ORCID Profile
0000-0001-5940-602X
Current Organisations
Monash University
,
University of Oxford
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Publisher: BMJ
Date: 07-05-2020
DOI: 10.1136/MEDETHICS-2019-106001
Abstract: Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19.
Publisher: Springer International Publishing
Date: 2016
Publisher: Wiley
Date: 23-12-2011
Publisher: BMJ
Date: 07-2023
DOI: 10.1136/BMJGH-2023-011884
Abstract: Phylogenetic analyses of HIV are an increasingly accurate method of clarifying population-level patterns of transmission and linking in iduals or groups with transmission events. Viral genetic data may be used by public health agencies to guide policy interventions focused on clusters of transmission or segments of the population in which transmission is concentrated. Analyses of HIV phylogenetics in high-income countries have often found that clusters of transmission play a significant role in HIV epidemics. In sub-Saharan Africa, HIV phylogenetic analyses to date suggest that clusters of transmission play a relatively minor role in local epidemics. Such analyses could nevertheless be used to guide priority setting and HIV public health programme design in Africa for sub-populations in which transmission events are more concentrated. Phylogenetic analysis raises ethical issues, in part due to the range of potential benefits and potential harms (ie, risks). Potential benefits include (1) improving knowledge of transmission patterns, (2) informing the design of focused public health interventions for subpopulations in which transmission is concentrated, (3) identifying and responding to clusters of transmission, (4) reducing stigma (in some cases) and (5) informing estimates of the (cost-)effectiveness of HIV treatment programmes. Potential harms include (1) privacy infringements, (2) increasing stigma (in some cases), (3) reducing trust in public health programmes, and (4) increased prosecution of legal cases where HIV transmission, homosexuality or sex work is criminalised. This paper provides analysis of relevant issues with a focus on sub-Saharan Africa in order to inform consultations regarding ethical best practice for HIV phylogenetics.
Publisher: BMJ
Date: 24-05-2023
Publisher: Springer Science and Business Media LLC
Date: 20-09-2023
Publisher: BMJ
Date: 03-10-2016
DOI: 10.1136/MEDETHICS-2015-103327
Abstract: Mass vaccination has been a successful public health strategy for many contagious diseases. The immunity of the vaccinated also protects others who cannot be safely or effectively vaccinated—including infants and the immunosuppressed. When vaccination rates fall, diseases like measles can rapidly resurge in a population. Those who cannot be vaccinated for medical reasons are at the highest risk of severe disease and death. They thus may bear the burden of others' freedom to opt out of vaccination. It is often asked whether it is legitimate for states to adopt and enforce mandatory universal vaccination. Yet this neglects a related question: are those who opt out, where it is permitted, morally responsible when others are harmed or die as a result of their decision? In this article, we argue that in iduals who opt out of vaccination are morally responsible for resultant harms to others. Using measles as our main ex le, we demonstrate the ways in which opting out of vaccination can result in a significant risk of harm and death to others, especially infants and the immunosuppressed. We argue that imposing these risks without good justification is blameworthy and examine ways of reaching a coherent understanding of in idual moral responsibility for harms in the context of the collective action required for disease transmission. Finally, we consider several objections to this view, provide counterarguments and suggest morally permissible alternatives to mandatory universal vaccination including controlled infection, self-imposed social isolation and financial penalties for refusal to vaccinate.
Publisher: AMPCo
Date: 07-02-2021
DOI: 10.5694/MJA2.50930
Publisher: Springer Science and Business Media LLC
Date: 31-08-2022
DOI: 10.1007/S11019-022-10103-1
Abstract: Moralization is a social-psychological process through which morally neutral issues take on moral significance. Often linked to health and disease, moralization may sometimes lead to good outcomes yet moralization is often detrimental to in iduals and to society as a whole. It is therefore important to be able to identify when moralization is inappropriate. In this paper, we offer a systematic normative approach to the evaluation of moralization. We introduce and develop the concept of ‘mismoralization’, which is when moralization is metaethically unjustified. In order to identify mismoralization, we argue that one must engage in metaethical analysis of moralization processes while paying close attention to the relevant facts. We briefly discuss one historical ex le (tuberculosis) and two contemporary cases related to COVID-19 (infection and vaccination status) that we contend to have been mismoralized in public health. We propose a remedy of de-moralization that begins by identifying mismoralization and that proceeds by neutralizing inapt moral content. De-moralization calls for epistemic and moral humility. It should lead us to pull away from our tendency to moralize—as in iduals and as social groups—whenever and wherever moralization is unjustified.
Publisher: Elsevier BV
Date: 2020
Publisher: BMJ
Date: 25-10-2018
DOI: 10.1136/MEDETHICS-2017-104336
Abstract: Pox parties are a controversial alternative to vaccination for diseases such as chickenpox. Such parties involve parents infecting non-immune children by exposing them to a contagious child. If successful, infection will usually lead to immunity, thus preventing infection later in life, which, for several vaccine-preventable diseases, is more severe than childhood infection. Some may consider pox parties more morally objectionable than opting out of vaccination through non-medical exemptions. In this paper, I argue that this is not the case. Pox parties involve immediate risk of harm for children and reduce future harms, whereas opting out of vaccination places children at long-term risk of harms that increase with time, at least for some pathogens. Regarding harm to others through onward transmission of infection, this can be easily prevented in the case of pox parties-given the relatively controlled timing of infection-by quarantining attendees after the party, whereas opting out of vaccination involves risks to others that are more difficult to control. I defend three criteria for an ethical pox party: (1) that the disease is sufficiently low risk, (2) that parents consent to their child's attendance and (3) that children exposed to infection are quarantined and isolated appropriately. I argue that, if these criteria are met, pox parties are morally preferable to non-vaccination such parties involve less risk to non-consenting others and, for some pathogens in some cases, even involve less risk for the children who participate. Thus, policies that permit non-medical exemption to vaccination should also permit ethical pox parties. Alternatively, if pox parties are not permitted, then vaccination should be mandated for those without medical contraindication.
Publisher: Elsevier
Date: 2024
Publisher: Elsevier BV
Date: 08-2020
Publisher: Oxford University Press (OUP)
Date: 28-08-2021
DOI: 10.1093/CID/CIAA1290
Abstract: WHO convened an Advisory Group (AG) to consider the feasibility, potential value, and limitations of establishing a closely-monitored challenge model of experimental severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) in healthy adult volunteers. The AG included experts in design, establishment, and performance of challenges. This report summarizes issues that render a COVID-19 model daunting to establish (the potential of SARS-CoV-2 to cause severe/fatal illness, its high transmissibility, and lack of a “rescue treatment” to prevent progression from mild/moderate to severe clinical illness) and it proffers prudent strategies for stepwise model development, challenge virus selection, guidelines for manufacturing challenge doses, and ways to contain SARS-CoV-2 and prevent transmission to household/community contacts. A COVID-19 model could demonstrate protection against virus shedding and/or illness induced by prior SARS-CoV-2 challenge or vaccination. A limitation of the model is that vaccine efficacy in experimentally challenged healthy young adults cannot per se be extrapolated to predict efficacy in elderly/high-risk adults.
Publisher: Elsevier BV
Date: 06-2022
Publisher: BMJ
Date: 05-2022
DOI: 10.1136/BMJGH-2022-008684
Abstract: Vaccination policies have shifted dramatically during COVID-19 with the rapid emergence of population-wide vaccine mandates, domestic vaccine passports and differential restrictions based on vaccination status. While these policies have prompted ethical, scientific, practical, legal and political debate, there has been limited evaluation of their potential unintended consequences. Here, we outline a comprehensive set of hypotheses for why these policies may ultimately be counterproductive and harmful. Our framework considers four domains: (1) behavioural psychology, (2) politics and law, (3) socioeconomics, and (4) the integrity of science and public health. While current vaccines appear to have had a significant impact on decreasing COVID-19-related morbidity and mortality burdens, we argue that current mandatory vaccine policies are scientifically questionable and are likely to cause more societal harm than good. Restricting people’s access to work, education, public transport and social life based on COVID-19 vaccination status impinges on human rights, promotes stigma and social polarisation, and adversely affects health and well-being. Current policies may lead to a widening of health and economic inequalities, detrimental long-term impacts on trust in government and scientific institutions, and reduce the uptake of future public health measures, including COVID-19 vaccines as well as routine immunisations. Mandating vaccination is one of the most powerful interventions in public health and should be used sparingly and carefully to uphold ethical norms and trust in institutions. We argue that current COVID-19 vaccine policies should be re-evaluated in light of the negative consequences that we outline. Leveraging empowering strategies based on trust and public consultation, and improving healthcare services and infrastructure, represent a more sustainable approach to optimising COVID-19 vaccination programmes and, more broadly, the health and well-being of the public.
Publisher: Cold Spring Harbor Laboratory
Date: 26-05-2020
DOI: 10.1101/2020.05.18.20106187
Abstract: Background: Human infection challenge studies (HICS) with SARS-CoV-2 are under consideration as a way of accelerating vaccine development. We evaluate potential vaccine research strategies under a range of epidemic conditions determined, in part, by the intensity of public health interventions. Methods: We constructed a compartmental epidemiological model incorporating public health interventions, vaccine efficacy trials and a post-trial population vaccination c aign. The model was used to estimate the duration and benefits of large-scale field trials in comparison with HICS accompanied by an expanded safety trial, and to assess the marginal risk faced by HICS participants. Results: Field trials may demonstrate vaccine efficacy more rapidly than a HICS strategy under epidemic conditions consistent with moderate mitigation policies. A HICS strategy is the only feasible option for testing vaccine efficacy under epidemic suppression, and maximises the benefits of post-trial vaccination. Less successful or absent mitigation results in minimal or no benefit from post-trial vaccination, irrespective of trial design. Conclusions: SARS-CoV-2 HICS are the optimal method of vaccine testing for populations maintained under epidemic suppression, where vaccination offers the greatest benefits to the local population.
Publisher: Jagiellonian University
Date: 17-10-2023
DOI: 10.33392/DIAM.1871
Publisher: Wiley
Date: 27-01-2011
DOI: 10.1111/J.1440-1843.2010.01917.X
Abstract: Haplotypes in the promoter region of the prostanoid DP receptor (PTGDR) gene have been shown to functionally influence gene transcription and to be associated with asthma in two previous case-control studies in Caucasians. This study tested the association of PTGDR haplotypes with asthma phenotypes in two large Caucasian-Australian populations. These results were incorporated in a meta-analysis with previously published data to determine the overall role for these haplotypes in the risk of asthma. Three PTGDR promoter-region single nucleotide polymorphisms (SNP) were genotyped in 368 in iduals from the Western Australian Twin Child Health study and 2988 in iduals from the Busselton Health Study. Logistic regression and transition disequilibrium tests were used to assess whether SNP genotypes and three SNP haplotypes were associated with doctor-diagnosed asthma or intermediate quantitative traits. Longitudinal data from the Busselton Health Study were used to examine whether PTGDR influences changes in lung function over time. Meta-analysis incorporated the findings of this study with those of two previous studies in Caucasian populations. Cross-sectional associations between PTGDR haplotypes and asthma phenotypes were non-significant (P > 0.05) in both populations. Longitudinal analyses of PTGDR and lung function were also non-significant. Meta-analysis, however, suggested that haplotype TCT was significantly associated with decreased risk of asthma (OR = 0.76 P = 0.02) while haplotype CCC was not significantly associated with asthma (OR = 1.30 P = 0.07). These results suggest that despite the non-significant findings in the present study populations, PTGDR promoter haplotypes may account for a small but significant proportion of the risk of asthma in Caucasian populations.
Publisher: BMJ
Date: 05-06-2023
Abstract: The public health benefits of herd immunity are often used as the justification for coercive vaccine policies. Yet, ‘herd immunity’ as a term has multiple referents, which can result in ambiguity, including regarding its role in ethical arguments. The term ‘herd immunity’ can refer to (1) the herd immunity threshold, at which models predict the decline of an epidemic (2) the percentage of a population with immunity, whether it exceeds a given threshold or not and/or (3) the indirect benefit afforded by collective immunity to those who are less immune. Moreover, the accumulation of immune in iduals in a population can lead to two different outcomes: elimination (for measles, smallpox, etc) or endemic equilibrium (for COVID-19, influenza, etc). We argue that the strength of a moral obligation for in iduals to contribute to herd immunity through vaccination, and by extension the acceptability of coercion, will depend on how ‘herd immunity’ is interpreted as well as facts about a given disease or vaccine. Among other things, not all uses of ‘herd immunity’ are equally valid for all pathogens. The optimal conditions for herd immunity threshold effects, as illustrated by measles, notably do not apply to the many pathogens for which reinfections are ubiquitous (due to waning immunity and/or antigenic variation). For such pathogens, including SARS-CoV-2, mass vaccination can only be expected to delay rather than prevent new infections, in which case the obligation to contribute to herd immunity is much weaker, and coercive policies less justifiable.
Publisher: S. Karger AG
Date: 2014
DOI: 10.1159/000358583
Abstract: b i Background: /i /b Population-based studies, as well as clinicians, often rely on self-report and hospital records to obtain a history of stroke. This study aimed to compare the validity of the diagnosis of stroke by self-report and by hospital coding according to their cross-sectional association with prevalent vascular risk factors, and longitudinal association with recurrent stroke and major cardiovascular outcomes in a large cohort of older Australian men. b i Methods: /i /b Between 1996 and 1999, 11,745 older men were surveyed for a self-reported history of stroke as part of the Health in Men Study (HIMS). Previous hospitalization for stroke was obtained with consent from linked medical records via the Western Australian Data Linkage System (WADLS). Subjects were followed by WADLS until December 31, 2010, for hospitalization for stroke, cardiovascular events, and all-cause mortality. The primary outcome was hospitalisation for stroke during follow-up. Secondary outcomes included incident vascular events and composite vascular endpoints. b i Results: /i /b At baseline, a history of stroke was reported by 903 men (7.7%), previous hospitalisation for stroke was recorded in 717 (6.1%), both self-report and hospitalisation in 467 (4.0%), and no history of stroke in 10,696 men (91.1%). Prevalent cardiovascular disease and peripheral arterial disease were more common among men with previous hospitalisation for stroke than a history of self-reported stroke (p 0.001). In longitudinal analyses, incident aortic aneurysm was also more common among men with baseline history of hospitalization for stroke (adjusted hazard ratio (HR) 1.71, 95% CI 1.12-2.60) than among men with self-reported stroke (HR 0.88, 95% CI 0.56-1.36) compared to men with no history of stroke. With regard to the primary outcome, the rate of hospitalisation for stroke during follow-up was significantly higher among men with self-reported stroke (HR 2.44, 95% CI 2.03-2.94), hospital-coded stroke (adjusted HR 3.02, 2.42-3.78) and both self-reported and hospital-coded stroke (adjusted HR 3.33, 2.82-3.92) compared to participants with no previous stroke. Time to recurrent stroke was similar among different methods of initial stroke diagnosis (p = 0.067). b i Conclusions: /i /b Self-reported stroke and hospital-coded stroke have a similar prognostic value for predicting the risk of recurrent stroke. This supports the use of these ways of assessing a history of stroke for the clinical purposes of secondary prevention and for further epidemiological studies.
Publisher: Oxford University Press (OUP)
Date: 11-10-2023
DOI: 10.1093/CID/CIAC820
Abstract: Few studies have assessed participant safety in human challenge trials (HCTs). Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective. A systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 7 October 2021. Of 2838 articles screened, 276 were reviewed in full. A total of 15 046 challenged participants were described in 308 studies that met inclusion criteria 286 (92.9%) of these studies reported mitigation measures used to minimize risk to the challenge population. Among 187 studies that reported on SAEs, 0.2% of participants experienced at least 1 challenge-related SAE. Among 94 studies that graded AEs by severity, challenge-related AEs graded “severe” were reported by between 5.6% and 15.8% of participants. AE data were provided as a range to account for unclear reporting. Eighty percent of studies published after 2010 were registered in a trials database. HCTs are increasingly common and used for an expanding list of diseases. Although AEs occur, severe AEs and SAEs are rare. Reporting has improved over time, though not all papers provide a comprehensive report of relevant health impacts. We found very few severe symptoms or SAEs in studies that reported them, but many HCTs did not report relevant safety data. This study was preregistered on PROSPERO as CRD42021247218.
Publisher: Wiley
Date: 02-2021
DOI: 10.1111/IMJ.15179
Publisher: BMJ
Date: 05-11-2020
Publisher: BMJ
Date: 25-09-2021
DOI: 10.1136/MEDETHICS-2020-106504
Abstract: COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies (also known as controlled human infection studies (CHIs)) with SARS-CoV-2 (the virus which causes COVID-19). Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 CHIs. Such evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment.
Publisher: American Association for the Advancement of Science (AAAS)
Date: 10-07-2020
Publisher: Springer Science and Business Media LLC
Date: 25-08-2020
Publisher: Springer Science and Business Media LLC
Date: 06-2021
Publisher: BMJ
Date: 02-2021
Publisher: Wiley
Date: 18-08-2019
DOI: 10.1111/BIOE.12642
Abstract: Drug-resistant bacterial infections constitute a major threat to global public health. Several key bacteria that are becoming increasingly resistant are among those that are ubiquitously carried by human beings and usually cause no symptoms (i.e. in iduals are asymptomatic carriers) until and/or unless a precipitating event leads to symptomatic infection (and thus disease). Carriers of drug-resistant bacteria can also transmit resistant pathogens to others, thus putting the latter at risk of resistant infections. Accumulating evidence suggests that such transmission occurs not only in hospital settings but also in the general community, although considerably more data are needed to assess the extent of this problem. Asymptomatic carriage of drug-resistant bacteria raises important ethical questions regarding the appropriate public health response, including the degree to which it would be justified to impose burdens on asymptomatic carriers (and others) in order to prevent transmission. In this paper, we (i) summarize current evidence regarding the carriage of key drug-resistant bacteria, noting important knowledge gaps and (ii) explore the particular implications of existing public health ethics frameworks for policy-making regarding asymptomatic carriers. Inter alia, we argue that the relative burdens imposed by public health measures on healthy carriers (as opposed to sick in iduals) warrant careful consideration and should be proportionate to the expected public health benefits in terms of risks averted. We conclude that more surveillance and research regarding community transmission will be needed in order to clarify relevant risks and design proportionate policies, although extensive community surveillance itself would also require careful ethical consideration.
Publisher: Wiley
Date: 25-03-2022
DOI: 10.1111/BIOE.13015
Abstract: COVID‐19 vaccination of children has begun in a number of countries with provisional regulatory approval and public support. This article provides an ethical analysis of COVID‐19 vaccination of healthy children. Specifically, we present three of the strongest arguments that might justify COVID‐19 vaccination of children: (a) an argument from paternalism, (b) an argument from indirect protection and altruism, and (c) an argument from global eradication. We offer a series of objections to each of these arguments to show that none of them is currently tenable. Given the minimal direct benefit of COVID‐19 vaccination for healthy children, the potential for rare risks to outweigh these benefits and to undermine vaccine confidence, the substantial evidence that COVID‐19 vaccination confers adequate protection to risk groups whether or not healthy children are vaccinated and that current vaccines do not provide sterilizing immunity, and given that eradication of the virus is neither feasible nor a high priority for global health, we argue that routine COVID‐19 vaccination of healthy children is currently ethically unjustified. Since mandates for children have already been implemented in some places (e.g., California) and may be considered elsewhere, we also present two additional arguments explicitly against making COVID‐19 vaccination mandatory for children.
Publisher: Springer International Publishing
Date: 2020
Publisher: Springer Science and Business Media LLC
Date: 06-2022
DOI: 10.1007/S40592-022-00163-7
Abstract: The global response to the recent coronavirus pandemic has revealed an ethical crisis in public health. This article analyses key pandemic public health policies in light of widely accepted ethical principles: the need for evidence, the least restrictive/harmful alternative, proportionality, equity, reciprocity, due legal process, and transparency. Many policies would be considered unacceptable according to pre-pandemic norms of public health ethics. There are thus significant opportunities to develop more ethical responses to future pandemics. This paper serves as the introduction to this Special Issue of Monash Bioethics Review and provides background for the other articles in this collection.
Publisher: Springer Science and Business Media LLC
Date: 08-2020
Abstract: The combination of measurements of the W boson polarization in top quark decays performed by the ATLAS and CMS collaborations is presented. The measurements are based on proton-proton collision data produced at the LHC at a centre-of-mass energy of 8 TeV, and corresponding to an integrated luminosity of about 20 fb − 1 for each experiment. The measurements used events containing one lepton and having different jet multiplicities in the final state. The results are quoted as fractions of W bosons with longitudinal ( F 0 ), left-handed ( F L ), or right-handed ( F R ) polarizations. The resulting combined measurements of the polarization fractions are F 0 = 0 . 693 ± 0 . 014 and F L = 0 . 315 ± 0 . 011. The fraction F R is calculated from the unitarity constraint to be F R = − 0 . 008 ± 0 . 007. These results are in agreement with the standard model predictions at next-to-next-to-leading order in perturbative quantum chromodynamics and represent an improvement in precision of 25 (29)% for F 0 ( F L ) with respect to the most precise single measurement. A limit on anomalous right-handed vector ( V R ), and left- and right-handed tensor ( g L , g R ) tWb couplings is set while fixing all others to their standard model values. The allowed regions are [ − 0 . 11 , 0 . 16] for V R , [ − 0 . 08 , 0 . 05] for g L , and [ − 0 . 04 , 0 . 02] for g R , at 95% confidence level. Limits on the corresponding Wilson coefficients are also derived.
Publisher: American Association for the Advancement of Science (AAAS)
Date: 22-05-2020
Abstract: High social value is fundamental to justifying these studies
Publisher: Wiley
Date: 08-2009
DOI: 10.1111/J.1440-1843.2009.01562.X
Abstract: Few longitudinal studies have examined the risk factors and natural history of adult-onset asthma. This study assessed the subject characteristics and lifestyle factors that predicted the new diagnosis of asthma in adulthood and how these factors changed over time in those who developed asthma compared with those who do not. The study enrolled 1554 adults from the Busselton Health Study seen in 1981 and again in 1994-1995 who initially reported never having had doctor-diagnosed asthma. Questionnaire measures were used to assess doctor-diagnosed asthma, respiratory history and tobacco smoking. Height, weight and spirometric measures of lung function were measured. Atopy was assessed by skin prick tests. Logistic regression analysis was used to identify risk factors for adult-onset asthma and changes over time. Reported wheeze, rhinitis, chronic cough, smoking and lower levels of lung function in 1981 each predicted asthma diagnosis by 1994-1995. Neither initial skin-prick reactivity nor newly positive skin-prick tests at follow up were associated with adult-onset asthma. Those diagnosed with asthma were more likely to have new wheeze, new rhinitis, new habitual snoring, weight gain and excess decline in lung function. Adult-onset asthma has risk factors that are distinct from those observed in childhood asthma. The presence of upper airway symptoms including rhinitis, as well as lifestyle factors, such as smoking, predicts those at greatest risk. However, neither pre-existing atopy nor new atopy as measured by skin prick tests was associated with adult-onset asthma.
Publisher: Wiley
Date: 30-08-2020
DOI: 10.1111/BIOE.12802
Publisher: BMJ
Date: 07-06-2023
Abstract: Antibiotic allergies are commonly reported among patients, but most do not experience reactions on rechallenge with the same agents. These reported allergies complicate management of infections in patients labelled as having penicillin allergy, including serious infections where penicillin-based antibiotics are the first-line (most effective and least toxic) treatment option. Allergy labels are rarely questioned in clinical practice, with many clinicians opting for inferior second-line antibiotics to avoid a perceived risk of allergy. Reported allergies thereby can have significant impacts on patients and public health, and present major ethical challenges. Antibiotic allergy testing has been described as a strategy to circumvent this dilemma, but it carries limitations that often make it less feasible in patients with acute infections or in community settings that lack access to allergy testing. This article provides an empirically informed ethical analysis of key considerations in this clinical dilemma, using Staphylococcus aureus bacteraemia in patients with penicillin allergies as a case study. We argue that prescribing first-line penicillin-based antibiotics to patients with reported allergies may often present a more favourable ratio of benefits to risks, and may therefore be more ethically appropriate than using second-line drugs. We recommend changes to policy-making, clinical research and medical education, in order to promote more ethically acceptable responses to antibiotic allergies than the status quo.
Publisher: Springer Science and Business Media LLC
Date: 12-2015
Publisher: BMJ
Date: 05-12-2022
Abstract: In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group (2) may result in a net harm to healthy young adults (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on c us but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates.
Publisher: Elsevier BV
Date: 08-2023
Publisher: Wiley
Date: 2020
DOI: 10.1111/IMJ.14466
Abstract: Clinical practice guidelines aim to assist medical practitioners in making efficient evidence-based decisions in daily practice. However, international studies have shown that the majority of recommendations in American and European guidelines are not based on strong evidence. To review Australian clinical practice guidelines across a broad range of high-impact conditions and determine how evidence-based they are. Australian guidelines published from January 2010 to May 2018 relating to the top 10 causes of death in Australia were identified from the National Health and Medical Research Council (NHMRC) clinical practice guideline database and other relevant sources. The graded recommendations in these guidelines were extracted for analysis and the systems used for grading the recommendations were recorded. Ten relevant Australian guidelines were identified, containing a total of 748 graded recommendations. All 10 guidelines used either the Grading of Recommendations Assessment, Development and Evaluation (GRADE) or NHMRC systems to assess recommendations. However, only 18% (n = 136) of these recommendations were based on Level I (or equivalent) evidence 25% (n = 185) were based on Level II evidence, 29% (n = 218) on Level III, and 9% (n = 66) on Level IV. Consensus-based recommendations accounted for 19% (n = 143) of all recommendations. Despite the enthusiasm of the evidence-based medicine movement and its documented successes, contemporary medicine appears to remain largely evidence-poor, not evidence-based. Future research should aim to provide reliable descriptions of what constitutes valid clinical reasoning in evidence-poor situations.
Publisher: Wiley
Date: 10-2020
DOI: 10.1111/IMJ.15038
Publisher: Cold Spring Harbor Laboratory
Date: 21-03-2022
DOI: 10.1101/2022.03.20.22272658
Abstract: There exists no prior systematic review of human challenge trials (HCTs) that focuses on participant safety. Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective. A systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 10/7/2021. Of 2,838 articles screened, 276 were reviewed in full. 15,046 challenged participants were described in 308 studies that met inclusion criteria. 286 (92.9%) of these studies reported mitigation measures used to minimize risk to the challenge population. Among 187 studies which reported on SAEs, 0.2% of participants experienced at least one challenge-related SAE. Among 94 studies that graded AEs by severity, challenge-related AEs graded “severe” were reported by between 5.6% and 15.8% of participants. AE data were provided as a range to account for unclear reporting. 80% of studies published after 2010 were registered in a trials database. HCTs are increasingly common and used for an expanding list of diseases. Although AEs occur, severe AEs and SAEs are rare. Reporting has improved over time, though not all papers provide a comprehensive report of relevant health impacts. From the available data, most HCTs do not lead to a high number of severe symptoms or SAEs. This study was preregistered on PROSPERO as CRD42021247218.
Publisher: Elsevier BV
Date: 04-2021
Publisher: Springer Science and Business Media LLC
Date: 12-2020
DOI: 10.1007/S40592-020-00123-Z
Abstract: Interactions between microbes and human hosts can lead to a wide variety of possible outcomes including benefits to the host, asymptomatic infection, disease (which can be more or less severe), and/or death. Whether or not they themselves eventually develop disease, asymptomatic carriers can often transmit disease-causing pathogens to others. This phenomenon has a range of ethical implications for clinical medicine, public health, and infectious disease research. The implications of asymptomatic infection are especially significant in situations where, and/or to the extent that, the microbe in question is transmissible, potentially harmful, and/or untreatable. This article reviews the history and concept of asymptomatic infection, and relevant ethical issues associated with this phenomenon. It illustrates the role and ethical significance of asymptomatic infection in outbreaks, epidemics, and pandemics–including recent crises involving drug resistance, Zika, and Covid19. Serving as the Introduction to this Special Issue of Monash Bioethics Review , it also provides brief summaries of the other articles comprising this collection.
Publisher: BMJ
Date: 16-11-2018
DOI: 10.1136/MEDETHICS-2017-104389
Abstract: Zika virus was recognised in 2016 as an important vector-borne cause of congenital malformations and Guillain-Barré syndrome, during a major epidemic in Latin America, centred in Northeastern Brazil. The WHO and Pan American Health Organisation (PAHO), with partner agencies, initiated a coordinated global response including public health intervention and urgent scientific research, as well as ethical analysis as a vital element of policy design. In this paper, we summarise the major ethical issues raised during the Zika epidemic, highlighting the PAHO ethics guidance and the role of ethics in emergency responses, before turning to ethical issues that are yet to be resolved. Zika raises traditional bioethical issues related to reproduction, prenatal diagnosis of serious malformations and unjust disparities in health outcomes. But the epidemic has also highlighted important issues of growing interest in public health ethics, such as the international spread of infectious disease the central importance of reproductive healthcare in preventing maternal and neonatal morbidity and mortality diagnostic and reporting biases vector control and the links between vectors, climate change, and disparities in the global burden of disease. Finally, there are controversies regarding Zika vaccine research and eventual deployment. Zika virus was a neglected disease for over 50 years before the outbreak in Brazil. As it continues to spread, public health agencies should promote gender equity and disease control efforts in Latin America, while preparing for the possibility of a global epidemic.
Publisher: Cold Spring Harbor Laboratory
Date: 05-12-2021
DOI: 10.1101/2021.12.02.21267207
Abstract: Infectious disease control measures often require collective compliance of large numbers of in iduals to benefit public health. This raises ethical questions regarding the value of the public health benefit created by in idual and collective compliance. Answering these requires estimating the extent to which in idual actions prevent infection of others. We develop mathematical techniques enabling quantification of the impacts of in iduals or groups complying with three public health measures: border quarantine, isolation of infected in iduals, and prevention via vaccination rophylaxis. The results suggest that (i) these interventions exhibit synergy: they become more effective on a per-in idual basis as compliance increases and (ii) There is often significant “overdetermination” of transmission: if a susceptible person contacts multiple infectious in iduals, an intervention preventing one transmission may not change the ultimate outcome (thus risk imposed by some in iduals may erode the benefits of others’ compliance). These results have implications for public health policy during epidemics.
Publisher: American Association for the Advancement of Science (AAAS)
Date: 05-05-2023
Abstract: Infectious disease control measures often require collective compliance of large numbers of in iduals to benefit public health. This raises ethical questions regarding the value of the public health benefit created by in idual and collective compliance. Answering these requires estimating the extent to which in idual actions prevent infection of others. We develop mathematical techniques enabling quantification of the impacts of in iduals or groups complying with three public health measures: border quarantine, isolation of infected in iduals, and prevention via vaccination rophylaxis. The results suggest that (i) these interventions exhibit synergy: They become more effective on a per-in idual basis as compliance increases, and (ii) there is often substantial “overdetermination” of transmission. If a susceptible person contacts multiple infectious in iduals, an intervention preventing one transmission may not change the ultimate outcome (thus, risk imposed by some in iduals may erode the benefits of others’ compliance). These results have implications for public health policy during epidemics.
Publisher: F1000 Research Ltd
Date: 16-06-2021
DOI: 10.12688/WELLCOMEOPENRES.16849.1
Abstract: Vaccination is a cornerstone of global public health. Although licensed vaccines are generally extremely safe, both experimental and licensed vaccines are sometimes associated with rare serious adverse events. Vaccine-enhanced disease (VED) is a type of adverse event in which disease severity is increased when a person who has received the vaccine is later infected with the relevant pathogen. VED can occur during research with experimental vaccines and/or after vaccine licensure, sometimes months or years after a person receives a vaccine. Both research ethics and public health policy should therefore address the potential for disease enhancement. Significant VED has occurred in humans with vaccines for four pathogens: measles virus, respiratory syncytial virus, Staphylococcus aureus, and dengue virus it has also occurred in veterinary research and in animal studies of human coronavirus vaccines. Some of the immunological mechanisms involved are now well-described, but VED overall remains difficult to predict with certainty, including during public health implementation of novel vaccines. This paper summarises the four known cases in humans and explores key ethical implications. Although rare, VED has important ethical implications because it can cause serious harm, including death, and such harms can undermine vaccine confidence more generally – leading to larger public health problems. The possibility of VED remains an important challenge for current and future vaccine development and deployment. We conclude this paper by summarising approaches to the reduction of risks and uncertainties related to VED, and the promotion of public trust in vaccines.
Location: Russian Federation
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Euzebiusz Jamrozik.