Alice Fabbri

Conflict of interest between professional medical societies and industry: a cross- sectional study of Italian medical societies' websites

Objective To describe how Italian medical societies interact with pharmaceutical and medical device industries through an analysis of the information available on their websites. Design Cross sectional study. Setting Italy. Participants 154 medical societies registered with the Italian Federation of Medical-Scientific Societies. Main outcome measures Indicators of industry sponsorship (presence of industry sponsorship in the programme of the last medical societies’ annual conference; presence of manufacturers’ logos on the homepage; presence of industry sponsorship of satellite symposia during the last annual conference). Results 131 Italian medical societies were considered. Of these, 4.6% had an ethical code covering relationships with industry on their websites, while 45.6% had a statute that mentioned the issue of conflict of interest and 6.1% published the annual financial report. With regard to industry sponsorship, 64.9% received private sponsorship for their last conference, 29.0% had manufacturers’ logos on their webpage, while 35.9% had industry-sponsored satellite symposia at their last conference. The presence of an ethical code on the societies’ websites was associated with both an increased risk of industry sponsorship of the last conference (relative risk (RR) 1.22, 95% CIs 1.01 to 1.48 after adjustment) and of conferences and/or satellite symposia (RR 1.22, 95% CIs 1.02 to 1.48 after adjustment) but not with the presence of manufacturers’ logos on the websites (RR 1.79, 95% CIs 0.66 to 4.82 after adjustment). No association was observed with the other indicators of governance and transparency. Conclusions This survey shows that industry sponsorship of Italian medical societies’ conferences is common, while the presence of a structured regulatory system is not. Disclosure of the amount of industry funding to medical societies is scarce. The level of transparency therefore needs to be improved and the whole relationship between medical societies and industry should be further disciplined in order to avoid any potential for conflict of interest.

A cross-sectional analysis of pharmaceutical industry-funded events for health professionals in Australia

Objectives To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages. Design Cross-sectional analysis. Participants and setting 301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015. Results Forty-two companies sponsored 116 845 events for health professionals, on average 608 per week with 30 attendees per event. Events typically included a broad range of health professionals: 82.0% included medical doctors, including specialists and primary care doctors, and 38.3% trainees. Oncology, surgery and endocrinology were the most frequent clinical areas of focus. Most events (64.2%) were held in a clinical setting. The median cost per event was

The Inclusion of Nurses in Pharmaceutical Industry–Sponsored Events: Guess Who Is Also Coming to Dinner?

A263 (IQR

Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries

A153–1195) and over 90% included food and beverages. Conclusions Over this 4-year period, industry-sponsored events were widespread and pharmaceutical companies maintained a high frequency of contact with health professionals. Most events were held in clinical settings, suggesting a pervasive commercial presence in everyday clinical practice. Food and beverages, known to be associated with changes to prescribing practice, were almost always provided. New Australian transparency provisions explicitly exclude meals from the reporting requirements; thus, a large proportion of potentially influential payments from pharmaceutical companies to health professionals will disappear from public view.

Reporting bias in the literature on the associations of health-related behaviors and statins with cardiovascular disease and all-cause mortality

The Inclusion of Nurses in Pharmaceutical Industry–Sponsored Events: Guess Who Is Also Coming to Dinner? The release of the Open Payments data in the United States, which detail payments from pharmaceutical and medical device companies to physicians, enables analysis of the financial relationships between physicians and industry.1 However, the Physician Payments Sunshine Act, which mandates these disclosures, omits registered nurses. A recent qualitative study suggests nurse-industry interactions in US hospitals may be common and influential.2 The limited prevalence data available, based on self-report, suggests that 51% to 96% of nurses have contact with industry representatives.3 Australia is one of the few jurisdictions to report payments to all registered health professionals. Since 2007, member companies of the industry trade association, Medicines Australia, have voluntarily reported sponsorship of functions for health professionals.4 This report describes the extent of inclusion of nurses in pharmaceutical company-sponsored events in Australia. In 2016, there were 271 423 practicing registered nurses in Australia. Of these, 1380 (0.005%) were nurse practitioners, which is the category of registered nurse permitted to prescribe medicines.5 Methods | We downloaded all available reports of sponsored events for health professionals from the Medicines Australia website. The reports covered 6-month intervals from October 2011 to September 2015 (n = 301 reports) and detailed 116 845 events. We converted the PDF reports to Excel format and coded the unstructured data using iteratively generated keywords and Excel’s filter function. We focused analysis on a subset of events (71%, [81 946]) to compare events with nurses in attendance and physician-only events. We excluded events without nurses or physicians, physician-only events with trainees, and those missing data on professional status of attendees. We used SPSS statistical software (version 22) to conduct descriptive analyses, Kruskal-Wallis tests for the differences among medians and χ2 tests for differences among proportions. Significance of post hoc comparisons was evaluated using a Bonferroni correction.

Does industry-sponsored education foster overdiagnosis and overtreatment of depression, osteoporosis and over­active bladder syndrome? An Australian cohort study

Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we collected information from each disclosure policy/code on: target industries, categories of healthcare professionals covered, scope of payments included, location and searchability of the disclosed data. Our analysis shows that although important improvements have been put in place in the past few years, significant gaps remain in disclosure requirements and their implementation. The situation differs substantially from country to country and the most striking differences are between governmental and self-regulatory approaches, especially with regard to the comprehensiveness of the disclosed data. In many cases, individuals can still opt out and reporting is incomplete, with common influential gifts such as food and drink excluded. Finally, in several countries data are only available as separate PDFs from companies, thus making the payment reports difficult to access and analyse. In order to overcome these gaps, minimum standards for disclosures should be implemented across Europe. All payments to healthcare professionals and organizations should be included, all health-related industries should be required to submit reports, and usability of disclosed data should be guaranteed.

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

Reporting bias in the literature occurs when there is selective revealing or suppression of results, influenced by the direction of findings. We assessed the risk of reporting bias in the epidemiological literature on health-related behavior (tobacco, alcohol, diet, physical activity, and sedentary behavior) and cardiovascular disease mortality and all-cause mortality and provided a comparative assessment of reporting bias between health-related behavior and statin (in primary prevention) meta-analyses. We searched Medline, Embase, Cochrane Methodology Register Database, and Web of Science for systematic reviews synthesizing the associations of health-related behavior and statins with cardiovascular disease mortality and all-cause mortality published between 2010 and 2016. Risk of bias in systematic reviews was assessed using the ROBIS tool. Reporting bias in the literature was evaluated via small-study effect and excess significance tests. We included 49 systematic reviews in our study. The majority of these reviews exhibited a high overall risk of bias, with a higher extent in health-related behavior reviews, relative to statins. We reperformed 111 meta-analyses conducted across these reviews, of which 65% had statistically significant results (P < 0.05). Around 22% of health-related behavior meta-analyses showed small-study effect, as compared to none of statin meta-analyses. Physical activity and the smoking research areas had more than 40% of meta-analyses with small-study effect. We found evidence of excess significance in 26% of health-related behavior meta-analyses, as compared to none of statin meta-analyses. Half of the meta-analyses from physical activity, 26% from diet, 18% from sedentary behavior, 14% for smoking, and 12% from alcohol showed evidence of excess significance bias. These biases may be distorting the body of evidence available by providing inaccurate estimates of preventive effects on cardiovascular and all-cause mortality.

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

Objectives To investigate patterns of industry-sponsored educational events that focus on specific health conditions for which there are concerns about overdiagnosis and overtreatment. Design and setting This retrospective cohort study examines publicly reported industry-sponsored events in Australia from October 2011 to September 2015 for three conditions potentially subject to overdiagnosis and overtreatment: depression, osteoporosis and overactive bladder. We used a database of transparency reports to identify events with a focus on depression, osteoporosis and overactive bladder and compared these with other sponsored events. We hypothesised that companies marketing treatments for each condition would sponsor related events and that target audiences would mainly work in primary care, reflecting a broad patient population. Main outcome measures Event and attendee characteristics, sponsoring companies, related marketed treatments, cost-effectiveness ratings and dispensing rates. Results Over the study period, we identified 1567 events focusing on depression, 1375 on osteoporosis and 190 on overactive bladder (total n=3132, with 96 660 attendees). These events were attended by primary care doctors more often than sponsored events without a focus on these three conditions: relative risk (RR)=3.06 (95% CI 2.81 to 3.32) for depression, RR=1.48 (95% CI 1.41 to 1.55) for osteoporosis and RR=2.59 (95% CI 2.09 to 3.21) for overactive bladder. Servier, which markets agomelatine and AstraZeneca (quetiapine) sponsored 51.2% and 23.0% of depression events, respectively. Amgen and GlaxoSmithKline, which co-market denosumab, sponsored 49.5% of osteoporosis events and Astellas and Commonwealth Serum Laboratories (CSL) (mirabegron and solifenacin) sponsored 80.5% of overactive bladder events. Conclusions This 4-year overview of industry-sponsored events on three overdiagnosed and overtreated conditions found that primary care clinicians were often targeted, dinner was often provided and that a few companies sponsored most events. In most cases, sponsors’ products are not cost-effective choices for the specified condition. This pattern highlights the need for professional education to be free of commercial sponsorship.

Study sponsorship and the nutrition research agenda: analysis of cohort studies examining the association between nutrition and obesity

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.

Association of Industry Sponsorship With Outcomes of Nutrition Studies: A Systematic Review and Meta-analysis

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.