ORCID Profile
0000-0002-8671-915X
Current Organisation
University of Sydney
Does something not look right? The information on this page has been harvested from data sources that may not be up to date. We continue to work with information providers to improve coverage and quality. To report an issue, use the Feedback Form.
In Research Link Australia (RLA), "Research Topics" refer to ANZSRC FOR and SEO codes. These topics are either sourced from ANZSRC FOR and SEO codes listed in researchers' related grants or generated by a large language model (LLM) based on their publications.
Health Policy | Studies of Asian Society | Law and Society | Other Studies in Human Society |
Expanding Knowledge through Studies of Human Society | Religion and Society | Health Policy Evaluation
Publisher: Springer Science and Business Media LLC
Date: 10-02-2020
Publisher: BMJ
Date: 25-10-2023
Publisher: BMJ
Date: 28-10-2021
Publisher: BMJ
Date: 22-01-2020
DOI: 10.1136/BMJ.L6925
Abstract: To investigate pharmaceutical or medical device industry funding of patient groups. Systematic review with meta-analysis. Ovid Medline, Embase, Web of Science, Scopus, and Google Scholar from inception to January 2018 reference lists of eligible studies and experts in the field. Observational studies including cross sectional, cohort, case-control, interrupted time series, and before-after studies of patient groups reporting at least one of the following outcomes: prevalence of industry funding proportion of industry funded patient groups that disclosed information about this funding and association between industry funding and organisational positions on health and policy issues. Studies were included irrespective of language or publication type. Reviewers carried out duplicate independent data extraction and assessment of study quality. An amended version of the checklist for prevalence studies developed by the Joanna Briggs Institute was used to assess study quality. A DerSimonian-Laird estimate of single proportions with Freeman-Tukey arcsine transformation was used for meta-analyses of prevalence. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of the evidence for each outcome. 26 cross sectional studies met the inclusion criteria. Of these, 15 studies estimated the prevalence of industry funding, which ranged from 20% (12/61) to 83% (86/104). Among patient organisations that received industry funding, 27% (175/642 95% confidence interval 24% to 31%) disclosed this information on their websites. In submissions to consultations, two studies showed very different disclosure rates (0% and 91%), which appeared to reflect differences in the relevant government agency’s disclosure requirements. Prevalence estimates of organisational policies that govern corporate sponsorship ranged from 2% (2/125) to 64% (175/274). Four studies analysed the relationship between industry funding and organisational positions on a range of highly controversial issues. Industry funded groups generally supported sponsors’ interests. In general, industry funding of patient groups seems to be common, with prevalence estimates ranging from 20% to 83%. Few patient groups have policies that govern corporate sponsorship. Transparency about corporate funding is also inadequate. Among the few studies that examined associations between industry funding and organisational positions, industry funded groups tended to have positions favourable to the sponsor. Patient groups have an important role in advocacy, education, and research, therefore strategies are needed to prevent biases that could favour the interests of sponsors above those of the public. PROSPERO CRD42017079265.
Publisher: BMJ
Date: 12-2023
Publisher: Elsevier BV
Date: 03-2022
DOI: 10.1016/J.CLINTHERA.2021.11.019
Abstract: Approximately 40% of randomized controlled trials are not published, leading to publication bias and less informed clinical decision-making. Qualitative interviews were conducted to understand whether and how industry sponsors of clinical trials of drugs and biologics in Canada influence decisions to report trial results. Participants eligible for an interview included clinical trial investigators and research coordinators with experience in drug research, research ethics board members with at least 1 year of experience in ethical review of trials, research administrators with knowledge of dissemination of clinical trial findings or relations with trial sponsors, and trial participants who had taken part in a drug trial as an adult in the 5 years before their interview. Semi-structured interviews were held in person or by telephone between March 2019 and April 2021 with participants in Alberta, British Columbia, and Ontario, Canada. Qualitative analysis included coding of interview transcripts and identification of key themes. Interviews were conducted with 34 participants, including 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, 3 research ethics board members, and 10 clinical trial participants. Participants involved in the conduct, administration, or ethical review of trials represented a range of medical disciplines. Interview participant accounts indicated that in some cases, industry sponsors influence whether results are reported. A core theme was that companies have a weaker incentive to publish trials with unfavorable findings and trials for products that they have decided not to develop further. Companies may influence reporting in various ways, including stopping trials early and not reporting results of stopped trials, owning and controlling access to data, and negotiating clinical trial agreements in multicenter trials that do not fully protect the ability of investigators to publish. Internal company trials represent an additional source of unpublished trials. More broadly, the research system creates a dependency on funding from industry sponsors that may weaken the ability of researchers and research institutions to negotiate terms with industry sponsors that would fully protect publication rights. Interviews with trial investigators and others connected to trial research indicate that in some cases, industry sponsors of clinical trial research in Canada influence whether results are reported. Policies aiming to bring about full reporting of trials could benefit from considering the commercial incentives of companies and the ways in which industry sponsors may influence clinical trial reporting. Future research could examine the generalizability of these findings to other jurisdictions.
Publisher: BMJ
Date: 12-10-2021
Abstract: The US Food and Drug Administration (FDA) has approved two drugs for ‘hypoactive sexual desire disorder’ in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none. Trials for both drugs feature shifts in primary outcomes and a contested indication. A politicised industry-sponsored advocacy c aign and conflicted patient and expert testimony likely influenced flibanserin’s approval at its third attempt. Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin. Reconsideration of regulatory decisions to approve these drugs is in order, as well as a broader examination of how future regulatory decisions can better address conflicts of interest and clinically meaningful benefit.
Publisher: Wiley
Date: 09-11-2020
DOI: 10.1002/PRP2.680
Publisher: Wiley
Date: 16-08-2021
DOI: 10.1111/BCP.15007
Abstract: Medicines regulators issue post‐market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia. Semi‐structured qualitative interviews were carried out with 40 primary care physicians, endocrinologists and other generalist specialists in Boston (USA) and Australia. Coding and analysis were performed inductively and iteratively to identify and examine key factors. Analysis centred around four areas: physicians' awareness of drug safety information, preferred information sources, opinion‐forming and sharing of information with patients. Uncertainty, trust and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion and experience. Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the “clinical grapevine” for awareness, and on clinical colleagues, specialists and experience for interpretation. Communicating risk to patients was complicated by uncertainty physicians tailored information to patients' health literacy and information needs. US physicians were more aware of their national regulator's post‐market safety role than Australian physicians of theirs. Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance and accessibility, and address physicians' needs in communicating risk to patients.
Publisher: Wiley
Date: 06-03-2019
DOI: 10.1002/PDS.4762
Abstract: There has been less attention to the transparency of postmarket evidence of harmful effects of medicines than of premarket clinical trial data. This is a case study of requests for Australian "direct health professional communications" (DHPCs). These letters are used by regulators and manufacturers to inform clinicians of emergent evidence of harm. DHPCs are not made public by Australia's Therapeutic Goods Administration (TGA). We requested all DHPCs sent out in Australia from 2007 to 2016 inclusive for 207 drugs that were subject to safety advisories over this decade in Canada, the United Kingdom, and/or the United States. We contacted 39 manufacturers (February to May 2018), with repeat requests to nonrespondents, and a follow-up freedom-of-information (FOI) request to the TGA. Fifteen companies provided information, either sending DHPCs (n = 4, on five drugs) or affirming none were sent out (n = 11). The remaining 24 of 39 (62%) companies did not provide DHPCs: nine (23%) refused the request, often citing commercial confidentiality the rest provided no answer despite repeat requests. In total, we had no information for 170 of 207 (82%) of the drugs. Our FOI request to the TGA was unsuccessful. Our experience highlights unacceptable secrecy concerning safety warnings previously sent to thousands of Australian clinicians. In the absence of explicit regulatory policy supporting disclosure, companies differed in their response. These letters warn of serious and often life-threatening harm and guide safer care full ongoing public access is needed, ideally in searchable online databases.
Publisher: BMJ
Date: 29-03-2023
Abstract: To evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in Europe. Document content analysis. European Medicines Agency. Anticancer drugs granted a first marketing authorisation by the European Medicines Agency, 2017-19. Whether written information on a product addressed patients’ commonly asked questions about: who and what the drug is used for how the drug was studied types of drug benefit expected and the extent of weak, uncertain, or missing evidence for drug benefits. Information on drug benefits in written sources for clinicians (summaries of product characteristics), patients (patient information leaflets), and the public (public summaries) was compared with information reported in regulatory assessment documents (European public assessment reports). 29 anticancer drugs that received a first marketing authorisation for 32 separate cancer indications in 2017-19 were included. General information about the drug (including information on approved indications and how the drug works) was frequently reported across regulated information sources aimed at both clinicians and patients. Nearly all summaries of product characteristics communicated full information to clinicians about the number and design of the main studies, the control arm (if any), study s le size, and primary measures of drug benefit. None of the patient information leaflets communicated information to patients about how drugs were studied. 31 (97%) summaries of product characteristics and 25 (78%) public summaries contained information about drug benefits that was accurate and consistent with information in regulatory assessment documents. The presence or absence of evidence that a drug extended survival was reported in 23 (72%) summaries of product characteristics and four (13%) public summaries. None of the patient information leaflets communicated information about the drug benefits that patients might expect based on study findings. Scientific concerns about the reliability of evidence on drug benefits, which were raised by European regulatory assessors for almost all drugs in the study s le, were rarely communicated to clinicians, patients, or the public. The findings of this study highlight the need to improve the communication of the benefits and related uncertainties of anticancer drugs in regulated information sources in Europe to support evidence informed decision making by patients and their clinicians.
Publisher: American Society of Clinical Oncology (ASCO)
Date: 07-2022
DOI: 10.1200/OP.21.00767
Abstract: Interactions between cancer physicians and the pharmaceutical industry may create conflicts of interest that can adversely affect patient care. We aimed to survey cancer physicians regarding their attitudes toward and interactions with industry. We surveyed Australian cancer physicians between December 2020 and February 2021, questioning how often they interacted with industry and their attitudes toward this. We also assessed factors associated with accepting payments from industry and the amount received, and opinions on policies and industry influence. We used logistic and linear regression to examine links between attitudes and behaviors. There were 116 responses (94 complete). Almost half (n = 53 of 115, 46.1%) felt that there was a positive relationship between cancer physicians and industry. Most (n = 79 of 104, 76.0%) interacted with industry at least once a month, and 67.7% (n = 63 of 93) had received nonresearch payments from industry previously, with a median value of 2,000 Australian dollars over 1 year. Most respondents believed that interactions could influence prescribing while simultaneously denying influence on their own prescribing (n = 66 of 94, 70.2%). Those who judged general sales representative interactions (odds ratio [OR] 9.37 [95% CI, 1.05 to 83.41], P = .045) or clinician sponsorship (OR 3.22 [95% CI, 1.01 to 10.30], P = .049) to be more acceptable also met with sales representatives more frequently. Physicians were more likely to accept industry payments when they deemed sponsorship of clinicians for conferences (OR 10.55 [95% CI, 2.33 to 47.89], P = .002) or honoraria for advisory board membership more acceptable (OR 3.91 [95% CI, 1.04 to 14.74], P = .04) or when they had higher belief in industry influence over own prescribing (OR 25.51 [95% CI, 2.70 to 241.45], P = .005). Australian cancer physicians interact with industry frequently, and those who feel positive about these interactions are likely to do so more often. More research is needed to understand the motivations behind these interactions.
Publisher: BMJ
Date: 12-12-2019
DOI: 10.1136/BMJ.L6694
Abstract: To understand and report on the nature of patient group interactions with the pharmaceutical industry from the perspective of patient group representatives by exploring the range of attitudes towards pharmaceutical industry sponsorship and how, why, and when interactions occur. Empirical qualitative interview study informed by ethics theory. Australian patient groups. 27 participants from 23 Australian patient groups that represented erse levels of financial engagement with the pharmaceutical industry. Groups were focused on general health consumer issues or disease specific topics, and had regional or national jurisdictions. Analytic techniques were informed by grounded theory. Interview transcripts were coded into data driven categories. Findings were organised into new conceptual categories to describe and explain the data, and were supported by quotes. A range of attitudes towards pharmaceutical industry sponsorship were identified that are presented as four different types of relationship between patient groups and the pharmaceutical industry. The dominant relationship type was of a successful business partnership, and participants described close working relationships with industry personnel. These participants acknowledged a potential for adverse industry influence, but expressed confidence in existing strategies for avoiding industry influence. Other participants described unsatisfactory or undeveloped relationships, and some participants (all from general health consumer groups) presented their groups’ missions as incompatible with the pharmaceutical industry because of fundamentally opposing interests. Participants reported that interactions between their patient group and pharmaceutical companies were more common when companies had new drugs of potential interest to group members. Patient groups that accepted industry funding engaged in exchanges of “assets” with companies. Groups received money, information, and advice in exchange for providing companies with marketing, relationship building opportunities with key opinion leaders, coordinated lobbying with companies about drug access and subsidy, assisting companies with clinical trial recruitment, and enhancing company credibility. An understanding of the range of views patient groups have about pharmaceutical company sponsorship will be useful for groups that seek to identify and manage any ethical concerns about these relationships. Patient groups that receive pharmaceutical industry money should anticipate they might be asked for specific assets in return. Selective industry funding of groups where active product marketing opportunities exist might skew the patient group sector’s activity towards pharmaceutical industry interests and allow industry to exert proxy influence over advocacy and subsequent health policy.
Publisher: Wiley
Date: 21-07-2020
DOI: 10.1002/PDS.5072
Publisher: Wiley
Date: 10-2021
DOI: 10.1111/IMJ.15513
Publisher: PeerJ
Date: 28-08-2018
DOI: 10.7287/PEERJ.PREPRINTS.27149V1
Abstract: Background Guidelines are systematically developed recommendations to assist practitioner and patient decisions about treatments for clinical conditions. Researchers, healthcare professionals and policy makers need to be able to retrieve clinical practice guidelines (CPGs) efficiently and quickly from the literature. Despite the widespread use of CPGs in practice and policy formulation, no filter for retrieval of guidelines has been validated to date. The use of a validated search filter for CPGs would make their retrieval from major bibliographic databases more efficient. Objectives We aim to fill this gap by validating search filters for use in the systematic retrieval of CPGs and measure their performance according to sensitivity and precision. Methods We found four search filters for retrieval of CPGs (two CADTH, PubMed and University of Texas filters) which we will validate in three databases (MEDLINE, Embase and PubMed). We will derive a test set of CPGs from a search of the TRIP and Epistemonikos databases. The citations retrieved will be randomly sorted and screened sequentially by two reviewers until at least 100 CPGs are included. We will include CPGs that provide at least two explicit recommendations for the treatment of any clinical condition, and that are produced by a group or organization (i.e., not authored by one person) . We will translate the filters into Ovid MEDLINE, Embase, and PubMed syntax as appropriate. Then, we will run the strategies and assess whether the filters retrieved the citations in our test set. We will calculate and compare the sensitivity and precision of the four filters in each database. The limitations of the CADTH, PubMed and University of Texas search filters for each database will be assessed by examining the keywords in the titles and abstracts of the citations not found by the search filters. Discussion Decision makers, healthcare providers and researcher will be able to choose the most precise and sensitive search strategy among the four available, which will enable them to more efficiently identify relevant clinical practice guidelines.
Publisher: Wiley
Date: 27-06-2023
DOI: 10.1111/IMJ.16148
Abstract: Pharmaceutical industry exposure is widespread during medical training and may affect education and clinical decision‐making. Medical faculties' conflict of interest (COI) policies help to limit this exposure and protect students against commercial influence. Our aim was to investigate the prevalence, content and strength of COI policies at Australian medical schools and changes since a previous assessment conducted in 2009. We identified policies by searching medical school and host university websites in January 2021, and contacted deans to identify any missed policies. We applied a modified version of a scorecard developed in previous studies to examine the content of COI policies. All data were coded in duplicate. COI policies were rated on a scale from 0 (no policy) to 2 (strong policy) across 11 items per medical school. Oversight mechanisms and sanctions were also assessed, and current policies were compared with the 2009 study. Of 155 potentially relevant policies, 153 were university‐wide and two were specific to medical schools. No policies covered sales representatives, on‐site sponsored education or free s les. Oversight of consultancies had improved substantially, with 76% of schools requiring preapproval. Disclosure policies, while usually present, were weak, with no public disclosure required. We found little indication that Australian medical students are protected from commercial influence on medical education, and there has been limited COI policy development within the past decade. More attention is needed to ensure the independence of medical education in Australia.
Publisher: Wiley
Date: 22-08-2023
DOI: 10.5694/MJA2.52088
Publisher: Springer Science and Business Media LLC
Date: 02-05-2018
Publisher: Springer Science and Business Media LLC
Date: 07-03-2022
Publisher: Wiley
Date: 27-07-2022
DOI: 10.1002/PDS.5508
Abstract: National regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age‐ and sex‐based impacts in each country. Interrupted time series analysis was used to compare pioglitazone use (prescriptions/100000 population) in Australia and the United Kingdom for the 24 months before and 11 months after the July 2011 safety advisories (study period July 2009–June 2012). Separate models were used to compare use by sex and age group (≥65 years vs. years) in each country. Pioglitazone use fell in Australia (17%) and the United Kingdom (24%) following the safety advisories. Use of pioglitazone fell more for males (18%) than females (16%) in Australia, and more for females (25%) than males (23%) in the United Kingdom however, neither difference was statistically significant (Australia p = 0.445, United Kingdom p = 0.462). Pioglitazone use fell to a similar extent among older people than younger people in the United Kingdom (23% vs. 26%, p = 0.354), and did not differ between age groups in Australia (both 18%, p = 0.772). The results indicate that differences in the Australian and UK safety advisories resulted in substantial reductions in pioglitazone use at the population level in both countries, however, differences by sub‐groups were not observed.
Publisher: BMJ
Date: 03-2023
DOI: 10.1136/BMJOPEN-2022-068221
Abstract: To understand how the experiences and views of trial participants, trial investigators and others connected to clinical trial research relate to whether researchers have a duty to participants to publicly report research findings. Qualitative interview study. Semistructured interviews held in person or by telephone between March 2019 and April 2021 with participants in the Canadian provinces of Alberta, British Columbia and Ontario. 34 participants, including 10 clinical trial participants, 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators and 3 research ethics board members. We conducted a thematic analysis, including qualitative coding of interview transcripts and identification of key themes. Key themes identified through qualitative coding of interview data. Most clinical trial participants felt that reporting clinical trial results is important. Accounts of trial participants suggest their contributions are part of a reciprocal relationship involving the expectation that research will advance medical knowledge. Similarly, comments from trial investigators suggest that reporting trial results is part of reciprocity with trial participants and is a necessary part of honouring informed consent. Accounts of trial investigators suggest that when drug trials are not reported, this may undermine informed consent in subsequent trials by withholding information on harms or efficacy relevant to informed decisions on whether to conduct or enroll in future trials of similar drugs. The views of trial participants, trial investigators and others connected to clinical trial research in Canada suggest that researchers have an obligation to participants to publicly report clinical trial results and that reporting results is necessary for honouring informed consent.
Publisher: Informa UK Limited
Date: 03-10-2022
DOI: 10.1080/14740338.2022.2134342
Abstract: Many adverse effects of medicines only become known after approval, prompting regulatory agencies to issue post-market safety advisories to support safer care. Our team evaluated advisories issued by national regulators in Australia, Canada, Denmark, the United Kingdom, and the United States from 2007 to 2016 inclusive, comparing regulators' decisions to warn, effects on prescribing, doctors' awareness and responses to warnings, relevant regulatory policies, and specific case studies. Based mainly on our research program and a narrative review, this commentary describes how often regulators issue safety advisories and effects on clinical practice. We found extensive differences in decisions to warn, timing and content of warnings. Monitoring advice is often inadequate. The most systematic estimate suggests an average reduction in prescribing of around 6% compared with settings with no advisory. Interviews with doctors suggest limited awareness, uptake, and at times belief in these warnings. Post-market safety advisories are an important intervention aiming to improve prescribing and use of medicines. However, differing warnings mean that some patients may be exposed to riskier prescribing than others. Better integration of safety information into clinical practice is needed, as well as improved transparency, independence, and public engagement in regulatory decision-making.
Publisher: Wiley
Date: 11-10-2020
DOI: 10.1002/CPT.2010
Publisher: BMJ
Date: 02-2021
DOI: 10.1136/BMJOPEN-2020-045140
Abstract: To study how patient groups that accept pharmaceutical industry money perceive and manage the risk of undue influence from their sponsors. Empirical ethics approach using a qualitative interview study. The Australian patient group sector. 27 participants from 23 patient groups, purposively recruited for ersity of group characteristics (degree of pharmaceutical industry funding, health focus, location) and participant role (staff, board members). Interview data were transcribed and read repeatedly to identify concepts and patterns in the data. These were grouped into conceptual categories that described and explained the findings. We used an inductive analytical approach to identify important themes and concepts in the data. Participants in this study described how the patient group sector receives pressure from pharmaceutical company funders to act in ways that prioritise company interests. Groups worked to try and protect their credibility and ability to act in ways of their own choosing using practical rules or ‘lines in the sand’ about industry funding activities. They were grouped around the dominant topics of: sponsor exclusivity, brand marketing, agenda setting, advocacy and content of group activities. Lines in the sand were largely experience-driven and ethically informed they varied between groups. There was also variable transparency among groups about financial interactions with pharmaceutical companies. It is important to know about patient group practices around pharmaceutical industry funders as this allows public scrutiny about the adequacy of such practices. Inadequate strategies may mean that funders can influence patient groups activities in ways that do not necessarily prioritise the interests of members. We found that groups differed in their approach, with little independent external guidance to inform responses to commonly encountered types of influence. Inadequate transparency limits the ability of the public to make informed assessments about the risk of bias over the activities of groups that accept industry funding.
Publisher: Public Library of Science (PLoS)
Date: 11-2019
Publisher: Springer Science and Business Media LLC
Date: 22-04-2021
Publisher: BMJ
Date: 20-01-2022
DOI: 10.1136/BMJQS-2021-013910
Abstract: To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories. We included advisories issued in Canada, Denmark, the UK and the USA during 2009–2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within ±6 months. Change in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses (for dose-related advisories), per 100 000 population. Among advisories without dose-related advice (n=20), the average change in drug utilisation was −5.83% (95% CI −10.93 to –0.73 p=0.03). Advisories with dose-related advice (n=4) were not associated with a statistically significant change in drug utilisation (−1.93% 95% CI −17.10 to 13.23 p=0.80). In a post hoc subgroup analysis of advisories without dose-related advice, we observed no statistically significant difference between the change in drug utilisation following advisories with explicit prescribing advice, such as a recommendation to consider the risk of a drug when prescribing, and the change in drug utilisation following advisories without such advice. Among safety advisories issued on a wide range of drugs during 2009–2015 in 4 countries (Canada, Denmark, the UK and the USA), the association of advisories with changes in drug utilisation was variable, and the average association was modest.
Publisher: BMJ
Date: 05-2023
DOI: 10.1136/BMJOPEN-2022-065719
Abstract: To understand how and why Australian cancer physicians interact with the pharmaceutical industry. Qualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes. Given the evidence on industry influences on clinical practice and the importance to the market of oncology drugs, we sought to better understand cancer physicians’ experiences. Practising consultant medical oncologists and clinical haematologists from four Australian states were interviewed over Zoom. 16 cancer physicians were interviewed between November 2021 and March 2022, from 37 invited (response rate 43%). Most were medical oncologists (n=12 of 16, 75%) and male (n=9 of 16, 56%). The analysis of all interviews was based on grounded theory. Transcripts were coded and then codes formed into themes with supporting quotes. The themes were then placed into categories, used to describe the broad areas into which the themes could be grouped. Six themes were identified that fell within two broad categories: cancer physicians’ views and experiences of interactions and management of these interactions . Views and experiences included: the transactional nature of relationships, risks of research dependence, ethical challenges and varied attitudes based on interaction type. Management themes included: lack of useful guidance and reduced interactions during the COVID-19 pandemic. These led to an overarching seventh theme, on the desire for a ‘middle road’. Cancer physicians identified the transactional nature of industry relationships and felt uncomfortable with several types of interactions, including those with sales representatives. Most wanted less contact with industry, and the forced separation that occurred with the COVID-19 pandemic was generally welcome. Cancer physicians may have difficulty balancing the perceived need to interact with industry in modern cancer care while maintaining distance to minimise conflicts of interest. Further research is needed to assess management strategies in this area.
Publisher: Elsevier BV
Date: 07-2022
DOI: 10.1016/J.DRUGPO.2022.103749
Abstract: Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal level. We used public drug and patent registries to critically examine Suboxone's Canadian history. First, we investigated Suboxone's entry into the Canadian market to understand how it achieved market exclusivity. Second, we examined Health Canada's risk mitigation process to address extramedical use and ersion to understand the intersection of regulation and brand promotion. Insights from these two analyses were then extended to the recent approval of two related buprenorphine-containing products and their specific pathways to Canadian market exclusivity. We identified inconsistencies in Suboxone's regulatory history that suggest Health Canada's functions of health protection and promotion were compromised in favour of an "innovations" agenda that supports profit-making. Despite six years of market exclusivity in Canada, there was no evidence suggesting Suboxone achieved formal exclusivity (i.e., through patent or data protection). Health Canada's process to address safety concerns of Suboxone were compromised by reliance on the manufacturer to carry out post-market education, allowing the manufacturer to create and market a branded "education" program for its product. Similar inconsistencies have afforded market exclusivity for two related products despite marginal innovation. These analyses reveal a case of permissive regulation, where principles of health protection are compromised by economic imperatives. Such a regulatory approach has the potential to adversely impact public health due to unnecessarily high costs for medicines deemed essential to stem a major health crisis. Alternative pharmaceutical policies are urgently needed to safely and efficiently expand treatment access for opioid use disorder.
Start Date: 06-2023
End Date: 06-2026
Amount: $159,067.00
Funder: Australian Research Council
View Funded Activity