Fraud and Deceit in Medical Research

Abstract

Photo by Agni B on Unsplash ABSTRACT The number of scientific articles published per year has been steadily increasing; so have the instances of misconduct in medical research. While increasing scientific knowledge is beneficial, it is imperative that research be authentic and bias-free. This article explores why fraud and other misconduct occur, presents the consequences of the phenomenon, and proposes measures to eliminate unethical practices in medical research. The main reason scientists engage in unethical practices is the pressure to publish which is directly related to their academic advancement and career development. Additional factors include the pressure to get research funds, the pressure from funding sources on researchers to deliver results, how scientific publishing has evolved over the years, and the over-publication of research in general. Fraud in medical research damages trust and reliability in science and potentially harms individuals. INTRODUCTION Since the introduction of Evidence-Based Medicine (EBM) in the early 1990s, scientific articles published per year have increased steadily. No one knows the exact number of scientific articles published per year, but several estimates point to around 2,000,000.[1] EBM aims to integrate the clinical experience and the best available scientific knowledge in managing individual patients.[2] The EBM model is based on the accumulation of as much clinical and research data as possible, which has propelled a significant rise in research. Unfortunately, its incentive structure has also led to a rise in research misconduct. “Fraud in science has a long history.”[3] Cases of misconduct began to surface in the late 1980s and increased during the 1990s. Experts suggest that today fraud is “endemic in many scientific disciplines and in most countries.”[4] In recent reporting, the majority of cases of scientific fraud involved falsification and fabrication of the data, while plagiarism was much less frequent. 8 percent of scientists and 10 percent of medical and life-sciences researchers admitted to falsifying data at least once between 2017 and 2021 in a Dutch study of 6,813 researchers, while more than half engaged in at least one questionable research practice.[5] Questionable research practices include research design flaws or unfairness in decisions surrounding publication or grants.[6] In an older study, closer to 2 percent of those surveyed reported having engaged in falsification or fabrication,[7] while in a more recent survey of 3,000 scientists with NIH grants in the United States, 0.3 percent of the scientists responding admitted fabricating research data and 1.4 percent of them admitted plagiarizing.[8] These numbers are almost certainly not reflective of the true incidence of fraud as many scientists admitted that they engaged in a range of behaviors beyond fabrication, falsification, and plagiarism that undermine the integrity of science, such as changing the results of a study under pressure from a funding source or failing to present data that contradicts one’s previous research. It is also unclear whether surveys are the best method to investigate misconduct because a scientist answering the survey may be unsure of anonymity and may not be truthful. This article explores why misconduct occurs, presents the consequences, and proposes measures to eliminate unethical practices in medical research. In the 1999 Joint Consensus Conference on Misconduct in Biomedical Research, “scientific fraud” was defined as any “behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards.”[9] ANALYSIS l. The Scientific Publishing Landscape There are several reasons scientists may commit misconduct and engage in unethical practices. There is an increasing pressure to publish, which the motto "publish or perish reflects.”[10] The number of scientific papers published by a researcher is directly related to their academic advancement and career development. Similarly, academic institutions rely on scientific publications to gain prestige and access research grants. Pressure to get research grants may create environments that make it challenging to research integrity. Researchers are often tempted to alter their data to fulfill the desired results, separately report the results of one research in multiple end publications, commonly referred to as “salami publication,” or even simultaneously submit their scientific articles to more than one journal. This creates a vicious cycle in which the need for funding leads to scientific misconduct, which in turn secures more research funding. Meanwhile, the pressure from the funding sources cannot be overlooked either. Although researchers must report the role of the funding sources, selection and publication bias often may advantage articles that support the interests of the financial sponsor. Disclosure does not alter the conflict of interest. The growing number of scientific articles published per year has practically overwhelmed the peer-review system. Manuscript submissions are often reviewed superficially or assigned to inexperienced reviewers; therefore, misconduct cases may go unnoticed. The rise of “predatory” journals that charge authors publication fees and do not review work for authenticity and the dissemination of information through preprints has worsened the situation. The way that profits influence scientific publishing has very likely contributed to the phenomenon of misconduct. The publishing industry is a highly profitable business.[11] The increased reliance on funding from sources that expect the research to appear in prestigious, open-access journals often creates conflicts of interest and funding bias. On the other hand, high-impact journals have not given space to navigate through negative results and previous failures. Nonsignificant findings commonly remain unpublished, a phenomenon known as “the file drawer problem.” Scientists often manipulate their data to fit their initial hypothesis or change their hypothesis to fit their results, leading to outcome-reporting bias. ll. Misconduct Concerning the Reporting and Publishing Data The types of misconduct vary and have different implications for the scientist’s career and those relying on the research. For example, plagiarism is generally not punished by law currently unless it violates the original author’s copyright. Nevertheless, publishers who detect plagiarism implement penalties such as rejection of the submitted article and expulsion of the author. While plagiarism can be either accidental or deliberate, in either case, it is a serious violation of academic integrity as it involves passing off someone else’s “work or ideas” as one’s own.[12] Plagiarism can be “verbatim” (copying sentences or paragraphs from previously published work without using quotation marks or referencing the source) or rephrasing someone’s work or ideas without citing them. In “mosaic” plagiarism, the work plagiarized comes from various sources. “Self-plagiarism” is defined as an author’s reproduction of their previous publications or ideas in the same or altered words. According to most scientific journals, all authors of an article in part must have contributed to the conception and design of the study, drafted the article, revised it critically, or approved of its final version.[13] The use of a ghost author (usually a professional writer who is not named an author) is generally not ethical, as it undermines the requirement that the listed authors created the article. Moreover, wasteful publication is another practice that contributes to misconduct. Wasteful publication includes dividing the results of one single study into multiple end publications (“salami slicing”), republishing the same results in one or more articles, or extending a previously published article by adding new data without reaching new conclusions. Wasteful publication not only skews the scientific databases, but also wastes the time of the readers, the editors, and the reviewers. It is considered unethical because it unreasonably increases the authors’ citation records. Authors caught engaging in such behaviors may be banned from submitting articles for years while the submitted article is automatically rejected. Wasteful publication is an example of how the pressure to publish more articles leads to dishonest behavior, making it look like a researcher has conducted more studies and has more experience. Conflicts of interest are not strictly prohibited in medicine but require disclosure. Although disclosure of financial interests is a critical step, it does not guarantee the absence of bias. Researchers with financial ties to a pharmaceutical company funding their research are more likely to report results that favor the sponsor, which eventually undermines the integrity of research.[14] Financial sponsors should not be allowed to influence publication; rather authors need to publish their results based on their own decisions and findings. lll. Misconduct in Carrying Out Scientific Research Studies Common forms of fabrication include concealing negative results, changing the results to fit the initial hypothesis or selective reporting of the outcomes. Falsification is the manipulation of experimental data that leads to inaccurate presentation of the research results. Falsified data includes deliberately manipulating images, omitting, or adding data points, and removing outliers in a dataset for the sake of manipulating the outcome. In contrast to plagiarism, this type of misconduct is very difficult to detect. Scientists who fabricate or falsify their data may be banned from receiving funding grants or terminated from their institutions. Falsification and fabrication are dangerous to the public as they can result in people giving and receiving incorrect medical advice. Relying on falsified data can lead to death or injury or lead patien