The Role of Conflict of Interest in Reporting of Scientific Information

doi:10.1378/chest.09-0890

Chest

Volume 136, Issue 1, July 2009, Pages 253-259

https://doi.org/10.1378/chest.09-0890 Get rights and content

We have come to appreciate that scientific misconduct is often not intuitively obvious to those who perpetrate it. Therefore, this commentary has been written to review what we know about the role of conflict of interest (COI) in the reporting of scientific information and to challenge those of us in educator roles to do a better job in mentoring our trainees, junior faculty, and associates on what is right and wrong; what is ethical and unethical. The review addresses the following questions: (1) Why has the public trust in the clinical research industry been eroded? (2) How often is the ethical concept of equipoise violated in industry-sponsored randomized controlled clinical trials? (3) How often are negative trials underreported and favorable trials selectively or redundantly over-reported in industry-sponsored randomized controlled clinical trials? (4) What is being done to restore the public trust? While there are multiple strategies to mitigate COI in the reporting of scientific information, we have come to appreciate that the disclosure of potential conflicts of interest is not enough. It is our hope that this article and its contents can serve as a stimulus for the development and incorporation of an educational series in all training programs on what is ethical and unethical in the conducting and reporting of scientific studies.

Section snippets

The Relationship of COI and Trust

The concepts of COI and trust are inextricably linked. According to Wiktionary, a wiki-based, open content dictionary,³ “A conflict of interest is a situation in which someone in a position of trust … has competing professional or personal interests.” “A conflict of interest exists even if no unethical or improper act results from it.” “A conflict of interest can create an appearance of impropriety that can undermine confidence ….” While the research of Hall et al⁴ on medical trust defines the

Erosion of the Public Trust

The public perceives that scientific misconduct is and has been pervasive because it is not a new phenomenon, not limited to the pharmaceutical industry, and not limited to the clinical scientific industry. Two major scandals regarding suppression by the pharmaceutical industry of adverse results that came to light in 2004 received an enormous amount of media attention.7, 16 From this, the public came to understand that there had been suppression of an increased suicide risk in children taking

Violations of Ethical Principles in the Medical Literature

Design bias and publication bias constitute violations of ethical principles. Unfortunately, much data exist that suggest that our literature has been contaminated by studies that are seemingly designed to be biased.

When randomized, controlled clinical trials are designed with a high likelihood of being positive in favor of the sponsor's drug, they are flawed by design bias. This type of bias is not consistent with the concept of equipoise (ie, the uncertainty principle) that is a central

Strategies To Mitigate COI and Restore the Public Trust

While there have always been multiple theoretical ways to mitigate COIs in the reporting of scientific information (Table 1), there is now a concerted effort on the part of many stakeholders from multiple disciplines to limit/eliminate scientific misconduct that has seemingly been spiraling out of control by some accounts.¹⁵ For example, medical societies such as the American College of Chest Physicians (ACCP) that develop clinical practice guidelines have instituted policies and firewalls to

Conclusions

Marcia Angell recently stated⁶⁴ the following: “It would be naïve to conclude that bias is only a matter of a few isolated instances. It permeates the entire system.” “Physicians can no longer rely on the medical literature for valid and reliable information.” “Clinicians just do not know anymore how safe and effective prescription drugs really are, but the products are probably nowhere near as good as the published literature indicates.” “It is more than a matter of perception or appearances;

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We categorized each experience/item used to measure childhood adversity in articles in which ACEs were included in a primary purpose. Funding sources may shape the emphasis of research (Bero, 2017; Irwin, 2009), and have been linked to research quality and biases in results and conclusions (Bekelman et al., 2003; Gómez-García et al., 2017). The original ACEs study originated from a collaboration between obesity researchers at an HMO and the CDC, both of which have interests in disease prevention (PL 93-222).
Adverse childhood experiences (ACEs) lead to excess morbidity and mortality. However, this evidence has not resulted in large-scale efforts to prevent ACEs. We conducted a scoping review of ACEs research to determine its direction and identify advancement toward solutions to prevent ACEs. The review was conducted using PRISMA guidelines. Articles were considered eligible for inclusion if they were empirical studies based on original quantitative data from humans published between 1999 and 2019 and used the term “adverse” or adversity” to refer to a construct under study or a specific measure in the methodology. After a comprehensive search across nine databases, screening of the abstracts of 3,944 articles and the full texts of 2,341 articles, 1,361 empirical articles met inclusion criteria. We coded year of publication; journal name; stated study purpose (e.g., descriptive, intervention); types of adversities used to define ACEs; funding sources and declared conflicts of interest; country of the sample; and affiliation with other studies. To characterize the extent to which ACEs research focuses on ACE prevention, we then coded “narratives” reflected in research goals, with a particular focus on whether this research focuses exclusively on ACEs as the primary predictor variables, or if it integrates “upstream” social determinants of health and health inequities that may lead to ACE exposure. Thus, we coded how the elements of the stated research goals related to ACEs (e.g., predictor, mediator, moderator, and outcome variables) using the World Health Organization’s framework on social determinants of health (Solar & Irwin, 2010). Finally, we coded whether protective factors were included in research designs and the level of these factors (e.g., individual vs. community), and researchers’ recommendations for translating their findings to action. All variables were coded by at least two coders; inter-rater reliabilities ranged from 79 to 100%. We found that 60.6% of articles were based on samples recruited from the U.S.; funding sources have shifted to U.S. institutions with biomedical or clinical concerns; that only 47.2% of articles included in their definition of ACEs all seven items from the original ACE study; and that the dominant narrative about ACEs started with ACEs as the “villains” who begin a story of decline and ended with “victims” who have behavioral and/or emotional problems. Studies overwhelmingly examined the downstream effects of ACEs rather than upstream causes or preventive interventions. That is, only 6.6% of articles proposed protective factors that went beyond the individual or family level; and researchers’ recommendations favored amelioration of ACEs after they occur, with only 20% of articles mentioning primordial or primary prevention. This disproportionate focus on downstream determinants after ACEs have already occurred limits the impact of this research in terms of potential cost-benefit, social justice, and mitigation of health inequities. We recommend that future ACEs research be incorporated into broader, strengths-based and action-oriented frameworks focused on social determinants of health and health inequities; link ACEs to their putative causes as a bridge to primordial/primary prevention; address obstacles to this shift toward upstream causes of ACEs; and communicate findings and recommendations more effectively.
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Reviewing the content of abstracts and comparing them with companion author inserts in other journals has led me to believe that other journals might also want to eliminate publishing these inserts. As I wrote in a commentary in 2009,2 I thought that I was prepared to carry out the duties of being Editor in Chief on July 1, 2005, and that nothing would surprise me. I was wrong.
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Bioethics for pediatric patient centers on seeking, respecting and incorporating preferences from children of varying ages and maturity while incorporating the preferences of surrogate decisions makers, most often the parents. Operationalizing these practices requires understanding the following social, ethical, and legal concepts: (1) How age enables giving assent and consent; (2) The best interest standard in determining what care is acceptable for a child unable to communicate; and (3) Assent in determining the extent of authority given to children's preferences, particularly as they near the age of majority. These concepts help guide decision making about prickly issues for minors, such as confidentially, pregnancy, abortion, emergency care, end-of-life care, and when parents are too impaired to give informed consent.
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Bioethics for pediatric patient centers on seeking, respecting and incorporating preferences from children of varying ages and maturity while incorporating the preferences of surrogate decisions makers, most often the parents. Operationalizing these practices requires understanding the following social, ethical, and legal concepts: (1) How age enables giving assent and consent; (2) The best interest standard in determining what care is acceptable for a child unable to communicate; and (3) Assent in determining the extent of authority given to children's preferences, particularly as they near the age of majority. These concepts help guide decision making about prickly issues for minors, such as confidentially, pregnancy, abortion, emergency care, end-of-life care, and when parents are too impaired to give informed consent.
Medical publishing in 2015: Mistakes to be careful to avoid
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How Japanese medical journals manage conflicts of interest
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: Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).

¹: Dr. Irwin is the Editor in Chief of CHEST. While CHEST is the official journal of the American College of Chest Physicians and the ACCP is the publisher, he has editorial independence from the publisher.

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Chest

CommentaryTransparency in Health CareThe Role of Conflict of Interest in Reporting of Scientific Information

Section snippets

The Relationship of COI and Trust

Erosion of the Public Trust

Violations of Ethical Principles in the Medical Literature

Strategies To Mitigate COI and Restore the Public Trust

Conclusions

Chest

Lancet

Lancet

Am J Med

Lancet

Lancet

Chest

Chest

Chest

Chest

Lancet

Chest

Chest

Chest

Chest

AMA manual of style: a guide for authors and editors

Conflict of interest

Trust in physicians and medical institutions: what is it, can it be measured, and does it matter?

Milbank Q

Medical trust: concepts and data

COX-2 inhibitors, other NSAIDs, and cardiovascular risk: the seduction of common sense

JAMA

Narrative review: the promotion of gabapentin; an analysis of internal industry documents

Ann Intern Med

Professional integrity in industry-sponsored clinical trials

Acad Med

Impugning the integrity of medical science: the adverse effects of industry influence

JAMA

Patient's attitudes about gifts to physicians from pharmaceutical companies

J Am Board Fam Pract

The FDA and the case of Ketek

N Engl J Med

Our daily meds

Failing the public health: rofecoxib, Merck, and the FDA

N Engl J Med

Korean cloning studies were fakes

BMJ

Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials

Can Med Assoc J

VNS therapy in treatment-resistant depression: clinical and putative neurobiological mechanisms

Neuropsychopharmacology

The undisclosed background of a paper on a depression treatment

Science

Commentary
Transparency in Health Care
The Role of Conflict of Interest in Reporting of Scientific Information