Papers by Paul Komesaroff
CLINICAL TRIALS-Human clinical trials are an important last hurdle in the development of new drug... more CLINICAL TRIALS-Human clinical trials are an important last hurdle in the development of new drugs and therapies. Today, The Conversation takes a closer look at this vital scientific endeavour with three articles that look at different aspects of the process.
Journal of Paediatrics and Child Health, Mar 5, 2022
ment with immunosuppressive therapy during the active phase of the disease strongly suggests an u... more ment with immunosuppressive therapy during the active phase of the disease strongly suggests an underlying immunologic-mediated process. Neurological symptoms (seizures, headache and facial pain) affect 15–20% of patients and brain involvement can be better evaluated with magnetic resonance imaging. There has been some controversy on the relationship between PRS and morphea ECDS, a type of linear morphea. The largest studied cohort with 54 patients found that both entities frequently co-exist and both are likely variants of morphea, lying on the same disease spectrum. Other authors believe that both can be distinguished by their histopathological features, such as the absence of cutaneous sclerosis and preservation of dermal elastic tissue in PRS, differentiating it from the spectrum of scleroderma diseases. Management of PRS is difficult and a multidisciplinary approach is often required. Treatment of PRS aims to slow disease progression and provide symptomatic relief. Immunosuppressive therapies, such as systemic corticosteroids, methotrexate, antimalarials or mycophenolate mofetil, have been used with variable success. When clinically stable, cosmetic procedures like autologous fat-grafting can be attempted. In conclusion, we report this case to highlight the importance of an early diagnosis on these potentially disfiguring diseases as well as the association between morphea ECDS and PRS. Verbal approval has been obtained from the patient’s parents for publication of their child’s photographs and case details.
The Medical Journal of Australia, Aug 1, 2001
Is there a future for clinical ethics services in Australia? Clinical ethics refers to the consid... more Is there a future for clinical ethics services in Australia? Clinical ethics refers to the conside ra tion of eth ical issues ar ising directly in the context of patient care. Hea lth professiona ls ar e generally adept at effective ly and sensitively managing eth ical is sue s in clinical ca re. Howeve r, in some sellings, multidisciplinary clinical ethics services ma y enhance clinical practice by assisting clinicians , pat ients and others to identify, understand an d ma na ge ethical issues. Clinical ethics services may be part icularly va luable for situat ions in which mora l perspectives diverge or co mmunication ha s deteriorated. Such services may facilitate discussion and he lp the pa rties find mutually satisf actory solut ions. Clinical ethics services may take va rious forms , including clinical ethics committees, et hics consultants , patient advocates or othe r mechanisms for responding to complaints an d grievances. The re is considerable disagreement about key aspects of c linical et hics services, including who shoul d con duct them , how they sh ould be run and what ro le they should play in decision-making .
Internal Medicine Journal, 2022
The question of whether vaccination against COVID-19 should bemandated, which has becomewidely co... more The question of whether vaccination against COVID-19 should bemandated, which has becomewidely contentious, is more complicated than it first appears. This is because the factual circumstances of the pandemic have varied according to time and local circumstances and because the conditions under which the debates are taking place have themselves become confused and antagonistic. It is also because any conclusion regarding whether mandatory COVID-19 vaccination is or is not ethically justifiable depends on whom and inwhat circumstances themandate should apply. Therefore, for clarity, we state the assumptions on which the following discussion is based. We assume certain factual propositions, which we take to be amply supported by the current available evidence. We assume that: COVID-19 is a deadly epidemic that has already claimed millions of lives and is likely to claim many more; high case numbers of infection impose significant pressures on the health system, including increasing costs and limiting the availability of care to patients not infected with the disease; vaccines are largely, but not completely, effective in preventing infection, hospitalisation and death; vaccines are largely safe but on rare occasions can be associated with serious, even lethal side-effects; and although in global terms Australia has had a good uptake of vaccination, significant numbers of people remain vulnerable to infection, especially in particular communities. In addition, although we place a strong value on respecting personal freedom, we accept the ethical principle that there are many circumstances in which governments may place constraints on individual behaviours and the ability to make personal choices to prevent harm to others or to protect the interests of society more generally. These may be as simple as smoking or alcohol restrictions or seat belt requirements, or as complicated as an obligation to defend one’s country against an external threat. While this principle is a general one, we recognise that its application in practice depends on the specific circumstances under consideration as well as the social environment in which the discussion is taking place.When decidingwhether or not such an imposition is reasonable it is important to weigh the likelihood and severity of the undesired occurrence and the likelihood that the intervention will be successful in preventing it. Simply restricting some aspect of individual liberty does not make it unethical. Those opposed to COVID-19 vaccination and social distancing may complain that their civil liberties are being infringed, but their refusal to be vaccinated may more grievously infringe the ‘rights’ or civil liberties of others to be protected reasonably from infection. It should also be noted that decisions considered appropriate in a highly individualistic society (such as the USA) may be quite different from those in a society with a stronger tradition of collective responsibility (such as Australia). Notwithstanding this, it is accepted that even where it is agreed that limitations on individual freedoms may be imposed these should be the least onerous possible in the given circumstances. The local conditions in Australia and the experience so far over the life of the pandemic have shaped the present discussions in characteristic ways. Across the country, there have been high levels of community support for public healthmeasures to limit the spreadof the virus and it is generally accepted that these measures have been largely successful. Further, the existence of a universal health insurance scheme, according to which publicly funded healthcare is made available to all those in need, has both mitigated the impact of the disease and established a cultural environment in which mutual support and responsibility are taken for granted. We also recognise that within this complex environment individualsparticipate invaccinationprogrammesfordifferent reasons, including both as acts of generosity to reduce the risks to others – either directly, by limiting the chanceof transmission of the virus, or indirectly, by reducing the burden onthehealthsystem–or toreducethedangers tothemselves. In both cases, decisions may be publicly encouraged and rewarded through incentives and benefits. People can choose not to be vaccinated, but because that choice imposes substantial burdens, risks and possible harms to others and potential costs to the community and health services, it is reasonable for thesechoices tocarrysignificantcosts.Thesecosts– for example, not being allowed to work, attend school or attend a public event – are undoubtedly coercive, but this coercion is justified in the faceof apandemicwherepeopleare being infected and dying every day and where particular groupscannotbeequallyprotectedorprotect themselves. Recognition of the context and cultural sensitivity of the issues relating to vaccination shows that there are no universal answers to the multiple questions…
Journal of Bioethical Inquiry, Jun 1, 2020
Journal of Bioethical Inquiry, Dec 1, 2014
Internal Medicine Journal, May 1, 2019
Although the concept of 'conflict of interest' (COI) arises in many contexts in healthcare, it is... more Although the concept of 'conflict of interest' (COI) arises in many contexts in healthcare, it is often poorly understood, and commonly accepted, definitions are often circular, self-contradictory and unable to provide procedural guidance. To overcome such confusion and imprecision, we offer a reformulation of COI that carefully defines interests, clarifies their scope and articulates a simple, non-punitive approach to managing them. We define an 'interest' as 'a commitment, goal, obligation or duty related to a particular social role or practice'. We show how in a particular setting multiple interests can be at play, which can be either financial or non-financial, with the latter often being the most potent drivers of behaviour. We define a 'conflict of interest' as the condition that arises when two coexisting interests directly conflict with each other: that is, when they are likely to compel contrary and incompatible outcomes. COI therefore reflect objective states of affairs rather than internal mental states; they do not imply moral error; and they are identified through public rather than private processes involving ethical dialogues among relevant stakeholders. Once a COI has been identified, responses must be determined based on the seriousness of the conflict and the conditions that generated it. Such responses may be minimal or they may require a formal disengagement from one of the conflicting interests. The framework described, reflects the rich diversity of interests in modern societies, is universally applicable and provides simple, readily applicable guidelines for the identification and management of conflicts arising between them.
Internal Medicine Journal, Nov 1, 2020
Over the course of the twentieth century, numerous national and international ethics 'codes' have... more Over the course of the twentieth century, numerous national and international ethics 'codes' have been developed. While such codes serve important substantive and symbolic functions, they can also pose challenges. In this article, we discuss these challenges, noting that they fall into four main categories relating to conceptual tensions, power imbalances, organisational barriers, and threats of exploitation. We illustrate these challenges using examples provided from the United Nations Educational Scientific and Cultural Organization (UNESCO) Universal Declaration on Bioethics and Human Rights. We emphasise the importance of accountability in the development and maintenance of national and international codes and argue that, despite all their challenges, codes provide an important common language among otherwise disparate and sometimes adversarial groups, and provide visible and explicit sets of standards that may be invoked by community members to criticise and hold powerful bodies to account. This is particularly important for practitioners and researchers who belong to organisations that are signatories to codes, who can use these codes to both guide and justify ethical behaviour in the face of competing organisational, professional and political imperatives. Funding: W. Lipworth is supported by a National Health and Medical Research Council (NHMRC) Career Development Fellowship. Conflict of interest: None. a APEC is a multilateral economic and trade forum established in 1989 to leverage the growing interdependence of the Asia-Pacific region. Its 21 members, which include the Unites States,
PubMed, Sep 1, 2015
In 1628, William Harvey presented his revolutionary theory of the circulation to ears at the Roya... more In 1628, William Harvey presented his revolutionary theory of the circulation to ears at the Royal College of Physicians that had been deafened by the unquestionable authority of Galen's teachings, from one and a half millennia in the past. Harvey's theory was initially rejected, despite his faith in his colleagues being eager for truth and knowledge, and never regarding themselves as so well informed that they would not welcome "further information". Recently Rodney Syme, the retired Melbourne urologist who for a long time has agitated for the legalisation of assisted dying, and also challenged the authorities to apply the current law in response to his admitted assistance to a number of individuals, was invited to address the 2015 Congress of the Royal Australasian College of Physicians. At the eleventh hour, the invitation to speak was withdrawn. In this column, we trace the course of events leading to this withdrawal of the invitation, and describe some of the correspondence to and from the College in response to the withdrawal. We draw parallels between the experiences of Harvey and Syme, and point to lessons to be learnt from the recent episode of apparent unwillingness, on the part of an institution that seeks to present itself as outward-looking, progressive and socially aware, to fulfil this promise in the increasingly important area of the end-of-life.
Australian Prescriber, Sep 1, 2013
Influenza vaccination The influenza vaccine should be administered with seasonal protection in mi... more Influenza vaccination The influenza vaccine should be administered with seasonal protection in mind so it protects pregnant women against strains circulating during the influenza season and protects babies likely to be born during that time. The vaccine is recommended during any trimester, 4 although the greatest risk of adverse outcomes from influenza for the pregnant woman is in
Internal Medicine Journal, Feb 27, 2013
(paywalled). This article may be used for non-commercial purposes in accordance with Wiley Terms ... more (paywalled). This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving. Self-archived in the Sydney eScholarship Repository by the Centre for Values, Ethics and the Law in Medicine
Internal Medicine Journal, Nov 1, 2018
In recent months a debate has raged across Australia about the introduction of a universal electr... more In recent months a debate has raged across Australia about the introduction of a universal electronic health record system called the 'My Health Record'. While the system itself has been in development for nearly 10 years, current interest has been stimulated by a decision to reverse the process for including individual citizens, from 'opt in'which attracted only a relatively small number of takersto 'opt out', according to which records would be automatically created if citizens failed to take action within a short time frame.
The Medical Journal of Australia, Feb 1, 2002
The Medical Journal of Australia, Jul 1, 2012
The Medical Journal of Australia, Aug 1, 2009
The Medical Journal of Australia, Jun 1, 2015
The scourge of managerialism and the Royal Australasian College of Physicians The managerialist o... more The scourge of managerialism and the Royal Australasian College of Physicians The managerialist organisational model has penetrated deeply into our institutions, with destructive consequences M any health practitioners will consider the theory of business management to be of obscure relevance to clinical practice. They might therefore be surprised to learn that the changes that have occurred in this discipline over recent years have driven a fundamental revolution that has already transformed their daily lives, arguably in perverse and harmful ways. They might also be interested to discover that these changes have by and large been introduced insidiously, with little public debate, under the guise of unquestioned "best practice".
Journal of Bioethical Inquiry, Jul 19, 2014
Recent discourses about the legitimacy of homeopathy have focused on its scientific plausibility,... more Recent discourses about the legitimacy of homeopathy have focused on its scientific plausibility, mechanism of action and evidence base. These, frequently, conclude not only that homeopathy is scientifically baseless, but that it is 'unethical.' They have also diminished patients' perspectives, values and preferences. We contend that these critics confuse epistemic questions with questions of ethics; misconstrue the moral status of homeopaths and have an impoverished idea of ethics-one that fails to account either for the moral worth of care and of relationships, or for the perspectives, values and preferences of patients. Utilitarian critics, in particular, endeavour to present an objective evaluation-a type of moral calculus-quantifying the utilities and disutilities of homeopathy as a justification for the exclusion of homeopathy from research and healthcare. But these critiques are built upon a narrow formulation of evidence and care, and a diminished episteme that excludes the values and preferences of researchers, homeopaths and patients engaged in the practice of homeopathy. We suggest that homeopathy is ethical as it fulfils the needs and expectations of many patients; may be practiced safely and prudentially; values care and the virtues of the therapeutic relationship; and provides important benefits for patients.
BMC Complementary and Alternative Medicine, Jun 1, 2012
With the advent of a national regulatory framework in Australia for major health care professions... more With the advent of a national regulatory framework in Australia for major health care professions, the inclusion of Chinese medicine (CM) in 2012 is a significant event. Based in mandatory legislation, this is the first comprehensive national regulation of acupuncture and Chinese herbal medicine practice to occur across all states and territories in a country outside China. This report is the largest survey on primary Chinese medicine practitioners to be carried out in Australia since 1997, and the first national qualitative study to investigate the developing cultural and clinical practice dynamics within CM. This research intends not only to describe and represent the nature and perspectives of the CM professional community, in line with the CM principles of inclusion and holism, but also to contribute to mutually beneficial dialogue and collaboration with other streams of healthcare. Methods Methodology includes an online and paper-distributed nationwide survey (current n=450) in English and Chinese languages, with both quantitative and qualitative items, and in-depth qualitative interviews (n=100) with practitioners and key stakeholders.
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Papers by Paul Komesaroff