Assessing whether to receive funding support from tobacco, alcohol, gambling and other dangerous consumption industries

AIM: To examine the risks taken by health, research and community organizations when they opt to receive funding from dangerous consumption industries and to identify ways in which they might generate their own assessment of these risks. METHODS: Common risks associated with industry involvements are examined, along with potential barriers to self-reflection. RESULTS: Funds derived from tobacco, alcohol, gambling and other dangerous consumptions are accessed increasingly by public good organizations. The variety of risks these involvements incur place individuals and organizations somewhere along a continuum of moral jeopardy, stretching from those with minor involvements to those with unmanageable conflicts of interest. The concept of a 'continuum' is preferable to a 'binary' interpretation in that the latter tends to lock understandings into all-or-nothing positions, thereby discouraging reflection and discussion regarding ethical and moral issues. Active scrutiny of these risks can be assisted through strategies that promote ongoing self-assessment. This is illustrated in the application of criteria that help breakdown risks and provide guidance in deciding on the extent of involvement with industry funding. CONCLUSION: The paper finishes with practical examples of educational and assessment strategies that could assist in reducing moral jeopardy.     

The alcohol industry and public interest science

Aims This report argues that the growing involvement of the alcohol industry in scientific research needs to be acknowledged and addressed. It suggests a set of principles to guide ethical decision‐making in the future. Methods We review relevant issues with regard to relationships between the alcohol industry and the international academic community, especially alcohol research scientists. The guiding principles proposed are modelled after expert committee statements, and describe the responsibilities of governmental agencies, the alcohol industry, journal editors and the academic community. These are followed by recommendations designed to inform individuals and institutions about current ‘best practices’ that are consistent with the principles. Findings and conclusions Growing evidence from the tobacco, pharmaceutical and medical fields suggests that financial interests of researchers may compromise their professional judgement and lead to research results that are biased in favour of commercial interests. It is recommended that the integrity of alcohol science is best served if all financial relationships with the alcoholic beverage industry are avoided. In cases where research funding, consulting, writing assignments and other activities are initiated, institutions, individuals and the alcoholic beverage industry itself are urged to follow appropriate guidelines that will increase the transparency and ethicality of such relationships.     

The corporate coauthor

Drug marketing techniques include the sponsorship of articles signed by academic physicians or researchers and submitted to peer-reviewed medical journals. Some of these articles are authored or coauthored by ghostwriters who work for pharmaceutical companies or medical education companies hired by pharmaceutical companies. Conflicts of interest may be difficult to detect in the subset of articles and presentations sponsored by pharmaceutical companies that never mention the targeted drug, but focus on stimulating the perceived need for the targeted drug or highlighting problems with competing drugs. The current voluntary standards for declaring conflicts of interest to readers of medical journals and audiences at medical conferences are inadequate. A public database that contains conflicts of interest of physicians and researchers would be useful.     

Conflict of interest: will it ever end?

Despite the inclusion of investigator–industry pecuniary and non‐pecunary associations in published clinical trials, the benefit of such disclosures may be limited. Two recent pivotal phase III drug studies that raised conflict of interest issues are discussed. It is recommended that in the future, a firewall should be erected between industry and investigators.     

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research

Background: Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. Method: We conducted a survey of HREC chairpersons in New South Wales. Results: HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. Conclusion: These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.     

Brief report: Resident and faculty perceptions of conflict of interest in medical education

OBJECTIVE: To determine resident and faculty perceptions of the pharmaceutical industry's influence on medical education. DESIGN, SETTING, AND PARTICIPANTS: Anonymous survey of categorical residents and faculty in the department of medicine at a large, Midwestern, urban, independent academic medical center. MAIN RESULTS: Eighty-one residents (69.2%) and 196 faculty (75.7%) responded to the survey. Residents believed that a significantly higher percentage of primary care and subspecialist faculty receives industry income or gifts compared to faculty respondents. Many faculty, and to a significantly greater degree residents, indicated that income or gifts influence the teaching of both internal attending physicians and visiting faculty in a variety of educational settings. The majority of residents (61.7%) and faculty (62.2%) believed that annual income or gifts less than $10,000 could influence an attending physician's teaching. Most residents (65.4%) and faculty (74%) preferred that lecturers report all financial relationships with industry regardless of which relationships the lecturer believes are relevant. CONCLUSIONS: Most internal medicine residents and their faculty perceive that industry influences teaching in different educational settings, and want teachers to disclose all of their financial relationships with industry. This information may guide further development of policies and curricula addressing industry relationships within graduate medical education.     

Conflicts of interest: new thinking,new processes

Although the concept of ‘conflict of interest’ (COI) arises in many contexts in healthcare, it is often poorly understood, and commonly accepted, definitions are often circular, self‐contradictory and unable to provide procedural guidance. To overcome such confusion and imprecision, we offer a reformulation of COI that carefully defines interests, clarifies their scope and articulates a simple, non‐punitive approach to managing them. We define an ‘interest’ as ‘a commitment, goal, obligation or duty related to a particular social role or practice’. We show how in a particular setting multiple interests can be at play, which can be either financial or non‐financial, with the latter often being the most potent drivers of behaviour. We define a ‘conflict of interest’ as the condition that arises when two coexisting interests directly conflict with each other: that is, when they are likely to compel contrary and incompatible outcomes. COI therefore reflect objective states of affairs rather than internal mental states; they do not imply moral error; and they are identified through public rather than private processes involving ethical dialogues among relevant stakeholders. Once a COI has been identified, responses must be determined based on the seriousness of the conflict and the conditions that generated it. Such responses may be minimal or they may require a formal disengagement from one of the conflicting interests. The framework described, reflects the rich diversity of interests in modern societies, is universally applicable and provides simple, readily applicable guidelines for the identification and management of conflicts arising between them.     

What principles should guide interactions between population health researchers and the food industry? Systematic scoping review of peer‐reviewed and grey literature

There is no explicit consensus amongst population health researchers regarding what constitutes acceptable or effective interactions with the food industry. This has led to confusion and disagreements over conflicts of interest, which can undermine the integrity of science. To clarify this issue, we aimed to systematically identify the key principles developed by population health researchers to prevent or minimize conflicts of interest when interacting with the food industry. Databases of peer‐reviewed literature were searched. In addition, an advanced Google search, a request to experts seeking related documents, and hand searching of references were undertaken. Thematic analysis of the extracted data was undertaken. We examined 54 eligible documents describing guidelines for population health researchers when interacting with the food industry. Fifty‐six principles were identified and synthesized in five themes. There were high levels of agreement in themes relating to research governance, transparency, and publication but less agreement and guidance on how principles should be applied in relation to funding and risk assessment. There is agreement on some of the general principles for preventing and minimizing conflicts of interests for population health researchers when interacting with the food industry. However, for issues such as assessing the appropriateness of an industry partner, greater clarity and consensus are required.     

Vested Interests in Addiction Research and PolicyPoisonous partnerships: health sector buy‐in to arrangements with government and addictive consumption industries

Aim This paper critically appraises relationship arrangements among three broadly conceived sectors: the government sector, the health sector (including researchers) and addictive consumption industries (particularly tobacco, alcohol and gambling). Method Three models for involvement are examined. In the ‘tripartite partnership model’ health sector agencies engage as co‐equals with the government and industry sectors in order to implement public health initiatives such as host responsibility and public education. In the ‘non‐ association model’ the health sector engages with government agencies but not with the industry sector. In the ‘managed association model’ the health sector engages for specific purposes with the industry sector but contact is monitored and managed by government agencies. Findings Government and industry sectors commonly favour tripartite partnership arrangements. Health sector agencies that opt to engage in these partnership arrangements can encounter conflicts of interest and find their voice subsumed by dominant influences. Furthermore, their partnership compliance generates divisions within the health sector, with partnership dissenters often silenced and excluded from policy processes and funding. The non‐association model is the least hazardous to the health sector because it protects against compromise and dominance. The managed association model is an option only when the government sector as a whole is committed strongly and clearly to the public health objectives. Conclusion In contexts where key parts of the government sector are conflicted over their public health responsibilities, health sector engagement in partnership arrangements entails too many risks.     

Where are clinical trials going? Society and clinical trials

Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.