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Journal ArticleDOI

Do Financial Conflicts of Interest Bias Research? An Inquiry into the “Funding Effect” Hypothesis

Sheldon Krimsky1
01 Jul 2013-Science, Technology, & Human Values (SAGE Publications)-Vol. 38, Iss: 4, pp 566-587
TL;DR: The concept of the "funding effect" was coined in the mid-1980s when it was discovered that study outcomes could be statistically correlated with funding sources, largely in drug safety and efficacy studies as mentioned in this paper.
Abstract: In the mid-1980s, social scientists compared outcome measures of related drug studies, some funded by private companies and others by nonprofit organizations or government agencies. The concept of a “funding effect” was coined when it was discovered that study outcomes could be statistically correlated with funding sources, largely in drug safety and efficacy studies. Also identified in tobacco research and chemical toxicity studies, the “funding effect” is often attributed, implicitly or explicitly, to research bias. This article discusses the meaning of scientific bias in research, examines the strongest evidence for the “funding effect,” and explores the question of whether the “funding effect” is an indicator of biased research that is driven by the financial interests of the for-profit sponsor. This article argues that the “funding effect” is merely a symptom of the factors that could be responsible for outcome disparities in product assessment. Social scientists should not suspend their skepticism a...
Citations
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Journal ArticleDOI
TL;DR: In this paper, a review explores contributions by science policy studies and the sociology of science to our understanding of the impact of governance on research content and concludes that little is known so far about the impact on knowledge content.
Abstract: This review explores contributions by science policy studies and the sociology of science to our understanding of the impact of governance on research content. Contributions are subsumed under two perspectives, namely an “impact of”—perspective that searches for effects of specific governance arrangements and an “impact on”—perspective that asks what factors contribute to the construction of research content and includes governance among them. Our review shows that little is known so far about the impact of governance on knowledge content. A research agenda does not necessarily need to include additional empirical phenomena but must address the macro-micro-macro link inherent to the question in its full complexity, and systematically exploit comparative approaches in order to establish causality. This requires interdisciplinary collaboration between science policy studies, the sociology of science, and bibliometrics, which all can contribute to the necessary analytical toolbox.

119 citations


Cites background from "Do Financial Conflicts of Interest ..."

  • ...In his reviews of these studies, Krimsky [2013] concludes that “[i]ndustry-sponsored trials are more likely than trials sponsored by non-profit organisations, including government agencies, to yield results that are consistent with the sponsor’s commercial interest” [Krimsky 2013: 582]....

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Journal ArticleDOI
TL;DR: A systematic search of reviews in English language-published peer-reviewed journals in 2006-2013 sought to assess the scientific quality and other characteristics that may be associated with the conclusions of reviews regarding the causal relation between SSB consumption and body weight.

61 citations

Journal ArticleDOI
TL;DR: In this paper, the authors empirically test for differences in the novelty of funded outputs between internal block funding and competitive project funding, in the setting of Japan, where both funding models play a significant role.

61 citations


Cites background from "Do Financial Conflicts of Interest ..."

  • ...competitive funding than by block funding (Krimsky, 2012)....

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  • ...Therefore, the effects of different statuses, associated with different levels of research constraints, will be observed more clearly and strongly when the research is supported by competitive funding than by block funding (Krimsky, 2012)....

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Journal ArticleDOI
TL;DR: The authors assessed what one group of environmental decision makers, Australian marine protected area (MPA) managers, viewed as the major risks associated with climate change and their perceptions regarding the role, importance, and achievability of adaptation for managing these risks.
Abstract: The rapid development of adaptation as a mainstream strategy for managing the risks of climate change has led to the emergence of a broad range of adaptation policies and management strategies globally. However, the success of such policies or management interventions depends on the effective integration of new scientific research into the decision-making process. Ineffective communication between scientists and environmental decision makers represents one of the key barriers limiting the integration of science into the decision-making process in many areas of natural resource management. This can be overcome by understanding the perceptions of end users, so as to identify knowledge gaps and develop improved and targeted strategies for communication and engagement. We assessed what one group of environmental decision makers, Australian marine protected area (MPA) managers, viewed as the major risks associated with climate change, and their perceptions regarding the role, importance, and achievability of adaptation for managing these risks. We also assessed what these managers perceived as the role of science in managing the risks from climate change, and identified the factors that increased their trust in scientific information. We do so by quantitatively surveying 30 MPA managers across 3 Australian management agencies. We found that although MPA managers have a very strong awareness of the range and severity of risks posed by climate change, their understanding of adaptation as an option for managing these risks is less comprehensive. We also found that although MPA managers view science as a critical source of information for informing the decision-making process, it should be considered in context with other knowledge types such as community and cultural knowledge, and be impartial, evidence based, and pragmatic in outlining policy and management recommendations that are realistically achievable.

58 citations

Journal ArticleDOI
TL;DR: It is argued that it is often difficult to detect significant influences of financial relationships that affect research credibility, and at least five factors can be examined to determine whether financial relationships are likely to enhance, undermine, or have no impact on the credibility of research.
Abstract: Many scientific journals, government agencies, and universities require disclosure of sources of funding and financial interests related to research, such as stock ownership, consulting arrangements with companies, and patents. Although disclosure has become one of the central approaches for responding to financial conflicts of interest (COIs) in research, critics contend that information about financial COIs does not serve as a reliable indicator of research credibility, and therefore, studies should be evaluated solely based on their scientific merits. We argue that, while it is indeed important to evaluate studies on their scientific merits, it is often difficult to detect significant influences of financial relationships that affect research credibility. Moreover, at least five factors can be examined to determine whether financial relationships are likely to enhance, undermine, or have no impact on the credibility of research. These include as follows: whether sponsors, institutions, or researchers have a significant financial stake in the outcome of a study; whether the financial interests of the sponsors, institutions, or researchers coincide with the goal of conducting research that is objective and reliable; whether the sponsor, institution, or researchers have a history of biasing research in order to promote their financial goals; how easy it is to manipulate the research in order to achieve financial goals; and whether oversight mechanisms are in place which are designed to minimize bias. Since these factors vary from case to case, evaluating the impact of financial relationships depends on the circumstances. In some situations, one may decide that the financial relationships significantly undermine the study's credibility; in others, one may decide that they have no impact on credibility or even enhance it.

50 citations


Cites background or methods from "Do Financial Conflicts of Interest ..."

  • ...…on the psychological, economic, and social aspects of scientific research, we propose that at least five factors are particularly relevant when assessing the impact of financial relationships on research (Greenberg, 2001; Resnik, 2007; Elliott, 2011; Krimsky, 2012; Lexchin, 2012) (see Table 2)....

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  • ...…a method, data collection, data analysis, or interpretation of results that, in the consensus view of scientists of a discipline, tends to yield results that distort the truth of a hypothesis under consideration, diminishing or negating the reliability of the knowledge claim” (Krimsky, 2012, p. 3)....

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  • ...Some argue that disclosure policies are little more than a Band-Aid that covers up larger problems because they do nothing to discourage problematic relationships that create bias (Krimsky, 2003; Elliott, 2008; Cosgrove and Krimsky, 2012)....

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  • ...A company could also decide not to fund a study based on preliminary evidence of lack of effectiveness (Krimsky, 2012)....

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  • ...Financial relationships can influence research outcomes in a variety of ways (Resnik, 2007; Michaels, 2008; Elliott, 2011; Lexchin, 2012; Krimsky, 2012) (see Table 1)....

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References
More filters
Book
01 Jan 1949

13,688 citations

Book
01 Jan 1989

6,659 citations

Book
01 Jan 1968
TL;DR: The Open Society and Its Enemies as mentioned in this paper is regarded as one of Popper's most enduring books and contains insights and arguments that demand to be read to this day, as well as many of the ideas in the book.
Abstract: Described by the philosopher A.J. Ayer as a work of 'great originality and power', this book revolutionized contemporary thinking on science and knowledge. Ideas such as the now legendary doctrine of 'falsificationism' electrified the scientific community, influencing even working scientists, as well as post-war philosophy. This astonishing work ranks alongside The Open Society and Its Enemies as one of Popper's most enduring books and contains insights and arguments that demand to be read to this day.

1,543 citations

Journal ArticleDOI
22 Jan 2003-JAMA
TL;DR: In this article, the authors reviewed original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research and concluded that financial relationships among industry, scientific investigators, and academic institutions are widespread.
Abstract: ContextDespite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed.ObjectiveTo review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research.Data SourcesStudies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts.Study SelectionAll English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria.Data ExtractionOne investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest.Data SynthesisApproximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals.ConclusionsFinancial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.

1,524 citations

01 Jan 2006
TL;DR: Original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research are reviewed to show a statistically significant association between industry sponsorship and pro-industry conclusions.
Abstract: CONTEXT Despite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed. OBJECTIVE To review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research. DATA SOURCES Studies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts. STUDY SELECTION All English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria. DATA EXTRACTION One investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest. DATA SYNTHESIS Approximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals. CONCLUSIONS Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.

1,501 citations


"Do Financial Conflicts of Interest ..." refers background in this paper

  • ...Strong and consistent evidence shows that industry sponsored-research tends to draw proindustry conclusions’’ (Bekelman, Li, and Gross 2003, 463)....

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