Disclosure Of Financial Conflicts Research Articles

Demanding Truth is not a Witch-Hunt

Started with the recent turmoil in the White House, the author further collected some examples of failure of disclosure of financial conflicts of interests between drug companies and researchers that lead to scandals and their aftermath. The author concluded that both politicians and researchers should hold high morality as to gain trust to people. The solution is to actively and voluntarily disclose any potential conflicts of interest in advance rather than impose strict regulations, as the latter may have some opposite effects.

A new method for scoring financial conflicts of interest.

There is a large and consistent body of evidence showing that research sponsored by for-profit industries tends to have pro-industry conclusions in comparison with similar research or re-analyses not funded by industry. Disclosure of financial conflicts via statements is presently the standard method for notification of potential biases. However, many journals are not consistent in publishing financial conflicts of interest (FCoI) statements. Furthermore, even when divulged, disclosure merely shifts the burden of evaluating conflicts to readers and the general public. Moreover, there has been an absence of a means of quantifying FCoI. To propose a solution for the question: What are we doing about FCoI that continue to compromise the integrity of the scientific enterprise? The FCoI Scale was developed for scoring and comparing FCoI and describing potential biases. The FCoI Scale consists of a score that may be expressed in whole numbers and decimal fractions, correlated to descriptive terms for potential biases and examples of financial conflicts at 11 levels. The FCoI score (FCoIS) provides a means for a more uniform and concise method of disclosure compared to statements, while at the same time permitting flexibility. It encourages the disclosure of relevant information and transparency in the reporting of financial conflicts. The FCoI Scale has the potential to become the standard basis for measuring, reporting, and comparing financial conflicts, suitable for disciplines in science, medicine, and beyond.

Conflict of Interest Disclosure in Early Education of Medical Students

MEDICAL EDUCATION HAS EMBRACED THE transparency movement by shining the light of disclosure on physician-industry interactions. Many medical journals mandate that authors report potential conflicts of interest and publish detailed financial relationship lists with their articles. Likewise, the Accreditation Council for Continuing Medical Education requires disclosure of lecturers’ conflicts before lectures qualifying for continuing medical education (CME) credits. Despite these changes in physician education, disclosure norms have not yet trickled down to the very start of medical education—the preclinical years. Are firstand second-year students justified in expecting conflicts of interest disclosure in their education? The clinicians and researchers who lead preclinical medical education at US medical schools are usually drawn from affiliated medical centers and therefore are likely to have financial ties to industry. In the context of physician education, financial relationships to the subject matter have been shown to induce selective presentation of data or biased interpretations. Nonetheless, the typical rationales for conflict of interest disclosure do not apply in the context of preclinical education. The ultimate justification for disclosure is that biased statements can influence the care patients receive. Because medical students do not prescribe medications and have little patient care responsibility, there is less direct potential for harm. In addition, the first 2 years of medical education are largely spent studying basic biological sciences and pathophysiology. In the context of a CME event, it is easy to see how a speaker’s financial relationship to a specific pharmaceutical company could be relevant to the therapeutic recommendations, such as the best choice for treatment-refractory depression. In an analogous lecture to medical students on the neurobiochemical basis for depression, the mention of specific therapies may only serve as examples to illustrate the underlying scientific concepts. However, these perspectives miss the essential role that disclosure can have in early medical education. For example, as students learn details about anatomy and physiology, they also are beginning to construct a framework for analysis of data and application of data to clinical reasoning they will use as practicing physicians. In this light, a policy that requires disclosure of financial conflicts of interest before the start of any lecture would serve as a powerful reminder to a medical student audience about the potential for bias in the presentation of scientific information and therefore the need to be critical evaluators of the material being taught. Such lessons will be particularly useful when these students later need to weigh the risks and benefits of a new, heavily promoted therapeutic product or analyze the design of clinical trials that led to treatment recommendations. Promoting critical thinking in medical professionals may be easier to accomplish at a time when students’ clinical reasoning skills are just beginning to be developed than trying to create this skill after the students graduate, enter residency training, and subsequently practice. The mere existence of a disclosure policy can also affect students’ professional development. In addition to lessons in the formal curriculum, students are deeply influenced by the behavior of role models, institutional policies, or other characteristics of the learning environment cumulatively known as the “hidden curriculum.” Most students do not enter medical school having reflected on the scope and influence of interactions between physicians and the pharmaceutical and medical device industries; however, the acculturation process can occur rapidly. For example, surveys reveal that students further along in training have more positive attitudes regarding issues such as the appropriateness of accepting gifts from pharmaceutical representatives. The existence of a disclosure policy would communicate that an institution values the integrity of medical education. The practice of disclosure also provides a stimulus for students to begin dialogues with peers and advisers and consider their own ethical views on the controversial topic of

An analysis of studies on piezoelectric surgery in the oral and craniomaxillofacial region with regard to human subject protection and financial conflicts

This retrospective, observational study investigated whether published studies on the use of piezoelectric surgery (PS) in the oral and craniomaxillofacial region fulfilled the requirements of the International Committee of Medical Journal Editors (ICMJE) and the Declaration of Helsinki (DoH) with respect to human subject protections (HSP) and disclosure of financial conflicts (FC). A Medline/PUBMED search was performed in April 2008 to identify all clinical studies on PS, published in English, French and German. Disclosure of HSP (obtaining ethical approval and subjects' informed consent) and FC mentioned in the retrieved articles were analysed. 29 clinical articles were identified in 18 journals, of which 14 journals (78%) required the disclosure of both HSP and FC. Ethical approval was documented in two studies (7%); patient consent was reported in four publications (14%). Four articles disclosed no FC. 21 reports (72%) mentioned neither HSP nor FC. The relationships between funding source and study outcomes could not be identified. Most studies on the use of PS hardly adhered to the regulations recommended by the ICMJE and DoH, and do not mention HSP and FC, indicating the study results with a high degree of suspicion. It is recommended that oral and craniomaxillofacial surgery journals adhere strictly to these regulations because they carry a heavy responsibility regarding the scientific integrity of publications in this specialty.

Bias in research and conflict of interest: why should we care?

s and papers presenting data from trials that are controlled and analysed by industry or contractors should not be accepted for presentation or publication in our journals and at our conferences due to the potential for bias, as outlined in recent WAME18 and ICMJE19 guidelines. Drug trials should be funded publicly9. Ghost-writing of research papers or inappropriately claiming authorship for ghost-written papers should be outlawed and be made subject to significant sanctions, e.g. expulsion from scientific societies or public blacklisting of ‘authors’. Meta-analyses and Cochrane reviews ought to be limited to publicly funded trials, with all industrycontrolled data excluded as a matter of course. In order for us to be able to gauge the potential for bias, IUGJ and other journals in our field should require full and detailed disclosure of financial conflict of interest from editors, referees and authors. The discussion surrounding financial conflict of interest is very likely to seriously affect individuals and professional associations. However, there is no way to avoid the issue. We will have to act soon to help restore the badly battered public confidence in clinical research. To quote a recent JAMA Editorial30: “The need for transparency in reporting the financial conflicts of interest of authors and the relationships between investigators and funding sources has never been greater and is essential to help maintain confidence and trust in the scientific integrity of medical research articles.” The simple fact that you’re reading this probably means it’s