Ethics

From July 2007, the Health Professions Registration Act 2005 (Vic) will significantly alter the medical disciplinary process in Victoria. For practitioners: Formal hearings for allegations of serious unprofessional conduct will be heard by the Victorian Civil and Administrative Tribunal (VCAT); There will be no right of appeal from a VCAT decision other than on a point of law; The maximum fine for serious unprofessional conduct will increase from $2000 to $50 000; Performance standards panels (PSPs) will be established to conduct informal hearings, with a power to impose conditions on registration; and Costs of the new system will cause an increase in annual registration fees. For complainants: There are new avenues for conciliation; There is a right to seek a review of certain Medical Practitioners Board of Victoria decisions; and Reasons for a PSP decision will be provided. Despite government argument that these changes will make the health complaints handling system fairer, the new Act has the potential to diminish the rights and interests of doctors.

Sarah L Middleton BA, LLB(Hons), PhD · Thomas D Pearce · Michael D Buist MB ChB, FRACP, FJFICM

To the Editor: The National Health and Medical Research Council’s National statement on ethical conduct in research involving humans1 recognises that prisoners can participate in research, but categorises them as “persons in dependent or unequal relationships”. They have limited capacity to provide informed consent. Responding to the high levels of transmission of bloodborne viruses in Australian prisons,2 the Australian Red Cross Blood Service excludes prisoners from donating blood and ex-prisoners are excluded for 12 months after they have been released from prison.3 The New South Wales Human Tissue Act 1983 is silent on whether prisoners can donate organs. We report here the case of a prisoner organ donor, highlighting the administrative, legal and operational hurdles that needed to be overcome. A 53-year-old male prisoner was a suitable living kidney donor for his first cousin. He provided consent willingly and without coercion. At initial assessment, the prisoner’s classification required that he be escorted to hospital and that constant surveillance by prison officers be maintained — at a cost of $1000 per day, for at least 7 days. These costs would have been borne by the family. Furthermore, as Australian prisoners are ineligible for Medicare under the Australian Constitution, the donor, as an uninsured patient, and his family would have been required to pay for all pre-, peri- and postoperative care. The donation was deferred for 14 months while these two administrative hurdles were overcome to permit the donation to proceed: 1. The Commissioner for the Department of Corrective Services gave approval for the prisoner to be reclassified to the lowest security classification, thus removing the need for surveillance while in hospital; and 2. A rarely used provision within the NSW Crimes (Administration of Sentences) Act 1999 was applied. Section 26(1) of the Act allows the Commissioner to issue a permit allowing an inmate to be absent from a correctional centre: (a) on such conditions and for such period as may be specified in the permit, and (b) for such purpose as the Commissioner considers appropriate. This allowed the prisoner to be temporarily reinstated to receive Medicare entitlements. The nephrectomy and transplantation were successfully performed. The donor returned to prison on the seventh postoperative day. The donor organ is functioning 4 months after the operation. Prisoners have a right to participate in organ donor programs; however, their precarious position to provide informed consent needs to be protected.

Elizabeth Magee · Michael H Levy

Health services research is important to ensure continued best quality of care, but often uses data obtained without explicit consent for this purpose. Obtaining consent may be difficult for many reasons, but excluding individuals may introduce biases that alter the significance of studies. Approval by ethics committees of a waiver of the need for consent allowed our study to proceed and provide evidence that has led to the implementation of a population-based screening policy for the prospective detection of hereditary non-polyposis colorectal cancer. This screening policy has resulted in more cases being detected routinely with better management for affected patients and their at-risk families. A need for consent would have prohibited this study, and the development of a more efficient screening policy could have been delayed for several more years. Ethics committees can effectively manage the need to uphold basic ethical principles without unnecessarily impeding socially useful research. Committees need to be familiar with the guidelines approved under sections 95 and 95A of the Privacy Act 1988 (Cwlth) in addition to the National Health and Medical Research Council National statement on ethical conduct in research involving humans.

Nikolajs Zeps PhD · Barry J Iacopetta PhD · Lyn Schofield MPH · Jillian M George BHealthSci, RN · Jack Goldblatt MB ChB, MD, FRACP

A recent conference raised issues about the environment in which lifestyle choices are made Even before it had started, the recent 1-day conference “Obesity: should there be a law against it?” provoked controversy. The very title of the conference, convened by the University of Sydney’s Centre for Health Governance, Law and Ethics and the Australian and New Zealand Institute of Health Law and Ethics, elicited outraged responses. The recipient of much of the outrage, Conference Convener, Roger Magnusson (Associate Professor, Faculty of Law, University of Sydney), explained to the conference attendees that law’s perceived role in society is all about coercion. While law is a potent tool for public health and disease prevention, it needs to be able to “justify its involvement and defend itself from ideological attacks”. The conference’s quirky title went to the very core of the issue. Surely, adults have a right to choose to be overweight if it fits with their desired lifestyle. Shouldn’t the law stay away from our refrigerators and couches? An insightful early question from the floor was, “How can the law help frame the debate which is now framed as freedom of choice versus paternalism?” A distinguished international group of speakers presented a range of approaches to this dilemma. The Australian context: Boyd Swinburn (Chair in Population Health, School of Exercise and Nutrition Sciences, Deakin University) considered obesity in terms of the conventional epidemiological triad, where host factors (human biology and behaviour) interact with vectors (excessive energy intake and inadequate expenditure) and the environment (physical, economic, policy and sociocultural). By far the major environmental drivers, said Swinburn, are economic ones, and these are weighted on the side of obesity. Products such as energy-dense foods and cars are heavily promoted, while others such as bicycles, the exercise industry, and fruit and vegetables are not. “If you look at obesity from a libertarian perspective, it is difficult to argue for an approach that involves laws, regulations and enforceable policies; people have a right to be unhealthy if they choose to be. A protectionist approach can be used for children, whom it can be argued have a right to be healthy. However, even in adults you can justify policies such as detailed food labelling on the grounds that they will support healthy choices — making healthy choices easy choices.” While he acknowledged vast differences between the tobacco industry and the food industry, Chris Reynolds (Senior Lecturer in Law, Flinders University) pointed out the similarities in the way the two industries have marketed their products. Restrictions on marketing have had a major role in tobacco control, but so far in Australia, public policy for obesity has centred on exercise, education, and consideration of the built environment. Recent calls for controls on a range of other fronts, including food marketing, have been controversial and not supported by the federal government. While supportive of the idea of personal responsibility, Reynolds did not see this as excluding a community or collective response to public health issues. Personal choice will be influenced by the environment in which people are making that choice. “People are more likely to exercise personal responsibility if they’re not expected to swim against a current of advertising and promotion.” Elizabeth Handsley (Associate Professor, School of Law, Flinders University) is currently involved in a multinational study of the regulation of food advertising to children in Australia, the United States, Canada, the United Kingdom, Sweden and Norway. These countries vary in their regulatory structures, rules (from minimal restrictions to a complete ban), and sanctions imposed for breaches. Interesting issues raised include: who should be the regulator (industry is more efficient but government is more independent)?; to what extent should surveillance rely on public complaint versus active monitoring?; what are the relative roles of parents and society?; how should the “rules” be defined?; and, what sanctions should be imposed? The US and the UK: According to James Hodge (Associate Professor, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA), Americans are split between viewing obesity as a public health issue or as a personal issue, and are more likely to support interventions aimed at children. He gave a colourful account of a raft of US strategies, covering various areas of the law. These occur at every level of government, with state and even local government jurisdictions not waiting for the federal government to act. They include incentives to encourage healthier behaviour, disincentives to discourage unhealthy behaviour, litigation by injured (obese) people seeking recourse (this has generally not been successful and many states have introduced “personal responsibility” laws that prohibit it), and restriction of access to unhealthy foods (local governments achieve this via zoning laws). Robyn Martin (Professor, Public Health Law, University of Hertfordshire, UK, and Visiting Professor, Public Health Law, Chinese University of Hong Kong) pointed out that, although obesity affects many different nations, the context differs. In the UK, the context includes the political system, a culture of long working hours, class- and age-related food traditions, and even the climate! Over the past 5 years, obesity has been variously categorised in government documents as a medical problem, an economic problem, a societal problem, a public health problem and, most recently, by Prime Minister Tony Blair, as a personal problem. In a 2006 speech, he said: “Our public health problems are not, strictly speaking, public health questions at all. They are questions of individual lifestyle . . . the result of millions of individual decisions.” Even within this narrow framework, argued Martin, there is much that the government can do in the way of legal support and structures to make it easier for people to live healthily. A spurious dichotomy: Despite all the controversy, personal responsibility and the wider community response are not on opposite sides of the fence, says Chris Reynolds. “These two ideas are inextricably linked. One is necessarily supported and sustained by the other. The community must create the environment that maximises the potential for people to make healthy choices.” And Magnusson’s answer to that question from the floor about how the law can help reframe this debate? “We can turn it around and say that, if we really want to deliver on autonomy or individualism, we need to introduce legislation that allows people full freedom of choice.”

Ruth M Armstrong BMed

To the Editor: No one denies the right of insurers, or law firms acting for an interested party, to obtain information relating to a claim with due authority from the patient. After all, it’s fair enough for insurers to check the details of a claim. This system has worked well for decades and allows the insurance industry to operate reasonably and fairly. But a recent development gives cause for great concern. There is a trend among both insurers and lawyers to demand copies of a patient’s entire medical file. Not just details relevant to the claim, but the entire medical file, often extending for years before the relevant event. A cynic has suggested this is financially motivated, as a reasonable fee for copying and forwarding a file is likely to be less than the fee for reviewing the file and preparing a report. Another equally uncharitable explanation is that insurers are embarking on “fishing trips”, hoping to find grounds to mitigate a claim. I’m sure the industry could produce examples in which fishing trips have identified dishonest claims that might not otherwise have been detected. But I cannot justify sacrificing the privacy of many patients to expose the occasional fraudulent claim. In one case, one of my patients suffered a work-related injury that prevented her working as a private contractor for some months. The case was clear-cut, simple and straightforward. Yet the insurer refused to process her claim without receiving a copy of her entire file — including very personal details of a sexual assault nearly 20 years earlier, together with confirmation that she had contracted a sexually transmitted infection and details of her subsequent breakdown. For a vulnerable and very private person, it was a terrible ordeal to have this brought up and to have to sanction its disclosure to a claims officer. My financially strapped patient was held to ransom when the insurer advised that the claim would not be processed until the disclosure was authorised. How can the individual claimant ever stand up to a multinational insurer? And, in this case, appeals to the industry regulatory body were peremptorily dismissed. I support any stand by our profession against this unjustifiable invasion of privacy.

Bernard S Pearn-Rowe

Comment: Agents for a workers compensation authority commonly assert they have the right to see the patient’s entire medical history to assess whether the injury arose from work or from another past or current illness or injury. Two points need to be underscored. Firstly, patients have a right to waive their right to privacy. A consent for total disclosure, given when initiating a claim for compensation, could be invalid, as it is a consent given under (economic) duress — that is, payments will not commence unless the patient consents to full disclosure. A doctor may feel a duty to point out to the patient that full disclosure will reveal distressing matters from the patient’s past that the doctor believes are not relevant to the claim. The doctor may recommend that the patient seek legal advice on how to object to full disclosure. Whether the patient objects or agrees to total disclosure is a decision for the patient, not the doctor, with the help of legal advice. Doctors should not give that advice. Secondly, the legislation governing statutory compensation schemes in Australia gives extraordinarily broad powers to the relevant authority to demand information. For example, section 239 of Victoria’s Accident Compensation Act 1985 states that the Victorian WorkCover Authority (and its agents) may “require any person – to furnish the Authority with such information as the Authority requires . . . and may require the person to produce all books in the custody or under the control of the person relating thereto.” Doctors and medical records are not excluded from the broad sweep of section 239. Notwithstanding such clauses, a claimant can object directly to WorkCover about a request or demand to supply his or her entire medical history if the claimant believes there are matters not relevant to the claim that he or she does not wish to be disclosed. If that process fails, the claimant then has a number of legal avenues that can be pursued. Pearn-Rowe may be concerned at the David–Goliath imbalance of power between patient and insurer, but that does not justify omission of information because the doctor thinks it is not relevant. The Medical Defence Association of Victoria recently settled a case in which a member, asked to provide a “Personal medical attendant’s report” for a patient applying for a new disability insurance policy, omitted information about the patient’s history that would have affected the insurer’s assessment of the application. The patient had signed a consent for full disclosure. The insurer issued the policy, and a short time later the patient was diagnosed as suffering a major illness, the premonitory symptoms of which were described in the omitted information. Whether or not it was a deliberate omission was not the point — it was a negligent omission. In summary, the patient has a right to object to disclosure. If the patient chooses not to, the doctor has a legal obligation to comply with the literality of the patient’s signed consent for disclosure.

Paul Nisselle

Institutions investigating allegations of research misconduct are vulnerable to claims that their processes are inadequate or that they have an institutional conflict of interest. The Office of Research Integrity in the United States sets down standards for and reviews the adequacy of investigations of research misconduct by institutions; recognises that internal politics and the involvement of non-experts can lead to honest mistakes being regarded as serious misconduct; requires complainants and investigators to act “in good faith”; and reduces damaging publicity when complaints are misconceived or false. Australia needs an office of academic integrity to ensure that all complaints are thoroughly investigated; the investigative procedures meet international standards; fair processes are provided for complainants and respondents; and institutions are protected from claims of “cover-up” and institutional conflict of interest.

Bruce M Hall MB BS, FRACP, PhD

A recent editorial discussed the issue of interactions between doctors and pharmaceutical companies (MJA 2006; 185: 299-300). The reactions ranged from agreement to offence. To the Editor: I would like to congratulate Tattersall and Kerridge on their recent editorial covering the issue of industry influence in medical education.1 Like the authors, I was dismayed on seeing the Australian Medical Association statement to the press regarding the recently revised Australian Competition and Consumer Commission guidelines for disclosure of industry support. Industry supports medical education because it pays, and we would be well advised to remain aware of this basic fact. It amazes me that anyone could subscribe to the view that doctors need industry freebies to remain informed of new therapeutic options in this age of electronic media. We are constantly inundated with information — the issue is to choose reliable, unbiased data. As a rule, industry-sponsored sources of information should be regarded as potentially biased and therefore suspect. In my view, direct industry sponsorship of continuing medical education activities is inappropriate and should not just be regulated, but abolished altogether.

Hans Peter Dietz

To the Editor: Tattersall and Kerridge make the argument that any interaction between industry and clinicians must, of necessity, compromise the decision as to the appropriateness of the particular treatment prescribed.1 The more common situation is that interactions do exist, and this is covered by a process of disclosure of, for example, honoraria or shareholdings. However, this situation is also inadequate, in that the extent of the potential for influence is not disclosed (eg, the size of the honoraria, or the volume of shares held in the company). This is also relevant when it comes to evaluating potential conflicts of interest in medical publications. As the authors note, the health care industry is complex, and interactions do occur between clinicians and industry. In this situation, full and frank disclosure — rather than the mere indication that a relationship exists — is far more appropriate.

Charles M Fisher

To the Editor: I am critical of the article by Tattersall and Kerridge.1 In my opinion, the article comprises a series of pompous announcements from an ivory tower, which hint without actually saying that doctors who attend educational symposia organised by pharmaceutical companies, and who subsequently order the product, are acting improperly. As I see them, the facts are quite otherwise. Medical practitioners have an obligation to do their best for their patients by giving them the most appropriate treatment available, and to keep up to date with their profession. Both these objectives can be achieved by educational symposia organised by the research-based pharmaceutical companies, which introduce new concepts in medicine as well as new products. Research-based pharmaceutical companies play a major role in the development of modern therapeutics through the introduction of new drugs. The development and manufacture in commercial quantities of life-saving compounds in the future, such as, for instance, the new biological agents and the new anticancer drugs that we need so urgently, would not be possible but for the pharmaceutical industry. One cannot imagine this important work being done by other agencies, such as the universities or the government. The Australian Government, in fact, sold its own pharmaceutical company (Commonwealth Serum Laboratories, now CSL Ltd) some years ago. Doctors attend educational symposia run by pharmaceutical companies so as to obtain information that will be useful for their patients, not because they can get a few free drinks and a dinner. The suggestion to this effect is offensive. I note that one of the authors is Director of the Centre for Values, Ethics and the Law in Medicine. I would value his opinion on doctors who advertise directly to the public, such as the eye surgeons who advertise repeatedly on talkback radio, and the promoters of alarming cardiovascular articles that predict catastrophes if one does not apply to the sponsors of the program. To criticise doctors for prescribing products promoted at educational symposia while allowing these other examples to flourish without criticism is, to my mind, hypocritical.

Ian S Collins

To the Editor: A new trend of doctors appearing in television advertisements is emerging in this country. This has occurred with some impetus over the past year, and now involves not just everyday medical practitioners, but highly regarded public figures. The ethical implications of such advertisements are worthy of some thought. There has been no formal discussion regarding these issues, and the New South Wales Medical Board does not cover it specifically within the Code of professional conduct.1 This has allowed medical practitioners to participate in the advertisements with no guilt about the possible ethical flaws of their actions. This is perhaps a premature response, as there are several areas where the ethics are potentially questionable. The first is the creation of a conflict of interest. The idea of a doctor being sponsored by a drug company is covered, to some extent, by the Code.1 As is well understood, a medical practitioner must declare to a patient any financial dealings he or she has with a company involved in the treatment of that patient.2 For the described commercials, the drugs are invariably over-the-counter general medications, like analgesics or vitamin supplements. A medical practitioner may recommend these frequently, and it would be difficult to explain to each patient the nature of the doctor’s connection to the drug company while maintaining the high level of integrity and trust expected within modern practice. Then there is the nature of the advertisements themselves. Medical practitioners can be seen advocating specific products for use by their patients, their families and sometimes even themselves. They display their medical qualifications as a reason for consumers to trust them, playing on the esteem and regard in which doctors are still held in large parts of the community. This is a big risk to take, especially when considering the questionable benefit of some of the treatments being advocated. I believe that the practice is poor for the public image of doctors and, even if ethically tolerable, it may be prudent for it to be openly frowned upon by the profession. However, the profession may consider it completely acceptable. What is lacking is a frank and open discussion on the ethics involved.

Adrian M J Pokorny

To the Editor: I would like to comment on two articles that appeared recently in the MJA. “Doctors behaving badly?”1 was an anticlimax. It was not, as would be expected, an exposure of misconduct by doctors, but dealt with the potential conflict of interest that occurs when they interact with the pharmaceutical industry. No evidence of doctors “behaving badly” was provided, yet a solution to this potential problem was proposed — “disclosure” (ie, yet more paperwork), accompanied by a disclaimer that this was unlikely to work. This is an important issue, but the content of the article cannot justify such a misleading title. I can only assume it was the result of editorial intervention, in which case there is some hypocrisy at work, given that the inside front cover and the outside back cover of the same issue of the Journal are taken up with full-page drug advertisements, and within, a $10 000 prize was offered for the best original research article published in the Journal (sponsored by a drug company). The second article, From the Editor’s Desk “Tilting at titles”,2 which cited the dreaded Australian values, suggested that titles such as “doctor” should be trashed altogether and replaced by an introduction such as “Hello. I’m Jean Smith. I am a urologist and together we will confront your prostate problem” — a statement that is unlikely to give great confidence to the average digger. Doctor Samuel Johnson put this argument to rest in 1775:3 What is implied by the term Doctor is well known. It distinguishes him to whom it was granted, as a man who has attained such knowledge of his profession as qualifies him to instruct others. A Doctor of Law is a man who can form lawyers by his precepts. A Doctor of Medicine is a man who can teach the art of curing diseases. My concern is that there appears to be an editorial assumption that doctors are preoccupied with titles and are willing to treat patients unethically for a few glasses of Kooyong Pinot Noir and a good feed. This might be good press, but not in the MJA. Perhaps some disclosure is required. To return to Johnson: There are but two reasons for which a physician can decline the title of Doctor of Medicine, because he supposes himself disgraced by the doctorship, or supposes the doctorship disgraced by himself.

Padraic J Grattan-Smith

In reply: We agree with Dietz that unbiased sources of information about new therapeutic options are increasing, and many are available electronically. Virtual Mentor, the American Medical Association’s ethics journal, has suggested reducing drug company influence on doctors’ prescribing by stopping companies paying for continuing medical education,1 and the Australian Competition and Consumer Commission is exposing this issue. Fisher recommends full and frank disclosure of links with industry, but he does not state to whom these disclosures should be made. The revised Royal Australasian College of Physicians guidelines recommend that employing hospitals create a Conflict of Interest Committee to receive employees’ declarations, and to advise when a duality of interest may be construed as a conflict of interest.2 The Box shows the disclosure statement that one of us displays in his consulting room, copies of which are sent to referring doctors when letters are written about patients. Grattan-Smith felt the title of our article was misleading. However, the title is stated as a question precisely because the assessment of professional behaviour, and particularly the assessment of possible conflicts of interest, is a matter of considerable dispute. It is clear that the relationships that doctors have with industry may constitute bad behaviour in the eyes of some, including the editorial writer in the Sydney Morning Herald.3 We do not, as Fisher suggests, contend that interaction with the pharmaceutical industry inevitably compromises prescribing decisions, but agree with him that full and frank disclosure, rather than the simple notification that a relationship exists, offers at least some reassurance that the possibility of influence is being acknowledged and managed. Collins asserts both that we hinted that doctors who attend educational symposia organised by pharmaceutical companies and subsequently order the product are acting improperly, and that doctors attend such meetings for the free food and wine. We do not believe that either statement is correct, and accept that the choices that doctors make to attend such events are generally motivated not by gluttony, but by a range of complex factors, including a desire for education, clinical feedback and professional collegiality. Nothing in the interaction between doctors and the pharmaceutical industry is simple. Although the editorial from the Sydney Morning Herald suggests that avoidance is the simplest response to this dilemma, we would argue that such a complex issue requires a complex response and that support for adequate disclosure should be a necessary (but insufficient) component of the medical profession’s response, if it hopes to maintain the high regard in which it is held by the Australian public. Example of a disclosure statement displayed in the consulting room and enclosed with letters about patients Disclosure of interests that might influence my prescribing and treatment of cancer patients Pharmaceutical companies I have received no honoraria or financial support for more than 10 years from pharmaceutical companies for: serving on advisory boards consultancies providing patients' data relating to drug use enrolling patients in a clinical trial speaking at a company-sponsored event During the past 10 years I have not: received financial or other support from pharmaceutical companies for my research activities or staff received travel, registration, accommodation or other support from pharmaceutical companies for me or my staff to attend regional, national, or international conferences or meetings received research support from pharmaceutical companies received personal gifts from pharmaceutical companies attended company-sponsored meetings, launches of new drugs I am not a principal investigator on trials supported by pharmaceutical companies. I do invite eligible patients to consider entry on some pharmaceutical company sponsored trials, but I derive no personal financial benefit. I do not accept free samples of drugs from pharmaceutical companies. I do not welcome visits from representatives of pharmaceutical companies. Martin Tattersall

Martin H N Tattersall · Ian H Kerridge

In reply: Grattan-Smith is obviously concerned about “Doctors behaving badly?” as an appropriate title for the editorial by Tattersall and Kerridge.1 He is also agitated by my column From the Editor’s Desk “Tilting at titles”.2 The editorial’s title was not the result of Machiavellian machinations — its creation belongs entirely with the editorialists. Grattan-Smith may not feel that accepting pharmaceutical company largesse is bad behaviour, but the public sees it otherwise, as evidenced by the unprecedented coverage of the “Roche affair” in The Australian,3,4 the Sydney Morning Herald,5 and the BMJ.6 The public comments were not flattering: “the gluttony of the whole thing was mind blowing”3 and its defence by doctors was “in poor taste and displays the supreme arrogance of the privileged”.7 The public and most doctors expect the relationships between the pharmaceutical industry and doctors to be open and transparent. We believe this to be the case with the pharmaceutical advertisements in the Journal, and the MJA/Wyeth Prize. Our advertising policy prevents pharmaceutical companies from placing advertisements within or adjacent to articles that might have relevance to the drug being advertised. Wyeth generously donates $10 000 each year to the authors of the best original research published by the Journal on the understanding that Wyeth has no input to the selection process. Research has already been independently peer reviewed for publication before being considered for the prize, and the winner is decided by the Journal staff and the members of our independent Content Review Committee. Grattan-Smith’s concern with my column was its questioning of the title “doctor”, which apparently is now a source of confusion for patients in busy hospitals. He cites Samuel Johnson’s concept of a doctor and quite rightly so. Physicians of his time had every right to call themselves Doctors. They were graduates from Oxford and Cambridge who pursued a long, formal and inflexible course. It began with a Masters in the liberal arts, proceeding through the Licentiate and then a Doctorate in Medicine by dissertation.8 These doctors were the epitome not only of scholarship but also of elitism. Those with moderate means were barred from pursuing medicine at Oxford and Cambridge, as were non-conforming Protestants and Roman Catholics. It took the Scottish medical schools in Edinburgh and Glasgow to break down the English citadel. In our times, the use of the title “doctor” by medical practitioners is a privilege granted by the community and the state, and has to be earned and sustained by open professional conduct. A closeted freebie of “a few glasses of Kooyong Pinot Noir and a good feed” is what most of the public perceives as doctors behaving badly, and it is perception that counts.

Martin B Van Der Weyden

A recent High Court decision held that children born with disabilities not caused by medical intervention, but not diagnosed antenatally, could not claim general damages for their pain and suffering, nor special damages for the needs created by their disabilities and their loss of earning capacity. The law has regularly struggled with how to deal justly with disability associated with medical interventions, particularly in relation to competence and consent, as well as causality and compensability. Terminology and concepts10 Wrongful birth — a “wrongful birth” action is one brought by the parent(s) of an initially unwanted or unintended child, born (with or without disability) as a consequence of negligence before birth.11 This was the situation in Cattanach v Melchior, a case of negligent sterilisation.7 Wrongful life — a “wrongful life” action is “. . . one brought by (or on behalf of) a child complaining of negligent conduct before birth which results in its birth when had there been no negligence it would not have been born. In short, the essence of the claim is that the child would have been better off not to be born at all.”11 The defendant medical practitioner does not cause the disability but, rather, fails to avert it. This was the situation in Harriton v Stephens8 and Waller v James.9 In both types of actions, the breach of duty may occur before conception (as was the situation with Waller v James, where the child’s father was not advised that he had a heritable condition), ex utero (eg, in vitro or in relation to fertility treatment), or in utero (eg, in failure to diagnose disability).11 For example, at least since the landmark litigation in the 1970s arising out of the effects of thalidomide,1,2 courts have trod warily in defining what is actionable and what is compensable. In the 1990s, leaving aside the ongoing ramifications of the Rogers v Whitaker decision,3 perhaps the most controversial medicolegal cases dealt with by the High Court of Australia were the decisions in Marion’s Case4 and P v P,5 both of which concerned the rights of children with profound disability, and whether, in their alleged best interests, they should be sterilised. Following judgment in both cases authorising the sterilisation, there was significant and understandable dispute about what enhanced, and what impaired, the human dignity of those with disability.6 Courts have endeavoured to be careful in recognising and awarding damages in novel areas of law, such as “wrongful birth” and “wrongful life”. The High Court of Australia has recently given judgment in both kinds of action: in 2003 allowing a claim for wrongful birth (Cattanach v Melchior),7 but in May 2006 disallowing two separate claims for wrongful life (Harriton v Stephens8 and Waller v James/Waller v Hoolahan9). Here, we briefly summarise the wrongful birth action,7 and then examine in detail the most recent High Court judgment on claims for wrongful life,8,9 which involved the intersection of congenital disability, claims for negligence and the award of damages. The terms “wrongful birth” and “wrongful life” are defined in the Box. The High Court and wrongful birthIn the 2003 claim for wrongful birth (Cattanach v Melchior),7,12 the High Court of Australia by a bare majority of 4 : 3, and contrary to recent authority in the United Kingdom,13 held a consultant obstetrician and gynaecologist, who had negligently performed a sterilisation procedure, liable for the costs of raising the child born subsequent to the failed procedure. The finding of negligence was relatively unproblematic.7,14 However, what did cause concern was the judgment that the medical specialist was liable for the costs of raising the healthy, but initially unwanted, child. Understandably, the decision unleashed a significant tide of comment.15,16 The then Premier of New South Wales, Bob Carr, called on the federal government to introduce legislation “that protects doctors in other categories, in private medicine . . .”.17 One immediate consequence of the Cattanach v Melchior judgment was the decision by three states — NSW, Queensland, and South Australia — to enact legislation that now prevents the bringing of wrongful birth suits in those jurisdictions (Civil Liability Act 2002 (NSW), s.71; Civil Liability Act 2003 (Qld), s.49A; Civil Liability Act 1936 (SA), s.67). The High Court and wrongful lifeThe 2006 decision of the High Court in Harriton v Stephens and Waller v James/Waller v Hoolahan, this time by a majority of 6 : 1, rejecting two separate claims for wrongful life, is certain to be welcomed by medical practitioners and politicians alike. The High Court resoundingly rejected claims for damages by two disabled children. The claims were on the basis that they would have been better off not being born rather than being born with their severe disabilities.8,9 The child appellants argued that their births were the result of negligent action by the treating medical practitioners and they sought compensation for being born with disabilities. Justice Susan Crennan summarised the issue at the end of her leading judgment in Harriton v Stephens: Cattanach v Melchior [in 2003] represents the present boundary drawn in Australia by the common law . . . in respect of claims of wrongful birth and wrongful life. Life with disabilities, like life, is not actionable [par. 277].8 Procedural anomaly and evidenceBefore going to the High Court, these cases were presented to the NSW Supreme Court, and this Court was asked, based only on an agreed set of facts, to determine whether the novel claim for wrongful life could, and should, be recognised. If this was so, the Court was then asked to assess what damages would flow from such a finding. The two children involved, Alexia Harriton and Keeden Waller, were unsuccessful in their claims. Later, in the High Court, reservations were expressed about the lack of a formal trial before the Supreme Court hearing and the difficulties that ensued in properly evaluating the untested evidence presented in the agreed set of facts. As well, the agreed set of facts was somewhat lacking in clinical detail. Indeed, the agreed set of facts posed a range of unanswered questions: for example, why was Dr Paul Stephens advised to concede that he was negligent in reassuring Alexia Harriton’s mother that she did not have rubella when the pathology report was very vague in its detail? Also not explained in any judgment is how or why Alexia’s parents’ claims were out of time and therefore statute-barred. The agreed factsHarriton v StephensAlexia Harriton was conceived naturally. In August 1980, her mother, Olga, contracted a fever and noticed a rash. She also suspected that she was pregnant. She went to her general practitioner, Dr Max Stephens, and told him of her concern about being pregnant and possibly having had rubella. Dr Stephens recommended that Mrs Harriton have a blood test to determine the pregnancy and the likelihood of having contracted rubella. The testing was done by Macquarie Pathology Services. Dr Stephens noted the clinical history of the patient as: “Urgent? Pregn? Recent rubella contact.” Nine days later, Mrs Harriton saw Dr Paul Stephens, the son of Dr Max Stephens. He had the report from Macquarie Pathology Services. It read: Rubella – 30; if no recent contact or rubella-like rash, further contact with this virus is unlikely to produce congenital abnormalities. Preg test – positive. Dr Paul Stephens advised Mrs Harriton that she was pregnant; he also assured her that she had not contracted rubella. In the agreed statement of facts presented to the Court, it was common ground that Dr Paul Stephens had been negligent in advising Mrs Harriton in the way that he did, and that he had, accordingly, breached his duty of care to her (i) in his advice that she did not have rubella, and (ii) in failing to arrange a more detailed blood test. It was also agreed that, in 1980, a reasonable medical practitioner in the position of Dr Stephens would have advised Mrs Harriton of the high risk of her child in utero having been exposed to rubella and, therefore, the risk of it being born profoundly disabled. The parties also agreed that had Mrs Harriton received competent medical advice, she would have terminated the pregnancy. Alexia was born with, and continues to suffer from, what the courts have described as “catastrophic disabilities”, which include blindness, deafness, mental retardation and spasticity. Waller v James/Waller v HoolahanKeeden Waller was conceived via in-vitro fertilisation (IVF) pro-cedures in August 2000. Keeden’s father suffered from “Factor III [antithrombin III; AT3] deficiency” as well as a low sperm count and poor sperm motility. Deficiency of AT3 is generally a hereditary condition, and is characterised by a predisposition to thrombosis. Mr Waller notified the family’s GP about the AT3 condition, and the GP in turn notified Sydney IVF Pty Ltd. Keeden’s father was taking warfarin daily for the AT3 deficiency. Tests were conducted to determine whether there was a genetic reason for the condition of his sperm. Mr and Mrs Waller were advised to proceed with intracytoplasmic sperm injection. This course was accepted. After collection of 19 eggs from Mrs Waller, and sperm from Mr Waller, 17 eggs were successfully fertilised. Two embryos were transferred to Mrs Waller and, on confirmation that she was pregnant, Mrs Waller was referred to Dr Hoolahan, an obstetrician and gynaecologist. One embryo implanted successfully. Subsequently, on the recommendation of Dr Hoolahan, the fetus Mrs Waller was carrying was tested for Down syndrome. This test proved negative. There was no screening of the fetus for Mr Waller’s AT3 condition. Nor were Keeden’s parents advised of the possibility that it was an inheritable condition. Mrs Waller’s labour was protracted. Keeden was diagnosed, 5 days after his birth, with cerebral thrombosis. As a consequence, he suffers from cerebral palsy and has uncontrolled seizures. He also has AT3 deficiency, inherited from his father. It was alleged that the defendants in this case, namely the treating obstetrician, Sydney IVF, the hospital at which Keeden was delivered, and others who attended Mrs Waller in the course of her delivery, should have advised her of the risk of AT3 deficiency being passed on to any offspring. Consequently, it was argued that, had Keeden’s parents been advised of this risk, they would have had the pregnancy terminated. The judgments of the High CourtJustice Crennan wrote the leading judgment in both cases. Gleeson CJ and Gummow, Hayne and Heydon JJ all concurred with her reasons. Callinan J wrote short separate judgments in both appeals which also found against the children in their claims. Kirby J was the sole dissentient in both matters. He accepted that a “compensatory principle” should apply so as to allow recovery. The remainder of this article considers the reasoning of the Court and what it might portend for the future. A crucial issue for the dissentient, Kirby J, was that Denying the existence of wrongful life actions erects an immunity around health care providers whose negligence results in a child who would not otherwise have existed, being born into a life of suffering [par. 153].8 While contentious, especially given that the High Court has never claimed or sought to quarantine health care providers, or anyone else for that matter, from the general operation of the law in relation to negligence, Kirby’s approach is consistent with the majority judgment in Cattanach v Melchior,7 but not with recent decisions in the UK.18 The crucial question for the majority of the Court was whether Alexia and Keeden suffered “damage” which was recognisable at law. The antecedent questions of whether either child was owed a duty of care, and whether there had been a relevant breach of that duty, were effectively subsumed by the focus of most of the majority Justices on whether there was damage recognisable by the law for which the defendants should be held liable. The duty postulated by Alexia was that Dr Paul Stephens should have diagnosed rubella and then advised Mrs Harriton to terminate the pregnancy. This duty also proposed that the measure of damages required that an assessment should be made so as to compensate Alexia to the degree necessary to place her in the position she would otherwise have been in but for the negligence of Dr Paul Stephens. That comparative position was one of “non-existence”. The High Court held that the law does not, and could not, recognise “non-existence” as a relevant comparator and, therefore, there was no compensable damage. Hayne J said emphatically: It is because the appellant [Alexia] cannot ever have and could never have had a life free from the disabilities she has that the particular and individual comparison required by the law’s conception of “damage” cannot be made [par. 172].8 After reviewing judgments from both common and civil law jurisdictions around the world (in which, with very few exceptions, claims for wrongful life have been rejected), and that Alexia had no cause of action against Dr Paul Stephens, Crennan J accepted the remarks of the Chief Justice of NSW, James Spigelman, when he said in his judgment in the NSW Court of Appeal that . . . in cases of this kind, to find damage which gives rise to a right to compensation it must be established that non-existence is preferable to life with disabilities [par. 251].8 Crennan J rejected arguments that (a) life with disability was a devalued life — rather, Alexia’s disabilities “are only one dimension of her humanity”; (b) a “new compensatory principle” required the awarding of damages in this case; and (c) a principle of “corrective justice” in this case would, and should, overcome the difficulties inherent in the claim.19 In relation to the rights of the parents, Alexia’s parents were statute-barred. The wrongful life action of Keeden’s parents has yet to be determined. ConclusionSo what does this case mean for the law and for medical practice? Firstly, it certainly does not diminish the responsibility of medical practitioners in their duty of care owed to patients, especially pregnant women. Secondly, it is clear that a “line in the sand” has been drawn as to what the law will recognise as compensable damage. As Crennan J said: To have a cause of action in negligence [Alexia] needs to show damage suffered by her and a duty of care on Dr P R Stephens to avoid that damage [par. 218].8 The Court pointed out that Dr Stephens did not cause the damage suffered by Alexia; that was caused by her mother’s rubella. Thirdly, it is more than a philosophical or jurisprudential point made by the Court and worthy of further consideration — that non-existence cannot be compared favourably to living a life with disabilities (Disability Discrimination Act 1992 [Cwlth]).20 As Gleeson CJ said in one of the three dissenting judgments in Cattanach v Melchior: The value of human life, which is universal and beyond measurement, is not to be confused with the joys of parenthood, which are distributed unevenly.7 This was undoubtedly the case here. Perhaps the larger question then is what, for a community, is the responsibility owed to people with disability and those who care for them? That is a question that politicians, judges and the rest of us must grapple with.

Warwick J Neville BA, LLB, STD · Buddhima Lokuge MB BS, MPH

In the event of an influenza pandemic, many ethical issues will arise in terms of health risks, resource allocation, and management decisions. Planning decisions may be controversial, such as rationing of antivirals, resource allocation (including hospital beds and vaccinations), occupational risk, rostering of staff, responsibilities of health care workers, quarantine measures, and governance issues. A clear ethical framework is needed to enable understanding of the decision-making process and optimise acceptance of decisions by health care workers and other members of an affected community. Planning decisions need to start being examined now, and will require input from a broad group of experts: health care providers, infrastructure managers, lawyers, ethicists, public health physicians, and community members. The process will need to be open, honest and dynamic.

Adrienne Torda FRACP, GradDipBioethics, PhD

To the Editor: A young man, a minor when sentenced in Sydney, was diagnosed with lymphoma soon after incarceration. Appropriate treatment was initiated, including pretreatment collection and storage of his semen. A local newspaper report that his sperm was collected and stored at taxpayers’ expense prompted outrage in some sections of the community. In response, the New South Wales Government drafted the Corrective Services Legislation Amendment Bill 2006, which would make it a crime for an individual imprisoned or awaiting sentencing for a “serious indictable offence”, such as homicide, rape or terrorism to store “reproductive material” (semen or ova).1 It is routine (many would say mandatory) for men of reproductive age who are about to undergo therapy for cancer to be offered the option to store semen. Without this option, male cancer survivors might be unable to father their own offspring. There is no current routine technology for storing unfertilised ova. In current practice for male prisoners, semen is stored before commencing treatment for cancers or similar conditions that may induce temporary or permanent infertility. This is the accepted standard of care, offered before such treatment to men who may not have completed their families. It is not current practice in NSW to store prisoners’ semen in any other circumstances. The proposed Bill will discriminate against prisoners in the quality and costs of their health care. Members of our community who require chemotherapy for cancer are offered collection and storage of their semen, provided free of charge by several public services in NSW. Under the proposed Bill, prisoners are required to pay storage fees during their imprisonment, even if their sperm were placed in storage before their incarceration. Discriminating against certain prisoners by demanding payment for otherwise free services could be seen as a “cruel and unusual punishment”. The NSW Legislative Assembly passed the Bill on 25 May 2006. Medical, legal and human rights organisations, and individuals expressed concern to parliamentarians. In the Legislative Council on 7 June 2006, a majority vote referred the Bill to the General Purposes Standing Committee No. 3. This Committee has received submissions and will provide recommendations as to how the Bill should proceed. If passed into law, the Bill would breach the principle of equivalence of health care for prisoners. The Australian Medical Association position statement on the Health care of prisoners and detainees states: “The duty of medical practitioners to treat all patients professionally with respect for their human dignity and privacy applies equally to the care of those detained in prison, whether convicted or on remand, irrespective of the reason for their incarceration.”2 I argue that the Bill implies an intention to rid society of “criminal seed” and begins a move towards eugenics. If our society really accepts the idea that inmates of correctional facilities may one day return to a full and productive life, then it is unreasonable to deny them the possibility of having their own children because they developed a serious cancer. If this legislation is passed, a discriminatory practice of medicine according to convict status will be enshrined in NSW law.

John E J Rasko

Re: “Doctors behaving badly?”, by Martin H N Tattersall and Ian H Kerridge, in the 18 September issue of the Journal (Med J Aust 2006; 185: 299-300). The first reference was attributed to the wrong newspaper. The reference should read: “1 Stop the gravy train [editorial]. The Sydney Morning Herald 2006; 7 Aug: 8.” The html and pdf versions of this article were corrected on 20 Nov 2006.

Martin H N Tattersall FRCP, FRACP, MB BChir · Ian H Kerridge FRACP, FRCPA, MPhil

On balance, new guidelines for parents and practitioners are helpful and workable Which infants at the margins of viability should receive neonatal intensive care and how should such decisions be made? These challenging questions are posed in this issue of the Journal by Lui and colleagues.1 Their answers, arrived at by means of a multidisciplinary conference, are presented as a consensus statement that makes several recommendations for practice. Although similar multidisciplinary conferences have been held in Australia over the past 20 years, there are no contemporary publications on the subject and this statement is timely. As has been apparent from other commentaries both here and overseas,2 these guidelines for New South Wales and the Australian Capital Territory confirm that the area of most debate concerns infants of 23–25 weeks’ gestation. However, several important questions can be asked about the consensus statement itself, including: How appropriate was the process undertaken to arrive at the statement? Was consensus reached? And, are the recommendations helpful and “workable”? As to the appropriateness of the process, there are several options for dealing with these difficult ethical and management decisions. I recall that, at two earlier conferences held at Westmead, Sydney, in 1985–1986, four approaches were identified: a “look to the courts” approach (this approach is not readily available, is expensive and generally produces conservative rulings); a “right to life” approach or, “if it can be done, it should be done”, whatever the burden this imposes on the patient, their family and society; a “muddle through” approach or, “doing what seems best at the time”; and an “institutional” approach. The “muddle through” approach has been a pragmatic solution in the past, leading to a great deal of sensible practice, and it is increasingly subject to controls, including audits and peer review. However, the “institutional” approach — particularly in the guise of a multidisciplinary conference — was, at that time, put forward as the most logical and coherent way of informing community debate and public policy. This approach has worked well in other areas (eg, providing guidelines for human organ transplantation). It would also seem very appropriate for this current debate. A prerequisite for this process would be that good data are available on the consequences of choosing resuscitation over comfort care. In this instance, the process worked well, because the workshop was presented with comprehensive population-based data from NSW and ACT on survival after live birth and neurodevelopmental status at 2–3 years of age. Although the numbers of infants at each gestational age were relatively small, the data are similar to those obtained from other Australian population-based studies.3 A longer-term follow-up would have been preferable, but such data are subject to the problem that elements of neonatal intensive care change over time. On the question of whether consensus was reached, the statement revealed that not all recommendations were agreed to by all participants; not surprisingly, there was considerable divergence of views in some areas. Delegates were asked to vote anonymously (using a five-point scale) on a range of scenarios and related statements. “Consensus” was defined as more than 90% “agree” or “strongly agree” or, for some statements “of lesser gravity”, as 75% “agree” or “strongly agree”. The process was rigorous and likely to have honestly reflected the group’s views. However, only 72% of participants agreed with a statement about not initiating resuscitation at a gestational age of between 25 weeks and 25 weeks 6 days (250–6) if requested by parents in an otherwise uncomplicated pregnancy. Although this was clearly a majority view, it did not, strictly speaking, reach the stated definition of “consensus”, but was incorporated in the consensus statements. The composition of the multidisciplinary group would also seem crucial to the process. Here, perhaps, there were some shortcomings. The group of 112 delegates convened by Lui and colleagues were mainly health professionals, although eight were non-clinical health administrators and seven were parents or community advocates. Including others, such as educationalists, ethicists, lawyers and religious leaders, would have made the delegates more broadly representative of society, and possibly different views would have emerged. However, various professional and consumer groups as well as the NSW Health Clinical Ethics Advisory Panel have subsequently reviewed the agreed guidelines. Are the guidelines helpful and “workable”? Certainly, it is helpful to have widely agreed and ethically approved written guidelines in this area of neonatal practice. In a commentary published in 2004, Jerold Lucey, the long-serving Editor-in-Chief of the leading United States journal Pediatrics, made it clear that in his view any treatment of these infants is experimental.4 In some sense, all medical treatment is an experiment, although commonly the outcome is more predictable than in the case of extreme prematurity. At these gestational ages, there are too few data relating to treatments found to be effective in more mature infants (eg, exogenous surfactant) to pretend that their use is evidence- based. Thus, as a key consensus recommendation says, within this gestational age range (23 weeks to 25 weeks 6 days) when gestation is known with reasonable certainty, “parents’ involvement in the decision-making process during prebirth counselling or subsequent management is mandatory”. The issue of non-directive counselling was discussed at the workshop. Not all parents demand total autonomy in decision making;5 indeed, some may be impossibly overburdened by the prospect.6 The important issue, as emphasised in these and earlier guidelines on preterm care,7 is that good communication is at the very core of the partnership between the medical team (the current caregivers) and parents (the future caregivers) that unfolds as perinatal and neonatal intensive care progresses. Information provided to parents by different members of the team should be consistent. Having appropriate written material, which will be available as a result of this consensus workshop, will facilitate this process. Perhaps the most important consensus recommendation states that, at gestational ages between 23 weeks and 25 weeks 6 days, treatment is discretionary. Lui and colleagues use the term “grey zone” to emphasise that, at these gestations, there is a complexity of maternal, obstetric and clinical factors known to influence outcome that need to be considered in making individualised decisions. Sex of the infant was not included in the discussions because it was stated that it was not usually known before birth. However, there is now extensive evidence that, at these short gestations, female infants do have a better survival rate, to some extent a better long-term outcome, and essentially are the equivalent of a week more mature than their male counterparts.8 Increasingly, the sex of the neonate is known before birth, and otherwise is immediately apparent at birth. It could be argued that there should be different grey zones for female and male infants. Certainly, not to consider the infant’s sex may be to discriminate against female infants.9 Many factors, including the sex of the neonate, should influence decisions not only within the zone but at its margins. Data from the Australian and New Zealand Neonatal Network show that survival rate at these short gestations increases by about 3% with each day of increased maturity.10 This, added to the fact that gestational age is often an estimate, means that the margins of any grey zone are somewhat indistinct. The consensus statement’s abstract states that “poor condition at birth” has an important influence on the decision not to initiate intensive care in this zone. However, there are few data to support the predictive value of condition at birth for survival and certainly not for neurodevelopment.11 A prediction that an infant of a certain gestational age will do poorly, coupled with non-aggressive resuscitation, is likely to be a self-fulfilling prophecy. However, a poor response to adequate resuscitative measures must clearly be a factor in decisions about ongoing intensive care. In their statement, Lui and colleagues have provided valuable guidelines for parents and practitioners dealing with impending extremely preterm delivery; they should be congratulated on the rigour of their process. It is now up to others to use these guidelines wisely. In the abstract (which may be the only part some people will read), the description of the grey zone seems a little too black and white, with clear margins. The main text of the statement — which should be read in its entirety — makes it clear that this zone is not uniform grey and that its limits are indistinct.

Brian A Darlow MD, FRACP

Perinatal care at the borderlines of viability demands a delicate balance between parents’ wishes and autonomy, biological feasibility, clinicians’ responsibilities and expectations, and the prospects of an acceptable long-term outcome — coupled with a tolerable margin of uncertainty. A multi-professional workshop with consumer involvement was held in February 2005 to agree on management of this issue in New South Wales and the Australian Capital Territory. Participants discussed and formulated consensus statements after an extensive consultation process. Consensus was reached that the “grey zone” is between 23 weeks’ and 25 weeks and 6 days’ gestation. While there is an increasing obligation to treat with increasing length of gestation, it is acceptable medical practice not to initiate intensive care during this period if parents so wish, after appropriate counselling. Poor condition at birth and the presence of serious congenital anomalies have an important influence on any decision not to initiate intensive care within the grey zone. Women at high risk of imminent delivery within the grey zone should receive appropriate and skilled counselling with the most relevant up-to-date outcome information. Management plans can thus be made before birth. Information should be simple, factual and consistent. The consensus statements developed will provide a framework to assist parents and clinicians in communication, decision making and managing these challenging situations.

Kei Lui MB BS, MD, FRACP · Barbara Bajuk MPH · Kirsty Foster MB ChB, DRCOG, MEd · Arnolda Gaston MPH · Alison Kent BM BS, FRACP · John Sinn MB BS, FRACP, MMed(Epi) · Kaye Spence RN, BEd(N), MN, FCN · Wendy Fischer BA(Hons), RN, CM · David Henderson-Smart MB BS, PhD, FRACP

Complex societal factors unrelated to evidence of efficacy influence the increasing use of complementary and alternative therapies, which can be viewed as one form of health consumerism. The “therapeutic footprint” is a conceptual model that “plots” medical therapies and complementary and alternative therapies in relationship to one another and to their levels of risk and supporting evidence, acknowledging that medical therapies also entail risks. Philosophies about management of risk and adverse effects differ between complementary and alternative therapies and standard medical care, due to fundamental differences between professionalism within medicine and the demands of health consumerism. In standard medical care, patients’ risks are mediated prior to treatment via the doctor–patient relationship and informed consent. With complementary and alternative therapies, protection mechanisms for consumers come into effect mainly after a problem has occurred. Understanding this difference helps doctors whose patients are using complementary or alternative therapies to define the boundaries between these therapies and professional medicine and provide appropriate disclosure of risks. Discussing complementary and alternative therapies and how they differ from standard medical care can provide opportunities to explore patients’ concerns and improve the therapeutic relationship.

Christine R Sanderson BM BS, MPH, FRACP · Bogda Koczwara BM BS, FRACP, MBioethics · David C Currow BMed, MPH, FRACP

To the Editor: Recent articles in the Journal by Kurrle1 and Finn and colleagues2 referred to advance care directives aiding the management of acute illness in elderly residents of aged care facilities. It is our experience that these directives are often unhelpful in elderly patients and, outside certain progressive medical conditions, can result in triage of elderly patients to inappropriate lower levels of care. In chronic medical conditions where the clinical course allows time for patient or family understanding, and the course of organ failure is predictable, then certain supportive but ultimately futile therapies can be avoided by instituting an advance care directive that specifically excludes them. However, these directives are less helpful in acute illnesses. They usually refer to “intensive care”, and “life support”, sometimes specified as mechanical ventilation, dialysis or cardiopulmonary resuscitation. These “general” advance care directives fail, as they assume that prognosis is immediately apparent, and that treatment is “all or nothing”, both of which assumptions are clearly untrue. Determining an accurate prognosis for recovery from a critical illness is difficult and takes time. It involves diagnosing the cause of the illness, quantifying the severity of comorbidities and, most importantly, assessing response to initial treatment. Whether severe sepsis is arising from the urinary tract or abdominal cavity may not be apparent initially. Many elderly patients survive severe septic shock caused by urosepsis with haemodynamic monitoring and short-term high-dose vasopressors. It is also not possible to distinguish which patients with severe respiratory failure will respond to non-invasive ventilation. We followed up critical care patients aged 75 years and over who survived to hospital discharge over a 12-month period and confirmed that acceptance of critical care admission in elderly people is high (unpublished study; details available from the authors). This is the very population that, in our experience, frequently says they do not want to be placed on “life support”, if asked when well. Together with the fact that an accurate prognosis takes time, then a prudent approach should begin with the presumption of aggressive treatment for acutely unwell elderly patients, rather than a presumption of limited therapy or palliation. Advance care directives that refer to therapies need to be specific and to recognise that critical care therapy can be graduated and readily terminated once a more accurate prognosis is known. Furthermore, some critical care therapies, such as non-invasive ventilation and high-concentration oxygen, can significantly improve patient comfort while management plans are formulated. In our experience, patients and their families are often very surprised when they understand the full implications of an advance care directive that refers to generic therapies, such as cardiopulmonary resuscitation and “intensive care”.

Andrew W Holt · Alnis E Vedig

It is in doctors’ and the drug industry’s best interests that their interactions be openly declared There is no such thing as a free lunch. Pharmaceutical companies lavish meals, five-star travel, cash and gifts on doctors for one reason: to encourage them to prescribe their drugs. The standard retort from the medical profession is that doctors have sufficient clinical objectivity — and personal integrity — not to be so crudely swayed. Perhaps so.1 The interaction between doctors and the pharmaceutical industry was recently catapulted into the public domain by a piece of investigative journalism published in The Australian, detailing the wining and dining of doctors by the pharmaceutical giant, Roche, at an educational meeting in Sydney.2 What surprised many observers was not the revelations regarding the extent of hospitality provided by pharmaceutical companies to doctors, but the response of the Australian Medical Association (AMA). The AMA’s public stance was that pharmaceutical industry sponsorship of accommodation and restaurant meals is perfectly acceptable, that drug company sponsorship serves to “oil the wheels” of medical education, and that industry-sponsored events provide valuable opportunities for doctors “to critically question the companies’ products” and that “no patient harm comes from this practice”.2 A review of the literature, however, suggests that this is not true.3,4 The Australian Competition and Consumer Commission (ACCC) had a differing view. Following the recent release of the ACCC’s revised guidelines for disclosure of industry support, the Chairman of the ACCC noted that “Consumers should be able to have confidence that decisions made by their doctors are made solely having regard to their best interest without any potential for influence by benefits or perks”.5 Stated in these terms, the issue is not so much the pharmaceutical industry itself, but the prevention, assessment and management of conflict of interest and, more fundamentally, the importance of public trust in doctors. The moral core of medicine and the therapeutic relationship has always been expressed in terms of the possession and expression of values such as honesty, integrity, benevolence, respect, compassion, courage and trustworthiness. Trust, which in relation to health care may denote faith, commitment, respect, belief and confidence, has been the focus of extensive academic exploration by a broad range of writers.6-10 All have pointed to the centrality of trust in therapeutic relationships, the “non-legal” expression of trust, the specific and contextual nature of trust and the manner in which trust can be threatened, diminished or destroyed by actions or behaviour including professional incompetence, abuses of power, boundary violations, experience of harm or the lack of care or respect, deception and manifest conflicts of interest.11 Of those things that may damage trust in doctors, much of the attention in recent years has been on recognising and managing conflict of interest. What then constitutes a conflict of interest and how may we avoid it occurring? Although medical codes of ethics and statements of medical professionalism often give the impression that doctors have a single higher duty to care for the sick, in reality, the relationships that doctors have with their patients are determined by multiple interests, many of which may influence care or decision making. Doctors may hold patient care as their highest professional ideal, but they may also be concerned with community welfare, participation in research, career advancement, student teaching, continued employment, public or professional recognition, and the obligations they have to their care for themselves and their families. While it is inevitable that doctors will have multiple interests, true conflicts of interest (a set of conditions in which professional judgement concerning a primary interest, such as a patient’s welfare, is unduly influenced by a secondary interest, such as financial gain) are neither inevitable nor common.12 But distinguishing where there are no conflicts between these interests from where there is a genuine conflict of interest is sometimes difficult, as any assessment of behaviour must take into account the ethical standards of the profession, the nature of the relationship in question, and the values of the community within which it occurs. What makes this assessment even more difficult is that standards of doctors’ behaviour may change as a consequence of deeper sociocultural changes, and according to changes in professional interests, and changes in public or patient needs and expectations. This means that the only way to establish that a conflict of interest exists is to have all the relevant facts available for scrutiny by the participants in the relationship, and by the community or an independent third party. This is only possible if there is a genuine commitment to disclosure and transparency in all areas of medical practice. Unfortunately, a review of the history of medicine suggests that the medical profession has, until recently, generally been reluctant to be exposed to public scrutiny, either out of fear of legal or social repercussions that may result from such disclosure, or on the grounds that that there is no need for it or no public desire for it. Although such concerns may be understandable, for the most part they are unfounded. Transparency and honest disclosure may actually reduce loss of trust, formal and informal complaints and litigation, and it is the culture of secrecy and sense of moral superiority that sometimes runs through the health professions, rather than “unnecessary” exposure to a disinterested public, that threatens public trust and undermines the doctor–patient or researcher–patient relationship. In this regard, it is of note that a recent randomised trial in the United States of disclosing doctors’ financial incentives to patients found that patients’ trust in their doctors was unharmed, and their loyalty to their doctor’s practice was strengthened.13 Therefore, it is hard to disagree with the ACCC that there is merit in increasing the degree to which the relationships between doctors and the pharmaceutical industry are transparent. It may, as has been claimed, ultimately prove to be the case that these relationships do not give rise to conflicts of interest and that the ACCC’s new reporting requirements are excessive or unreasonable, but at this stage we do not know that this is true, and we have ample evidence that interaction with industry can create complex and dependent relationships and influence decision making, prescribing, formulary requests, attitudes and knowledge regarding pharmaceuticals and therapeutics, and the design and interpretation of research.14 In light of this, it is in doctors’ and the industry’s best interests that their interactions be openly declared in the relevant context. This will enable informed public and professional consideration of the legitimacy of each group’s interest and determination of whether a conflict of interest exists and what measures should be taken to deal with it. There are many means for encouraging transparency, responsibility and accountability in health care, including the incorporation of ethics in medical education; support for inquiries into professionalism and trust; introduction of templates for disclosure of secondary interests in the research and clinical setting;15 development and compliance with codes of ethics by the major medical colleges and industry groups; incorporation of patients’ representatives and conflict of interest committees into hospitals; and establishment of health care complaints commissions by government. All are deserving of support, even though currently there are insufficient data to evaluate the effect of most such interventions. Given what we know about the fragility of trust in medicine and the interaction between doctors and the pharmaceutical industry, the profession should support moves to increase disclosure. Even though disclosure may not, in itself, reduce the frequency of unethical behaviour or relationships, and may have no effect on public awareness, it is impossible to adequately identify, manage or prevent conflicts of interest if doctors, the peak bodies that represent them, and the industry groups with which they deal are not completely open about their interactions. Claims that the medical profession is not subject to influence, that the possibility of conflicts of interest arising in relationships between doctors and the pharmaceutical industry does not exist, and that disclosure requirements will lead to the collapse of continuing medical education are naïve, unfounded, inappropriate, and counterproductive. Doctors occupy a unique position of trust in society. They should act solely in the best interests of the patient — as many do. But drug companies spend billions of dollars on promotions because they work. The medical profession cannot have it both ways. If doctors want to be seen to be beyond influence, the remedy is simple. Be willing to say thanks, but no.1

Martin H N Tattersall FRCP, FRACP, MB BChir · Ian H Kerridge FRACP, FRCPA, MPhil

Australia is largely self-sufficient in its supply of safe, fresh blood products because of the goodwill of non-remunerated, volunteer donors, plus rigorous testing and processing standards. CSL Limited is the sole provider of plasma fractionation services in Australia, enjoying exclusive rights under the Plasma Fractionation Agreement with the Australian Government. In the Australia–United States Free Trade Agreement (AUSFTA), Australia agreed to review its current contract with CSL Limited, and to recommend to the states and territories that the process be opened up to overseas tender. Overseas tenders for off-shore fractionation services are likely to be highly competitive due to their low manufacturing costs and accumulated expertise. Off-shore fractionation could compromise the safety of Australia’s blood supply through delays in processing and transportation, issues related to quality control, and even the siphoning of stock to overseas markets. This could compromise the long-term care of Australian patients and create a serious national security risk in the event of a terrorist attack or natural disaster. Australia’s AUSFTA obligation to recommend changes does not equate to an obligation to actually proceed. The states and territories should carefully consider whether such changes would be in our national interest. The long-term security of the Australian people in the current security environment is dependent on continuance of an on-shore fractionation plant and appropriate back-up facilities.

Hilary J Bambrick BSc, BA(Hons), PhD · Thomas A Faunce LLB(Hons), BMed, PhD · Kellie Johnston BSc(Hons), LLB(Hons)

Objectives: (i) To determine the proportion of patients in New Zealand who claim compensation from the national no-fault compensation program after experiencing a compensable injury; and (ii) to identify characteristics of injured patients who are least likely to claim despite having sustained a compensable injury.Design: We estimated the percentage of eligible patients who claim no-fault compensation by linking a national claims database (Accident Compensation Corporation) to records reviewed in the New Zealand Quality of Healthcare Study (NZQHS). Bivariate and multivariate analyses were used to investigate socioeconomic and sociodemographic differences between claimants and injured non-claimants.Participants and setting: Patients who experienced an adverse event associated with care in NZ public hospitals in 1998 and claimed compensation with the ACC, the national no-fault insurer (n = 741). Patients identified by the NZQHS as having sustained an adverse event associated with hospital care in the same year who did not file a compensation claim (n = 839).Main outcome measures: Adverse events, compensable adverse events, and compensation claims.Results: Among patients judged by NZQHS reviewers to be eligible for compensation, 2.9% (6/210) claimed. Odds of claiming after an adverse event were significantly lower for patients who were elderly (odds ratio [OR], 0.20; 95% CI, 0.14–0.28), from the most deprived areas (OR, 0.36; 95% CI, 0.23–0.57), or of Māori; or Pacific ethnicity (OR, 0.47; 95% CI, 0.32–0.69 and OR, 0.26, 95% CI, 0.11–0.58).Conclusions: Despite few apparent institutional or economic barriers, the proportion of injured patients in NZ who seek compensation after sustaining a compensable injury is very low. Hence, substantial underclaiming occurs in both negligence and no-fault systems. The disproportionately low propensity of elderly, poor and minority patients to seek compensation also appears to be pervasive.

Marie M Bismark MB ChB, LLB, MBHL · Troyen A Brennan MD, JD, MPH · Peter B Davis PhD · David M Studdert LLB, ScD, MPH