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"Bero, Lisa A"
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Why Having a (Nonfinancial) Interest Is Not a Conflict of Interest
2016
A current debate about conflicts of interest related to biomedical research is to question whether the focus on financial conflicts of interest overshadows \"nonfinancial\" interests that could put scientific judgment at equal or greater risk of bias. There is substantial evidence that financial conflicts of interest such as commercial sponsorship of research and investigators lead to systematic biases in scientific research at all stages of the research process. Conflation of \"conflicts of interest\" with \"interests\" in general serves to muddy the waters about how to manage conflicts of interest. We call for heightened disclosure of conflicts of interest and policy action beyond disclosure as the sole management strategy. We propose a different strategy to manage interests more broadly to ensure fair representation and accountability.
Journal Article
Relationship between Research Outcomes and Risk of Bias, Study Sponsorship, and Author Financial Conflicts of Interest in Reviews of the Effects of Artificially Sweetened Beverages on Weight Outcomes: A Systematic Review of Reviews
by
Kearns, Cristin E
,
Mandrioli, Daniele
,
Bero, Lisa A.
in
Authorship
,
Beverages
,
Beverages - adverse effects
2016
Artificially sweetened beverage consumption has steadily increased in the last 40 years. Several reviews examining the effects of artificially sweetened beverages on weight outcomes have discrepancies in their results and conclusions.
To determine whether risk of bias, results, and conclusions of reviews of effects of artificially sweetened beverage consumption on weight outcomes differ depending on review sponsorship and authors' financial conflicts of interest.
We performed a systematic review of reviews of the effects of artificially sweetened beverages on weight. Two assessors independently screened articles for inclusion, extracted data, and assessed risks of bias. We compared risk of bias, results and conclusions of reviews by different industry sponsors, authors' financial conflict of interest and journal sponsor. We also report the concordance between review results and conclusions.
Artificial sweetener industry sponsored reviews were more likely to have favorable results (3/4) than non-industry sponsored reviews (1/23), RR: 17.25 (95% CI: 2.34 to 127.29), as well as favorable conclusions (4/4 vs. 15/23), RR: 1.52 (95% CI: 1.14 to 2.06). All reviews funded by competitor industries reported unfavorable conclusions (4/4). In 42% of the reviews (13/31), authors' financial conflicts of interest were not disclosed. Reviews performed by authors that had a financial conflict of interest with the food industry (disclosed in the article or not) were more likely to have favorable conclusions (18/22) than reviews performed by authors without conflicts of interest (4/9), RR: 7.36 (95% CI: 1.15 to 47.22). Risk of bias was similar and high in most of the reviews.
Review sponsorship and authors' financial conflicts of interest introduced bias affecting the outcomes of reviews of artificially sweetened beverage effects on weight that could not be explained by other sources of bias.
Journal Article
Pharmaceutical industry sponsorship and research outcome and quality: systematic review
by
Bero, Lisa A
,
Clark, Otavio
,
Lexchin, Joel
in
Clinical trials
,
Clinical Trials as Topic - standards
,
Cohort analysis
2003
Abstract Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Methods Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. Results 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Conclusion Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
Journal Article
Correction: Relationship between Research Outcomes and Risk of Bias, Study Sponsorship, and Author Financial Conflicts of Interest in Reviews of the Effects of Artificially Sweetened Beverages on Weight Outcomes: A Systematic Review of Reviews
by
Kearns, Cristin E
,
Mandrioli, Daniele
,
Bero, Lisa A.
in
Beverages
,
Corporate sponsorship
,
Ethical aspects
2020
[This corrects the article DOI: 10.1371/journal.pone.0162198.].
Journal Article
How can the integrity of occupational and environmental health research be maintained in the presence of conflicting interests?
by
Soskolne, Colin L.
,
Baur, Xaver
,
Bero, Lisa A.
in
Boards of directors
,
Commentary
,
Conflict of Interest
2019
Background
The sciences, and especially the research subspecialties of occupational and environmental health, are being misused. The misuse serves to interfere with the advancement of policies that depend on rational evidence needed for policies to protect public health.
Methods
We selectively surveyed the independent scientific literature. In addition, the efforts of respected international professional organizations of scientists whose focus is on maintaining and improving public health have been considered. This commentary is unique in assembling not only the factual basis for sounding alarms about significant bias in occupational and environmental health research, but also about the manipulative mechanisms used, and, in turn, the methods needed to keep science honest.
Results
Scientific integrity is based on the principle that research is conducted as objectively as possible; it cannot be compromised by special interests whose primary goals are neither to seek truth nor to protect human health. Evidence demonstrates a significant risk of bias in research reports sponsored by financial interests. Practices of corporate malfeasance include the orchestrated contamination of editorial boards of peer-reviewed scientific journals with industry apologists; interference with activities of national regulatory bodies and international review panels engaged in safeguarding occupational and public health; constructing roadblocks by capitalizing on uncertainty to undermine scientific consensus for much-needed government regulation of carcinogenic, endocrine-disrupting and/or immunotoxic agents; promoting “causation” criteria that lack foundation and effectively block workers’ access to legal remedies for harms from occupational exposures resulting in morbidity and premature mortality; and, violating standards of professional conduct by seducing reputable scientists with financial incentives that make them beholden to corporate agendas.
Conclusions
Well-orchestrated assaults on science continue unabated and must now be met head-on. Success could be achieved by promoting and protecting the integrity of research. Furthermore, avoiding influence by conflicted corporate affiliates in occupational and public health regulations is needed. Identifying, managing and, ideally, eliminating corporate influence on science and science policy are needed to protect research integrity. Protecting the public’s health, preventing disease, and promoting well-being must be the unambiguous goals of research in occupational and environmental health.
Journal Article
Toolkit for detecting misused epidemiological methods
by
Gochfeld, Michael
,
Advani, Shailesh
,
Sass, Jennifer
in
Commentary
,
Conflict of Interest
,
Disinformation
2021
Background
Critical knowledge of what we know about health and disease, risk factors, causation, prevention, and treatment, derives from epidemiology. Unfortunately, its methods and language can be misused and improperly applied. A repertoire of methods, techniques, arguments, and tactics are used by some people to manipulate science, usually in the service of powerful interests, and particularly those with a financial stake related to toxic agents. Such interests work to foment uncertainty, cast doubt, and mislead decision makers by seeding confusion about cause-and-effect relating to population health. We have compiled a toolkit of the methods used by those whose interests are not aligned with the public health sciences. Professional epidemiologists, as well as those who rely on their work, will thereby be more readily equipped to detect bias and flaws resulting from financial conflict-of-interest, improper study design, data collection, analysis, or interpretation, bringing greater clarity—not only to the advancement of knowledge, but, more immediately, to policy debates.
Methods
The summary of techniques used to manipulate epidemiological findings, compiled as part of the 2020 Position Statement of the
International Network for Epidemiology in Policy
(INEP) entitled
Conflict-of-Interest and Disclosure in Epidemiology
, has been expanded and further elucidated in this commentary.
Results
Some level of uncertainty is inherent in science. However, corrupted and incomplete literature contributes to confuse, foment further uncertainty, and cast doubt about the evidence under consideration. Confusion delays scientific advancement and leads to the inability of policymakers to make changes that, if enacted, would—supported by the body of valid evidence—protect, maintain, and improve public health. An accessible toolkit is provided that brings attention to the misuse of the methods of epidemiology. Its usefulness is as a compendium of what those trained in epidemiology, as well as those reviewing epidemiological studies, should identify methodologically when assessing the transparency and validity of any epidemiological inquiry, evaluation, or argument. The problems resulting from financial conflicting interests and the misuse of scientific methods, in conjunction with the strategies that can be used to safeguard public health against them, apply not only to epidemiologists, but also to other public health professionals.
Conclusions
This novel toolkit is for use in protecting the public. It is provided to assist public health professionals as gatekeepers of their respective specialty and subspecialty disciplines whose mission includes protecting, maintaining, and improving the public’s health. It is intended to serve our roles as educators, reviewers, and researchers.
Journal Article
Interactions between Australian cancer physicians and the pharmaceutical industry: a qualitative study
by
Bero, Lisa A
,
McEwin, Eliza J
,
Pokorny, Adrian M J
in
Attitude of Health Personnel
,
Australia
,
Bioethics
2023
ObjectivesTo understand how and why Australian cancer physicians interact with the pharmaceutical industry.DesignQualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes.SettingGiven the evidence on industry influences on clinical practice and the importance to the market of oncology drugs, we sought to better understand cancer physicians’ experiences. Practising consultant medical oncologists and clinical haematologists from four Australian states were interviewed over Zoom.Participants16 cancer physicians were interviewed between November 2021 and March 2022, from 37 invited (response rate 43%). Most were medical oncologists (n=12 of 16, 75%) and male (n=9 of 16, 56%).Outcome measuresThe analysis of all interviews was based on grounded theory. Transcripts were coded and then codes formed into themes with supporting quotes. The themes were then placed into categories, used to describe the broad areas into which the themes could be grouped.ResultsSix themes were identified that fell within two broad categories: cancer physicians’ views and experiences of interactions and management of these interactions. Views and experiences included: the transactional nature of relationships, risks of research dependence, ethical challenges and varied attitudes based on interaction type. Management themes included: lack of useful guidance and reduced interactions during the COVID-19 pandemic. These led to an overarching seventh theme, on the desire for a ‘middle road’. Cancer physicians identified the transactional nature of industry relationships and felt uncomfortable with several types of interactions, including those with sales representatives. Most wanted less contact with industry, and the forced separation that occurred with the COVID-19 pandemic was generally welcome.ConclusionsCancer physicians may have difficulty balancing the perceived need to interact with industry in modern cancer care while maintaining distance to minimise conflicts of interest. Further research is needed to assess management strategies in this area.
Journal Article
Improving the Quality of Systematic Reviews in Public Health: Introduction to the Series
2020
Synthesizing evidence relevant to public health is now more important than ever. The global health threat posed by the COVID-19 pandemic has stimulated research production across the spectrum of prevention, detection, treatment, and recovery. As of July 2020, the Cochrane COVID-19 Registry contained more than 11 000 ongoing primary studies started within the first three months of the pandemic. The rate of scientific publication appears to be doubling every 14 days. At the same time, the number of evidence syntheses has skyrocketed and includes rapid reviews, systematic reviews, \"living\" systematic reviews, and meta-analyses. Decision makers need trustworthy, rigorous primary studies and evidence syntheses. I am launching a series of commentaries on advances in methods for designing and conducting systematic reviews relevant to public health. The series will advance AJPH s mission of publishing rigorous intervention and policy research by focusing on methodological issues in prioritizing, conducting, and disseminating the results of systematic reviews. Using systematic reviews and experience from the Cochrane Public Health and Health Systems Network as examples, the series aims to demonstrate the value and challenges in preparing systematic reviews and using them in public health policy and practice.The series will describe ways that systematic reviews can be improved to better meet the needs of public health policymakers. It will highlight the main advances in methods for conducting systematic reviews on public health topics. Lastly, the series will outline future directions for methods development that is needed to tackle areas of debate or uncertainty. Specific topics will include methods for stakeholder engagement in systematic reviews, use of logic frameworks to plan systematic reviews, the values and challenges of qualitative evidence synthesis and synthesis of observational studies, core outcome sets for public health questions, and synthesis without meta-analysis. We aim for the series to provide helpful tips for authors and users of public health-relevant systematic reviews.
Journal Article
Response to Toshihide Tsuda, Yumiko Miyano and Eiji Yamamoto 1
2022
Background
In August 2021, we published in
Environmental Health
a Toolkit for detecting misused epidemiological methods with the goal of providing an organizational framework for transparently evaluating epidemiological studies, a body of evidence, and resultant conclusions. Tsuda et al., the first group to utilize the Toolkit in a systematic fashion, have offered suggestions for its modification.
Main body
Among the suggested modifications made by Tsuda et al., we agree that rearrangement of Part A of the Toolkit to reflect the sequence of the epidemiological study process would facilitate its usefulness. Expansion or adaptation of the Toolkit to other disciplines would be valuable but would require the input of discipline-specific expertise. We caution against using the sections of the Toolkit to produce a tally or cumulative score, because none of the items are weighted as to importance or impact. Rather, we suggest a visual representation of how a study meets the Toolkit items, such as the heat maps used to present risk of bias criteria for studies included in Cochrane reviews. We suggest that the Toolkit be incorporated in the sub-specialty known as “forensic epidemiology,” as well as in graduate training curricula, continuing education programs, and conferences, with the recognition that it is an extension of widely accepted ethics guidelines for epidemiological research.
Conclusion
We welcome feedback from the research community about ways to strengthen the Toolkit as it is applied to a broader assemblage of research studies and disciplines, contributing to its value as a living tool/instrument. The application of the Toolkit by Tsuda et al. exemplifies the usefulness of this framework for transparently evaluating, in a systematic way, epidemiological research, conclusions relating to causation, and policy decisions.
Postscript
We note that our Toolkit has, most recently, inspired authors with discipline-specific expertise in the field of Conservation Biology to adapt it for use in the Biological Sciences.
Journal Article