Topics
Ethics
Ethics and site-specific governance approvals for multi-centre, inter-sector health care research
Time is ticking: administrative delays to undertaking low risk health research need to be minimised
Holly Foot · Ian A Scott · Grant M Russell · Neil Cottrell · Nancy Sturman · Christopher R Freeman
Regulating consumer use of transcranial direct current stimulation devices
Despite limited evidence of improvements in cognition, transcranial direct current stimulation devices are being marketed to healthy consumers for performance enhancement.
Anne-Maree Farrell · Adrian Carter · Nigel C Rogasch · Paul B Fitzgerald
Mandatory data breach notification requirements for medical practice
By establishing well functioning internal procedures and by informing patient expectations as to how their information is managed and by whom, the aftermath of a data breach may be reduced in severity
David J Carter · Samuel Hartridge
Informed consent and internet-based research in epidemiology
National guidelines are needed for internet-based research and to provide guidance on acceptable standards for storing evidence of informed consent
Laura Goddard · Fiona J Bruinsma · Graham G Giles
Children as haematopoietic stem cell donors: ethically challenging and legally complex
Clinicians should be aware of the particular physical and psychological risks of haematopoietic stem cell donation in the paediatric setting, and the varying laws between states and territories
Shih-Ning Then · Ian H Kerridge · Michael Marks
Potential solutions to improve the governance of multicentre health services research
We need to improve bureaucratic behaviour in health services research
Robyn Clay-Williams · Natalie Taylor · Jeffrey Braithwaite
The other source of government funding for medical research that needs reform
Gifted funding runs the risk of bypassing peer review
Anthony F Jorm
Compassion and evidence in prescribing cannabinoids: a perspective from the Royal Australasian College of Physicians
The RACP emphasises the need for caution until there is sufficient quality evidence to support the use of medicinal cannabis
Jennifer H Martin · Yvonne Bonomo · Adrian DB Reynolds
Disease prestige and the hierarchy of suffering
Suffering should not be hierarchical, and care should not be predicated on the prestige that a disease attracts
Louise Stone
Legal does not mean unaccountable: suing tobacco companies to recover health care costs
The potential benefits of holding tobacco companies to account through litigation may affect future Australian tobacco control strategies.
Ross MacKenzie · Eric LeGresley · Mike Daube
Euthanasia and physician-assisted suicide: focus on the data
To the Editor:Emanuel1 enjoins readers to focus on the data concerning euthanasia and physician-assisted suicide (PAS), and to aim at improving the care of dying patients, but advances straw arguments on the basis of three claims in the end-of-life debates that are disputed by neither advocates nor opponents of assisted dying. From the fact that euthanasia and PAS are rarely requested and rarely cause death, Emanuel argues that legalising them will not help solve the problem of inadequate symptom management or improve palliative care. But he adduces no evidence that supporters of legalisation make this claim. Describing legalisation as “really a sideshow in end-of-life care — championed by the few for the few” minimises the plight of those who would avail themselves of euthanasia and PAS, and is belied by the consistent majority support in Western communities for legalisation.2 Pain is recognised, by both advocates and opponents of legalisation, to not be the primary reason why people seek euthanasia and PAS. To claim that the real motivators of requests for assistance (eg, depression, loss of control and loss of dignity) “are not relieved by increasing the dose of morphine, but by antidepressants and therapy”, perpetuates the myth that medicine can, and should, always provide therapeutic answers to such personal dilemmas.3 Emanuel describes requests for euthanasia and PAS as amounting to “traditional suicide condoned and assisted by the medical community”, on the grounds that they are motivated by psychological factors. This statement begs the question about the ethical and legal propriety of euthanasia and PAS by equating PAS with other categories of suicide, without adequate analysis. No one would be surprised at the data supporting Emanuel’s claim that all medical procedures have problems and complications, and that euthanasia and PAS are no exceptions. But to conclude from this that “the common view of euthanasia and PAS as quick, flawless, and painless ways to die is unrealistic” introduces an alleged “common view” that is also unsupported. These are all examples that seem to advance evidence-based arguments in support of a particular ethical and policy position, but one that has been decided ahead of the evidence.
Malcolm H Parker
The right to know versus the right to privacy: donor anonymity and the Assisted Reproductive Treatment Amendment Act 2016 (Vic)
Recent Victorian legislation is ethically defensible but will need to be closely monitored
Xavier Symons
No Jab, No Pay and vaccine refusal in Australia: the jury is out
To the Editor:While vaccine refusal is but one contributor among several to failures of vaccine-preventable disease control, as stated by Beard and colleagues,1 there are important ethical aspects of vaccine refusal. Intentionally opting out of vaccination imposes risks on others, and policies allowing some to opt out weigh their freedom to do so against the rights of others not to be harmed by vaccine-preventable diseases.2 In particular, people who cannot be safely vaccinated (eg, infants) or maintain immunity (eg, the immunosuppressed) are at increased risk of severe disease — including death — and depend on the immunity of others.2 It is true that herd immunity has no “magic threshold”:1 even with high population vaccination levels, severe harm may be caused when just one unvaccinated person has contact with an infectious person and then a vulnerable person. The death of an immunosuppressed woman from measles pneumonitis in the state of Washington, United States, in 2015 is a case in point.3 Tighter legislation on universal vaccination does not unfairly target vaccine refusal. Indeed, Victorian No Jab, No Play legislation has a general objective: “to increase immunisation rates for young children,”4 which applies equally to people who have unintentionally failed to vaccinate and those who intentionally opt out due to hesitancy or refusal. Policy should make vaccination the norm and aim for the highest possible coverage. Moreover, while we should revise financial penalties if they unfairly burden poor families (while the wealthy may pay to opt out), policy should, in some way, recognise that conscientious objection to vaccination has consequences for others.5 Measles outbreaks are correlated with vaccine refusal6 and lead to significant social costs, which Australia may avoid if high levels of vaccination are maintained. Though the true epidemiology is certainly more complex, if measles vaccination leads to immunity in 99% of vaccine recipients, and 95% of people are vaccinated,1 the population level of immunity would be 94.05%. Threshold concepts have limitations, but whether this is “comfortably exceeding” 94%,1 or perilously close to recurrent measles outbreaks — which impose avoidable risks of harm on others — is a matter for debate.
Euzebiusz Jamrozik
No Jab, No Pay and vaccine refusal in Australia: the jury is out
In reply
Frank H Beard · Julie Leask · Peter B McIntyre
Performance data and informed consent: a duty to disclose?
Evidence mounts for a legal duty to disclose performance data as part of informed consent
Rebekah E McWhirter
Robotic prostatectomy took off, despite a lack of evidence and risks of inequity
Editor’s note: The Lancet recently published an important Australian randomised controlled trial of robotic and open prostatectomy. We publish the following non-commissioned correspondence by Hutchison and colleagues together with an invited response from the corresponding author of the trial, Robert Gardiner, because of the relevance of the debate to Australian health care. To the Editor: Robotic prostatectomy took off quickly, despite the cost. In Australia, most prostatectomies are now done with a robot that costs almost $10 000 in capital and maintenance per procedure, or between $442 and $3548 more than an open prostatectomy.1 The robotic option was meant to reduce side effects relating to impotence and incontinence; however, preliminary findings from the world’s first randomised controlled trial suggest that this is not the case.2 Uptake of innovative surgery tends to outpace evidence because it is hard to design and run randomised studies. In addition, placebo surgery is rare and controversial, and recruitment is challenging, as surgeons and patients often prefer one option. Trial results may also be difficult to interpret: if the same surgeon performs both operations, they may be better at one; or if different surgeons operate, one may be superior.3 Australia is not immune to these challenges, despite local initiatives to improve quality of care4 and evaluate the benefits of the robotic procedure.5 The industry understands this. Intuitive Surgical aggressively marketed its robot while the jury was still out on its comparative benefits. Celebrity stories have also driven demand; for instance, radio personality Alan Jones has been an outspoken advocate.6 But even when evidence commends a surgical innovation, introducing it to the public health care system may create or exacerbate inequity. Suppose that the robot, or some successor, eventually proves superior to alternatives. Expensive equipment and difficult procedures require high patient throughput to justify the costs and maintain surgeons’ skills, so they tend to be concentrated in the biggest, busiest hospitals. Therefore, patients in regional areas are often expected to travel for treatment, with little or no financial support; and the barrier is even higher for people who do not have the social and economic resources to get themselves to a big city hospital.7 We should resist the hype of a new technology and wait for good evidence before expending scarce health care dollars. This will sometimes mean lagging behind other countries and saying no to patients. However, it will also mean safeguarding patients and the public purse from innovations that turn out to be no better, or maybe worse, than existing options. Moreover, when a new technology is introduced, we should also fund the supports that people need to access it.
Katrina Hutchison · Drew Carter · Jane Johnson
Including minority populations in research: we must do better
Time, money and commitment are needed to increase the value of medical research — and to respect participants
for the CREATE Methods Group
Exclusions from clinical trials in Australia based on proficiency in English
One in five registered clinical trials in Australia documented exclusion of participants with low English proficiency
Fiona Stanaway · Robert G Cumming · Fiona Blyth
Psilocybin-assisted therapy for anxiety and depression: implications for euthanasia
Contemporary research suggests potential benefits of psychedelic drugs in treatment-resistant depression and terminally ill patients
Nigel Strauss
Premature deaths of nursing home residents: an epidemiological analysis
A national policy framework is needed to reduce the number of premature deaths in nursing homes
Joseph E Ibrahim · Lyndal Bugeja · Melissa Willoughby · Marde Bevan · Chebiwot Kipsaina · Carmel Young · Tony Pham · David L Ranson
Should there be an MBS item number for advance care planning?
To the Editor:Advance care planning (ACP) promotes conversations about future health care, in case a person should lose capacity for decision making. Advance care directives (ACDs) provide written documentation of these conversations. Yet, although the Australian Medical Association advocates ACP within routine clinical practice,1 ACD completion rates remain low.2 While recognising numerous barriers to ACP, including patient, practitioner and health care system factors,3 a dedicated ACP Medicare Benefits Schedule (MBS) item number was mentioned in a number of general discussions at the 2016 Advance Care Planning Australia national conference (Melbourne, 15–17 November) as a potential incentive to increase the use of ACDs in primary care. In general, we support this recommendation. Health economics tells us that where there is a shortage of a specific service, as could be argued for ACP, the supply of this service will increase under fee-for-service payment.4 Patients are less knowledgeable about prices, services and associated benefit than providers; however, the existence of an agency relationship5 (where the patient assigns decisional authority on the basis that they have less information) between general practitioners and patients would facilitate ACDs from which patients are most likely to benefit. On the other hand, there is some risk that financial incentives will motivate GPs to do more than is optimal or desired, especially if the service is priced above standard consultation fees. There is also an opportunity cost; if GPs are providing more ACP services they will have less time to provide other primary care services. However, the risk of financial incentives may be mitigated by the non-financial barriers to ACP (fear or reluctance of patients, insufficient GP skills or organisational factors). Therefore, in designing policies to increase uptake, especially where financial incentives are the driver, a multifaceted approach should be considered. Service reimbursement mechanisms and potential barriers should also be balanced against maintenance of ACP values such as patient autonomy and informed decision making. As a starting point, a two-tiered MBS item number could be beneficial, the first item billable for initiation of ACP and the second used for revisitation of ACDs after a given time period (eg, annual review). Subsequent review of policy responses, including patient and medical practitioner input, will be needed to ensure appropriate directions surrounding MBS billing. Further accompanying strategies may be required to address non-financial barriers to ACP uptake.
Amanda Pereira-Salgado · Jennifer J Watts
A positive step for pharmaceutical payment transparency
To the Editor: Since 1 October 2016, under changes in the Medicines Australia code of conduct,1 the names of all doctors receiving payments from pharmaceutical companies are being published online, together with the dollar amount received; the data will remain available for 3 years. Up until now, this information could only be published with the doctor’s consent. This change — part of the latest edition of the code of conduct — is the industry’s response to attempt to legislate for greater transparency. It represents a significant step forward in the transparency of the relationships between doctors and pharmaceutical companies. In 2015, pharmaceutical company-funded educational expenses for doctors included a $70 000 trip to Sweden for six oncologists and a $176 000 trip to Vancouver for nine dermatologists.2 With the new changes, it is likely that doctors will think twice before accepting large pharmaceutical company funding for educational events, given this information will be available to the public. Despite a considerable body of evidence showing that receipt of meals and sponsorship is associated with altered prescribing patterns,3,4 many doctors continue to incorrectly believe that they can effectively manage the influence of pharmaceutical company promotion on their decision making.4 The challenge for the profession is to foster doctor–pharmaceutical company relationships that benefit patients, while maintaining freedom from undue influence on prescribing habits. This requires system and individual change. Medicines Australia should be commended for its efforts to improve transparency; its measures are a lesson for other companies with financial interests relating to the practice and preferences of doctors, including medical devices companies. However, to fully realise the benefit of the code of conduct changes, all information on doctor payments must be accessible via a centralised repository that allows patients and third parties to search for an individual doctor. Regarding individual change, doctors must take heed of the evidence above and eschew gifts and education funding provided by pharmaceutical companies. Moreover, up to date and freely accessible evidence-based information is available via independent organisations such as NPS MedicineWise. Greater transparency in the relationships between doctors and pharmaceutical companies is a positive step to maintaining high levels of accountability and public trust in the medical profession.
Jessica Dean · Malcolm P Forbes · Richard Di Natale
Euthanasia and physician-assisted suicide: focus on the data
We should aim at improving the care of dying patients
Ezekiel Emanuel
Voluntary euthanasia laws in Australia: are we really better off dead?
To the Editor:In her MJA article, Murphy poses the question “who are we talking about when we discuss voluntary euthanasia laws?” and presents two hypothetical scenarios.1 The South Australian Voluntary Euthanasia Bill 2016 defines an eligible person as a competent adult, subject to unbearable and hopeless suffering, with no impaired decision-making capacity, and who has lived in the state for no less than 6 months.2 The degree to which the suffering is unbearable is determined subjectively. A person’s suffering is considered hopeless if medical treatment cannot reduce or relieve the suffering to a level that is bearable to the person. The nature, availability and potential effectiveness of such treatment are determined objectively under the provisions of the Bill. As Murphy observes: “Every person’s story is different and we must be careful not to lump them together”.1 It is also true that aged care and mental health systems need much greater government investment. However, this alone will be unable to deal with the highly particularised needs of people whose lives have become unbearable despite the best medical or palliative care. The 2016 Victorian inquiry into end of life choices stated: “Under the existing legal framework, Victorians with serious and incurable conditions and irremediable suffering are exposed to the possibility of a traumatic death. Some are driven to suicide.”3 The inquiry recommended a legal framework to allow assisted dying for the small number of people who seek help to end their suffering. Such legal reform would surely provide great reassurance by ending the fear of enforced protracted suffering, which leads to pre-emptive and often violent suicides. Examples of the tragic circumstances triggering these actions were compellingly recounted by Coroner John Olle before the Victorian inquiry4 and alluded to in Murphy’s own account of reading “emotionally draining” case files of suicides in nursing homes. The legal status quo is an indictment of a civilised society.
Julia M Anaf