Ethics

Objective: To survey the use of declarations of ethical commitment made by graduating medical students in Australia and New Zealand.Methods: Information, obtained by email and telephone, from faculty officers of all faculties of medicine (or medicine and health sciences) in Australia and New Zealand.Results: Declarations are made by graduating medical students at seven of 12 Australasian faculties of medicine. To date, declarations have been based on the Declaration of Geneva or the Hippocratic Oath or have been formulated by academic staff or the students themselves. In six of the seven universities, declarations are made as part of a special declaration ceremony (usually combined with a prize-giving ceremony). One university includes a declaration as part of the official graduation ceremony.Discussion: We discuss the relative merits of a declaration selected for students by staff members and a declaration written anew by each group of graduating students.

Paul M McNeill MA, LLB, PhD · S Bruce Dowton MD, FACMG, FRACP

To the Editor: In response to Leeder and Rychetnik's article,1 evidence-based medicine (EBM) also has significant potential to reduce the quality of patient care, with obvious ethical implications. I refer to two specific issues of concern. The first relates to the increased expectation that clinicians, and especially trainees, not only understand the role of EBM in clinical practice, but actively contribute to its underlying database. Indeed, some of the professional colleges (eg, the Faculty of the Australian and New Zealand College of Anaesthetists) now include formal projects (which are often, but not necessarily, clinical trials) in their final assessment of trainees.2 This is leading to increasing numbers of poorly designed trials that are unlikely to make useful contributions to the clinical database. These commonly take two forms: studies which lack sufficient power to confirm the absence of a true difference between groups,3,4 or studies which use a placebo when effective therapeutic alternatives exist.5 Yet such studies are frequently published in reputable, peer-reviewed journals.6 Both of these types of studies are unethical, and both impact adversely on patient care. Increasing the evidence base of clinical medicine is important, but our primary responsibility remains the maintenance of quality of care of all patients, especially those involved in clinical trials. Therefore, education of clinicians, and especially trainees, must emphasise the role and importance of statistics, epidemiology and study design in all areas of medicine to prevent unnecessary reductions in the quality of care of this subset of patients. The second concern relates to the increase in "quality improvement" projects that are rarely submitted to ethics committees for approval. These activities also contribute to the evidence base, primarily at a local level, but patients are usually unaware that they are involved in these projects, and that these activities may have significant quality-of-care implications for them. It is therefore important that internal hospital quality assurance activities undergo a similar level of scrutiny by ethics committees to that of clinical trials. Patients involved in any audit or project that has the potential to influence their care should be required to give informed consent. Only then can we reassure a patient that, while we are continually striving to improve the care we provide by developing the evidence base for clinical medicine, the care of each individual remains our primary concern.

Simon R Tomlinson · Kerry J Breen · Malcolm H Parker · Chris B Del Mar · Paul P Glasziou · Lucie Rychetnik and · Stephen R Leeder

Comment: Tomlinson raises two important ethical issues in clinical research. While there are several ethical issues which may arise in acquiring and applying evidence to clinical practice and health administration, as outlined previously by Kerridge et al1 and picked up well by Leeder and Rychetnik,2 it is misleading if Tomlinson wishes to imply that the two issues he has raised can be attributed to the evidence-based medicine (EBM) movement. His first issue could be summarised as "badly designed clinical research should be seen as unethical", for reasons which may include wasting scarce resources or placing participants at discomfort or risk when the likelihood of benefit is slight. He alleges that poorly designed studies are "frequently published in reputable peer-reviewed journals", a statement which would surprise most editors. Peer review prior to publication, and the earlier independent prospective scrutiny of research proposals by human research ethics committees (HRECs) (according to updated national guidelines published by the National Health and Medical Research Council [NHMRC] in 19993), are two processes designed to prevent this. Assessment of the quality of design and execution of clinical research protocols is to some extent subjective, so these processes will never be perfect. His second issue relates to the definition of quality improvement/assurance and clinical audit, and whether such studies should be regarded as clinical research, and thus subject to prospective ethical review by an HREC. His own conclusion "that internal hospital quality assurance activities should undergo a similar level of scrutiny by ethics committees" is not consistent with the NHMRC guidelines,3 which, in the context of outlining the difficulties in defining research, state (on page 6) "such lists risk including activity that would not normally be included, like quality assurance activities or audits". Nevertheless, there are definitional uncertainties. The Australian Health Ethics Committee (AHEC) of the NHMRC has recognised that clinicians, HRECs and their hospitals need clear advice on how quality assurance and audit activities, which may not need ethical review, are to be separated from clinical research, which does need review. We are not the only country considering this matter.4 AHEC has established a working party to prepare such advice. The working party includes members drawn from AHEC, HRECs, consumer groups, medical colleges and health administrators. Draft advice will be subject to wide stakeholder consultation. The working party commenced its task in November 2001 and its final report is expected by mid-2002.

Simon R Tomlinson · Kerry J Breen · Malcolm H Parker MB BS, MLitt · Chris B Del Mar MD, FRACGP, FAFPHM · Paul P Glasziou MB BS, PhD · Lucie Rychetnik MPH, PhD · Stephen R Leeder FRACP, FFPHM, FAFPHM

To the Editor: We consider that Leeder and Rychetnik make several mistakes in their exploration of the relationships between ethics and evidence-based medicine (EBM).1 We share some of their ethical concerns about the determinants of the research agenda — lack of consumer input, emphasis on the benefits of interventions rather than harms, and funding structures favouring commercially promising interventions or biased by the status of the methodology to be used. However, these are criticisms that relate to producing new research, not using available research. The definition of EBM used by Leeder and Rychetnik2 values evidence that is non-quantitative, and explicitly demands the inclusion of patient preferences in clinical decision-making. Evidence about effects comes from research, while evidence about concerns and values comes from individual patients. To incorporate a patient's pre-ferences in the consultation is crucial to ethical practice, but quite independent of any particular hierarchy of evidence. Similarly, in claiming that treatment may be denied those of low social utility if patient autonomy is not valued, they mistakenly confuse preference or value with the quality of the evidence. The sin of old-fashioned paternalism is falsely attributed to EBM. The suggestion that EBM can exclude the importance of patient narrative is also at odds with the authors' chosen definition, which emphasises the "identification and compassionate use of patients' predicaments, rights, and preferences". Next, they worry that EBM might be misused in public health policy by neglecting areas where evidence is difficult to obtain, offering mental illness as an example. In fact, mental health attracts considerable attention3 and funding as one of the Commonwealth's current priority health areas.4 It has also been an area of considerable activity in EBM, with the Cochrane Mental Health groups and the BMJ's evidence-based summary journal Evidence-Based Mental Health. It may be that EBM has done the opposite of their prediction by highlighting an area of "evidence need". We agree that patients require support when they confront ambiguity and uncertainty. Nevertheless, doctors are ethically and legally obliged5 to provide full disclosure. Patients should be given correct information — warts, uncertainty and all — as often as possible. To suggest that the time spent seeking evidence threatens other elements of clinical practice is misleading. Clinical practice requires judgement to balance all its competing demands. We suggest that, by increasing the efficiency of continuing education, EBM should actually release more time for other requirements. Leeder and Rychetnik also misinterpret the relation between EBM and the law. They suggest that some practitioners who consult evidence, but practise against published guidelines, may be compromised. The point of EBM is to find the best available evidence. If that is clinical experience, consensus or narrative, rather than quantitative data, then so be it. Similarly, it is wrong to imply that those who practise EBM may be sued because they fail "to try everything". EBM, which is simply the getting of the best available information, changes nothing in the formal relationship between clinical evidence and the legal standard of care. Moreover, we believe that, by fostering patient involvement in decision-making, EBM should help protect clinicians from medicolegal dispute. We are always at risk of using new tools overzealously. But the champions of EBM temper its promotion with words like "judgement", "incorporating patient preference" and "conscientiousness". EBM involves a sensible and systematic search for the best information to include in the decision-making process. Great care should be exercised in issuing warnings about how it might be misused, in case EBM becomes unfairly caricatured, which may reduce the motivation of health professionals to find and apply the best treatment.

Simon R Tomlinson

In reply: Much of the literature about evidence-based medicine (EBM) has focused on the science of generating evidence, or the technical process of critically appraising and interpreting evidence for individual patients. In our article1 we opted to discuss EBM as a social activity with inherent potential for multiple manifestations. To describe EBM as a social activity is to emphasise how its definition, interpretation and application, and the ethical implications of those factors, are dependent on societal values and priorities — be they explicit or implicit. Debate about what EBM means, or should mean, in the context of Australian policy and practice does not degrade or negate the clearly ethical practice of consulting the best available research when making clinical or policy decisions. We challenge the view of Parker et al that by identifying and discussing how the concepts or language associated with EBM could be misused or misappropriated we will somehow reduce the motivation of health professionals to find and apply the best treatments. Indeed, our proposition is quite the opposite. Few of today's readers of the MJA will be unfamiliar with the benefits of systematic reviews of the best available research in their clinical area, and few are likely to be dissuaded of that view by our article. Our exploration of the relationship between ethics and EBM does not "misinterpret" EBM, but, rather, purposefully describes scenarios or social consequences about which there may be ethical concerns. If we can articulate clearly what we do not want EBM to mean, and describe the processes and consequences that we would consider unethical, it can only strengthen the development of an ethical and acceptable notion of what we do want from evidence-based policy and practice.

Simon R Tomlinson

For some time, I have taught communication and relational skills to medical students and physicians-in-training in an internal medicine residency program in the United States. What became apparent to me early on was that the humanistic, relationship-centred attitudes and behaviours being fostered in the classroom were not always finding their way into the clinic or onto the hospital floors. Sadly enough, this observation is supported by studies on patient–physician communication.1,2 In discussing this phenomenon with my students and colleagues, a common response emerged. They believe the relational behaviours taught in the classroom are not wholly credible in the “real world” of medical practice. Empathic attitudes and behaviours make little sense in terms of survival in residency training or success in practice. It seems as if these compassionate behaviours are being extinguished by a lack of incentive or reward in the system. Valued and rewarded instead are academic acumen, technical knowledge and skill, business savvy, and financial success. To better understand this situation, I began to study the “real world” of medicine more intently. Based on this examination, it is my impression that the fundamental problem in the current healthcare system is a lack of meaning. For the purpose of this article, “meaning” will be defined as the underlying beliefs, guiding principles, and defining philosophies that make up the professional ethic of medicine. What follows are my observations and thoughts, as well as a brief outline of my recommendations. Over the past century, there has been an insidious decline in attention to the philosophy of medicine. We have become less interested in or aware of the age-old values and ethical traditions of our healing profession. This claim is supported by the many studies demonstrating that medical training and professional socialisation, rather than developing and fostering humanistic attitudes and behaviours, actually erode them.3,4 As a result, the core meanings of medicine have been subsumed by the current, dominating societal paradigms of business,5 consumerism,6 the information age,7 technology,8 and the legal system. Clearly, these paradigms are integral and necessary to world culture and modern healthcare, but problems arise when they control the healthcare system, directing the way we care for patients and relate to clinicians. Patient-care surveys reveal a steady decline in public satisfaction with medical care. Research studies repeatedly demonstrate a lack of communication, empathy, and trust in the doctor–patient relationship.9 Although a significant percentage of patients are satisfied with their individual physicians, they and their families are largely displeased with the overall healthcare experience.10 Escalating discontent and distrust are evidenced weekly in newspaper articles and best-selling books.11,12 This widespread public discontent with mainstream medical care is further evidenced by the large and growing movement to seek alternative avenues of medical treatment by turning, literally, to “alternative” practitioners.13 Dangling on the other end of the stethoscope, physicians and other clinicians increasingly find themselves frustrated and demoralised by a work environment devoid of respect and compassion for its employees.14 Morale within the healthcare work environment is at an all-time low.15 Physicians, emotionally exhausted and burned-out, are claiming disabilities and leaving the practice of medicine in unprecedented numbers.16 Loss of autonomy in medical decision-making, burdensome and time-consuming administrative hurdles, fear of malpractice litigation, and financial disincentives threaten physicians' livelihood and their sense of responsibility and professionalism.17 Clinicians, entering the profession with an expectation of providing humanistic medical care, quickly become disappointed and disillusioned.18 The present healthcare system, embedded in the principles of the marketplace, has become a caustic and dehumanising environment for patient and physician alike. Physicians are reduced to interchangeable “providers” and patients to generic “consumers". Clinicians, now treated like factory-line workers, are forced to process patients as if they were items on a conveyor belt. And so we find ourselves entangled in the paradox of modern healthcare19 — despite astounding scientific achievements and dazzling technological sophistication over the past few decades, societal satisfaction with the healthcare system is declining.20 The question we return to is why. One of the greatest tragedies of the 20th century is that in developing the means we have forgotten the “meaning".21 Our society has forgotten that the practice of medicine is primarily a humanistic endeavour, not a scientific one.22 We have forgotten that medicine is a healing profession, not a technological one, and that the contribution of a doctor adds up to more than the sum of his or her knowledge and skill. We have forgotten that the patient, as a person, is far more important than the illness; that the illness is far more than the presence of a disease; and that when the cure of disease is not possible, as is so often the case, the humanistic care of patient and family fosters hope and healing. Our society has become myopic in its focus on technical treatment to the exclusion of how we might treat each other as sublime human beings. The fundamental flaw in applying technological and mercantile approaches to healthcare is that they do not acknowledge or allow for a relational response to the inherent suffering in being a patient or a family member of a patient. Peering through the prisms of consumerism, informatics, science, and technology blinds us to the deeply personal relationships necessary for the transcendence of suffering and its transformation into a healing experience. Strategic plans, business ledgers, and diagnostic codes do not account for the unique and graceful relationships required in patient care. Yet, one of our primary responsibilities in medical practice involves this complex and time-consuming process of helping people cope with suffering.23 Suffering which extends from the physical, to the emotional, relational and spiritual domains. The personal care that a doctor, nurse, social worker and every other healthcare professional offers to his or her patients on these multiple levels cannot be scripted, packaged, or coded. These intimate, sometimes gut-wrenching relationships are often “white knuckle journeys” in which patient, family and doctor hang on, literally, for dear life. It has been eloquently described by one patient as a journey in which the doctor “[enters] my condition . . . [mingles] his daemon with mine; . . . [and] we . . .wrestle with my fate together".24 Compassion and a sense of service to humanity are not commodities or provider services. Medical care, notwithstanding the current industry nomenclature, is an offering, not a provision. Mindful, dignified and collaborative healthcare requires time — the time to listen, to touch, and to create meaningful relationships together. Research strongly suggests that, more than any other aspect of medical care, it is the empathic bond and trusting relationship between patient and physician that bring about measurable improvements in health outcomes.25 It is this humanistic and relational approach that the mechanistic paradigms of business, science, and technology cannot fathom. These intangible qualities are difficult to document in quarterly earnings reports or customer satisfaction surveys, or even in blinded, randomised, placebo-controlled trials. The question remains — how to advocate for and re-create the practice of a humanistic healthcare philosophy in the modern era of medicine. First, I believe it would be useful to begin on the individual level by re-evaluating our personal philosophies toward medicine and healing.26 A few examples of questions I have found myself asking are: How do I define “health” and “healing"? How do my behaviours and relationships reflect and represent those values? What values would I want my patients and colleagues to recognise in my behaviours? What might I do to increase the likelihood of those values being expressed? To aid in this exploration, seminars in medical history and philosophy should become a staple in medical schools, residency training programs, and postgraduate continuing medical education conferences. Even more importantly than formal educational programs, physicians should use each clinical and teaching encounter as an opportunity to develop and foster a meaningful philosophy of medicine for themselves, their patients, and their students. Second, we need to be supported in caring for our families and ourselves. If we are physically, emotionally and spiritually exhausted, it is unlikely that we will be able to provide the type of medical care and healing that our patients want and need.27 We must advocate for a healthcare system that not only allows, but also encourages and even requires, the healing of its healers.28 Third, we need to create an ongoing public dialogue around the relational and ethical aspects of healthcare.29 This dialogue must include non-professional partners and extend outside of hospitals and healthcare centres into communities across the country. Given the pluralism of ethnicity and language in our society, it is essential that this dialogue be made available and accessible to people from a wide variety of cultural backgrounds and socioeconomic standings. Also of importance is the inclusion of patients' family members and non-professional caregivers as integral partners in this dialogue. Fourth, what is required is a renewed focus on institutional or systemic ethics. The practical application of medical ethics has been, in large part, devoted to individual case analysis.30 What is sorely needed is an examination of the principles and behaviours of the larger system. We must examine the messages and beliefs underlying the verbiage, policies, and actions of healthcare organisations. And we must challenge them if we believe they are inconsistent with a healthful vision and mission.31,32 Examples of questions that demonstrate this initiative are: What healing values and principles does my healthcare organisation demonstrate in its daily functioning? How does my organisation support the development of its staff and encourage collaborative relationships? What healthful visions would I want to see implemented and integrated into the infrastructure? What might I do within this organisation to move it closer to that vision? Fifth, we must take advantage of every opportunity to act and be perceived as agents of positive change within the system, rather than as protectors of the status quo. Needless to say, attaining and maintaining clinical and technical competence within any field of medicine requires a tremendous amount of time and effort. However, given the inter-relatedness and interdependence of medical practice, it is no longer sufficient for physicians to limit themselves to being individually competent practitioners in examination rooms, operating rooms or on hospital wards. What is required is not only clinical competence but also “systemic competence". Finally, we must re-create the system so that it recognises, rewards, reinforces and reimburses humanistic standards of medical care.33 Accreditation and regulatory bodies should evaluate for the presence of these ethical and empathic attitudes and behaviours in individuals and within healthcare organisations. We must legislate these ideals so they become mandated and integral to the way our society provides healthcare, preserving the unique healing relationships between patients and clinicians. We must operationalise these ideals so they become active, functional components of our organisations — a dominant, leading presence within the system rather than a marginalised addendum. Ultimately, it is our larger societal context that will determine how medical care is practised. It is the public who will choose which philosophies govern the healthcare system. The 20th century brought miraculous advances to medicine, but it also bled our healing profession of some of its vital meaning. Perhaps one of our chief professional responsibilities in the 21st century will be to repair the torn relational fabric of our healthcare system. Perhaps, as suggested here, our critical role as physicians at this particular moment in history is to reclaim the moral compass of our profession and to map out the lost meanings of medicine. It is my hope and belief that physicians will seize this opportunity and rise to meet the challenge of assisting our society to develop a more healing healthcare system — a system that combines the caring with the curing, the healing with the fixing, and the sacred with the science.

Zeev E Neuwirth MD

When a dying patient lacks decision-making capacity, the general practitioner needs to collaborate with family members in making decisions about forgoing life-sustaining treatment. The key to working out the best course of action is for the doctor to have a very clear idea of which treatment options he or she considers acceptable or unacceptable. The choice of treatment depends on a thorough evaluation of all the clinical information and careful reflection, bearing in mind that medicine has its own proper limits. Life-sustaining treatment may legitimately be forgone if it is (a) therapeutically futile, (b) overly burdensome to the patient, (c) not reasonably available without disproportionate hardship to the patient's carers or others, or (d) refused by the patient.

Paul A Glare FRACP, MAApplEth(Healthcare) · Bernadette Tobin MA, PhD

Medicine and the media Clinical research in the emergency setting: the role of ethics committees It is important that discussions and decision-making processes be free, open and transparent MJA 2001; 175: 630-631 Probably because of its mixed history of triumph and abuse, medical research has always been regarded with a combination of awe and suspicion. Not surprisingly, research into innovative technologies and dangerous illnesses arouses particular anxieties, and sometimes public controversy. The complexities associated with clinical research in the emergency setting are illustrated by the story recounted in this issue of the Journal of the trial proposed by investigators at Sydney's Royal North Shore Hospital (RNSH) to compare two models of care for patients with acute myocardial infarction (AMI).1 While fibrinolysis has been standard treatment for AMI since the mid-1980s, evidence has suggested that coronary artery angioplasty with stenting produces better outcomes. However, the latter treatment requires advanced technology and skills, limiting its availability. Accordingly, it was proposed to conduct a randomised trial to compare outcomes for patients with AMI of transport to the nearest regional hospital for "conventional" treatment versus transport to RNSH for possible angioplasty. . . . the scientific questions are well founded and the answers are likely to carry significant implications for medical practice around the world. Two major issues were recognised from the outset: Patients assigned to RNSH would often experience increased transport times to hospital; and It would be difficult to obtain patients' fully informed consent. The first issue is important because delays in initiating treatment after AMI increase the risk of death. The second issue of difficulty obtaining informed consent is encountered in research involving interventions for acute, life-threatening illness, because of shortness of time and the inevitable stress associated with the life-threatening circumstances. Both these issues were taken up by the RNSH ethics committee that meticulously examined the study. After examination of preliminary data, the committee accepted the arguments of the investigators that the benefits of stenting would exceed any increased risk associated with transport delays. It was also decided that it was acceptable to delay provision of detailed information about the trial until the patients arrived at RNSH, even though, in reality, this would often exclude alternatives. Despite complaints provoked by concern within the medical community, approval was eventually granted, but before the trial could begin the Sydney Morning Herald published an article questioning this decision.2 A storm of publicity followed and, months later, the trial has still not commenced. There are several points raised by this case on which there is widespread agreement. In the emergency setting, as elsewhere, rigorous testing is important to identify the most effective treatments and to exclude ineffective, risky or unnecessarily expensive ones. However, the gravity and urgency of the circumstances will often limit the extent to which patients can make carefully considered judgements about whether to participate. Often compromises need to be found. It is the sometimes unenviable job of the responsible ethics committee to attempt to find such a compromise, after considering all the issues and balancing possible risks and benefits. In this case, the scientific questions are well founded and the answers are likely to carry significant implications for medical practice around the world. However, whatever decision is ultimately reached it is unlikely to find acceptance by all protagonists. The complexity of the issues emphasises the importance of the ethics committee process. As with the courts, public confidence in the outcome of ethics committee deliberations depends on a belief that it is fair, free from interference and takes into account all relevant issues. The RNSH ethics committee appears to have acted with propriety and professionalism, but, like other ethics committees, its deliberations are not open to public scrutiny. In addition, it is possible that it did not consider issues affecting other hospitals within the region — for example, the interests of private providers of angioplasty and their patients who could be disadvantaged by the study. The absence of the need to justify decisions in contentious cases, and of a defined appeals process for most committees, creates an appearance of arbitrariness and peremptoriness. The role of the media, which the investigators found so disturbing here, also raises important issues. Medical research is a matter of public interest, and ethics review is not a mere technical function, but a means by which the community ensures that research proposals are adequately evaluated and supervised. Press coverage may be of variable quality, and may itself represent undeclared vested interests. However, as cumbersome and inconvenient as the process may be, if a study has sufficient merit and the review process has been sufficiently robust it is unlikely that public debate and critical reflection will ultimately prevent it from proceeding. This imbroglio provides several important lessons. There are no short cuts to the solution of difficult ethical problems and complete consensus may never be possible. What is most important is that discussions and decision-making processes be free, open and transparent. For these reasons, the tendency for ethics committees to keep their deliberations secret, in the mistaken belief that this is necessary to protect intellectual property, should be reassessed. Promising new models for ensuring public accountability and sharing of experience of committee processes should be examined, such as open access to meetings, chat rooms and the concept of the health ethics archive.3,4 In addition, care must be taken to ensure that current efforts to streamline ethics review processes in the interests of cost and efficiency do not erode the democratic, decentralised nature of the system. In the case of the RNSH trial of treatment for AMI, the investigators should be encouraged to continue dialogue with their interlocutors until the best possible compromise can be reached. Paul A Komesaroff Director, Monash Centre for the Study of Ethics in Medicine and Society Melbourne, VIC Competing interests: None declared. Rasmussen HH, Hansen PS, Koyama Y, et al. Trial of a trial by media. Med J Aust 2001; 175: 625-628. Ryle G. A trial of the heart. Sydney Morning Herald 2001; 29 March: 11. The Institutional Review Board — discussion and news forum. <http://www.irbforum.org> (accessed November 2001). Health Ethics Archive. <http://www.ethics-archive.org> (accessed November 2001). Make a comment

Paul A Komesaroff

Death and the Physician Intention, the law, and clinical decision-making in terminal care The duty of doctors is to strive to satisfy the wishes and interests of their patients and their patients' loved ones MJA 2001; 175: 516 The criminal law governing medical decision-making about the end of life is based on the doctor's intention. If the intention of treatment is to hasten or bring about the patient's death, whether by withdrawal of life-prolonging treatment, by administration of terminal sedation or a lethal bolus injection, the doctor could be prosecuted for murder. The survey of attitudes and practices of general surgeons in Australia by Douglas and colleagues in this issue of the Journal highlights some of the problems with using "intention" as the key factor for determining the moral and legal status of medical acts. Of the survey respondents, 36% indicated that, for the purpose of relieving a patient's suffering, they had given drugs "in doses greater than those required to relieve symptoms, with the intention of hastening death".1 This type of intervention has been referred to as "slow euthanasia".2,3 Theoretically, if the existing criminal code could be unswervingly applied, the survey findings suggest that many general surgeons in Australia could be prosecuted for murder, and possibly imprisoned, because of their care of terminally ill patients! In South Australia, the Consent to Medical Treatment and Palliative Care Act 1995 states: A medical practitioner responsible for the treatment or care of a patient in the terminal stage of a terminal illness . . . incurs no civil or criminal liability by administering medical treatment with the intention of relieving pain or distress . . . even though an incidental effect of the treatment is to hasten the death of the patient.4 The Act acknowledges the special context of a therapeutic clinical relationship, and affords some protection to clinicians who palliate terminal suffering. But the SA Act does not encourage openness and honesty in reporting responses to patients' requests for a hastened death, nor does it protect doctors who intentionally hasten death to relieve suffering. Under existing criminal law in SA and elsewhere, doctors could be prosecuted because of the way they express their intent about a treatment which hastens death, while other doctors who administer the same kind of treatment, but express their intent as "palliative only", could remain free to practise. If they were brought before the criminal courts, many of the general surgeons who participated in the survey by Douglas et al, and indicated they administered medication with the intention of hastening death, would probably give different answers about their care, perhaps with less forthright honesty. Can a hastened death be truly described as "unintended" and "incidental" if clinical reasoning makes it foreseen, it is discussed with the patient and carers, agreed to, and then deliberately proceeded with? Intention is inherently subjective; it can be complex, ambiguous, and paradoxical.5 The clinician's intention may also be difficult to infer, for example when the method of hastening death involves a separation (in time) between the initiation of an infusion of drugs and the patient's death. Moreover, the progression of disease can confound any causal link between administration of the drugs and the patient's death. On the other hand, a lethal injection reveals a clear intention to end the patient's life and it is therefore more amenable to being policed. According to the survey by Douglas et al, 54% of respondents thought that there were circumstances in which it might be morally acceptable to give large doses of drugs with the intention of hastening death, although the proportion agreeing with this varied widely according to religious affiliation — from 31% for Roman Catholics to 70% for those of no religion.1 Some religious organisations have vigorously opposed medical euthanasia, but, for many people, the values of compassion, mercy for those who are suffering and the "do unto others" principle are sometimes compatible with euthanasia. The survey findings highlight an obvious discrepancy between the existing legal framework and what a majority of general surgeons in Australia see as morally acceptable terminal care. In the context of suffering with advanced disease, a rational patient may genuinely want a hastened death and this may not be regarded as "bad" (as assumed by traditional laws about murder). Those closest to a terminally ill patient will frequently regard his or her eventual death as a "merciful release" and "a blessing". The duty of doctors is to strive to satisfy the wishes and interests of their patients and their patients' loved ones, and this duty can conflict with the crude criminal code. This conflict serves neither medicine nor respect for the law. Intention in relation to the time of death, by itself, is an inadequate moral and legal basis for medical decisions in terminal care. Quill observed that "our current ethical thinking and legal prohibitions reinforce self-deception, secrecy, isolation, and abandonment at a time when the exact opposite is needed".5 I question medical organisations' support for the existing law that puts many doctors at risk of most serious charges. If a doctor can demonstrate competent care that is in accordance with the patient's wishes and interests there should be immunity from prosecution. The survey by Douglas et al adds weight to arguments for a refinement of the criminal code or a reform of statute law. It also points to the need for further research to better understand the ethical paradigms used by doctors in terminal care. Roger W Hunt Senior Consultant and Lecturer in Palliative Care Flinders University, Adelaide, SA Douglas CD, Kerridge IH, Rainbird KJ, et al. The intention to hasten death: a survey of attitudes and practices of surgeons in Australia. Med J Aust 2001; 175: 511-515. Hunt RW. Palliative care — the rhetoric-reality gap. In: Kuhse H, editor. Willing to listen — wanting to die. Melbourne: Penguin, 1994. Billings JA, Block SD. Slow euthanasia. J Palliat Care 1996; 12: 21-30. Consent to Medical Treatment and Palliative Care Act, 1995. <www.pallcare.asn.au/jcpall.htm> (accessed October 2001). Quill TE. The ambiguity of clinical intentions. N Engl J Med 1993; 329: 1039-1040. Make a comment

Roger W Hunt

Death and the Physician The intention to hasten death: a survey of attitudes and practices of surgeons in Australia Charles D Douglas, Ian H Kerridge, Katherine J Rainbird, John R McPhee, Lynne Hancock and Allan D Spigelman MJA 2001; 175: 511-515 For commentaries, see Hunt and Ashby See also: Survey instrument Abstract - Methods - Results - Discussion - Acknowledgements - Competing Interests - References - Authors' details - - - More articles on Ethics Abstract Objective: To determine attitudes among surgeons in Australia to assisted death, and the proportion of surgeons who have intentionally hastened death with or without an explicit request. Design: Anonymous, cross-sectional, mail-out survey between August and November 1999. Participants: 683 out of 992 eligible general surgeons (68.9% response rate). Main outcome measures: Proportion of respondents answering affirmatively to questions about administering excessive doses of medication with an intention to hasten death. Results: 247 respondents (36.2%; 95% CI, 32.6%-39.9%) reported that, for the purpose of relieving a patient's suffering, they have given drugs in doses that they perceived to be greater than those required to relieve symptoms with the intention of hastening death. More than half of these (139 respondents; 20.4% of all respondents; 95% CI, 17.4%-23.6%) reported that they had never received an unambiguous request for a lethal dose of medication. Of all respondents, only 36 (5.3%; 95% CI, 2.9%-6.1%) reported that they had given a bolus lethal injection, or had provided the means to commit suicide, in response to an unambiguous request. Conclusions: More than a third of surgeons surveyed reported giving drugs with an intention to hasten death, often in the absence of an explicit request. However, in many instances, this may involve the use of an infusion of analgesics or sedatives, and such actions may be difficult to distinguish from accepted palliative care, except on the basis of the doctor's self-reported intention. Legal and moral distinctions based solely on a doctor's intention are problematic. The use of drugs to intentionally hasten the death of a terminally ill patient is prohibited in most countries, including Australia. The only country that has openly allowed medically assisted deaths is the Netherlands, where 3.4% of all deaths are reported as (intentional) medically assisted deaths.1 Most of these are voluntary euthanasia or assisted suicide, but about a quarter are "life-terminating acts without explicit and persistent request".2 The most recent survey indicates that 53% of Dutch doctors have practised euthanasia or assisted suicide and 23% report that they have performed "life-terminating acts without explicit and persistent request".1 Medically assisted deaths also occur in countries where they are prohibited and the figures have been remarkably consistent — in the United States,3-6 Denmark,7 England8 and Australia,9 between 2.2% and 12.3% of doctors report that they have assisted death in response to an explicit request. Outside of the Netherlands, however, few studies have broadened the question of assisted death to include instances where there has been no explicit request. In a study comparing North American and Dutch physicians, 2% and 15%, respectively, reported "ending of life without an explicit request from the patient", but the numbers were small and the difference not statistically significant.10 In Australia, it has been claimed that 3.5% of all deaths are cases of "ending life without explicit request".11 A potentially confounding issue faced by all researchers of assisted deaths is that of intention. Doctors sometimes give large doses of potentially lethal drugs to terminally ill patients to treat symptoms, foreseeing but not necessarily intending a medically hastened death. This kind of action has been shown consistently to have the approval of more than 80% of doctors.1,5,7,12 However, there may be considerable ambiguity about a doctor's intention,13 and some studies have indeed noted partial or dual intentions (to relieve pain and to hasten death) when analgesic drugs are given.1 An intention to hasten death has been suggested as being best distinguished by the use of drugs in doses greater than those required for symptom control.14 Our study incorporates such a distinction. Our objective was to conduct a survey of attitudes to and practices regarding assisted death using questions that were absolutely explicit about the agent's intention. Methods Sample A list was obtained of all doctors with Australian mailing addresses registered as general surgeons with the Royal Australasian College of Surgeons (n = 1218). No attempt was made to exclude those who had recently retired or who had subspecialised. After excluding 200 surgeons who had been randomly selected for pretesting and those who had moved, were ill or deceased (26), a final eligible sample of 992 remained. Survey instrument The survey instrument was an anonymous, self-administered, mail-out questionnaire (available on the MJA website at <http://www.mja.com.au>. The questionnaire was developed from a review of the literature, discussion within a multidisciplinary research group and extensive pretesting, including 13 interviews and consistency checks on the responses to 200 mailed questionnaires. Advice was sought on specific questions from three independent ethicists with substantially different ethical backgrounds in ethics. All questions were closed (mostly "Yes/No"), but respondents were invited to make additional comments on the final page of the survey. The survey instrument included a clinical vignette (see Appendix), and some of the questions alluded to this vignette. Our main question on experience with assisted death (Question 1, Box 2) was presented alone under a separate heading and was prefaced by the comment "All further questions address general issues and are not specific to the scenario [clinical vignette] . . .". Key words in Question 1 ("greater" and "intention") were printed in bold and underlined. Further testing of the understanding of this question was undertaken by interview with 10 general physicians after they had completed the entire questionnaire. Administration of questionnaire The questionnaire and three subsequent reminder letters were sent according to a set protocol15 commencing in August 1999. Intention to participate was indicated by return of a labelled consent or refusal card separate from the unmarked questionnaire, and reminders were sent to those who had not returned a consent or refusal card. Statistical analysis Affirmative responses are reported as a proportion of all respondents (not just those answering the question), except where explicitly stated. The rate of missing data was less than 4.4% for all questions and less than 2.3% for questions reported here. The Wilson procedure with correction for continuity was used to calculate 95% confidence intervals (CI) for single proportions.16 To determine the influence of the five demographic variables (Box 1) on attitudes and practice, logistic regression analysis was performed using SAS for Windows.17 Variables which were significant at α = 0.2 (Pearson's χ2 or Fisher's exact test) were entered into the logistic regression model and then eliminated in a backward stepwise procedure until only those variables remained that were statistically significantly associated with an affirmative response. Ethical approval Ethical approval for our study was obtained from the Hunter Area Research Ethics Committee, from the Human Research Ethics Committee of the University of Newcastle, and from the Ethics Committee of the Royal Australasian College of Surgeons. Results Of the eligible sample of 992 surgeons, 683 returned questionnaires (response rate, 68.9%). This sample size was associated with a precision of ± 4% (95% CI). Six hundred and fifty-four surgeons (65.9%) returned a separate consent card or other communication indicating intention to participate; 166 (16.7%) indicated that they did not wish to participate and 172 (17.3%) did not respond. Of those who declined to participate, 25 volunteered reasons. Of the respondents, 210 (30.7%) volunteered additional comments. Demographic features of respondents are summarised in Box 1. Only age, sex and years in practice were available for non-respondents. There were no sex differences between respondents and non-respondents, but older surgeons and those who had been in practice for longer were slightly less likely to respond. Results for selected questions are given in Box 2, with wording and textual emphasis unchanged from that in the questionnaire. Use of drugs with the intention of ending life or hastening death Twenty-nine respondents (4.2%) reported having given a bolus lethal injection "in response to a sincere and unambiguous request", 13 (1.9%) reported assisting with suicide (Questions 3, 4, 5 and 6 in Box 2), and 36 respondents (5.3%; 95% CI, 3.8%-7.3%) had done one or both of these. Two hundred and forty-seven respondents (36.2%) reported that they had, for the purpose of relieving a patient's suffering, given drugs in doses greater than those required to relieve symptoms with the intention of hastening death (Question 1, Box 2). Of these, 139 indicated (in response to questions 3, 5 and 6, Box 2) that they had never received a sincere and unambiguous request for a lethal injection, and had never granted a request for assisted suicide. Thus, at least 20.4% of the entire sample (139/683; 95% CI, 17.4%-23.6%) have apparently given drugs with the intention of hastening death, but without the explicit request of the patient. Of the remaining 108 respondents who reported having given drugs with the intention of hastening death, it is unknown whether they have ever done so in the absence of a request. Effect of religion Religious affiliation was a significant predictor of response to questions on attitudes to and practice of intentionally assisted death. Roman Catholics were about 4-10 times more likely, and Protestants about 2-3 times more likely, to give a negative answer than colleagues who had no religious affiliation (Box 3). Discussion Our finding that very few doctors report having given a bolus lethal injection in response to a patient's request agrees with the findings of previous reports.3-9 Our study also reveals that many doctors report giving drugs in doses greater than those required to relieve symptoms, with the intention of hastening death, often in the absence of an explicit request. Outside the Netherlands, this has not been widely reported. Our main question on experience with assisted death was deliberately written to include the use of infusions of drugs, with or without a request. That some doctors are prepared to hasten death by infusion (but not by bolus) was confirmed by volunteered comments: "It is difficult to actually administer a lethal injection, but setting up a potentially lethal system allows a degree of psychological and physical separation from the actual event." "The giving of a single lethal injection would be unusual. Increasing infusion is a far preferable and controllable method." "I also appreciate the inconsistency between being prepared to 'up the dose', but not being prepared to give it as a bolus — but that's the way I feel . . ." "I have frequently used large doses of morphine (previously heroin!) to hasten death . . . I can't see the ethical difference between this and a bolus injection in a fully informed patient . . . but simply would not be capable of the deed myself." "Talk of bolus injections in fully competent patients is not the real-life situation. We help very ill patients to die by a combination of sustenance withdrawal, increasing analgesia and 'masterly inactivity'." Clearly, surveys that have limited their inquiry to the administration of a bolus lethal injection are likely to have underestimated doctors' involvement with assisted death. It may be that researchers have avoided addressing the use of infusions because of uncertainty about a doctor's intentions in such circumstances. However, it is possible to be unambiguous. Our question specified an intention to hasten death, and a dose of drug greater than that required to treat symptoms. Physician interviews confirmed that the question was indeed understood by most respondents, but there is also quantitative evidence of this from the survey itself. Firstly, there was internal consistency: 95% of those who answered affirmatively to Question 1 also answered affirmatively to a question on the morality of giving drugs by slow intravenous infusion with the intention of hastening death (Question 2, Box 3), although the questions were separated in the questionnaire. Secondly, there was a profound effect of religious affiliation on responses to both Questions 1 and 2, with odds ratios that were similar to those measured for questions relating to euthanasia by bolus lethal injection or assisted suicide (Box 3). The only plausible explanation for this strong association is that the respondents understood Questions 1 and 2 to be about the intentional hastening of a patient's death. In contrast, responses to a question about the use of an infusion of drugs that might incidentally hasten death (Question 7, Box 3) showed no effect of religion, with more than 90% of respondents supporting such action regardless of religious affiliation. Euthanasia and palliative care — same drugs, same doses? Our question specified a dose of drugs greater than that required to relieve symptoms, but it may be difficult to assess symptoms once consciousness has begun to deteriorate in a dying patient. Possibly the only way to be sure that a patient is not suffering at this point is to render him or her deeply unconscious by giving generous doses of opiates and/or sedatives. It would then be probable, but not certain, that the doses used were greater than those required to relieve symptoms. One respondent volunteered a comment to this effect: "Intravenous infusion may be used to induce an unconscious state at a rate equal or greater than that to relieve symptoms, whereby the practitioner and family are then guaranteed that all the patient's symptoms are relieved . . ." Whether the use of generous doses of analgesic or sedative drugs constitutes "good palliative care" or "non-voluntary euthanasia" depends, according to a widely held view, on the doctor's self-professed intention.14 Question 1 clearly specified an intention to hasten death. Doctors who responded affirmatively to this question have therefore crossed a legal threshold and, according to some, a moral threshold. However, it is not clear that they have acted differently from their colleagues other than by reporting their own mental state differently. Furthermore, it may be hard to distinguish many of their actions from those of Dutch doctors who have performed "life-terminating acts without explicit request". At least 20% of our entire sample appears to have given drugs with the intention of hastening death in the absence of an explicit request, similar to the 23% of Dutch doctors who report performing "life-terminating acts without explicit request".1 There is a discrepancy between the relatively large proportion (36.2%) of surgeons who report giving drugs with the intention of hastening death, and the small proportion (5.3%) who report giving a bolus lethal injection or assisted suicide in response to an explicit request. We believe that many of those who make up this difference have given generous doses of analgesics or sedatives by infusion to dying patients. The circumstances of these deaths, other than in the agent's reported intention, may not differ substantially from what is widely accepted as good palliative care. Acknowledgements We would like to thank Professor Miles Little for critical reviews of our questionnaire and methodology, and Professor Grant Gillett and Dr Bernadette Tobin for providing opinions on the wording of key questions. This research project was conducted with the assistance of a Royal Australasian College of Surgeons research scholarship. Competing Interests None declared. References 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. Pijnenborg L, van der Maas PJ, van Delden JJM, Looman CWN. Life-terminating acts without explicit request of patient. Lancet 1993; 341: 1196-1199. Meier DE, Emmons C, Wallenstein S, et al. A national survey of physician-assisted suicide and euthanasia in the United States. N Engl J Med 1998; 338: 1193-1201. Back AL, Wallace JI, Starks HE, Pearlman RA. Physician-assisted suicide and euthanasia in Washington State. JAMA 1996; 275: 919-925. Fried TR, Stein MD, O'Sullivan PS, et al. Limits of patient autonomy. Arch Intern Med 1993; 153: 722-728. Lee MA, Nelson HD, Tilden VP, et al. Legalizing assisted suicide - views of physicians in Oregon. N Engl J Med 1996; 334: 310-315. Folker AP, Holtug N, Jensen AB, et al. Experiences and attitudes towards end-of-life decisions amongst Danish physicians. Bioethics 1996; 10: 233-249. Ward BJ, Tate PA. Attitudes among NHS doctors to requests for euthanasia. BMJ 1994; 308: 1332-1334. Kuhse H, Singer P. Doctors' practices and attitudes regarding voluntary euthanasia. Med J Aust 1988; 148: 623-627. Willems DL, Daniels ER, van der Wal G, et al. Attitudes and practices concerning the end of life: a comparison between physicians from the United States and from The Netherlands. Arch Intern Med 2000; 160: 63-68. Kuhse H, Singer P, Baume P, et al. End-of-life decisions in Australian medical practice. Med J Aust 1997; 166: 191-196. Emanuel EJ, Fairclough DL, Daniels ER, Clarridge BR. Euthanasia and physician assisted suicide: attitudes and experiences of oncology patients, oncologists, and the public. Lancet 1996; 347: 1805-1810. Quill TE. The ambiguity of clinical intentions. N Engl J Med 1993; 329: 1039-1040. Gillon R. Foreseeing is not necessarily the same as intending. BMJ 1999; 318: 1431-1432. Dillman DA. Mail and telephone surveys: The total design method. New York: Wiley, 1978. Newcombe, Robert G. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med 1998; 17: 857-872. SAS system for Windows [computer program], version 6.12. Cary, NC: SAS Institute Inc, 1998. (Received 28 May, accepted 3 Sep, 2001) Appendix: Abridged version of the clinical vignette Mrs S, a 60-year-old widow, presents to hospital with peritonitis and confusion and is found at operation to have a perforated carcinoma of the rectosigmoid junction which is unresectable, and is associated with peritoneal metastases. You perform a limited resection and end-colostomy. After 10 days she has recovered from her sepsis, but has persistent pain from her metastatic disease, and is devastated to find that she has a colostomy. She says she has "had enough" and she repeats this on several occasions over the next week. You organise consultations with a psychiatrist (who does not believe she is clinically depressed), a social worker, a stomal therapist and a palliative-care specialist who prescribes oral slow-release morphine and a co-analgesic and sees her daily to adjust doses. Five weeks after her operation, Mrs S remains in hospital because of general weakness, lack of a carer at home, and because of her pain, which is still not adequately controlled with oral analgesia. She says that she doesn't want to go on living, and that it is not just the severe pain. She complains of having lost her independence, that she is uncomfortable, and that she dislikes living with a stoma. She says that she has had a good life, but that she is "ready to go". Mrs S then asks if you will help her to die. Subsequent questions clarified explicitly what Mrs S meant by "help her to die". The complete vignette is included in the survey instrument which is available at <http://www.mja.com.au>. Authors' details Faculty of Medicine and Health Sciences, University of Newcastle, Newcastle, NSW. Charles D Douglas, BMed(Hons), BSc(Maths), Surgical Registrar, Discipline of Surgical Science, School of Medical Practice; Ian H Kerridge, FRACP, MPhil, Lecturer, Clinical Unit in Ethics and Health Law; John R McPhee, BCom(Hons) (LegStud), Consultant in Health Law, Clinical Unit in Ethics and Health Law; Lynne Hancock, BSc(Hons), PhD, Senior Lecturer, Discipline of Behavioural Science; and Program Manager, Hunter Centre for Health Advancement, Wallsend, NSW; Allan D Spigelman, FRACS, MD, Professor, Discipline of Surgical Science, School of Medical Practice. Hunter Centre for Health Advancement, Wallsend, NSW. Katherine J Rainbird, BA(Hons), PhD, Research Associate. Reprints will not be available from the authors. Correspondence: Dr C D Douglas, c/- Professor A D Spigelman, Discipline of Surgical Science, Faculty of Medicine and Health Sciences, University of Newcastle, Locked Bag No 1, Hunter Region Mail Centre, Newcastle, NSW 2310. cdouglasauATyahoo.com.au Make a comment 1: Demographic characteristics of general surgeons — respondents and non-respondents Frequency Demographic characteristic Respondents Non-respondents Age* n=680 n=342 35 or less 27 (4.0%) 5 (1.5%) 36-45 147 (21.6%) 71 (20.8%) 46-55 199 (29.3%) 72 (21.1%) 56-65 154 (22.6%) 90 (26.4%) More than 65 153 (22.5%) 104 (30.5%) Sex† n=680 n=341 Male 651 (95.7%) 330 (96.8%) Female 29 (4.3%) 11 (3.2%) Years in practice‡ n=680 n=342 Less than 10 12 (1.8%) 2 (0.6%) 11-20 150 (22.1%) 70 (20.5%) 21-30 205 (30.1%) 71 (20.8%) 31-40 162 (23.8%) 86 (25.2%) More than 40 151 (22.5%) 113 (33.1%) Practice setting n=674 Teaching hospital 368 (54.6%) Other urban hospital 167 (24.8%) Rural hospital 139 (20.6%) Religious group n=675 Roman Catholic 115 (17.0%) Protestant 225 (33.3%) Jewish 24 (3.6%) Other 25 (3.7%) No religion 286 (42.4%) *<0.01 (χ2=17.4). †=0.10. ‡<0.01 (χ2=20.5). Back to text 2: Frequency of affirmative responses to selected questions. Data are number of affirmative responses and percentage of entire sample, with 95% CIs in parentheses Question* Affirmative responses Administration of drugs with the intention to hasten death 1. Have you ever, for the purpose of relieving a patient's suffering, given drugs (orally or parenterally, by bolus or by infusion) in doses greater than those required to relieve symptoms, with the intention of hastening the patient's death? 247 36.2% (32.6%-39.9%) 2. Do you believe that there are any circumstances in which it is morally acceptable to give a terminally ill patient sedatives or analgesics by slow intravenous infusion, in doses greater than those required to relieve symptoms, with the intention of hastening the patient's death? 370 54.1% (50.4%-58.0%) Administration of lethal drugs by bolus injection on request* 3. Have you ever received a similar request (that is, a sincere and unambiguous request, from a competent patient, for you to administer a lethal dose of a drug)? 187 27.4% (24.1%-30.9%) 4. Have you ever granted such a request by giving a bolus lethal injection? 29 4.2% (2.9%-6.1%) Assisted suicide* 5. Have you ever received such a request (ie, an apparently sincere request, from a competent patient, to provide him or her with the means to commit suicide)? 70 10.2% (8.1%-12.8%) 6. Have you ever agreed to and carried out such an action? 13 1.9% (1.1%-3.3%) Treatment of pain by analgesic infusion* 7. Would you be prepared to commence an opioid analgesic infusion for Mrs S's pain, and to run this at whatever dose is necessary to keep Mrs S comfortable (even if this may, incidentally, hasten her death)? 641 93.9% (91.7%-95.5%) 8. Suppose Mrs S continues to complain of pain until the infusion has been increased to a rate at which she is drowsy but rousable. She is apparently comfortable, and the infusion is left at this rate overnight. The following morning, the nursing staff inform you that her respiratory rate has dropped to 6, that she is no longer rousable, and that her oxygen saturation is 82%. What would you do now? -Reduce the infusion rate to see if she is comfortable at a lower dose 318 46.6% (42.8%-50.4%) -Continue the infusion at the current rate 296 43.3% (39.6%-47.2%) -Increase the infusion rate 24 3.5% (2.3%-5.3%) *Questions 3, 4, 5, 6, 7, and 8 refer to the clinical vignette (see Appendix). All questions are "Yes/No" questions, except Question 7, which included "undecided" as an alternative, and Question 8, which offered the three alternatives indicated. The numbering and grouping of questions have been changed from the original questionnaire, but the wording and textual emphasis are identical. The headings used in this Box were not used in the original questionnaire. Back to text 3: Influence of religious affiliation on response to selected questions.* Results are proportions in each religious group responding affirmatively (odds ratios [OR] are relative to "No religion", with 95% CIs in parentheses). (The numbering of the questions coincides with that for Box 2.) 1. Have you ever, for the purpose of relieving a patient's suffering, given drugs (orally or parenterally, by bolus or by infusion) in doses greater than those required to relieve symptoms, with the intention of hastening a patient's death? Roman Catholic Protestant Jewish Other No religion 19.3% OR, 0.28 (0.16-0.47) P 33.9% OR, 0.59 (0.41-0.86) P 33.3% OR, 0.58 (0.24-1.4) P=0.22 36.0% OR, 0.65 (0.28-1.52) P=0.32 46.4% OR, 1.00 2. Do you believe that there are any circumstances in which it is morally acceptable to give a terminally ill patient sedatives or analgesics by slow intravenous infusion, in doses greater than those required to relieve symptoms, with the intention of hastening the patient's death? Roman Catholic Protestant Jewish Other No religion 31.0% OR, 0.19 (0.12-0.31) P 48.6% OR, 0.40 (0.28-0.59) P 62.5% OR, 0.71 (0.29-1.75) P=0.46 60.0% OR, 0.61 (0.26-1.44) P=0.49 70.0% OR, 1.00 7. Would you be prepared to commence an opioid analgesic infusion for Mrs S's pain, and to run this at whatever dose is necessary to keep Mrs S comfortable (even if this may, incidentally, hasten her death)? (see Appendix)† Roman Catholic Protestant Jewish Other No religion 93.0% 95.1% 100% 96.6% 92.7% *Question 7 refers to the clinical vignette (see Appendix). †Because of the small numbers of negative responses to this question, χ2 analysis was potentially invalid using the categories listed. Analysis was repeated with all religious groups combined. The results were: religious groups, 94.9%; no religion, 92.7% (P=0.22). Back to text

Charles D Douglas · Ian H Kerridge · Katherine J Rainbird · John R McPhee · Lynne Hancock · Allan D Spigelman

Death and the Physician On causing death Palliative-care specialists should be the ones fine-tuning pain and symptom control MJA 2001; 175: 517-518 Fellows of the Royal Australasian College of Surgeons were recently asked to complete a postal survey about end-of-life decisions and euthanasia. The questions related to a clinical vignette of a competent and informed woman with advanced intra-abdominal colonic cancer who had made a clear request for assistance to die. She has the active involvement of a specialist palliative care service, and appears to have reached the preterminal stage of her illness course. This means that the goals of her care are palliative, but she is not yet quite at the stage of needing terminal care (care given during the last hours or days of life), and indeed could be some weeks or even months away from death.1 The grounds for this request are generalised weakness (for which little more can probably be done), lack of a carer at home (for which there are practical solutions, although these may not be emotionally satisfactory), and poor pain control (for which much could still be done, as she has only had an oral opioid and "a co-analgesic"). In this issue of the Journal, Douglas and colleagues present the findings of this survey,2 the latest in a series of such studies in Australia and elsewhere.3-6 The claims to novelty lie in the study population (surgeons in Australia) and the strong focus of questioning on intention, and the presence or absence of patient consent (20% of the surgeons in this study reported that they had performed life-terminating acts without an explicit and persistent request). Douglas et al infer that the discrepancy between the relatively large proportion of surgeons who report giving drugs with the intention of hastening death and the small proportion who report giving a bolus lethal injection or assisting suicide in response to a specific request is made up of surgeons who "have given generous doses of analgesics or sedatives by infusion to dying patients", and conclude that "the circumstances of these deaths, other than in the agent's reported intention, may not differ substantially from what is widely accepted as good palliative care". Thus, the argument of the article by Douglas et al might be paraphrased as follows: a small proportion of a sample of Australian surgeons report that they have practised active euthanasia and assisted suicide, but about a third have intentionally hastened death by infusion, and over half say they agree with the practice. As they used infusions, and palliative-care practitioners use infusions, intention is the only basis for a distinction between what the surgeons did and "accepted" palliative care, and indeed there may be no distinction. The logic of this line of argument is questionable, but it is certainly true to say that modern palliative-care therapeutic practice regularly involves the infusion of analgesic and sedative drugs, and it is based on intention. In a previous editorial in the MJA, I discussed the variability of palliative care knowledge and experience in the medical profession, which would no doubt also apply to this study population. In the absence of formal training in palliative care . . . doctors' attitudes and clinical behaviour are complex and variable. They range from abrupt cessation of treatment, minimalist palliative care and treatment directed at bringing about a rapid dying process, to excessive caution about being seen to be instrumental in causing the death, particularly with regard to the providing pain and symptom relief, withdrawal or non-initiation of artificial hydration and alimentation and cardiopulmonary resuscitation.7 While a doctor's intention may not always be easy to validate, evaluation of intention and motive is fundamental to legal analysis, and many would argue that intention also determines the moral character of medical interventions. Any drug can endanger life if used inappropriately. However, the knowledge and skills built up over some 30 years of palliative care practice have shown that opioids and sedative drugs can be used quite safely for symptom control without bringing causation into question if the parameters of accepted practice are followed. Indeed, Douglas et al acknowledge that there are "safe" doses by the very fact that their study questions probe intent by asking specifically about doses "greater than those required to relieve symptoms". Pain control does not require opioid dose escalation which hastens death, and titration against pain and adverse effects is the norm. In terminal sedation, the sedative drugs (usually the benzodiazepines midazolam and clonazepam) are titrated according to the level of agitation and distress displayed by the patient. We cannot know when a particular patient would have died in the absence of palliative interventions or treatment abatement, particularly during the final dying process.8 There is agreement that the final process of dying should not be prolonged, and that there should be no compromise on symptom control and patient dignity. Searching for the distinction between accepted palliative care and euthanasia in unverifiable outcomes in the last hours of life will not clarify unnecessarily muddied waters, and does not of itself seem to be an important question. This distinction has to rest on intention and the titration of drug doses to effects, balancing the wanted with the unwanted effects. The volunteered comments of the surgeons quoted in the report by Douglas et al reflect serious causal and ethical confusion. Respondents appear to take dubious comfort from some sort of proximate causal argument, whereby infusions are seen intuitively as a less direct and immediate, and therefore acceptable, means of causing death, in contrast to a bolus injection, where causation is immediate, direct and unambiguous. The goals and intentions of drug prescribing and principles of pharmacology in palliative care can and should be made clear, and, as in any domain of medicine, honest communication of anticipated outcomes from treatment is required. The Chief Coroner of Ontario (Dr James Young, 1997) seems to have captured the essence of the basic underlying principles of therapeutic intervention in palliative medicine in laying down four conditions which need to be satisfied for palliative care interventions to be legal in his jurisdiction. These conditions should be universally applicable: care must be intended solely to relieve suffering; it must be administered in response to suffering or signs of suffering; it must be commensurate with that suffering; and it cannot be a deliberate infliction of death. Documentation is required, and drug doses must increase progressively.9,10 Australian surgeons have a vital role to play in ensuring that their patients receive timely and appropriate palliative care. Their clinical skills and knowledge about diseases and surgical management are valued, and surgical procedures have a real role in the palliation of symptoms in selected patients. Continuity of care is of paramount importance. However, the community does not look to the surgical workforce to fine-tune pain and symptom control in palliative care patients, and assistance from palliative-care specialists should be sought. If surgeons in this country are really intending to hasten their patients' deaths, with 20% reporting that they have done so without patient knowledge or consent, then the community needs to know, and the study by Douglas et al meets that purpose. However, in the absence of actual case data, it is impossible to say whether these surgeons are delivering good palliative care, whether the patients and families are satisfied, or indeed whether their prescribing really is any different from that of palliative care practitioners. Michael A Ashby Professor, and Director of Palliative Care, McCulloch House Monash Medical Centre, Southern Health; and Southern Clinical School Faculty of Medicine, Nursing and Health Sciences Monash University, Melbourne, VIC Ashby M, Stoffell B. Therapeutic ratio and defined phases: proposal of an ethical framework for palliative care. BMJ 1991; 302: 1322-1324. Douglas CD, Kerridge IH, Rainbird KJ, et al. The intention to hasten death: a survey of attitudes and practices of surgeons in Australia. Med J Aust 2001; 175: 511-515. Stevens CA, Hassan R. Management of death, dying and euthanasia: attitudes and practices of medical practitioners in South Australia. J Med Ethics 1994; 20: 41-46. Kuhse H, Singer P. Doctors' practices and attitudes regarding voluntary euthanasia. Med J Aust 1988; 148: 623-627. Baume P, O'Malley E. Euthanasia: attitudes and practices of medical practitioners. Med J Aust 1994; 161: 137-144. Kuhse H, Singer P, Baume P, et al. End of life decisions in Australian medical practice. Med J Aust 1997; 166: 191-196. Ashby M. The fallacies of death causation in palliative care [Editorial]. Med J Aust 1997; 166: 176-177. Ashby M. Natural causes? Palliative care and death causation in public policy and the law [MD Thesis]. Adelaide: University of Adelaide, 2001. Of life and death: Report of Special Senate Committee on Euthanasia and Assisted Suicide. Ottawa: Minister of Supply and Services, Canada, 1995: 26-27. (Catalogue No. YC2-351/1-OIE.) Lavery JV, Singer P. The "Supremes" decide on assisted suicide: what should a doctor do? CMAJ 1997; 157: 405-406. Make a comment

Michael A Ashby

Death and the Physician The emotional impact on physicians of hastening the death of a patient Ilinka Haverkate, Agnes van der Heide, Bregje D Onwuteaka-Philipsen, Paul J van der Maas and Gerrit van der Wal MJA 2001; 175: 519-522 For commentaries, see Kelly and Ryan Abstract - Methods - Results - Discussion - Acknowledgements - Competing Interests - References - Authors' details - - More articles on Palliative care Abstract Objective: To investigate the emotional feelings reported by physicians in the Netherlands after having performed euthanasia or other medical end-of-life decisions. Design: Nationwide interview study in the Netherlands, November 1995 through February 1996. Participants and setting: A random sample of 405 physicians (general practitioners, nursing home physicians, and clinical specialists). Main outcome measures: Subsequent feelings of physicians about their most recent cases (if any) of euthanasia, assisted suicide, life-ending without an explicit request from the patient, and alleviation of pain and other symptoms with high doses of opioids. Results: The response rate was 89%. In 52% of all cases of hastening death, physicians had feelings of comfort afterwards, which included feelings of satisfaction in 44% and of relief in 13%. Feelings of discomfort were reported in 42%, most frequently referred to as emotional (28%) or burdensome (25%). Feelings of discomfort were highest for euthanasia (75%; P < 0.000). 95% of physicians were willing to perform euthanasia or assisted suicide again in similar situations. Afterwards, 5% had doubts, but none had regrets, about performing euthanasia. Conclusions: Hastening the death of a patient evokes different feelings among physicians. Although performing euthanasia is often experienced as burdensome and emotional, granting the ultimate wish of a competent patient may also give physicians a feeling of having contributed to the quality of the dying process. In the Netherlands, the Dutch Termination of Life on Request and Assisted Suicide (Review Procedures) Act has been accepted by the Dutch parliament and will be effective probably by the end of 2001. Under this law, euthanasia and assisted suicide are still criminal offences, but the penal code has been amended to exempt doctors from criminal liability if they report their actions and show that they have satisfied the requirements for prudent practice. The most important requirements are unbearable and hopeless suffering; voluntary, persistent and well-considered request; consultation; written reporting of the decision; and notification. In most other countries, no such procedure exists. Although the open debate about euthanasia and assisted suicide in the Netherlands has resulted in relatively transparent medical practice, they are still exceptional acts that go beyond "normal" medical decision-making and are potentially emotionally troubling for doctors. We know of just a few studies of the personal feelings of physicians after participating in euthanasia and assisted suicide.1-3 Here we present the results of an analysis of the emotional feelings reported by doctors in the Netherlands after performing euthanasia or other medical end-of-life decisions. The data are derived from the 1995/1996 nationwide survey on end-of-life decision-making in the Netherlands.4,5 Methods Study population The study design and methods of this study are the same as those described in the 1995/1996 investigation.4 A random sample of 405 doctors was interviewed. The sample was obtained from the registration files of the Royal Dutch Medical Association and the Dutch Institute for Health Care Research, and included 124 general practitioners, 74 nursing home physicians, and 207 clinical specialists from five fields of medicine (cardiology, surgery, internal medicine [including oncology], respiratory medicine and neurology). Physicians in these categories attend 87% of all deaths which occur in hospitals, and almost all other deaths outside hospitals, in the Netherlands. Inclusion criteria were that doctors must have been practising in their registered specialties since 1 January 1994, and that they had been working in the same institution ever since. Data collection Interviews were conducted from November 1995 through February 1996 by over 30 experienced doctors who had received intensive training for this purpose. Interviews were guided by a semistructured questionnaire (participants were not paid). In the interview, doctors were asked to provide detailed information about their last case, if any (1 or 0), of euthanasia, assisted suicide, the ending of life without an explicit request from the patient, and alleviation of pain and other symptoms with high doses of opioids. For the purpose of this study, the questionnaire contained questions about doctors' subsequent feelings, doubts or regrets and support-seeking. The responses were partly open-ended (prestructured for the research team only, which meant that the interviewers made their own judgement on the content and then categorised it; this was checked with the respondents) and partly closed to questions. Further, the reported feelings were categorised for the analyses as either feelings of "comfort", which included feelings of satisfaction and relief, or feelings of "discomfort", which included feelings described as burdensome, emotional or a heavy responsibility. Definitions Euthanasia: Administering drugs with the explicit intention of ending a patient's life at the patient's explicit request. Assisted suicide: Prescribing or supplying drugs with the explicit intention of enabling the patient to end his or her own life. Life ending without an explicit request: Administering drugs with the explicit intention of ending the patient's life without a concurrent explicit request from the patient. Alleviation of pain and other symptoms with opioids: Administering drugs in doses which the interviewees believed large enough to have a probable life-shortening effect. Statistical analysis To extrapolate the findings to all physicians in the Netherlands, weights were calculated based on the percentages of the various types of physicians represented in the sample. Our estimates of the different variables were corrected for the 13% of in-hospital deaths attended by physicians in specialties other than the five sampled, on the assumption that among these remaining deaths the various types of medical end-of-life decisions were as frequent as among the deaths studied. Associations between physician or patient characteristics and reported feelings were tested for statistical significance with χ2 tests for categorical variables and with t tests for continuous variables. Results Response rate Of the original random sample of 559 physicians, 83 did not meet the inclusion criteria, 21 either had a chronic illness or could not be located, and 50 were unwilling to participate in the study, giving a response rate of 89%. Feelings reported by physicians Data on the feelings of physicians after "perceived" hastening of the death of a patient by giving life-ending drugs were available for 159 cases (by 159 physicians) of euthanasia, 34 cases of assisted suicide, 74 cases of ending life without an explicit request from the patient, and 291 cases of alleviation of pain or other symptoms with potentially life-shortening effects. Our findings are shown in Box 1. In 52% of all cases, physicians reported that they had feelings of comfort afterwards, while feelings of discomfort were reported in 42% (most frequently, emotional or burdensome). Feelings of comfort and discomfort were analysed for possible associations with the type of end-of-life decision and physician or patient characteristics (Box 2). The percentage of physicians who had feelings of comfort (satisfaction or relief) afterwards was lowest in cases of alleviating pain or other symptoms and highest when they had assisted with suicide, but the differences between the various types of end-of-life decisions were not significant. For physicians who had feelings of discomfort (burdensome, emotional, heavy responsibility) there were significant differences between the end-of-life decisions (see Box 2). General practitioners reported both feelings of comfort and discomfort more frequently than clinical specialists and nursing home physicians, but other physician characteristics, such as age, sex, religious affiliation and the number of previous cases of euthanasia or assisted suicide, were not related to feelings of comfort or discomfort. Patient characteristics significantly related to a higher frequency of feelings of comfort were female sex, and shortening of life by less than one month. Feelings of discomfort were related to patients' younger age, male sex, a diagnosis of cancer, and shortening of life by more than one month. The degree of suffering (assessed only for cases of euthanasia and assisted suicide) was related to feelings of comfort in that more severe suffering was more frequently related to feelings of comfort. Finally, ending a patient's life without an explicit request, and alleviation of pain or other symptoms, more frequently evoked later feelings of discomfort when the explicit intention of the physician had been to hasten death, compared with cases where the intention had only partially been to hasten death. Most recent case compared with former cases Of the 110 physicians who had performed euthanasia previously, 45% reported that their most recent case of euthanasia had been just as difficult as previous cases. Among all physicians, 26% found their most recent case less difficult than previous cases and 29% thought it had been more difficult. The percentages finding their most recent case equally difficult, less difficult and more difficult for assisted suicide (n = 14) were 38%, 23% and 40%, respectively, and for life ending without an explicit request from the patient (n = 45) 55%, 34% and 10%, respectively. Willingness to perform again Box 3 shows that the vast majority of the physicians would be willing to perform euthanasia or assisted suicide again in similar circumstances. Afterwards, 9 of the physicians (5%) had doubts, but none had regrets, about performing euthanasia; these doubts concerned, among other things, the consideration of treatment alternatives, the amount of time and latitude involved in the decision-making, the choice between euthanasia and assisted suicide, and the role of the relatives. In 85% of cases, the physician thought that the quality of dying had been improved considerably by euthanasia, and 12% thought that it had been improved somewhat. Six physicians (7%) had subsequent doubts about ending a patient's life without an explicit request. These doubts concerned (each mentioned once) the amount of time taken to make the decision, the involvement of the patient, the competence of the patient, possible pressure from others, the delay in administering the drugs, and neglect of the formal aspects of the decision-making. Three physicians (4%) had regrets; one about the amount of latitude involved in decision-making, one about being pressured by others and one because the relatives were not sufficiently involved in the decision-making. In 67% of cases, the physician thought that the quality of dying had been improved considerably by the end-of-life decision, and in 26% the physician thought it had been improved somewhat. In two cases, the physicians thought the quality of the dying process had not been improved at all. Support afterwards Box 3 shows that, among the 159 physicians who had performed euthanasia, 43% later sought support in coping. Most sought support privately from friends or family and many sought support from colleagues. One sought professional help. Of the 74 physicians who had ended a life without an explicit request from the patient, 16% sought support later. Again, most sought support privately, many sought support from colleagues, and none sought professional help. Discussion We found that approximately half of the physicians who had performed euthanasia or assisted suicide found it emotional or burdensome, but almost the same percentage of physicians felt satisfaction afterwards. The use of the word "emotional" in this context deserves some explanation. By "emotional", we mean a mixture of feelings such as being "touched", "out of balance" or "upset". We are aware that the classification in the analyses of emotional under the heading of "discomfort" is a simplification which does not fully capture the nuance of the feeling. One limitation of our study is that the design was retrospective, and may therefore be prone to recall bias. Further, all data are based on self-reporting by the physicians, and the number of cases in some subgroups was small. We realise that the process of decriminalisation of euthanasia and assisted suicide is quite unique to the Netherlands. However, we believe that, to a degree, our data are transferable to other countries, as these data involve decision-making that is potentially emotionally troubling for physicians outside the Netherlands as well. Although our data are five years old, we have no reason to assume that our findings regarding the emotional impact on physicians would have changed. It is striking that ending a patient's life without an explicit request later evoked feelings of discomfort (burdensome, emotional or a heavy responsibility) less frequently than did performing euthanasia or assisted suicide. Also, more physicians sought support after they had performed euthanasia than after they had ended the life of a patient without an explicit request. Thus, life-ending without an explicit request from the patient seems to have a different emotional impact on physicians than life-ending on request (ie, euthanasia or assisted suicide). This may be associated with other findings, such as the distribution of causes of death, the amount of time by which life is shortened and the medications administered, which suggests that life ending without an explicit request is more comparable with decisions to alleviate pain (where morphine was virtually the only drug given) than with euthanasia (in which neuromuscular relaxants were mostly used).4 The number of previous cases of euthanasia or assisted suicide performed by a physician seems to have had no effect on the reported emotional impact. Thus, our data do not indicate that repeated performance "numbs" the emotions or that this emotionally laden type of medical decision-making becomes part of "normal" medical practice. This was confirmed by our finding that the percentage of physicians who found their most recent case of assisted suicide less difficult than any previous cases was similar to the percentage who found their most recent case more difficult than previous cases. Despite our finding that many physicians find performing euthanasia burdensome and emotional, the vast majority indicated that they would be willing to perform euthanasia again for a patient in a comparable situation, and only a few (5%) had doubts or regrets. In a study among American oncologists, it was found that a greater percentage of oncologists (24%) later regretted having performed euthanasia. However, most of those who had participated in euthanasia or assisted suicide (54%) found comfort in knowing that they "helped a patient end his or her life the way the patient wished", and this is comparable with the results of another US study.1,3 Granting the ultimate wish of a competent patient may give many physicians a feeling of having contributed positively to the quality of the dying process. Acknowledgements This study was supported by a grant from the Dutch Ministry of Justice and Health, Welfare and Sports. Competing Interests None declared. References Emanuel EJ, Daniels ER, Fairclough DL, Clarridge BR. The practice of euthanasia and physician-assisted suicide in the United States: adherence to proposed safeguards and effects on physicians. JAMA 1998; 280: 507-513. Ponsioen BP. How does the physician learn to live with euthanasia? [in Dutch]. Ned Tijdschr Geneeskd 1983; 127: 961-964. Meier DE, Emmons CA, Wallenstein S, et al. A national survey of physician-assisted suicide and euthanasia in the United States. N Engl J Med 1998; 338: 1193-1201. 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. (Received 23 Apr, accepted10 Jul, 2001) Authors' details Vrije Universiteit Medical Centre, Institute for Research in Extramural Medicine, Department of Social Medicine, Amsterdam, The Netherlands. Ilinka Haverkate, PhD, Psychologist; Bregje D Onwuteaka-Philipsen, PhD, Researcher; Gerrit van der Wal, MD, PhD, Professor. Department of Public Health, Erasmus University Rotterdam, Rotterdam, The Netherlands. Agnes van der Heide, MD, PhD, Epidemiologist; Paul J van der Maas, MD, PhD, Professor. Reprints will not be available from the authors. Correspondence: Dr I Haverkate, VU Medical Centre, EMGO-Institute, Van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands. I. Haverkate.gpnhATmed.vu.nl Make a comment 1: Physicians' feelings after their most recent case of euthanasia, assisted suicide, life ending without an explicit request, and alleviation of pain and symptoms (weighted percentages) Euthanasia (n=159) Assisted suicide (n=34) Life ending without an explicit request (n=74) Alleviation of other symptoms (n=291) Total (n=558) Feelings of "comfort"* Satisfactory 43% 60% 43% 42% 44% Relief 13% 7% 18% 14% 13% Total* 52% 63% 56% 48% 52% Feelings of "discomfort"* Burdensome 50% 40% 19% 7% 25% Emotional 48% 49% 24% 11% 28% Heavy responsibility 32% 22% 12% 6% 17% Total 75% 58% 34% 18% 42% Other feelings* Unnatural 3% —† 3% —† 1% Natural —† —† —† 52 10% Other 2% 3% 20% 9% 8% * More than one answer possible. †Not reported. Back to text 2: Physicians' feelings after having made an end-of-life decision: relationship with type of decision and physician characteristics, and with patient characteristics (weighted percentages) Feelings of comfort Feelings of discomfort Yes No P* Yes No P* Type of end-of-life decision 0.1 0.000 Euthanasia (n=159) 52% 48% 75% 25% Assisted suicide (n=34) 63% 37% 58% 42% Life ending without an explicit request from the patient (n=74) 56% 44% 34% 66% Alleviating pain or other symptoms (n=291) 48% 52% 18% 82% Physician characteristics Specialty 0.001 0.02 General practitioner (n=221) 56% 44% 45% 55% Nursing home physician (n=62) 43% 57% 26% 74% Clinical specialist (n=275) 39% 61% 34% 66% Age 0.2 0.5 <45 (n=239) 49% 51% 40% 60% >44 (n=312) 54% 46% 57% 43% Sex 0.5 0.1 Female (n=81) 49% 51% 49% 51% Male (n=470) 52% 48% 40% 60% Religious affiliation 0.3 0.1 Yes (n=230) 49% 51% 38% 62% No (n=328) 53% 47% 44% 56% Number of previous cases of euthanasia and assisted suicide (mean [SD])† 1.5 (2.1) 1.2 (2.0) 0.2 1.3 (2.1) 1.4 (1.9) 0.8 Patient characteristics Age in years (mean [SD])† 66 (13) 64 (18) 0.1 61 (18) 68 (14) 0.000 Sex 0.04 0.04 Female (n=316) 47% 53% 46% 54% Male (n=239) 55% 45% 38% 62% Diagnosis 0.1 0.004 Cancer (n=359) 55% 45% 46% 54% No cancer (n=120) 46% 54% 30% 70% Shortening of life 0.001 0.000 More than one month (n=74) 36% 64% 86% 14% One to four weeks (n=155) 59% 41% 47% 53% Less than seven days (n=329) 52% 48% 29% 71% Degree of suffering‡ 0.002 0.3 Extreme (n=108) 63% 37% 67% 33% Unbearable (n=50) 51% 49% 76% 24% Moderately severe (n=35) 36% 64% 77% 23% Intention with which the act was performed§ 0.001 0.1 Hastening death was partially the intention (n=304) 54% 46% 19% 81% Hastening death was the explicit intention (n=58) 32% 68% 28% 72% *P value for χ2 test. †Mean (SD) for cases that resulted/did not result in feelings of comfort and that resulted/did not result in feelings of discomfort, respectively; P value for t test. ‡Degree of suffering was assessed only for cases of euthanasia and assisted suicide. §Includes only cases of life ending without an explicit request from the patient and alleviation of pain or other symptoms. Back to text 3: Willingness of physicians to assist in death again, subsequent doubts or regrets and seeking support after performing euthanasia or ending a patient's life without an explicit request (weighted percentages) Euthanasia (n=159) Life ending without an explicit request (n=74) Willingness to perform physician-assisted death again Yes 95% 82% No 3% 9% Don't know 2% 9% Subsequent doubts or regrets Doubts 5% 7% Regrets —* 4% No 95% 89% Physician sought support afterwards Yes 43% 16% If yes, from whom (n=57) (n=12) Professional 0 Colleagues 60% 44% Privately (friends or family) 83% 72% Other 0 —* *Not reported. Back to text

Ilinka Haverkate · Bregje D Onwuteaka-Philipsen

Editorial Confronting conflict of interest in research organisations: time for national action There is a pressing need for an open inquiry and the formulation of national guidelines MJA 2001; 175: 396-397 Public trust in universities and research institutes is embedded in notions of intellectual integrity and independence. Crucial to this trust is the belief that these virtues are protected by an environment that values intellectual freedom, an unfettered exchange of information and ideas, and the pursuit of research for the public good. Of late, however, this trust is threatened by the increasing involvement of industry in research funding and a blurring of research ideals and corporate interests.1,2 At the present time, this situation is more acute in the United States, but, as our governments, universities and research institutes increasingly pursue policies which blend research creativity and corporate capital,3-5 there is no reason to believe that Australia will escape placing research integrity and public trust at risk. Developments in the United States that have prompted a focus on the propriety of biomedical and clinical research include: A shift in the source of research funding from predominantly government and private foundations to industry. A substantial proportion of the US$55-$60 billion of industry research and development capital is now directed to basic biomedical research and clinical trials.6 Indeed, in 1999, the top 10 pharmaceutical companies spent US$22.7 billion primarily on clinical research, compared with the US$17.8 billion provided mostly for basic research by the US National Institutes of Health.2 A shift away from academic centres to non-academic research organisations for the performance of clinical trials. In the United States, contract research organisations now receive up to 60% of the research funding available from the pharmaceutical industry for clinical trials.7 This shift has seen untoward effects on the control of trial design, the access to and analysis of data, and the publication of results.8 There is growing evidence that researchers with industry ties are more likely to report results favourable to corporate sponsors,9-12 to conduct research of lower quality,13,14 and to either delay publication15 or not to publish at all.16,17 A shift in the free flow of information. Researchers receiving funding from industry are more likely to restrict communications with their colleagues.18 A shift to an entrepreneurial ethos in universities and research institutes. The securing of the all-important patent plays an increasing role in research and often represents the first move of researchers and institutions towards entrepreneurship. In the United States, university-generated patents have increased from about 250 per year before 1980 to nearly 5000 in 1998.19 At the centre of the disquiet attending these developments are concerns about conflict of interest — a conflict which may affect ethical behaviour, the quality of research undertaken, or the dissemination of its outcomes. Most guidelines for conflict of interest pertain to individual researchers or faculty members, but conflicts of interest may also apply to institutions such as universities or research institutes. Can these entities effectively oversee their investigators when both the institutions and the investigators share parallel aspirations in acquiring industry funding, equity or royalties? In Australia, extensive examination of and public debate on conflict of interest involving institutions is of low priority; indeed, some of our leaders in academia, research and bureaucracy have dismissed this issue as irrelevant to the business of research.20,21 Not so in the United States, where exploring the extent of and solutions to conflict of interest is firmly on the national agenda.22,23 Indeed, Moses and Martin have recently advanced some general principles that may guide the exploration of appropriate frameworks.6 These include: The veracity of results of basic research and clinical trials research should not be compromised. Research integrity is best protected by isolating research from economic pressures. Oversight of the industry-research relationship should be by a disinterested party. Independent individuals without a financial stake should examine the relationship from its inception and at appropriate junctures. Proprietary rights, control of intellectual property and the right to publish should be established at the onset, with minimal caveats on non-disclosure and confidentiality and provisions to ensure future flexibility of research directions. Financial and non-financial incentives should be designed to fulfil the needs of both the researchers and the institution. Potential solutions advanced by Moses and Martin to accommodate the fusion of industry, academia and research include: The creation by universities of separate entities to isolate commercially sponsored research from other research, yet still allow movement of researchers back and forth within defined limitations. The creation of entities independent of universities or research institutes to hold and control equity, thus solving the problem of the holding of equity by individuals. Individual components of equity could be managed as a portfolio of investments, with individuals assigned units of equity.6 All the above considerations are propelled by concerns about conflict of interest. But, as Korn recently noted: Conflicts of interest are ubiquitous and inevitable in academic life; indeed, in all professional life. The challenge for academic medicine is not to eradicate them, which is fanciful and would be inimical to public policy goals, but to recognize and manage them sensibly and effectively.24 In 2000, the US Department of Health and Human Services sponsored a conference to explore new ways to deal with financial conflict of interest and to ensure the integrity of research and the protection of human subjects in research.22 Such a public discourse is long overdue in Australia. We are at the beginning of industry involvement in research and this involvement should be vigorously promoted and pursued. But, instead of some time in the future, inheriting the US concerns about the propriety of biomedical research and clinical trials, should we not now confront institutional conflict of interest by open inquiry and the formulation of national guidelines? This will require a more visible leadership by the national overarching bodies in academia, science and medical research. Failure to do so will only lead to the impression that research is yet another commercial commodity and invite the inevitable erosion of public trust. Without public trust medical research is doomed. Martin B Van Der Weyden Editor, Medical Journal of Australia Angell M. Is academic medicine for sale [editorial]. N Engl J Med 2000; 342: 1516-1518. DeAngelis CD. Conflict of interest and the public trust, [editorial]. JAMA 2001; 284: 2237-2238. Wills PJ (Chair). The Health and Medical Research Strategic Review. The virtuous cycle — working together for health and medical research. Canberra: Commonwealth Department of Health and Aged Care, 1999. Innovation. Unlocking the future. Final report of the Innovation Summit Implementation Group. Canberra: Commonwealth Department of Industry, Science and Resources, 2000. Backing Australia's ability: an innovation plan for the future. Canberra: Commonwealth Department of Industry, Science and Resources, 2001. Moses H III, Martin JB. Academic relationship with industry. A new model for biomedical research. JAMA 2001; 285: 933-935. Henderson L. More AMCs finding growth from reform. Centerwatch 2000; 7(6) 1: 10-13. Bodenheimer T. Uneasy alliance. Clinical investigators and the pharmaceutical industry. N Engl J Med 2000; 342: 1539-1543. Bero LA, Galbraith A, Rennie D. The publication of sponsored symposiums in medical journals. N Engl J Med 1992; 327: 1135-1140. Rochon PA, Gurwitz JH, Simms RW, et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 1994; 154: 157-163. Cho MK, Bero LA. The quality of drug studies published in symposium proceedings. Ann Intern Med 1996; 124: 485-489. Stelfox HT, Chua G, O'Rourke K, Detsky AS. Conflict of interest in the debate about calcium channel antagonists. N Engl J Med 1998; 338: 101-106. Rochon P. Evaluating the quality of articles published in journal supplements compared with the quality of those published in the parent journal. JAMA 1994; 272: 108-113. Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care 1996; 12: 209-237. Rennie D. Thyroid storm. JAMA 1997; 227: 1238-1243. Friedberg M, Saffran B, Stinson TJ, et al. Evaluation of conflict of interest in economic analysis of new drugs used in oncology. JAMA 1999; 282: 1453-1457. Blumenthal D, Campbell EG, Anderson MS, et al. Withholding research results in academic life science. Evidence from a national survey of faculty. JAMA 1997; 277: 1224-1228. Blumenthal D, Campbell EG, Causino N, Louis KS. Participation of life-science faculty in research relationships with industry. N Engl J Med 1996; 335: 1734-1739. The United States Association of University Technology Managers (AUTM). The AUTM Licensing Survey. FY 98. http://www.autm.net/ and http://www.autm. net/pubs/survey/1998/execsumm.html (accessed September 2001). Quiddington PT. When science, knowledge, truth and sex collide. Science debate turns up the heat. Campus Review August 29-Sept 4 2001; 1. Moynihan R. The devil's dollar: the commercial pressure on science and medicine. The Australian Financial Review, 2001; Sept 8-9: 22-23. Agnew B. HHS Conference on conflict of interest in clinical research will raise a new question: should research universities worry about their own conflicts of interest? Washington Fax July 20 2000 <http:// www.washingtonfax.com/p1/ 2000/20000720.html> (accessed September 2001). Stolberg SG. Biomedicine is receiving new scrutiny as scientists become entrepreneurs. The New York Times 2000; February 20. <http:// www.nytimes.com> (accessed September 2001). Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Make a comment

MJA 2001; 175: 379-381 Abstract Predictive genetic testing should only be performed on children if it is in their best interests. "Interests" include psychosocial elements. Predictive testing is performed on children when there are interventions to prevent disease or to detect and treat it early and it is necessary to begin these interventions in childhood. It is also performed for diseases known to commence in childhood. Predictive testing in children for adult-onset conditions for which there is no medical intervention is highly controversial. Competent children and adolescents can consent to predictive genetic testing. Predictive testing can result in harm, such as discrimination (eg, in insurance entitlement or employment) and stigmatisation. Predictive testing can have important non-medical benefits in terms of self-knowledge and life planning. A hypothetical clinical encounter (bold comments in brackets refer to bolded points in Boxes 1 and 2): Mrs Smith presents to Dr Jones for a script for an oral contraceptive. She is 38 years old and has recently been diagnosed as carrying the gene for Huntington's disease. She will develop progressive and irreversible dementia and movement disorder between the ages of 40 and 60. Mrs Smith has an 11-year-old daughter, Jane, and a 16-year-old son, John, who both have a 50% chance of carrying the gene. Mrs Smith: I wanted to talk to you about getting Jane and John tested for Huntington's. [Parental autonomy] Dr Jones: Why do you want them tested? Mrs Smith: We all saw my father start getting dementia at 50. He's 56 and in a nursing home now. They're smart kids. They know they've got a 50/50 chance of getting it themselves. John has been on the net and knows there's a test. I think he's old enough to know, and he wants to know. I think it would be bad if he knew and Jane didn't. [Competent children] Dr Jones: Shouldn't we wait until they're adults and can make that decision for themselves? Maybe as adults they'll wish they hadn't been tested. If they're tested now, they won't have the option of not knowing. Most adults who have a chance of carrying the Huntington's gene have decided not to have testing. [Predictive testing fails to respect child's later autonomy; right not to know] Mrs Smith: We've always been open about Huntington's in our family. Everyone's been tested except Jane and John. Huntington's is nothing to be ashamed of. I think they should know what their life is going to be like. That'll help them to make the best decisions about what to do with their life, like which career to choose. That's not relevant to Jane now, but it will be soon. Just because most people don't want it doesn't mean it isn't good for us. [Beneficial in non-medical sense; broad definition of interests] I also think, if they're not tested now, they won't have the chance to adapt to the knowledge as they grow up. It won't affect them in the same way as it would if they found out when they were 30 when they've got firm commitments to their jobs and maybe partners. [Better psychosocial adjustment] Dr Jones: All the genetics societies around the world advise against genetic testing in children when you can't do anything to prevent or treat the disease, like in Huntington's. What's the problem with waiting a few years? [Professional guidelines] Mrs Smith: I read that Professor Bob Williamson, a professor of genetics, said that studies showed that if you give mice who will get Huntington's coloured baubles and tubes to play with it delays the onset of symptoms. He said this might be a reason to test children and then intellectually challenge them."13 Dr Jones: I don't think giving your kids coloured baubles to play with will do anything. No, seriously, I'm not sure that you can extrapolate from mice to humans. But even if there are benefits, there may be serious harms as well. It's important for kids to feel they belong and that they aren't different and abnormal. Some children would get depressed if they knew they were going to get Huntington's. It might stop them from taking up a challenging career. And, in the future, it may be much harder for them to get a job or insurance. [Non-maleficence] Mrs Smith: Our children already know they're different — they've got a 50% chance of getting Huntington's. I think it's better to resolve the uncertainty. Even if they have the gene, in one sense they won't be different — they'll share something pretty important with me. [Resolve uncertainty] Dr Jones: Even if you're right, there's a lot of potential for psychological harm. Some people who have tested positive for Huntington's have committed suicide. [Non-maleficence] Mrs Smith: Our kids aren't like that. You don't know them like I do. Anyway, I thought there was some research which showed that people who have testing are better off psychologically than people who don't, even if the result is positive.11 And kids seem to adjust to these sorts of things. My cousin's daughter has kidney problems. She'll probably get kidney failure and need dialysis eventually. No one thought to not tell her that. [Better psychosocial adjustment] Dr Jones: One of my other patients has Huntington's disease. She was pregnant and had prenatal testing because she thought she might terminate the pregnancy if she had a child with Huntington's. The test was positive, but she decided she wanted to keep the baby. She grew up knowing that he had the Huntington's gene. She was always very anxious about him, and he had a very disturbed upbringing. I think it was really bad for both of them to know. [Non-maleficence; parental guilt] Mrs Smith: I think it's good to know. For some people it may be bad because of the way they react to things. But if I'd known I was carrying the Huntington's gene earlier, maybe I would've had children sooner, or I wouldn't've worked so hard and spent more time with them. But that's all past now. I want them to have what I didn't have: knowledge about themselves. [Self-knowledge] Dr Jones: But what about the mystery and surprise of life? Don't you think that's important? Mrs Smith: There'll still be mystery. Does your knowing you'll kick it by 85 take away the mystery of life? They won't know who they're going to marry. They won't know what their children will be like. It's not like knowing the ending to a thriller. Huntington's is only one part of our lives. I want them to have the best life they can. But to do that they need to know something about themselves.14 Life isn't always how we want it to be, but we have to accept reality and make the most of it, not just bury our heads in the sand and hope our problems will go away. [Self-knowledge] Dr Jones: I'd like you to think about how it would be for you and your children if they knew they were going to suffer like your father did. I don't know if I should do what you ask. I have to do what I believe is best for your children. But I want to go away and think about it, look at some of the research on psychosocial effects of genetic testing and discuss it with some of my colleagues. We need to discuss it with your children and your husband as well. Can we all meet next week to have another talk about this? [Best interests; dialogue] Clinical ethics involves engaging in open dialogue with patients, and listening to their arguments and reasons. Ultimately, doctors should not intentionally harm their patients. So they must make a decision about whether a medical intervention is in the patient's best interests. That decision must be based on the particularities of the situation, including the social circumstances and the patient's psychology, desires, values and reasons.15,16 Whatever his final decision, Dr Jones was engaged in clinical ethics. References Working Party of the Clinical Genetics Society (UK). The genetic testing of children. J Med Genet 1994; 31: 785-797. Points to consider: ethical, legal and psychosocial implications of genetic testing in children and adolescents. American Society of Human Genetics Board of Directors, Advisory Council on Medical Genetics Board of Directors. Am J Hum Genet 1995; 57: 1233-1241. Human Genetics Society of Australasia. Predictive genetic testing in children and adolescents. March 1999. Available at: <http://www.hgsa.com.au/policy/ptca.html>. Accessed 23 July 2001. Clarke A. The genetic testing of children. J Med Genet 1996; 32: 492. Marteau TM. The genetic testing of children. J Med Genet 1994; 31: 743. Harper PS, Clarke A. Should we test children for "adult" genetic diseases? Lancet 1990; 305: 1205-1206. Dickenson DL. Can children and young people consent to be tested for adult onset genetic disorders? BMJ 1999; 318: 1063-1066. Harper PS, Glew R, Harper R. Response to requests for genetic testing is not based on age alone. BMJ 1999; 319: 578. Robertson R, Savulescu J. Is there a case in favour of predictive testing of children? Bioethics 2001; 15: 26-49. Clarke A, Flinter F. The genetic testing of children: a clinical perspective. In: Marteau TM, Richards MPM, editors. The troubled helix: social and psychological implications of the new human genetics. Cambridge: Cambridge University Press, 1996: 164-176. Wiggins S, Whyte P, Huggins M, et al. The psychological consequences of predictive testing for Huntington disease. N Engl J Med 1992; 327: 1401-1405. Meiser B, Gleeson MA, Tucker KM. Psychological impact of genetic testing for adult-onset disorders. Med J Aust 2000; 172: 125-129. Williamson B. Using your brain keeps you bright. Aust Med 2000; 12: 16. Savulescu J, Momeyer RW. Should informed consent be based on rational beliefs? J Med Ethics 1997; 23: 282-288. Savulescu J. Liberal rationalism and medical decision-making. Bioethics 1997; 11: 115-129. Savulescu, J. Rational non-interventional paternalism: why doctors ought to make judgements of what is best for their patients. J Med Ethics 1995; 21: 327-331. Authors' details Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC. Julian Savulescu, MBBS, PhD, Associate Professor and Director, Ethics Unit, and Ethics Programme, Centre for the Study of Health and Society, University of Melbourne. savulesjATcryptic.rch.unimelb.edu.au Make a comment 1: Key facts about predictive genetic testing in children The Human Genome Project will reveal unprecedented amounts of information about our predisposition to develop disease. No test, including any genetic test, should be performed on a child unless it is in the child's best interests. "Interests" should not be construed in narrow medical terms, but according to a broad definition of interests which includes biological, social and psychological elements. Decisions about interests can only be made after dialogue with patients to elucidate their particular psychosocial circumstances. The Clinical Genetics Society in the United Kingdom,1 the American Society of Human Genetics (ASHG)2 and the Human Genetics Society of Australasia3 have each published guidelines that strongly advise against genetic testing in children for a disease in which surveillance, pre-emptive or definitive medical treatment is not available in childhood. Predictive testing is performed in children for some familial bowel cancers (eg, familial adenomatous polyposis) because definitive treatment exists and surveillance must commence in childhood.4-6 Predictive testing may have implications for the child's later employment (although federal antidiscrimination legislation protects against such discrimination in theory) and if the child wants to take out life insurance. It may also result in stigmatisation, resulting in diminished marriage, reproduction and education opportunities.3 Most adults at risk of having the Huntington gene have so far decided not to have the genetic test. In deciding whether to perform predictive testing, the competence or developmental stage of the child should be considered. Older, competent children or adolescents can consent to predictive genetic testing.3,7-9 Younger, incompetent children should still participate in counselling according to their developmental age. Testing without disclosure of the results to the child should not be performed.3 There is little evidence on the psychosocial impact of genetic testing in children.3,9 Back to text 2: Arguments for and against predictive genetic testing in children (all controversial9) Arguments in favour Information about one's predisposition to disease can be beneficial in non-medical sense to allow more informed reproductive decision-making, career choice, financial planning and end-of-life decision-making.3,9 Self-knowledge can promote more autonomous decision making about one's life.9 Testing can resolve uncertainty and consequent anxiety in parents and children.3 Testing can show respect for parental autonomy and avoid professional paternalism.3 Participation of a child in decisions about testing can promote the development of autonomy.9 Early testing may result in better psychosocial adjustment than later testing, when lifestyle and life plans have been firmly established.9 Arguments against Predictive testing fails to respect the child's later autonomy to decide whether to have testing or not and violates the future adult's "right not to know".4,10 Testing breaches the child's right to confidentiality.4,10 Non-maleficence (not harming): testing may cause harm to the child through causing disturbed family dynamics (as parents treat that child differently), negative parental attitudes to the child, depression, anxiety, low sense of self-esteem, discrimination and stigmatisation (see Box 1).6,11,12 Parental guilt.12 Back to text

Julian Savulescu

MJA 2001; 175: 183-184 In this issue of the Journal, Braunack-Mayer and colleagues present a manifesto for an ethics core curriculum for Australasian medical students.1 It is a position paper by teachers of ethics from most of the medical schools in Australasia. The authors wisely "offer" this curriculum framework and ask that it be a "living document, open to challenges . . .". Some will debate its contents, while others will debate whether an ethics curriculum should be delivered separately from other key areas of the curriculum needed to train new doctors. Both these debates will be more productive if the ethics curriculum is considered from other perspectives, which include context, continuity and challenges. Firstly, the context. There has been a quiet revolution taking place in medical education in Australia over the past 10 years, with origins traceable to the Doherty Report on medical education and the workforce,2 and encouraged and fostered by the medical schools accreditation system of the Australian Medical Council.3 Australia now has four medical schools with graduate-entry programs, and virtually all Australian and New Zealand schools have made significant changes to their curricula as they seek to train doctors to meet the needs of our society.4 Foremost among the changes has been the vertical integration of the theme of "professional and personal development", a domain that covers elements such as communication skills, professional attitudes, ethics, health law and issues of health and fitness to practise. The core ethics curriculum outlined by Braunack-Mayer et al should form part of this domain, and, if delivered effectively, may not be readily visible. Similarly, assessment of the acquisition of the skills, knowledge and attitudes of the ethics component of this domain should be fully integrated into the broader assessment of professional skills. Secondly, achievement of continuity between undergraduate and postgraduate curricula needs to be considered. Some attention has been paid to ethics and health law as part of the professional development programs offered to interns,5 but our specialist training and continuing education programs have lagged behind. The most common response when a problem relating to doctors' professionalism arises is to add the topic to the undergraduate or primary medical curriculum! Few of the medical colleges responsible for postgraduate training address or examine important aspects of professionalism such as communication skills, professional attitudes and ethical and medicolegal issues. A notable exception is the Australasian College of Dermatologists, which, every two years, gathers its trainees for a four-day course that includes a day of interaction between trainees and dermatologists on ethical and medicolegal topics. Other colleges need to take up the challenge and devise their own ethics programs. It is to be hoped that the proposed process of external accreditation of providers of postgraduate education currently being piloted by the Australian Medical Council (in concert with the colleges) will give impetus to this.6 Thirdly, there is no lack of ethical and professional challenges for today's doctors. The changes to the medical curricula reflect responses to community concerns about communication skills, attitudes and common ethical and medicolegal problems, as identified by consumer groups, healthcare complaints commissions and medical boards.7 More recent challenges include the possible adverse consequences for patient care of corporatisation of medical practices, the risks of unfettered advertising, and dilemmas for doctors who are expected to act as patient advocates as well as "gatekeepers" of the public purse. Most currently practising doctors were not required to consider these issues as part of their medical training. It is unwise for the medical profession to put its efforts solely into training tomorrow's doctors and overlook the need to engage today's doctors in the challenge of meeting changing community expectations. If we can successfully implement postgraduate training programs in ethics, some of the difficulties that our ethics teachers have identified (eg, faculty awareness and role-modelling) might be more rapidly overcome. No one today should argue against the need for medical ethics to be a central element of medical education, but we do need to debate how this can best be done. Braunack-Mayer and colleagues seem to suggest, by their request for resources and recognition, that they are not truly committed to an integrated curriculum. I argue that, if ethics teaching is not fully integrated, medical ethics risks being perceived by students as irrelevant to medical practice. The new curricula introduced throughout Australia and New Zealand have been designed with this integration in mind. The Association of Teachers of Ethics and Law in Australian and New Zealand Medical Schools is well positioned to examine whether our current approach is working. My own belief is that medical students are now very aware of ethical issues, but that there is a failure to build on this in the early postgraduate years. Kerry J Breen Immediate Past President, Australian Medical Council, Canberra Association of Teachers of Ethics and Law in Australian and New Zealand medical Schools (ATEAM). An ethics core curriculum for Australasian medical schools. Med J Aust 2001; 175: 205-210. Doherty RL (chairman). Committee of Inquiry into Medical Education and Medical Workforce. Australian medical education and workforce into the 21st century. Canberra: AGPS, 1988. Australian Medical Council. Guidelines for the assessment and accreditation of medical schools. Canberra: AMC, 1998. Lawson KA, Armstrong RM, Van Der Weyden MB. A sea change in Australian medical education. Med J Aust 1998;169: 653-658. Australian Medical Council. National guidelines for intern training. Canberra: AMC, 1996. Australian Medical Council. Specialist recognition and accreditation. AMC, 2001. Available at <http://www.amc.org.au/nsqac.asp>. Accessed 10 July 2001. Daniel AE, Burn RJ, Horarik S. Patients' complaints about medical practice. Med J Aust 1999; 170: 598-602. Make a comment

Kerry J Breen

MJA 2001; 175: 205-210 For editorial comment, see Breen Abstract - Background to the development of our position statement - Content of a core curriculum - Knowledge - Skills - Attitudes - Teaching methods - Assessment - The challenge of implementing the curriculum - Conclusion - References - Authors' details - - More articles on Ethics - More articles on Education Abstract Teaching ethics incorporates teaching of knowledge as well as skills and attitudes. Each of these requires different teaching and assessment methods. A core curriculum of ethics knowledge must address both the foundations of ethics and specific ethical topics. Ethical skills teaching focuses on the development of ethical awareness, moral reasoning, communication and collaborative action skills. Attitudes that are important for medical students to develop include honesty, integrity and trustworthiness, empathy and compassion, respect, and responsibility, as well as critical self-appraisal and commitment to lifelong education. In recent years, an international consensus has emerged that ethics and health law should be essential components of medical curricula.1-3 In line with this, teachers of medical ethics and law in UK medical schools have recently published a model for a core ethics curriculum.4 In Australia, concern for ethics teaching has developed, in part, as a result of the findings of the Doherty Report5 and through the Australian medical school accreditation process. The Australian Medical Council's statement, Goals and objectives of basic medical education,6 specifies that graduates completing basic medical education "should have knowledge and understanding of the principles of ethics related to health care and the legal responsibilities of the medical profession", and that graduates should have "an appreciation of the complexity of ethical issues related to human life and death, including the allocation of scarce medical resources". There is, however, less consensus as to what ethics should be taught, how it should be taught and who should teach it. In part, this is because ethics offers not so much a discrete or limited area of content, but a place for the consideration of values and for dialogue across boundaries and between different perspectives. In addition, there are many different ways to think about and analyse ethical issues in practising medicine, from a "principlist" approach through to virtue ethics, narrative ethics and ethics of care (Box 1). Despite this diversity, there is a core of skills and knowledge related to ethics that is as fundamental to the practice of medicine as basic sciences or clinical skills. This core is concerned primarily with equipping students to recognise and understand important ethical issues, to know how to make decisions about those issues, and to have a better basis for knowing what should be done (in any given situation) and why. Consideration of questions such as "What are ethical reasons and how do they differ from other reasons?", "What does 'informed consent' mean and how does it work in practice?", and "How do people wish to die?" is an essential component of medical education that falls within the domain of ethics. As members of the Association of Teachers of Ethics and Law in Australian and New Zealand Medical Schools (ATEAM), we offer here a position statement on an ethics core curriculum for Australasian medical schools. We believe that this curriculum meets the goals outlined by the Australian Medical Council.6 Background to the development of our position statement Our outline of an ethics core curriculum arose out of a meeting in June 1999 of teachers of ethics and law in medicine from 10 universities in Australia and New Zealand. The meeting covered a wide range of issues, with participants exchanging views on the teaching of ethics, based on personal experiences and informal consultations within their own institutions. Following this meeting, three separate working parties developed statements on the knowledge, attitudes and skills considered desirable for students to acquire from an ethics curriculum. The whole group met again in July 2000 and agreed to develop and refine the initial statements from the working parties by an email exchange of views. The core curriculum outlined here is the consensus statement that resulted from this process. During our meetings and subsequent consultations, it became apparent that most of the existing Australasian ethics courses are strongly congruent with one another and with other existing statements, such as the consensus statement by teachers of medical ethics and law in UK medical schools.4 We see our consensus statement very much as a living document, open to challenges and revisions as changes in medicine and society raise new and different ethical questions and as medical education continues to evolve. Content of a core curriculum Knowledge A core curriculum of ethics knowledge must address both the foundations of ethics and specific topics in ethics (Box 2). We have made a distinction between basic ethical concepts and ethics in clinical settings to highlight the importance of understanding basic principles and terminology that apply to ethical problems irrespective of any clinical situation. For example, informed consent can not be understood adequately without an understanding of autonomy, individual rights and paternalism. Skills The construction of a knowledge base in medicine involves skills of problem-solving, reasoning, critical thinking, collaboration and the active use of knowledge.11 Specific learning outcomes, in terms of these transferable skills, are sought as part of the process of independent life-long learning. Such skills are as relevant in ethics as they are in other domains of medicine. More specific skills (those of ethical awareness, moral reasoning and ethical practice) are also required to translate this knowledge into practice. Ethical awareness relates to the ability to recognise ethical issues present in a medical setting. This requires students, in practising medicine, to maintain and develop sensitivity to issues involving their patients. Skills in moral reasoning involve the ability to analyse ethical issues in a medical setting, to construct arguments and counterarguments that are valid and sound, and to examine and interpret the arguments of others. The specifically moral nature of these arguments requires that students have some familiarity with ethical theory and principles. After weighing competing claims and interests, justification for a particular moral position can be offered. Skills of ethical practice concern a range of skills necessary for ethically sensitive practice. They include the ability to communicate about ethical issues with patients, their relatives and other healthcare professionals; effective negotiation and collaboration with patients, their families and other members of the healthcare team; and skills necessary to implement ethical decisions in the face of institutional constraints. Students' relative powerlessness in the medical hierarchy can often inhibit them from presenting a dissenting ethical view, and so they need to be able to recognise and analyse an institutional culture, with specific attention given to how students might act ethically in the face of it.12-14 Attitudes The traditional model of medical ethics education suggests that its goal is not to improve the moral character of future physicians, but to give those with already formed sound moral character "the knowledge and skills required to practice good medical care".15However, increasing concern about the dehumanising and detrimental effects of institutional practice and the medical education process itself has led to recognition of the importance of promoting humanistic qualities and behaviour in medical ethics education.16 A broad community consensus on unacceptable professional behaviour also exists. Awareness and discussion of professional values, attitudes and behaviours should be fostered among students and their teaching staff, both to minimise direct patient harm and to recognise and reduce individual and cultural factors that may erode professional trust. Attitudes that are important for medical students to develop are those that promote patients' interests through the doctor-patient relationship, the interests of colleagues through professional relationships, and students' own well-being (Box 3). These attitudes are core components of professional identity; placing them within the ethics curriculum does not imply ethical ownership, but is a mechanism to ensure explicit teaching in this area. Teaching methods It is imperative that ethics teaching be precise, challenging and clinically relevant. The curriculum should target students' needs,17 reflect the ethical issues encountered in clinical and professional practice,18 and take account of empirical research in ethics where appropriate. Ethics teaching should also consider the informal, "hidden" curriculum displayed in the values and behaviours of clinical and preclinical teachers and in the ways in which hospitals and medical schools are organised. The subtle messages students acquire from their teachers and institutions are, arguably, the most important determinant of what values are learnt, how they are learnt and the impact they have on practice and the profession. There is no single "best" method by which ethics should be taught and, indeed, the evolution of ethics education has profited enormously from curricular experimentation and innovation. However, all forms of teaching must remain cognisant of the centrality of the individual's experience, or narrative, and must also be committed to the notion of dialogue between individuals and between professions, perspectives and ideologies. This creates the basis for the incorporation of multiple perspectives and multiple teachers into ethics programs. Although the conceptual and theoretical knowledge of ethics can easily be introduced through readings, lectures, seminars or computer-assisted instruction, ethics education is fundamentally discursive, and thus it is essential to facilitate at least some learning of ethics knowledge in small groups. Small-group learning using case studies and problem-solving exercises can be used both to amplify and extend more didactic teaching methods and also to reinforce the relevance of ethics to medicine (Box 4).19 Professional, clinical and social issues can also be taught by integration with clinical teaching in a number of other settings, including: formal "ethics" ward rounds;20 formal "ethics" grand rounds and unit meetings; discussion of ethical issues within clinical seminars; ethics journal clubs. The teaching of attitudes deserves particular mention. The capacity to clarify and critically evaluate one's own values and to integrate personal and professional values in the life of the student and doctor should be an essential part of the medical school curriculum. Teaching methods that have been employed successfully to accomplish these tasks include: values journals or portfolios; discussion of cases, with particular emphasis on critical appraisal of personal and professional values and attitudes; debriefing sessions that allow for reflection and discussion of attitudes and behaviours encountered in the day-to-day experience of medical students. Role modelling by teachers is a crucial influence on the attitudes and behaviour of future doctors.21,22 The unconscious assimilation of professional culture and the ethical capitulations that have been seen as necessary for advancement within that culture can be better recognised and dealt with in educational programs that explicitly aim to include these elements. Teachers of ethics can play an important role in modelling the very nature of ethics: the teaching process should be perceived as being emotionally supportive and academically encouraging, should be tolerant of multiple perspectives, should be interdisciplinary, and should actively involve clinicians as co-instructors and as role models for students. This also underscores the responsibility of teachers to develop as an ethical community and be alert to, and respond to, unethical behaviour among themselves and their students. Deeper and more focused learning of specific issues through elective courses in ethics should also be available, either as part of the medical curriculum or through interfaculty cooperative arrangements. Advanced elective modules in ethics that may be taken during the degree are an efficient way to offer courses for students with a particular interest in ethics. Finally, although it is essential to introduce ethics within the medical curriculum, ethics may be best learnt when individuals are faced with real-life ethical issues in clinical practice. For this reason, education in ethics should continue through postgraduate and vocational training and continuing education. Ethical, legal and institutional issues are now addressed in structured-release sessions within the Commonwealth-supported National Curriculum for Junior Doctors in the Prevocational Years.23 Assessment It is important that ethical knowledge, skills and attitudes be assessed. This signals to students that their medical school regards ethics as important and acknowledges the fact that students give more attention to the areas that are assessed. Assessment also provides an opportunity to demonstrate the relevance and integral nature of ethics in basic sciences as well as in clinical and professional interactions. There is no single method for assessing ethics knowledge and skills. A number of methods have been used, including written case reports, objective structured clinical examinations24 and group assessment of students' self-directed, problem-based learning skills. Skills of problem-solving, cooperation and self-motivation may be assessed by such means as self- or peer-ratings, assessments by tutors, literature searches, diaries or portfolios.25,26 The critical issue is not so much the method of assessment, but whether the assessment instrument is well designed and appropriate to the task. The challenge for ethics educators is to develop valid, relevant, rigorous and reliable measures for assessing ethics and for evaluating the incorporation of ethics into practice. The challenge of implementing the curriculum The breadth and depth of ethics teaching and the time devoted to it vary considerably between Australasian medical schools. Given the integrated nature of many programs, it is difficult to assess the total number of hours devoted to ethics teaching, but the nominal number of hours per year varies between three and 20 (Box 5). Some medical schools already have dedicated staff teaching ethics with recognised allocation of curriculum time, while others face a number of challenges in reaching the aims we have outlined. These challenges include the following: (a) Shortage of skilled staff. There are no uniform qualifications for teaching ethics in medical schools. Staff require not only a good understanding of moral philosophy, but also familiarity with (and confidence in dealing with) the medical environment. It is difficult to stipulate specific qualifications required, but, as with all university teaching, a higher degree with a major focus on ethics or an appropriate topic is highly desirable. (b) Competition for curriculum time. Many Australasian medical schools have revised their curricula in recent years. There continues to be pressure of curriculum time on all aspects of medical teaching. We have not stipulated the number of contact hours required to successfully implement the core curriculum, as this will vary with methods of teaching, available staff and other factors. An integrated curriculum will incorporate many ethical issues into existing topics — for example, a clinical term in surgery should include teaching on ethical aspects of informed consent to surgical treatment. The issue is not so much competition for extra time, but judicious collaboration with clinical colleagues. Perhaps the greatest challenge facing implementation of a core curriculum in ethics is that of gaining recognition of the skills and expertise required to teach ethics. Until ethics is accepted as an essential domain in medicine, no less important or specialised than anatomy or pharmacology, support for an ethics core curriculum may be lacking. However, given the relatively recent recognition of the need for teaching of communication skills, we trust that support for teaching of ethics is not far behind. Conclusion In this position statement we have argued for the importance of a core curriculum in medical ethics. We believe that the curriculum we have presented meets the Australian Medical Council's medical ethics education goals. Moreover, there continues to be an essential flexibility in the interpretation and implementation of such a curriculum within diverse medical schools. We have also considered the challenges involved in delivering a medical ethics curriculum within an integrated teaching program. These challenges are not insurmountable. Educating the doctors of tomorrow in the ethical practice of medicine is surely a task deserving of our continued best efforts. References Royal College of Physicians and Surgeons of Canada. Bioethics curricula. available at: <http://rcpsc.medical.org/english/ethics>. Accessed 10 July 2001. The teaching of medical ethics: fourth consultation with leading medical practitioners. Geneva: World Health Organization, 1995. Culver CM, Clouser KD, Gert B, et al. Basic curricular goals in medical ethics. N Engl J Med 1985; 312(4): 253-256. Teaching medical ethics and law within medical education: a model for the UK core curriculum. J Med Ethics 1998; 24(3): 188-192. Doherty RL (chairman). Committee of Inquiry into Medical Education and Medical Workforce. Australian medical education and workforce into the 21st century. Canberra: AGPS, 1988. Australian Medical Council. Goals and objectives of basic medical education. Guidelines for assessment and accreditation of medical schools. Canberra: AMC, 2000. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York: Oxford University Press, 1994. Gillon R, Lloyd A, editors. Principles of health care ethics. Chichester: Wiley, 1994. Tovey P. Narrative and knowledge development in medical ethics. J Med Ethics 1998; 24: 176-181. Boyd KM, Higgs R, Pinching AJ, editors. The new dictionary of medical ethics. London: BMJ, 1997. Driscoll M. Psychology of learning for instruction. Boston: Allyn and Bacon, 1999. Christakis D, Feudtner C. Ethics in a short white coat: the ethical dilemmas that medical students confront. Acad Med 1993; 68(4): 249-254. Hicks LK, Lin Y, Robertson DW, et al. Understanding the clinical dilemmas that shape medical students' ethical development: questionnaire survey and focus group study. BMJ 2001; 322: 709-710. Doyal L. Closing the gap between professional teaching and practice. BMJ 2001; 322: 685-686. Miles SH, Lane LW, Bickel J, et al. Medical ethics education: coming of age. Acad Med 1989; 64: 705-713. Hafferty FW, Franks R. The hidden curriculum: ethics teaching and the structure of medical education. Acad Med 1994; 69: 861-871. Jacobson JA, Tolle BW, Stocking CB, Siegler M. Internal medicine residents' preferences regarding medical ethics education. Acad Med 1989; 64: 760-764. Pellegrino ED, Siegler M, Singer PA. Teaching clinical ethics. J Clin Ethics 1990; 1(3): 175-180. Parker M. Autonomy, problem-based learning and the teaching of medical ethics. J Med Ethics 1995; 21: 305-310. Siegler M. A legacy of Osler: teaching clinical ethics at the bedside. JAMA 1987; 239: 951-956. Wright S, Wong A, Newill C. The impact of role models on medical students. J Gen Intern Med 1997; 12: 53-56. Gordon JJ, Lyon PM. As others see us: students' role models in medicine. Med J Aust 1998; 169: 103-105. Postgraduate Medical Education Committee. Early postgraduate medical education. Available at: <http://meded.qmec.uq.edu.au/cpmec/index.asp>. Accessed 18 July 2001. Singer PA, Robb A, Cohen R, et al. Performance-based assessment of clinical ethics: the ethics objective clinical examination. Acad Med 1996; 71: 495-498. Savulescu J, Crisp R, Fulford KW, Hope T. Evaluating ethics competence in medical education. J Med Ethics 1999; 25: 367-374. Swanson D, Case S, Vleuten C. Strategies for student assessment. In: Boud D, Feletti G, editors. The challenge of problem-based learning. London: Kogan Page, 1991. Authors' details Department of Public Health, University of Adelaide, Adelaide, SA. Annette J Braunack-Mayer, BMedSci(Hons), PhD, Lecturer in Ethics. Centre for the Study of Health and Society, University of Melbourne, Melbourne, VIC. Lynn H Gillam, MA(Oxon), PhD, Lecturer in Health Ethics; and Research Fellow, Ethics Unit, Murdoch Children's Research Institute, Melbourne. Clinical School, St Vincent's Hospital, Melbourne, VIC. Edwina F Vance, MB BS, MBioethics, Fellow. Otago Bioethics Centre, University of Otago Medical School, New Zealand. Grant R Gillett, DPhil(Oxon), FRACS, Professor of Medical Ethics. Clinical Unit in Ethics and Health Law, University of Newcastle, Newcastle, NSW. Ian H Kerridge, MPhil, FRACP, Lecturer in Ethics; John McPhee, BCom (Hons)(Leg Stud), Consultant in Health Law; Peter Saul, FFICANZCA, MA, Clinical Lecturer in Ethics; David E Smith, MB BS, GradCertBioethics, General Medical Practitioner; Henry M Wellsmore, MAE, MSocSc, Lecturer in Ethics. School of Medicine, Flinders University, Adelaide, SA. Bogda Koczwara, FRACP, MBioethics, Coordinator, Personal and Professional Development; Wendy A Rogers, MRCGP, PhD, NHMRC, Sydney Sax Research Fellow, Department of General Practice; Brian F Stoffell, BA(Hons), PhD, Director of Medical Ethics. School of Community Medicine, University of New South Wales, Sydney, NSW. Paul M McNeill, LLB, PhD, Associate Professor of Ethics and Law in Medicine. School of Medicine, University of Tasmania, Hobart, TAS. Christopher J Newell, MA(Hons), PhD, Senior Lecturer. School of Medicine, University of Queensland, Brisbane, QLD. Malcolm H Parker, MB BS, MLitt(Hons), Senior Lecturer in Ethics and Professional Development. Department of Medical Education, University of Sydney, Sydney, NSW. Merrilyn Walton, BSW, MSW, Associate Professor of Ethical Practice. School of Medicine, James Cook University, Townsville, QLD. John S Whitehall, MB BS, FRACP, Associate Professor; and Domain Chair of Ethics and Personal Development, Director of Neonatology. Reprints will not be available from the authors. Correspondence: Dr A J Braunack-Mayer, Department of Public Health, University of Adelaide, SA 5005. annette.braunackmayerATadelaide.edu.au Make a comment 1: Approaches to ethics The "four principles" approach The "four principles" approach to ethics is based on principles of ethics articulated by Beauchamp and Childress.7 These principles are: Beneficence (the obligation to provide benefits); Non-maleficence (the obligation to avoid harm); Respect for autonomy (the obligation to respect the decision-making capacity of others); Justice (the obligation of fairness). It is claimed that these four principles encompass most, if not all, ethical issues in healthcare and provide a common set of moral commitments and a common language for discussing ethical issues.8 Narrative ethics Narrative ethics offers an alternative approach to principles, in which personal narrative, rather than a pre-identified framework, is central to any analysis and to decision-making. The emphasis is upon understanding the meaning of the situation for those involved. Narrative analysis draws upon skills of interpretation and reasoning by analogy to reach sound and defensible conclusions.8 This approach assumes that the most appropriate ethical solution can be reached through knowledge of the personal, cultural and social context of the individual.9 Ethics of care Ethics of care gives priority to caring as the most important moral principle in healthcare ethics, rejecting abstract and impersonal approaches to ethical analysis. In particular, care is contrasted with justice as a more appropriate moral principle. Like narrative ethics, ethics of care relies upon detailed information about the context of ethical decision-making in order to provide ethically sensitive and morally supportive care.10 Virtue ethics Virtue ethics starts with a consideration of particular qualities or virtues such as honesty, wisdom, or kindness rather than with concepts or rules. Becoming a good doctor involves learning through experience and from others and adopting an internal, value-based perspective, rather than following external rules or principles.10 This approach emphasises character and wisdom rather than focusing on the "right" result. Virtue ethicists believe that the intention to be a kind and compassionate person, rather than following a set of prescribed rules, results in a more integrated life with better-quality interactions. Back to text 2: Core knowledge for ethics in the medical curriculum FOUNDATIONS TOPICS Bioethical concepts Ethics in practice Disease, illness and suffering Models of the doctor-patient relationship Autonomy and agency Empathy, responsibility and accountability Personhood Determining capacity Competence and rationality Consent to and refusal of treatment Duty of care/beneficence Informed decision-making and disclosure Medical paternalism Legal aspects of the duty of care Vulnerability and trust Surrogate decision-making Medical veracity Involuntary treatment Harm Privacy and confidentiality issues Justice Compliance and adherence to treatment Life and death Futility/limiting, withdrawing treatment End-of-life decisions and causation of death Reproductive issues (including abortion) Professional ethical concepts Professionalism Professionalism, unprofessional conduct, self-regulation Professional issues for medical students and clinical governance Codes of ethics Student and physician impairments (eg, illness) Maintaining clinical competence Responding to clinical error Social ethical concepts Medical practice and research in society Individual and common good Cultural sensitivity in practice Individuals, families, societies and cultures Decision-making in conditions of uncertainty Human rights Resource allocation issues Models of healthcare delivery Public health ethics and legal obligations History and philosophy of medicine Evidence-based medicine and clinical judgement Status and uncertainties of science Ethical issues in complementary medicine Models of health, disease and care Commercialisation of medicine (including e-health) Medicalisation Human research ethics Goals and scope of medicine Issues in genetics and biotechnology Back to text 3: Core attitudes for ethics in the medical curriculum Honesty, integrity and trustworthiness Critical self-appraisal (including recognition of limitations and errors) Empathy and compassion Respect for (the dignity of) patients as people Respect for the roles of other healthcare professionals in the care of the patient Responsibilities of the medical professional towards the local and global community Responsibility and reliability Commitment to clinical competence and lifelong education Commitment to self-care Back to text 4: Examples of strategies for teaching ethics Scenarios incorporating ethical issues are used to prompt discussion, provide material for debate, or to set up role plays. Scenarios are used as triggers to explore issues. Students may be required to present their findings and understanding to others at a later time. This approach works in both "traditional" and "problem-based learning" courses. Students and their tutor discuss particular issues such as respect for colleagues and teachers, fidelity, promise-keeping and professional standards of behaviour, and how these concepts translate into a clinical setting. Issues of this sort may arise from the learning situation itself (eg, establishing and maintaining rules for attendance and commitment in shared tasks). Clinical situations are used as a prompt for students and staff to discuss ethical issues as they arise in the day-to-day practice of medicine. Students are required to keep a portfolio of current events as they are reported in the media, and to discuss this material in an essay and/or tutorial presentation. Students participate in a series of ethics tutorials, integrated with their clinical teaching, culminating in a group presentation to clinicians and students involving scripted role-plays on diverse ethical topics. Final-year students work on a statement of values that is incorporated into a declaration to be made during a prize-giving or graduation ceremony. Back to text 5: Ethics teaching in Australasian medical schools* University Year level taught Format Time allocated Adelaide All years† Lectures, seminars, PBL tutorials, self-directed learning, clinical modules Year 1: 10 hours Year 2: 10 hours Year 3: 25 hours Years 4-6: 3 hours/year Flinders All years Lectures, PBL tutorials, electives, web-based learning, portfolios, clinical teaching Year 1: 18 hours Year 2: 18 hours Year 3: 4 hours of formal lectures Melbourne All years Lectures, seminars, tutorials, PBL, self-directed learning, research projects, clinical teaching Year 1: 22 hours Year 2: 16 hours Year 3: 12 hours Years 4-6: 15 hours New South Wales All years Lectures, tutorials, workshops, clinical teaching Year 1: 6 hours Year 2: 35 hours Year 3: 28 hours Years 4-6: 5 hours/year Newcastle All years Seminars, tutorials, self-directed learning, clinical teaching Years 1-6: 40-50 hours Queensland All years† PBL tutorials, lectures, symposia, web-based learning, clinical teaching Years 1-2: 10% Years 3-4: 15% (% of curriculum) Sydney All years Lectures, theme sessions, PBL tutorials, portfolios, clinical teaching Years 1-3: weekly sessions Years 4-6: forum and integrated teaching Tasmania All years Lectures, tutorials, seminars, self-directed learning, electives, clinical teaching Years 1-6: 4 hours/year of formal lectures * As reported by ATEAM members. † Taught within EPPD stream. PBL = Problem-based learning. EPPD = Ethics, personal and professional development. Back to text

A Working Group, on behalf of the Association of Teachers of Ethics and Law in Australian and New Zealand Medical Schools (ATEAM)

GP Corporatisation The why and the wherefore Barry R Catchlove MJA 2001; 175: 68-70 For editorial comment, see Van Der Weyden Abstract - What is corporatisation? - Why corporatisation now? - What do GPs think? - What are the consequences of corporatisation? - Alternative models? - References - Authors' Details - - More articles on General practice and primary care Abstract Through their clearly defined gatekeeper role, GPs have considerable market power to influence the flow of revenue associated with referrals and prescriptions. For this reason, and because the whole healthcare industry is going through a transition from a cottage industry to a more commercially sophisticated structure, corporatisation of general practice is on the increase. If properly and ethically run, corporatised general practices can provide high-quality, efficient primary care. There are four far-reaching, potential consequences of general practice corporatisation — an increase in healthcare spending; limitation of GPs' choice of practice environment; difficulty justifying GPs' legitimate fee increases; and de-skilling of GPs. Over the past two years there has been a huge upsurge in corporatisation of Australian general practice. It began in Perth, Western Australia, and is now spreading across metropolitan Australia. An estimated 2500 GPs (about 10% of those in practice) now work in practices owned by large corporations.1 What is corporatisation? Definitions of corporatisation vary, but all include the concept of changing the traditional ownership and practice structures to improve the profitability of general practice.2 In terms of what is happening now in Australian general practice, a working definition would comprise: A third party — doctor(s) or non-doctor(s) — acquires an interest in one or more general practices. Whatever the equity arrangements, GPs enter into a contract whereby they assign a proportion of their gross income in return for management of their practice, provision of support services, and a goodwill payment. The third party then gains access to the flow-on services of the practice (eg, pathology and radiology) and may benefit financially from the GPs' referrals. The practices are merged into a single medical centre, which is generally separately owned by the same third party. In Australia, corporatisation of medical services is not a new phenomenon. Large corporations own many private hospitals and most pathology and radiology services, and third parties, be they entrepreneurial doctors or people from outside healthcare, have been acquiring general practices for years. The current situation is therefore not unique, because: GPs are being offered previously unheard of goodwill payments. The rate of practice acquisitions has increased dramatically. Ownership of diagnostic services by corporate entities is now common. Specialists are now joining these corporate medical centres. The new corporate owners are often listed companies and may have "big name" investors, adding further to the high profile of the new structure. There is a clear intention to capitalise on the GPs' market power (in addition to achieving some economies of scale). Why corporatisation now? The interesting question is not why corporatisation is happening, but why it is happening now. After a review of corporatisation commissioned by the Commonwealth Department of Health and Aged Care in 2000,3 the answer to this question is still not entirely clear. As is often the case in the commercial world, there is no obvious trigger. It is worth recalling the 18th-century economist Adam Smith's famous remark about the "invisible hand of the market".4 However, two important and relevant issues, external to the medical profession, shed some light on the upsurge of corporatisation. Firstly, GPs have considerable market power, which, in this context, means the ability, through a clearly defined gatekeeper role, to influence the flow of revenue associated with referrals, prescriptions and suchlike. We know that for each dollar of Medicare revenue earned by a GP, another $1.60 is generated directly in diagnostic and specialist consultations. Based on the flow-on effects of one GP's initial decisions, it is estimated that 20 GPs' decisions could be responsible, directly and indirectly, for as much as $50 million of healthcare expenditure per annum.3 In the past, the cottage industry nature of general practice, with an average of fewer than two doctors per practice, made it difficult to exploit collective market power. Secondly, the whole healthcare industry is going through a transition from a cottage industry to a more commercially sophisticated structure. Ironically, this started in the public sector — public hospitals were grouped into areas, regions and networks. In the 1990s, it spread to the private sector with the involvement of large third party commercial organisations, the rationalisation of pathology then radiology services, and it is now having an impact on general practice. Even the charity hospitals have been forced into merging and forming corporatised structures. This process appears inevitable and unstoppable. What do GPs think? Despite widespread concerns being voiced within the profession and in the media, GPs currently involved in corporate-run practices are not complaining. At this early stage of corporatisation most appear happy. There is no evidence to suggest they are being pressured into overservicing or into directing patients to particular diagnostic services or specialists. GPs who previously owned practices have received a relatively large and unexpected goodwill payment. They are probably earning about the same as they did before corporatisation, but they have been freed from the administrative tasks of running their practice. In a business sense many would agree that GPs from inefficient and grossly undercapitalised practices needed to be dragged into the 21st century. If properly and ethically run, corporatised general practices can provide high quality, efficient primary care. On a more sober note, it must also be remembered that all these new entrants into corporatised general practice have only existed for a short time and therefore can only be judged on short-term performances. What are the consequences of corporatisation? At this stage, the real issues of corporatisation are not about the compromise of clinical autonomy (although there is no denying this could be a problem but not necessarily associated with corporatisation alone). I believe that, apart from some of the more obvious issues such as ownership of records and freedom to refer, there are four far-reaching, albeit subtle, consequences of corporatisation. Although corporatisation will get the blame, these four are in reality consequences of the inevitable changes associated with transforming healthcare from a cottage industry to a more rational, market-driven service sector. These include limitation of choice, increases in healthcare spending, difficulty justifying legitimate fee increases, and de-skilling of GPs. Limitation of choice There is a real risk that the corporate model will become so dominant that future GPs will have little choice about the sort of practice in which they wish to work. This is already happening to some extent in metropolitan Perth.5 For general practice to attract doctors, it needs to offer a range of alternative models from solo general practice right through to large corporate medical centres. The only way is to ensure viable alternatives offering equivalent benefits and advantages. Crucial to this is the creation of saleable goodwill. Increases in healthcare spending The real profitability in owning a general practice is not in the direct revenue, but in the "downstream" revenue, which is the product of GPs' gatekeeper role. The corporate groups believe that access is the key (not coercion). If a pathology collection centre or pharmacy is placed within the confines of a medical centre, then about 95% of the referrals can be assumed without any need to adopt overt pressure. The corporate practice benefits from ownership of diagnostic services, but, even if it doesn't (as is often the case for pharmacy and allied health services), it benefits from being able to demand premium rentals for floor space. Specialists who take consulting space in these medical centres may also be prepared to pay excessive rentals to gain access to a large number of GPs. The real concern is the subtle impact on referral rates, diagnostic and pharmaceutical expenditure. Take as a hypothetical example the presence of a full time dermatologist in a large medical centre (please forgive me for selecting a dermatologist, it could equally apply to other specialists). It is inevitable that many of the patients previously managed, and managed quite effectively, by GPs will now be referred. Again, access is key, with higher patient expectations, convenience, and perhaps even medicolegal concerns about not referring when the service is so readily available. Given the cost differential between GP and specialist consultations, both the referral rate and the cost per patient attendance will inevitably rise. If this situation is extrapolated to other possible diagnostic and specialist referrals, there is a potential for considerable increases in Medicare and Pharmaceutical Benefits Scheme spending. How will governments react to this? Very simply, they will encourage the already developing move to fund-holding, coordinated care, fund pooling — call it what you will. All these mean a move away from fee-for-service and towards managed-care models and the associated transfer of risk. If GPs control the budget, will government allow corporatised practices to share the savings, and if GPs have a vested interest in reducing referral rates what will be the impact on the downstream revenue? Could this undermine the viability of the corporate players already paying high prices for general practice acquisitions? Difficulty justifying legitimate fee increases Being owned by high profile, often publicly listed, successful corporate entities might decrease the ability of the medical profession to argue a case for legitimate fee increases. Imagine the situation — two large publicly listed corporate practices, perhaps partly owned by high profile entrepreneurs, announce record profits at the same time that representatives of general practice organisations are meeting with government to discuss increases in the fee schedule. De-skilling of GPs If every conceivable diagnostic test, specialist and ancillary service is available on site, and this results in increased referrals, then there is a likelihood that GPs will become nothing more than a postbox, and there is a real potential for de-skilling of GPs. A GP's clinical judgement will become largely unnecessary. Taking this situation to extremes, someone might eventually ask whether the GP's gatekeeper role is working and mightn't a much cheaper nurse practitioner fill the same role? Alternative models? What corporatisation has demonstrated is that there are more efficient ways to deliver primary healthcare. For those who acknowledge this, the challenge is to provide alternative models, drawing on the lessons of corporatisation. The KPMG report to the Commonwealth Department of Health and Aged Care asked some searching questions about the use of GP market power. Properly managed and with due regard to ethics, this market power can be used to improve care, reduce costs and improve the quality of practice. If GPs are prepared to responsibly manage their gatekeeper role, which often requires increased time and effort, they should be rewarded. GPs should be best suited to manage and control their market power. However, it is something of a truism that if you have such power and do not use it or control it then someone else will. Corporatisation in general practice is merely one aspect of the movement of health services from the cottage industry to a more rational and rationalised model. To argue a return to the good old days and the status quo would be attempting to do what King Canute proved was impossible — holding back the tide. References Corporate structure [news review]. Australian Doctor 2001; 27 April: 29-31. Australian Medical Association. General practice corporatisation. AMA scoping paper. Canberra: AMA, November 2000. Commonwealth Department of Health and Aged Care. Corporatisation of general practice: scoping paper. KPMG Consulting, May 2000. Smith A. An inquiry into the nature and causes of the wealth of nations. London: W Strahan, T Cadell, 1776. Kron J. Risky business. Australian Doctor 2001; 16 Feb; 45. Authors' Detials Barry R Catchlove, MB BS, FRACP, Director. No reprints will be available from the author. Correspondence: Dr Barry R Catchlove, Director, Padua Consulting Pty Ltd, Health Services Consulting, 11 Burton Street, Mosman, NSW 2088. bcatchloATbigpond.net.au Make a comment

Barry R Catchlove

Editorial Safety and quality in Australian healthcare: making progress The newly formed Australian Council for Safety and Quality in Health Care has ambitious plans MJA 2001; 174: 616-617 Australian healthcare is comprehensive and accessible, supported by modern technology and a well trained and motivated workforce. Neverthless, problems occur, typically as a result of a series of systems failures which lead almost inevitably to mishaps by doctors or nurses.1,2In the 21st century, we can, and should, be doing better to identify and manage risks and systemic failures in the healthcare system. There is much that we can learn from industries such as aviation, mining and road safety, and from human-factors engineers and cognitive psychologists, about how to shift to a system that, although inevitably high risk, has high reliability (ie, lessons are learnt from problems, and changes made so that the problems do not recur).3 These industries have seriously tackled these issues and made measurable improvements in safety. Healthcare needs to recognise that safety concerns are real, that the system is prone to error and failure, and that we need to work to reduce the risk in areas that are inherently risky. . . . we need to move beyond a "bad apples" approach, with media sensationalism . . . We need to redesign and simplify many aspects of healthcare. Management of the system needs to change dramatically to allow clinicians and nurses at the frontline to influence management decisions effectively. Otherwise we will fail to engage their active support in improving safety and quality. Management has a necessary focus on improving efficiency, but this alone will not improve safety and quality. Management must also fund, support and encourage redesign of systems, monitor activity reports, feed their results back into the systems, and encourage and reward safety improvements. As well as very significant potential benefits to patients, there are likely to be significant savings through more efficient use of resources. For example, medication error has been estimated to result in at least 80 000 hospital admissions and costs of at least $350 million per year.4 Ultimately, we need to change the culture in healthcare. As part of this change, all who work in or have responsibility for the healthcare system need to be willing to work with their peers to examine more openly and objectively their performances and patient outcomes. In the broader community, we need to move beyond a "bad apples" approach, with media sensationalism, towards a more mature level of understanding and acceptance of the inevitable risks in healthcare. There is much to be done to achieve the desired changes. To promote and facilitate these changes, the Australian Council for Safety and Quality in Health Care was formed in January 2000 by the Federal, State and Territory health ministers. Its role is to lead national efforts to promote systemic improvements in the safety and quality of healthcare in Australia, with a particular focus on minimising the likelihood and effects of error. The Council's first report, Safety first, was presented to health ministers in July 2000. In it, the Council identified the broad areas that it would lead to make "a difference where it counts".5 The health ministers endorsed the Council's terms of reference, agreed in principle to provide $50 million for a five-year national program led by the Council, and required it to report annually on progress and planned action. The Safety first report also highlighted the significant personal and financial costs of adverse events4,6 and noted that existing efforts to improve healthcare safety were valuable but insufficient. After wide consultation, the Council has produced its first national action plan for 2001.7 The major emphasis is on developing and strengthening national standards, with educational support to help healthcare professionals and managers put the standards in place effectively. As no single group can deliver change on its own, a collaborative approach is being taken. Council will work closely with governments, health departments, healthcare funders and management, providers, consumers and educators to ensure that standards developed are put in place and monitored. A key initiative of the Council is to learn lessons through better use of data. Activities to achieve this will include the establishment of national standards for incident monitoring and investigation in healthcare facilities, as well as the design of improved methods to survey and report improvements in healthcare quality. The type of activities that the Council would like to see implemented across the country are exemplified in the report from Wolff and colleagues in this issue of the Journal.8 They present the results of the long-term risk management activities of the Wimmera Health Care group in Horsham, Victoria. Wolff and his colleagues have developed an integrated clinical risk management program, detected adverse events in a variety of ways, analysed both the events and the risks, and taken action to improve care and monitor progress, using a systems approach. Through this systemic approach, they reduced the rate of adverse events from 1.35% of all patients discharged in the first year of the program to 0.74% in the eighth year. In the emergency department, the rate was reduced from 2.71% of all patients attending in the first quarter of monitoring to 0.48% in the eighth quarter. These event rates are very low, but comparison is difficult, as the rate of adverse events found in any study depends not only on standards of care and systems design, but also on study methods and the reporting rate. This allows for wide variability in results. For example, other reported rates of adverse events range from 3.7% in the Harvard study,9 to 16.6% in the Quality in Australian Health Care study,10 30% in a recent study in Victorian hospitals,11 and 45.8% in Florida.12 The study by Wolff and colleagues was prospective and used consistent methods to detect adverse events, thus allowing meaningful comparisons over time. The important finding was a reduction in rates of adverse events, particularly more serious adverse events. The actions taken to reduce their frequency were simple: changes to local protocols, audits, worksheets and supervision practices, as well as the incorporation of feedback, discussion, checklists and assessment tools. All are low-cost activities. Such information about how to improve safety may well be used to inform the development of national standards by the Council. Other priorities of the Council during 2001 are: to address known high-risk areas which contribute significantly to adverse events. These include reducing hospital-acquired infections, promoting safer use of medications and blood products, preventing patient falls and improving patient assessment; to develop national standards for credentialling and performance assessment; to develop specialist and vocational registers; to develop curricula for educational modules in systems safety, human factors and communication; to develop standards for national audits and benchmarking, full disclosure of adverse events and saying "sorry"; and to develop standards for organisational certification, accreditation and licensing, addressing such issues as best practice, structured risk management, teamwork and team training, resource use, skill mix and safety standards. When these priorities have been achieved, the Council will have gone some way towards developing a culture of safety, providing resources for data collection, analysis and feedback, and developing national standards in key areas. It will have a system that is informed by the needs of consumers. There should also be improved morale in healthcare, less unnecessary variation in this care, better performance assessment, more satisfactory outcomes and a reduction in adverse events. The Council will need the willing help of all involved in the system to achieve the benefits available to the community from this ambitious plan. Bruce H Barraclough Chairman, Australian Council for Safety and Quality in Health Care Professor of Cancer Services, University of Sydney, Sydney, NSW Reprints: Professor B H Barraclough, Department of Surgery, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065. Berwick DM. Not again! Preventing errors lies in redesign — not exhortation. BMJ 2001; 322: 247-248. Berwick DM, Leape LL. Reducing errors in medicine. BMJ 1999; 219: 136-137. Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ 2000; 320: 759-763. Roughead EE. The nature and extent of drug-related hospitalisations in Australia, 1999. J Qual Clin Pract 1999; 19: 19-22. Australian Council for Safety and Quality in Health Care. Safety first. Report to the Australian Health Ministers Conference. Canberra: Commonwealth Department of Health and Aged Care, July 2000. Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Committee on Quality of Health Care in America. Institute of Medicine. Washington, DC: National Academy Press, 1999. Australian Council for Safety and Quality in Health Care. National action plan. Canberra: Commonwealth Department of Health and Aged Care, 2001. Wolff AM, Bourke J, Campbell I, Leembruggen D. A clinical risk management program: detecting and reducing hospital adverse events. Med J Aust 2001; 174: 621-625. Brennan TA, Leape LL, Laird NM. 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. Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australian Health Care Study. Med J Aust 1995; 163: 458-471. O'Hara DA, Carson NJ. Reporting of adverse events in hospitals in Victoria, 1994-1995. Med J Aust 1997; 166: 460-463. Krizek TJ. Surgical error. Ethical issues of adverse events. Arch Surg 2000; 135: 1359-1366. Make a comment

Bruce H Barraclough

MJA 2001; 174: 637-640 Abstract - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - More articles on Infectious diseases and parasitology Abstract Objective: To determine attitudes towards doctors and hospitals as data custodians, and patients' experiences of unauthorised information releases from health services. Design: Analysis of data from a cross-sectional, descriptive household survey (October-November 1999). Setting: South Australian community. Participants: 3013 randomly selected residents over 15 years of age. Main outcome measures: Level of confidence in doctors and hospitals as data custodians, and patient-reported experience of unauthorised information releases by health services. Results: 288 survey participants (9.6%) were not confident that healthcare providers keep and use information responsibly, 108 (3.6%) reported that healthcare providers had released information without their consent (although at least 48 of these disclosures were legally defensible), and 57 (1.9%) reported harm arising from unauthorised disclosures by health services. Projecting these findings to the South Australian population, over 2000 people experienced harm arising from unauthorised information release in 1999. However, in the same period, there were fewer than 20 formal complaints to major agencies (eg, Ombudsman, Medical Board). Conclusions: Healthcare providers have lost the confidence of a minority of patients. For some, this mistrust is based on experience of unauthorised information release. Some disclosures are mandated by legislation. These findings provide baseline performance measures for benchmarking trends in patient confidence and prevalence of unauthorised release of patient information. The promise of confidentiality encourages the candid communication between doctors and patients required for high quality care. In legal actions concerning breaches of confidence it has been argued that "It is important that those who require medical assistance should not be inhibited in any way from seeking or obtaining it".1This view is supported by research showing that without a guarantee of confidentiality some groups of patients will not seek healthcare2 and others would withdraw from activities such as blood donation.3Australians place more trust in doctors and hospitals to keep and use information in a responsible way than they do in other organisations.4 However, many Australians believe there is less privacy now than there was and that computers make it easier for confidential information to fall into the wrong hands.4 The collection and use of health information has also been identified as a cause for public concern in other countries.5,6 Commentators within the profession have warned that electronic patient records may reduce the protection of patient privacy7 and there is consumer concern about the potential for direct marketing of pharmaceuticals.8 The current legal provisions for protecting confidentiality in South Australia are summarised in Box 1. However, it is not known whether these privacy safeguards are adequate. There is little evidence to support the contention that patient confidentiality is being undermined. In the United States, there has been limited quantitative assessment of the effectiveness of the methods currently used to protect confidential patient information,11 the frequency with which unauthorised releases of information occur,12 or the consequences for patients of these events. Using data from a population survey in South Australia, I investigated the level of confidence in health services, the prevalence of unauthorised information release by health services and the likelihood of harm resulting from these events. Methods Participants A representative sample of South Australians was interviewed in October and November 1999 during the annual Omnibus Health Survey for the South Australian Health Commission Epidemiology Branch. Interviewers started from a random point within each of 340 metropolitan and 100 country Collectors Districts (used by the Australian Bureau of Statistics in the 1996 Census) and chose every fourth dwelling until 10 were selected from each district. Of the 4400 dwellings selected, 133 were vacant. Interviews were conducted with one household member aged over 15 years (the one with the most recent birthday) in 3013 of the remaining 4267 households, giving a response rate of 70.6%. The interview questions are shown in Box 2. Statistical analysis Data were analysed using χ2 tests and the Statistical Package for the Social Sciences (SPSS).13For population projections, I used 1999 figures from the Australian Bureau of Statistics (South Australian population by age and sex).14 Ethical approval Approval to use the data collected in the Omnibus Health Survey was granted by the Flinders University Social and Behavioural Sciences Research and Ethics Committee. Results Confidence in healthcare providers as data custodians While most participants expressed confidence in doctors or hospitals to keep and use information responsibly, nearly one in 10 participants did not share this confidence (Box 3). There was no significant difference between men and women in level of confidence, but there were significant differences in confidence with age: participants aged 25-34 years were significantly less confident about doctors and hospitals as data custodians than those in other age groups (P < 0.001). Prevalence and sources of unauthorised information release One hundred and eight of the 3013 participants (3.6%) had become aware that information had been released by a health service without their permission on at least one occasion. There was no significant difference in reported information release between the sexes or between metropolitan and country dwellers. For 33 (1.1%) participants, the information release had occurred in the previous 12 months. The 108 participants identified 123 instances of information release without authorisation. The services reported to have released the information were general practitioners (47), public hospitals (31), private specialists (23), private hospitals (9), mental health services (4) and other health organisations (9). Lawful and unlawful disclosures Of the 108 participants who reported information disclosures: 48 participants (1.6% of the total sample) reported information releases which would be legally defensible. Of these, 24 participants described information being passed from one treating practitioner to another. While these disclosures are accepted practice, they had not been authorised by the patients. For the other 24 participants, information release had been permitted or mandated by legislation or authorised by the patient. For example, some patients had been required to consent to release information in order to become entitled to benefits such as workers compensation or social security. 32 participants (1.1% of the total sample) described disclosures which would be legally indefensible. Among these were two who had received personally addressed advertisements for respiratory medications and who believed that their addresses and diagnoses had been released to a pharmaceutical company. Others had experienced disclosures by a practitioner of pregnancy, contraceptive use or a diagnosis to family members. 28 participants (0.9% of the total sample) gave responses which did not allow analysis of the lawfulness of the disclosures. Harm resulting from disclosures Of the 108 participants who said that information had been released by health services without their permission, 51 (1.7% of the total sample) were unconcerned, some commenting that it seemed appropriate or that the information release had been required by law. Fifty-seven participants (1.9% of the total sample) reported that unauthorised disclosures had caused trouble or problems for them. For 12 of these (0.40% of the total sample), this had occurred in the previous year. Participants reported distress, embarrassment, arguments between family members and loss of trust in medical services as a result of unauthorised release of information. There were also more tangible losses, such as loss of employment, compensation and insurance entitlements or child custody. Projections to the South Australian population Projecting the proportion of participants who became aware of information releases to the adult population of South Australia indicates that as many as 43 170 ± 8130 South Australians (2 x standard error of the proportion) may have become aware of unauthorised releases of information by a health-care provider, with an estimated 13 190 ± 4550 occurrences in the previous year. Projecting the proportion of participants who reported harm from information release to the South Australian population would indicate that between 2022 and 7530 such events (4776 ± 2 x standard error of the proportion) had occurred in South Australia in the 12 months before the interviews were conducted. Healthcare complaints reported in South Australia Complaints related to healthcare issues, including unauthorised releases of health information, in South Australia may be directed to individual healthcare practitioners, the Medical Board of South Australia, the Ombudsman or individual health units. However, not all complaints are recorded. Box 4 shows complaints recorded by major agencies in South Australia in 1999. Events causing harm could be expected to lead to formal complaints or legal action. However, although there were an estimated 2000 or more South Australians who experienced harm after unauthorised information release in 1999, fewer than 20 formal complaints were made to the largest complaint-handling agencies. It follows that only a minority of patients harmed by unauthorised information release actually initiate a formal complaint. Discussion Healthcare providers have lost the confidence of some patients. For some members of the population, there has been personal experience of harm resulting from the unauthorised release of information. Release of information without authorisation by the patient is not a perfect proxy for breach of confidence. Some disclosures do not require the patient's consent. They may be mandated by law and protect the interests of individuals other than the patient (eg, reporting of child abuse). Transfers of information between treating practitioners have not been the subject of legal sanctions and are accepted as routine practice. However, patients may still experience adverse consequences or become mistrustful as a result of these disclosures. For this reason, all unauthorised releases of patient information resulting in harm may be viewed as adverse events, while recognising that some would not be found to be breaches of confidence if tested in a court. The fact that general practitioners and public hospitals were most often identified as the source of unauthorised releases of information need not indicate less stringent data-handling practices in these settings, but reflects the volume of services being provided. In South Australia, in the 12 months before the survey, there were 7 329 500 Medicare rebates for general practitioner services, 337 144 separations reported by public hospitals and 154 613 separations reported by private hospitals. The cumulative experience of perceptible health information "leaks" is nearly 4% in the adult population in South Australia. By comparison, data from the United States indicate that nearly 20% of adults become aware that health services have disclosed their information "improperly", and nearly 40% do not trust doctors and hospitals to keep information private and confidential.12 While these figures suggest that the South Australian healthcare system compares favourably with that in the United States, healthcare practices vary greatly between countries, as do social expectations of health services. Thus, caution must be exercised in making international comparisons of confidentiality in health services. The South Australian data do not include instances of information release without the patient's being aware of it; nor do they show whether the use of electronic medical records is undermining patient privacy. They do suggest that few harmful disclosures of health information result in formal complaints by patients. The findings provide baseline performance measures for benchmarking trends in patient confidence in health services and in the prevalence of unauthorised disclosures by healthcare providers. It would be important for future research to distinguish between lawful and unlawful disclosures. Apart from the harm to individuals resulting from information disclosures, there is a public interest in ensuring that the general population has confidence in the integrity of health services. Acknowledgements Partial funding for this project was provided by the Royal Australian College of General Practitioners. This research was also supported by an Australian Postgraduate Award and stipend granted by Flinders University of South Australia. References R v Dept of Health, ex parte Source Informatics [1999] 4 All ER 185, Latham J at 196.17(269): 1404. Cheng T, Savageau JA, Sattler AL, De Witt TG. Confidentiality in health care: a survey of knowledge, perceptions, and attitudes among high school students. JAMA 1993; 269: 1404-1407. Banks HD, Williams AE, Nass CC, Gimble J. Changes in intention to donate blood under a hypothetical condition of reduced confidentiality. Transfusion 1993; 33: 671-674. Privacy Commissioner. Community attitudes to privacy. Information paper no 3. Sydney: Human Rights and Equal Opportunity Commission,1995. Bennett C. How do public attitudes on privacy vary among nations: comparative analysis of national privacy surveys prepared for the Global Business Privacy Project of the Center for Social and Legal Research. <http://www.privacyexchange.org> (accessed February 2001). Carman D, Britten N. Confidentiality of medical records: the patient's perspective. Br J Gen Pract 1995; 45: 485-488. Regan BG. Computerised information exchange in health care. Med J Aust 1991; 154: 140-144. Carter M. Integrated electronic health records and patient privacy: possible benefits but real dangers. Med J Aust 2000; 172: 28-30. <eMJA full text> Bray and Smith v Workers Rehabilitation (1994) 62 SASR 218, 30 Mar 1994. Organisation for Economic Cooperation and Development. Guidelines governing the protection of privacy and the transborder flows of personal data 1980. Geneva: OECD, 1980. Saffran C, Rind D, Citroen M, et al. Protection of confidentiality in the computer-based patient record. Clin Comput 1995; 12: 187-192. Princeton Survey Research Associates. Medical privacy and confidentiality survey. Sacramento: California Healthcare Foundation, 1999. Statistical Package for the Social Sciences (SPSS). Version10. Chicago: SPSS Incorporated, 2000. Australian Bureau of Statistics. Population by age and sex, South Australia, as at 30th June, 1999. Canberra: ABS, 2000. (Received 17 Jul 2000, accepted 1 Mar 2001) Authors' details Flinders University of South Australia, Adelaide, SA Ea C Mulligan, BM BS, BMedSci(Hons), MHA, PhD candidate, School of Law. Reprints: Dr E C Mulligan, School of Law, Flinders University of South Australia, GPO Box 2100, Adelaide, SA 5001. Correspondence: Dr E C Mulligan, School of Law, Flinders University of South Australia, GPO Box 2100, Adelaide, SA 5001. ea.mulliganATflinders.edu.au Make a comment 1: Legal provisions protecting confidentiality in South Australia There is no general right to privacy in Australian law. Although there has been a gradual expansion of circumstances in which confidentiality may be defended by the courts, civil action is infrequent. The most recently reported South Australian case involving breach of confidence in health records was decided in 1994.9 In parallel with legislation in other Australian States (Health Administration Act 1991 [NSW] s.22, Health Services Act 1988 [Vic] s.18, Health Services Act 1991 [Qld] s.100), the South Australian Health Commission Act 1976 (s.64) prohibits employees from divulging personal information relating to any patient obtained in the course of employment unless authorised or required by law or by their employer. Other State statutes either permit or require medical practitioners to release specific kinds of patient information (eg, mandatory reporting of child abuse, Children's Protection Act 1993 [SA] s.11), providing a defence to action for breach of confidence in specific circumstances. The Commonwealth Privacy Act 1988 (s.14) includes a set of Privacy Principles derived from the internationally recognised "Guidelines governing the protection of privacy and the transborder flows of personal data".10 The Privacy Act applies to Commonwealth agencies and has recently been amended to apply to the private sector, including private medical practices. Back to text 2: Questions in a 1999 survey of South Australians about confidentiality in health records I am going to ask you some questions about organisations which hold medical records about you. There would be health records about you at the hospital where you were born, with any general practitioners or private specialists you have consulted and at any hospital or mental health service or special clinic where you have been treated. How confident are you in doctors and hospitals to keep and use information in a responsible way? As far as you are aware, has information about you ever been released by a doctor or health service to another person without getting your permission? Did this happen in the last twelve months? Was this information released by a public hospital, private hospital, mental health service, general practitioner, private specialist, or other? When information about you was released without your permission, did it cause any trouble or problems for you? Could you briefly explain what happened and how it affected you? Back to text 3: Confidence in doctors and hospitals as data custodians (n = 3013) Confident/very confident Not very/not at all confident Neither/don't know 2549 (84.6%) 288 (9.6%) 176 (5.8%) Back to text 4: Healthcare complaints recorded in South Australia in 1999 All complaints Complaints concerning confidentiality Medical Board 174 5 Ombudsman 319 1 8 metropolitan hospitals 1792 12 Back to text

Ea C Mulligan

Viewpoint Truth in clinical research trials involving pharmaceutical sponsorship Large clinical trials are expensive to mount. Funding comes mainly from pharmaceutical companies seeking information on drug efficacy and adverse events. Patients should be informed of the financial and publication agreements reached between those conducting the trials. This is unlikely to have a significant effect on trial participation and will provide patients with information relevant to informed consent. A small proportion of monies raised from drug trials could be set aside to fund both a trial register site and further studies on adverse drug reactions. Chris A Commens MJA 2001; 174: 648-649 Intellectual property - Publication bias has consequences - Financial disclosure as part of informed consent - Suggested requirements for drug trials - Is trial information reward enough for the public? - References - Authors' details - - More articles on Statistics, epidemiology and research design More articles on Ethics In recent years, economic rationalism has forced public institutions to look for non-governmental sources of income and links with industry.1 Our dermatology department needed equipment for which funds were not available from the hospital budget, but would be available from payment for participating in a drug trial. The trial sponsors wished to compare their product with the current "best" cream and a placebo in a randomised controlled trial. Participation would be voluntary, the risk of harm minimal, privacy would be protected and patients would be "suitably informed". An administrative and financial agreement was arranged between our department and the professional contract research organisation responsible for the study. Details of this trial are shown in the Box. There was some pressure for quick approval, as doctors working from their private rooms had an impressive head start and were already entering patients in the trial. Our institutional ethics committee sought a number of changes to the trial protocol, but it was eventually approved. We had no sooner entered patients into the trial than it was closed: the required number of patients had been supplied by private practitioners. Was this a case of a public institution being too slow in responding to the demands of industry? Perhaps, but there were other, more important issues, particularly those relating to restrictions of intellectual property, the opportunities for publication bias and informed consent of patients in clinical trials. Intellectual property The rights to the information gathered by the drug trial were legally under the control of the contract research organisation. It is likely that many patients enter drug trials believing that the resulting knowledge will be available for the common good. Would the public readily enter similar trials if they knew the intellectual property was controlled by the sponsors and may not be available for the public record? Commercial sensitivity, the complexity of running multicentre trials and timing of publication demand some flexibility, but an insistence on public record of all trial results should be non-negotiable. Publication bias has consequences My concerns about publication bias are shared by others,2,3 and are as follows: If the findings remain the property of the sponsor, then how much evidence is never reported? How truthful is medical evidence that relies on publications selected by an industry which needs to sell new drugs or variations on existing drugs ("me-too" drugs)? "Me-too" drugs require clinical trials showing some advantage, and these trials may be designed with marketing strategies as the driving hypothesis. Trials that show no difference or no effect, or even adverse effects, are less likely to be published, while positive results are likely to be published and promoted. Pharmaceutical companies have to make a profit or they fail.4 There is evidence for selective publication of drug trial information,5 and even manipulation of information6 and opinion.7,8 Publication bias may result in unsafe or more expensive therapies being used. Health resources are limited and inefficient use results in rationing elsewhere. We need all available information to be on the public record to inform us in clinical decision-making. Financial disclosure as part of informed consent Recent judgments in the Australian justice system suggest that informed consent should involve disclosing all issues that might be significant to the patient making the decision.9 Patients may enter drug trials as part of an ongoing doctor-patient relationship, and this may make them feel more secure in the rigours and supervision imposed by trial conditions.10 Patients' trust in doctors is based on the belief that it is their health that remains the central focus. Full disclosure of financial interests might disturb this trust, particularly in trials conducted in private clinics with financial payment made directly to the medical investigator. In public institutions money gained from trials is not usually paid directly to doctors. Generally, most of it is spent on acquiring necessary equipment or to support further research — something likely to be supported by the public. Disclosing trial financial details to patients will create additional difficulties, but truth is more important than false trust. The Royal Australasian College of Physicians' Ethical guidelines in the relationship between physicians and the pharmaceutical industry11 and the National Health and Medical Research Council's National statement on ethical conduct in research involving humans12 state that there should be disclosure to research participants of relevant aspects of the budget. More recently, financial disclosure in clinical trials has come under scrutiny in the media.13,14 If we don't ensure such disclosure, then either the political or judicial system might impose it on us. Suggested requirements for drug trials We have progressed a long way in the ethical review of research. However, ethics committees also have increasing workloads and diminishing budgets. They are not necessarily equipped to obsessively interrogate and supervise all submitted projects.15,16 I propose that trial submission forms to ethics committees have two or three further questions confirming a commitment to publish trial results17 and to disclose financial details. This would flag this requirement to both researchers and the industry. Some ethics committees may already have these requirements. The resulting transparency would increase public trust in clinical trials, which, in turn, might make patients more likely to volunteer, ensuring wide and valid representation of different trial subjects. Is trial information reward enough for the public? In entering drug trials the public are risking more than the pharmaceutical industries and the investigators. We all agree that clinical trials are necessary and that, in the right setting, they provide information on new and effective therapies. However, there are other rewards that could be offered to the public. Ready public availability of information on the risks of pharmaceutical products would be an appropriate reward. It is estimated that 80 000 Australians are admitted yearly to Australian hospitals with adverse reactions to pharmaceutical products.18 A proportion of drug trial monies could be dedicated to the study and education of adverse drug reactions. Another proportion of drug trial monies could be dedicated to funding a trial register site17 to provide abstracts of all clinical trials and their results. Finally, we need to examine how and by whom clinical trials are conducted as they are taken from academic medical centres into other sites.3,19 Public institutions are the most protective environment for the public for pharmaceutical and biotechnology trials, provided they have transparent and available guidelines on their interactions with the pharmaceutical industry.20-23 References Health and Medical Research Strategic Review. The virtuous cycle. Working together for health and medical research. Canberra: Canberra Info 1999. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990; 263: 1405-1408. Bodenheimer T. Uneasy alliance — clinical investigators and the pharmaceutical industry. New Engl J Med 2000; 342: 1539-1544. Angell M. The pharmaceutical industry — to whom is it accountable? New Engl J Med 2000; 342: 1902-1904. Rennie D. Fair conduct and fair reporting of clinical trials. JAMA 1999; 282: 1766-1768. Hailey D. Scientific harassment by pharmaceutical companies: time to stop. CMAJ 2000; 162: 212-213. Weatherall D. Academia and industry: increasingly uneasy bedfellows. Lancet 2000; 355: 1574. Larkin M. Whose article is it anyway? Lancet 1999; 354: 136. Rogers v Whitaker (1992) 175 CLR 479. Chalmers I. What do I want from health research and researchers when I am a patient? BMJ 1995; 310: 1315-1318. Royal Australasian College of Physicians. Ethical guidelines in the relationship between physicians and the pharmaceutical industry. Sydney: The College, 2000. National statement on ethical conduct in research involving humans. Canberra: National Health and Medical Research Council, 1999. Pyle G. The drug-body snatchers; No cure, Mrs James, but thanks for all the money; Playing patients in the fast lane; It's the money they have to have. Sydney Morning Herald 13 Feb 2001: 1,4. Pyle G. Patient drug tests enrich hospitals; Vulnerable used as guinea pigs but who guards the guardians? Sydney Morning Herald 14 Feb 2001: 1,4. Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996; 313: 1390-1393. Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committees of the Royal College of General Practice. BMJ 1996; 313: 1245-1248. Scroccaro G, Venturini F, Alberti C, et al. Registering clinical trials. BMJ 2000; 320: 1339. Roughead E, Gilbert A, Primrose J, Sansom LN. Drug related hospital admissions: a review of Australian studies published 1988-1996. Med J Aust 1998; 168: 405-408. Angell M. Is academic medicine for sale? New Engl J Med 2000; 342: 1515-1518. Lemmens T, Singer PA. Bioethics for clinicians: 17. Conflict of interest in research, education and patient care. CMAJ 1998; 159: 960-965. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701-2711. Boyd EA, Bero LA. Assessing faculty financial relationships with industry. A case study. JAMA 2000: 284: 2209-2214. DeAngelis C. Conflict of interest and the public trust. JAMA 2000; 284: 2237-2238. Authors' details Department of Dermatology, Westmead Hospital, Sydney, NSW. Chris A Commens, MB BS, FACD, Director. Reprints will not be available from the author. Correspondence: Dr C A Commens, 20 Hillcrest Road, Pennant Hills, NSW 2120. ccommensATmail.usyd.edu.au Make a comment Details of the proposed trial Trial: Phase IIb double-blind, placebo-controlled, parallel-group, multicentre study. Aim: Assess the efficacy of topical creams in different bases. Duration: 12 weeks, with five assessment visits. Procedures: Evaluation and count of lesions and assessment of tolerance of treatments. Patient numbers: 300 patients throughout Australia. Payment: $1200 per patient who completed the trial. Patient travel expenses: $20 per visit. Back to text

Chris A Commens

Viewpoint Physician-assisted suicide in Oregon: why so few occurrences? Howard Wineberg MJA 2001; 174: 353-354 In the first three years that physician-assisted suicide (PAS) has been legal in Oregon, about two persons per month have taken medication to end their life. Most physicians are unwilling to prescribe the lethal medication. Because many terminally ill people are confined to their bed or home, the difficulty of finding a willing physician may have resulted in many abandoning the idea of using PAS. People living a long way from a large urban centre may be severely disadvantaged in their ability to obtain medication to end their lives. Legal requirements - Oregon - Using PAS - Not using PAS - Conclusion - References - Authors' details - - More articles on Ethics Physician-assisted suicide (PAS) has been legal in the state of Oregon, USA, for more than three years. The Oregon Health Division, the agency responsible for monitoring Oregon's Death with Dignity Act, has produced official reports documenting the number and characteristics of Oregonians who have used the provisions in the law to take medication to end their lives in the years 1998-2000.1-3 Only 70 people legally took medication to hasten their death during this period — in this article I examine some of the reasons why. Legal requirements Under Oregon's law,4 only Oregon residents who are aged 18 or over and have a terminal illness with a life expectancy of less than six months are eligible to request a prescription for medication to end their life. Patients must self-administer (swallow) the medication — euthanasia (involving a physician's active intervention) is not allowed. The physician's prognosis for the patient must be confirmed by a consulting physician and both physicians must determine that the patient is capable of making his or her own decision and does not have a mental health condition that impairs his or her judgement. The patient must make two oral and one written requests for the medication, and at least 15 days must elapse between the first and the final request. Physicians are not obligated to participate in PAS. Population and geography of Oregon Oregon occupies 96 000 square miles and borders the Pacific Ocean. Of the 3.3 million residents of Oregon, 1.4 million live in the Portland Metropolitan Area.5 Many of Oregon's counties are sparsely populated — half of the counties are east of the Cascade Range, yet this area contains only one city of at least 20 000 people.5 Many people living in eastern Oregon are a 5-7-hour drive from Portland or another metropolitan area. The number of people using PAS In the first three years of operation of Oregon's law (1998-2000), 70 people legally took medication to end their lives. Although the number increased from 16 in year one to 27 in years two and three, only about two people per month, on average, are using PAS,1 and only 0.07% of Oregonians die of PAS in a year.6 By comparison, around 545 people per month die of cancer in Oregon.7While the United States and the Netherlands are not directly comparable to one another, it is noteworthy that in the Netherlands about 2.4% of all deaths are from euthanasia and 0.3% from PAS.8 In Oregon, approximately 10% of all requests for PAS result in the person taking the medication to end their life, whereas in the Netherlands about a third of the requests result in death by euthanasia or PAS.9,10 In Australia, despite threats that physicians participating in euthanasia would be legally culpable, in the nine months that euthanasia was legal in the Northern Territory (from July 1996 to March 1997) four people died by this means,11 representing 0.7% of all deaths in the Northern Territory during that time.12 I must emphasise that my focus is on legal PAS in Oregon. Illegal PAS and euthanasia probably still occur, although their extent is unknown. Reasons for terminally ill people not using PAS One reason why so few people may have taken medication to end their lives is that an individual must wait at least 15 days after making the initial request to receive medication. This makes it difficult for people to use PAS on a whim. Terminally ill individuals have mentioned that the process one needs to go through to finally receive the medication can be quite burdensome (because of the waiting period, the need to get two physicians to confirm that the patient has a life expectancy of less than six months, and the requirement that the patient must get two people to witness the written request for the lethal medication).9 Approximately 30% of patients requesting a prescription may die before completing the requirements of the law.9Recent improvements in palliative care in Oregon13 may have allowed some people to die in relative comfort without having to hasten their death. Oregon has one of the highest rates of hospice admission and morphine usage per capita in the United States.14 It is estimated that about 45% of the patients for whom a substantive intervention is made will change their minds about wanting a prescription for a lethal medication.9 Just knowing that they can receive medication to end their life, if desired, is comfort enough for some individuals15 — the Oregon Health Division statistics show that 19 people who eventually died of their underlying illness had had the medication but not used it.1 Some people may be unable to swallow the medication themselves and thus can not use PAS.4 Others may fear that even if they swallow all the medication it may not kill them,16 and thus they do not attempt PAS. The above factors notwithstanding, I believe the most important reason for the limited use of PAS is that this service is not readily accessible to many Oregonians. Approximately 60% of the patients had to go to more than one physician before finding one who would write the prescription.1 The Oregon Health Division reported that only a fifth of physicians of control patients dying of similar terminal illnesses would have prescribed a lethal medication if asked,2 and, in a study of Oregon physicians, Ganzini et al9 found that only 16% of those asked actually wrote a prescription. The Veterans Affairs system, the Indian Health Services system and a major Catholic healthcare system do not allow PAS in their facilities.3 Some physicians willing to prescribe the medication have had difficulty finding a second physician to confirm the prognosis or a pharmacist willing to fill the prescription.9 Some physicians fear being penalised if they prescribe a lethal medication. In November 1997 Thomas Constantine, head of the US Drug Enforcement Administration, stated that if physicians prescribed a lethal medication to end a person's life it would be a violation of federal law.17 Then, in June 1998, United States Attorney General Janet Reno ruled that physicians in Oregon could legally write such a prescription.18 (This may be one reason why the number of people using PAS was higher in 1999 than in 1998.) However, the US Congress is now considering a bill that would make it illegal for physicians to prescribe a controlled substance to end a person's life. Consequently, some physicians may consider it risky to write such a prescription, particularly as to do so remains against professional guidelines.9,19 People residing in small cities, particularly those in eastern Oregon who are 75-400 miles from Portland or another metropolitan area, may be severely disadvantaged in getting access to PAS. Ganzini et al9 found that it was extremely rare for physicians practising in areas of fewer than 25 000 people (94% of Oregon's cities have fewer than 25 000 people5) to prescribe the medication. Physicians who do not have a large population base from which to draw patients may fear that if they participate in assisted suicide they could be the target of demonstrations outside their homes and offices, similar to those directed at physicians who perform abortions.20 Two-thirds of the physicians writing a lethal prescription expressed concern about reporting the fact to the Oregon Health Division.9 Because many terminally ill people are confined to their bed or home, the difficulty of finding a physician to prescribe the medication may result in many people abandoning the idea of using PAS as an end-of-life option. Conclusion Although PAS is legal for terminally ill people in Oregon, relatively few appear to have used medication to end their lives. The process of finding a physician willing to write the prescription, fulfilling all the legal requirements and finally receiving the medication can be time consuming, and perseverence is required. Once diagnosed with a serious or terminal illness, patients should probably start looking for a physician who is willing to prescribe a lethal medication if necessary. Without adequate planning for the possibility of using PAS, some terminally ill Oregonians may be unable to take medication to hasten their death. References Oregon's Death with Dignity Act: three years of legalized physician-assisted suicide. Portland, OR: Oregon Health Division, 22 February 2001. Sullivan AD, Hedberg K, Fleming DW. Legalized physician-assisted suicide in Oregon - the second year's experience. N Engl J Med 2000; 342: 598-604. Chin AE, Hedberg K, Higginson GK, Fleming DW. Oregon's Death with Dignity Act: the first year's experience. Portland, OR: Oregon Health Division, 18 February 1999. Haley K, Lee M, editors. The Oregon Death With Dignity Act - a guidebook for health care providers. Portland, OR: Oregon Health Sciences University, 1998. Wineberg H. Population estimates for Oregon: July 1, 1997. Portland, OR: Center for Population Research and Census, 1998. Center for Health Statistics. Oregon vital statistics annual report, 1997. Volume 2: Mortality. Portland, OR: Oregon Health Division, 2000. Center for Health Statistics. Oregon vital statistics county data 1998. Portland: Oregon Health Division, 2000. 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. Ganzini L, Nelson HD, Schmidt TA, et al. Physicians' experiences with the Oregon Death with Dignity Act. N Engl J Med 2000; 342: 557-563. Van der Maas PJ, Van Delden JJM, Pijnenborg L, Looman CW. Euthanasia and other medical decisions concerning the end of life. Lancet 1991; 338: 669-674. Kissane DW, Street A, Nitschke P. Seven deaths in Darwin: case studies under the rights of the Terminally Ill Act, Northern Territory, Australia. Lancet 1998; 352: 1097-1102. Australian Bureau of Statistics. Deaths, Australia. Canberra: ABS, 1996, 1997. (Catalogue No. 3302.0). <http://www.abs.gov.au>. Lee MA, Tolle SW. Oregon's assisted suicide vote: the silver lining. Ann Intern Med 1996; 124: 267-269. Tolle SW. Care of the dying: clinical and financial lessons from the Oregon experience. Ann Intern Med 1998; 128: 567-568. Muskin PR. The request to die: role for a psychodynamic perspective on physician-assisted suicide. JAMA 1998; 279: 323-328. Groenewoud JH, Van der Heide A, Onwuteaka-Philipsen BD, et al. Clinical problems with the performance of euthanasia and physician-assisted suicide in the Netherlands. N Engl J Med 2000; 342: 551-556. Hill GK, Barnett J. Push is on to assess DEA clout on suicide. Oregonian November 13, 1997: D1, D5. Hogan D. Bills blocking assisted suicide continue to move. Oregonian July 25, 1998: B1, B3. Lee MA, Ganzini L, Brummel-Smith K. When patients ask about assisted suicide: a viewpoint from Oregon. West J Med 1996; 165: 205-208. Lee MA, Tolle SW. Oregon plans to legalise suicide assisted by a doctor: how much more open will the practice become? BMJ 1995; 310: 613-615. Authors' details Portland, Oregon, USA. Howard Wineberg, PhD, Private consultant. Reprints will not be available from the author. Correspondence: Dr H Wineberg, 1513 SE Oak Street, Portland, Oregon, USA 97214-1454. wineberghAThotmail.com Make a comment

Howard Wineberg

The Research Enterprise Australian medical patents granted in the United States in 1984-1999 Eugen Mattes and Michael C Stacey MJA 2001; 174: 83-87 Abstract - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - More articles on Law Abstract Objective: To describe all medical patents granted in the United States to Australian-resident inventors between 1984 and 1999. Data sources: All patent data originated from the US Patent and Trademark Office. Data for 1984-1994 were compiled by CHI Research Inc, and data for 1995-1999 were obtained from the Community of Science website. Main outcome measures: Number of medical patents granted in the US to Australian-resident inventors; assignees (owners) of these medical patents; proportion of these medical patents related to biotechnology. Results: From 1984 to 1999, 7835 utility patents were granted in the US to Australian-resident inventors. Of these, 1308 patents (17%) were identified as medical patents; 489 (37%) of these were biotechnology patents. Medical patents account for an increasing proportion of all US patents granted to Australian inventors, increasing from 10% in 1984 to 25% in 1999. Biotechnology accounted for an increasing proportion of medical patents, rising from 10% to 55% between 1984 and 1999. More than half the medical patents are owned by commercial interests, and 33% by only 14 organisations, six of which are universities and their affiliated institutions. Conclusion: Only a few organisations account for most of the patenting of medical technology. The inventors and their organisations listed on medical patents could be canvassed when developing government policy and targeted for support in commercialising their medical technology. Interest in harnessing the economic value of medical technology conceived and created in Australia has been growing.1-3 This is reflected in the creation of Cooperative Research Centres (CRCs). Since 1991, 67 CRCs have been created, of which 10 have a medical focus.4 Despite these initiatives, medical inventors, unlike sports stars, are virtually unrecognised by the Australian public and scientific community. Where do our new technologies in medicine come from -- industry, universities, or the lone inventor? We chose to study all patents for inventions (utility patents) granted in the United States to Australian residents. These patents are economically more significant than patents granted in Australia, as the increased cost and effort of patenting in another country is thought to filter out trivial inventions.5 Because of the importance of the US market, the US is also the first country where multinational corporations submit their patent applications outside the patent's country of origin.6 Thus, Australian patents in the US are arguably the most important subset of Australian patents in other countries.7 Our aim was to describe Australian medical patents and to compare them with non-medical patents. Methods This is a descriptive study of patents granted in the US from 1984 to 1999 to inventors resident in Australia. Utility patents were examined, with design and plant patents excluded. Sources of data All patent data originated from the US Patent and Trademark Office. US patents listing one or more Australian-resident inventors for 1984-1994 were compiled by Computer Horizons Incorporated (CHI) Research Inc8 of the US and, for 1995-1999, were updated from the Community of Science website.9 Our electronic patent database contained the following information for each patent: year of patent being granted; US patent registration number; title of patent; all listed inventors and assignees and their country of residence; and number of citations of scientific literature. When required for classifying patents, the patent abstracts or full patents were examined on the Internet (using the US patent registration number) at either the US Patent and Trademark Office Web Patent Database Centre,10 or the Delphion (formerly IBM) Intellectual Property Network.11 Categorisation of medical patents As there are no published guidelines for selecting medical patents, we defined a medical patent as any technology used for: managing patients and their illnesses, such as drugs, diagnostic tests, surgical instruments, and rehabilitation devices (dental technologies were excluded); preventing illness, such as sunscreen lotion; or medical research, such as laboratory instruments. Generic technologies used in other fields, such as information technology, were excluded. Patents were classified as medical, possibly medical or non-medical after reading the title and the name of the assignees (owners). For all patents labelled as possibly medical, we read the abstract, and if necessary the complete patent, to properly classify the patent. Medical patents related to biotechnology12 were identified separately, and included devices, processes, DNA sequences, transgenic animals and manufacturing processes in the medical industry. Biotechnology patents related to other industries, such as agriculture, mining and food processing, were excluded. Describing inventors and assignees The inventors and assignees on patents were sorted alphabetically in Microsoft Excel,13 and any errors or differences in spelling were corrected. The median number of inventors and assignees per patent was calculated as a measure of collaboration. The assignees on each patent were categorised as a business, university, government, research institute, CRC, non-government organisation, technology transfer office, or individual. Categorising was usually straightforward using the name of the assignee, but, if there was uncertainty, a search was made on the Internet using the search engine Dogpile.14 Data analysis The data were stored, tabulated and graphed in Microsoft Excel,13 and statistical analysis was conducted using SPSS for Windows.15 The χ2 test or Fisher's exact test was used to compare independent proportions. The Mann-Whitney U test was used to compare medians. Ethical issues All the information in this study, including the names of inventors and companies, is publicly available on numerous patent bibliographic databases. Results From 1984 to 1999, 7835 utility patents were granted in the US to Australian-resident inventors. From examination of the title and assignee names of these patents, 9% (673/7835) were classified as medical and 35% (2767/7835) as possibly medical. The abstracts of all patents classified as possibly medical were examined, and 11% (869/7835) required the full patent to be read. In total, 1308 (17%) Australian patents in the US were classified as medical. Of these, 489 (37%) were biotechnology patents. Trends in medical patenting The annual number of patents granted in the US to Australian-resident inventors in 1984-1999 more than doubled, rising from 310 to 800 (Box 1). During this 16-year period, the proportion of medical patents rose from 10% (30/310) to 25% (202/800). Biotechnology accounted for an increasing proportion of medical patents, rising from 10% (3/30) to 55% (112/202) over the same period. Comparison of medical and non-medical patents In terms of inventors, medical patents were: more likely to have multiple inventors listed, with a median of two inventors per medical patent versus one per non-medical patent (P < 0.001, Box 2); and twice as likely to be part of an international collaboration, with co-inventors who are residents of other countries in 21% (275/1308) of medical and 10% (649/6527) of non-medical patents (P < 0.001, Box 3). Most US patents listing Australian inventors have either an Australian inventor or assignee owning the patent (68% for medical and 81% for non-medical patents) (Box 3). The technology most likely to arise from another country is that owned by an assignee in another country and listing an inventor from another country. Thus, 15% of medical and 7% of non-medical patents in our study may have originated outside Australia (Box 3). Patents are either assigned, usually to an organisation, or unassigned (thus owned by the inventor). We found 82% of medical patents were assigned, compared with 69% of non-medical patents (P < 0.001, Box 2). For assigned patents, both medical and non-medical patents usually have one assignee (Box 2). For these assigned patents, there were three large differences, with medical patents being (Box 4): less likely to be owned by a business; four times more likely to be owned by a university; and 40 times more likely to be owned by a research institute. Both medical and non-medical patents are increasingly owned by business and universities, with fewer being unassigned. From 1984 to 1999, patents assigned to business increased from 49% to 63%; patents assigned to universities increased from 2% to 7%; and unassigned patents decreased from 36% to 20% of all patents. Medical patents were three times as likely as non-medical patents to quote from published scientific articles. Sixty per cent (785/1308) of medical patents cited one or more scientific publications, compared with only 23% (1475/6527) of non-medical patents (P < 0.001). Characteristics of medical patents Most of the 1785 medical inventors are not prolific, with 67% (1200/1785) listed only once in 1984-1999. About 18% (318/1785) of medical inventors are listed on three or more medical patents. However, the 17 most prolific medical inventors (Box 5) were responsible for 13% (169/1308) of Australian medical patents. Eleven of these prolific inventors are clustered around four different technologies: electromedical devices (cardiac pacemakers and cochlear ear implants), biosensors, ribozymes, and the relaxin gene. Just 14 organisations own 33% (438/1308) of medical patents; six of these organisations are Australian universities and their affiliated institutions (Box 6). Surprisingly, 20% (264/1308) of medical patents were owned by just five organisations: the University of Melbourne, Telectronics, the Commonwealth Scientific and Industrial Research Organisation (CSIRO), Biotech Australia, and the University of New South Wales. The three most common types of medical technologies are cardiac pacemakers (7%), syringes or parenteral drug delivery technology (4%), and cochlear ear implants (3%). Discussion Principal findings We believe that this is the first published report that has examined Australian medical patents in detail. Australia, like all countries of the Organisation for Economic Co-operation and Development (OECD), has shown a strong rise in the number of US patents granted per capita since the 1960s.5,16 However, Australia is still ranked a low 16 of 20 OECD countries,7 with only a modest increase in the proportion of utility patents granted to Australian inventors in the US during 1984-1999 (from 0.46% [309/67200] to 0.52% [800/153492]16). As expected, Australia's comparative technological advantage is found mainly in mining and agriculture. This is similar to other resource-abundant OECD countries like Canada, Finland and Norway.5,7 However, our study, along with others,7,17 indicates a shift in Australia to patenting in higher technologies. Our study suggests that medical technology, especially medical biotechnology, is an increasingly important part of Australia's intellectual property portfolio. This may explain why Australia appears to be developing a technological advantage in biotechnology and pharmaceuticals.17 To place this trend in a global perspective, our study would need to be repeated for other, especially OECD, countries. There is a dip in the total number of US patents granted to Australian inventors from 1990 to 1993 (Box 1), possibly reflecting the economic recession at the time. Interestingly, the trend in medical and medical biotechnology patents did not show this decrease, suggesting that development of such technology may be more resistant to downturns in the economy. Another feature was the 51% jump in the number of US patents granted to Australian inventors from 1997 to 1998 -- possibly a flow-on from the 54% increase in the number of patent applications filed by Australians in the US between 1994 and 199818 (noting that it usually takes two years from lodging a patent application until it is granted19). This trend coincides with increased research and development spending in Australia, particularly by business (which unfortunately declined in 1996-97).20 However, these changes may also reflect increased processing of patent applications by the US Patent and Trademark Office7 -- the overall number of utility patents issued jumping 32% from 111 983 in 1997 to 147 520 in 1998.16 Our study lends support to recent findings of the importance of university-based research in underpinning high-technology patents and industries.1,21 Universities and their affiliated institutions: make up more than a third of the most prolific patenting organisations; own an increasing proportion of US patents granted to Australian inventors; and are the source of 97% of the scientific articles cited in Australian medical patents.17 These findings could be the result of Australian governments actively encouraging universities to fund and commercialise research and develop links to industry. The CRCs were part of such initiatives, but the fact that only eight patents are owned by CRCs suggests that they are not very productive in commercialising research. However, this is difficult to judge, as the patents may be assigned to commercial or university partners. Our data also support the emerging ideas on the importance of clusters of co-located industries and universities where collaboration and competition act as constant spurs to innovation, such as is seen in Silicon Valley in California.21 In Australia, such clusters appear to be growing in Melbourne and Sydney for industries in biotechnology and electromedical devices. This is demonstrated by examining the prolific inventors and their assignees, indicating varied links between industry and publicly funded institutions. Strengths and weaknesses of the study Possible weaknesses in our study relate to three areas of potential misclassification in our patent data. Classification of country of origin: We classified patents as Australian if any inventor was an Australian resident. This may result in the inclusion of technology originating in another country but which had an Australian inventor working on it (estimated to be about 15% for medical and 7% for non-medical patents). Definition of medical patents: Given the absence of any published guidelines, it could be debated whether certain technologies are really "medical" (such as those related to optometry and sunscreen lotions) and whether dental technologies should have been excluded. Classification of assignees as "business": Assignees with a business-type suffix (ie, "Pty Ltd", "Ltd", "Corp", "Inc", "NV", "AG" and "GMBH"), unless detected through searches on the Internet as belonging to another category such as a technology transfer organisation, would have been misclassified as a business. It is difficult to predict whether the first two potential biases could alter our conclusions. The third may lead to an overestimation of the number of patents owned by business. When identifying the country of origin of a patent, the main convention is to use the residency of the inventor16,17 rather than assignees, partly because a large proportion of patents are unassigned (29% in our study). Like other technology or innovation indicators, patent statistics have advantages and disadvantages.22,23 Our study treats all patents as being of equal importance; however, a patent's commercial value can vary enormously.23,24 Furthermore, patent data do not capture all new technology, as some may not be patentable, and patenting can vary with economic conditions and with the strategic concerns of companies.23,24 For example, patenting as a means of protecting intellectual property is very important for the pharmaceutical industry but of little relevance to the rubber industry.24 In addition, the difficulty when describing patents owned by business is that many are granted under the names of subsidiaries and divisions that are different from the names of parent companies. Some companies even actively hide emerging technologies under different company names, so-called "submarine" patents.5,25 Possible mechanisms and implications for policymakers Australia has a substantial and growing trade deficit in high-technology goods,21 making it more imperative to capture more of the economic value of Australian medical patents. But how? First, the more prolific medical inventors and their organisations could be canvassed when developing government policy which may impact on the commercialisation of medical technology. Such surveys could also identify emerging technologies, which may be the basis of new industries, enabling government to take an anticipatory stance on industry policy. Second, the medical inventors and assignees could be actively targeted with assistance in developing their medical technology. To foster the growing culture of enterprise and innovation within academia,4 it may be worth considering a reward for the prolific inventors and assignees. Such rewards may encourage other inventors and promote inventors as role models for other scientists. Acknowledgements We are grateful to Associate Professors Sam Garrett-Jones and Tim Turpin from the Centre for Research Policy at the University of Wollongong for providing the database of Australian patents in the US for 1984-1994, and to Ms Christine Porter, Manager of the European and Commonwealth Office, Community of Science, for providing free access to the US patents on their website. We would like to thank Dr Dora Marinova from ISTP at Murdoch University and Professor Jane Marceau, Pro Vice Chancellor (Research) at the University of Western Sydney Macarthur, for their valuable advice. Eugen Mattes was the recipient of an Eva K A Nelson Medical Research Scholarship from the University of Western Australia from 1995 to 1998 and an advanced academic registrar funded by the Royal Australian College of General Practitioners in 1999 and the Registrar Scholarship and Research Fund of the College in 2000. We also want to acknowledge the support of Professor Max Kamien and the Department of General Practice, University of Western Australia. We would also like to thank the reviewers for their helpful comments. References 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. The National Innovation Summit. <http://www.isr. gov.au/industry/summit/index.html> Accessed 24 February 2000. Biotechnology Australia. Developing Australia's biotechnology future. Discussion Paper. Canberra: Commonwealth of Australia, 1999. Mercer D, Stocker J (Steering Committee). Review of greater commercialisation and self funding in the Cooperative Research Centres Programme. Canberra: Department of Industry, Science and Tourism, 1998. Patel P, Pavitt K. Australia's technological capabilities: an analysis using US patenting statistics. Brighton: Science Policy Research Unit, University of Sussex, 1995. Bertin G, Wyatt S. Multinationals and industrial property: the control of the world's technology. Hemel Hempstead, Hertfordshire, England: Harvester-Wheatsheaf, 1988. Department of Industry, Science and Technology (DIST). Australian business innovation: a strategic analysis. Report No. 5. Canberra: AGPS, 1996. CHI Research Inc. <http://www.chiresearch.com/> Accessed 7 February 2000. Community of Science. US patents. <http://patents.cos.com/> Accessed 10 July 2000. US Patent and Trademark Office. USPTO Web Patent Database. <http://www.uspto.gov/patft/index.html> Accessed 7 February 2000. Intellectual Property Network. <http://www. delphion.com/home> Accessed 7 December 2000. National Science and Technology Council. Biotechnology for the 21st Century: New Horizons. Washington: USGPO, 1995. Available at <http://www.nal.usda.gov/bic/bio21>. Microsoft Excel 97 SR-2 [computer program]. Cambridge, Massachusetts: Microsoft, 1997. Dogpile. <http://www.dogpile.com/> Accessed 7 February 2000. SPSS for Windows [computer program]. Version 8.0. Chicago, Illinois: SPSS Inc, 1997. Patent counts by country/state and year. Utility patents. January 1, 1963 - December 31, 1999. Technology Assessment and Forecast (TAF) Program, Office for Patent and Trademark Information, US Patent and Trademark Office. <http://www.uspto.gov/web/offices/ac/ido/oeip/taf/ cst_utl.pdf> Accessed 10 July 2000. Narin F, Albert M, Kroll P, Hicks D. Inventing our future: the link between Australian patenting and basic science. <http://www.arc.gov.au/ publications/arc_pubs/00_02.pdf> Accessed 30 October 2000. Number of utility patent applications filed in the United States, by country of origin, calendar years 1965 to present. Technology Assessment and Forecast (TAF) Program, Office for Patent and Trademark Information, US Patent and Trademark Office. <http://www.uspto.gov/web/offices/ac/ido/oeip/taf/ appl_yr.pdf> Accessed 30 October 2000. Trilateral Statistical Report 1997. US Patent and Trademark Office. <http://www.uspto.gov/web/offices/ dcom/olia/trilat/tsr97/> Accessed 10 July 2000. Science and Technology Policy Branch of the Department of Industry, Science and Resources. Australian science and technology at a glance 2000. <http://www.isr.gov.au/science/analysis/glance2000/> Accessed 30 October 2000. Marceau J, Manley K, Sicklen D. The high road or the low road? Alternatives for Australia's future. Sydney: Australian Business Foundation; 1997. Patel K, Pavitt K. Paterns of technological activity: their measurement and interpretation. In: Stoneman P, editor. Handbook of the economics of innovations and technical change. Oxford: Blackwell, 1995; 14-51. Industry Analysis Branch of the Department of Industry, Science and Resources. Measuring the knowledge-based economy. How does Australia compare? Canberra: Commonwealth of Australia, 1999. Geroski P. Markets for technology: knowledge, innovation and appropriability. In: Stoneman P, editor. Handbook of the economics of innovation and technical change. Oxford: Blackwell, 1995; 90-131. Garrett-Jones S, Aylward D. Measuring linkages between basic scientific research and Australian industrial technologies using patent data. Wollongong: Centre for Research Policy, University of Wollongong, 1995. (Received 14 Jul, accepted 2 Nov, 2000) Authors' details University of Western Australia, Perth, WA. Eugen Mattes, MB BS, MPH, Advanced Academic Registrar, Department of General Practice, and PhD Scholar, Department of Surgery, Fremantle Hospital; Michael C Stacey, DS, FRACS, Associate Professor, Department of Surgery. Reprints will not be available from the authors. Correspondence: Dr E Mattes, Visiting Research Fellow, TVW Institute for Child Health Research, Division of Population Sciences, 100 Roberts Road, Subiaco, WA 6008. emattesATcyllene.uwa.edu.au Make a comment 1: Number of utility patents granted in the United States to Australian-resident inventors from 1984 to 1999 Back to text 2: The number of medical and non-medical patents granted in the United States to Australian-resident inventors between 1984 and 1999, and numbers of inventors and assignees (owners) Medical Non-medical Total Patents 1308 6527 7835 Inventors Number listed Number of individuals Inventors/patent (median)* 3270 1785 2 11127 7092§ 1 14397 8744¶ Assigned patents† 1068 (82%) 4533 (69%) 5601 Assignees Number listed Number of individual assignees‡ Assignees/assigned patent (median)* 1192 448 1 4909 2309 1 6101 2701¶ * The medians were significantly different (Mann-Whitney U test; P < 0.003). For assignees this is unlikely to be of practical significance. † Medical and non-medical groups are significantly different (Pearson χ2, P < 0.001). ‡After correcting errors or differences in spelling (16% of medical and 9% of non-medical assignees were either misspelt or spelt differently). § Calculated using ratio from medical patents: there were 1785 individual medical inventors after correcting the spelling of the initial list of 1878 individuals. So, for non-medical inventors, it was estimated that there were 7092=7461 x (1785/1878) individuals, assuming a similar 5% difference in spelling of the 7461 non-medical inventors listed initially. ¶Not equal to the sum of inventors or assignees on medical and non-medical patents, as 133 inventors and 56 assignees are on both types of patents. Back to text 3: The location of inventors and assignees for United States patents listing Australian inventors for 1984-1999 Location of inventors Location of assignees Medical Non-medical Australia Unassigned patents* Australia Australia and other countries Other countries* Subtotal 226 (17%) 660 (50%) 8 (1%) 139 (11%) 1035 (79%) 1942 (30%) 3357 (51%) 74 (1%) 505 (8%) 5878 (90%) Australia and other countries (international collaboration) Unassigned patents Australia* Australia and other countries* Other countries* Subtotal 14 (1%) 48 (4%) 22 (2%) 191 (15%) 275 (21%) 52 (1%) 114 (2%) 40 (1%) 443 (7%) 649 (10%) Total 1308 (100%) 6527 (100%) Global Pearson χ2 is significant (P <0.001.). * Significant difference between medical and non-medical patents (P <0.001). Back to text 4: Classifications of assignees listed on the 1068 medical and 4533 non-medical assigned US patents listing Australian-resident inventors for 1984-1999 Assignee Medical patents Non-medical patents Business* University* Research institute* Government* CSIRO Individual* Technology transfer organisation Non government organisation† Cooperative research centre Total 700 (59%) 206 (17%) 97 (8%) 70 (6%) 60 (5%) 30 (2.5%) 22 (1.8%) 6 (0.5%) 1 (0.1%) 1192 (100%) 3913 (80%) 181 (4%) 8 (0.2%) 195 (4%) 272 (6%) 257 (5%) 69 (1%) 7 (0.1%) 7 (0.1%) 4909 (100%) Global Pearson χ2 is significant (P <0.001). Pairwise comparisons were done using Pearson χ2, except where Fisher's exact test was needed when an expected count was less than 5. *Significant difference between medical and non-medical patents (P <0.004). †Significant difference between medical and non-medical patents (P=0.027). CSIRO=Commonwealth Scientific and Industrial Research Organisation. Back to text 5: The 17 most prolific Australian medical inventors listed on 10 or more Australian medical patents in the US for 1984-1999, grouped by technology Main technology Inventor Number of patents Main assignees Method for constructing proteins and other molecules Simpson R 18 Ludwig Institute for Cancer Research, US Cardiac pacemakers and cochlear ear implants Money D Kuzma J Daly C Milijasevic Z 15 12 10 10 Telectronics Pty Ltd, NSW, and Cochlear Pty Ltd, NSW Biosensors Cornell B Braach-Maksvytis V Raguse B 14 13 10 Australian Membrane and Biotechnology Research Institute, NSW Ribozymes - gene shears Jennings P Cameron F 14 (1) 11 Gene Shears Pty Ltd, NSW and ACT Vitamin B12 as carrier for oral drugs Russell-Jones G 14 (1) Biotech Australia Pty Ltd, NSW Intraocular lenses Barrett G 13 Alcon Laboratories Inc, and Chiron, US, and Oversby Pty Ltd, WA Relaxin gene Tregear G Niall H 13 (1) 10 (1) Howard Florey Institute, VIC Syringe or drug infusion devices Whisson M 12 Eastland Technology Australia Pty Ltd, WA Matrix metalloprotease inhibitors Grobelny D 10 Glycomed Inc, US, and Narhex Ltd, Hong Kong Contact lenses Meijs G 10 (6) CIBA Vision Group, US Back to text 6: The most prolific assignees listed on 15 or more Australian medical patents in the United States for 1984-1999 Assignee Medical Non-medical Total University of Melbourne and affiliated institutions 76 28 104 Telectronics NV or Telectronics Pty Ltd or Telectronics Pacing Systems Inc 75 0 75 CSIRO 60 272 332 Biotech Australia Pty Ltd 28 3 31 University of New South Wales and affiliated institutions 25 51 76 Australian National University and Anutech Pty Ltd 23 30 53 University of Sydney 22 26 48 Monash University and affiliated institutions 21 8 29 AMRAD Corp Ltd 21 3 24 Ludwig Institute for Cancer Research* 21 0 21 University of Queensland and Queensland Institute of Medical Research (QIMR) Council 20 18 38 Cochlear Pty Ltd 16 0 16 Commonwealth of Australia 15 87 102 Gene Shears Pty Ltd 15 0 15 Total 438 526 964 *16 of the 21 patents originated from the Melbourne branch (Dr C Thumwood, Scientific Administrator, Ludwig Institute for Cancer Research, personal communication). Back to text

Eugen Mattes · Michael C Stacey

Cracking the code Cracking the code: how will the Human Genome Project affect life as we know it? " I have seen the Devil in my microscope and I have chained him . . . The Devil . . . is nothing more than a tiresome collection of genes" (Marlon Brando as Dr Moreau in The Island of Dr Moreau; New Line Productions, 1996) MJA 2000; 173: 590 Thus says the scientist who plays God in a film adaptation of H G Wells's novel The island of Dr Moreau.1 As envisioned by Wells in the late 19th century, Moreau used vivisection in attempting to create the perfect human. A hundred years later, movies have turned to gene therapy. Fiction has given voice to some of our worst fears of science and technology out of control. It is therefore not surprising that, as the massive international effort of the Human Genome Project completes the sequencing of the human genome, the hype and hope have been blunted by legitimate concern about the potential for abuse of this technology. Cracking the DNA code is only the beginning. The challenges which lie beyond include detecting the clinical significance of variations in genetic sequences, identifying different functions of DNA, RNA and other molecular systems in the cell, and unravelling the complexities of gene-gene and gene-environment interactions.2,3 The tasks ahead are fraught with difficulties not just technical in nature -- ethical, legal and social implications are yet to be worked through.3 For the clinician, cracking the code will affect everyday practice in the not-too-distant future. Disease taxonomy will evolve from phenotype or clinical descriptors to genotype and molecular labelling.3 Recognising genetic variants which increase a person's susceptibility to certain diseases will lead to practical interventions which may be pharmacological (the burgeoning field of "pharmacogenetics"), environmental or behavioural.4 Picture these patients in a day's consultation: Guanosino, a 28-year-old with newly diagnosed type 2 diabetes mellitus and hypercholesterolaemia, consents to genetic analysis to determine his risk of further cardiovascular morbidity after routine genetic counselling. From a blood-spot sent to the laboratory, he is found to have a genetic mutation of the peroxisome proliferator-activated receptor gamma molecule, predictive for a severe form of diabetes.5 This leads you, his doctor, to advocate more aggressive treatment, including lifestyle measures and a new drug targeted specifically at this molecule. Guanosino also carries a variant cholesteryl ester transfer protein gene which lowers high-density lipoprotein cholesterol levels -- fortunately, treatment with pravastatin has been shown to retard the progression of coronary atheroma in such patients.6 Cytosina has been diagnosed with epilepsy and has come for the results of a metabolic screen for her genetic variants. The readout showing Cytosina's predictive profile for anticonvulsants enables you to prescribe the anticonvulsant to which she is most likely to respond and least likely to develop an adverse reaction, at the exact dose required for efficacy and her metabolism. True individual tailoring of therapy is now possible! Thymidinos has tinea of the toenails -- his blood-spot test shows genetic polymorphism of one of his cytochrome P450 enzymes, indicating that, should he take the preferred antifungal agent, his usual dose of antidepressant will need to be reduced to prevent toxicity.7 Adenina wonders whether she should take the Pill -- her mother once had a clot in the leg after surgery and was told never to take the Pill. Genetic susceptibility testing reveals Adenina has a prothrombin-gene mutation which greatly increases her risk of cerebral and deep-vein thrombosis, and, as the Pill would raise the risk even further, it is contraindicated.8 You spend the rest of the consultation discussing other forms of contraception and prevention of thromboembolic events. We asked people from diverse fields to explore the issues related to this genetic New World. What do two geneticists, a sociologist, a High Court judge and a politician have to say on the matter? No crystal ball gaze is complete without a reminder of how far we have come, and this journey is recounted by geneticist Ron Trent.9 And, back to the future, is eternal youth within our grasp? Geneticist Grant Sutherland speculates on the possible defeat of pathology, pathogens and the process of ageing,10 while sociologist Riaz Hassan ponders the socioeconomic impact of living longer.11 Michael Kirby and Natasha Stott Despoja take on the thorny ethical12 and legislative issues.13 Fiction may be overtaken by fact in the future, but it is more than likely the Human Genome Project will reaffirm that what constitutes humanity is much more than "a tiresome collection of genes". Mabel Chew Deputy Editor, MJA Wells HG. The Island of Dr Moreau. London: Heinemann, 1960. Cardon LR, Watkins H. Waiting for the working draft from the human genome project. BMJ 2000; 320: 1223-1224. Zimmern RL. The human genome project: A false dawn? BMJ 1999; 319: 1282. van Ommen GJB, E Bakker, den Dunnen JT. The Human Genome Project and the future of diagnostics, treatment, and prevention. Lancet 1999; 354 (suppl 1): 5-10. Barroso I, Gurnell M, Crowley VEF, et al. Dominant negative mutations in human PPARgamma associated with severe insulin resistance, diabetes mellitus and hypertension. Nature 1999; 402: 880-883. Kuivenhoven JA, Jukema JW, Zwinderman AH, et al. The role of a common variant of the cholesteryl ester transfer protein gene in the progression of coronary atherosclerosis. N Engl J Med 1998; 338: 86-93. Nebert DW. Polymorphisms in drug-metabolising enzymes: What is their clinical relevance and why do they exist? Am J Hum Genet 1997; 60: 265-271. Martinelli I, Sacchi E, Landi G, et al. High risk of cerebral-vein thrombosis in carriers of a prothrombin-gene mutation and in users of oral contraceptives. N Engl J Med 1998; 338: 1793-1797. Trent RJA. Milestones of the Human Genome Project: genesis to post genome. Med J Aust 2000; 173: 591-594. Sutherland GR. Just how long can we live? Med J Aust 2000; 173: 594-596. Hassan R. Social consequences of manufactured longevity. Med J Aust 2000; 173: 601-603. Kirby MD. The Human Genome Project in the dock. Med J Aust 2000; 173: 599-600. Stott Despoja N. The Human Genome Project: how do we protect Australians? Med J Aust 2000; 173: 596-598.

Mabel Chew

In June this year, United States President Clinton and British Prime Minister Blair jointly announced that the human genome had been sequenced. In another year or so, this information should be assembled into a much more useful form than that in which it now exists. The advances which will be made possible by the Human Genome Project and new genetic technologies may well extend the human life span still further. MJA 2000; 173: 594-596 Genetic susceptibility to common diseases - Cancer - Infectious disease - Aging genes - A longer life? - Acknowledgements - References - Authors' details - - More articles on Genetics The Human Genome Project will not be completed, in my view, until the functions of all human genes have been determined, knowledge of genetic variation between individuals is documented, and interaction between genes and between each gene and the environment and the contributions of these factors to human development and disease are established. This may take much of the coming century; however, substantial amounts of information of major importance to health and wellbeing have begun to emerge. In Australia, life expectancy rose by a little more than 20 years for males and 22 years for females in the 20th century (Box 1). Similar rises were recorded in most countries in which Western medicine was fairly readily accessible. This increase was achieved without input from the Human Genome Project, and involved factors that improved the environment (eg, sanitation, seat belts), as well as medical factors such as vaccines and antibiotics. How can the outcomes of the Human Genome Project be expected to eventually affect life expectancy? Genetic susceptibility to common diseases There are more than 100 relatively common diseases for which there are susceptibility genes present in the population (Box 2). Each of these genes may have only a small effect, but the additive actions of unknown numbers of such genes and their interactions with often unrecognised environmental factors lead to disease. Almost all these common diseases can shorten life, and many will be direct causes of death. Major academic and industrial research efforts are currently aimed at identifying susceptibility genes for these diseases.1Genes that confer a marked increase in risk of a common disease are fairly easy to find using standard genomic and molecular genetic approaches. Good examples of such genes are BRCA1 and BRCA2 for breast/ovarian cancer, and the DNA mismatch repair genes which lead to non-polyposis colorectal cancer. Although these genes are extremely important for those families in which they are present, heritable variations in them appear to be minor causes of the common diseases, accounting for less than 5%-10% of cases. Many susceptibility genes, which may only individually increase or decrease a baseline risk of disease by a few percent, are very difficult to identify using current approaches. This might change as a result of the Human Genome Project. There are two emerging technologies for the identification of susceptibility genes: SNP typing and DNA microarrays (Box 3).2 During the next few decades, these two approaches (and possibly new ones) should identify most of the susceptibility genes for most common human diseases. Once an understanding of the genetic basis of susceptibility is obtained, intervention should be possible. Many of the protein products of susceptibility genes will be novel targets for the development of new drugs that may either delay the onset of disease, or treat it once it is present, or both. There will be opportunities to identify, before starting treatment, the most appropriate treatment to use. This will be based both on an understanding of the genetic variations contributing to disease and on genetic variations that will determine drug side effects, dose and efficacy. Environment is certainly a key factor in much common disease, even if the environmental factors that are important for any particular disease are not known at all or are poorly understood. Once susceptibility genes are found, further research may identify the environmental factors that interact with them to increase the risk of disease onset. Public health education aimed at lifestyle changes may be targeted to genetically susceptible people, and be more likely to be heeded than education aimed at the whole population. Once genes are identified, diagnostic and therapeutic regimens will be developed. Then combinations of drug treatment, environmental modification (ie, lifestyle changes) and possibly even gene therapy will be able to delay onset of disease and provide effective treatment once onset occurs. Cancer Cancer at the cellular level is a genetic disease. The US National Cancer Institute has established a Cancer Genome Anatomy Project (http://www.ncbi.nlm.nih.gov/ncicgap), which will delineate the genetic changes in cancer cells at a whole-genome level. Understanding the cellular mechanisms of cancer will surely improve disease classification and prognostication and provide many therapeutic opportunities, including choice of the most appropriate treatment. Eventually cancer may be no more of a threat to life than is the common cold. Infectious disease Infectious diseases are still major causes of death, mainly in Third World countries, but also (although perhaps to a lesser extent) in First World countries. Genetic techniques have the potential to prevent these diseases through DNA-based vaccines, as well as to provide new treatments. Genomic approaches to infection will lead to tests for rapid identification of infecting organisms, allowing early commencement of specific therapy. In addition, DNA microarray analysis of gene expression in human macrophages is likely to identify infecting organisms that are resistant to culture or can not be identified by other means. The genomes of most common human pathogens (including viruses, bacteria and parasites) have already been sequenced. These genome sequences are providing a range of new targets for the development of novel antibiotics, antiviral and antiparasitic agents. The spectre of multiple drug-resistant bacteria should soon fade. However, we are likely to have to cope with the common cold and, more seriously, HIV, for a long time, until there are new approaches to dealing with highly mutable viruses. Aging genes Genes involved in the aging processes in simple organisms have been identified;7 however, in mammals, the only intervention shown to delay aging is caloric restriction,8 and the molecular mechanisms by which this acts are just beginning to be unravelled.9I think it unlikely that knowledge of the genetic basis of aging will lead to widespread anti-aging therapy in humans. However, this view could be proven wrong and aging genes, when identified, may be targets for the development of anti-aging drugs. If (when) gene therapy becomes relatively simple and safe, there may be ways to modify the actions of aging genes. A longer life? From anecdotal press reports we learn of rare individuals who live for about 120 years. Is this a genetically programmed maximum human lifespan? If it is, why can not most of us achieve it? Barring accidents (and there may be genes that promote risk-taking behaviours) or suicide (and there are certainly susceptibility genes here, possibly for suicide itself and certainly for a number of the psychiatric disorders that too frequently lead to suicide), we mostly die of common or infectious diseases before reaching 120 years. With mastery to be gained over many of our pathogens and with strategies to treat or to delay the onset of common diseases (including cancer), it is likely that the 21st century will see a similar increase in life expectancy to that witnessed in the 20th century. To be even more speculative, tinkering with our aging genes could add yet another 20 years in the 22nd century and get most of us up to or beyond 120 years of age. Unfortunately, none of the readers of this article will ever know the outcome of this speculation. And, if it is correct, the 120-year-olds had better be sprightly, as there may be standing room only on a grossly overpopulated planet. Acknowledgements I thank Dr Eric Haan and Dr John Mulley for constructive criticism of an earlier draft of this article. References Collins FS. Shattuck lecture -- medical and societal consequences of the Human Genome Project. N Engl J Med 1999; 341: 28-37. Young RA. Biomedical discovery with DNA arrays. Cell 2000; 102: 9-15. Martin ER, Lai EH, Gilbert JR, et al. SNPing away at complex diseases: analysis of single-nucleotide polymorphisms around APOE in Alzheimer disease. Am J Hum Genet 2000; 67: 383-394. Kruglyak L. Prospects for whole-genome linkage disequilibrium mapping of common disease genes. Nat Genet 1999; 22: 139-144. Celera Genomics launches SNP reference database product with more than 2.8 million unique SNPs [press release]. <http://www.pecorporation.com/press/ prccorp091300.html>. Accessed 14 November 2000. DeRisi JL, Iyer VR, Brown PO. Exploring the metabolic and genetic control gene expression on a genomic scale. Science 1997; 278: 680-686. Vanfleteren JR, Braeckman BP. Mechanisms of life span determination in Caenorhabditis elegans. Neurobiol Aging 1999; 20: 487-502. Weindruch R, Walford RL. The retardation of aging and disease by dietary restriction. Springfield, Illinois: CC Thomas, 1988. Campisi J. Chromatin and food restriction -- connecting the dots. Science 2000; 289: 2062-2063. Authors' details Department of Cytogenetics and Molecular Genetics, Women's and Children's Hospital, Adelaide, SA. Grant R Sutherland, AC, FAA, FRS, Professor and Director. Reprints will not be available from the author. Correspondence: Professor G R Sutherland, Department of Cytogenetics and Molecular Genetics, Women's and Children's Hospital, 72 King William Road, North Adelaide, SA 5006. gsutherlandATmedicine.adelaide.edu.au Make a comment 1: Life expectancy at birth for males and females born in Australia during the 20th century. Source: Australian Bureau of Statistics (www.abs.gov.au). Copyright in ABS data resides with the Commonwealth of Australia. Used with permission. Back to text 2: Some common diseases for which there is evidence for genetic susceptibility Arthritis Asthma Bipolar disorder Breast cancer Cardiovascular disease Colon cancer Depression Diabetes Endometriosis Epilepsy Hypertension Melanoma Schizophrenia Toxaemia of pregnancy And if you can't remember all these, Alzheimer disease is also in the group. Back to text 3: Emerging technologies for identifying disease-susceptibility genes SNP (single nucleotide polymorphism, pronounced "snip") typing is yet to be widely applied. In principle, typing large numbers of SNPs, perhaps up to 500 000 per individual, on large groups of patients with the same common disease will reveal clusters of SNPs that overlay susceptibility genes.3 This process is known genetically as looking for linkage disequilibrium.4 Celera Genomics recently announced that it had a database of 2.4 million proprietary SNPs, and had gleaned another 0.4 million from public databases, and, for a fee, this collection could be viewed, and presumably used to help find genes for common diseases.5 DNA microarrays come in several guises. One form contains very large numbers of DNA samples spotted at high density on glass slides. Most work to date has used arrays of the yeast genome -- all the genes of this organism can be displayed on a 2 cm x 2 cm area of glass.6 Arrays can then be used to determine which genes are active in any tissue, or the relative levels of gene expression in, say, normal compared with diseased tissue. For yeast, the response of the entire genome to changes in physiological conditions of culture (eg, temperature, nutrient stress) can be assessed with microarrays. For humans, the response of the entire genome is now beginning to be explored. The research question of which protein is involved in a particular process is being replaced by the simultaneous detection of the regulatory response of all proteins within a tissue in response to disease or experimentally induced conditions. Back to text

Grant R Sutherland

Cracking the Code The Human Genome Project: how do we protect Australians? Natasha Stott Despoja It is the moon landing of the nineties: the ambitious Human Genome Project -- identifying the up to 100 000 genes that make up human DNA and the sequences of the three billion base-pairs that comprise the human genome. However, unlike the moon landing, the effects of the genome project will have a fundamental impact on the way we see ourselves and each other. MJA 2000; 173: 596-598 Are consumers currently protected? - Is genetic information being misused? - References - Authors' details - - More articles on Genetics Within the next decade, the genetic information revolution will provide an abundance of genetic population screening tests, diagnostic tests and therapies. There is no doubt that these have the potential to bring great benefits, but technology's "double-edged sword"1 means that there will also be human costs and consequences. Thus, the community must determine how this new technology will be used. Genetic information has a number of characteristics that set it apart from other sensitive health and personal information. Unlike other personal information, genetic information is predictive. It may indicate a condition that might be expressed as a full-blown disease, a milder variant of that disease, or never be expressed at all. Techniques of genetic testing (and the assessment of its results) are still being perfected, raising the issue of the "quality" of genetic information.2 Moreover, genetic information can allow inferences to be drawn about blood relatives. It is an intimate part of an individual's identity which can not be superseded by events or changes in circumstances, and is potent for the entirety of that individual's life. Among the wide-ranging issues that face consumers and regulators are the ethical, legal and social issues designated "ELSI" under the Human Genome Project.3 They include questions about personal privacy, discrimination, and distribution and funding of healthcare services, such as: Will the promise of genetic therapies compensate for their costs or for a possible reduction in other health therapies or services? Will consumers be willing to subsidise the opportunity for would-be parents to preselect embryos produced by in-vitro fertilisation for desirable characteristics? What characteristics will be deemed undesirable? What will be the effect on the community if only those who can personally fund such services use this knowledge? What is the likelihood of a dystopian genetic underclass developing? Equity of access to genetic testing and therapies is gaining attention as a consumer issue. However, it is the ability of parties like employers, credit providers and insurers to obtain and draw conclusions from personal genetic information (and the dissuasive effect this may have on individuals considering a genetic test) which is of most concern to Australians. Genetic testing for many medical disorders is now routine in Australia. Neonatal screening for phenylketonuria, hypothryoidism and cystic fibrosis is standard practice, and tissue samples obtained during prenatal screening for cystic fibrosis, along with the corresponding test results, can be stored indefinitely.4 In fact, to qualify for accreditation in Australia, laboratories are required to store clinical genetic test results, the corresponding diagnosis and other written information indefinitely after reporting the results to the requesting doctor.5 If the test is for the purpose of research, the result is stored for a period "in accordance with good research practice".4 The accumulation of such information raises questions about its appropriate use and how individuals' interests should be protected, particularly in situations where diagnostic testing and research have moved from the public to the private sector. Are consumers currently protected? Existing legislation in Australia dealing with the protection of genetic information and its use for negative discriminatory purposes relies on a number of Commonwealth, State and Territory legislative instruments, self-regulatory guidelines and the common law.6The Commonwealth's human rights package and privacy laws, self-regulation through the National Health and Medical Research Council (NHMRC), the Therapeutic Goods Administration (TGA), the Genetic Manipulation Advisory Committee (GMAC), incidental legislation (eg, Section 29 of the Australian Institute of Health and Welfare Act 1987 [Cwlth]) and some self-regulatory measures in confined sectors provide some protection. Similarly, there is State and Territory legislation and additional legislation dealing with the donation of human tissues for specific purposes. The Australian Capital Territory's Health Records (Privacy and Access) Act 1997 covers personal health information (including genetic information) held in both public and private sectors. However, there is presently no legislation in any Australian jurisdiction dealing specifically with genetic privacy and non-discrimination, and there are a range of sectors in Australia which are not regulated and have no requirements to conform to any privacy or non-discrimination practices (specifically, interactions and transactions in the private sector, which is not covered by the Privacy Act 1988 [Cwlth]). The Interim Office of the Gene Technology Regulator, or the regulatory system proposed in the Gene Technology Bill 2000 (Cwlth), does not seek to amend the current regulatory arrangement for genetic information and samples. The Privacy Amendment (Private Sector) Bill 2000, introduced into the House of Representatives on April 12 this year, seeks to extend to the private sector the National Privacy Principles and privacy protection currently required under the Privacy Act. This Bill aims to establish "a comprehensive national scheme providing for the appropriate collection, holding, use, correction, disclosure and transfer of personal information by organisations in the private sector".6 Under this Bill, genetic information is classified as sensitive health information, in the same category as infectious health information. Consumers' genetic information is best protected under a comprehensive privacy scheme, such as that proposed by the federal Attorney General. However, whether such protection is provided for genetic information under the Privacy Amendment (Private Sector) Bill 2000 is currently under dispute as the Bill is debated in Federal Parliament. Privacy protection and the development of privacy "rights" in Australia should evolve with technological innovation and development. The unique nature of genetic information makes protecting such information integral to the evolution of privacy "rights" in Australia and worthy of specific legislative protection. It was from this conviction, rather than because of specific Australian examples of genetic discrimination or breach of privacy of which I was aware, that my Private Member's Bill (the Genetic Privacy and Non-discrimination Bill 1998) originated. The Privacy Amendment (Private Sector) Bill 2000 does not reflect the uniqueness of genetic information. Under the Bill, genetic information is defined as sensitive health information, being treated as prescriptive health information. This classification, when coupled with the specific exemptions for employee records and all transactions for businesses with an annual turnover of $3 million or less (estimated to exempt 94% of Australian businesses from the National Privacy Principles or similar approved privacy codes under the self-regulatory regime7), significantly undermines any protections to genetic privacy, specifically for online ehealth applications. Genetic privacy may be said to be the confidentiality that should apply to any "[g]enetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose".8 The Bill I introduced seeks to establish a "right" to genetic privacy. It also seeks to protect Australians from genetic discrimination. Genetic discrimination may be positive or negative. Positive discrimination can be either beneficial or adverse. For example, providing reduced premiums to individuals with a favourable record of genetic health may benefit the individual, but be argued from a consumer or public policy perspective to be unconstructive. On the other hand, positive discrimination on the basis of chromosome screening for potential susceptibility to workplace carcinogens and other toxins could arguably be a positive use of the technology. However, my concern is to protect individuals from treatment by a third party which would be disadvantageous to their interests. Is genetic information being misused? While there were examples of genetic discrimination in international jurisdictions,9-11 there were no documented Australian examples at the time my Bill was introduced. Barlow-Stuart and Keays12 have since reported 48 cases of genetic discrimination in Australia, 46 of which involved adverse treatment by insurance companies following genetic test results. In the absence of legislative protection, the Insurance and Financial Services Association (IFSA) has drafted a policy for genetic testing. This policy stipulates that: Insurers will not initiate any genetic tests for applicants for insurance or use genetic tests as the basis of preferred-risk underwriting; Results of existing genetic tests are only obtained by written consent of the tested individual for the sole purpose of assessing an insurance application for the individual on whom the test was conducted; Strict standards of confidentiality apply to the handling and storage of the results of genetic tests; and Access to the results of genetic tests will be restricted to the insurer's underwriters and reinsurers, and only other third parties with written authorisation of the insured individual. However, the policy endorses disclosure of the results of any genetic test undertaken voluntarily by a potential policy holder in assessing risk and therefore premium price. While IFSA's policy provides some protection to consumers in the absence of legislative protection, it still allows for certain negative genetic discrimination. Under Commonwealth law, the holder of the insurance policy has a duty to disclose information which is relevant to the insurer in assessing risk (Insurance Contracts Act 1984 [Cwlth]). State and federal antidiscrimination legislation provides consumers some protection, preventing discrimination by insurance companies on the basis of a disability or impairment. However, insurers are allowed to use reasonable actuarial or statistical data (which could include genetic information) in determining risk, and are able to discriminate if assessment was based on so-called other relevant "reasonable" factors if such information is not available (Disability Discrimination Act 1992 [Cwlth], s 46). International developments include United States President Clinton's endorsement of legislation banning genetic discrimination for employment purposes in United States federal agencies, and US presidential candidate George W Bush's announcement that he will ban genetic discrimination if elected to office. By contrast, in the United Kingdom, the government has ignored the recommendations of the Human Genetics Advisory Commission and consumers' calls for protection, and the UK has become the first country in the world to allow life insurers to require results of voluntarily taken genetic tests from any potential policy holder.13,14 The Australian Federal Government has announced an inquiry with the Australian Health Ethics Committee and the Australian Law Reform Commission which will extend over two years. In the meantime, consumers deserve privacy protection and legislative safeguards against genetic discrimination. The Human Genetics Society of Australasia and the Australian Consumers' Association have suggested a moratorium on the use of predictive test results by insurers while the Government performs its inquiry.15 While I welcome the Government's belated recognition of the issue and its commitment to explore the most appropriate way to ensure genetic privacy and non-discrimination, Australian consumers remain unprotected and affected industries remain uncertain in the interim. A moratorium would provide such protection and certainty for our community. References Suzuki D. Inventing the future: reflections on science, technology and nature. Sydney: Allen & Unwin, 1990: 55-78. Boyle P. Genetic services, social context, and public priorities. In: Aronowitz S, Martinsons B, Menser M. Techno science and cyber culture. London: Routledge, 1996: 206. Human genome project information. <http://www.ornl.gov/hgmis> (accessed October 2000). National Health and Medical Research Council. Ethical aspects of human genetic testing: an information paper. Canberra: NHMRC, February 2000: 24. National Pathology Accreditation Advisory Council, Retention of laboratory records and diagnostic material. Canberra. AGPS, 1998. Attorney General, Privacy Amendment (Private Sector) Bill 2000 Explanatory Memorandum: 6. Senate Legal and Constitutional Legislative Committee. Hansard. Department of Workplace Relations and Small Business. 8 September, 2000; 46. Universal Declaration on the Human Genome and Human Rights. Article 7. United Nations Educational, Scientific and Cultural Organisation, 29th Session of the General Conference, 11 November 1997. <http://unesdoc. unesco.org/images/0010/001096/109687eb.pdf> (accessed October 2000). Billings P, Kohn MA, de Cuevas M, et al. Discrimination as a consequence of genetic testing. Am J Hum Genet 1992; 50: 476-482. Lapham E, Kozma C, Weiss JO. Genetic discrimination: perspectives for consumers. Science 1996; 274: 621-624. Geller LN, Alper JS, Billings CI, et al. Individual family and societal dimensions of genetic discrimination: a case study analysis. Sci Engineer Ethics 1996; 2: 71-88. Barlow-Stuart K, Keays D. Genetic discrimination in Australia. J Law Med. In press. Highfield R. UK: News -- Insurance firms to use results of gene tests. Daily Telegraph. October 13, 2000; 13. Lee A, UK: British life insurers can use genetic tests. Straits Times. October 15, 2000. Petschler L. Access denied: genetic testing and your insurance. Australian Consumers' Association. Choice October 2000. <http://www.choice.com.au/ articles/a101713p1.htm> (accessed November 2000). Authors' details Adelaide, SA. Natasha Stott Despoja, BA, Deputy Parliamentary Leader, Australian Democrats: Senator for South Australia; Science and Consumer Affairs Spokesperson. Reprints will not be available from the author. Correspondence: Senator Natasha Stott Despoja, 212 Grenfell Street, Adelaide, SA 5000. Senator. Stott. DespojaATaph.gov.au Make a comment