Individual Conflicts Of Interest Research Articles

It Is Not Enough to Assess Conflicts of Interest When We Bring the Commercial Sector to the Policy Table Comment on "Towards Preventing and Managing Conflict of Interest in Nutrition Policy? An Analysis of Submissions to a Consultation on a Draft WHO Tool".

Ralston et al offer us an interesting analysis of the consultation process of World Health Organization’s (WHO’s) "Draft approach on the prevention and management of conflicts of interests in the policy development and implementation of nutrition programs at country level," in which it shows us how the industry tries to frame the discussion in individual conflicts of interest, avoiding structural conflicts of interest. We must not forget other issues of importance in policy-making, such as the imbalance of power between different actors and the strategies of undue influence used by food and beverage corporations. It is essential to develop regulatory-based tools and procedures that embody ethics and good governance and that can be applied systematically and routinely to prevent corporate influence in health policy-making. A global observatory of corporate practices would also be needed to recommend to governments efficient actions to avoid corporate capture of their policies.

Increase your Confidence in Opioid Prescribing: Marketing Messages in Continuing Medical Education Activities on ER/LA Opioids

Overprescription of opioids has fueled an epidemic of addiction and overdose deaths. The FDA required manufacturers of extended-release/long-acting (ER/LA) opioids to fund continuing medical education (CME) on opioids as part of a Risk Evaluation and Mitigation Strategy (REMS). We sought to determine whether industry-funded REMS on long-acting opioids were consistent with the FDA's goal to reduce serious, adverse outcomes resulting from inappropriate prescribing, misuse, and abuse. In 2018, we analyzed all internet-based REMS CME activities funded by the REMS Program Companies (RPC), a consortium of ER/LA opioid manufacturers. We utilized systematic narrative thematic analysis, an inductive approach that allows for mapping of concepts and meanings across a body of data by identifying, recording, analyzing, and refining key narrative points, called "themes". Authors viewed all REMS activities multiple times. Ten themes were identified, all of which were at least somewhat incongruent with federal guidelines and their goals: 1. Chronic pain is a common, under-treated problem. 2.Chronic pain is a chronic disease.3.Opioids are an appropriate treatment for chronic pain. 4.LAs are more appropriate than immediate-release (IR) opioids for chronic pain. 5.Tolerance is normal, expected, and beneficial. 6. Opioid rotation" can maximize analgesia and minimize adverse effects.7. There is no population for whom opioids are absolutely contraindicated or inappropriate. 8. Screening and monitoring tools are effective for preventing opioid-related problems. 9. Opioid related adverse effects, such as respiratory depression and addiction, are due only to misuse and abuse. Addiction, overdose, and death are due to street drugs such as heroin and fentanyl, not prescription opioids.Themes and statements repeated in these activities were inconsistent with current medical knowledge, evidence-based federal guidelines, and FDA goals. We evaluated only online, not live, CME. We also did not evaluate individual conflicts of interest of faculty. Industry-funded REMS-compliant CME on opioids contain messages that misrepresent scientific evidence and may foster overprescribing of opioids.

Ethics Centers’ Conflicts of Interest and the Failure of Disclosure to Remedy this Endemic Problem

Individual and institutional conflicts of interest arise with increasing frequency and negative sequelae as universities and their principals, as well as individual faculty members, engage in research (and other activities) with support from profit/not-for-profit entities. This essay examines how institutional and individual conflicts of interest (COI) arise for ethics centers and their faculty/staff, respectively. It defines COI, endorses a reasonable person standard for determining when COI exist, and considers problems that arise when disclosure of COI is embraced as a remedy for them. It argues that transparency and disclosure are generally inadequate measures to address COI, especially those of ethics centers. It concludes by sketching other measures that may be ingredients in attempts to avoid, manage, or mitigate the COI of ethics centers and their faculty/staff.

Conflicts of Interest in Sport: A Comparative Analysis of International and European Remedies

This research studies the management of conflicts of interest in sporting context, trough a comparative analysis of the current wave of reforms at national and international level. It suggests that the notion of conflict of interests in sport is wholly specific and it requires particular remedies, illustrating potential convergences with the public and private governance practices. Firstly, the paper identifies the endemic conflicts of interest due to the specific pyramid structure of sports movement, and the individual conflicts of interest that could occur in sporting organisations. Secondly, it detects the solution foreseen by the European authorities and the recent reforms concerning the sporting organizations adopted at national and international level. The study shows the elements that characterize conflicts of interest in sporting context, identifying convergences, limits, and the specific solutions suggested by the ethical and social function of sport.

Reporting of Financial and Non-financial Conflicts of Interest in Systematic Reviews on Health Policy and Systems Research: A Cross Sectional Survey

Background: Systematic reviews are increasingly used to inform health policy-making. The conflicts of interest (COI) of the authors of systematic reviews may bias their results and influence their conclusions. This may in turn lead to misguided public policies and systems level decisions. In order to mitigate the adverse impact of COI, scientific journals require authors to disclose their COIs. The objective of this study was to assess the frequency and different types of COI that authors of systematic reviews on health policy and systems research (HSPR) report. Methods: We conducted a cross sectional survey. We searched the Health Systems Evidence (HSE) database of McMaster Health Forum for systematic reviews published in 2015. We extracted information regarding the characteristics of the systematic reviews and the associated COI disclosures. We conducted descriptive analyses. Results: Eighty percent of systematic reviews included authors’ COI disclosures. Of the 160 systematic reviews that included COI disclosures, 15% had at least one author reporting at least one type of COI. The two most frequently reported types of COI were individual financial COI and individual scholarly COI (11% and 4% respectively). Institutional COIs were less commonly reported than individual COIs (3% and 15% respectively) and non-financial COIs were less commonly reported than financial COIs (6% and 14% respectively). Only one systematic review reported the COI disclosure by editors, and none reported disclosure by peer reviewers. All COI disclosures were in the form of a narrative statement in the main document and none in an online document. Conclusion: A fifth of systematic reviews in HPSR do not include a COI disclosure statement, highlighting the need for journals to strengthen and/or better implement their COI disclosure policies. While only 15% of identified disclosure statements report any COI, it is not clear whether this indicates a low frequency of COI versus an underreporting of COI, or both.

Conflicts of Interest

The primary interest of both physicians and patients lies in optimal medical care based on current scientific knowledge, with avoidance of harm. The ideal health-care system has: decision-makers who set its framework conditions according to the values of society at large; medical research that creates knowledge and makes it accessible; professional training and continuing education that enable physicians to handle information critically. Public opinion is sensitive to the risk of undue influence on physicians from third-party interests and from their own individual conflicts of interest. An ongoing, rational discussion of this risk is important if public confidence in the health-care system is to be sustained.

Guideline Funding and Conflicts of Interest

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. This is the fourth of a series of 14 articles prepared to advise guideline developers in respiratory and other disease. It focuses on commercial funding of guidelines and managing conflict of interest effectively in the context of guidelines. In this review, we addressed the following topics and questions. (1) How are clinical practice guidelines funded? (2) What are the risks associated with commercial sponsorship of guidelines? (3) What relationships should guideline committee members be required to disclose? (4) What is the most efficient way to obtain complete and accurate disclosures? (5) How should disclosures be publicly shared? (6) When do relationships require management? (7) How should individual conflicts of interest be managed? (8) How could conflict of interest policies be enforced? The literature review included a search of PubMed and other databases for existing systematic reviews and relevant methodological research. Our conclusions are based on available evidence, consideration of what guideline developers are doing, and workshop discussions. Professional societies often depend on industry funding to support clinical practice guideline development. In addition, members of guideline committees frequently have financial relationships with commercial entities, are invested in their intellectual work, or have conflicts related to clinical revenue streams. No systematic reviews or other rigorous evidence regarding best practices for funding models, disclosure mechanisms, management strategies, or enforcement presently exist, but the panel drew several conclusions that could improve transparency and process.

Confronting Conflict: Addressing Institutional Conflicts of Interest in Academic Medical Centers

Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest ("ICOIs") in academic medical centers ("AMCs") engaged in research and clinical care-have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a "Centralized System" model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding. The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education-academic detailing-in place of current marketing-focused "education." Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.

Invited Article: Conflicts of interest for authors of American Academy of Neurology clinical practice guidelines

Clinical practice guidelines (CPGs) shape clinical care worldwide but are prone to potential error and bias due to conflicts of interest (COI). To explore the extent and scope of American Academy of Neurology (AAN) guideline author reported COI and implications for management; and to review process of AAN guideline COI management to highlight challenges, establish comparative benchmarks, and identify areas to be improved. Authors of AAN clinical practice guidelines with an active membership panel completed a COI reporting form. Authors were asked to report current interests including the 1 year prior to the date of completing the form. Interests include personal income relationships (consulting, speaker's bureaus, advisory boards), equity (stocks/stock options), patent/royalties, research, clinical practice, fiduciary interest in a company, and expert testimony. Comparisons were made between the two committees that oversee CPG development at the AAN: the Quality Standards Subcommittee (QSS) and the Therapeutics and Technology Assessment (TTA) Subcommittee. There were 50 CPG with an average of 8.5 authors per CPG. There were a total of 425 available authors, 351 of whom completed a COI reporting form (83% response rate). Forty-six of the 50 guidelines had at least one author with a COI. The most commonly reported COIs were research-related (45% of authors), clinical practice-related (42%), and personal income relationships (33%). Authors of QSS guidelines were more likely to have personal income COIs with pharmaceutical and medical device companies (39% vs 24%, p < 0.01), whereas authors of TTA guidelines were more likely to have clinical practice-related COIs (50% vs 38%, p < 0.05). A minority of authors had individual COIs exceeding >$25,000 or had multiple interests (>10) that overlapped with content of the guidelines. Conflicts of interest are common for authors of American Academy of Neurology clinical practice guidelines across many domains of personal and professional interests. More research is needed to improve the methods to identify and quantify the types of conflicts and their potential biasing effects on selecting guideline topics, grading research evidence, and formulating practice recommendations.

Industry Influence in the Creation of Pay-for-Performance Quality Measures

With the impact of pay for performance likely to broaden and deepen in the coming years, ensuring that the quality measures used in these initiatives are based on the best possible clinical evidence and expert consensus is paramount. Two types of organizations greatly influence the content of quality measures: measure development organizations-such as the National Committee for Quality Assurance-and medical professional societies. The process by which emerging measures of quality are created is subject to bias resulting from organizational and individual conflicts of interest in both types of organizations. This article examines the financial ties between those who-both directly and indirectly-help create the standards used in pay-for-performance programs and those firms whose revenues will increasingly depend on the substance of these measures. Several examples of inappropriate industry influence in the drafting of clinical practice guidelines by professional societies illustrate that these groups' future management of conflicts of interest may ultimately affect the success of pay-for-performance programs. Finally, policy options for minimizing the effects of these conflicts on the development of quality measures are discussed.

Guidelines, Editors, Pharma And The Biological Paradigm Shift

Guidelines, Editors, Pharma And The Biological Paradigm Shift

Where Next after SPACE and EVA-3S: ‘The Good, the Bad and the Ugly!’

SPACE and EVA-3S are the latest to publish outcomes in recently symptomatic patients who were randomised to carotid endarterectomy (CEA) or angioplasty and stenting (CAS). Contrary to expectations, both found that CAS was not 'as good as' CEA, while EVA-3S found CEA to be statistically superior. Not surprisingly, these trials have aroused considerable controversy and many in the pro-CAS lobby have simply dismissed them as being methodologically flawed and unrepresentative of contemporary CAS practice. However, to simply dismiss SPACE and EVA-3S as maverick trials is unacceptable. Unlike the landmark 'symptomatic' and 'asymptomatic' studies, the history of randomised trials comparing CAS and CEA has been characterised by repeated trial suspension (because of excess risk in the CAs cohort) and a systematic failure to achieve randomisation targets (thereby preventing any prospect of a statistically meaningful outcome) amid a milieu of corporate and individual conflicts of interest. SPACE and EVA-3S have certainly informed the dabate but they have not resolved it. Two trials are actively randomising recently symptomatic patients (ICSS in Europe and CREST in North America). Both require our support so that future guidelines are 'evidence based' rather than 'marker driven'.

Food Patchiness, Territory Overlap and Social Systems: An Experiment with Dunnocks Prunella modularis

1. Dunnocks Prunella modularis inhabit dense scrub where females defend small, exclusive territories. Individuals have one to two mates depending on how the territories of males overlap the female territories, resulting in monogamy, polygyny, polyandry or polygynandry. 2. The congeneric alpine accentor Prunella collaris inhabits high mountains where food is more patchily distributed. Two to five females have large, overlapping ranges defended by two to five males in a polygynandrous group. 3. We tested whether dunnocks would adopt the alpine accentor's social system when provided with an artificial patchy food supply. 4. At regular feeding sites, where food was provided each day, dunnocks defended small, exclusive territories. At variable feeders, where food was allocated at random each day to one of several adjacent sites, dunnocks adopted larger, overlapping ranges typical of alpine accentors, with two to five males overlapping two to four females. 5. Unlike alpine accentors, however, the dunnocks with variable feeders did not have a consistent dominance hierarchy over the whole of the shared range and females did not gain mating access to more males. 6. We suggest that whereas ecological conditions influence the spacing system, social relationships are affected by individual conflicts of interest.