Cross-sectional examination of commercial milk formula industry funding of international, regional and national healthcare professional associations: protocol.

INTRODUCTION: Commercial milk formula manufacturers often emphasise their role in supporting infant and young child nutrition and breastfeeding, but their commercial goals to increase volume and profit margin of formula sales conflict with these declarations. Healthcare professional associations have an important role in healthcare worker education, shaping clinical practice. When healthcare professional associations enter into financial relationships with formula manufacturers, conflicts of interest arise, which may undermine education and practice that promotes optimal infant and young child feeding. The World Health Assembly calls on all parties to avoid such conflicts of interest, but it is uncertain how often this recommendation is followed. This protocol documents a systematic method to identify funding from the commercial milk formula industry among international, regional and national associations of healthcare professionals. METHODS AND ANALYSIS: Using systematic search strategies in the Gale Directory Library and Google, we will identify international healthcare professional associations relevant to maternal and child health. Data regarding funding relationships with the commercial milk formula industry over the past 24 months will be extracted from the official websites or, in their absence, social media accounts by two independent analysts. The analysis will focus on the presence of conflict of interest or sponsorship policies and type of funding, such as sponsorship or payment for services. ETHICS AND DISSEMINATION: This study does not require ethical approval and will use data available in the public domain. The results will be disseminated through peer-reviewed journal articles, at conferences and among the healthcare professional associations.

Conflict of interest policies at Australian medical schools.

BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: 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 samples. Oversight of consultancies had improved substantially, with 76% of schools requiring preapproval. Disclosure policies, while usually present, were weak, with no public disclosure required. CONCLUSION: 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.

Defining and conceptualising the commercial determinants of health.

Although commercial entities can contribute positively to health and society there is growing evidence that the products and practices of some commercial actors-notably the largest transnational corporations-are responsible for escalating rates of avoidable ill health, planetary damage, and social and health inequity; these problems are increasingly referred to as the commercial determinants of health. The climate emergency, the non-communicable disease epidemic, and that just four industry sectors (ie, tobacco, ultra-processed food, fossil fuel, and alcohol) already account for at least a third of global deaths illustrate the scale and huge economic cost of the problem. This paper, the first in a Series on the commercial determinants of health, explains how the shift towards market fundamentalism and increasingly powerful transnational corporations has created a pathological system in which commercial actors are increasingly enabled to cause harm and externalise the costs of doing so. Consequently, as harms to human and planetary health increase, commercial sector wealth and power increase, whereas the countervailing forces having to meet these costs (notably individuals, governments, and civil society organisations) become correspondingly impoverished and disempowered or captured by commercial interests. This power imbalance leads to policy inertia; although many policy solutions are available, they are not being implemented. Health harms are escalating, leaving health-care systems increasingly unable to cope. Governments can and must act to improve, rather than continue to threaten, the wellbeing of future generations, development, and economic growth.

Association Between Conflicts of Interest and Authors' Positions on Harms of Varenicline: a Cross-Sectional Analysis.

BACKGROUND: Few studies have investigated the relationship between industry funding/conflicts of interest and authors' positions in opinion pieces on drug safety. Harmful effects of varenicline, a treatment for smoking cessation, have been highly contested. OBJECTIVE: To examine the association between pharmaceutical industry funding/authors' financial conflicts of interest and position on varenicline in opinion articles, especially in relation to the minimization of harms; to assess whether opinion pieces on drug safety issues written by authors with conflicts of interest are more frequently cited in the news or social media. DESIGN: Cross-sectional analysis. PARTICIPANTS: English language opinion pieces and narrative reviews about varenicline published between May 2006 and February 2019. MAIN MEASURES: Odds ratios and 95% confidence intervals; the Mann-Whitney two-sample statistic was used to test for differences in Altmetric scores, a measure of media attention. KEY RESULTS: Of the 221 included articles, 30.3% (67) disclosed the funding source and 62.9% (139) disclosed authors' conflicts of interest. Authors of opinion pieces on varenicline who reported financial ties to the pharmaceutical industry (as a conflict of interest or funding source) were more likely to minimise the cardiovascular and psychiatric risk of varenicline compared to those without conflicts of interest or industry funding (OR: 4.00; 95% CI: 1.32 to 12.16 for cardiovascular risk; OR: 8.51; 95% CI: 3.79 to 19.11 for psychiatric risk). These associations persisted in sensitivity analyses. No statistically significant difference in Altmetric score was found between articles with (mean 15.83, median 3) and without (mean 11.90, median 1) conflicts of interest, indicating similar media attention (p-value=0.11). CONCLUSIONS: We found that authors with financial ties to drug companies were more likely to publish opinion pieces that minimised harms of varenicline. These results raise questions about journals' editorial policies to accept reviews of treatments from authors with financial relationships with manufacturers.

Interactions with the pharmaceutical industry and the practice, knowledge and beliefs of medical oncologists and clinical haematologists: a systematic review.

BACKGROUND: No previous review has assessed the extent and effect of industry interactions on medical oncologists and haematologists specifically. METHODS: A systematic review investigated interactions with the pharmaceutical industry and how these might affect the clinical practice, knowledge and beliefs of cancer physicians. MEDLINE, Embase, PsycINFO and Web of Science Core Collection databases were searched from inception to February 2021. RESULTS: Twenty-nine cross-sectional and two cohort studies met the inclusion criteria. These were classified into three categories of investigation: (1) extent of exposure to industry for cancer physicians as whole (n = 11); (2) financial ties among influential cancer physicians specifically (n = 11) and (3) associations between industry exposure and prescribing (n = 9). Cancer physicians frequently receive payments from or maintain financial ties with industry, at a prevalence of up to 63% in the United States (US) and 70.6% in Japan. Among influential clinicians, 86% of US and 78% of Japanese oncology guidelines authors receive payments. Payments were associated with either a neutral or negative influence on the quality of prescribing practice. Limited evidence suggests oncologists believe education by industry could lead to unconscious bias. CONCLUSIONS: There is substantial evidence of frequent relationships between cancer physicians and the pharmaceutical industry in a range of high-income countries. More research is needed on clinical implications for patients and better management of these relationships. REGISTRATION: PROSPERO identification number CRD42020143353.

Pharmaceutical industry payments and assisted reproduction in Australia: a retrospective observational study.

OBJECTIVES: To investigate the extent and nature of pharmaceutical industry payments related to fertility and assisted reproduction in Australia. DESIGN AND SETTING: This retrospective observational study employed four databases compiled from publicly available pharmaceutical industry transparency reports on educational event sponsorship (October 2011-April 2018), payments to healthcare professionals (October 2015-April 2018) and patient group support (January 2013-December 2017). Analyses were restricted to fertility-related payments by two major manufacturers of fertility medicines in Australia: Merck Serono and Merck, Sharp and Dohme (MSD). PRIMARY AND SECONDARY OUTCOME MEASURES: Descriptive statistics on fertility-related payments and other transfers of value (counts, total and median costs in Australian dollars) for educational events and to healthcare professionals and patient groups. RESULTS: Between October 2011 and April 2018, Merck Serono and MSD spent $A4 522 263 on 970 fertility-related events for healthcare professionals, including doctors, nurses and fertility scientists. 56.8% (551/970) events were held by fertility clinics and 29.3% (284/970) by professional medical associations. Between October 2015 and April 2018, Merck Serono spent $A403 800 across 177 payments to 118 fertility healthcare professionals, predominantly for educational event attendance. Recipients included obstetricians and gynaecologists (76.3% of payments, 135/177), nurses (11.3%, 20/177) and embryologists/fertility scientists (9.6%, 17/117). The highest paid healthcare professionals held leadership positions in major fertility clinics. Merck Serono provided $A662 850 to fertility-related patient groups for advocacy and education (January 2013-December 2017). CONCLUSIONS: The pharmaceutical industry sponsored a broad range of fertility clinicians and organisations, including doctors, nurses, embryologists, professional medical organisations, fertility clinics and patient groups. This sponsorship may contribute to the overuse of fertility services.

A critical perspective on patient groups and industry funding

Patient groups are non-profit organizations that focus on the needs of people affected by a specific disease. Over the years, patient groups have assumed an increas-ingly decisive role in the healthcare decision-making process, and may influence the governments' decisions on key cru-cial health matters. Financial support for patient groups can come from different sources, including the pharmaceutical and medical device industries. Although patient groups may certainly benefit from drug companies economic support, in this commentary we address concerns regarding the pres-ence of potential conflict of interests (COIs), which may affect the independence, objectivity, integrity and reputation of the organizations.

'Lines in the sand': an Australian qualitative study of patient group practices to promote independence from pharmaceutical industry funders.

OBJECTIVES: To study how patient groups that accept pharmaceutical industry money perceive and manage the risk of undue influence from their sponsors. DESIGN: Empirical ethics approach using a qualitative interview study. SETTING: The Australian patient group sector. PARTICIPANTS: 27 participants from 23 patient groups, purposively recruited for diversity of group characteristics (degree of pharmaceutical industry funding, health focus, location) and participant role (staff, board members). ANALYSIS: 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. RESULTS: 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. CONCLUSIONS: 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.

"There are ways drug companies will get into DTC decisions": How Australian drug and therapeutics committees address pharmaceutical industry influence.

AIMS: One tool for protecting quality use of medicines in hospitals is a drug and therapeutics committee (DTC) that oversees medicines availability. Pharmaceutical industry marketing to prescribers is associated with less appropriate prescribing and increased costs. There is little data on decision-making practices of DTCs so it is unknown whether or how they might be vulnerable to pharmaceutical industry influence. This project explores DTC decision-making with a focus on how pharmaceutical industry influence on access and use of medicines is identified and managed. METHODS: We used a qualitative methodology with individual interviews of 29 participants who were current or recent members of public hospital DTCs across New South Wales, Australia. Participants included medical, pharmacy and nursing staff and 1 citizen. Committees were linked to specific hospitals or regions, and some were affiliated with paediatric, neonatal, rural or mental health services. RESULTS: Drug committee processes for oversight of medicines in public hospitals are vulnerable to pharmaceutical industry influence at several points. Applications for formulary additions are sometimes initiated and completed by company representatives. Conflict of interest disclosures among applicants and committee members may be incomplete. In some institutions, medicines are available from pharmaceutical companies without committee review, including through free samples and industry-supported medicines access programmes. Participants noticed the presence and impact of pharmaceutical company marketing activities to local clinicians, resulting in increased prescriber demand for products. CONCLUSION: Improved DTC practices and review of hospital policies concerning pharmaceutical marketing activities might preserve the independence of evidence-based decision-making for safe, cost-effective prescribing.

Mixed methods evaluation of workshops for citizen health advocates about financial conflicts of interests in healthcare.

OBJECTIVES: To evaluate workshops delivered to citizen health advocates about financial conflicts of interest in healthcare, transparency databases which disclose industry payments in the USA and Australia and the pros and cons of advocacy groups accepting industry sponsorship. DESIGN: Thematic analysis of workshop participant recorded discussions, and pre, post and 3-month follow-up questionnaires on confidence and knowledge about financial conflicts of interest, transparency databases and the merits of advocacy organisations accepting industry sponsorship. PARTICIPANTS AND SETTING: 48 citizen health advocates participated in a half-day workshop, held in four Australian cities, which ended with a 1-hour recorded discussion. Participants were recruited with assistance from leading state-based health advocacy organisations. RESULTS: The thematic analysis of the recorded discussions revealed two major themes, (i) transparency and (ii) relationships with industry; and three minor themes: a lack of awareness about conflicts of interest and transparency, issues relating to trust and next steps in terms of potential reforms. In relation to transparency, participants felt strong support for transparency, strongly favouring the mandatory, extensive and accessible US Open Payments over the self-regulatory Australian model. Participants also noted that transparency had limitations, including the utility of disclosed information. In relation to industry sponsorship of advocacy groups, some participants expressed an openness to and support for accepting sponsorship, while many expressed a caution around potential downsides. Questionnaire results showed increases in both confidence and knowledge after the workshop, though only 23 of 48 participants returned the 3-month follow-up questionnaire. CONCLUSIONS: Following a half-day workshop, citizen health advocates recruited by leading health advocacy organisations expressed strong support for tough transparency rules, and mixed feelings about advocacy groups accepting sponsorship from industry. Study limitations include a non-representative sample and a large drop-out at the 3-month post-workshop follow-up.

Pharmaceutical industry payments to leaders of professional medical associations in Australia: Focus on cardiovascular disease and diabetes.

BACKGROUND AND OBJECTIVES: Pharmaceutical industry interactions with professional medical associations have come under scrutiny, yet industry ties among the leadership of these associations are often overlooked. The aim of this study was to investigate pharmaceutical industry payments to leaders of Australian diabetes or cardiovascular associations, and general associations serving doctors who manage these conditions. METHOD: Payments were identified using publicly available industry transparency reports (October 2015 to April 2018). RESULTS: Overall, 48/197 (24.4%) leaders received payments, predominantly for speaker (51.4%) and advisory board (25.3%) engagements. The proportion of paid leaders was higher for diabetes- and cardiovascular-specific associations (72.7% and 41.2%, respectively) than for general associations (7.6%). DISCUSSION: These findings raise concerns about industry influence on clinical practice and policy.

Industry funding of patient and health consumer organisations: systematic review with meta-analysis.

OBJECTIVE: To investigate pharmaceutical or medical device industry funding of patient groups. DESIGN: Systematic review with meta-analysis. DATA SOURCES: 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. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: 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. REVIEW METHODS: 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. RESULTS: 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. CONCLUSION: 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. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017079265.

"Asset exchange"-interactions between patient groups and pharmaceutical industry: Australian qualitative study.

OBJECTIVE: 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. DESIGN: Empirical qualitative interview study informed by ethics theory. SETTING: Australian patient groups. PARTICIPANTS: 27 participants from 23 Australian patient groups that represented diverse 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. ANALYSIS: 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. RESULTS: 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. CONCLUSIONS: 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.

Association of industry ties with outcomes of studies examining the effect of wholegrain foods on cardiovascular disease and mortality: systematic review and meta-analysis.

OBJECTIVE: To determine if observational studies examining the association of wholegrain foods with cardiovascular disease (CVD) with food industry sponsorship and/or authors with conflicts of interest (COI) with the food industry are more likely to have results and/or conclusions that are favourable to industry than those with no industry ties, and to determine whether studies with industry ties differ in their risk of bias compared with studies with no industry ties. DESIGN: Systematic review and meta-analysis of observational studies. DATA SOURCES: We searched eight databases from 1997 to 2017 and hand searched the reference lists of included studies. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Cohort and case-control studies that quantitatively examined the association of wholegrains or wholegrain foods with CVD outcomes in healthy adults or children. RESULTS: 21 of the 22 studies had a serious or critical risk of bias. Studies with industry ties more often had favourable results compared with those with no industry ties, but the Confidence Interval (CI) was wide, Risk Ratio (RR)=1.44 (95% CI 0.88 to 2.35). The same association was found for study conclusions. We did not find a difference in effect size (magnitude of RRs) between studies with industry ties, RR=0.77 (95% CI 0.58 to 1.01) and studies with no industry ties, RR=0.85 (95% CI 0.73 to 1.00) (p=0.50) I2 0%. These results were comparable for studies that measured the magnitude using Hazard Ratios (HR); industry ties HR=0.82 (95% CI 0.76 to 0.88) versus no industry ties HR=0.86 (95% CI 0.81 to 0.91) (p=0.34) I2 0%. CONCLUSIONS: We did not establish that the presence of food industry sponsorship or authors with a COI with the food industry was associated with results or conclusions that favour industry sponsors. The association of food industry sponsorship or authors with a COI with the food industry and favourable results or conclusions is uncertain. However, our analysis was hindered by the low level of COI disclosure in the included studies. Our findings support international reforms to improve the disclosure and management of COI in nutrition research. Without such disclosures, it will not be possible to determine if the results of nutrition research are free of food industry influences and potential biases. PROSPERO REGISTRATION NUMBER: CRD42017055841.

Secret safety warnings on medicines: A case study of information access requests.

PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Medical donations are not always free: an assessment of compliance of medicine and medical device donations with World Health Organization guidelines (2009-2017).

Medicine and medical device donations have the potential to improve access to healthcare in some of the poorest parts of the world, but can do more harm than good. World Health Organization guidelines advise donors on how to make effective and useful donations. Our objective was to assess compliance of recent medicine or medical device donations with WHO guidelines from 2009 onwards. We searched media, academic and gray literature, including industry and organizational documents, to identify reports describing specific incidences of the donation of medicines or devices. We collected data on donation characteristics and guideline compliance. We identified 88 reports describing 53 donations. Most did not comply with at least some items in WHO guidelines and no reports provided sufficient information to assess compliance against all items. Donations that fail to comply with guidelines may be excessive, expired and/or burden recipient countries with storage and disposal costs. It was estimated that 40-70% of donated medical devices are not used as they are not functional, appropriate, or staff lack training. More effective donations involved needs assessments, training and the use of existing distribution networks. The donation of medicines and medical devices is frequently inadequately reported and at times inappropriate. Guidelines need to be enforced to ensure effective donations.

Pharmaceutical Industry Funding of Health Consumer Groups in Australia: A Cross-sectional Analysis.

Relationships between consumer organizations and pharmaceutical manufacturers are the focus of transparency efforts in some jurisdictions, including Australia. This study describes the frequency and nature of industry sponsorship of Australian health consumer organizations and examines the link between sponsorship of the most highly funded organizations and manufacturers' requests for public reimbursement of products for related health conditions. We downloaded 130 transparency reports covering the period January 2013 to December 2016 from the website of Medicines Australia and carried out a descriptive analysis. For the most heavily funded organizations and their sponsors, we examined Public Summary Documents of the Pharmaceutical Benefits Advisory Committee to identify relevant products under consideration for public reimbursement over the study period. Thirty-four pharmaceutical companies provided 1,482 sponsorships to 230 organizations, spending a total of AU$34,507,810. The top clinical areas in terms of amount of funding received were cancer, eye health, and nervous system disorders. The sponsors of the most highly funded groups were companies that in most cases had drugs under review for public reimbursement for conditions covered by these organizations. Interactions between the pharmaceutical industry and consumer organizations are common and require careful management to prevent biases that may favor sponsors' interests above those of patients and the public.

How do health consumer organisations in Australia manage pharmaceutical industry sponsorship? A cross-sectional study.

Objective The aim of this study was to investigate how health consumer organisations manage their relationships with the pharmaceutical industry in Australia. Methods We identified 230 health consumer organisations that received pharmaceutical industry support from 2013 to 2016 according to reports published by Medicines Australia, the industry trade association. A random sample of 133 organisations was selected and their websites assessed for financial transparency, policies governing corporate sponsorship and evidence of potential industry influence. Results In all, 130 of the 133 organisations evaluated received industry funding. Of these 130, 68 (52.3%; 95% confidence interval (CI) 43.4-61.1%) disclosed this funding. Nearly all (67; 98.5%) reported the identity of their industry donors, followed by uses (52.9%), amount (13.2%) and proportion of income from industry (4.4%). Less than one-fifth (24/133; 18.0%; 95% CI 11.9-25.6%) had publicly available policies on corporate sponsorship. Six organisations (7.2%; 95% CI 2.7-15.1%) had board members that were currently or previously employed by pharmaceutical companies, and 49 (36.8%; 95% CI 28.6-45.6%) had company logos, web links or advertisements on their websites. Conclusion Industry-funded health consumer organisations in Australia have low transparency when reporting industry funding and few have policies governing corporate sponsorship. Relationships between health consumer organisations and the industry require effective actions to minimise the risks of undue influence. What is known about this topic? Pharmaceutical industry funding of health consumer organisations is common in the US and Europe, yet only a minority of such organisations publicly disclose this funding and have policies regulating their relationships with industry. What does this paper add? Industry-funded health consumer organisations in Australia have inadequate financial transparency and rarely have policies addressing corporate funding. Organisations that have received more industry funding are more likely to report it publicly. What are the implications for practitioners? Robust policies addressing corporate sponsorship and increased transparency are needed to maintain the independence of health consumer organisations. Governments may also consider regulating non-profit organisations to ensure public reporting of funding sources.

The Influence of Industry Sponsorship on the Research Agenda: A Scoping Review.

BACKGROUND: Corporate interests have the potential to influence public debate and policymaking by influencing the research agenda, namely the initial step in conducting research, in which the purpose of the study is defined and the questions are framed. OBJECTIVES: We conducted a scoping review to identify and synthesize studies that explored the influence of industry sponsorship on research agendas across different fields. SEARCH METHODS: We searched MEDLINE, Scopus, and Embase (from inception to September 2017) for all original research and systematic reviews addressing corporate influence on the research agenda. We hand searched the reference lists of included studies and contacted experts in the field to identify additional studies. SELECTION CRITERIA: We included empirical articles and systematic reviews that explored industry sponsorship of research and its influence on research agendas in any field. There were no restrictions on study design, language, or outcomes measured. We excluded editorials, letters, and commentaries as well as articles that exclusively focused on the influence of industry sponsorship on other phases of research such as methods, results, and conclusions or if industry sponsorship was not reported separately from other funding sources. DATA COLLECTION AND ANALYSIS: At least 2 authors independently screened and then extracted any quantitative or qualitative data from each study. We grouped studies thematically for descriptive analysis by design and outcome reported. We developed the themes inductively until all studies were accounted for. Two investigators independently rated the level of evidence of the included studies using the Oxford Centre for Evidence-Based Medicine ratings. MAIN RESULTS: We included 36 articles. Nineteen cross-sectional studies quantitatively analyzed patterns in research topics by sponsorship and showed that industry tends to prioritize lines of inquiry that focus on products, processes, or activities that can be commercialized. Seven studies analyzed internal industry documents and provided insight on the strategies the industry used to reshape entire fields of research through the prioritization of topics that supported its policy and legal positions. Ten studies used surveys and interviews to explore the researchers' experiences and perceptions of the influence of industry funding on research agendas, showing that they were generally aware of the risk that sponsorship could influence the choice of research priorities. CONCLUSIONS: Corporate interests can drive research agendas away from questions that are the most relevant for public health. Strategies to counteract corporate influence on the research agenda are needed, including heightened disclosure of funding sources and conflicts of interest in published articles to allow an assessment of commercial biases. We also recommend policy actions beyond disclosure such as increasing funding for independent research and strict guidelines to regulate the interaction of research institutes with commercial entities. Public Health Implications. The influence on the research agenda has given the industry the potential to affect policymaking by influencing the type of evidence that is available and the kinds of public health solutions considered. The results of our scoping review support the need to develop strategies to counteract corporate influence on the research agenda.