Ethics

Most specialised mental health services in Australia are delivered in community settings and one in six services comprise involuntary treatment. Despite a growing demand for community treatment orders (CTOs) worldwide — and comparatively high rates of use in Australia — the clinical, legal and ethical aspects of CTOs remain contentious. This article examines ...

Edwina M Light BA(Comms), GradCertJournalism, GradCertBioethics · Ian H Kerridge MPhil, FRACP, FRCPA · Christopher J Ryan MB BS(Hons), MHL, FRANZCP · Michael D Robertson MB BS(Hons), FRANZCP, PhD

Reconsidering the place of disease monitoring after treatmentWomen who have completed primary chemotherapy for ovarian cancer commonly have serial assessment of the serum tumour marker cancer antigen 125 (CA-125).1 This practice has been based on the ...

Paul Harnett MB BS(Hons), FRACP, PhD · Ian H Kerridge BMed(Hons), FRCPA, FRACP · Christopher F C Jordens BA(Hons), MPH, PhD · Kim Hobbs BSocStud(Hons) · Catherine Mason MB BS, MPH, FRANZCP · Bronwen M Morrell BA(Hons)

Objectives: To document the existence and provisions of Australian universities’ policies on the competing interests of academic staff and university practices in recording, updating and making these declarations publicly accessible. Design and setting: ...

Simon Chapman PhD · Bronwen Morrell BA(Hons) · Rowena Forsyth BA(Hons), PhD · Ian Kerridge BMed(Hons), FRCPA, FRACP · Cameron Stewart BEcLLB(Hons1), PhD, FACLM(Hons)

Findings from a Queensland coronial inquest highlight the complex clinical, ethical and legal issues that arise in end-of-life care when clinicians and family members disagree about a diagnosis of clinical futility. The tension between the law and best medical practice is highlighted in this case, as doctors are compelled to seek family consent to not commence a futile intervention. Good communication between doctors and families, as well as community and professional education, is essential to resolve tensions that can arise when there is disagreement about treatment at the end of life.

Sean Lawrence MB BS, FACEM · Lindy Willmott BCom, LLB(Hons), LLM · Eleanor Milligan PhD, BA(Hons), BSc · Sarah Winch BA(Hons), PhD · Ben White LLB(Hons), DPhil · Malcolm Parker MB BS, MHealth

Futility assessments, which are unavoidable in end-of-life settings, need to be procedurally fair. This necessitates communication between health professionals and substitute decisionmakers regarding the decision to define treatments as futile. The common law test for whether treatment should be withheld or withdrawn is the best interests test. A futile treatment is not in any patient’s best interests. While it is rare for the law to disagree with a futility determination made by health professionals, if a determination has been made without consultation and fails to reflect the patient’s best interests, the courts will overturn it. The best regulatory regimes provide for a balance between the powers of health professionals and substitute decisionmakers to make decisions for incompetent patients, and for clear and efficient dispute resolution. The Queensland law and its requirement for consent to withhold or withdraw futile treatment represents a good model of futility determination, with clear powers given to substitute decisionmakers and health professionals. Disputes concerning the treatment of incompetent patients automatically trigger the appointment of the adult guardian as the decisionmaker, and there are avenues for appeal.

Cameron L Stewart BEc, LLB(Hons), PhD

Recent federal trade policy commitments could protect Australia’s tobacco control legislation and the Pharmaceutical Benefits Scheme in the Trans-Pacific Partnership Agreement negotiations In its Trade Policy Statement of April 2011, the Australian Government committed to “preserve the right of Australian governments to make laws in important public policy areas” and to reject provisions in trade agreements that could “limit its capacity to put health warnings or plain packaging requirements on tobacco products or its ability to continue the Pharmaceutical Benefits Scheme”.1 One forum in which this resolve is likely to be tested is the Trans-Pacific Partnership Agreement (TPPA) negotiations. The TPPA is a proposed regional free trade agreement between Australia, Brunei, Chile, Malaysia, Peru, Singapore, New Zealand, the United States and Vietnam — a diverse assortment of countries from several continents around the Pacific rim. The TPPA differs from existing bilateral and regional free trade agreements in its sheer size and geographic diversity. It has the potential to restrict national policy space — “the freedom, scope and mechanisms that governments have to choose, design and implement public policies to fulfil their aims”2 — on an unprecedented scale. This article explores the potential for the TPPA to constrain Australia’s national health policy space through two illustrative case studies: tobacco plain packaging and the Pharmaceutical Benefits Scheme (PBS). Investor–state dispute settlement and plain packaging of tobacco productsDuring 2011, the Australian Government introduced legislation requiring tobacco products to be packaged in plain paper (with graphic health warnings, but minimal branding). This represents an important assault on one of the last bastions of tobacco marketing — the appeal to personal identity.3 Strong tobacco control policies such as Australia’s tobacco plain packaging laws are consistent with a substantial body of scientific literature and the World Health Organization’s Framework Convention on Tobacco Control, but they can be challenged under international trade and investment agreements, which are driven by economic rather than public health goals. Philip Morris Asia (PMA) — a subsidiary of Philip Morris International (PMI) — has launched an investor–state dispute against the Australian Government over its tobacco plain packaging legislation. While several tobacco companies have taken their complaints to the High Court, PMA has also been able to pursue its case in international arbitration (where it has a greater chance of success) through an investor–state dispute settlement (ISDS) clause in a bilateral investment treaty signed between Australia and Hong Kong in the early 1990s. This is the second investor–state dispute to arise over tobacco labelling; PMI is bringing a similar case against Uruguay through a Swiss subsidiary.4 PMI has also been prominent in calling for an ISDS provision in the TPPA.4,5 Ironically, the corporate restructuring that has allowed PMI to access the Hong Kong bilateral investment treaty (PMA was made the sole shareholder in Philip Morris Australia in February 2011) has also significantly weakened its claims. This is because the investment was made with the company’s full knowledge that the plain packaging legislation was being developed.6 The government has a strong case. Nevertheless, the dispute with PMA highlights broader problems of including ISDS provisions in trade treaties, and demonstrates why it is important that they be excluded from the TPPA. The arbitration rules that govern PMA’s dispute with the Australian Government are those of the United Nations Commission on International Trade Law. The case will be decided by a tribunal made up of three members: one chosen by PMA, one chosen by Australia, and a third, mutually agreed upon, which will act as president. This method of appointing arbitrators has been described as neither independent nor impartial.7 In sharp contrast to domestic forms of adjudication, individuals can serve as a legal representative in one ISDS case and an arbitrator in another, further undermining their ability to act without bias. Furthermore, although the arbitrators will be experts in international investment law, they may have little or no experience with specific fields of public policy such as tobacco control. While the public has a stake in investor–state disputes, confidentiality is a dominant principle in investment arbitration. Hearings are rarely opened to the public unless both parties agree, and investors have opted for closed hearings in several recent cases concerning public policy. In this regard, it is commendable that the Australian Government has adopted a high standard of transparency in advance of the commencement of formal proceedings by posting PMA’s claims and their response on a public website.8 The arbitration will be expensive for Australian taxpayers, although the government may be able to recoup some of the costs if it prevails. In several investor–state disputes to date, legal fees alone have amounted to over US$4 million and in one case have exceeded US$13 million.9 There are also arbitrator’s fees, administration fees and additional costs for involving experts and witnesses. Even more significant are the awards in investor–state cases, which are widely enforceable.7 The Czech Republic was obliged to pay more than US$350 million in compensation to a Dutch investor, which according to one report meant a near doubling of the country’s public sector deficit.10 It can readily be seen how insertion of a TPPA ISDS mechanism into Australia’s national health policy space might skew legislation away from the public interest towards supranational corporate interests. This is why it is significant that the government has vowed to no longer include provisions on ISDS in the bilateral and regional trade agreements that it signs.1 Australia’s refusal to consent to ISDS in the TPPA is a significant step towards limiting the encroachment of international trade agreements into our national health policy space and retaining our sovereign right to regulate significant areas of public health policy. US proposals for medicines policy in the TPPAChallenges to Pharmaceutical Benefits Advisory Committee processesThe PBS is another area of domestic health policy that the Australian Government has committed to protect in international trade agreements. However, US TPPA negotiators are seeking substantial changes to Australia’s laws and administrative processes. Certain draft TPPA provisions relate to the PBS directly and also indirectly, by seeking to prolong pharmaceutical patents and minimise exceptions to them made in the public interest. We examine these proposals as another instance of how the TPPA may promote incursions into our national health policy space. In October 2011, a draft annex to the transparency chapter of the TPPA was leaked.11 Under the rubric of transparency and procedural fairness, this TPPA annex seeks to impose new restrictions on the operation of national pharmaceutical reimbursement and pricing schemes (Box 1). It is an annex because it is not designed to apply to the US, as it would if it was in the body of the treaty. Clause (d) of paragraph X.3 of the draft annex would require countries to reimburse pharmaceutical companies based on “competitive market-derived prices in the Party’s territory”, or other benchmarks that “appropriately recognize the value” of the patented product. This wording represents a shift away from the more science-based standard in Annex 2-C of the Australia–United States Free Trade Agreement (AUSFTA), which refers to the “objectively demonstrated therapeutic significance” of the new patented pharmaceutical (http://www.dfat.gov.au/fta/ausfta/final-text). This provision includes no mechanism for proving that prices are derived from “competitive” markets. It undermines the world-class science-based mechanisms used by the Pharmaceutical Benefits Advisory Committee (PBAC) to determine whether a new patented medicine has sufficient health innovation to be listed on the PBS (based on a determination of cost-effectiveness, as well as efficacy, quality and safety). Paragraph X.3 of the draft annex seeks to impose a new independent appeals process on determinations by government bodies such as the PBAC (Box 1). This is contrary to what was decided (after prolonged and acrimonious negotiations) under Annex 2-C of the AUSFTA, which only provides for independent expert review as a quality improvement exercise for the PBAC. The threat and the use of an independent appeals process would increase the capacity of the pharmaceutical industry to lobby against PBAC decisions and undercut their expert-informed determinations. Paragraph X.4 of the draft annex requires parties to permit pharmaceutical companies to disseminate information to health professionals and consumers via the internet — a practice that is not permitted for prescription drugs in Australia due to concerns about overprescribing. This is also contrary to Annex 2-C of the AUSFTA, which makes the direct advertising of pharmaceuticals subject to Australia’s domestic laws, regulations and procedures. There is a consensus against such advertising in the Australian national policy space, chiefly because of its capacity to increase lobbying of the medical profession for purposes of corporate gain rather than public health benefit. While the effect of US TPPA proposals on Australia’s PBS would be economically damaging and reduce the affordability of medicines in Australia, the effects on access to medicines in other TPPA countries could be far more severe, particularly for developing countries and those required to make greater changes to their domestic laws.12 Extending intellectual property rightsUS TPPA proposals on intellectual property applying to patents13,14 (Box 2) would also add to the cost of medicines overall, affecting the sustainability of the PBS. Non-government organisations have undertaken extensive analyses of these proposed provisions,12,15 and have shown areas where TPPA provisions extend patent protection beyond comparable AUSFTA patent provisions and existing Australian law.15 For example, proposed article 8.1 of the intellectual property (IP) chapter of the TPPA provides patent protection for new forms, uses or methods of using a known product, whereas article 17.9.1 of the AUSFTA does not require patent protection to be provided for new forms of existing drugs.15 Although, in practice, new forms are sometimes patented, the TPPA proposals would restrict efforts to tighten patenting standards in future. Proposed IP article 8.2 requires patenting of diagnostic, therapeutic and surgical methods, whereas article 17.9.2 of the AUSFTA allows for its exclusion.15 This change could restrict expeditious patient access to new clinical developments and substantially add to health care costs. Proposed IP article 8.7 would also eliminate pre-grant opposition to patent applications by third parties, a safeguard provided for in the Australian Patents Act 1990, which is designed to prevent unwarranted patents from being granted.15 Most concerning are the provisions for data exclusivity periods — where generic manufacturers cannot use clinical trial data to prepare and register their products for springboarding after patent expiry. Proposed IP article 9.214 provides an additional 3 years of data exclusivity for new uses of existing pharmaceutical products, on top of the 5 years of data exclusivity already permitted under article 17.10.1 of the AUSFTA. There is also a placeholder for specific provisions for biologics (medicines produced from biological products, which are not currently dealt with separately in Australia). US pharmaceutical companies are reportedly lobbying for 12 years of data exclusivity for biologics. If adopted, these proposals would lead to higher costs to the PBS (as drugs stay under patent for longer periods) and delayed entry of cheaper generic medicines into the market. The US TPPA proposals for extended intellectual property rights and data exclusivity for pharmaceutical companies would require changes to Australian laws and administrative processes. They would also conflict with the spirit of the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, which is currently before the Senate and seeks to raise patent standards and facilitate faster regulatory approval for generic medicines. ConclusionRecent Australian trade policy commitments to exclude ISDS and provisions that would affect the PBS from the TPPA are a positive step towards preserving sovereign, democratic and science-based control over our national health policy space. It is important that Australia continues to insist that future trade agreements, including the TPPA, do not extend the intellectual property privileges of patent holders, interfere with the operation of the PBS or provide foreign corporations with ISDS rights to challenge domestic public health policies. 1 Leaked United States demands for changes to schemes such as Australia’s Pharmaceutical Benefits Scheme Pharmaceutical Benefits Advisory Committee (PBAC) recommendations to be based on competitively derived market forces or systems that appropriately value patented pharmaceuticals (no mention of “objectively derived therapeutic significance” as in the Australia–United States Free Trade Agreement) Appeals process able to challenge PBAC recommendations Heightened capacity for direct-to-patient pharmaceutical advertising 2 Some United States proposals for extensions to intellectual property rights applying to patents Patent protection for new forms of existing drugs Patenting of diagnostic, therapeutic and surgical methods Elimination of pre-grant opposition Extensions to data-exclusivity periods for some drugs

Deborah H Gleeson BSc(MLS), MPH, PhD · Kyla S Tienhaara PhD · Thomas A Faunce BA LLB(Hons), BMed, PhD

To the Editor: Le and Chapman’s article1 on capacity at the end of life raises a number of timely issues, given our ageing population and the autonomous rights of individuals in end-of-life decision making.2 The authors made a best-interests decision, based on the patient’s humanity and their responsibility not to let him die “alone, cold and probably in pain”, contrary to his “decision” to die what would not be “a good death”. This stance can be problematic because best interests or good death are entirely subjective, and doctors who provide treatment to a competent patient may be committing trespass.3 Thus, the question of whether he was capable of making a decision to die “a bad death” is possibly more crucial. Structured capacity assessment is beneficial for the peace of mind of clinicians, patients and family. This patient lay on the floor “because he wished to do so” — a “limited realistic choice”. He was delirious and therefore deemed incompetent. Did the delirium affect his ability to weigh the pros and cons of staying on the floor and refusing hospital admission? Assessment of capacity to consent to medical treatment involves determining whether the patient is capable of understanding the ramifications of treatment and its alternatives (including no treatment). His premorbid choices (precedent autonomy)4 of living a squalid, isolated existence and refusing treatment for some time must also be noted. Yet capacity is dynamic and can change over time. Careful capacity assessment can justify decisions made on behalf of patients.

Sharon G Reutens · Carmelle Peisah

In reply: We thank Reutens and Peisah for their response to our article.1 We agree that careful capacity assessment is of critical importance — a patient’s capacity should be assessed rather than assumed. Delirium can often affect capacity due to the impact of attentional deficit on the process of decision making.2 In our case, the patient could neither reason through the ramifications of his decision to stay on the floor nor be involved in a logical discussion as to why we had concerns about his choice. Indeed, he had not chosen to be on the floor but was there because of his fall, his delirium and his inability to rise. However, we do caution that clinicians should trust their own clinical decisions when these are based on sound assessment. Choosing not to make hard decisions for fear of litigation (eg, committing trespass) does neither the patient, the community nor our profession any favours.

Brian H Le · Michael D Chapman

To the Editor: In reply to my critics whose letters were published in the 20 February issue of the Journal1-4 after the publication of my article “What is wrong with Medicare?”,5 I would ask them to look broadly at Australia’s health care dollar and how it may be misspent. It is clear that the percentage of practitioners who wilfully set out to defraud Medicare, Veterans’ Affairs, workers compensation and other forms of insurance is relatively small. However, the current structure of Medicare, which is the result of poor policy decisions, allows inappropriate practice, as well as inefficiency and cost-shifting. Inertia in health care reform will continue to diminish our ability to deliver a first-world standard of care into the future. My critics would do well to consider this.

Tony D Webber

To the Editor: We welcome the article by Williams and colleagues on conflicts of interest in clinical guidelines,1 and agree that such conflicts can undermine trust in guidelines, compromise patient care and skew health care spending. One challenge in managing conflicts is the lack of evidence that disclosure minimises their impact. For example, research at the United States Food and Drug Administration found that, despite disclosure, for every committee member with a conflict, there was a 10% greater likelihood of the meeting favouring the drug reviewed.2 Recusal (self-disqualification) is also problematic, especially in Australia where there may be a relatively small pool of experts available. Given these problems, we are concerned that some of the recommendations made by Williams and colleagues lack supporting evidence and fail to adequately address conflicts of interest. One of their recommendations, a tiered system within guideline panels limiting those with conflicts to contributions regarding the nature of the disease under discussion, for example, ignores what we know about the way that conflicts of interest operate. Research has shown that this apparently innocuous element of guideline development is not immune to influence, as conflicts of interest can influence how disease is defined, leading to broader disease definitions and lower treatment thresholds.3 A second recommendation was that guideline developers declare that “any benefits received have not influenced their professional opinion”. But surely this misses the real danger of such conflicts, which is not that of making deliberately biased decisions. Rather, the issue is that professional opinion may be unconsciously swayed by conflicts.4 Finally, they suggest an exclusion period of 3 years between receipt of industry support and involvement in guideline development. But no evidence is provided to ensure that this is “sufficient time for the conflict to have lost its potential for ‘undue influence’”. Without supporting evidence, the choice of 3 years, rather than 4 or 2 and a half, appears arbitrary. We need more research into the way conflicts of interest operate, and perhaps we need to seek a fresh pool of experts who, while less experienced, may be significantly less conflicted.

A Jane Johnson · Wendy A Rogers

In reply: We thank Johnson and Rogers for their letter. A tiered system has benefits but is not foolproof; vigilance by panels is needed to ensure disease definitions are appropriate. Delphi methodology, which can make participants anonymous via use of a facilitator, may prevent the influence of senior panel members over more junior ones in this and other regards. Although declarations would not affect conflicts operating at a subconscious level, turning one’s attention to conflicts at the time of recommendations may lead to greater awareness in some panelists. Declarations have almost no cost. We welcome more research into the length of time that “cures” conflicts. Including less experienced but less conflicted people on panels is a reasonable suggestion, though significant industry relations begin during trainee years, and expert input is likely to be beneficial for authority and take-up. Conflicts are a thorny issue, with undeniable tension between a purist approach and pragmatic considerations, particularly in a small pond. Given the present lack of transparency, we should urgently trial proposals supported by logic or evidence, and look forward to guidance from the National Health and Medical Research Council.

Michael J Williams · Dev A S Kevat · Bebe Loff

To the Editor: The perspective by Williams and colleagues,1 based on analysis of guidelines hosted on the National Health and Medical Research Council (NHMRC) portal (http://www.clinicalguidelines. gov.au), highlights the need for a culture of transparency and disclosure to effectively manage conflicts of interest. With the current health reform agenda being dependent on the availability of clear and unbiased clinical guidance, the NHMRC continues to actively address this persisting challenge. In July 2011, new standards for guideline developers seeking NHMRC approval were released. The standards make it mandatory for guideline developers to publish all sources of funding for the guideline; to publish a complete list of all the people involved, including professions, organisational affiliation and role in the guideline development process; and to publish how potential competing interests are identified, managed and documented. A competing interest declaration must be completed by each member of the guideline development group.2 The NHMRC is committed to implementing management practices for improving transparency of the development of evidence-based health advice. We recently conducted public consultation on policies for identifying and managing conflicts of interest in relation to NHMRC committees and working groups who are developing guidelines. Submissions to the consultation will be taken into account for the finalised policies, to be released in 2012. The draft policies can be viewed at http://consultations.nhmrc.gov.au/open_public_consultations/conflict-of-interest. The NHMRC has also established the Australian Guideline Developers Network and holds national workshops to help guideline developers identify and manage issues, including conflict of interest, with the aim of reducing the variability in the quality of guidelines (http://www.nhmrc.gov.au/guidelines/nhmrc-initiatives-support-high-quality-clinical-practice-guideline-development). These strategies, combined, will strengthen the role of the NHMRC in supporting the translation of health research into trustworthy clinical guidance, in areas that will most benefit the health of the Australian population.

Warwick P Anderson · John McCallum

A High Court of Australia ruling has reinstated the need for patients to prove causation of injury. The tort (ie, civil wrong) of medical negligence has recently changed, to the advantage of doctors. By its judgment in the case of Tabet v Gett in 2010....

Neera Bhatia LLB(Hons), LLM · James Tibballs MD, MHlth&MedLaw, FCICM

To the Editor: Since the claims made by Webber in his recent article1 were, in his own words, not based on any substantiated data, it is disappointing that the Medical Journal of Australia did not seek to contact either the Australian Society of Ophthalmologists (ASO) or the Royal Australian New Zealand College of Ophthalmologists (RANZCO) for comment. Certainly, considerable work can be done to improve the operation of Medicare. We are on record as having raised our concerns with successive governments.2 However, Webber’s generalised, sensationalist and unsubstantiated claims add nothing to constructive debate about Medicare. It is disappointing that the Journal would risk damaging its reputation, by choosing to publish a perspective without offering an alternative view to demonstrate balance and evidence, as one would expect in a peer-reviewed journal. Ophthalmology involves more than just removing cataracts, and while technology has made cataract procedures safer and less invasive, they remain complex and the technology very expensive.3 The RANZCO and ASO have worked with government through the Medicare Benefits Schedule Review to address concerns and shortcomings, as well as providing supportive evidence.4 On at least two occasions, we have offered revisions to the funding of treatment of macular degeneration that could save many millions of dollars in the health budget. Additionally, our proposal to reinvigorate the key subspecialty of paediatric ophthalmology has been accepted by government.

Arthur Karagiannis · William J H Glasson

To the Editor: Webber raises some well meaning points in his recent viewpoint article, some of which were taken out of context by the media.1 With respect to his comments on ophthalmologists, I would like to place on record some facts. The Access Economics ophthalmology practice costs survey,2 commissioned by the Australian Society of Ophthalmologists (ASO) in 2011, analysed the costs of delivering ophthalmic services for the financial year 2008–09. The report showed that the average overhead cost per full-time-equivalent ophthalmologist was $506 000, compared with $232 617 in 19993 — an average annual increase of 9%, during which time fees for ophthalmology items on the Medicare Benefits Schedule (MBS) increased by only 2.1% annually.4 Thus, the MBS items become increasingly irrelevant in the context of a small private ophthalmic business model. The cost to the taxpayer of a cataract procedure in New South Wales public hospitals is about $3500 (diagnosis-related group), compared with a Medicare schedule fee of $731 (item 42702). Thus, the procedure can be performed privately for about 20% of the taxpayer cost. Clearly, private surgery is a very efficient use of taxpayer money for an operation with a quality-of-life-adjusted score of about 30 times what is considered cost-beneficial.5 The average eye surgeon performs fewer than half the cataract procedures per week than the 20 which Webber anecdotally claimed (and then multiplied by the entire cost of the procedure, presumably including the theatre fee and prosthesis). Webber is to be congratulated for speaking his mind, but ought to factually balance his writings. The ASO encourages other craft groups to commission their own practice-cost surveys when fiction needs to be separated from fancy.

Peter M Sumich

To the Editor: The “thinking doctor’s” Journal has degenerated to one for doctor’s random thoughts. The commissioned and peer reviewed article by Webber1 was disappointing. For many disenfranchised colleagues, the usual whinge over a cuppa at the local meeting is now plainly inadequate after this Medical Journal of Australia offering. The unsubstantiated claim about billions in Medicare “wastage”1 was reckless. The implication that the current cataract surgery rebate was poor value and had never changed was just plain wrong. Since the introduction of the Schedule of Medical Benefits, cataract surgery now requires entirely different surgical skills, implants a lens, and requires expensive, sophisticated equipment (for examples, see websites2-4). Patients can now expect vastly improved vision without the need for full-time visual aids. The rate of significant sight-threatening complications is now less than 7 in 1000 — one of the lowest complication rates in surgery. The rebate was reduced by about 40% in 1987, 10% in 1996, and 12% in 2009. Even before the last reduction, the total cost provided a significantly better gain (that is, lowest cost) in quality-adjusted life-years than any other surgical procedure,5 something conveniently ignored by the then Health Minister Roxon when cutting costs. With more than 500 ophthalmologists performing over 200 000 operations a year, the statistical distribution will certainly include the few surgeons performing high volumes of procedures or charging high fees, as it does with any other procedure listed on the MBS. Webber’s implied generalisation is totally invalid, as the distribution tail in no way represents the average. I am afraid that Webber has only provided us with sloppy commentary and cheap shots — nice if you can get away with it, but it is poor editorial policy.

Nigel Morlet

To the Editor: Webber is to be congratulated for his concise statement of the ills of Professional Services Review (PSR) audit,1 but his estimate of multiple billions being wasted each year is unsupported by evidence. This remark has already been picked up by several of the nation’s daily newspapers, and well suits those of certain political persuasions. However, it is also essential that the operation of the PSR be subject to scrutiny. The past performance of the PSR must be examined — including the correctness and consistency of the information it uses, its investigative processes, the defence evidence it does and does not accept, and the available avenues of appeal. These issues are all of great concern to doctors who have come to the PSR’s attention. I note that the most recent edition of Medicare’s Forum promises more Medicare audits.2 The fun has only just begun.

A Stuart Reece

When “should not” becomes “must not” — how mandatory compliance with guidelines can threaten professional independence There is a proliferation of rules and red tape at all levels of society. In New South Wales, for example, the Department of Health has been generating around 70–100 policy directives a year. Among other things, such directives tell obstetricians when and how to deliver babies — compliance is mandatory, under threat of disciplinary action and loss of indemnity cover. One of the most prominent recent directives, PD2010_045 (Maternity — towards normal birth in NSW), requires a reduction in caesarean section rates to 20% by 2015,1 a target that is illusory and possibly dangerous. Others are worse. Policy directive PD2007_024 (Maternity — timing of elective or pre-labour caesarean section) states: The risk of respiratory morbidity is increased in babies born by caesarean section before labour, but this risk decreases after 39 completed weeks. Therefore elective or pre-labour caesarean section must not routinely be carried out before 39 completed weeks. These findings are supported by recent studies.2 This text is taken almost verbatim from a guideline of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom3 and, at the time, accorded with the relevant Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) guideline on the timing of elective caesarean section, the wording of which has since been softened slightly.4 However, there is one very substantial difference: the “should not” of NICE and RANZCOG became a “must not”. The NICE guideline was produced by a committee of 16 members, two of whom were obstetricians. Nicholas Fisk, then chairman of the Royal College of Obstetricians and Gynaecologists (RCOG) Scientific Advisory Committee, strongly criticised the outcome and stated that the committee “selectively interpreted” the facts to suit its case.5 Timing of elective caesarean delivery is a complex issue. There are factors (mainly related to pulmonary maturity) suggesting delay until 39 weeks’ gestation, and others (mainly related to unexplained stillbirth6,7) supporting the traditional timing between 38 weeks and 38 weeks and 6 days. A large randomised controlled trial (RCT) or a carefully conducted observational study employing propensity scoring would be required to provide a solid evidence base. For the moment it remains a matter of opinion, and RCOG, NICE and RANZCOG can, and should, express expert opinion and review the available evidence. Guideline committees and their products make an important contribution to improving clinical practice, and the voluntary work of countless individuals in this regard should not be denigrated. However, the situation may be altered completely once bureaucrats become involved. Changing the “should” of a College guideline to a “must” in a NSW Health policy directive has major implications. PD2007_024 effectively forbids doctors in NSW public hospitals to schedule routine elective caesarean section before 39 weeks. Anyone doing so risks disciplinary action and may forfeit their indemnity cover. PD2007_024 is not currently supported by high-level evidence, and even if there were solid data from a large RCT or a meta-analysis, it would be inappropriate to stipulate “mandatory compliance”. Evidence-based medicine has great potential to improve patient care, but it is a tool to inform clinicians, not an excuse to switch off one’s brain. As recently argued in the case of mesh use in pelvic reconstructive surgery,8 guidelines derived from a large RCT (or a valid meta-analysis of appropriate trials) are of limited use as a guide to the care of an individual patient if that patient is far off the trial sample mean in predictors of outcome. The Term Breech Trial9 is an excellent example. If there is a very high likelihood of an uncomplicated birth for an individual woman (eg, fast progress, small baby, previous normal births), a clinician may want to ignore the findings of the Term Breech Trial when deciding how to advise her. The process of starting with some initial information (probabilities of events of interest) and combining it with data related to an individual case or circumstance has been mathematically formalised by statisticians as “Bayesian updating”.10-13 Information from a clinical guideline, prevalence study or meta-analysis provides the “prior probability”, the data related to the individual case at hand are embodied in the “likelihood”, and the application of Bayes’ theorem13,14 gives the updated “posterior probability” on which a decisionmaker can act. This implies that even the best evidence in literature and guidelines can provide only prior probabilities. It is our job to adapt these to the clinical management of the individual patient, generating posterior probabilities that have been updated by the relevant particulars of the patient and processed by clinical intuition and common sense. However, in a trend that is encouraged by guidelines and policy directives, clinicians increasingly omit this updating process. Once a document — a seminal paper, a guideline, a policy directive — is published, it is likely to be interpreted cautiously (ie, as widely as possible) because of the litigious, risk-averse nature of our society. We do not particularise to the individual patient because our work environment strongly discourages doing so. Finally, even if a guideline is produced after an optimally diligent process and published so rapidly that it is up to date at its launch, it still freezes current best practice. Inevitably, today’s best practice will be obsolete tomorrow. Practice guidelines therefore have the potential to slow down progress, and unthinking adherence to such documents is unlikely to deliver the best outcomes to the greatest number of individuals. The expert system of our brains, employed in the assessment and treatment of the individual patient — and using relevant prior information from evidence-based sources — is a potentially superior tool when compared with the replication of a course of action outlined in a document issued by a government agency or professional body. It is time to reassert our professional independence.

Hans Peter Dietz MD, PhD, FRANZCOG · Barrie J Stokes BSc, MMath

To the Editor: I would like to add my perspective, after nearly 50 years of experience in Australian medicine, to the very welcome articles by Moynihan1 and Webber.2 A few months after Medibank (Mark I) was launched in 1975, a colleague and I wrote a satirical article called “How to rob Medibank blind”.3 We deliberately wrote this article anonymously, so that it could be judged on its merits, and not by its authors. It was picked up by the Sydney Sunday Telegraph and featured across its middle pages. The responses of the then Minister for Health, Ralph Hunt, and Australian Medical Association (AMA) president, Lionel Wilson, were, to paraphrase their words, “doctors are not like that!” This view was shared by Medibank architect, economist John Deeble, when I asked, 20 years later, why he and his co-architect Richard Scotton had designed “a mechanism with an accelerator pedal but no brakes”. They had, he said, not thought it necessary. Around that time, on behalf of the AMA, I advised on the restructuring of the Professional Services Review (PSR). I had been fortunate, meanwhile, to have chaired Professional Standards Committees of the New South Wales Medical Board, and to have sat on the bench of the NSW District Court Medical Tribunal, looking at alleged poor professional conduct. This opened my eyes to the small number of doctors whose standards were poor overall, and led to the Board’s performance assessment program. Many had also been investigated by Medibank or Medicare. Instead of having the PSR chasing illusionary and indefinable “over-servicing” by general practitioners (curiously, specialists were almost never investigated), I suggested peer review, whereby trustworthy, practising GPs or relevant specialists could advise on whether or not a doctor’s pattern of practice was inappropriate. This could be judged on an overall view of their work, much as was being done in the NSW Board’s Performance Program. Another decade later, as Chairman of the Doctors Health Fund (then the AMA Health Fund), I attended a small dinner in Melbourne with the chairmen of a few restricted membership funds and the then Minister for Health, Tony Abbott, who asked me to sit next to him. I asked pointedly how he could justify commercial corporations’ continuing to make profits for their shareholders out of Medicare benefits which were supposed to reflect the value of a doctor’s professional services. How could there be so much fat in the system that these corporations could cream off their substantial profits? His disappointing response was that it was too difficult to do anything about it. Webber is correct — both sides of politics are to blame.

Peter C Arnold

To the Editor: An ethical concern that was raised by Conway in his article supporting the freedom to practise in accordance with conscience1 related to the problems that arise when patients — specifically children — are unable to express a considered opinion on any conflict between their clinicians and their legal guardians about their best interests. Parents know their child best, are responsible for continuing care of the patient (including during any adverse effects of treatments) as well as of any other dependants. However, they may also be guided more by strongly held beliefs than by the views of clinicians on the best interests of their child. The law gives parents considerable rights and obligations to make decisions in the best interests of their children, but the law also recognises that children have rights, independent of the parents. When children are able to form and express opinions, these are considered; when they can’t, they are dependent on others to promote their interests. Within this legal framework of competing rights, the solution can only be a legal one, as occurred with the patient in Conway’s example.1 Clinicians have to be prepared to go to court to put their case for the best interests of the child, and then accept the legal decision with good grace, however personally distressing. This is just another example in medicine of the need for all to work with less than desirable outcomes. And one must always remember that not complying with a court order is an option — with consequences — that may seem ethically justifiable to a clinician or parent.

William R Adam

To the Editor: In a recent Opposing Views article, Conway claims that doctors should be able to practise according to their personal values,1 but the argument he uses is not persuasive. The ethical dilemma in the case is not characterised correctly. Autonomous choices can be made while treatment options, based on scientific knowledge, are available. If there are no medical options to improve the outcome — if we are at the very limits of medicine — there is no duty to provide anything other than palliation. In other words, the “do no harm” principle takes precedence over the duty to treat the patient according to his or her needs. Under these circumstances, refusing to “treat” is to practise with medical knowledge and the comfort of the patient (in Conway’s example, a child) in mind, regardless of the parents’ wishes. There is no ethical dilemma in that sense. In fact, the dilemma doctors have is not clinical, but a professional one created by the court order compelling doctors to continue futile treatment, causing unnecessary discomfort that obviously conflicts with the “do no harm” principle. Hence, Conway’s case does not support his argument. In addition, his argument may lead to the violation of patient wellbeing and of professional values. The moral problem related to defining a space for personal values in medical care is that they may conflict with professional values, legitimising discrimination. Then it would be nearly impossible to criticise doctors and institutions that refuse abortion, do not examine patients of the opposite sex on religious grounds, and refuse to operate on HIV-positive patients or to treat people with different political affiliations. It would be hard to call that kind of environment a “healthy diversity”. As well as defending the right to health, we should protect the professional value of non-discrimination to preserve trust between medicine and society. In fact, in order to “safeguard against abuses of power, error and exploitation in medicine”,1 we have already established universal professional codes, instead of leaving the stage to the relativity of personal values.

Murat Civaner

To the Editor: I am disappointed by Williams and colleagues’ blinkered view on “conflict of interest”.1 Their focus is solely on that of influence by profit-making medical supplies companies, often loosely referred to as “big pharma”. However, many careers are made and lost by government-influenced appointments and funding. The careers of some doctors in government-funded positions may hinge on whether they support the health department stance on a particular guideline. Rarely have I seen a future promotion, government research funding, committee appointment or professorial sinecure listed as a conflict of interest. This, I believe, is the real elephant in the room.

Peter J McLaren

Our health system places great responsibility on doctors to act in the best interests of patients, and in the interests of the system itself. Laws and regulation apart, the system functions well primarily because practitioners act ethically and fairly. In return, society accords doctors considerable trust, respect and financial reward. There is no question that any abuses of this trust that occur need to be stopped. The Professional Services Review (PSR) scheme was established in 1994 to safeguard the integrity of Medicare and the Pharmaceutical Benefits Scheme by providing, according to the PSR website, “an effective peer review mechanism to deal quickly and fairly with concerns about inappropriate practice” (http://www.psr.gov.au/aboutpsr/history.asp). One of last year’s most controversial topics was that of the role and behaviour of the PSR. Despite a recent Pricewaterhouse Coopers draft report recommending substantial changes to the PSR, significant issues remain to be discussed (The Australian 2011; 28 Dec). In this issue we feature lively opinion pieces by two key players — Tony Webber (doi: 10.5694/mja11.11431), recently retired director of the PSR, and Scott Masters (doi: 10.5694/mja11.11560), a vocal critic of the PSR and a doctor who has himself been investigated by the PSR. Ray Moynihan (doi: 10.5694/mja11.11524) adds fuel to the fire, looking at the difficulties the PSR faces when investigating large medical corporations, an issue which was flagged by Webber at the 2011 Senate inquiry into the PSR scheme. “Quickly and fairly” are at the heart of the current dispute. Critics say that there is a lack of due process, and that it often takes years for the PSR to complete its investigations, resulting in enormous stress and financial loss for the practitioner involved. I think we should applaud Webber for his willingness to tell us an insider’s view. Whether one agrees with him or not, there is always a personal cost to the “whistleblower”. He is frustrated by the lack of audit and oversight of the huge public expenditure on health, and by Medicare’s failure to adapt to the pursuit of profit in medicine. He highlights the poor sense in a system that remunerates doctors for completing paperwork for a convoluted referral system instead of enabling them to refer directly to allied health providers. He notes that rebates for Medicare Benefits Schedule (MBS) items need to be constantly reviewed in the context of improved efficiencies and the adoption of new technologies. Webber is scathing of the design of the “safety net”, which he feels is open to easy exploitation by avaricious practitioners, and of cost-shifting by state health entities, in violation of the Council of Australian Governments National Health Care Agreements. Masters, on the other hand, argues that Medicare’s screening procedures for identifying doctors who will be reviewed by the PSR are blunt instruments that are unable to differentiate the bad from the busy. There is certainly support for this view, especially among doctors who work in poorly resourced settings. He articulates the problem of vaguely defined MBS item numbers that increase the vulnerability of practitioners to unknowingly misuse them. He is angry at what he sees as the lack of transparency in PSR processes and heavy-handedness of the organisation. The PSR is part of the audit process in our health system, which should reassure taxpayers that their money has been well spent. It is, in reality, a “defence” for honest and ethical doctors. The current debate is about process. A clear definition is needed of what data will be examined, along with the development and application of a transparent, respectful and efficient process of review.

Annette Katelaris MB BS, MPH, FRACGP