Ian Kerridge

• BA, BMed(Hons), MPhil(Cantab), FRACP, FRCPA
• Managing Director at The University of Sydney

The objective of this scoping review was to systematically review the literature on how non-financial conflicts of interest (nfCOI) are defined and evaluated, and the strategies suggested for their management in health-related and biomedical journals. PubMed, Embase, Scopus and Web of Science were searched for peer reviewed studies published in Eng...

Peripheral blood stem cell (PBSC) mobilisation in multiple myeloma (MM) patients after exposure to daratumumab (D), a CD38 targeting monoclonal antibody, produces a lower stem cell yield possibly due to an effect on CD34+ stem cells (Hulin et al., 2021). Similarly, the GRIFFIN study reported greater plerixafor usage to facilitate PBSC mobilisation...

BACKGROUND Survival rates in multiple myeloma (MM) have significantly improved in recent decades with the advent of high-dose chemotherapy conditioned autologous stem cell transplantation (ASCT) and the availability of novel agents for induction therapy (Kumar SK et al. Blood 2008). Failure to respond to front-line bortezomib-based induction therap...

BACKGROUND Bortezomib-based induction (V-IND) approaches are used in >90% of Australian newly diagnosed transplant eligible multiple myeloma (NDTE MM) patients (pts) with a maximum of 4 cycles of V-IND therapy available via the pharmaceutical benefits scheme (PBS) prior to a planned autologous stem cell transplantation (ASCT). However, NDTE MM pati...

Background Patients with secondary acute myeloid leukaemia (sAML), defined as AML that follows a diagnosis of myelodysplastic syndrome or myeloproliferative neoplasm, are known to have a poor prognosis with conventional chemotherapy alone, when compared to de novo AML (dnAML). Allogeneic stem cell transplant offers the best chance of cure due to th...

Introduction Serious infection is common in patients with multiple myeloma (MM), and associated with major morbidity and mortality. Immunoglobulin (Ig) replacement is frequently used to reduce frequency and severity of infections, however evidence is based on small trials conducted >20 years ago. Ig utilisation and associated costs in this patient...

Introduction Daratumumab, when added to standard of care regimens in relapsed and untreated myeloma, has consistently demonstrated significant improvements in response rates, induction of MRD negative responses and prolonged progression-free survival (PFS) while proving highly tolerable with minor increases in overall regimen toxicity. In non-trans...

Introduction A majority of patients with diffuse large B cell lymphoma (DLBCL) will be cured with frontline chemoimmunotherapy, however a significant number of patients will relapse. Although autologous haematopoietic stem cell transplantation (autoHCT) may lead to sustained survival in some relapsing patients, long term survival with relapsed DLBC...

Introduction: Understanding placebo and nocebo responses (context/meaning effects [CMEs]) is fundamental to physician agency. Specific instruction in CMEs is often lacking in medical education. Patient-practitioner interactions may challenge medical students' understanding of biomedical causality and the nexus between this, practical ethics and pr...

Objective: To review the published literature assessing adherence rates to antifungal guidelines and reasons for nonadherence in the adult malignant hematology inpatient setting. Data sources: The databases Embase, MEDLINE, and PubMed (from data inception to May 2019) were searched using the terms hematology, oncology, antifungal, guidelines, adher...

Background Despite the advantageous spectrum of activity of itraconazole, it is rarely used as a prophylactic agent due to limited bioavailability and intolerance of the conventional formulation. After the development of a novel formulation SUBA-itraconazole® (SUper BioAvailability), we undertook a study to assess therapeutic levels, safety, tolera...

Clinical uses of unproven stem cell-based interventions abound, yet many patients may be harmed by receiving them, raising complex ethical, economic, and societal concerns. Regulators, scientists, clinicians, professional societies, and patient advocacy groups need to collaboratively articulate expectations related to the proper development and del...

Corruption is a word used loosely to describe many kinds of action that people find distasteful. We prefer to reserve it for the intentional misuse of the good offices of an established social entity for private benefit, posing as fair trading. The currency of corruption is not always material or financial. Moral corruption is all too familiar with...

There are increasing demands on regulators and insurers internationally to provide access to medicines more quickly, and often on the basis of less robust evidence of safety, efficacy or cost-effectiveness than have traditionally been required. These demands arise from a number of sources, including those advocating for access to medicines for pati...

Background Oral and dental disease is a major cause of long‐term morbidity following allogeneic blood and marrow transplantation (Allo‐BMT). This study aimed to describe the extent and range of oral and dental complications in BMT recipients, and to identify gaps in service provision provided to this high‐risk group. Methods Participants were Allo...

Ideological biases influence medical research and practice and should be disclosed and managed, say Miriam Wiersma and colleagues. But Marc Rodwin argues that many of these interests are widespread and inherent to life and cannot be avoided or eliminated. © Published by the BMJ Publishing Group Limited. For permission to use (where not already gran...

The term innovation is frequently used as a justification for allowing clinicians to offer unproven autologous stem cell-based interventions (SCBIs) to their patients. Proponents of this kind of innovation (which we refer to as "clinical innovation") argue that physicians should be free to administer whatever interventions they choose, and informed...

Background: Advance care planning (ACP) is defined in a variety of ways, although it is widely understood as a process undertaken by patients, when they have capacity, to define and communicate their treatment preferences for future care. Few studies have explored the meaning and importance patients place on their ability to participate in directi...

Biobanks are increasingly being linked together into global networks in order to maximise their capacity to identify causes of and treatments for disease. While there is great optimism about the potential of these biobank networks to contribute to personalised and data-driven medicine, there are also ethical concerns about, among other things, risk...

Non-financial interests, and the conflicts of interest that may result from them, are frequently overlooked in biomedicine. This is partly due to the complex and varied nature of these interests, and the limited evidence available regarding their prevalence and impact on biomedical research and clinical practice. We suggest that there are no meanin...

Aim: This article examines online marketing practices of Japanese and Australian clinics offering putative autologous stem cell treatments. Materials & methods: We conducted google searches for keywords related to stem cell therapy and stem cell clinics in English and Japanese. Results: We identified websites promoting 88 point-of-sale clinics...

In this Symposium on the Ethics and Epistemology of Big Data, we present four perspectives on the ways in which the rapid growth in size of research databanks-i.e. their shift into the realm of "big data"-has changed their moral, socio-political, and epistemic status. While there is clearly something different about "big data" databanks, we encoura...

Aim: This paper reports on the findings from 6 focus groups conducted with Australian medical students. The focus groups sought students' perspectives on how the influence of commercial interests on medical practice and education could be managed. Method: We conducted 6 focus groups with medical students in New South Wales, Australia. Participan...

In Australia, the growing assisted reproductive technologies (ART) industry has recently received some public criticism. Much of this criticism centres on the concern that doctors are increasingly motivated by profit, rather than patient interests. These concerns appear to suggest that the growing business of ART generates conflicts of interest (CO...

The Australian government recently released its response to the Review of Medicines and Medical Devices Regulation, accepting most recommendations. One recommendation involves the introduction of provisional approvals for perceived life-saving and innovative new treatments, allowing these to be approved on the basis of more limited data on the cond...

Objectives: To assess therapeutic levels, safety and tolerability of a novel formulation SUBA-itraconazole (where SUBA stands for SUper BioAvailability) when compared with conventional itraconazole liquid when used as antifungal prophylaxis in patients undergoing allogeneic HSCT or in haematological malignancy patients with an intermediate/high ri...

Background: Research has begun to focus on whether Advance Care Planning (ACP) has the capacity to influence care, and to examine whether ACP can be effective in meeting patients' wishes at the end of their lives. Little attention has been paid, however, to the validity and clinical relevance of existing measures. Methods: A search of Medline an...

Although randomized controlled trials remain the scientific ideal for determining the efficacy and safety of new treatments, they are sometimes insufficient to address the evidentiary requirements of regulators and payers. This is particularly the case when it comes to precision medicines because trials are often small, deliver incomplete insights...

Context: Conflicts of interest (CoIs) are considered to be ubiquitous in health care and biomedicine. The disclosure of relevant interests is a first step in managing conflicts, although its usefulness is contested. Although several countries have mandated the public disclosure of doctors' financial relationships with the pharmaceutical industry,...

Conflicts of interest (COI) are considered ubiquitous in many healthcare arrangements,1 but there is disagreement on how COI should be defined, whether non-financial conflicts deserve attention and the relationship between COI and harm. We conducted a study of Australian healthcare professionals and students to gain a better understanding of the wa...

In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an...

Biomedical innovation and translation are increasingly emphasizing research using “big data.” The hope is that big data methods will both speed up research and make its results more applicable to “real-world” patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethica...

(Aust N Z J Obstet Gynaecol. 2016;56(2):127–136) In situations where the administration of blood or blood products is not a therapeutic option, management of obstetric hemorrhage can be extremely difficult and require additional multidisciplinary communication as well as unique approaches. Transfusion may not be an option when a woman has complex r...

In recent years, a range of initiatives have been introduced to provide patients with access to medicines outside of traditional regulatory and/or funding channels; we term these processes “accelerated access to medicines.” These generally take 1 of 3 forms: those that provide access by making existing regulatory and funding processes more efficien...

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences a...

PurposeThe aim of this qualitative study was to gain a rich understanding of the impact that haematopoietic stem cell transplantation (HSCT) has on long-term survivor’s quality of life (QoL). Method Participants included 441 survivors who had undergone HSCT for a malignant or non-malignant disease. Data were obtained by a questionnaire positing a s...

Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide, and the burdens of this disease continue to track prior disadvantage. In order to galvanise a coordinated global response, WHO has recently launched the End TB Campaign that aims to eliminate TB by 2050. Key to this is the introduction of population screening programmes...

The process of globalization is commonly espoused as a means for promoting global health. Efforts to "go global" can, however, easily go awry as a result of lack of attention to local social, economic, and political contexts and/or as a result of commercial and political imperatives that allow local populations to be exploited. Critical analysis of...

Purpose: The aims of this study were to describe the long-term nutrition, body weight and body image issues facing survivors of Allogeneic Blood and Marrow Transplant (BMT) and their impact on quality of life. It also describes survivors' perception of enteral feeding during BMT. Methods: Four hundred and forty-one survivors who had undergone a...

This study aimed to determine whether the label status of a medicine penetrates into the clinical reasoning of Australian medical practitioners and to explore the possible reasons for our findings using semistructured interviews with 14 Australian physicians. The interviews revealed 3 broad catalysts for off-label prescribing. The first of these wa...

In addition to prescribed conventional medicines, many allogeneic hematopoietic stem cell transplant (HSCT) survivors also use complementary and alternative medical therapies (CAM), however, the frequency and types of CAMs used by allogeneic HSCT survivors remain unclear. Study participants were adults who had undergone an allogeneic HSCT between 1...

Concerns over conflicts of interest (COI) in academic research and medical practice continue to provoke a great deal of discussion. What is most obvious in this discourse is that when COIs are declared, or perceived to exist in others, there is a focus on both the descriptive question of whether there is a COI and, subsequently, the normative quest...

A research report prepared for NSW Ministry of Health by: Dr Evan Doran, Dr Jennifer Fleming, Associate Professor Ian Kerridge and Professor Cameron Stewart for the Clinical Ethics Capacity Building Project Reference Group.

A report of the literature reviews for the Clinical Ethics Capacity Building Project commissioned by the NSW Ministry of Health ISBN 978-1-74187-115-9

Objective The aim of the present study was to examine stakeholder perspectives on how the operation of the mental health system affects the use of involuntary community treatment orders (CTOs).Methods A qualitative study was performed, consisting of semi-structured interviews about CTO experiences with 38 purposively selected participants in New So...

Purpose As part of work to understand the experiences of young people who had cancer, we were keen to examine the perspectives of peers who share their social worlds. Our study aimed to examine how cancer in young people, young people with cancer and young cancer survivors are represented through language, metaphor and performance. Methods We gener...

In this paper we report on the findings from six focus groups conducted with Australian medical students. The focus groups discussed students’ perceptions of conflicts of interest and the influence of commercial values in health care and medical education. Our research revealed that students were aware of a number of structural influences that affe...

The cost of pharmaceuticals is overwhelming health budgets around the world. A growing proportion of this burden stems from the ever-increasing demand for subsidisation of cancer medicines. Those making decisions about which cancer medicines should be subsidised are often criticised by patients, clinicians and the pharmaceutical industry for withho...

Allogeneic haematopoietic stem cell transplantation (allo-HSCT) entails long-term morbidities that impair survivors' quality of life through broad physical and psychosocial sequelae. Current data and survival measurements may be inadequate for contemporary Australian allo-HSCT recipients. This study sought to comprehensively describe survivorship i...

This Handbook provides an authoritative overview of current issues and debates in the field of health care management. It contains over twenty chapters from well-known and eminent academic authors, who were carefully selected for their expertise and asked to provide a broad and critical overview of developments in their particular topic area. The d...

Allogeneic Blood and Marrow Transplant (BMT) survivors are at high risk of secondary cancers. Although current guidelines endorse survivors following Country-specific general population screening recommendations to mitigate this risk, little is known about cancer screening adherence in Australian BMT survivors. We conducted a cross-sectional survey...

Young people who have a parent with cancer experience elevated levels of psychological distress and unmet needs. In this study, we examined the associations between demographics, cancer variables and family functioning and levels of distress and unmet needs amongst young people who have a parent diagnosed with cancer. Young people aged 12-24 years...

Concern is growing about the implications of rising drug prices for individuals and health systems around the world. With little transparency around the costs of drug development, Narcyz Ghinea and colleagues call for greater accountability from drug companies to ensure a fair price for new medicines In 2014, the IMS Institute for Healthcare Infor...

Justifying involuntary psychiatric treatment on the basis of a judgment that a person lacks capacity is controversial because there are questions about the meaning and utility of the concept in this context. There are complexities to using capacity in this way, which are further amplified in the community outpatient setting compared with acute inpa...

Introduction: High dose melphalan (HDM) and autologous stem cell transplantation (ASCT) retains a central role in the treatment of myeloma. Aim: The aim of this study was to determine whether HDM exposure (area-under-the-concentration-versus-time-curve, AUC), is significantly associated with transplant outcomes. Methods: Melphalan concentratio...

Social, political, and economic environments play an active role in nurturing professional virtue. Yet, these environments can also lead to the erosion of virtue. As such, professional virtue is fragile and vulnerable to environmental shifts. While physicians are often considered to be among the most virtuous of professional groups, concern has als...

Globally, genomic research is generating unprecedented advances in the understanding of the biology, pathogenetic mechanisms and prognostic markers of many cancers and is creating the possibility of precision (personalised) therapies. As more data are generated, it becomes increasingly necessary to determine the clinical significance of this data a...

Background ‘One Health’ represents a call for health researchers and practitioners at the human, animal and environmental interfaces to work together to mitigate the risks of emerging and re-emerging infectious diseases (EIDs). A One Health approach emphasizing inter-disciplinary co-operation is increasingly seen as necessary for effective EID cont...

Background Clostridium difficile infection (CDI) is an important and increasingly prevalent healthcare-associated infection. Strongly associated with antibiotic exposure, CDI may result in diarrhea, colitis and death-particularly in at-risk patients. While the incidence of both CDI and CDI-associated complications appears more common in hematology...

Background Though the majority of patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL) are curable with R-CHOP chemotherapy, a significant proportion will relapse or have refractory disease. The most commonly used clinical tool is the international prognostic index (IPI), though this cannot fully capture the heterogeneity of ca...

Background PET-CT has become an essential tool in the management of Lymphoma. PET-CT is utilized in both the initial staging of lymphoma as well as assessing treatment-response. High grade transformation of a low grade lymphoproliferative disorder (LPD) is associated with a poor prognosis. Patients (pts) are usually treated with standard of care fo...

Four hundred and twenty-one adult allogeneic haematopoietic stem cell transplant (HSCT) survivors participated in a cross-sectional study to assess sexual dysfunction and infertility post-transplant. Survey instruments included the Sydney Post-Blood and Marrow Transplant (BMT) Survey, Functional Assessment of Cancer Treatment (FACT) - BMT, the Depr...

Four hundred and forty-one adult allogenic Blood and Marrow Transplant (BMT) survivors participated in a cross-sectional survey to assess Long Term Follow Up (LTFU) model of care (MOC) preference. Survey instruments included the Sydney Post Blood and Marrow Transplant (BMT) Survey, FACT-BMT, DASS 21, The Chronic GVHD Activity Assessment- Patient Se...

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality and morbidity globally. Obstetric bleeding can be catastrophic and management is challenging, involving a coordinated multidisciplinary approach, which may include blood products. In settings where blood transfusion is not an option, either because of patient refusal (most comm...

Personalized medicines hold promise for many diseases. However, demonstrating the clinical efficacy and cost effectiveness of these medicines can be difficult. It is essential that decision-making processes for funding new medicines, including personalized medicines, are both robust and fit for purpose. We will argue that randomized trials of perso...

Background Over the last decade, managing the disclosure of findings of genomic research has been the subject of extensive scientific, ethical and legal commentary and is a major challenge for biobanks.AimsTo examine views of the general Australian public about the disclosure of individual research results (IRR) and incidental findings (IF) from bi...

Background: Patients with advanced cancer may benefit from end of life (EOL) planning, but there is evidence that their willingness and desire to engage in advance care planning (ACP) varies. The reasons for this remain poorly understood. Previous reviews on ACP most commonly report outcome measures related to medical interventions and type of car...

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 knowled...

Is it ethically appropriate in some circumstances for HCWs to decline to care for patients with EVD? How should treatment decisions be made regarding limitation of therapy for patients with EVD? There are two main ethical questions regarding the critical care of patients with EVD in an Australian setting: Is it ethically appropriate in some circums...