already strong, justifiable pressure not to use scarce community resources to provide access to these new technologies. Thus, couples receiving IVF and PGD for sex selection in Sydney receive no Medicare rebate and fund the full cost themselves. Economic considerations will deny many people access to these interventions. Who will be having sex in 2099? It is possible that only the poor will be having sex, for either pleasure or reproduction. This would have at least one bad effect. The rich will enjoy the highest pleasures and select or create the babies they judge to be best. While some people are better off and no-one is worse off, this is potentially divisive and inegalitarian. There may be serious conflict between efficiency and equality. There may also not be a conflict. If genetic and reproductive technology is used to prevent genetic disease or correct genetic inequality, this may promote both equality and efficiency. Some have argued that genetic enhancement of those disadvantaged by the genetic lottery is required by justice.25 What if there is an irresolvable tension between equality and efficiency? There are several alternatives. One is to ban the use of technology in these ways and so to ensure that nobody has access to it. If the divisiveness that differential access to these technologies causes is great enough to threaten social stability, this may be the best option. Another option is to ensure that everyone has some access to AR, or a right to a "fair go". Consider a parallel: football. Everyone can go to the football. Some have better seats, some meet the players, some get to go to the Grand Final, some even have individual boxes, but everyone can go and watch and barrack and feel a part of the footy culture. When there is talk of building a new football stadium, no-one ever says (at least not publicly) that the resources would be better used to reduce hospital waiting lists or on improving health in other ways. Our challenge may be to find some way in which all the community can enjoy, to some level, the perceived benefits of technological advance, whether these be new forms of pleasure or different modes of reproduction, even if the benefits are not the prevention or treatment of disease. Even if we do not use community resources from the health budget to fund access to these new technologies (because they represent "personal preferences" and not "medical needs"), perhaps we can access other budgets -- sport and leisure for example -- to fund more equitable access. At any rate, what all of us have a legitimate claim to is a tolerably good life in a broad sense, and not the longest life, or even the healthiest possible life. Acknowledgements Thanks to Evan Hollonds and Ainsley Newson. References Nozick R. Anarchy, state and utopia. New York: Basic Books, 1974; 43-44. Kurzweil R. The age of spiritual machines. Sydney: Allen and Unwin, 1999; 146-149. Broderick D. The spike. Melbourne: Reed Books, 1997. Hurst T, Shafir E, Lancaster P. Assisted conception Australia and New Zealand 1997. Sydney: Australian Institute of Health and Welfare National Perinatal Statistics Unit, 1999; 1. Newson A, Williamson R. Should we undertake genetic research into intelligence? Bioethics 1999; 13: 327-342. Savulescu J. Sex selection: the case for. Med J Aust 1999; 171: 373-375. Harris J. Rights and reproductive choice. In: Harris J, Holm S, editors. The future of reproduction. Oxford: Clarendon Press, 1998. Robertson JA. Children of choice: freedom and the new reproductive technologies. Princeton: Princeton University Press, 1994. Brennan Z. Woman to freeze embryo for the sake of her career. The Sunday Times (London) 1998; 16 August. Porcu E, Fabbri R, Seracchioli R, et al. Birth of a healthy female after intracytoplasmic sperm injection of cryopreserved human oocytes. Fertil Steril 1997; 68: 724-726. Gook DA, Edgar DH. Cryopreservation of the human female gamete -- current and future issues. Hum Reprod. In press, 1999. Kolata G. Researchers report breakthrough using frozen eggs to create pregnancy. New York Times 1997; 17 October: 1. Tucker MJ, Wright G, Morton PC, Massey JB. Birth after cryopreservation of immature oocytes with subsequent in vitro maturation. Fertil Steril 1998; 70: 578-579. Wilmut I, Schnieke AE, McWhir J, et al. Viable offspring derived from fetal and adult mammalian cells. Nature 1997; 385: 810-813. National Bioethics Advisory Commission. Cloning human beings. Maryland: National Bioethics Advisory Commission, 1997. UNESCO. Declaration on the Human Genome and human rights, adopted on 11 November 1997 (13), Article 11. UNESCO, 1997. Lamb D. Down the slippery slope: arguing in applied ethics. New York: Croom Helm, 1988. Burgess JA. The great slippery slope argument. J Med Ethics 1993; 19: 169-174. Harris J. Goodbye Dolly? The ethics of human cloning. J Med Ethics 1997; 23: 353-360. Tooley M. The moral status of the cloning of humans. In: Humber JM, Almeder RF, editors. Human cloning. New Jersey: Humana Press, 1998; 65-101. Harris J, Holm S, editors. The future of reproduction. Oxford: Clarendon Press, 1998. Rachels J. When philosophers shoot from the hip. Bioethics 1991; 5: 66-71. Hastings Center Report 1994; May/June: 2. Lamperd R. Race for life. Sun Herald (Melbourne) 1998; 2 July: 1. Holtug N. Does justice require genetic enhancements? J Med Ethics 199; 25: 137-143. Authors' details Royal Children's Hospital, Melbourne, VIC. Julian Savulescu, MB BS, PhD, Director, Ethics Unit, Murdoch Institute, and Director, Ethics Program, Centre for the Study of Health and Society, University of Melbourne. Reprints will not be available from the authors. Correspondence: Associate Professor J Savulescu, Murdoch Institute, Royal Children's Hospital and Centre for the Study of Health and Society, University of Melbourne, Parkville, VIC 3052. savulesjATcryptic.rch.unimelb.edu.au Make a comment 1: Benefits of freezing eggs or embryos for non-medical reasons Promotes equal participation by women in employment Gives women time to find a partner May allow establishment of a family at a better time Allows women and couples to have another child if circumstances change An option for women and children at risk of premature ovarian failure May reduce risk of genetic abnormality Freezing gametes avoids some of the moral objections to freezing embryos Back to text 2: The Ayala case A 17-year-old girl, Anissa Ayala, had leukaemia. When no donor had been found after two years, her father had his vasectomy reversed with the intention of having another child to serve as a bone marrow donor. There was a one-in-four chance the child would be compatible with Anissa. The child who was born, Marissa, was a compatible donor, and a successful transplant was performed.22 A report later noted: "Marissa is now a healthy four-year-old, and, by all accounts, as loved and cherished a child as her parents said she would be. The marrow transplant was a success, and Anissa is now a married, leukaemia-free, bank clerk."23 Back to text

Julian Savulescu

Clinical Practice Surgery in the Information Age Currently, surgical procedures involve direct data flows of sensation and mechanical output. As information technology progresses, surgery will change to a system of electronic data flows, with technical, ethical, and training implications. Patrick Cregan MJA 1999; 171: 514-516 Introduction - Electronic sensory input - Electronic mechanical output - The patient -- the data source - The surgeon - Conclusion - References - Authors' details - - More articles on Surgery Introduction Currently, a surgical procedure is a direct human-to-human process in which sensory input and mechanical output data flow directly between patient and surgeon (Box 1). Procedures are usually taught using human or animal models and the utility of the procedure and the surgeon's ability are measured predominantly by patient outcomes. However, new technologies in which computing, graphics, robotics, telecommunications and touch converge are changing all this. A surgical procedure will become a flow of electronic data: sensory input will be transmitted electronically to the surgeon, the surgeon's responses and actions will be converted to electronic data, and then translated back to mechanical intervention at the patient. Electronic sensory input The application of television to surgery was the basis for the revolution in laparoscopic cholecystectomy and similar advances in arthroscopic and other endoscopic surgical techniques (Box 2). With these techniques, the surgeon receives and responds to electronic data. Not only vision but other sensory input data -- force feedback sensation, touch and proprioception -- can be relayed locally or at a distance in real time.1,2 "Telesmell" is under development;3 currently about 30 smells can be rendered via an electronic interface. Implications Electronic sensory input can be manipulated. Images can be overlaid with other digital data -- a television monitor can display the patient's tumour, as imaged with spiral computed tomography (CT) or magnetic resonance imaging (MRI), superimposed on the live image to guide the surgeon (eg, Navitrack, Orthosoft Inc, Montreal4). Other data, such as history, vital signs or other physiological data, can be included in the image, or the image can be magnified, enhanced or rendered in three dimensions. The surgeon now has enhanced sensory input beyond that which is currently available in the traditional surgical scenario of the patient on the operating table. Additional sensory inputs can be added to further enhance skills; for example, proximity sensing with ultrasound can drive an audio feedback similar to that used in aircraft signalling ground approach.5 Electronic mechanical output Sensory input is only one half of the data loop in a surgical procedure. For electronic surgery the surgeon's actions must be translated reliably into electronic data which can be translated back to mechanical output. The means for mechanical-to-electronic translation is already in use in our daily lives -- the mouse and keyboard on our computer, or controllers for video games. Surgical control interfaces have been developed: these include hand-controlled adapted instruments (eg, Virtual Laparoscopic Interface, Immersion Corporation, San Jose, California6); gloves to measure and translate hand movement to data flows (eg, CyberGlove, Virtual Technologies Inc, Palo Alto, California7); and sensors fitted to ordinary instruments (eg, the 3D tool developed at Stanford University using a miniBIRD sensing system [Ascension Technology Corporation, Burlington, Vermont]8). Implications An electronic interface allows for other methods of data input. Voice control and activation are in routine use in operating rooms with the AESOP camera-holding robots (Computer Motion Inc, Santa Barbara, California)9 and the HERMES system of controlling many functions of the operating room (Computer Motion). Other possibilities for interaction being explored include electromyographically driven devices. Machines are good at things that humans are poor at. Machines can be immensely strong or gentle, they are perfectly still when required or can move very rapidly. Their motion can be scaled up and down and they do not become tired or bored. Electronic-to-mechanical translation has been slower to develop, but there are now robots (AESOP)9 holding and moving laparoscopic cameras in operating rooms, approved by the US Food and Drug Administration (FDA). The first fully robotic procedure, in which all the instruments were held and moved by a robot (ZEUS, Computer Motion),9 was performed in a real life tubal reanastomosis procedure at the Cleveland Clinic in June 1998. The FDA has now given approval for a trial in humans of ZEUS for microvascular cardiac and other minimally invasive procedures, and daVinci surgical robotic systems (Intuitive Surgical Inc, Mountain View, California)10 are being assessed for use in many common surgical procedures (Box 3). French surgeons have operated on human hearts using robots to hold and use the instruments,9 and in the United States several institutions are assessing these technologies.11,12 Implications A surgeon can be actively involved in mechanical movement in an operative procedure at a remote site (telesurgery). This has been performed at several places around the world, including a demonstration at the Royal Australasian College of Surgeons' Annual Scientific Congress in Sydney in 1998. Surgical skills can be improved and new procedures may be realised; for example, beating heart coronary bypass grafts with the effectors suturing under the surgeon's control while the heart and instruments appear still to the surgeon because the view and effector instruments are electronically synchronised with the heart's movements. The patient -- the data source In the electronic data flow model, the patient is the main source of data, encompassing anatomy, pathology, mechanical and physiological responses to tissue handling (local and general). These data change continuously in response to the surgeon's actions. There are now a number of virtual reality (VR) simulators where training can occur using a simulated system as the "patient", with excellent graphics and the ability to change anatomy, pathology and operative problems (eg, to simulate bleeding). For example, HT Medical Inc (Gaithersburg, Maryland) produces a realistic intravenous catheterisation simulator,13 and bronchoscopy, colonoscopy, gastroscopy and arthroscopy simulators are now appearing.5,14Implications The electronic data that represent the patient can be simulated, manipulated, stored and accessed at a distance in time and space from the surgeon. The need for live-patient or animal training is past; virtual surgery and VR surgical simulation have arrived. Preoperative simulation may raise ethical dilemmas as well as improve technique: do we believe a simulation that says that the patient is unsuitable for operation, or try anyway in a "hopeless" case? Patient privacy may be hard to guarantee when patients are reduced to "data pools". The surgeon Can the surgeon then be replaced in the data loop? Ultimately, the answer is "yes". However, there are technical limitations, which mean that this will happen slowly. In particular, the human ability to recognise complex patterns in real time, to develop and amend complicated strategies and to monitor the results, combined with machine limitations (insufficient computing power, lack of bandwidth to transfer the necessary data in real time and poor pattern recognition by machines), mean that surgeons will be needed at least for the foreseeable future. Implications Because the surgeon's actions are now a stream of data, they can be stored, measured, scored, reproduced and used as educational tools. One surgeon can teach procedures to many individuals simultaneously, assess their progress, and certify competence against a scale of objective measures. There is evidence that VR training using the MIST VR trainer15 or similar interface16 improves skill acquisition beyond conventional techniques. Skills decomposition studies, in which the various actions in a procedure are separated out and analysed, suggest that VR training may have a useful role in learning technique.17 Recertification or skills upgrading can be assessed through VR simulations. New techniques can be learned remotely and rehearsed prospectively. Ongoing monitoring of competence is available not only to the surgeon, but also to patients, hospital administrations, registration authorities, colleges and government. A glimpse of the future Dr Mary Jones wishes to perform a new technique for minimally invasive liver resection. She has studied the literature and videos, and attended a virtual workshop at the liver resection Internet site. The basic procedure was rehearsed at her surgical workstation, using a medical VR model developed by Dr Stephen Lucasberg. Her technical skills in the procedure have been assessed and accredited by the College of Surgeons' virtual certification process, and permission for the procedure was granted by the hospital's credentials committee. A virtual simulation of the procedure, using the actual patient's MRI- and CT-derived images, indicates a 92% likelihood of success, so, after discussion with the patient, the procedure is undertaken. As this is the first time the procedure has been done in Australia, the surgery is being telementored and assisted by Dr Gates in Seattle, using a telesurgery interface so that he will be able both to assist and complete the procedure if there are problems. The image of the patient's lesion is overlaid with data from the preoperative MRI scan, and CT scan data are available to overlay as well. After introduction of the instruments, the procedure commences. Despite the patient's respiratory excursion, and therefore movement of the liver, the working image and instruments remain still, as they are linked electronically to fiduciary points in the image. Magnification of the image is readily available as needed, and proximity sensors fitted to the tips of the instruments will help identify and avoid damage to the inferior vena cava, which lies close behind the lesion. As Dr Jones recently fractured her forearm while skiing, she will use electromyography to control her left-hand instruments and retinal tracking to control the picture. A voice interface controls the light and camera settings, cable position, and data display on the screen, and can call up laboratory results and other data. The procedure was completed successfully and Dr Jones's movements were all stored, analysed, and subsequently scored. Dr Gates reviewed the scores and noted some over-shooting of the liver resector posteriorly, and recommended that Dr Jones undertake additional training in depth perception analysis before her next procedure. Her registrar will replay the procedure a number of times, being guided by haptic feedback to the instruments she is holding so as to learn the tissue "feel" and proprioception in the procedure. Conclusion The convergence of Information Age technologies such as computing, robotics and telecommunications will radically alter the performance, teaching, recording and assessment of surgical procedures. The concept of surgery as a flow of data between surgeon and patient gives a framework for assessing these technologies and developing new techniques. References Satava RM, Jones SB. Human interface technology. In: Satava RM, editor. Cybersurgery: advanced technologies for surgical practice. In: Sackier JS, Series editor. Protocols in general surgery. New York: John Wiley & Sons, 1998; 24, 28, 30. Satava RM, Jones SB. Telepresence surgery. In: Satava RM, editor. Cybersurgery: advanced technologies for surgical practice. In: Sackier JS, Series editor. Protocols in general surgery. New York: John Wiley & Sons, 1998; 143-144. Krueger MW. Olfactory stimuli in virtual reality for medical applications. In: Medicine meets virtual reality. 7: The convergence of physical and informational technologies: options for a new era in healthcare. Proceedings of the Seventh Medicine Meets Virtual Reality Conference. 1999 Jan 20-23, San Francisco. 61. Navitrack. Orthosoft.<http://www.orthosoft.ca/navitrack.html>. Accessed 12 October 1999. Karron DB, Bucholz RD, Wegner K, Zicarelli D. Tactical audio for neurosurgical navigation: first clinical experience. In: Medicine meets virtual reality. 7: The convergence of physical and informational technologies: options for a new era in healthcare. Proceedings of the seventh Medicine Meets Virtual Reality Conference. 1999 Jan 20-23, San Francisco. 58. Immersion Corporation. <http://www.immerse.com/>. Accessed 12 October 1999. Virtual Technologies, Inc. <http://www.virtex.com/>. Accessed 12 October 1999. Ascension Technology Corporation. <http://www.ascension-tech.com/>. Accessed 12 October 1999. Computer Motion, Inc. <http://www.computermotion.com/>. Accessed 12 October 1999. Intuitive Surgical, Inc. <http://www.intusurg.com/>. Accessed 12 October 1999. Department of Surgery. Uniformed Services University of the Health Sciences.<http://surgery.usuhs.mil/>. Accessed 12 October 1999. Department of Surgery. Yale University. <http://yalesurgery.med.yale.edu/>. Accessed 6 October 1999. HT Medical Systems, Inc. <http://www.ht.com>. Accessed 12 October 1999. Englmeier K, Haubner M, Krapichler C, Reiser M. A new hybrid renderer for virtual bronchoscopy. In: Westwood JD, Hoffman HM, Robb RA, Stredney D, editors. Medicine meets virtual reality. In: studies in health technology and informatics technology. Vol. 62. Ohmsha: IOS Press, 1999; 109-115. Chaudhry A, Irvine V, Sutton C, McCloy R. Quality of human-computer interaction, learning rate, fixed and variable factors affecting performance on a laparoscopic simulator, MIST VR. In: Medicine meets virtual reality. 7: The convergence of physical and informational technologies: options for a new era in healthcare. Proceedings of the seventh Medicine Meets Virtual Reality Conference. 1999 Jan 20-23, San Francisco. 43-44. Gorman PJ, Lieser JD, Murray WB, Haluck RS, Hummel TM. Evaluation of skill acquisition using a force feedback, virtual reality based surgical trainer. In: Westwood JD, Hoffman HM, Robb RA, Stredney D, editors. Medicine meets virtual reality. In: studies in health technology and informatics technology. Vol. 62. Ohmsha: IOS Press, 1999; 121-123. Cao CGL, MacKenzie ML, Ibbotson JA, et al. Hierarchical decomposition of laparoscopic procedures. In: Medicine meets virtual reality. 7: The convergence of physical and informational technologies: options for a new era in healthcare. Proceedings of the seventh Medicine Meets Virtual Reality Conference. 1999 Jan 20-23, San Francisco. 43. Authors' details Nepean Hospital, Penrith, NSW. Patrick Cregan, FRACS, Surgeon, Department of Surgery. Reprints: Dr P Cregan, PO Box 1124, Penrith, NSW 2751. Patrick_CreganATonaustralia.com.au Back to text Back to text Back to text

Patrick Cregan

Abstract Objective: To ascertain general practitioners' perceptions of medicolegal risk when screening for prostate cancer, and explore the potential impact of three national guidelines on perceptions and clinical practice. Design: Postal survey in August 1997. Participants: 219 randomly selected GPs in New South Wales (65% response rate). Main outcome measures: Response to case scenarios; perceptions of medicolegal risk and protection afforded by national guidelines before and after reading extracts of three national guidelines; ratings of current and potential strategies to increase GPs' sense of medicolegal protection. Results: 90% (95% CI, 86.5%-94.3%) would screen an asymptomatic male patient and 61% (95% CI, 54.2%-67.2%) indicated GPs would be at risk if they did not screen. Although significant changes in responses were found after respondents had read guideline extracts, 46% (95% CI, 39.5%-52.7%) continued to perceive medicolegal risk if screening was not performed. About two-thirds (65%; 95% CI, 59.9%-72.5%) supported a clear statement about the legal status of guidelines in a court of law to increase their sense of medicolegal protection. Conclusions: Even when made aware of national evidence-based guidelines against prostate cancer screening, GPs in our survey perceived limited hypothetical medicolegal protection. Introduction In Australia, the risk of medical litigation has increased. For general practitioners, the risk of being sued doubled from 1:160 in 1990 to 1:84 in 1994.1 If doctors believe these risks are substantial, this belief alone may influence their clinical behaviour.2-5Medicolegal risk may be reduced if practice is within existing clinical practice guidelines.6 Prostate cancer screening represents a "test-case" for such guidelines.7 Although there is no evidence that premature mortality from prostate cancer will be reduced by screening (see Box 1), Australian men report high rates of testing.12,13 GPs use prostate-specific antigen (PSA) assays for screening, either alone or combined with digital rectal examination (DRE).11,14,15 Current tests cannot distinguish innocuous from aggressive malignancy.16 Treatment options for men with localised prostate cancer currently available are "unnecessary for some and insufficient for others".17 On current evidence, men's quality of life may be diminished by anxiety, unnecessary treatment and adverse complications if screening is recommended.16 Unsurprisingly, 39% of GPs surveyed in 1995 indicated that prostate cancer screening guidelines would be "extremely" or "very" useful.18 Three sets of guidelines ensued, each recommending against screening.9,19,20 Yet, Pinnock et al recently reported that there is "anecdotal evidence that general practitioners are concerned that if a PSA test is not offered, and prostate cancer is later diagnosed, they may be seen as negligent".13 In a US survey, physicians who perceived that a patient who develops prostate cancer would be successful in suing his physician if he had not been previously screened were more likely to report using PSA tests to screen than those who perceived that such litigation would be unsuccessful.21 No published Australian research has quantified the influence of medicolegal concerns on prostate cancer screening. We designed this study to ascertain GPs' perceptions of medicolegal risk when asked to screen for prostate cancer, and, by using case scenarios, to assess the potential impact of national guidelines on their views. Methods Questionnaire The first section of our self-administered questionnaire commenced with this case scenario: Mr Smith, a 58-year-old employed repairman, presents to his regular GP after prompting by his wife to have a test for prostate cancer. He has no urinary symptoms, no family history of prostate cancer and has not had a vasectomy. GPs were asked: when they had last had a similar request; what should be done; whether the GP would be at risk medicolegally if she or he either did or did not perform either or both tests for screening purposes; what they would do if they were the GP and which test(s) they would advise as being the best available. We also randomised respondents to receive one of two versions of the case scenario which were identical, except that in one the patient was an architect, and in the other he was a repairman. We next provided verbatim the policies of the Australian Cancer Society,9 the National Health and Medical Research Council (NHMRC)19 and the Royal Australian College of General Practitioners (RACGP)20 about screening for prostate cancer, and asked if the respondents were aware of each guideline and whether, having read excerpts from all three, they would change their answers to the initial scenario. We then repeated the first scenario and questions. Our second case scenario read as follows: Imagine the following scenario with the earlier patient, Mr Smith. Having presented for a PSA test, you discouraged him from having it. Imagine that six months later, he is diagnosed with prostate cancer after a blood test organised by a locum. He then proceeds with a formal complaint against you because you did not do the test when he first requested it. We asked respondents to indicate if the three guidelines would protect them in the event of such a complaint, the extent to which such a possibility influenced their practice, and their perceptions of the likelihood of such a scenario. We next asked respondents to indicate their opinion of each of seven statements about prostate cancer screening, using a five-point Likert scale. Respondents then ranked five current and 14 potential strategies to increase GPs' sense of medicolegal protection in this aspect of clinical practice. The questionnaire concluded with six sociodemographic questions. Survey administration and analysis We purchased a list of all NSW GPs from a commercial company and randomly selected 400 names. Questionnaires and reply-paid envelopes were mailed in mid-1997, after an advance telephone prompt. At Day 16, non-responders received a reminder letter. At Day 35, a second questionnaire was posted to remaining non-responders. Two weeks after the second mail-out, a research assistant telephoned any remaining non-responders. The initial sample size was calculated to yield at least 200 questionnaires for analysis, thereby permitting independent and paired univariate analyses. Descriptive statistics were calculated, using SPSS version 6.0.22 We used univariate analysis to examine differences in GPs' responses to either repairman or architect scenarios. Univariate analysis was also performed to determine significant associations between respondents' beliefs and five nominated outcome variables. For these analyses, categories were collapsed into dichotomous variables. McNemar's χ2 was used to determine differences in GPs' responses to the scenarios before and after reading the three guidelines. The Royal Prince Alfred Hospital Ethics Committee approved the study. Results Of the 400 randomly selected GPs, 64 were ineligible (2 dead, 9 retired, 25 not in general practice, 5 on extended leave, 8 outside Australia, 15 uncontactable). From the 336 eligible GPs, 219 (65%) usable questionnaires were received. Our sample comprised 161 male respondents (74%) and 55 female respondents (26%), compared with 68% and 32%, respectively, for the NSW reference sample.23 Median age of our respondents was 47 years (range, 28-70 years); half had been in general practice for more than 17 years (range, 1-47 years) and 127 (58%) worked in the Sydney metropolitan area, somewhat comparable with the NSW reference sample (51% aged 45 years or over and 70% practising in Sydney).23 As only proportions (not actual numbers) for the NSW sample have been published,23 statistical testing of response bias was precluded. Responses to Scenario 1 Of the 219 GPs, 116 (53%) had received the repairman version of the case scenario and 103 (47%), the architect. There was no significant difference in GPs' answers to management of a patient's request for screening before (odds ratio [OR], 0.6; 95% CI, 0.19-1.85; P = 0.4) or after (OR, 0.79; 95% CI, 0.38-1.63; P = 0.5) reading the guidelines. Responses to all scenarios were therefore combined irrespective of patient occupation. More than two-thirds (95% CI, 62.8%-75.0%) of the participating GPs had had a request for prostate cancer screening from an asymptomatic man within the previous week (21.9%; 95% CI, 16.4%-27.4%) or the previous month (47.0%; 95% CI, 39.9%-53.2%). Of the total sample, 52.5% (95% CI, 45.9%-59.1%) indicated that PSA and DRE in combination should be done if a man requested a screening test and 55.3% (95% CI, 48.7%-61.9%) would perform the two tests (Box 2). The proportion of GPs perceiving that the GP would be at medicolegal risk if she or he did not screen for prostate cancer (61.2%) was significantly higher than that perceiving a risk if she or he did screen (15.1%; OR, 0.13; 95% CI, 0.03-0.44; P < 0.001) (Box 3). Only a quarter of the sample was aware of all three guidelines used in our survey (24.2%; 95% CI, 18.5%-29.9%). After reading the guidelines, significantly more respondents perceived less medicolegal risk if not proceeding to screening (Box 3). In addition, more respondents perceived risk if proceeding to screening (Box 3). Twenty-eight per cent (95% CI, 21.96%-33.8%) indicated that, given the three sets of guidelines, the GP would be protected medicolegally if screening tests were not performed (Box 3). Responses to Scenario 2 In the second case scenario, 14.6% (95% CI, 9.92%-19.3%) of respondents thought that the three guidelines would "most likely" protect them in the event of such a complaint. Respondents who thought such a scenario would "most likely" or "likely" influence their practice (68.9%; 95% CI, 62.8%-75.0%) were significantly more likely than those indicating it "unlikely" (23.7%; 95% CI, 18.1%-29.3%) to consider such a scenario could happen (OR, 2.72; 95% CI, 1.48-5.0; P = 0.0001). Compared with respondents who had stated, after reading the three Australian guidelines, that they would not screen an asymptomatic man, those who had stated they would screen were significantly less likely to indicate that guidelines would protect them medicolegally (OR, 0.08; 95% CI, 0.03-0.19; P < 0.001). Respondents who did not indicate that the GP would be at risk medicolegally if she or he did not perform any screening test were significantly more likely to consider that the guidelines would protect them than those who did (OR, 8.76; 95% CI, 4.45-17.23; P < 0.001). GPs who had reported that they would change their response to the case scenario after reading the guidelines presented in the survey were significantly more likely to think that the guidelines would protect them compared with those who had reported that they would not (OR, 2.55; 95% CI, 1.34-4.88; P = 0.004). GPs' views about influences on prostate cancer screening Box 4 summarises responses to seven statements about prostate cancer screening in general practice. Of the sample, 87.2% (95% CI, 82.8%-91.6%) "strongly agreed" or "agreed" that patients' decisions to be screened should be based on full disclosure of what is known about diagnosis and treatment of early prostate cancer. Respondents were significantly more likely to agree that a GP could be sued by a patient who subsequently developed prostate cancer for not performing a PSA test than by a patient who subsequently experienced adverse consequences of treatment resulting from a PSA test which had been performed (OR, 2.98; 95% CI, 1.22-8.34; P = 0.01). GPs' views of strategies to increase their sense of medicolegal protection In rating five current strategies to increase their sense of medicolegal protection, 50% (95% CI, 43.6%-56.8%) of respondents considered guidelines based on systematic reviews of the evidence as "very important", followed by NHMRC endorsement (44%; 95% CI, 37.2%-50.3%), quality of patient information (44%; 95% CI, 37.2%-50.3%) and availability of patient information about prostate cancer screening (38%; 95% CI, 31.96%-44.8%). A minority (11%; 95% CI, 6.9%-15.1%) were unsure of the impact of the current adversarial court system, which is seen as adversarial rather than conciliatory. With regard to potential strategies, there was strong support for written advice about the legal status of guidelines and inviting GP peers as well as specialists as expert witnesses in court (Box 5). Discussion Evidence-based guidelines appear to have little influence on GPs confronted by an asymptomatic man requesting prostate cancer screening. At least 90% of respondents in our study would proceed with at least one screening test (DRE, PSA, or both in combination). Furthermore, a significant majority of respondents considered the GP in the first scenario would be "at risk" medicolegally if she or he did not screen, and more so than if she or he did screen. Awareness of national guidelines was low. Surveys repeatedly demonstrate poor penetration of guidelines into general practice,24 generating interest in more deliberate implementation.7,25,26Our proxy for assessing the impact of guidelines on clinical practice augurs poorly for their influence in reducing perceptions of risk of being sued. Although, after reading the guidelines, significantly fewer considered the GP was at risk if she or he did not screen, only 28% indicated the GP was protected medicolegally by three sets of evidence-based guidelines when complying with their recommendations against screening. Even fewer (15%) considered protection would be afforded them if a man, having been diagnosed elsewhere with prostate cancer, then proceeded to initiate legal action for previous failure to screen. Those who perceived such a situation was likely were also more influenced by it in their practice. In contrast, those who would not screen were more likely to feel protected by guidelines. Most of the respondents supported a clear statement about the legal status of guidelines in a court of law. This is in contrast to the recommendation of a forum held in 1997 to examine legal implications of guidelines.27 Our results also confirm the observation of Pinnock et al that prostate cancer screening can be motivated by medicolegal concerns.13 In the US, physicians' self-reported screening correlates with their views about a medical malpractice vignette.21 Our findings suggest this to be the case also in Australia, prompting us to agree that "if physicians perform PSA tests at least to some extent out of fear of malpractice, then the standard of care may eventually be set by these defensive practices".21 GPs nonetheless support "informed decision-making" by men themselves. Specifically, 88% of the respondents "agreed" or "strongly agreed" that men's decisions to be screened should be based on "full disclosure" of what is known about the diagnosis and treatment of early prostate cancer. Two methodological caveats are recognised. First, the validity of our use of scenarios before and after exposure to guidelines has not been formally tested against actual behaviour. However, we know of no other feasible method to examine perceptions of medicolegal risk on test-ordering. Second, our response rate (65%) was lower than we had hoped, but the professional and demographic characteristics of our sample were comparable with the NSW GP profile. In summary, GPs in our survey perceived limited medicolegal protection from evidence-based guidelines. Their lack of confidence in a legal defence based on national guidelines is troubling. Those strategies suggested by GPs as important in increasing their sense of medicolegal protection could be considered further by health departments, medical defence organisations and clinical colleges. Acknowledgements The study was conducted while S Girgis was completing the NSW Health Department Public Health Officer Training Program. We thank Geoff Hirst for advice; Drs Buhagier, Stan, Gordon, Foran, Reid, Young, McGuigan and Sladden for their comments as GPs on questionnaire drafts; Nancy Harding for research support; Margaret Lesjak for assisting with telephone prompts; and Neil Donnelly for statistical advice. References Keaney MA. Is there a medical litigation crisis? Individual viewpoints on the perceived medical litigation crisis. Is litigation increasing? Med J Aust 1996; 164: 178-179. Weisman C, Morlock L, Teitelbaum M, et al. Practice changes in response to maplractice litigation climate. Results of a Maryland physician survey. Med Care 1989; 27: 16-24. Kessler D, McClellan. Do doctors practice defensive medicine? National Bureau of Economic Research working paper series. Cambridge, 1996. Summerton N. Positive and negative factors in defensive medicine: a questionnaire study of general practitioners. BMJ 1995; 310: 27-29. Hancock L. Defensive medicine and informed consent: a research paper. Review of professional indemnity arrangements for health care professionals. Canberra: AGPS, 1993. Barratt A, Bates P. O tell me the truth about evidence. Aust N Z J Public Health 1997; 21: 441-444. Ward J. Prostate cancer screening: too much, too soon? Cancer Forum 1998; 22: 18-23. Report of the US Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Baltimore: Williams & Wilkins, 1996; xlii. Australian Cancer Society. Prostate cancer screening: guidelines for health professionals. Cancer Forum 1995; 19: 47-50. Wald N, Morris J. What is case-finding? J Med Screening 1996; 3: 1. Ward J, Young J, Sladden M. General practitioners' views and use of tests to detect early prostate cancer. Aust N Z J Public Health 1998; 22: 374-380. Ward J, Hughes AM, Hirst G, Winchester L. Men's estimates of prostate cancer risk and self-reported rates of screening. Med J Aust 1997; 167: 250-253. Pinnock C, Weller D, Marshall V. Self-reported prevalence of prostate-specific antigen testing in South Australia: a community study. Med J Aust 1998; 169: 25-28. Sladden M, Dickinson J. General practitioners' attitudes to screening for prostate and testicular cancer. Med J Aust 1995; 162: 410-413. Ward J, Gupta L, Taylor N. Do general practitioners use prostate-specific antigen as a screening test for early prostate cancer? Med J Aust 1998; 169: 29-31. Hirst G, Ward J, Del Mar C. Prostate cancer screening: the case against. Med J Aust 1996; 164: 285-287. Whitmore W. Management of clinically localised prostate cancer: an unresolved problem. JAMA 1993; 269: 2676-2677. Gupta L, Ward J, Hayward R. Future directions for clinical practice guidelines: needs, lead agencies and potential dissemination strategies identified by Australian general practitioners. Aust N Z J Public Health 1997; 21: 495-499. Australian Health Technology Advisory Committee. Prostate Cancer Screening. Canberra: AGPS, 1996. Royal Australian College of General Practitioners. Guidelines for preventive activities in general practice. 4th ed. Sydney: RACGP, 1996; 26. Collins M, Fowler F, Roberts R, et al. Medical malpractice implications of PSA testing for early detection of prostate cancer. J Law Med Ethics 1997; 25: 234-242. SPSS for Windows [computer program]. Version 6.0. Chicago Ill: SPSS Inc, 1992. Commonwealth Department of Health and Family Services. General practice in Australia: supplementary tables 1997. Canberra: GP Branch, 1997; 19. (Publication no. 1838.) Gupta L, Ward J, Hayward R. Clinical practice guidelines in general practice: a national survey of recall, attitudes and impact. Med J Aust 1997; 166: 69-72. Hirst G. Clinical practice guidelines -- to what end? [letter]. Med J Aust 1997; 167: 288. Puech M, Ward J, Hirst G, Hughes AM. Local implementation of national guidelines: what do general practitioners suggest will work? Int J Qual Health Care 1998; 10: 339-343. Pelly JE, Newby L, Tito F, et al. Clinical practice guidelines before the law: sword or shield? Med J Aust 1998; 169: 330-333. (Received 7 Oct 1998, accepted 5 Jul 1999) Authors' details Needs Assessment and Health Outcomes Unit, Sydney, NSW. Seham Girgis, MB ChB, MPH, Public Health Officer; Jeanette E Ward, PhD, FAFPHM, Director, and Clinical Associate Professor, Department of Public Health and Community Medicine, University of Sydney. Australian Institute of Health, Law and Ethics, Sydney, NSW. Colin J H Thomson, BA, LLM, Executive Officer. Reprints: Associate Professor J E Ward, Needs Assessment and Health Outcomes Unit, Central Sydney Area Health Service, Locked Bag 8, Newtown, NSW 2042. jwardATnah.rpa.cs.nsw.gov.au 1: Defining "screening" for prostate cancer "Screening" is defined as the testing of asymptomatic individuals to detect risk factors or preclinical disease which has not manifested itself clinically.8 A screening test must satisfy two major requirements to be considered worthwhile: The test must be able to detect the target condition earlier than without screening and not produce large numbers of false positive and false negative results; Screening for and treating persons with early disease should improve the likelihood of favourable health outcomes compared with treating patients when they present with signs or symptoms of disease.8 Community-based randomised controlled trials are in progress to assess whether prostate cancer screening reduces the risk of premature mortality from prostate cancer among men offered it.9 When the results of these trials are published in the peer-reviewed scientific literature, data with which to calculate men's mortality risk in the absence of screening and risk reduction in its presence will be publicly available. The absence of evidence of effectiveness of prostate cancer screening to reduce premature mortality explains why four Australian authorities have recommended against it. Until such evidence is available, "case finding" by GPs who order PSA tests and/or perform DREs on asymptomatic men inadvertently implies prostate cancer screening is worthwhile, even though its effectiveness is yet unproven.10 Inadequate efforts to disseminate evidence-based guidelines to Australian GPs compound this misguided clinical practice, now known to be incorporated at disturbingly high rates in preventive health check-ups.11 In the scenario used in our survey, a 58-year-old man presents to his regular GP after prompting by his wife to have a test for prostate cancer. Testing in this context equates with screening, irrespective that the man has requested it himself. Back to text 2: Tests recommended by general practitioners in response to a patient request before and after reading extracts from the national guidelines (n=219)Which test should be done?Which test would you do?BeforeAfterBeforeAfterDRE and PSA53%37%55%43%DRE alone31%19%28%18%PSA alone4%7%7%12%Neither10%32%6%19%†DRE = digital rectal examination. PSA = prostate specific antigen. *McNemar's χ2 = 47.02; P < 0.001. †McNemar's χ2 22.78; 1 df; P < 0.001. Bold indicates a response consistent with the national guidelines. Where columns do not add to 100%. Data are missing. Back to text3: General practitioners' perception of medicolegal risk before and after reading the guidelines (n=219BeforeAfterIs the GP at risk medicolegally if she or he does not perform either or both tests for screening?Yes61%46%No26%42%Unsure13%11%McNemar χ2=20.02; 1 df; P < 0.0001Is the GP at risk medicolegally is she or he does perform either or both tests for screening?Yes15%19%No69%62%Unsure16%18%McNemar χ2=4.05; 1 df; P = 0.041Given the three recommendations, is the GP protected medicolegally if she or he does not perform either or both tests for screening?Yes-28%No-33%Unsure-33%Bold indicates a response consistent with the national guidelines. Where columns do not add to 100%, data are missing. Back to text4: General practitioners' views about seven statements pertinent to prostate cancer screening (n=219)Strongly agreeAgreeUnsureDisagreeStrongly disagreePatients' decisions to be screened should be based on full disclosure of what is known about the diagnosis and treatment of early prostate cancer46%42%5%6%1%A positive PSA test result may cause unnecessary anxiety for the patients25%62%3%9%1%A GP could be sued for not ordering a PSA test for someone who subsequently develops cancer of the prostate.16%43%12%20%7%A positive PSA test result leads to investigations and treatments of unknown effectiveness10%44%14%27%3%A GP could be sued for ordering a PSA test for someone who subsequently experiences adverse consequences from treatment6%18%25%35%16%A positive PSA result will lead to investigations associated with unacceptable morbidity3%20%21%49%6%Patients should sign a 'consent form' explaining benefits and potential complications of PSA testing before the GP orders it7%14% 23%41%14%Where rows do not add to 100%, data are missing. Back to text 5: Percentage of respondents rating as "very important" 14 potential strategies to increase a sense of medicolegal protection (n=219) GuidelinesClear statement about the legal status of the guidelines in a court 65%That guidelines summarise any relevant medicolegal judgments44%Public educationPamphlets for patients about prostate cancer screening tests in languages other than English 49%Mass media campaign targeting men older than 50 years which reassures men that screening is ineffective44%A standard consent form explaining benefits and consequences of prostate-specific antigen screening which would need to be signed by the man before he has the test29%A standard consent form also available in languages other than English27%CourtsRequiring a peer expert GP as well as a specialist as expert witnesses66%Legislation that a false screening report does not of itself establish negligence59%Requiring all expert witnesses refer to evidence-based guidelines in court56%Requiring peer expert GPs instead of expert specialists as expert witnesses53%Expert panels to advise the judge instead of juries49%A system of "No fault compensation"46%Removing cases of malpractice from the adversarial legal system46%Juries to include members with medical backgrounds in medicolegal cases35% Back to text

Seham Girgis · Jeanette E Ward

For Debate Sex selection: the case for There is a strong argument in favour of sex selection, based on respect for procreative autonomy -- the autonomy of couples to decide for themselves how to procreate, and what children to have. Objections based on possible harm to the child, the parents, or society, are not compelling, particularly in Australia. Julian Savulescu MJA 1999; 171: 373-375 Introduction - Inconsistency - Harm - Procreative autonomy - Playing God - Conclusion - Acknowledgements - References - Authors' details - - More articles on Obstetrics & gynaecology and women's health Introduction Various methods now exist for attempting to choose to have a baby of a desired sex (see Box). With the recent advent of flow cytometric separation of X and Y sperm and preimplantation genetic diagnosis (PGD) (see Box), couples no longer have to employ abortion to select sex. Sex selection may therefore become more acceptable to some couples, and requests for clinics to provide it may become more common. In Australia, requests for medically assisted sex selection are not common; for example, one in-vitro fertilisation (IVF) clinic in Australia receives about 15-20 requests for sex selection each year (L Wilton, Consultant, Melbourne IVF, personal communication). Medically assisted sex selection for non-medical reasons is banned in the United Kingdom and Canada.7 In Australia, sex selection employing artificial insemination or IVF is banned explicitly in Victoria by section 50 of the Infertility Treatment Act 1995. In South Australia, section 13 of the Reproductive Technology Act 1988 requires that artificial fertilisation only be used for the treatment of infertility. Both Acts provide exceptions to avoid the risk of transmission of a genetic defect (assisted reproduction for medical reasons). In Australia, IVF clinics now offer PGD. One centre performs sex selection for non-medical reasons using IVF and PGD. This has been provided for fertile couples, but has been fully funded privately, costing couples around $10 000. So far, two boys and two girls have been born after sex selection for non-medical reasons (R Jansen, Medical Director, Sydney IVF, personal communication). In Victoria and South Australia, where it is illegal to perform PGD for sex selection, PGD to exclude aneuploidy may reveal the sex of embryos. Couples might in the future request "healthy" embryos of a desired sex -- "incidental sex selection". The legality of transferring embryos of a desired sex in this circumstance is not clear. Although many jurisdictions ban sex selection for non-medical reasons, there are a number of arguments in favour of allowing it. Inconsistency Paradoxically, it is legal to attempt periconceptual sex selection by "natural" means, even if these employ technology developed specifically for that purpose.7 Prenatal testing and termination of undesired-sex pregnancies is also accepted practice in some centres. It is inconsistent to provide couples with information from prenatal testing which allows them to select sex and not allow them to select sex by means which are more acceptable to them. Harm Harm to the child: The mutagenic risks of the sex selection procedure to children born must be evaluated.8 Many of the methods use well established procedures (such as IVF), though the long term consequences of some are not certain: these include PGD, intracytoplasmic sperm injection,9,10 and cryopreservation.11,12 Despite encouraging data from animal studies and existing human experience,13 there is a theoretical mutagenic risk associated with ultraviolet light and bisbenzimide used in sperm separation. Concerns about these risks should be addressed by scientific investigation and by ensuring that consent is properly informed, not by banning the procedure. Sex selection might also cause psychological harm if the procedure does not produce a child of the desired sex. However, parents inevitably have hopes and expectations for their children which are deflated every day. Most parents come to accept and love the child they have, even if that child has a serious disease or disability. Some parents want their children to be great musicians. Sometimes this desire becomes overbearing, as depicted in the film Shine. But the answer is not to ban music schools. The solution is to help parents to be more tolerant and accepting. Sex selection may be beneficial to the child born if parents will treat a child of that sex more favourably. However, it might be argued that the desire to select sex itself reflects a dysfunctional psychology. Furthermore, sex selection may allow people who are "unsuitable" to be parents to believe that they could cope with a child of a particular sex. It is dangerous to make such judgements about the "suitability" and the "functionality" of people as parents in the absence of any good evidence -- society is now rightly loath to enquire into people's fitness to parent. Moreover, preventing sex selection is no guarantee that such people, even if dysfunctional, will not have children. One objection in bioethics is that sex selection represents a violation of Kant's dictum never to use a person as a means, but always to treat him or her as an end. According to this argument, by selecting sex parents use their child to fulfil their own desires and fail to respect the child as a person. In one way this objection is fanciful. Parents have many desires related to their children: perhaps to have a companion, to have a friend to the first child, or to hold a marriage together. It is unlikely that any parent ever desires a child solely as an end in itself. Moreover, Kant's dictum is actually never to use a person solely as a means.14 Provided that parents love their child as an end in itself, there is no problem with the child's life also fulfilling some of the parents' desires for their own lives. Most importantly, without sex selection, without a unique sperm and egg uniting, that particular child would not have existed. Even if the child is disadvantaged psychologically, this is only wrong from the child's perspective if its life is so bad that it is not worth living. It is difficult to point to any life which can be judged from the outside to be not worth living (possible examples might include Lesch-Nyhan or Sanfilippo syndrome). Harm to other family members: It is hard to see how sex selection harms parents if they have a child of the desired sex; they may even benefit. If a parent will not be able to accept a child of a certain sex (say, a woman was sexually abused as a child and wants to have a girl), then it may be better for both parent and child if the parent selects sex. Another example might be parents who have one autistic boy. Autism is more common in boys but is not sex linked.15 Such parents might be happier with a girl. Could other siblings of the undesired sex be mistreated? Firstly, choosing to have a child of a certain sex does not imply that the other sex is undesired in other children. Secondly, treatment of children of the other sex will be largely determined by the pre-existing belief structure of parents. Social harm: Does sex selection represent a slide to eugenics and the creation of "designer babies"? We already allow parents to select the kind of children they have. Parents have enormous power (often unconscious) in shaping the kind of people their children become. Parents have the right to choose the environment according to what they believe is best for their child. Moreover, they are already allowed to choose what they believe will be the best children. Parents are allowed to use prenatal testing for disability -- even repairable disability such as cleft palate -- because they are allowed to decide whether they can accept that child. If parents can decide whether they can accept a child with cleft palate, they should be allowed decide whether they can accept a child of a given sex. Are women harmed by sex selection? Some critics claim that allowing sex selection implies that, in general, one sex is superior to the other16 -- to do so is sexist.17 According to Tonti-Filippini, it "devalues girls".2 However, it does not, any more than choosing to play Australian Rules football rather than soccer implies the former is "better" in some general sense. Boys and girls are different, and this difference matters to different families in different ways. Sex selection is more likely to harm women in Asia. There, sex selection is already common. The male-to-female ratio has risen to close to 1.2 in China18 and some urban parts of India.19 This situation has worsened since the advent of prenatal sex determination.8 It was estimated in 1990 that, globally, there are 100 million women "missing" (died prematurely) as a result of various forms of discrimination.20 It has been claimed that sex selection would "foster the already existing bias against the female child".8 Yet, even in Asia, it is not clear that sex selection should be banned.21 Disturbed sex ratios may not be a bad thing.22 Advantages which have been postulated include increase in influence of the rarer sex, reduced population growth and interbreeding of different populations.23 Most importantly, a false belief in the inferiority of women is not a product of sex selection -- sex selection is the product of that belief. Education and improving social and employment arrangements for women are more important in correcting these false beliefs than preventing sex selection. Consider an analogous argument: some disability advocates argue disability is a social construct; the lives of such people are made worse by the discriminatory attitudes of others.24 They argue prenatal testing serves to reinforce these attitudes and question whether it should be available for conditions like spina bifida.25,26 The community accepts that parents should be allowed to employ prenatal testing and selective termination to have a child without a disability, even if having a child with a disability would improve the plight of the disabled. By analogy, parents should be able to choose the sex of their child, even if not being able to choose the sex of their child would improve the plight of women. Procreative autonomy "Procreative autonomy" is the liberty to decide when and how to have children according to what parents judge is best.14 Parents know best their own circumstances, and ultimately it is parents who must live with and make sacrifices for their children. Procreative autonomy should not be sacrificed to correct social inequality. It is totalitarian for the State to dictate which children parents should have and rear. In the US, 90% of couples wanting sex selection wished to balance sex within the family. Parents were in their mid thirties, had two or three children and only wanted one more.1 In both the US and UK, just over half of couples choose a girl.27,28 Sex selection for family balancing would prevent, rather than contribute to, a disturbed sex ratio and harm to women. There is no risk of psychological harm to anyone with this kind of sex selection. Playing God Is selecting sex playing God? People have been playing God ever since they first decided to control which children they would have by abortion or by contraceptive use or abstinence. The fundamental question is: to what degree should parents be allowed to decide which children they will bear? Conclusion I have considered objections that sex selection might harm the child, other members of the family or society. Although, in a few cases, these objections may be valid, none is necessarily compelling in a country like Australia, where there will not be a systematic bias in favour of one sex across the whole community. The harm that might arise from sex selection is not of a degree sufficient to warrant State infringement of liberty. In my view, legislation in Victoria and South Australia should be changed to permit sex selection for balancing family sex. Acknowledgements The following people are thanked for critical comments on earlier drafts: Robert Jansen, Leeanda Wilton, Lach De Crespigny, John Rogers, Agnes Bankier, Mike Parker, Bob Williamson. References Fugger EF, Black SH, Keyvanfar K, Schulman JD. Births of normal daughters after Microsort sperm separation and intrauterine insemination, in-vitro fertilization, or intracytoplasmic sperm injection. Hum Reprod 1998; 13: 2367-2370. Carter H. Couple buy a baby girl to order. Herald Sun (Melbourne) 1998; Sept 12: 9. Carter H. Pick-the-sex test. Herald Sun (Melbourne) 1999; May 5: 5. Carter H. Baby sex selection method draws fire. Herald Sun (Melbourne) 1999; Jan 29: 4. Carson SA. Sex selection: the ultimate in family planning. Fertil Steril 1988; 50: 16-19. R v Davidson [1969] VR 667, Menhennitt J. Jansen RPS. Evidence based ethics and the regulation of reproduction. Hum Reprod 1998; 9: 2068-2075. Benagiano G, Bianchi P. Sex preselection: an aid to couples or a threat to humanity? Hum Reprod 1999; 14: 868-870. te Velde ER, van Baar AL, van Kooij RJ. Concerns about assisted reproduction. Lancet 1998; 351: 1529-1534. Bowen JR, Gibson FL, Leslie GI, Saunders DM. Medical and developmental outcome at 1 year for children conceived by intracytoplasmic sperm injection. Lancet 1998; 351: 1529-1534. Dulioust E, Toyama K, Busnel MC, et al. Long-term effects of embryo freezing in mice. Proc Natl Acad Sci USA 1995; 92: 589-593. Wennerholm UB, Albertsson WK, Bergh C, et al. Postnatal growth and health in children born after cryopreservation as embryos. Lancet 1998; 351: 1085-1090. Simpson JL, Carson SA. The reproductive option of sex selection. Hum Reprod 1999; 14: 870-872. Harris J. "Goodbye Dolly?" The ethics of human cloning. J Med Ethics 1997; 23: 353-360. Ralph I. Autism. N Engl J Med 1997; 337: 97-104. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Screening and counselling for genetic conditions. Washington, DC: US Government Printing Office, 1983; 58-59. Wertz DC, Fletcher JC. Ethics and human genetics: a cross cultural perspective. Heidelberg: Springer-Verlag, 1989. Zeng Y, Tu P, Gu BC, et al. Causes and implications of the recent increase in the reported sex ratios at birth in China. Pop Dev Rev 1993; 19: 283-302. Registrar General of India. Census of India 1991. Final population totals. Series I. India, Paper 2. New Delhi: Registrar General and Census Commissioner, 1992. Sen A. More than 100 million women are missing. New York Review of Books 1990; Dec 20; 61. Young R. The ethics of selecting for fetal sex. Ballieres Clin Obstet and Gynaecol 1991; 5: 576-590. Singer P, Wells D. The reproduction revolution. Oxford: Oxford University Press, 1984; 171. Sureau G. Gender selection: a crime against humanity or the exercise of a fundamental right? Hum Reprod 1999; 14: 867-868. Newell C. The social nature of disability, disease and genetics. J Med Ethics 1999; 25: 172-175. Davis A. From where I sit. London: Triangle, 1989; 19. Davis A. Yes, the baby should live. New Scientist 1985; Oct 31: 54. Batzofin JH. XY sperm separation for sex selection. Urological Clinics of North America 1987; 14: 609-618. Lui P, Rose GA. Social aspects of over 800 couples coming forward for gender selection of their children. Hum Reprod 1995; 10: 968-971. Authors' details Royal Children's Hospital, Melbourne, VIC. Julian Savulescu, MB BS, PhD, Director, Ethics Unit, Murdoch Institute, and Director, Ethics Program, Centre for the Study of Health and Society, University of Melbourne. Reprints will not be available from the author. Correspondence: Associate Professor J Savulescu, Murdoch Institute, Royal Children's Hospital and Centre for the Study of Health and Society, University of Melbourne, Parkville, VIC 3052. savulesjATcryptic.rch.unimelb.edu.au Methods of sex selection Preconceptual The most reliable preconceptual method of sex selection is flow cytometric separation of X and Y sperm.1 This technique provides couples with a five- to six-times greater chance of having a girl rather than a boy.1 It is about 85% effective at producing a girl, and 65% effective in producing a boy. One child was born using this method in Sydney,2 but it is no longer employed (R Jansen, Medical Director, Sydney IVF, personal communication). Periconceptual Periconceptual choice of sex is based on the observation that conception close to ovulation is more likely to result in a boy. Attempts to predict the time of ovulation have been made by measuring hormonal levels,3 polarity of the egg membrane,4 and cervical mucus thickness. Other "folk" methods include positioning during intercourse, vaginal douching, and so on.5 These methods are commonly employed throughout the world, but the effectiveness of periconceptual methods has not been well documented. Postconceptual Postconceptual medically assisted sex selection is possible by in-vitro fertilisation (IVF) and preimplantation genetic diagnosis (PGD), or by employing prenatal testing (chorionic villus sampling, amniocentesis, ultrasound) and termination of pregnancy, or infanticide. The most accessible reliable method is chorionic villus sampling (CVS) at about 11 weeks' gestation, followed by abortion if the fetus is not of the desired sex. Although CVS for sex selection is not accepted by any professional body and CVS is not routinely offered for sex selection, some clinicians will provide it; at any rate, couples can access CVS if they are concerned about possible chromosomal abnormalities. In practice, at 11 weeks' gestation couples are free to choose to terminate a pregnancy on any grounds, though legislation in all States imposes some constraints. For example, the Menhennitt ruling in Victoria requires that abortion protect the woman from serious danger to her life or health.6 Preimplantation genetic diagnosis (PGD) provides an alternative which does not require abortion. It requires IVF and intracytoplasmic sperm injection. Embryo biopsy, removing one or two cells, is performed on Day 3 at the 8-cell stage. PGD can be used to detect chromosomal abnormalities (by fluorescence in situ hybridisation [FISH]) and single gene disorders such as cystic fibrosis or haemophilia (by DNA probe or polymerase chain reaction amplification of specific DNA sequences). In Australia, there are two FISH kits currently in use: one tests for chromosomes 13, 16, 18, 21, 22 and the other for 13, 18, 21, X and Y. FISH can thus be used for embryo sexing. Testing takes one day. Back to text

Julian Savulescu

Research Impact of written information on knowledge and preferences for cardiopulmonary resuscitation Ian H Kerridge, Sallie-Anne Pearson, Isobel E Rolfe, Michael Lowe and John R McPhee MJA 1999; 171: 239-242 Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - More articles on Ethics Abstract Aim: To investigate knowledge about and attitudes to cardiopulmonary resuscitation (CPR), and to determine whether written information about CPR alters knowledge and choices made. Design: Questionnaire-based survey before and immediately after provision of written information describing CPR and its risks and benefits. Subjects and setting: All health professionals (803) and competent inpatients (260) in a tertiary care hospital (John Hunter Hospital, Newcastle, New South Wales, Australia) in June 1994. Main outcome measures: CPR knowledge scores and choice scores (number of hypothetical clinical scenarios in which CPR would be chosen) before and after provision of information about CPR. Results: Response rates were 64% (health professionals) and 58% (patients). Patients had limited awareness of procedures involved in CPR, while both patients and health professionals overestimated its success rates. Mean knowledge scores increased after provision of information: for patients, from 6.4 out of 18 (95% confidence interval [CI], 6.0-6.9) to 10.4 (95% CI, 9.9-11.1); and for health professionals, from 11.9 (95% CI, 11.7-12.1) to 13.9 (95% CI, 13.7-14.2). In contrast, mean choice scores decreased after provision of information: for patients, from 5.3 out of 12 (95% CI, 4.7-5.7) to 4.4 (95% CI, 3.9-4.8); and for health professionals, from 4.1 (95% CI, 3.9-4.2) to 3.5 (95% CI, 3.3-3.7). Conclusion: Our results imply that people understand and use prognostic information to make decisions about CPR. To make autonomous judgements, patients and health professionals need better education on CPR outcomes. Introduction While cardiopulmonary resuscitation (CPR) can be lifesaving, success rates (survival to discharge) are less than 5% in some types of patients, particularly those with chronic illness or multiple comorbidities.1 Among those who survive, quality of life is often poor and life expectancy often short.2 In the mid-1970s, growing concern about inappropriate application of CPR and increased awareness of patient rights led to the development of "do-not-resuscitate" (DNR) orders.3 Health professionals are now increasingly encouraged to discuss DNR decisions with patients and their families.4 However, for decision-making about CPR to be appropriate, patients and their surrogates must have some understanding of the likelihood of surviving CPR and the possible adverse effects. Previous research has found that 50%-80% of patients claimed awareness of CPR, but their knowledge was very limited and derived mainly from television dramas. Most patients believed erroneously that CPR is generally successful,5,6 and both patients and health professionals were found to overestimate its success by up to 300%.7 We aimed to investigate knowledge of and attitudes to CPR among hospital inpatients and health professionals and to determine whether written information about CPR alters knowledge and preference for CPR. We have previously reported the opinions of patients and health professionals on the process of decision-making about CPR.8 Methods Subjects and setting The study was conducted at the John Hunter Hospital, Newcastle, New South Wales (a 530-bed tertiary care hospital), over a four-day period in June 1994. Subjects comprised all health professionals working in the hospital (doctors, nurses and allied health professionals) and all eligible (competent) inpatients, as described previously.8 Informed consent was obtained by trained interviewers, and a Mini Mental State Examination (MMSE) performed on patients. Those with MMSE scores < 24 were excluded. A questionnaire for self-completion was administered before and immediately after provision of written information about CPR. Questionnaire The questionnaire asked about: sociodemographic characteristics; sources of information on CPR (respondents could nominate as many as applied from a list of 11); whether each of 10 procedures is part of CPR (possible answers: yes, no or don't know); how successful CPR is in eight clinical scenarios, using a five-point scale: rarely (< 5%), seldom (5%-30%), sometimes (31%-60%), mostly (61%-90%) or almost always (> 91%); and whether respondents would like CPR performed on themselves in 12 specific clinical scenarios (possible answers: yes or no). On completing the questionnaire, respondents were given a one-page information sheet that explained various aspects of CPR, including its definition, procedures that may or may not be considered part of CPR, risks and benefits, success rates, and prognostic indicators (good prognosis: after acute myocardial infarction; poor prognosis: cancer, severe infection, organ failure). Respondents were then asked to repeat the questions on knowledge and choices. Statistical analyses Data were analysed with SPSS version 6.0 for Windows.9 Sociodemographic characteristics of patients and health professionals were compared using continuity-corrected χ2 analyses. All other analyses were performed for patients and health professionals separately. Knowledge of CPR was scored by allocating a point for each correct response. We assessed the relationship between this score and sociodemographic characteristics by standard multiple linear regression, with knowledge score as the dependent variable. For this analysis, we converted the discrete sociodemographic variable (health professional background) into a set of dichotomous independent variables using dummy variable coding (ie, doctors versus all other health professionals, and nurses versus all other health professionals). Significance of change in knowledge scores after provision of information was examined by one-way repeated-measures analysis-of-variance (ANOVA). As answers to some of the knowledge questions may be contentious (whether CPR involves intravenous drugs, intubation and defibrillation), analyses were repeated using scores with these questions omitted. Composite "choice scores" about CPR were calculated by allocating a point for each condition in which the subject would choose to have CPR. The relationship between choice score, sociodemographic characteristics and knowledge score after provision of information was assessed by standard multiple linear regression, with choice score as the dependent variable and knowledge score and sociodemographic factors as independent variables. Significance of change in choice scores after provision of information was examined by ANOVA. Ethical approval The study was approved by the Hunter Area Health Service Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. Results Subjects Of the 803 questionnaires delivered to health professionals, 511 (64%) were returned (148 from doctors, 312 from nurses and 51 from allied health professionals). Of the 443 adult patients in the hospital during the study, 183 were excluded (because of dementia, neurological impairment or delirium [110], incompetence as assessed by MMSE [35], visual or language problems [24], psychiatric illness [9], or as they were undergoing procedures [5]); 153 (58%) of the remaining 260 completed the questionnaire. Sociodemographic characteristics of respondents are shown in Box 1. Knowledge about CPR Sources of information about CPR most commonly identified by health professionals were first aid or in-service courses (33% of responses); school, college or university (27%); and other health professionals (17%). Sources most commonly identified by patients were television (28% of responses), books or magazines (15%), first aid classes (15%), and school (10%). Knowledge before provision of information is shown in Box 2. Patients' knowledge scores were low (mean, 6.4 out of 18; 95% confidence interval [CI], 6.0-6.9), mainly because of lack of awareness of success rates of CPR, with 90% overestimating success for the "all patients" category. Health professionals' knowledge scores were higher than patients' (mean, 11.9; 95% CI, 11.7-12.1), but health professionals also overestimated success of CPR, with 65% overestimating success for "all patients". ANOVA showed that knowledge scores improved significantly after provision of written information for both patients and health professionals (patients: mean, 10.4; 95% CI, 9.9-11.1; health professionals: mean, 13.9; 95% CI, 13.7-14.2). The only sociodemographic characteristics that significantly predicted knowledge scores before provision of information were age (for patients) and professional background (for health professionals): younger patients achieved higher scores than older patients, while doctors and nurses achieved higher scores than allied health professionals. Repeat analysis of the data after omission of contentious questions did not affect the relationship between sociodemographic variables and knowledge scores or the change in knowledge scores after provision of information. Choices about CPR Percentages of patients and health professionals who chose CPR are shown in Box 3. Percentages varied between clinical scenarios, but decreased after provision of information for almost all. ANOVA showed that choice scores also decreased significantly for both patients and health professionals. Mean choice scores decreased for patients from 5.3 out of 12 (95% CI, 4.7-5.7) to 4.4 (95% CI, 3.9-4.8), and for health professionals, from 4.1 (95% CI, 3.9-4.2) to 3.5 (95% CI, 3.3-3.7). CPR was chosen for more scenarios by patients who were younger or had lower knowledge scores and by health professionals who were younger, male, tertiary educated or had better self-reported health status. Discussion We found that patients in an Australian teaching hospital had poor knowledge of CPR, and that both they and, to a lesser extent, hospital staff had unrealistic expectations about its success rates. We also found that provision of written information about CPR risks, benefits and success rates had a clear impact on whether patients and health professionals reported wanting CPR performed on themselves in hypothetical clinical scenarios, decreasing their preference for CPR. Other studies have also found that patients are unaware of the procedures involved in CPR and, along with their relatives, generally overestimate success rates.10 This is not surprising, as television, books and magazines are often their most common sources of information. In addition, community education tends to be positive about CPR, often failing to describe its real success rates. Several previous studies have investigated the relationship between choices about CPR and estimated probability of survival.5,11 They found, similarly to us, that many patients change their minds about wanting CPR when they learn the true probability of survival. Furthermore, formal processes of information disclosure, including discussion of the likely outcome of resuscitation in specific clinical situations, has been shown to modify preferences for CPR.12 In our study, the change in preference followed provision of a one-page information sheet. It is possible that a more optimal form of education (eg, repeated explanations tailored to the individual, with time for reflection and questions) would have produced a greater change in preferences. Perceived morbidity after CPR also strongly influences many people's choices. A survey of 200 medical inpatients found that choice of CPR or DNR status was strongly influenced by anticipated outcome; 90% of patients desired CPR if they were to be restored to their normal health, 30% if the likely outcome after recovery was dependence, 15% if it was perceived as "hopeless", and 6% if it was coma.13 Other studies from the United States14 and United Kingdom15 have found that senile dementia, more than any other condition, is associated with a preference for DNR status. We found similarly that patients and health professionals would be unlikely to opt for CPR in the presence of brain injury or severe dementia. Nevertheless, as found by others,6,10 some patients continued to opt for CPR even if they were likely to have a serious disability, such as coma or terminal illness. We also found, in common with others overseas, that health professionals vastly overestimate the success rates of CPR. These rates (3%-30% in general hospitals) have not changed significantly in the past 30 years.1,16 However, they are well below the rates perceived by physicians and nurses, who are responsible for making decisions about resuscitation status and informing patients and their surrogates.17,18 There are several limitations to our study. Subjects included hospitalised patients with acute illness, and the findings may not be generalisable to other patient populations. The study instrument was a self-report questionnaire using hypothetical clinical scenarios; answers may not accurately reflect what individuals would choose in reality. However, the study has strengths; it assessed both knowledge of and attitudes to CPR in variable clinical contexts and included a formal assessment of competence (the MMSE). The study also used trained interviewers rather than clinicians to distribute questionnaires and so was less likely to introduce bias and perhaps more likely to elicit patients' true preferences. As factors such as likelihood of survival and functional status after resuscitation may contribute to patients' wishes for CPR, it is ethically and clinically desirable that patients be provided with this information. Furthermore, the High Court of Australia has reaffirmed that patients must be given adequate information when making decisions concerning their healthcare.19,20 It is also essential that health professionals who advise patients are aware of the real success rates of CPR. Otherwise, they have failed to meet the standards required both for ethical medical care and by law.21 Respect for autonomy demands that the views of patients or their surrogates should be sought in decision-making about CPR. Our study implies that patients understand and use prognostic information in their decision-making. For truly autonomous judgements, patients and health professionals clearly need better education on risks and benefits of CPR. Acknowledgements We would like to thank the interviewers and patients and staff of the John Hunter Hospital for their generous participation in this study. References Robinson GR, Hess D. Post-discharge survival and functional status following in-hospital cardiopulmonary resuscitation. Chest 1994; 105: 991-994. Landry FJ, Parker JM, Phillips YY. Outcome of cardiopulmonary resuscitation in the intensive care setting. Arch Intern Med 1992; 152: 2305-2308. Rabkin MT, Gillerman JD, Rice NR. Orders not to resuscitate. N Engl J Med 1976; 295: 364-366. Decisions relating to cardiopulmonary resuscitation. A statement from the British Medical Association and the Royal College of Nursing in association with the Resuscitation Council (UK). London: BMA, 1993. Miller DL, Jahnigen DW, Gorbien MJ, Simbarti L. Cardiopulmonary resuscitation: how useful? Attitudes and knowledge of an elderly population. Arch Intern Med 1992; 152: 578-582. Schonwefter RS, Walker RM, Kramer DR, Robinson BE. Resuscitation decision-making in the elderly: the value of outcome data. J Gen Intern Med 1993; 8: 295-300. Potter JM, Stewart D, Duncan G. Living wills: would sick people change their minds? Postgrad Med J 1994; 70: 818-820. Kerridge IH, Pearson SA, Rolfe IE, Lowe M. Decision making in CPR: attitudes of hospital patients and health care professionals. Med J Aust 1998; 169: 128-131. SPSS. Statistical package for the social sciences. Version 6.0 for Windows. Chicago, Ill: SPSS Inc, 1990. Schmerling RH, Bedell SE, Lilienfeld A, Delbanco TL. Discussing cardiopulmonary resuscitation: a study of elderly outpatients. J Gen lntern Med 1988; 3: 317-321. Murphy DJ, Burrows MD, Santilli S, et al. The influence of the probability of survival on patients' preferences regarding cardiopulmonary resuscitation. N Engl J Med 1994; 330: 545-549. Schonwetter RS, Teasdale TA, Taffet G, et al. Educating the elderly: cardiopulmonary resuscitation decisions before and after intervention. J Am Geriatr Soc 1991; 39: 372-377. Frankl D, Oye RK, Bellamy PE. Attitudes of hospitalised patients toward life support: a survey of 200 medical inpatients. Am J Med 1989; 6: 645-648. Ebell MH, Doukas DJ, Smith MA. The do-not-resuscitate order: a comparison of physician and patient preferences and decision-making. Am J Med 1991; 91: 255-260. Robertson GS. Resuscitation and senility: a study of patients' opinions. J Med Ethics 1993; 19: 104-107. Bedell SE, Delbanco TL, Cook EF, Epstein FH. Survival after cardiopulmonary resuscitation. Crit Care Med 1983; 309: 569-576. Miller DL, Gorbien MJ, Simbarti LA, Jahnigen DW. Factors influencing physicians in recommending in-hospital cardiopulmonary resuscitation. Arch Intern Med 1993; 153: 1999-2003. Wagg A, Kinirons M, Stewart K. Cardiopulmonary resuscitation: doctors and nurses expect too much. J R Coll Physicians Lond 1995; 29: 20-24. Rogers v Whitaker (1992) 175 CLR 479. Chappel v Hart [1998] HCA 55. Wyong Shire Council v Shirf (1980) 146 CLR 40. (Received 13 Jan, accepted 7 Jul, 1999) Authors' details Faculty of Medicine and Health Sciences, University of Newcastle, Newcastle, NSW. Ian H Kerridge, MPhil, Lecturer in Clinical Ethics; Sallie-Anne Pearson, PhD, Research Academic; Isobel E Rolfe, MMedEd, Senior Lecturer in Medical Education; Michael Lowe, FRACP, Tutor in Clinical Ethics; John R McPhee, BCom(Hons) (Legal Studies), Consultant in Health Law. Reprints will not be available from the authors. Correspondence: Dr I H Kerridge, Clinical Unit in Ethics and Health Law, Locked Bag 1, Hunter Region Mail Centre, Newcastle, NSW 2310. Email: ikerridgATmail.newcastle.edu.au 1: Sociodemographic characteristics of patients and health professionals surveyed about cardiopulmonary resuscitationPatients (n =153)Healthcare professionals (n =511)PAge > 35 years*90 (59%)235 (46%) 0.007Female98 (65%)373 (73%)< 0.001Marital status† Married/de facto97 (64%)328 (64%) Single/divorced/widowed55 (36%)183 (36%) 0.99Education† Secondary or less117 (77%)72 (14%) Tertiary35 (23%)438 (86%) < 0.001Religion† Religious‡127 (84%)401 (79%) Not religious25 (16%)109 (21%) 0.18Ethnic background† Australian/British144 (95%)463 (91%) Other7 (5%)45 (9%) 0.09Self-reported health status Good68 (45%)493 (97%) Fair/poor/very poor84 (55%)17 (3%)< 0.001CI = confidence interval. * Median split. †Data were missing for some respondents. ‡Any belief system: Christian, Jewish, Islamic, Hindu or Buddhist. Back to text 2: Percentages of 153 patients and 511 health professionals who replied correctly to questions about cardiopulmonary resuscitation (CPR) before provision of written information% Correct (95% confidence interval)QuestionCorrect responsePatientsHealthcare professionalsWhat is involved in CPR?Chest compression (external cardiac massage)Yes*84% (77%-90%)100%Kidney machine (dialysis)No62% (54%-70%)99% (98%-100%)Intravenous drugsYes*25% (18%-33%)84% (80%-87%)Mouth-to-mouth (artificial respiration) Yes86% (80%-91%)99% (98%-100%)Feeding tube into the nose (nasogastric tube)No48% (40%-56%)96% (94%-98%)AntibioticsNo56% (48%-64%)98% (93%-97%)Tube into the throat to assist breathing (intubation)Yes*35% (27%-43%)85% (82%-88%)External electric shock to the heart (defibrillation)Yes*60% (51%-68%)91% (88%-93%)SurgeryNo48% (40%-56%)98% (96%-99%)Breathing machine (ventilator)No27% (20%-35%)57% (53%-61%)How successful is CPR?All patients5%-30%1% (0-4%)26% (22%-30%)Nursing home patients< 5%8% (4%-13%)62% (58%-66%)Patients who have had recent heart attack31%-60%40% (32%-48%)40% (36%-44%)Patients with widespread cancer< 5%42% (34%-50%)61% (57%-65%)Patients with severe infections (eg, pneumonia)< 5%17% (11%-24%)28% (24%-32%)Patients with kidney failure< 5%25% (18%-33%) 39% (35%-43%)Patients under 60 years5%-30%5% (2%-10%)22% (18%-26%)Patients over 70 years5%-30%15% (10%-22%)34% (30%-38%)* As these answers are contentious, analyses were performed using both responses. Back to text

Ian H Kerridge · Sallie-Anne Pearson · Isobel E Rolfe · Michael Lowe · John R McPhee

Editorial Angered patients and the medical profession Changing from "doctor's orders" to "patient's choice" MJA 1999; 170: 576-577 Medical treatment is not entirely risk free. The doctor-patient relationship involves two individuals -- both human, and therefore fallible. One seeks assistance with a problem and the other has the skills to deal with that problem. In this human interaction anything can go wrong. A doctor may be responsible for a negligent act or omission, or a patient may wrongly accuse a doctor of negligence. Preventing things from going wrong is called risk management, which, in Australian medicine, is in its infancy. A term more acceptable to clinicians is "quality assurance". The subtle difference is that quality assurance programs focus on "getting things right", whereas risk management programs focus on "not getting things wrong". Clinical quality assurance programs in Australia largely analyse technical performance, but, unlike most other service industries, rarely focus on consumer satisfaction, or dis-satisfaction. Thus, the article by Daniel et al in this issue of the Journal,1 which reports a survey of 290 complainants to the New South Wales Health Care Complaints Commission (HCCC) in 1996 and 1997, is a welcome addition to the scant literature in this area. There are now multiple avenues in Australia for patients to address complaints or concerns about medical management: the doctor involved or the hospital or practice management, the State-based medical ombudsmen (variously described as Health Rights Commissioners, Health Services Commissioners, and, in New South Wales, the HCCC), the Medical Board, the police, or civil litigation through the courts. The role of the medical ombudsmen -- to conciliate or mediate and not to judge or punish -- is, as Daniel et al found, often misunderstood by aggrieved patients. Daniel et al report the same four motivators for complaints to the HCCC as other studies2 have found: Punishment -- this is largely a function of the criminal courts; Regulation -- this is the responsibility of the registration boards, which exist primarily to protect public safety and not to deliver "justice" to complainants; Compensation -- this is still most commonly sought through civil litigation, but increasingly is negotiated outside litigation, perhaps using the conciliation services of the medical ombudsmen; and Accountability -- this is sought by many complainants, who want to see the "guilty" parties brought to account and systems changed so that what happened to them will not happen to other patients in the future. Doctors are now sensitised, if only by the rising cost of professional liability protection, to the increasing incidence and cost of patient complaint and litigation. However, despite their increased medicolegal anxiety, the medical profession has not adapted to this consumer-driven environment. The same rigorous standards used in the management of disease have not been applied to an examination of the causes -- and hence the prevention -- of patient dissatisfaction. It would appear that many doctors prefer the medical defence organisations, or other professional organisations, to do whatever is necessary to make these problems go away, rather than adapt to them by changing long-established habits of practice. Despite evidence to the contrary from the Harvard Medical Practice Study,3 the belief remains prevalent that most litigation results from gross errors in medical diagnosis and treatment, and that these are best minimised through clinical quality control. While clinical errors are usually involved, the likely precipitant is more likely to be a communication error. It is not sufficient for a doctor to reach a conclusion regarding diagnosis and optimal treatment. This must be conveyed to the patient and then skill exercised to motivate the patient to adopt that same point of view. The patient is the one with the problem and it is for the patient to decide, on the basis of the information provided, whether or not to take the doctor's advice. It is no longer "doctor's orders", it is "patient's choice". Furthermore, "informed refusal" is as important as "informed consent". How much non-compliance is uninformed refusal? The results of the Harvard Medical Practice Study (HMPS)3 not only suggested that if you are sued you are unlikely to have been negligent, but also that if you are negligent you are unlikely to have been sued! In about 300 of the 30 000 New York hospital records reviewed, it was assessed that an adverse outcome had resulted from avoidable negligence -- but in only about one in eight of these had a claim for compensation been made. Conversely, of all the legal actions commenced against the surveyed hospitals in that period, only about a third involved one of those 300-odd files. Two conclusions can be inferred from the HMPS. Firstly, that other intervening factors, such as communication failures in the doctor-patient relationship, determine whether or not an adverse event will result in litigation, and, secondly, that a negligent act or omission is a necessary, but not the sole, condition for a successful claim in negligence. A third possible conclusion, of course, is that patients do not sue when they have no inkling that their adverse outcome arose from a negligent error! The Bristol case4 shows that, even when a negligent error is reported, instead of facilitating communication the first response of the medical community may be to suppress the information by "killing the messenger". The factors driving a patient to sue were surveyed in a 1994 study in the United Kingdom of 227 patients who had commenced legal action for alleged medical negligence.2 Only about a quarter said their primary motive was money (compensation). The rest were evenly spread between "it was the only way we could find out what really happened" (information/communication), "we wanted someone brought to account for what happened" (acknowledgement/accountability) and "we want to ensure this doesn't happen again" (regulation/discipline). Litigation (seeking compensation through a civil action) can only provide money, and a poultice of money does not cure all ills. These UK and US findings are reflected in the study by Daniel et al, which found that "Only a few [of the complainants] want compensation; more want acknowledgement of the harm done; most want the doctor punished." The study by Daniel et al, however, is not directly comparable with the UK study; they surveyed patients lodging complaints, whereas the UK study was of litigants. Moreover, Daniel's study may not necessarily reflect the experience in other Australian States because of the different roles of the NSW HCCC (includes prosecution) and other States' medical ombudsmen services (principally mediation). It would be interesting to make a comparable survey of complainants finalised through (for example) the Victorian Heath Service Commissioner's office. When something goes wrong in any area of human endeavour, the instinctive response is to ask, "What happened?" and "How did it happen?". If answers to these questions are not provided quickly, anger explodes and the questions become "Whose fault was it?" and "Who's going to pay?". The NSW study confirms that anger fuels a demand for retribution. Doctors, being human, rarely, but inevitably, make mistakes. Some of these satisfy the legal test of negligence. But not all result in actions in negligence. A doctor's behaviour after an adverse event, or after receipt of a complaint (Box), is often the major factor determining whether the patient proceeds to litigation or chooses another avenue of complaint or does nothing. Paul Nisselle Chief Executive, The Medical Indemnity Protection Society Melbourne, VIC Daniel AE, Burn RJ, Horarik S. Patients' complaints about medical practice. Med J Aust 1999; 170: 598-601. Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994; 343: 1609-1613. Weiler PC, Hiatt HH, Newhouse JP, et al. A measure of malpractice. Medical injury, malpractice, litigation and patient compensation. Cambridge, Mass: Harvard University Press, 1993. Bolsin SN. Professional misconduct: the Bristol case. Med J Aust 1998; 169: 369-372. What to do when an adverse event occurs Inform the patient as soon as possible If a letter of complaint is received, forward a reply promptly Supply information which is detailed and factual but contains neither positive nor negative "spin" Self-flagellation by the doctor or the hospital involved is inappropriate, but so is denial Acknowledge the effect ("I appreciate how distressing this is to you") Express sincere regret and genuine concern for the patient's welfare ("I'm sorry this has happened to you") Do not admit liability ("I'm sorry I did this to you"). It is inappropriate to admit liability in the heat of the moment; calmer reflection, and after seeking advice, may lead to the conclusion that there is no liability. Back to text

Paul Nisselle

Medicine and the Community Patients' complaints about medical practice Ann E Daniel, Raymond J Burn and Stefan Horarik MJA 1999; 170: 598-602 For editorial comment, see "Nisselle" Abstract - Introduction - Methods - Discussion - Acknowledgements - References - Authors' details - - More articles on Law Abstract Objectives: To survey complainants' experience and the outcome of lodging a complaint about medical treatment. Design and setting: Random sample survey. A 32-item questionnaire was sent to 500 complainants by the New South Wales Health Care Complaints Commission (HCCC), and responses were returned reply-paid to the university. Participants: 290 people with complaints finalised by the HCCC between February 1996 and August 1997. Outcome measures: Profile of complainants and doctor involved; type and place of incident; complainants' emotions at the time of the incident and at the conclusion of the complaints process; outcome of complaint, and satisfaction with outcome and intention to take further action. Results: After excluding non-medical complaints, 290 of 314 questionnaires returned were analysed, giving a response rate of 63% (314/500): 64% of complaints were about clinical care, and the remainder related to rudeness or poor communication (22%), and unethical or improper behaviour (14%); 70% of complainants were women, and 44% of complaints were on behalf of another person; Complainants had a high socioeconomic status, and 60% were currently in paid employment; More than half the incidents occurred in doctors' consulting rooms; 87% of the doctors involved were men, and over half were general practitioners. 37% of complaints were dismissed; 21% of complainants did not know the outcome of their complaint, and 40% believed that the doctor had been disciplined. Most complainants were dissatisfied with the outcome; a quarter stated that they would sue, but 70% would do nothing further. All but two complainants would never consult the doctor involved again. Conclusions: Most of the respondents were not satisfied with either the process or the outcome. Typically they wanted stronger measures taken. Only a few wanted compensation; more wanted acknowledgement of harm done; and most wanted the doctor punished. Introduction Patients may make a formal complaint if they believe that good medical practice has failed them. The implications of these complaints for the medical profession in the United Kingdom, the United States and Australia have been assessed recently.1-5Although the medical profession has been assiduous in self-regulation, governments in many countries have responded to well publicised concerns about the efficacy of professional self-regulation by establishing complaints handling bodies. For example, in New South Wales, the highly public failure of the healthcare system exposed by the Royal Commission into deaths and injuries as a result of psychiatric treatment at the Chelmsford Private Psychiatric Hospital6 prompted the NSW Government to establish a Health Care Complaints Commission (see Box 1). In Australia, these units have been developed under the auspices of State health departments, and in some States have been accorded statutory independence. The impact of complaints on doctors has been studied;9,10 less researched are patients' perspectives. One study of litigants11 explored the views of patients suing in 227 medical negligence cases. Focusing on standards of care, the authors argued against proposals for no-fault compensation and concluded that, while litigation may provide compensation and possibly some explanation, it does not address litigants' concerns about standards of care and accountability.11 Our study takes up such concerns about care, competence and responsibility as voiced by patients who bring a formal complaint, but usually do not become litigants -- a somewhat different population, but one which is likewise disgruntled and distressed about a medical incident. We examined the experience of healthcare complainants, and their satisfaction (or otherwise) with the process and outcome of bringing a formal complaint. Methods We surveyed people whose complaints were finalised by the NSW Health Care Complaints Commission (HCCC) during the 18 months February 1996 to August 1997. The HCCC agreed to address our survey package to complainants at the time of closing each file. This ensured that complainants' privacy was maintained, and that respondents answered questions about a process, often lengthy, which had just concluded. Questionnaire The 32-item questionnaire asked for a description of the incident leading to the complaint; where the incident occurred; the specialty, sex and approximate age of the practitioner; demographic details of the complainant (who was not necessarily the patient); feelings of the complainant at the time of the incident, at the time of making the complaint and subsequently; their expectations of the outcome; and whether they intended to take the matter further. The survey instrument was piloted and revised. The survey packages, 500 in total, were mailed intermittently from the HCCC office, a procedure which gave us only remote control over the distribution. Statistical analysis SPSS software was used for the analysis.12 The results are given as the percentage of respondents answering particular questions, and Pearson's χ2 tests of independence were used to determine the significance of the association among reported (dis)satisfaction, nature of the incident, demographic characteristics of complainants and practitioners, respondents' expectations and the outcome of the complaints. Ethical approval The Ethics Committee of the Health Care Complaints Commission requested some minor changes to the questionnaire and then approved the study in July 1995. At that time, there was no requirement for ethical approval for such surveys by the University of New South Wales. The Results of the analysis of the survey are shown in Box 2. Discussion Patients who make formal complaint continue to view very seriously the incident which prompted the complaint. They recall vividly their negative emotions about the incident, although at the time most were glad of the opportunity and satisfied with the procedures for lodging a complaint. Their dissatisfaction mounts, as finalisation of complaints typically takes many months, even years, and by the time of our survey, when the file was closed, most were dissatisfied with the process and the outcome of making a complaint. Almost a third of the respondents declared that they would take the matter further: 26% intended to sue, and 4% would inform police, and appeal to the Minister for Health. Despite the common view that most people who file a complaint simply want an apology or acknowledgement of harm,15 such a response would have satisfied only 16% of complainants. Complainants' expectations seem to be at odds with the role of the HCCC and cannot be met by its statutory functions. Its role is protection of the public, not punishment or restitution. That only five respondents' complaints (1.7%) had been successfully conciliated is surprising given the Commission's vigorous commitment to this course of action. The 1996-97 HCCC report records successful conciliation in 50 of the 82 complaints in which this was attempted, and, in 1997-98, 74 complaints were resolved through conciliation and a further 278 by "direct resolution". These latter had been judged as important but to "not warrant investigation or conciliation".16 The complaints of our five respondents which had been settled by conciliation involved poor communication on part of a specialist (3 cases) and refusal to attend by general practitioner (2 cases). Two were satisfied, and three were dissatisfied, with the process. The numbers were too small for further analysis. Our respondents were better educated and of a higher occupational status than is typical of the population as a whole, perhaps because people of higher occupational status are more likely to respond to surveys. However, we found no significant association between employment status, sex, age or occupation of respondents and their report of dissatisfaction/satisfaction, expectations of the outcome, and intention to pursue the matter in the courts. The one pointer to intention to sue was the nature of the event. Complaints about clinical incidents are not more likely than those involving communication or personal ethics to bring disciplinary action, but they are significantly more likely to lead to litigation. The health consumer's disappointment, anger or outrage over inadequacy, incompetence or failed ethics on the part of health practitioners can find voice through the powers of complaints units such as the NSW HCCC. Its powers of investigation, referral, prosecution, conciliation, and accountability to Parliament protect the public and monitor health service standards. Perhaps the increase in complaints about health services signals a rising consumerism and disenchantment with professions generally. Robert Hughes' diagnosis of "a culture of complaint" that engulfs daily life is widely accepted.17 The known availability of effective complaints mechanisms certainly gives legitimate outlet for discontentment. Our survey indicates that people are aware of their rights as consumers and are glad to have ready access to avenues of complaint. They felt that initiating the complaint was the right thing to do, but they were often disappointed with the outcome, because their expectations were at variance with what does, or indeed can, ensue. Knowing more about what people see as a breakdown in one or other of the many facets of good medical practice, and understanding what they expect, as well as what they can feasibly and legitimately expect by way of resolution, may obviate some of the difficulties and disappointments revealed by our survey. Acknowledgements Our thanks to our UNSW colleague, Ms Frances Lovejoy, who advised on statistical analysis. The authors are grateful to the NSW Health Care Complaints Commission for facilitating the survey. This study is part of a larger project on the regulation of professions funded by a grant from the Australian Research Council. References Rosenthal M. The incompetent doctor: behind closed doors. Buckingham, Philadelphia: Open University Press, 1995. Vincent CA, Ennis J, Audley RJ, editors. Medical accidents. Oxford: Oxford University Press, 1993. Ingram K, Roy L. Complaints against psychiatrists: a five year study. Psychiatric Bull 1995; 19: 620-622. Nettleon S, Harding G. Protesting patients: a study of complaints submitted to a family health service authority. Sociol Health Illness 1995; 16 (1) 38-61. The Tito Report. Review of professional indemnity arrangements for health care professionals. Compensation and professional indemnity in health care. Final Report. Canberra: AGPS, 1995. New South Wales. Report of the Royal Commission into Deep Sleep Therapy. The Honourable Acting Justice J P Slattery. Sydney: The Commission, 17 December 1990. Workforce Planning Unit, NSW Health Department. Medical Labour Force Annual Survey New South Wales, 1997. Health Care Complaints Commission. Annual Report 1996/97: 39, 44, 44-45, 11. Marjoribanks T, Delrecchio, Good MJ, et al. Physicians' discourses on malpractice and meaning of medical malpractice. J Health Social Behav 1996; 37: 163-178. Mulcahy L. From fear to fraternity: doctors' construction of accounts of complaints. J Social Welfare Fam Law 1996; 18 (4): 397-412. Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994; 343: 1609-1613. SPSS (Statistical Package for the Social Sciences) [computer program], version 4. Chicago, Ill: SPSS Inc, 1990. Australian Bureau of Statistics. Educational attainment in 1997. Canberra: ABS, 1998. (Catalogue No. 4224.0.) Daniel A. Power, privilege and prestige: occupations in Australia. Melbourne: Longman Cheshire, 1983. Simanowitz A. Standards, attitudes and accountability in the medical profession. Lancet 1985; 2: 546. Health Care Complaints Commission: 1997-98. Annual Report. Sydney: HCCC, 1998: 42-43. Hughes R. Culture of complaint: the fraying of America. New York: Oxford University Press, 1993. (Received 24 Sep 1998, accepted 14 Apr,1999) Authors' details School of Sociology, University of New South Wales, Sydney, NSW. Ann E Daniel, PhD, BA, Professor of Sociology. Raymond J Burn, BE, MB BS, LLB, General Practitioner. Stefan Horarik, BE, MEngSc, BA, Research Assistant. Reprints will not be available from the authors. Correspondence: Professor A Daniel, School of Sociology, University of New South Wales, NSW 2052. Email: a.daniel@unsw.edu.au 1: The New South Wales Health Care Complaints Commission The NSW Health Care Complaints Commission (HCCC) was established in 1994. Its role is to protect the public against incompetent or irresponsible health practitioners, and its work involves monitoring professional standards, advising and conciliating, or invoking sanctions when standards are flouted. The Commission was established and its powers defined by the Health Care Complaints Act 1993 (NSW). It is required to inform the Medical Board of complaints and of how it intends to proceed. Complaints may be prosecuted before the Medical Tribunal or the Professional Standards Committee, two statutory authorities established under the Medical Practice Act 1992 (NSW). That Act defined the powers of the Medical Board and the two separately constituted disciplinary bodies. The HCCC determines how complaints are to be handled. Complaints may be brought before the statutory Medical Tribunal and Professional Standards Board, but it is not legislatively authorised to be punitive or restitutive of damages. Complainants seeking damages or punishment must approach the Courts. The Annual Report of the HCCC details the frequencies of each complaint category and of each category of health professional involved. In the past five years complaints about doctors have remained fairly static -- from 971 in 1992-93 to 803 in 1996-97 and 984 in 1997-98. In that period 23 023 medical practitioners7 were registered in New South Wales and the number practising is estimated to be 18 200 (79% of all registrants), suggesting that one doctor in 20 may be the subject of complaint in any one year. Thus, very few services prompt a formal complaint. Nonetheless, although most are dismissed, patients' complaints trigger a disturbing and disruptive experience for the practitioner and diminish the profession's reputation. The HCCC Report for 1996-97 describes the outcome of all complaints. Some breakdown of completed investigations involving doctors is possible:8 52% of complaints were about doctors; 14% involved other health practitioners; 34% hospitals and other health facilities. The Report does not provide comparable data for the 712 complaints finalised, but it might be assumed that these proportions apply to cases completed in 1996-97. On this basis, 370 investigations specific to doctors were completed in 1996-97.8 Of these the HCCC referred 74 (20% of all medical complaints concluded) to the Medical Board requiring that the practitioner be counselled; it brought 41 (11%) medical matters to the Medical Professional Standards Committee for hearing; and it prosecuted six complaints (< 2%) before the Medical Tribunal. The remaining 249 (67%) medical practice investigations were dismissed, conciliated, or terminated.8 Back to text2: ResultsCharacteristics of complainants Of the 500 questionnaires, 66 were returned unopened (address not known), leaving 434; responses were received from 314 complainants, giving a response rate of 63% (314/500). Twenty-four forms describing complaints about non-medical health practitioners were discarded, leaving 290 questionnaires for the analysis. The complainants ranged in age from early 20s to over 70 years; the median category was the 30-39 year olds; 153 respondents (54%) were in their 30s or 40s. 70% of complainants were women. The respondents were well educated: 85% had completed high school, 26% had a university degree and 34% held an occupational certificate or diploma. This profile is significantly different from that for all Australians of workforce age in 1997 (58% had completed high school; 14% had a university degree; and 26% held an occupational certificate or diploma13) (P < 0.001, df = 2) Sixty per cent were in paid employment. Their higher than average socioeconomic status is reflected in their occupational distribution (according to the Daniel Scale of Occupational Prestige).14 Very few respondents identified as Aboriginal (5; 1.7%) and only 13 (4.5%) reported speaking a language other than English at home. Almost half of all complaints (128; 44%) were brought on behalf of someone else. Of these, 42 concerned the complainant's child or ward; 31 complaints were on behalf of a spouse or partner; 43 for a parent or other relative; and in 12 cases a complaint was brought by another practitioner. In the remaining 162 cases (56%) patients complained on their own behalf. Very few respondents (10; 3.4%) had ever complained formally about a medical practitioner before this occasion. Incidents prompting a complaint Respondents described the treatment or behaviour which led to a formal complaint. The incident was classified under one or, if necessary, two categories (eg, complainants might say the doctor failed to diagnosis their illness and was also rude to them.) Most complaints (64%) were about clinical care, with incompetence/ negligence being the most frequent. This agrees with HCCC statistics for 1996-97, with clinical care complaints making up 61% of the total.11The next most frequent complaints involved failure of communication and lack of courtesy. The comparative HCCC figure is 13%. More than half the incidents occurred in doctors' consulting rooms, more than half the doctors involved were general practitioners, and 87% were men. Emotions triggered by the incident of complaintRespondents wrote passionately of their emotional responses to the incident. The questionnaire listed 12 possible emotional responses, with the opportunity to add to the list. The percentage of all respondents recalling each emotion is shown in the Box. In recalling the incident complainants described a mean of 4.1 emotional responses each. The most frequent were anger, shock, and a sense of betrayal. At the beginning of the complaints process two-thirds (63%) of the 290 respondents had felt satisfied that they had done the right thing; some recalled being worried (19%), confused (10%), or cynical and angry (8%) about the process itself. By the time the complaint file was closed (the median time to finalise a complaint was 18 months, range one month to 6 years), initial satisfaction had faded, and the majority (61%) were dissatisfied; 23% remained satisfied and 16% were unsure about their feelings. Outcome of complaintsOver a third of complaints were dismissed; in 40% the doctor had been disciplined, and the result was not known in 21%. After excluding complaints with outcome unknown, there was no significant association between category of complaint as described by respondents and the outcome; nor was there any significant association between demographic characteristics of respondents and outcome or respondents' intentions to take further action. Heightened levels of dissatisfaction at the conclusion of the process were significantly associated with the outcome (P = 0.001; χ2 = 70.02, df = 8). Satisfaction was much more likely if strong action had been taken against the doctor. With disciplinary measures or counselling of the doctor, 42% of complainants were satisfied, 43% dissatisfied and 15% undecided. With complaint dismissal, 6% were satisfied, 90% dissatisfied and 4% undecided. Further action and outcomes complainants wantedAsked whether they were contemplating further action, 70% said no; 26.2% declared they would sue in the civil courts; and 4% would inform police, appeal to the Minister of Health or publicise their complaint. The intention to take the matter further was not related to respondents' sex, age, education or occupation. Respondents were much more likely to take further action (usually litigation) when the complaint involved clinical issues. Complaints about practitioners' rude or inadequate communication or personal ethics were significantly less likely to lead to intention to sue (P < 0.001; χ2 = 10.03, df = 2). At closure of their complaint file, many respondents remained angry and most wanted stern measures taken. All but two people would never consult the doctor involved again. Back to text

Ann E Daniel · Raymond J Burn · Stefan Horarik

Viewpoint Aboriginal health: why is reconciliation necessary? Lisa R Jackson and Jeanette E Ward MJA 1999; 170: 437-440 Introduction - Health and land - What is reconciliation? - A populist movement - Acknowledgements - References - Authors' details - - More articles on Aboriginal health Many health professionals are deeply troubled by the persistent health inequities between Aboriginal and non-Aboriginal Australians. From a social and political perspective it is clear that, for there to be appreciable improvement in Aboriginal health, a process of reconciliation which acknowledges the past in the light of the present needs to be adopted across all sectors of society. We give some practical advice for promoting reconciliation. Introduction Before the arrival of Europeans, the Aboriginal peoples of Australia were a strong and healthy race of hunters and gatherers whose active lifestyle promoted good health. Little evidence has been found of widespread illness or disease in Aboriginal people,1 making it unlikely that they suffered from obesity, hypertension, diabetes, renal failure, coronary heart disease, cancer, arthritis or other diseases endemic in Aboriginal people today.2 It is possible that, in 1770, when Cook charted the east coast of Australia, Aboriginal people were healthier than the average person in Britain or other parts of Europe.1 Further, Aboriginal people had a strong oral pharmacopoeia which was passed down from generation to generation.3 The early European colonists, without a means of replenishing their medical supplies, were taught by Aboriginals to use "medicinal plants growing in the new country".4 After at least 50 000 years of a strong and intact culture, the Aboriginal population was decimated by diseases introduced by Europeans, and those remaining were displaced from their lands and forced to change their lifestyle.1 Now, more than 200 years on, and despite attempts to improve Aboriginal health, the health of Aboriginal people is markedly worse than that of other Australians and of the indigenous peoples of New Zealand and the United States.5 While mortality rates for the total Australian population have been improving in recent decades, mortality rates for Indigenous women have not changed and the rates for Indigenous men have fallen only slightly.6 These data are from Western Australia, the Northern Territory and South Australia. Age-specific mortality rates in these three States in 1992-1994 were higher for all age groups of Indigenous people. The difference was most pronounced -- about five to seven times that of non-Indigenous Australians -- for those aged 25-54 years.7 Infant mortality, although decreasing among Aboriginal people over the past decade, also remains a problem, with rates reported in 1996 that are two to four times higher than the national average.7Hospital separation statistics also indicate a greater burden of illness in Indigenous people: during 1992-93, there were 2.5 and 2.7 times more admissions for Indigenous men and women, respectively, than would be expected, based on all-Australian rates.6 Social disadvantage for many Aboriginal people is likely to contribute to their ill-health. At least 20 000 Aboriginal people still live in communities with permanently inadequate or contaminated water supplies.8 Almost a third (29%) of Aboriginal and Torres Strait Islander people older than 15 years who responded to a health survey were worried about having sufficient food.9 Health and land Since the arrival of Europeans there has been very little formal recognition of the profound spiritual links of Aboriginal peoples to their land. The common law principle of Terra Nullius -- a territory belonging to no one -- was applied unilaterally. The British "took possession" of the land because they considered it to be unoccupied. Moreover, unlike the experience of Maori in Aotearoa (New Zealand) or the indigenous peoples in both the United States and Canada, there has never been a formal treaty between the Aboriginal people and the newcomers to Australia. It has been argued that the absence of a treaty with Aboriginal peoples is causally associated with their poor health and social disadvantage.5 Disempowerment has been accepted as a causative factor by the Royal Australasian College of Physicians in its Darwin Declaration (1997): . . . that the health of Aboriginal and Torres Strait Islander Australians is disastrously poor compared with other Australians, and that the fundamental cause is disempowerment, due to various factors including continued dispossession from land, cultural dislocation, poverty, poor education and unemployment.10 To Aboriginal people, ill-health is more than physical illness; it is a manifestation of other factors, including spiritual and emotional alienation from land, family and culture. Aboriginal people have a spiritual link with the land which provides a sense of identity, and which lies at the centre of their spiritual beliefs.11 Land is the crux of Aboriginal health and well-being. In 1990, the National Aboriginal Health Strategy (NAHS) developed a widely accepted definition of health as perceived by Aboriginal peoples: Health does not just mean the physical well-being of the individual but refers to the social, emotional, spiritual and cultural well-being of the whole community. This is a whole of life view and includes the cyclical concept of life-death-life.12 This definition of health places in context our history, the importance to Aboriginal people of their links with the land, and their disenfranchisement, sense of loss and present-day marginalised position within the Australian community. Accordingly, to understand Aboriginal ill-health, one must first acknowledge the impact of dispossession, theft, genocide, lost and stolen generations of families and the attempted decimation of the innumerable cultures of the people inhabiting Australia before 1770 (Box 1). Furthermore, Aboriginal health is not just the domain of the healthcare system. By accepting the need for an approach that is multifaceted and covers all aspects of people's lives, including housing, education, employment and social justice, we can then understand that physical and symptomatic relief of disease will not in itself redress the burden of Aboriginal ill-health. What is reconciliation? There is no agreed definition of reconciliation. It is agreed, however, that reconciliation encompasses reparation, as recommended by the National Inquiry into the Separation of Aboriginal and Torres Strait Islander Children from Their Families.14 In the report, Bringing them home, five components of reparation have been recommended. These have been taken from the van Boven Principles,15 drawn up by the United Nations Commission on Human Rights as guidelines for reparation of victims of gross violation of human rights: Acknowledgement and apology Guarantees against repetition Measures of restitution Measures of rehabilitation Monetary compensation Reconciliation always begins with acknowledgement or, more colloquially, "truth telling". Alexander Boraine, Vice Chair of the Truth and Reconciliation Commission of South Africa, has spoken of the capacity for forgiveness by those who suffered most under apartheid.16 In Australia, there is a need to acknowledge that the benefits now enjoyed by some have been at the expense of incalculable suffering to others. "Truth telling" is unresolved "sorry business" for our nation. If contemporary Aboriginal health is accepted to be a manifestation of a population dying of despair, anger and disillusionment, then reconciliation is fundamental. It has been compellingly argued that "The diseases of anger and despair which wrack Aboriginal communities in Australia clearly have many of their roots in childhood."17 Acknowledgement of the causes of this anger and despair must occur as the first step in the process of reconciliation. Reconciliation is necessary but is not, in and of itself, sufficient to guarantee improved Aboriginal health. Reconciliation becomes the foundation for health services development. The Australian Medical Association has stated that "The process of reconciliation would be incomplete without the provision of substantial additional resources for Indigenous health."18 As we await proper political processes to implement recommendations from the Muirhead Royal Commission into Aboriginal deaths in Custody19 and the National Inquiry into the Separation of Aboriginal and Torres Strait Islander Children from Their Families,14 individuals and organisations can consider their own processes for reconciliation. A populist movement There are many ways reconciliation can be facilitated through a populist movement. The Council for Aboriginal Reconciliation has published eight key issues considered crucial to restoring Aboriginal community and culture.20Box 2 proposes some practical strategies that health organisations and individuals can adopt as part of their commitment to reconciliation with the Aboriginal and Torres Strait Islander peoples of Australia. These processes can be built upon and adapted by healthcare providers according to their needs and expectations and those of their communities. A people's movement of reconciliation is required to encourage and promote better health for Aboriginal Australians. To recognise the link between Aboriginals' burden of illness and their cultural destruction is the first step towards significant and lasting change. Health professionals can consider a proactive partnership to promote reconciliation. Doing what we have always done to improve Aboriginal health will only give us the same health outcomes, and the statistics will continue to show the shameful morbidity and mortality rates of Australia's first peoples. Although the Council of Aboriginal Reconciliation will be disbanded at the end of the year 2000, reconciliation itself will not cease. As many Aboriginal people are currently saying, now is a time for building bridges. It will take an insightful and committed group of people to take on the challenge of restoring the justice which is long overdue. We hope that health professionals adopt reconciliation as a fundamental issue in their workplaces. Acknowledgements We acknowledge the land on which we live and work as belonging originally to Aboriginal people. We thank the generosity of all those who sent us information, read our manuscript and gave us feedback. We also would like to thank the Indigenous Health Workers Network of the CSAHS for their support. This article was written while Lisa Jackson was completing the New South Wales Health Department Public Health Officer Training Program. References Australian Institute of Health. First biennial report of the Australian Institute of Health. June 1988. Canberra: AGPS, 1988: 1-2. Cowlishaw G. Infanticide in Aboriginal Australia. 1978: In: The health of Aboriginal Australia. Reid J, Trompf P, editors. Sydney: Harcourt Brace Jovanovich, 1991: 3. Latz P. Bushfires and bushtucker. Alice Springs: IAD Press, 1995: 44-72. Cribb AB, Cribb JW. Wild medicine in Australia. Sydney: Fontana/Collins, 1981: 10. Ring IT, Firman D. Reducing indigenous mortality in Australia: lessons from other countries. Med J Aust 1998; 169: 528-531. Australian Bureau of Statistics/Australian Institute of Health and Welfare. The health and welfare of Australia's Aboriginal and Torres Strait Islander peoples. Canberra: ABS/AIHW, 1997: 87-89, 68. (Catalogue No. 4704.0.) Australian Institute of Health and Welfare. Australia's health 1998. Canberra: AIHW, 1998: 29, 32. Dodson M. Linking international standards with contemporary concerns of Aboriginal and Torres Strait Islander peoples. In: Pritchard S, editor. Indigenous peoples, the United Nations and Human Rights. Annandale, Sydney: Federation Press, 1998. Australian Bureau of Statistics. 1994 National Aboriginal and Torres Strait Islander Survey: Detailed findings. Canberra: AGPS, 1994: 10, 11, 13. (Catalogue No. 4190.0.) Royal Australasian College of Physicians. CommuniquŽ of the 1997 Cottrell Conference hosted by the Royal Australasian College of Physicians: Statement on the Delivery of Specialist Services to Remote and Rural Aboriginal and Torres Strait Islander Communities, 1997. http://www.racp.edu.au/open/cottrell.htm Woodward AE. Aboriginal Land Rights Commission Report. Canberra: AGPS, 1974. National Health and Medical Research Council. Promoting the health of Indigenous Australians. A review of infrastructure support for Aboriginal and Torres Strait Islander health advancement. Final report and recommendations. Canberra: NHMRC, 1996: part 2: 4. Independent Commission on International Humanitarian Issues. Proceedings of Conference, 1987: In: The health of Aboriginal Australia. Reid J, Trompf P, editors. Sydney: Harcourt Brace Jovanovich, 1991: xi. Human Rights and Equal Opportunity Commission. Bringing them home. Report of the National Inquiry into the Separation of Aboriginal and Torres Strait Islander Children from Their Families. Sydney: Sterling Press, 1997. Van Boven T. Revised set of basic principles and guidelines on the right to reparation for victims of gross violations of human rights and humanitarian law. United Nations Commission on Human Rights, 24 May 1996. (UN Doc: E/CN4/Sub2/1996/17.) McKendrick JH. Aboriginal reconciliation: a role for psychiatrists? Aust N Z J Psych 1997; 31: 617-621. Bartlett B, Legge D. Beyond the maze. Proposals for more effective administration of Aboriginal health programs. Canberra: National Centre for Epidemiology and Population Health, Australian National University, 1994. (NCEPH Working Paper Number 34.) Australian Medical Association. Australia Day Statement: Greater commitment to indigenous health would boost reconciliation. Media release. Canberra: AMA, 1999. Royal Commission into Aboriginal Deaths in Custody. Reports Vol 1-5. Canberra: AGPS, 1992. Council for Aboriginal Reconciliation. Eight key issues of reconciliation, the community consultative process. Sydney: Australians For Reconciliation, 1996-1967. Horton D, general editor. The encyclopaedia of Aboriginal Australia [CD-ROM]. Canberra: Aboriginal Studies Press, Australian Institue of Aboriginal and Torres Strait Islander Studies, 1994. Aboriginal and Torres Strait Islander Commission. As a matter of fact: answering the myths and misconceptions about Indigenous Australians. Canberra: Office of Public Affairs, 1998. Office of the Minister for Aboriginal and Torres Strait Islander Affairs. Rebutting the myths: some facts about Aboriginal and Torres Strait Islander affairs. Canberra: Office of the Minister for Aboriginal and Torres Strait Islander Affairs, Parliament House Canberra, 1997. Flood S. Essay for the Theosophical Society. Sydney, Public Defenders Office, 1997. Authors' details Needs Assessment and Health Outcomes Unit, Central Sydney Area Health Service, Sydney, NSW. Lisa R Jackson, RN, MPH, Aboriginal Public Health Officer. Jeanette E Ward, PhD, FAFPHM, Director. Reprints: Associate Professor J E Ward, Needs Assessment and Health Outcomes Unit, Central Sydney Area Health Service, Locked Bag 8, Newtown, NSW 2042. Email: jwardATnah.rpa.cs.nsw.gov.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> 1: Land is the crux of Aboriginal health and well-being Next to shooting Indigenous peoples, the surest way to kill us is to separate us from our part of the Earth. Once separated, we will either perish in body or our minds and spirits will be altered so that we end up mimicking foreign ways, adopt foreign languages, accept foreign thoughts and build a foreign prison around our Indigenous spirits, a prison which suffocates rather than nourishes as our traditional territories of the Earth do. Over time, we lose our identity and eventually die or are crippled as we are stuffed under the name of "assimilation" into another society. A senior official of the World Council of Indigenous Peoples.13 Back to text 2: Practical strategies for promoting reconciliation between Aboriginal and Torres Strait Islander peoples and other Australians 1. Understanding country Understanding the significance of land and sea to Aboriginal and Torres Strait Islander societies Accept that for Aboriginals and Torres Strait Islanders, their cultural identity is bound up by ties to the land and sea. Acknowledge that Aboriginal peoples inhabited Australia for at least 50 000 years before Europeans came. 2. Improving relationships Building new relationships between Aboriginal and Torres Strait Islander peoples and all other Australians Invite Aboriginal or Torres Strait Islander people to give talks to professional and community groups to which you belong. Ensure that the people with whom you work do not have preconceived notions of Aboriginal people, in accordance with recommendation 9a of the Bringing them home report.14 Allow staff to attend cultural awareness sessions presented by Aboriginal and Torres Strait Islanders. Join a local study circle and join the mailing list for the Council for Aboriginal Reconciliation. Work with local Aboriginal people in your area towards a statement of commitment to reconciliation for your external communications (eg, a sentence on faxes and letterheads). Find out if your local hospital has an Aboriginal Liaison Health Worker; if not, give your written support to the organisation to employ one. 3. Valuing cultures Recognising the valuable contribution the cultures of Indigenous people make to the Australian heritage Acknowledge the strength of Australia's Indigenous cultures and their importance to our national pride and our international image and trade. Find out the name of the traditional owners of the land where you live and work. Attend cultural events where the focus is on Aboriginal and/or Torres Strait Islander people and their lifestyles. Obtain a copy of the Aboriginal Australia map, published by the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS). Borrow or buy a copy of the Encyclopaedia of Aboriginal Australia.21 Read works by Aboriginal authors, such as Sally Morgan, Monty Prior, Ruby Langford Ginibi, Oodgeroo Noonuccal, Kevin Gilbert or James Miller. Understand that Aboriginal people have had, and some continue to have, a strong traditional health practice. 4. Sharing history Understanding that the history of Australia began long before the arrival of Captain Cook in 1770 Read general textbooks about Aboriginal history: A secret country, Unfinished business, Six Australian battlefields, The world of the First Australians or Invasion to embassy. Read the summary of the Muirhead Royal Commission into Aboriginal Deaths in Custody19 and Bringing them home14 (the Report of the National Inquiry into the Separation of Aboriginal and Torres Strait Islander Children from Their Families). Read information documents on contemporary Aboriginal issues such as As a matter of fact22 or Rebutting the myths.23 Encourage Aboriginal and Torres Strait Islanders to share their knowledge and perspective of history. Ensure schools attended by your children have Aboriginal and Torres Strait Islander resources in their classrooms and libraries. Watch videos that tell the story, including Women of the sun, Lousy little sixpence and Around the kitchen table (to name just a few), or see movies made by Aboriginal people such as Radiance. 5. Addressing disadvantage Acknowledging that Indigenous people are the most disadvantaged group in Australian society Acknowledge that inequities in such basic areas as education, health, housing and the justice system are very real to Aboriginal people. Having learned from reading, watching and listening, speak up when others voice myths, errors and prejudices about Aboriginal and Torres Strait Islander peoples. Do not allow people speaking untruths to ever believe that your silence means agreement. Support your children when they make friends with Aboriginal and Torres Strait Islander children. Favour businesses that support reconciliation. Encourage affirmative action in your workplace. 6. Custodial levels Drawing attention to the fact that Aboriginal and Torres Strait Islander people continue to be arrested and imprisoned at a rate far above that of the wider community Find out what has been done in your State or Territory to implement the recommendations of the Muirhead Royal Commission into Aboriginal Deaths in Custody.19 Support efforts by the healthcare sector to implement the recommendations of this report specific to health. 7. Destiny Supporting empowerment of Indigenous peoples -- giving them greater control over their own destiny and a right to self-determination Join a study circle or attend local community consultations to discuss ideas and initiatives for self-determination in the spirit of partnership. Phone your local Members to let them know of your support and that of your organisations. Ask what specific actions they have taken during their term in office. Invite Indigenous people to participate and ensure their voices are heard in the formulation and implementation of policy decisions. 8. Formal document(s) of reconciliation Determining whether reconciliation would be helped by a formal document(s) of reconciliation. Support recognition of the unique position of Aboriginal and Torres Strait Islander peoples as the Indigenous peoples of Australia. Put into policy in your organisation a process of reconciliation with an outcome date. Once the formal documents of reconciliation are available, adapt them for your practice and ensure they enter as policy into your organisation. 9. Native Title Recognising the implications of the Native Title debate Realise that matters such as the current Native Title legislation have significant implications in areas (other than land usage), such as health and social justice. The Public Defender, Sean Flood, in a talk given at the Theosophical Society (Sydney) in November 1997, explained this clearly: The Nation's soul is at risk. Extinguishment of Native Title is extinguishment of Indigenous culture and ultimately the cause of sickness and death of Indigenous peoples.24 Learn more about Native Title. Acknowledge a component of restitution, as documented in the Bringing them home14 report, which allows Native Title holders the authority under traditional law to define the content and scope of that title. 10. Stolen generations Acknowledging the injustice and the trauma of forcibly removing Indigenous children from their families and communities, as has been done since the earliest days of European colonisation in Australia Recognise and acknowledge the consequences of the past and seek ways to make amends. Participate in Sorry Day, National Aboriginal Day Organising Committee (NADOC) and National Reconciliation Week activities. Speak out against prejudiced views. Support programs that help Aboriginal and Torres Strait Islander individuals and families overcome the trauma they are still suffering. Listen to Aboriginal and Torres Strait Islander people talking about what has happened and ask what you can do. Back to text

Lisa R Jackson · Jeanette E Ward

Editorial Euthanasia consultants or facilitators? Few euthanasia consultants in the Netherlands act as independent evaluators of the patient's situation MJA 1999; 170: 351-352 As the Netherlands alone has long practised legally sanctioned assisted suicide and euthanasia, its experience is of great interest to the rest of the world. Of particular significance have been the Dutch government-sponsored studies conducted by van der Maas and his colleagues in 19901 and 1995.2,3 Those studies relied on data collected from a stratified sample of physicians selected because their practices were likely to involve them in end-of-life decisions. In each of the studies, more than 6000 physicians were surveyed and over 400 were interviewed. Informative data were collected. However, the investigators' analysis of their data has been criticised for emphasising procedural problems in the Dutch system while ignoring more basic substantive flaws, such as whether patients were offered treatment alternatives that might have made euthanasia seem unnecessary.4-6 The same might be said of the article in this issue of the Journal by Onwuteaka-Philipsen et al7, which draws on the individual interviews with physicians conducted in 1995 to discuss the use of consultants, a requirement in the Netherlands in intended cases of assisted suicide and euthanasia. The purpose of consultation is to confirm that the attending physician has followed established guidelines regarding the voluntary, well-considered nature of the patient's decision, the presence of suffering that must be unbearable and hopeless, and the absence of any alternative treatment. In a substantial number of cases, however, a consultation is not obtained. Most of these cases involve violation of another Dutch guideline: although all cases of assisted suicide and euthanasia must be reported to the authorities, most (59%) are not.2 Only a minority of unreported cases involve consultants.3 In the most flagrant violation of Dutch guidelines, consultants are not called: between 900 and 1000 patients' lives are ended without their explicit consent each year.1,2 In the 1995 study, 21% of these patients were competent; in the 1990 study, 37% were competent. A consultant was virtually never called when the lives of competent patients were ended without their explicit consent.1 Onwuteaka-Philipsen et al report that 42% of the interviewed physicians had at some time served as a consultant in an assisted suicide or euthanasia case. More general practitioners than specialists had done so (49% v. 30%). The authors note that, of the physicians who had been a consultant more than once, 50% had previously been consulted by the same physician. In 24% of these cases, the treating physician and the consultant had previously acted as consultants for each other. Recognising that such "pairs" may compromise the independence of the consultants, the authors appropriately suggest appointing independent consultants. The Dutch cases I have reviewed warrant the need for concern. The consultant basically functioned in a pro forma way, asking questions to confirm that the patient wished to go forward with euthanasia.8 The current article indicates that physicians did not actually see the patients in 12% of consultations. This probably reflects the view frequently expressed to me by Dutch physicians that the consultations were for the purpose of meeting legal requirements. The authors point out that most Dutch physicians do not have much experience in consulting in assisted suicide and euthanasia cases. Only 27% of Dutch physicians who have served as consultants have done so more than three times, and only 3% more than 10 times. The authors state that "consultants need to have knowledge relevant to euthanasia and assisted suicide, such as the possibilities of palliative care. Gaining experience as a consultant seems to be important for a physician to become comfortable in this role." No one should assume that experience as a consultant in euthanasia cases would make physicians knowledgeable about palliative care. My own experience with a few physicians in the Netherlands who had performed or been consultants in dozens of euthanasia cases was that they were surprisingly uninvolved in palliative care. Nor did they show sensitivity to the ambivalence that accompanies most requests to die, clearly evident in some of the cases we discussed.8 They seemed to be facilitators of the process rather than independent evaluators of the patient's situation who might be able to relieve suffering so that euthanasia seemed less necessary to the patient. One physician described his role as easing the doubts of physicians who were uncertain whether to go forward with euthanasia. He and the other consultants were certainly knowledgeable in what the authors refer to as the "medicotechnical" aspects of euthanasia -- they could end life quickly and efficiently. The Dutch have been widely criticised for their failure to provide adequate palliative care or hospice care for terminally ill patients.9,10 In recent testimony before the British House of Lords, Zbigniew Zylicz, one of the few palliative care experts in the Netherlands, emphasised Dutch deficiencies in palliative care, attributing them partly to the easier alternative of euthanasia. He saw the lack of hospice care in the Netherlands and the fact that there are only 70 palliative care beds in the country as reflections of this easier option.11 The conclusion in the Dutch studies that physicians in the Netherlands essentially practise euthanasia when there is no other alternative has been challenged.6,9,12,13 As neither the attending doctors, nor the consultants, nor the physician-interviewers in the government-sponsored studies were trained in palliative care, they were not in a position to make such a determination. Dr Zylicz, who has devoted his professional life to relieving the suffering of terminally ill patients and to training individual physicians in palliative care, finds his task complicated by the attitude of a medical establishment that insists on regarding euthanasia as a form of palliative care.14,15 This attitude encourages physicians to find euthanasia, which is far less demanding and challenging than what is ordinarily regarded as palliative care, a suitable alternative. Although the Dutch courts have ruled that unrelievable suffering must be present for a physician to be justified in carrying out euthanasia, it is increasingly accepted in the Netherlands and elsewhere that suffering can be considered unrelievable if patients simply exercise their right to refuse treatment for it. A prominent Dutch investigator sees a shift away from unrelievable suffering towards patient choice as the natural progression of a liberal society's increasing emphasis on autonomy.16 The problem with this position is that it ignores what actually happens when a suffering patient is confronted with a physician who does not know how to relieve that suffering except by euthanasia. If the only alternatives are continued suffering and an early death, patients are not likely to feel they have a choice. Study in the United States has shown that the more physicians know about palliative care, the less they favour legalisation of assisted suicide and euthanasia; the less they know, the more they favour it.17 Caring for people at the end of life is challenging, not only taking considerable skill but also requiring a great deal emotionally of physicians. Medical schools and residency training programs have only begun to prepare physicians to meet this challenge. If they succeed, the question of "euthanasia consultants" may become irrelevant. Herbert Hendin Professor of Psychiatry, New York Medical College, and Medical Director, American Foundation for Suicide Prevention, New York, USA van der Maas PJ, Van Delden JJM, Pijnenborg L. Euthanasia and other medical decisions concerning the end of life. New York: Elsevier Science Inc, 1992. van der Maas PJ, van der Wal G, Haverkate I, et al. Euthanasia, physician-assisted suicide, and other medical practices involving the end of life in the Netherlands, 1990-1995. N Engl J Med 1996; 335: 1699-1705. van der Wal G, van der Maas PJ, Bosma JM, et al. Evaluation of the notification procedure for physician-assisted death in the Netherlands. N Engl J Med 1996; 335: 1706-1711. Hendin H. Seduced by death: doctors, patients, and the Dutch cure. Issues Law Med 1994; 20: 123-168. Keown J. Euthanasia in the Netherlands. In: Keown J, editor. Euthanasia examined: ethical, clinical, and legal perspectives. Cambridge: Cambridge University Press, 1995. Hendin H, Rutenfrans C, Zylicz Z. Physician-assisted suicide and euthanasia in the Netherlands: lessons from the Dutch. JAMA 1997; 277: 1720-1722. Onwuteaka-Philipsen BD, van der Wal G, Kostense PJ, van der Maas PJ. Consultants in cases of intended euthanasia or assisted suicide in the Netherlands. Med J Aust 1999; 170: 360-363. Hendin H. Seduced by death: doctors, patients and assisted suicide. New York: W W Norton & Company, 1998. Zylicz Z. Euthanasia [letter]. Lancet 1991; 338: 1150. Dorrepaal KL, Aaronson NK, Van Dam F. Pain experience and pain management among hospitalized cancer patients. Cancer 1989; 63: 593-598. Matthews H. Better palliative care could cut euthanasia [news]. BMJ 1998; 317: 1613. Gomez C. Regulating death: euthanasia and the case of the Netherlands. New York: Free Press, 1991. Jochemsen H, Keown J. Voluntary euthanasia: under control? Further empirical evidence from the Netherlands. J Med Ethics 1999; 25: 16-21. Admiraal PV. A physician's responsibility to help a patient die. In: Misbin RI, editor. Euthanasia: the good of the patient, the good of society. Frederick, Md: University Publishing Group, 1992. Borst-Eilers E. Euthanasia in the Netherlands: brief historical review and present situation. In: Misbin RI, editor. Euthanasia: the good of the patient, the good of society. Frederick, Md: University Publishing Group, 1992. Van Delden JJM. Slippery slopes in flat countries -- a response. J Med Ethics 1999; 25: 22-24. Portenoy RK, Coyle N, Kash KM, et al. Determinants of the willingness to endorse assisted suicide: a survey of physicians, nurses and social workers. Psychosomatics 1997; 38: 277-287. Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Herbert Hendin

Research Consultants in cases of intended euthanasia or assisted suicide in the Netherlands Bregje D Onwuteaka-Philipsen, Gerrit van der Wal, Piet J Kostense and Paul J van der Maas MJA 1999; 170: 360-363 For editorial comment, see Hendin Abstract - Introduction - Methods - Results - Discussion - Acknowledgement - References - Authors' details - - More articles on Ethics Abstract Objective: To investigate how often physicians act as a consultant in the review of intended euthanasia and assisted suicide (EAS), by whom physicians are asked to act as a consultant, and the consultant's reasons for not agreeing with the intended performance of EAS. Design: A retrospective descriptive study. Setting: The Netherlands. Participants: A stratified random sample of 405 Dutch physicians. Main outcome measures: Number of times the physician has been a consultant; how often a physician had previously been asked to be a consultant by the same treating physician; why consultants advised against EAS. Results: 42% of interviewed physicians had acted as a consultant for EAS and 11% had been a consultant more than three times. Half the physicians who acted as a consultant more than once were invited to do so by the same attending physician, and 41% of consultants had previously consulted the attending physician. The main reasons consultants advised against EAS were because treatment options were still available, the patient's request was not well-considered or persistent, and the patient's suffering was not unbearable and hopeless. Conclusions: Many physicians have at some time been a consultant in a case of intended EAS, but only very few have been able to gain experience in consultancy. To guarantee high standards of consultation, it may be advisable to appoint and train specific consultants for EAS. Introduction In the Netherlands, physicians can be involved in euthanasia or assisted suicide (EAS) either by performing or by being consulted by another physician who intends to perform EAS. Consultation is considered to be an important aspect in the review of cases of EAS,1 and is a requirement that must be met to avoid prosecution for performing EAS. Consultation takes place in about 99% of reported cases of EAS (41% of cases are reported) and in about 37% of unreported cases. In 88% of cases of EAS in which consultation took place the consultant had seen the patient.2,3 In a consultation, a physician formally confers with an independent colleague in considering whether to grant a request for EAS. The consultant determines whether the patient's physician has acted according to the requirements for prudent practice: the patient's request is voluntary, well-considered and persistent, the patient's suffering is unbearable and hopeless, and there are no alternatives for treatment remaining. A consultant should be competent and independent of both the attending physician and the patient, and should visit the patient.1,4 Consultation for EAS is a relatively new task for physicians, and is not part of general medical training. Physicians generally are not used to pronouncing formal judgement on the decision-making process of their colleagues and are not used to seeing patients in a consultancy role. Moreover, consultants need to have knowledge relevant to EAS, such as the possibilities of palliative care.5 Gaining experience as a consultant seems to be important for a physician to become comfortable in this role. As part of a nationwide study on EAS and other practices involving the end of life in the Netherlands,3,6 we set out to determine how often physicians act as a consultant, whether physicians frequently consult the same colleague (or vice versa), whether groups of physicians are asked to be a consultant more often than other groups, the reasons why consultants do not agree with the intended performance of EAS, and the extent to which the consultant feels responsible for the attending physician's final decision to grant or refuse a request for EAS. Methods Study population For this retrospective, descriptive study, we interviewed a stratified random sample of Dutch physicians.2 Participants were stratified according to specialty. The physicians in each stratum were ordered by postal code of their work address and every nth physician was selected. The stratum size was based on the frequencies of medical decisions concerning the end of life and the homogeneity of the patient population (morbidity and age) per stratum. To interview the desired number of physicians, 559 were included in the sample; 83 did not meet the selection criteria and 21 had a chronic illness or could not be located. Of the remaining 455, 50 (11%) did not respond. The final sample of 405 physicians included 124 general practitioners, 74 nursing home physicians (nursing homes in the Netherlands are multifunctional institutions which care for predominantly elderly patients with chronic diseases and physical and/or mental disorders and handicaps) and 207 specialists in cardiology, surgery, internal medicine, respiratory medicine and neurology (oncology and palliative care are not distinct specialties in the Netherlands, but are practised by specialists in other disciplines, such as internal medicine). Physicians in the above-listed specialties attend 87% of all deaths occurring in hospitals. Together with the general practitioners and nursing home physicians, they attend about 95% of all deaths in the Netherlands. Physicians who were not practising in their registered specialty in the same institution since 1 January 1994 were excluded. Measuring instruments The interviews were conducted from November 1995 to February 1996 by 30 experienced physicians who were specially trained for the study. The questionnaire consisted mainly of open-ended questions for the respondents, with prestructured response categories for the interviewers. In the interviews, the definitions of euthanasia, assisted suicide and consultation (Box 1) were explicitly described to the respondents. The interviews took about 2-3 hours. For this study we predominantly used data on how often the respondents had been consultant ever and in 1994 and 1995, and data on the most recent case (all 108 cases occurred between 1994 and 1996) in which the respondent had been a consultant. Analysis To make the data of the stratified samples representative for all deaths in the Netherlands, we weighted the data per stratum. We calculated weights based on the proportion of the various types of physicians in the sample. In addition, the weights of the five specialties were corrected for the 13% of in-hospital deaths that were attended by other medical specialists. Proportions and 95% confidence intervals for these proportions were obtained by direct standardisation7 to adjust for marked variation among the different types of physicians. The normal approximation to the binomial distribution was used. Estimates of the number of consultations in 1995 were based on the (weighted) data on how often each physician had acted as consultant in 1994 and 1995. Multiple logistic regression analyses were used to obtain insight into determinants of whether physicians had ever been a consultant. Because of the stratification according to specialty, the variable "specialty" was included in all analyses. To deal with this categorical variable we used indicator variables, choosing the general practitioners as the reference category. Results In 1995, in the Netherlands, we estimate that almost 4000 consultations took place in cases of intended EAS. In most of these, the consultant was a general practitioner; nursing home physicians rarely acted as a consultant (Box 2). Physicians who had been a consultant Of the 405 physicians in the sample, 42% at some time had been a consultant in intended EAS (Table 1). In 1994 (the year in which the notification procedure was legally enforced) or 1995, 32% of physicians had been a consultant -- general practitioners more often than medical specialists, and specialists more often than nursing home physicians (Box 2). Eight physicians had refused to act as a consultant, for various reasons: lack of time (2), not independent of the attending physician or the patient (2), doubt whether requirements for prudent practice had been met (2), disagreement with notification procedure (1), or the attending physician did not intend to perform euthanasia (1). Eleven per cent of the physicians had been a consultant more than three times (Box 3), and in 1995, 3% had been a consultant three or more times. Previous consultations between consultant and consulting physician Half of the physicians who had been a consultant more than once had previously been consulted by the same physician who consulted them in their most recent case. In 24% of these cases, the treating physician and the consultant had previously acted as consultants for each other (Box 4). Physicians who previously consulted or had been consulted by the same physician agreed more often with the intended EAS than physicians who did not (90% v. 80%), but this difference was not significant. Reasons for advising against EAS The 28 physicians who had at some time advised against the performance of EAS were each asked to describe up to three such cases. Together, they described 48 cases in which they had given this advice. In 42 cases EAS was not carried out, in three it was, and in three instances the consultant did not know the outcome. The consultants gave the following reasons for advising against EAS: there were still alternative treatment options (20 cases), the patient's request was not well-considered or persistent (12 cases), the patient's suffering was not unbearable and hopeless (nine cases), the request was made under pressure of the family (five cases), the patient was already dying (five cases), and the attending physician felt manipulated by the patient (one case). The consultant's responsibility Sixty-five per cent of consultants considered that they had joint responsibility only in those cases in which the attending physician acted according to their judgement, and 30% did not consider that they had any joint responsibility. Medical specialists felt that they had joint responsibility more often than general practitioners (80% [95% CI, 68.6%-91.3%] v. 61% [95% CI, 47.7%-74.6%]). Determinants of having been a consultant With univariate analyses corrected for specialty, physician's age, sex, religion, region in which the physician lives, belief that every case of EAS should be reviewed and belief that consultation should take place in every case of EAS were not significantly related to whether the physician had been a consultant. The results of multiple logistic regression analysis for those determinants that were predictive in the univariate analysis are shown in Box 5. Male physicians had more often been a consultant than female physicians. The strongest association was found for the variable "ever performed EAS". Physicians who had performed EAS had been a consultant more frequently than physicians who had never performed EAS. Discussion We estimate that consultation with another physician in cases of intended EAS took place almost 4000 times in the Netherlands in 1995 (see Box 6). In about 60% of consultations, the consultant was a general practitioner. Overall, 42% of Dutch physicians had been a consultant; 11% had been a consultant more than three times. The most common reason why consultants advised against the performance of EAS was the availability of alternative treatment options. Most consultants considered that they have joint responsibility for the final decision to grant or refuse a request for EAS. Male physicians, general practitioners and physicians who had performed EAS had more frequently been a consultant. The forming of "pairs" of consultants suggests that familiarity is very important in the choice of consultant. An earlier study found that an important reason for choosing a consultant is accessibility and that physicians mainly consult physicians of their own specialty.2 A problem with these consultations may be that the independence of the consultant with regard to the attending physician might be threatened. This is suggested by the fact that "consultants of a pair" more often agree with the intended performance of EAS than other consultants, although this difference is not statistically significant. A possible way of assuring independence of the consultant while safeguarding the consultant's accessibility would be to appoint independent trained consultants who could be contacted by all physicians in a region. Such a system was implemented for general practitioners in Amsterdam in 1997.8 It might also be useful in increasing the frequency of consultation, and possibly the reporting of EAS. The reasons given by consultants for advising against EAS all related to the requirements for prudent practice; the fact that physicians very rarely carry out EAS when the consultant advises against it suggests that consultation can have an important function in assuring the quality of this kind of medical practice. However, our results do not show how often consultants agreed with EAS in cases in which not all the requirements for prudent practice were met. Nursing home physicians, neurologists, surgeons and cardiologists are less likely than general practitioners to have been a consultant. A possible explanation is that, for being asked to act as a consultant, it is not only important to have carried out EAS, but also to have done so relatively frequently: general practitioners, respiratory specialists and specialists in internal medicine carry out EAS more frequently than other physicians.6 In general, Dutch physicians do not have much experience in acting as a consultant in cases of intended EAS. Of the 42% of physicians who have been a consultant, only 27% had been a consultant more than three times, and only 3% more than 10 times. Because acting as a consultant differs greatly from a physician's normal working relationship with colleagues and patients, and because the consultation concerns a matter of life and death, it is important that consultants are experienced and specifically trained. A training program for consultants, in which the skills needed, knowledge about the requirements for prudent practice, palliative care and medicotechnical aspects of EAS are addressed, has been developed by the Royal Dutch Medical Association. In the future it might be advisable to permit only specifically trained physicians to act as a consultant. Acknowledgement This study was funded by the Dutch Ministry of Health, Welfare and Sports and the Ministry of Justice. We are indebted to Professor J Th M van Eijk for his comments on previous versions of this manuscript. References Board of the Royal Dutch Medical Association. Vision on euthanasia. In: Euthanasia in the Netherlands. 5th ed. Utrecht 1996. 24-56. Van der Wal G, van der Maas PJ. Euthanasia and other medical decisions concerning the end of life. The Hague, the Netherlands: Staatsuitgeverij, 1996 (in Dutch). Van der Wal G, van der Maas PJ, Bosma JM, et al. Evaluation of the notification procedure for physician-assisted death in the Netherlands. N Engl J Med 1996; 335: 1706-1711. Van der Wal G, Dillmann RJM. Euthanasia in the Netherlands. BMJ 1994; 308: 1346-1349. Onwuteaka-Philipsen BD. The role of the consultant. In: Legemaate J, Dillmann RJM, editors. Physician-assisted death: between norm and practice. 105-114. Bohn Stafleu Van Loghum, Houten 1998 (in Dutch). Van der Maas PJ, van der Wal G, Haverkate I, et al. Euthanasia, physician-assisted suicide, and other medical practices involving the end of life in the Netherlands, 1990-1995. N Engl J Med 1996; 335: 1699-1705. Armitage P, Berry G. Statistical methods in medical research. 3rd ed. Oxford: Blackwell, 1994; 436-440. Dillman RJM, Krug CHM, Onwuteaka-Philipsen B, et al. Support and consultation in cases of euthanasia in Amsterdam. Med Contact 1997; 52: 743-745 (in Dutch). (Received 7 Jul, accepted 21 Dec, 1998) Authors' details Institute for Research in Extramural Medicine, Vrije Universiteit, Amsterdam, The Netherlands. Bregje D Onwuteaka-Philipsen, MSc, Researcher, and Department of General Practice, Nursing Home Medicine and Social Medicine; Gerrit van der Wal, MD, PhD, Professor, and Department of General Practice, Nursing Home Medicine and Social Medicine; Piet J Kostense, PhD, Epidemiologist/Statistician, and Department of Epidemiology and Biostatistics. Department of Public Health, Erasmus University, Rotterdam, The Netherlands. Paul J van der Maas, MD, PhD, Professor. Reprints will not be available from the authors. Correspondence: B D Onwuteaka-Philipsen, Vrije Universiteit, Institute for Research in Extramural Medicine, Van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands. Email: B. Philipsen. EMGOATmed.vu.nl Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> 1: Definitions Euthanasia was defined as the administration of drugs with the explicit intention of ending the patient's life, at the patient's explicit request. Assisted suicide was defined as the prescription or supply of drugs with the explicit intention of enabling the patient to end his or her own life. Consultation was defined as consultation of a colleague, as stipulated in the notification procedure for EAS. Back to text 2: Physicians consulted in cases of intended EAS, and number of consultations in 1995 in the NetherlandsGeneral practitioners Medical specialists (n=124)* (n=207)† Proportion§ (95% CI) Proportion§ (95% CI) Physicians consultedEver consulted49% (40.2%-58.1%) 30% (23.9%-36.6%) Consulted in 1994 or 199540% (31.3%-49.1%) 22% (16.5%-28.2%) Number (95% CI) Number (95% CI) Consultations in 19952502 (2004-3086) 1424 (1217-1631) Nursing home physicians Total (n=74)‡ (n=405) Proportion§ (95% CI) Proportion§ (95% CI) Physicians consultedEver consulted19% (10.9%-30.1%) 42% (35.6%-47.7%) Consulted in 1994 or 199514% (6.77%-23.7%) 32% (25.1%-40.4%) Number (95% CI) Number (95% CI) Consultations in 199559 (33-98) 3985 (3419-4551) * 4 missing observations; †1 missing observation; ‡ 6 missing observations; § Calculated by direct standardisation.7 Back to text 3: Number of consultations (ever and in 1995) by physiciansGeneral practitioners (n=124)* Specialists (n=207)* Total (n=405)* Proportion‡ (95% CI) Proportion‡ (95% CI) Proportion‡ (95% CI) Number of consultations everno consultation51% (41.9%-59.8%) 69% (62.3%-75.5%) 58% 1 consultation15% (8.61%-21.4%) 10% (5.9%-14.7%) 13% more than one34% (25.7%-42.7%) 21% (15.1%-26.4%) 29% 2 or 323% 7% 18% 4 or 5 5% 4% 5% 6 to 10 5% 7% 5% more than 101% 2% 1% Number of consultations in 1995no consultation54% (70.0%-85.0%) 83% (77.3%-88.1%) 80% one or more46% (36.9%-54.7%) 17% (11.9%-22.7%) 20% 1 consultation32% 9% 13% 2 consultations9% 3% 4% more than 25% 5% 3% * General practitioners: 4 missing observations; medical specialists: 2 missing observations; total: 7 missing observations. †Includes 74 nursing home physicians. ‡ Calculated by direct standardisation.7 Back to text4: Previous consultations between attending physician and consultant*General practitioners (n=40) Specialists (n=39) Total (n=80) Proportion‡ (95% CI) Proportion‡ Proportion‡ Attending physician previously consulted the consultant§53% (36.1%-68.5%) 40% 50% Consultant previously consultedthe attending physician¶46% (30.1%-62.8%) 22% 41% Attending physician and consultantpreviously consulted each other§28% (14.6%-43.9%) 11% 24% CI = confidence interval. * Analysis is restricted to those physicians who had been a consultant twice or more and described their most recent consultation for EAS. †Numbers are too small for calculating confidence intervals. ‡ Calculated by direct standardisation. § Medical specialists: 4 missing observations; total: 4 missing observations. ¶General practitioners: 1 missing observation; medical specialists: 3 missing observations; total: 4 missing observations. Back to text5: Determinants of having ever been a consultant (n = 405)*Number Odds ratio (95% CI) Specialtygeneral practice119 1 nursing homemedicine72 0.42 (0.20-0.87) neurology34 0.36 (0.15-0.89) respiratorymedicine35 0.96 (0.43-2.12) surgery35 0.36 (0.15-0.90) cardiology32 0.21 (0.07-0.65) internal medicine64 0.78 (0.41-1.49) Male327 2.14 (1.08-4.85) Ever carried outEAS166 3.04 (1.91-4.85) * 14 missing observations. CI = confidence interval. EAS = euthanasia or assisted suicide. Back to text6: Confirmation of our estimate of number of consultations From our data on how often physicians had acted as a consultant in 1994 and 1995, we estimated that almost 4000 consultations took place in 1995. This estimate is reasonably consistent with the estimate we can make based on other data. There were 3600 granted requests for EAS, and 44% of 6100 refused requests. Consultation occurs in 63% of acceded requests (in 10%, the attending physician consults two, and in 2% three or more, colleagues) and in 16% of refused requests.2,3 Number of consultations = 0.63 x 3600 + 0.63 x 0.1 x 3600 + 0.63 x 0.02 x 3600 x 2 + 0.16 x 0.44 x 6100 = 3015 consultations. This estimate does not take into account the (unknown) frequency of consultation in the approximately 2625 (0.43 x 6100) requests for EAS that were not carried out because the patient died.6 Back to text

Bregje D Onwuteaka-Philipsen · Piet J Kostense

Ethics Ethical implications of competition policy in healthcare We need to debate the ethical and philosophical questions underlying the application of market economics to healthcare Paul A Komesaroff MJA 1999; 170: 266-268 Introduction - Assumptions underlying competition policy - Effects of competition policy - Ethical and cultural implications of competition policies in healthcare - Conclusion - References - Authors' details - - More articles on Ethics Introduction The Melbourne Age of 28 July 1998 reported the case of Dr Stephen Vaughan, a medical oncologist, who, after 23 years in public hospitals, resigned, disillusioned and dispirited. According to the Age, Dr Vaughan left medical practice because the value he holds dearest -- caring -- seems to have disappeared. In Dr Vaughan's own words: The personal dimension of care is regarded in the public sector as an optional extra -- but it shouldn't be optional. It is essential. . . . Public hospitals used to be the holder of the values of community and personal caring, irrespective of ability to pay . . . but now they're just another organisation chasing the buck, and if you don't get paid you don't do it.1As the responses in the letters columns seem to attest, this experience of contemporary medicine is common in Australia today. There appears to be a widely felt sense that the opening up of medicine to commercial interests and the promotion of economic competition have undermined fundamental values and seriously threaten patient care. It is widely felt, too, that these issues have been substantially neglected in the public debates, which have focused almost exclusively on technical issues of financing at the expense of ethical and cultural questions.2 I shall argue that the social policy which promotes economic competition as a major technique for regulating the healthcare industry raises a wide range of issues about the organisation and dynamics of healthcare and is likely to lead to a variety of outcomes that are not beneficial. Before committing ourselves irrevocably to such a policy we need to consider not just the economic variables, narrowly defined, but also the underlying ethical and philosophical questions. Assumptions underlying competition policy Soon after taking office, in May 1996, the Minister for Health, Dr Michael Wooldridge, declared the government's commitment to promoting competition in the healthcare sector: One fundamental of micro-economic reform has been the application of competition principles to industry -- including those where public sector funding and provision has been significant, as it is in the health sector. These principles are based upon an approach [in] which decisions about the use of resources are made in the light of independent bids for the provision of goods or services made by players who are not in any way in collusion.3An increasing emphasis on the role of the market in regulating decision making is at the centre of the national competition policy for healthcare in Australia (Box). Its advocates argue that enhanced conditions of competition among doctors, hospitals and insurers should be supported for two reasons: because they are necessary to contain healthcare costs and because they will provoke a shift in the healthcare power balance from providers -- that is, doctors -- to consumers -- that is, patients. Many of the assumptions underlying such a perspective, however, depend on a view of human action and relationships that can be contested on both philosophical and factual grounds. For example, it is assumed that consumers always act out of self-interest, that they use their own money to buy all goods and services, and that they seek the best price quantity/quality combination to maximise total utility. Similarly, it is assumed that providers are also primarily concerned with their own interests, adapt their prices and throughput in the light of consumers' purchasing, act to maximise profits by increasing market share at acceptable prices, and always seek to use labour and resources sparingly. All of these assumptions are mistaken, at least with respect to medicine. Although economic constraints of some kind are obviously unavoidable, it does not follow that these must be derived from the market. As is widely acknowledged, the healthcare market is not a perfect one.9 Individual patients by and large do not behave like typical consumers. Ordinary people cannot always understand the complex healthcare field, their needs are immediate, and decisions need to be taken under conditions of duress. In addition, patients become dependent on doctors with whom they have established ongoing relationships of trust and who in turn are sincerely committed to their patients' interests. Effects of competition policy Where competition policies have been introduced elsewhere it is not clear that they have produced beneficial effects. Indeed, economic competition in healthcare may raise costs rather than reducing them.3,10 For example, in California, where these models have been heavily promoted, healthcare-spending growth is faster than in any other American state and costs are now the second highest in the country. Likewise, in New Zealand, where similar policies were introduced over the past six years, it is claimed that distortions created by the economic incentives have led to overservicing in some areas and underservicing in others.11-13Similarly, the effect of competition policies on consumer choice has been mixed. Limitation of the sovereignty of physicians does not necessarily mean increased possibilities for patients. On the contrary, to the extent that market-based incentives tend to operate against the most needy and vulnerable members of the community, the indigent and socially disadvantaged populations are likely to be worse off under a more competitive system. In the US, where it is commonplace for healthcare organisations to seek openly to maximise their profits by restricting medical care in individual cases, this appears commonly to be the case.3,14 In Australia, the introduction of casemix funding has openly discouraged admissions for social or compassionate reasons by attributing low weights in these categories, and there is evidence that specific social groups may be particularly disadvantaged.15 Ethical and cultural implications of competition policies in healthcare The promotion of market-based incentives and discentives as the main regulating mechanism for the healthcare system affects not just the "economic variables" -- it also influences the quality of healthcare in general and the experiences of patients and doctors that emerge from it. Indeed, competition policies explicitly seek to challenge many of the traditional norms underlying medical practice, on the assumption that these are simply devices for protecting the financial interests and power of physicians.10As both doctors and patients have always recognised, however, the medical relationship cannot be understood purely as a commercial relationship. Patients come to doctors because they are experiencing pain, illness or fear. They offer access to their bodies and to the intimate recesses of their personal lives. They grant wide discretion and decision-making power to doctors, on the understanding that doctors will exercise their judgement in a disinterested and compassionate manner. It is mutually agreed that the power of doctors is subject to rigorous ethical constraints arising from the long tradition of medicine, which have been upheld by the professional organisations for hundreds of years. These constraints, which constitute a complex, self-generated system of professional norms, limit the nature of personal relations between doctors and patients, the use and dissemination of information, licensing and credentialling of practitioners, and specific commercial practices such as fee splitting, advertising, self-referral, and ownership of pharmacies and hospitals by physicians. They primarily reflect altruistic concerns of doctors to separate personal and financial considerations from the paramount professional goal of doing what is best for their patients, even if, undeniably, they also have the effect of protecting doctors' financial interests. They do not prohibit competition, but rather channel it into non-economic forms, such as competition for reputation, recognition and status, and social influence. Emphasising economic values undermines the role and power of ethical values.16 This fundamental shift may in the longer run prove deeply significant for society as a whole, for it may lead to changes in the structure and dynamics of the clinical process itself. A crucial aspect of the medical encounter is that it is not purely "instrumental" in character. It does not merely subserve technical functions, the solution of problems in biochemistry or physiology through the application of scientific modes of thought and analysis. It is also involved in setting goals, in identifying and scrutinising meanings, and in establishing the frameworks within which the technical problems are identified and given a value. These latter functions are "non-instrumental" in character, and become possible because of the peculiar nature of the contact between doctor and patient: its intimacy and openness, its reliance on vulnerability and trust, the moment of sanctuary it offers with respect to the utilitarian relationships of everyday life. It is through the contact that the doctor is granted with the lifeworld of the patient that the healing process becomes possible. This contact, which occurs through a variety of mechanisms, including language and touch, stands at the irreducible core of clinical medicine. It is an unavoidable consequence of the introduction of the unrestrained operation of market forces into healthcare that economic values penetrate to the heart of the medical relationship. Indeed, it is precisely the rationale of the policy that financial imperatives take over as the motivating principle of all medical decision making. To open up the clinical relationship to such forces, to subject it to criteria that are purely calculable and quantitative, risks undermining the dynamic structure on which the entire medical enterprise rests. The physician becomes the agent of the hospital or the system rather than of the patient. His or her primary obligation to act on behalf of the patient is displaced in favour of conformity to a complex system of economic incentives and disincentives. The scope for disinterested, compassionate care is greatly contracted.17 The opportunities to respond to individual needs, to the specific details of the predicament of a particular patient, are severely contracted in the face of the overwhelming power of economic imperatives.18 Health-financing policies cannot be understood as exclusively technical, or "value free", mechanisms for regulating the healthcare system. Rather, they must be interpreted and evaluated in accordance with philosophical and ethical criteria and in relation to their social and cultural consequences.19 We need to ask not merely Is this a way to balance the books? but also Is this the kind of healthcare system we want to have? If this simple test is adopted it becomes immediately apparent that a reliance on economic incentives to regulate the quality and distribution of healthcare resources is, through its effect on the conduct of doctors and the outcomes for patients, very likely to lead to consequences widely considered unacceptable. Conclusion Clearly, action to limit healthcare costs is widely supported in the community. Among the possible strategies for achieving this end, an enhanced emphasis on economic incentives and disincentives has gained popularity around the world. Although the stated aim of this policy is to reduce healthcare costs and increase consumer sovereignty, whether it will achieve these objectives is open to question. The employment of economic competition as a key device in the regulation of the healthcare system, however, is more than a mere technical solution to a fiscal problem. It is an intervention that raises issues at medicine's philosophical core. One of the major objectives of competition policies is to challenge the traditional system of norms that guide the behaviour of physicians; the implications of this are potentially far-reaching. The possibility that the introduction of economic imperatives at the heart of the medical endeavour may compromise it in a fundamental way also needs to be considered. The globalisation of the economy -- in the dual sense of the elimination of national boundaries and the universalisation of economic values -- has the capacity to profoundly transform the nature of the entire domain of healthcare. To be sure, it may usher in lower prices for some services and enhanced availability of others. However, the cost of these gains may be very high, for it may also lead to the corruption of some of the central values of medicine, and to a contraction of the sphere for individual action in favour of the uncompromising demands of the ever-expanding system. This scenario -- and that depicted by Dr Vaughan -- may, of course, be too bleak. Perhaps the traditional values of medicine will prove to be sufficiently resilient to survive under the changed social and economic conditions, as indeed they have over the millennia. Naturally, it is to be hoped that this will be the case. Nonetheless, it is essential that proposed new directions in healthcare policy are subjected to rigorous scrutiny in relation not merely to narrowly conceived fiscal criteria but also to cultural and ethical ones in open, public debate. References Toy M-A, Birnbauer B. This man has been a cancer specialist for 23 years. Last week he quit. Why? The Age (Melbourne) 1998; 28 July: 1. Lown B. Physicians need to fight the business model of medicine. Hippocrates 1998; 12: 25-28. Wooldridge M. Opening. In: AMA Summit proceedings. Competition in health: a brave new world? Canberra: Australian Medical Association, 1996; 2-9. Glaser WA. The competition vogue and its outcomes. Lancet 1993; 341: 805-812. Enthoven AC, Kronick R. Consumer-choice health plan for the 1990s. N Engl J Med 1989; 320: 29-37, 94-101. Kuttner R. Physician-operated networks and the new antitrust laws. N Engl J Med 1997; 336: 386-391. Changra J, Kakabsadse A. Privatisation and the National Health Service. Aldershot: Gower, 1985. Fels A. The ACCC approach to health. In: AMA Summit proceedings. Competition in health: a brave new world? Canberra: Australian Medical Association, 1996; 14-20. Reinhardt UE. Accountable health care: is it compatible with social solidarity? London: Office of Health Economics, 1997. Robinson JL, Luft HS. Competition and the cost of hospital care. JAMA 1987; 257: 3241-3245. Pezaro D. The New Zealand view. In: AMA Summit proceedings. Competition in health: a brave new world? Canberra: Australian Medical Association, 1996; 9-13. Hemenwon D, Killen A, Cashman SB, et al. Physicians' responses to financial incentives: evidence from a for-profit ambulatory care center. N Engl J Med 1990; 322: 1059-1063. Hillman A, Pauly MV, Kerstein JJ. How do financial incentives affect physicians' clinical decisions and the financial performance of health maintenance organisations. N Engl J Med 1989; 321: 86-92. Brown ER, Dallek G. Changing health care in Los Angeles. In: Ginzberg E, Berliner HS, Oston M, Brown ER, editors. Changing US health care: a study of four metropolitan areas. Boulder: Westview, 1993. Ruben AR, Fisher DA. The casemix system of hospital funding can further disadvantage Aboriginal children. Med J Aust 1998; 169 Suppl Oct 19; S6-S10. Pellegrino ED. Ethics. JAMA 1994; 271: 1668-1670. Agich GJ, Begley CE. Some problems with pro-competition reforms. Soc Sci Med 1985; 21: 623-630. Weber M. Science as a vocation. In: Gerth HH, Mills CW, editors. From Max Weber: essays in sociology. London: Routledge and Kegan Paul, 1964; 129-158. Charlesworth M. The new ideology of health care: ethical issues. In: Halasz G, on behalf of the Psychiatrists Working Group, editors. She won't be right, mate: the impact of managed care in Australian psychiatry and the Australian community. Melbourne: Psychiatrists Working Group, 1997; 104-110. A version of this article was given as an oral presentation at the Australian Medical Association conference Competition in health, Canberra, 31 July 1998. Authors' details Department of Medicine, Monash University, Melbourne, VIC. Paul A Komesaroff, PhD, FRACP, Associate Professor, and Director, Eleanor Shaw Centre for the Study of Medicine, Society and Law, Baker Medical Research Institute, Melbourne. Reprints will not be available from the author. Correspondence: Dr P A Komesaroff, Director, Eleanor Shaw Centre for the Study of Medicine, Society and Law, Baker Medical Research Institute, PO Box 6492, St Kilda Central, VIC 8008. Email: Paul. KomesaroffATbaker.edu.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> What is competition policy? Competition policy is an economic and political strategy for ensuring that market forces operate as the principal device for the regulation of economic relations. Several approaches reflect the range of economic theories and philosophical perspectives represented.4 In the United States, antitrust laws are used to break up arrangements such as fee schedules by medical associations, corporations among hospitals, collective bargaining between providers and insurance carriers and payer reimbursement. More recently, managed care has emerged as a major approach to cost containment.5,6 In the United Kingdom under the Thatcher Government, certain services were contracted out to private firms and hospital and general practitioners were granted a substantial degree of financial autonomy.7 In Australia, a National Competition Policy was introduced in 1995 with bilateral support, establishing competition and cost considerations as the guiding principle of public policy at every level of government. This policy is enforced through a framework of law -- including the Trade Practices Act 1973, the Competition Policy Reform Act 1995 and the Prices Surveillance Act 1983 -- and two key regulatory bodies, the Australian Competition and Consumer Commission and the National Competition Council.8 These regulatory bodies have very wide powers to oppose "anti-competitive conduct and unfair market practices" of all kinds, and to regulate "mergers or acquisitions of companies, product safety/liability and third party access to facilities of national significance". Back to text

Paul A Komesaroff

Medicine and the Law Confidentiality and the courts There is a general belief that, once in the witness box, doctors are compelled to reveal confidential information about their patients if asked by counsel. Where no issue of public interest is involved, a medical witness should ask the court to rule in its inherent discretion that the information sought is confidential and privileged. Paul Gerber MJA 1999; 170: 222-224 Introduction - The judge's discretion - When confidentiality may be ignored - Conclusion - References - Authors' details - - More articles on Law Introduction It is said that there is no rule of law which permits a doctor in court proceedings (except in Victoria, Tasmania and the Northern Territory) to refuse to give evidence or disclose information merely because it was supplied to him or her in confidence. The Evidence Acts of the Commonwealth (which applies also in the Australian Capital Territory) and of New South Wales provide that evidence is admissible if "relevant in a proceeding".1 Therefore, except in Victoria, Tasmania and the NT, the law stands in stark contrast with the code of ethics that has stood unchallenged since the days of Hippocrates. This code demands that whatever is revealed in the doctor-patient relationship "ought not to be spoken abroad", although this obligation of confidentiality was diluted in the Australian Medical Association's revised Code of Ethics in 1996.2 In contrast, the law recognises that a party to a marriage is not compellable to disclose a communication made to the other during the marriage, relying on the fundamental right of spouses to confide in each other freely without interference from the law. Likewise, a member of the clergy may refuse to divulge a religious confession to a court in NSW, the ACT and a federal court, but not elsewhere. Client legal professional privilege is justified on the basis that it promotes candour and trust between lawyer and client. Yet nothing is more calculated to destroy candour and trust in the doctor-patient relationship than making a medical witness compellable. But is it the law? My purpose in this article is to clarify the law and to argue that in some circumstances a doctor can, and should, seek the inherent discretion of the court for a claim of privilege. If this is granted, evidence otherwise relevant may be withheld from the court. When in doubt, medical witnesses should voice their concern to the judge and request a ruling. The judge's discretion A judge, being master of his or her own court, has a residual discretion to disallow certain evidence to be given. This discretion will only be exercised where non-disclosure will not result in concealing a crime or endangering the health of others, where the public interest in discovering the truth cannot be advanced as legitimately prevailing over the betrayal of a medical confidence, or where the probative value is substantially outweighed by the danger that the evidence might be unfairly prejudicial to a party. A good starting point is an early decision of the English Court of Appeal in which Lord Denning MR noted: The only profession that I know which is given the privilege from disclosing information to a court of law is the legal profession, and then it is not the privilege of the lawyer but of his client. Take the clergyman, the banker or the medical man. None of these is entitled to refuse to answer when directed to by a judge. Let me not be mistaken. The judge will respect the confidences which each member of these honourable professions receives in the course of it, and will not direct him to answer unless not only it is relevant but also it is a proper, and indeed, necessary question in the course of justice to be put and answered. A judge is the person entrusted, on behalf of the community, to weigh these conflicting interests -- to weigh on the one hand the respect due to confidence in the profession and on the other hand the ultimate interest of the community in justice being done.3 Lord Justice Donovan arrived at a similar conclusion, finding that it would be wrong to hold that a judge should invariably be required to order that the question be answered, and to punish a refusal to answer once it is shown that the question is technically admissible.3 On the same facts, the Full Court of the Supreme Court of New South Wales held in Re Buchanan that: It has never been suggested that, if the question is relevant and proper, any further discretion remains in the trial judge as to whether or not the witness should be compelled to answer, and if it did it is difficult to see upon what material it could be exercised. . . . litigants cannot be constrained by private codes of strangers.4 However, the Full Court went on to add this rider -- that there may be circumstances: ...impossible to define in advance arising out of an infinite number of facts and circumstances which a court encounters which may lead a judge to conclude more harm than good would result from compelling disclosure.4 Both the above cases, involving newspaper journalists claiming to protect their sources, are readily distinguishable from that of the doctor whose disclosure may contain no element of public interest-- for example, medical evidence in divorce proceedings, which is of interest only to the parties and of no concern to the general public -- in which case a judge may be more readily inclined to exercise a discretion in favour of a medical witness. Whatever discretion a court may have in not compelling disclosure of confidential information, it will not be exercised where withholding evidence may protect a criminal or endanger public health. In Hunter v Mann,5 Dr Mann had treated the driver of a stolen vehicle and his passenger after they were involved in an accident. Although Dr Mann advised his patients to go to the police, he did not seek their consent to identify them to the authorities. When a police officer asked for the name and/or address of the man and his passenger, Dr Mann refused to give the information as he considered it confidential, following the British Medical Association code of conduct for members. This code included the principle that a doctor should refrain from voluntarily disclosing to a third party information which he or she learned directly or indirectly in his or her professional relationship with a patient, subject to exceptions, including: "(1) the patient gives his consent; (2) the information is required by law". The prosecutor alleged that Dr Mann was guilty of an offence under the Road Traffic Act 1972 (UK), and the doctor was convicted. An appeal was dismissed, although the judge added this rider: I accept that the doctor ... has no right to refuse to disclose confidential information in the course of judicial or quasi-judicial proceedings; but I also accept that the judge in certain circumstances, and in the exercise of his judicial discretion, may refuse to compel the doctor to do so.5 When confidentiality may be ignored The Australian Medical Association's revised Code of Ethics recognises that in some circumstances medical confidentiality may be ignored, although it would have been more helpful if the guidelines had been more specific. A doctor is entitled -- and indeed bound -- to disclose confidential information where a failure to do so would constitute a threat to public or private interests. Suppose a patient confesses to his psychiatrist that he intends to kill his girlfriend. If the psychiatrist takes this threat seriously, can it possibly be suggested that he or she is not duty bound to alert the authorities? This situation did occur in the United States; the patient did kill his girlfriend and the psychiatrist's employer was held vicariously liable for the girl's death.6The different States and Territories have various reporting laws, dealing with matters such as child abuse, fitness to hold a driving licence, and notifiable diseases, which require medical practitioners to provide certain information to relevant authorities. Child abuse is notifiable in all States and Territories except South Australia and Queensland. South Australia imposes a duty on doctors, opticians and physiotherapists to inform the relevant traffic authorities if they have reasonable cause to believe that a person whom they have examined suffers from a disability such that, if driving a motor vehicle, he or she would be likely to endanger the public.7 New South Wales merely provides immunity from suit for medical practitioners if they provide advice to the Roads and Traffic Authority about a patient's fitness to drive a motor vehicle or fly an aircraft;8 Victoria, Queensland, Western Australia and Tasmania are silent on the matter. In the absence of mandatory reporting requirements, I suggest that a doctor is nonetheless under a positive duty to inform the relevant authorities where he or she reasonably suspects that a patient suffers from a psychiatric or other medical disorder which may pose a threat to that person or to the lives or safety of others. For example, the patient may be a train driver suffering from a serious heart condition who refuses to give up his job, or may suffer from a communicable disease (whether notifiable or not) which poses a health risk to others, including his or her partner. Where practical or meaningful, the patient's permission to disclose the information should be sought, and, if permission is refused, the patient should be warned that the information will be passed on to the relevant authority. But taking such a course of action may result in legal action. In 1983, a general practitioner in New Zealand had been treating a bus driver who had had a coronary bypass and whose heart condition was unstable. The doctor advised the man to give up driving, but the patient refused. On learning that the man proposed to take a group of schoolchildren on an excursion in his bus, the doctor informed the traffic authorities that, in his opinion, the man was unfit to drive and was a danger to the public. The bus driver brought legal proceedings against the doctor, resulting in an award of damages, severe censure by the New Zealand Medical Council,9 and the doctor's suicide. However, it is most unlikely that an Australian court would award damages in similar circumstances, if only because the bus driver would be unable to prove a "loss" recognised at law. Another New Zealand case, Furniss v Fitchett (Box), undoubtedly represents the current law in Australia. According to this case, the duty of care is dependent on the foreseeability of the harm in suit.10 Conclusion Doctors should always seek judicial guidance before answering any question in court involving confidential information about a patient. Where a party causes a subpoena duces tecum to be issued to a medical practitioner, calling for all records relating to a patient to be produced, these documents must be produced to the court. It is then for the court to decide whether the documents may be inspected by the parties or their advisers. As a matter of law, medical records cannot be adduced in evidence except when proved by the doctor, and it is at that point that the doctor should seek to invoke the court's discretion, pleading confidentiality of the material unless waived by the patient. If the judge rules against the doctor, the choice is between compliance and prison, although a fine is more likely. Medical defence organisations will fund a doctor's resistance to the disclosure of confidential medical information. However, if the judge compels disclosure and the doctor refuses to comply, any fine is unlikely to be covered by the doctor's indemnity -- idealism is rarely rewarded. Where there is little conflict on medical evidence, a patient's notes may be produced to the court by agreement and admitted into evidence without the doctor being present, after affording the patient the opportunity to claim privilege. Doctors would be well advised to explore this option in appropriate cases. It provides an alternative to waiting needlessly in court in the many cases where a medical witness is not called, either because after a conference with counsel the medical evidence is thought to be unhelpful, or because the case is settled just before or during the hearing. Finally, a word of warning. A doctor unhappy to provide records or give evidence must not take the law into his or her own hands. When in doubt, consult your medical defence organisation. References Evidence Act 1995 (Cwlth), sec 55; Evidence Act 1995 (NSW), sec 55. Australian Medical Association. AMA Code of Ethics. Canberra: AMA, 1996. Attorney-General v Mulholland [1963] 2 QB 477. Re Buchanan [1964-5] NSWR 1379. Hunter v Mann [1974] QB 767. Tarasoff v Regents of the University of California 529 P 2d 253 (1974). Motor Vehicle Act 1959 (SA), sec 148. Traffic Act 1909 (NSW), sec 17A. Duncan v Medical Practitioners Disciplinary Committee [1986] 1 NZLR 513. Furniss v Fitchett [1958] NZLR 396. Author's details University of New South Wales (ATAX), Sydney, NSW. Paul Gerber, LLB, DJur, Professor of Law. Reprints will not be available from the author. Correspondence: Professor P Gerber, GPO Box 9955, Brisbane, QLD 4001. Make a comment Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> Furniss v Fitchett Dr Fitchett, a GP in New Zealand, was the medical attendant of both Mrs Furniss and her husband. In about 1956, Mrs Furniss began to think that her husband was poisoning her and that he was mentally unsound. She told Dr Furniss that her husband was cruel to her and even violent. These suspicions and charges were without foundation, but led to domestic discord, which affected the health of the husband. The husband consulted a solicitor about a separation and/or whether his wife could be certified. During a subsequent consultation with Dr Fitchett, the husband, in a distraught state, asked the doctor to provide a medical report on his wife. Dr Fitchett, "after deep thought", wrote and signed a document, to be given to the husband's solicitor, which, after listing a series of symptoms, stated that the doctor considered that the wife "exhibits symptoms of paranoia and should be given treatment for same if possible. An examination by a psychiatrist would be needed to fully diagnose her case and its requirements." Some 12 months later, this document came to light in proceedings by Mrs Furniss against her husband for separation and maintenance. The lady may have exhibited symptoms of paranoia, but she recognised a good claim against a doctor. Her action against Dr Fitchett in damages succeeded.10 Chief Justice Barrowclough held that the doctor should reasonably have foreseen that the contents of the report were likely to come to his patient's knowledge and that she would be likely to suffer hurt as the result of his action. In these circumstances, there arose a duty of care on his part to prevent the foreseeable harm which the circulation of such a report would cause, notwithstanding that the certificate was true and accurate. Back to text

Paul Gerber

Editorial Posthumous conception and the need for consent We should require prior consent to safeguard the interests of the deceased MJA 1999; 170: 53-54 The spectre of a bereaved family member attempting to cope with the tragic death of a loved one by harvesting the deceased's gametes for procreative purposes is indeed a moving one. But sympathy alone should not inform law and public policy. Rather, we need to grapple with the complex moral issues emerging from the advent of medical techniques that, for the first time in history, have made posthumous conception a reality. Any attempt to formulate a coherent ethical framework in this area must be sensitive to the many interests at stake. In addition to considering the grieving family member's desire to produce a child, policymakers must identify and evaluate other important interests. For example, protecting the psychological well-being of the resulting child should receive serious attention. Might the child be adversely affected by being knowingly denied access to one biological parent? Also, the interests of the deceased's family are important, as posthumous conception of a child will probably have enduring emotional, psychological and financial implications for the family. However, the issue most easily overlooked, as the dead have no voice, concerns the interests of the deceased. Specifically, what significance ought to be afforded the deceased's interests when we have little or no evidence regarding his or her wishes for, or objections to, posthumous procreation? Some may claim that we cannot speak sensibly of the dead as having "interests" which can be "harmed" by the conduct of surviving parties because, once a person dies, that individual no longer has any interests and therefore concepts of "harm" or "benefit" are inapposite.1 It is clear, though, that certain acts committed after a person's death can either harm or promote that individual's interests. For example, a posthumous event that destroys a deceased person's reputation harms his or her interests because it adversely affects the way that individual is remembered after death.2 Posthumous conception likewise affects the deceased's interests, because it recasts the content and contours of the deceased's life. When it occurs without the person's consent, it deprives an individual of the opportunity to be the conclusive author of a highly significant chapter in his or her life. Indeed, this is one of the reasons why any attempted analogy between posthumous conception and organ donation fails. Controlling the fate of gametes is different from -- and more significant than -- controlling the fate of cadaveric organs, because procreation is central to an individual's identity in a way that organ donation is not. As the consequences of posthumous conception profoundly affect core values held by the deceased while alive, respect for autonomy requires that this procedure should not be permitted unless the deceased's consent is clear. The interests of the living can also be adversely affected by permitting the harvesting of a deceased person's gametes without his or her consent. As a society, we recognise that most people find it important to attempt to control certain postmortem events.3 Consequently, we have developed procedures that allow us to control certain matters after death, such as the transfer of property, the nomination of beneficiaries, or the transplantation of organs.1,3 Given that it is important to individuals that their wishes be respected after death, it is also important that they have the assurance that their bodies will not be used in a manner inconsistent with their expectations. In our culture today, most people do not expect that their gametes will be used for procreation after death. As this possibility is rarely contemplated, people generally do not make their views regarding this practice explicit. In the vast majority of cases, then, considerable uncertainty exists concerning the deceased's wishes in this regard. The claim might be made that, as it is possible that using the deceased's gametes for procreation would have been consistent with that person's wishes, a request to do so should be granted. However, it is both unfair and undesirable to place the onus upon individuals to state their opposition to posthumous conception. As posthumous conception is not the norm in our society, there is no reason to expect people who might be opposed to the practice to make their objections known. When the living can only speculate about the deceased's wishes, posthumous conception should not be permitted. Even if there is evidence that the deceased desired parenthood in life, it is a considerable leap to assume that he or she would have wished to become a parent posthumously. Evidence indicating a desire for the former does not necessarily support a conclusion that the latter was also desired. If the deceased person's wishes are to be safeguarded adequately in posthumous reproduction, clear evidence of intent to reproduce after death should be required. The strong procreative interest of family members seeking posthumous conception may tempt them to portray the deceased's values and desires in ways that are not necessarily compatible with the interests of the deceased. Given that posthumous procreation, unlike organ donation, entails significant and permanent implications for the deceased's family, the potential for a serious conflict of interest justifies a far more limited decision-making role for the family. Despite the finality of death, the relationship of the living to the dead does not altogether cease with the grave. To some extent, it continues through the actions of the living as they carry out the last wishes of the dead. A presumption against the unauthorised use of gametes after death represents an important statement about the value of bodily integrity and self-determination. We should approach posthumous procreation with great caution, even when the deceased's wishes are known. When these wishes are unknown, respect for individual autonomy and dignity requires that the deceased's body should not be used in a way that, in all probability, was never contemplated in life. Anne Reichman Schiff Associate Professor of Law University of Pittsburgh School of Law, Pittsburgh, PA, USA Partridge E. Posthumous interests and posthumous respect. Ethics 1981; 91: 244-247, 259-261. Feinberg J. Harm and self-interest. In: Hacker PMS, Raz J, editors. Law, morality, and society: essays in honour of HLA Hart. Oxford: Clarendon Press; 1977: 304-308. Feinberg J. The rights of animals and unborn generations. In: Blackstone WT, editor. Philosophy & environmental crisis. Athens: University of Georgia Press; 1974: 57. Reprints: Associate Professor A R Schiff, University of Pittsburgh School of Law, 3900 Forbes Avenue, Pittsburgh PA, 15260 USA. Make a comment Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Editorial Ethics committees: is reform in order? Ethical review of multicentre studies is necessarily complex, but the system is improving MJA 1999; 170: 9-10 The introduction by the National Health and Medical Research Council (NHMRC) of the requirement for ethical approval of all grant applications in 1973 marked the beginning of the present institutional ethics committee (IEC) system in Australia. This ended the "closed shop" research era, reflecting a wider community demand for more open government, greater public accountability, expanded civil liberties and respect for human rights. It also came at a time when public confidence in "experts" was declining, when complex new technologies were being introduced, and when details of grossly unethical research, such as the Tuskegee syphilis study in the USA, were revealed.1Until the early 1990s, most research involving humans was conducted within individual institutions; this was reflected in the NHMRC Statement on human experimentation and supplementary notes,2 where emphasis was placed on institutional responsibility for ethical oversight. Only passing reference was made to the possibility of multicentre research, with the stipulation that an IEC shall "give its own consideration to projects that involve research in more than one institution", accompanied by a footnote indicating that "An IEC is free to discuss a project with other IECs if it chooses, with due regard to confidentiality." In 1991, in response to perceived bureaucratic delays within the Therapeutic Goods Administration in its centralised approval process for clinical trials, the Baume Report recommended decentralisation of the system, with IECs assuming responsibility for evaluating study design and safety as well as ethical aspects.3 Despite initial uncertainties and difficulties, the clinical trials notification system has proved enormously popular. Notifications have risen from 147 trials at 350 sites in financial year 1991-92 to 400 trials at nearly 1500 sites projected for 1997-98. These figures demonstrate not only increased overall clinical trial activity in Australia, but also a substantially greater number of multicentre studies. Difficulties in the handling of multicentre studies within the IEC system soon became apparent, and were a major focus of discussion at a series of ethics workshops organised by NHMRC in 1995.4 From the researchers' point of view, problems identified included duplication of effort, inconsistencies in documentation requirements and in decisions between IECs, and delays in approval. For IECs, problems included inadequate resources, and uncertainties about the implications of an IEC accepting another committee's decision without its own detailed consideration of the proposal. In this issue of the Journal, Jamrozik and Kolybaba5 raise the possibility of centralised ethics approval of multicentre studies, a suggestion which has been advocated by others in the pages of the MJA recently.6-9 Similar ideas were canvassed at the 1995 NHMRC workshops, and discussed in a 1996 review of the role and functioning of IECs,10 but were not recommended for several reasons. First, institutions have ethical obligations and legal duties towards their own patients, students or staff who become research subjects, and IECs are loath to transfer these responsibilities. Second, important aspects of ethical review are "local". For example, local IECs have the best knowledge of the expertise of investigators, the availability of facilities and resources to support particular types of research, institutional administrative requirements, and the ethnic and cultural mix of the local community.11 Thus, centralised review could assist, but not substitute for, local IEC review of multicentre research. Similar considerations in other countries have led to the conclusion that central review is likely to increase rather than decrease unnecessary bureaucracy and paperwork.12,13 Are other solutions possible? National introduction of a standardised application form, acceptable to all IECs, is currently under consideration by the Australian Health Ethics Committee (AHEC) as a means of minimising inconsistencies and reducing the duplication involved in preparing applications for multiple IECs. Independent initiatives are already under way in NSW and Victoria, where common application forms, developed collaboratively, are undergoing evaluation by local IECs, and there have been expressions of interest from other States. Also, in the not-too-distant future, electronic submission of applications via the Net will become a practical proposition, further reducing the amount of time and paperwork involved in making multiple submissions. Jamrozik and Kolybaba highlight the lack of consistency in decisions reached by different IECs considering the same proposal. Two approaches are relevant. First, to maintain scientific and ethical validity in multicentre studies it is essential for there to be agreement on study design and safety aspects. This could be achieved by participating IECs being prepared to accept a single scientific assessment by an appropriate expert panel. This would not preclude an IEC from drawing on additional advice from its own assessors, but scientific disagreements should be resolved collectively before final ethical approval by the participating IECs. Approaches of this kind have already been suggested,14,15 and the NSW Health Department has established a working party to explore the practicalities. Secondly, participating IECs can be encouraged to harmonise their views on general ethical concerns through better communication (via email, for example, or by teleconferences of the secretaries and chairmen of the IECs involved). Is reform of the IEC system necessary? Although it may not yet be apparent, this is already under way. New NHMRC guidelines on ethical conduct of research involving humans are currently undergoing the final stages of public consultation and revision, and are due for release in early 1999. The need for better resourcing of IECs and training of their members is now recognised. In relation to multicentre research, the guidelines will allow for more procedural flexibility and will shift the emphasis towards a more cooperative approach. Electronic communication, thought to be impractical at the 1995 NHMRC Ethics Workshops, is now a reality. An electronic discussion forum has been enthusiastically embraced by NSW IECs, and is now becoming national. Ultimately, it is to be hoped that widespread formal and informal networking among IECs and researchers will encourage a convergence of views on the solutions to ethical problems, promoting a more consensual culture in the ethical review of research.16 Robert H Loblay Chairman, Ethics Review Committee Central Sydney Area Health Service (RPAH Zone) Email: roblobATmed.usyd.edu.au Donald R C Chalmers Chairman, Australian Health Ethics Committee National Health and Medical Research Council McNeill P. The ethics and politics of human experimentation. Melbourne: Cambridge University Press, 1993: 61-62, 65. National Health and Medical Research Council. Statement on human experimentation and supplementary notes 1992. Canberra: NHMRC, 1992. Baume P. A question of balance: report on the future of drug evaluation in Australia. Canberra: AGPS, 1991. Australian Health Ethics Committee. Report of 1995 ethics workshops. Canberra: NHMRC, 1995. Jamrozik K, Kolybaba M. Are ethics committees retarding the improvement of health services in Australia? Med J Aust 1999; 170: 26-28. Beran RG. Should there be an accredited ethics committee system for centralised review of multicentre clinical research? Med J Aust 1998; 168: 174-176. Clarke CW. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 283. Henman MJ, Tattersall MHN, Brown RF. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 283-284. O'Brien EA, Saltman DC, Berglund CA. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 284. Report of the review of the role and functioning of Institutional Ethics Committees. Report to the Minister for Health and Family Services. Canberra: AGPS, 1996. Weeramanthri T, Currie BJ. Isn't one institutional ethics committee's approval enough [letter]? Med J Aust 1994; 161: 398-399. Moran J. Local research ethics committees: Report of the 2nd national conference. J Roy Coll Physicians Lond 1992; 26: 423-431. Montgomery J. Improving review of multi-centre trials. Bull Med Ethics 1994 (February): 19-22. Cohen M. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 168: 528. Gandevia SC, McKeown T, Wright M, et al. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 285. Chalmers D, Pettit P, on behalf of the Australian Health Ethics Committee. Towards a consensual culture in the ethical review of research. Med J Aust 1998: 168; 79-82. Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1998 Medical Journal of Australia.

Robert H Loblay

Multicentre studies are now required to go through multiple systems of ethical approval, which adds to costs and delays MJA 1999; 170: 26-28 For editorial comment, see Loblay and Chalmers Introduction - Case study - Discussion - Conclusion - Acknowledgements - References - Authors' details - - More articles on Ethics Introduction This article uses a case study to show that the system of institutional ethics committees (IECs) that has been created in Australia now stands to impede the identification of suboptimal practice and waste in the healthcare system, and that there is a grave danger that IECs will delay or even prevent identification of avoidable threats to health originating either inside or outside the medical system. It presents the case for simplifying the requirements for ethical review of multicentre investigations that require only access to medical records. Case study -- review of prostate cancer management The incidence of cancer of the prostate rose steeply in Australia in the first half of the 1990s, due partly to widespread use of the prostate-specific antigen test for case-finding.1 The rapid increase in incidence, with little concomitant change in mortality,1 had major consequences for the many more men who had to live with the diagnosis and for the health services that had to be provided to them. Recognising this, a multidisciplinary group of investigators is documenting the presentation, investigation and primary management of all cases of prostate cancer diagnosed in Western Australia (WA) in 1992, the year before active case-finding began. Records from the State Cancer Registry, to which notification of cases is mandatory, indicate that 634 new diagnoses of prostate cancer were made in 1992. Linkage to official mortality statistics for WA, for which permission was granted by the Confidentiality of Health Information Committee of the Health Department of Western Australia, revealed that 265 of these men had died by the time that a retrospective review of medical records began in early 1997. The protocol for the study was approved by both the Confidentiality of Health Information Committee and the Committee for Human Rights of the University of Western Australia, the latter being an IEC operating within the terms of the NHMRC statement on human experimentation2 and supplementary note 1 to that statement.3 All but one of the 16 urologists in WA also gave permission for a research nurse to review relevant medical records, to abstract details of each case and to copy pertinent laboratory reports. Information has now been collected for nearly all relevant cases, but only after the investigators had sought and gained ethical clearance from a further 29 IECs or their representatives. Each IEC was sent an initial letter of application, including a copy of the approved research proposal outlining the background, aims and objectives of and methods to be employed in the project, together with copies of the approval from the Committee for Human Rights and the Confidentiality of Health Information Committee. For two IECs, misplaced correspondence necessitated resubmission of the application. In most instances (62%), the hospital IEC approved the project once it had been provided with evidence that another Committee had reviewed and passed the protocol, but this process still took several weeks. Six IECs required multiple copies of an application in a form unique to their institution before the application would even be considered. Four IECs initially took the view, despite the investigators having permission from the creators of the records to inspect them, that the written consent of each patient would be required before his record could be inspected. One committee has remained firm in this view, even when, in supplementary correspondence and in face-to-face discussion, it has been pointed out that this provision might introduce substantial selection bias into the project, that it was not clear who might legitimately give permission on behalf of a deceased patient, and that to ask the investigators to identify and trace next-of-kin was not only an unduly onerous request that would make the study logistically impracticable, but could also result in undue anxiety to the bereaved. The Table shows that it took between two and 11 weeks to obtain rulings on applications to IECs in public hospitals, with the median time from application to receipt of a written response being 6.5 weeks and 75% responding within 8.6 weeks. In the private sector, the median time was five weeks, with 75% responding within 11 weeks. Although one private hospital responded within a week, correspondence with another continued for more than a year after the initial application was submitted before it finally approved access to records with all identifying information removed. This defeats the purpose of the study, as such an arrangement makes it impossible to relate treatment given to outcome of treatment for a particular patient. In the event, at least a tenth of the resources committed to the investigation have been used in preparing applications to and dealing with correspondence from IECs. Discussion This case study highlights many of the issues mentioned in a recent review of the system of IECs in Australia, chaired by Professor Don Chalmers:4 the number of IECs has grown very rapidly in recent years; there is a lack of uniformity in application processes and decisions of different committees; and Australia's present system of ethical overview does not cater well for multicentre investigations. Similar problems have been reported overseas,5 as have long delays and high costs in gaining ethical approval for multicentre studies.6The report from the Review Committee identifies two guiding principles for our system of IECs, namely that the prime responsibility of an IEC is to protect the interests of the subject of the research, and that the responsibility for ethical conduct of the research is vested in the investigator and ultimately in the institution to which he or she is affiliated.4 It does not consider whether an IEC also has a duty in relation to the collective interests of the community that stands to benefit from the results of research. Distinguishing between retrospective and prospective studies The primacy of the interests of an individual participant in a research project seems simple enough, especially when human experimentation is proposed, but, when what is under consideration is only a systematic review of records, how should an IEC balance the likely desire of individuals for confidentiality and privacy against their likely desire for confidence that the system of healthcare they are using, and for which they are paying, is running effectively, efficiently and safely? In our experience, patients see follow-up surveys of their long-term outcome after an admission to hospital as important and they support them strongly. Response rates of 80% or more are readily achieved in such studies, and many participants add complimentary remarks to postal questionnaires to the effect that they perceive such activities as evidence of a commitment to maintaining excellence in the healthcare system. Positive comments are many times more frequent than negative ones. Retrospective reviews of medical records are even less intrusive than postal surveys and are a cheap, relatively rapid and efficient way of gaining a comprehensive view of the health system's response to a particular medical problem. Clearly, they involve use of medical notes for other than the primary purpose for which they were created, but, equally clearly, systematic reviews of this kind are qualitatively different from other research in which participants are asked to undergo additional or novel tests or treatments. For example, in an appropriately designed Phase III trial of a new treatment, there is at least an 80% chance that patients receiving one of the two treatments will have a significantly worse outcome than those randomised to receive the other. It is therefore entirely proper that such studies are subjected to rigorous ethical scrutiny, although, as a recent commentator points out,7 the requirement that the IEC of every hospital participating in a multicentre trial review the same protocol seems needlessly wasteful of time and energy. Contrast such a prospective trial with an investigation of the same drug after it has been on the market for some time when the possibility of a rare teratogenic effect is raised. Under the present Australian system of ethical oversight, investigators collecting data to confirm or refute this association would have to submit a detailed application to the IEC of every health institution with which the mothers of affected and unaffected control children had had contact within the year before the child's birth. The example of Debendox shows that, faced with the threat of litigation and unable to wait for independent investigators to complete a cumbersome and time-consuming series of applications to IECs before even beginning their research, the manufacturer of what may be a safe and useful drug may feel that there is no option but to withdraw the product from the market. In Australia one peer-reviewed case-control study of a possible life-threatening side effect of a drug used in the treatment of asthma was rejected by one IEC, and the investigators estimate that it cost them $20 000 and a year's work to gain approval from 14 other IECs.8 Thus, significant amounts of public money from government agencies or charitable organisations are wasted by IECs requiring that generally innocuous retrospective studies go through multiple ethical reviews. Investigators conducting retrospective studies of all types -- be they of alleged side effects of pharmaceutical agents, the long-term consequences of occupational exposures or military service, or simply descriptions of how particular presenting complaints were investigated and treated by the medical system at a given time -- are acutely aware of the privilege of using existing medical records for their work as well as of the need to observe the highest ethical and scientific standards in their enquiry. Such studies are motivated as much by the public interest as by scientific curiosity, but it is obviously also in the investigators' own interests to ensure that the privileges extended to them are respected and not abused. As supplementary note 6 of the NHMRC statement on human experimentation9 makes clear, in considering applications for approval of research of this kind IECs need to find a balance between protecting the interests of individual patients and not jeopardising the validity and hence broader utility of the results of the research. Need for clear ethical guidelines on retrospective research The focus of IECs is on safeguarding the interests of subjects associated with single institutions and of the single institutions themselves. Supplementary note 1 of the NHMRC statement on human experimentation3 includes no requirement that the membership of an IEC include someone with training or experience in a population-based discipline, and many IECs appear to struggle with the need for a whole-of-population study to include every single case of interest from a defined community, regardless of where that case was diagnosed or treated. Sometimes this is motivated by a reluctance to make "our data" available to outsiders, but more often it seems related to a failure to grasp issues surrounding selection bias and statistical power in studying infrequent but important events. In retrospective research, any harm that might have been done has already occurred, and the challenge is to strike a balance between the risks to privacy and confidentiality associated with a review of existing records and the potential benefits to existing patients, future patients and the public in general.10 If we are not to have regional or whole-of-State ethics committees, IECs should distinguish between retrospective studies based entirely on records, retrospective studies involving contact with patients or their families (and thus collection of new information) and prospective studies, and develop mechanisms for expeditious consideration of at least the first of these. For multicentre studies requiring only access to records, the combination of an established research investigator, clearance from one IEC constituted according to guidelines set down by the NHMRC and permission from the relevant professional specialist body might be the minimum required for approval-in-principle by Chairs of other IECs. Conclusion Currently, the healthcare system has embarked upon a quest for effectiveness and efficiency embodied by the "Golden Fleece" of evidence-based medicine. Measuring our progress towards that goal requires systematic review of past and present practice, which entails applying medical records to a purpose other than that for which they were primarily, but not exclusively, created. This immediately raises complex ethical questions, answers to which are rarely absolute. Yet, IECs should not tie down such studies with red tape, nor needlessly impede the interests of past and future patients and of the broader community. Acknowledgements The study of prostate cancer mentioned in this report is supported by the Health Department of Western Australia and the Cancer Foundation of Western Australia. Professor D'Arcy Holman kindly provided comments on an early draft of the manuscript. References Threlfall T, Whitford M, Thompson J. Cancer incidence and mortality in Western Australia 1992-94. Perth: Health Department of Western Australia, 1996. National Health and Medical Research Council. Statement on human experimentation. Canberra: NHMRC, 1992. National Health and Medical Research Council. Statement on human experimentation: supplementary note 1 -- institutional ethics committees. Canberra: NHMRC, 1992. Review Committee (Chair: Professor D Chalmers). Report of the review of the role and functioning of institutional ethics committees. Canberra: Australian Government Publishing Service, 1996. White AE. Research ethics committees at work: the experience of one multi-location study. J Med Ethics 1996; 22: 352-355. Ahmed AH, Nicholson KG. Delays and diversity in the practice of local research ethics committees. J Med Ethics 1996; 22: 263-266. Beran RG. Should there be an accredited ethics committee system for centralised review of multicentre clinical research? Med J Aust 1998; 168: 174-176. Smith MA, Jalaludin B, Leeder SR, Smith WT. Isn't one institutional ethics committee's approval enough? Med J Aust 1994; 160: 662. National Health and Medical Research Council. Statement on human experimentation: supplementary note 6 -- epidemiological research. Canberra: NHMRC, 1992. Emson HE. Minimal breaches of confidentiality in health care research: a Canadian perspective. J Med Ethics 1994; 20: 165-168. Authors' details Konrad Jamrozik, MB BS, DPhil, FAFPHM, Associate Professor in Public Health. Marlene Kolybaba, BSc, MPH, Research Officer. Reprints will not be available from the authors. Correspondence: Associate Professor Konrad Jamrozik, Department of Public Health, University of Western Australia, Nedlands, WA 6907. Email: konradATdph.uwa.edu.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1998 Medical Journal of Australia.

Konrad Jamrozik · Marlene Kolybaba