Annals Internal Medicine, Author Interviews, Cannabis, Yale / 19.03.2020 Interview with: Joshua D. Wallach, MS, PhD Assistant Professor of Epidemiology (Environmental Health Sciences) Yale School of Public Health New Haven, CT What is the background for this study? Response: Over the past few years, there has been growing interest in the potential health benefits of cannabidiol (CBD), a chemical compound in cannabis. Although only one CBD-derived prescription drug has been approved by the US Food and Drug Administration (FDA) for the treatment of epilepsy, I recently started seeing products containing CBD advertised and sold across the US (e.g. CBD in foods, beverages, dietary supplements, and cosmetics). I noticed that many of these products were being marketed with unproven claims to prevent, cure, and treat various conditions, and became interested in learning more about the research supporting the use of CBD, the potential for misleading claims, and impact that the CBD-industry may be having on research that is being generated and disseminated to the public. Research funding sources and other author conflicts of interests (e.g. consulting fees, honoraria, travel expenses) can influence the way that research is designed, conducted, and reported. Previous studies have consistently demonstrated associations between authors' conflicts of interest and proindustry conclusions in clinical research. Given the growing number of companies invested in CBD's commercial success, we decided to analyze the disclosed funding sources, conflicts of interest statements, author employment details, and CBD-related conclusions in a large sample of published articles on the characteristics, use, and therapeutic effects of cannabidiol. (more…)
Author Interviews, Dartmouth, JAMA, Pharmaceutical Companies, Primary Care / 27.01.2020 Interview with: Steven Woloshin, MD, MS Professor of Medicine and Community and Family Medicine Professor, The Dartmouth Institute for Health Policy and Clinical Practice What is the background for this study? Response: Industry spends more on detailing visits and free samples than any other form of prescription drug marketing.  There is good evidence that these activities can lead to more use of expensive new drugs over equally effective cheaper options.  Given these concerns there have been efforts by some hospitalls and practices to restrict these forms of marketing. We asked physicians in group practices delivering primary care about how often pharmaceutical reps visit their practice and whether they have a free sample closet.  (more…)
Author Interviews, Education / 23.01.2020 Interview with: Brian Piper PhD Department of Medical Education Geisinger Commonwealth School of Medicine Center for Pharmacy Innovation & Outcomes Geisinger Precision Health Center What is the background for this study? Response: Disclosure of funding sources is standard practice for journal articles and clinical practice guidelines in order to alert readers to potential conflicts of interest (CoI). However, CoI disclosure is uncommon for textbooks. A new edition of Goodman and Gilman’s Pharmacological Basis of Therapeutics (GG-PBT) was recently published. This is affectionately known as “the blue bible of pharmacology” because it is widely used in the training of doctors, pharmacists, dentists, scientists, and nurses. This provided an opportunity to extend upon past research2,3 and determine whether the authors and editors had undisclosed CoIs. (more…)
Author Interviews, Cost of Health Care, JAMA / 30.10.2018 Interview with: Samir C. Grover MD, MEd, FRCPC Division of Gastroenterology Program Director Division of Gastroenterology Education Program University of Toronto What is the background for this study? What are the main findings? Response: We know that physician-industry interactions are commonplace. Because of this, there has been a movement to make the presence of these relationships more transparent. For clinical practice guidelines, this is especially important as these documents are meant to be objectively created, evidence based, and intended to guide clinical practice. The standard in the US come from the National Academy of Medicine report, "Clinical Practice Guidelines We Can Trust", which suggests that guideline chairs should be free of conflicts of interest, less than half of the guideline committee should have conflicts, and that guideline panel members should declare conflicts transparently. Other studies, however, have shown that some guidelines don't adhere to this advice and have committee members who don't disclose all conflicts. We thought to look at this topic among medications that generate the most revenue, hypothesizing that undeclared conflicts would be especially prevalent in this setting. We found that, among 18 guidelines from 10 high revenue medications written by 160 authors, more than (57%) had a financial conflict of interest, meaning they received payments from pharmaceutical companies that make or market medications recommended in that guideline. About a quarter of authors also received, and didn't disclose payments from one of these companies. Almost all the guidelines did not adhere to National Academy of Medicine standards. (more…)
Author Interviews, Education, Pharmaceutical Companies / 01.08.2018 Interview with: Brian J. Piper, PhD, MS Department of Basic Sciences Geisinger Commonwealth School of Medicine Scranton, PA 18509 What is the background for this study? Response: The authors of this study are biomedical scientists, health care providers and educators who teach medical and pharmacy students. It is a standard practice in reputable medical journals like the New England Journal of Medicine to disclose conflicts of interest (CoI). Reputable sources like the Cochrane Library also disclose CoIs and analyze for their potential impact on the evidence base. Unfortunately, textbooks, which can be highly influential in the training of medical professionals, usually do not disclose their conflicts of interest. A prior study in this quantitative bioethics area found that more than one-quarter of a team-authored pharmacology textbook, Goodman and Gilman’s Pharmacological Basis of Therapeutics, had an undisclosed patent (PLoS One, 2015; 10: e0133261).  The goal of this investigation was to determine whether there were undisclosed CoIs in textbooks used in the training and as a reference for allopathic physicians, osteopathic physicians, dentists, pharmacists, nurses and other allied healthcare providers.  (more…)
Author Interviews, BMJ / 19.01.2017 Interview with: Salomeh Keyhani MD Associate professor of general internal medicine San Francisco VA Medical Center and University of California San Francisco, CA 94121, USA What is the background for this study? What are the main findings? Response: Randomized controlled trials are the foundation of the evidence base. We examined the prevalence of financial ties in randomized controlled trials and also examined the relationship of financial ties of principal investigators (PI) with trial outcome. We defined a financial tie as the direct compensation (e.g., consulting fees) of a PI by the drug manufacturer of interest. Although there have been past studies that have examined this relationship, many did not separate financial ties from funding source for the trial and many were focused on one specialty, journal, or type of drug. This study identified a random sample of RCTs published in 2013 that were focused on assessing drug efficacy. Both the disclosure section of the paper and several online databases (Medline, Google, Propublica’s Dollars for Doctors, and the US Patent Office) were searched for evidence of financial ties. Principal investigators financial ties with industry were independently associated with positive study outcomes. (more…)
Author Interviews, Outcomes & Safety / 11.03.2015

Stephen Gallo, Ph.D. Technical Operations Manager American Institute of Biological Sciences Scientific Peer Advisory and Review Services Reston, VA Interview with: Stephen Gallo, Ph.D. Technical Operations Manager American Institute of Biological Sciences Scientific Peer Advisory and Review Services Reston, VA  20191 Medical Research: What is the background for this study? What are the main findings? Dr. Gallo: Peer review is an evaluation process widely used to help research funders identify the best projects to support. A cornerstone of the process is the independence and integrity of the review panel, which includes a fair and non-conflicted evaluation of the proposed research. Despite the importance of the process, there are few research studies  investigating the frequency and type of conflicts that occur, particularly with regard to the independent peer review of basic science research proposals. To improve our understanding of conflict of interest in the peer review process, the American Institute of Biological Sciences (AIBS) conducted a retrospective analysis of conflict of interest data from the independent peer review of 282 biomedical research applications. The overall ‘conflicted-ness’ of these panels was significantly lower than that reported for regulatory review panels, which have been studied by others. This might be explained by the fact that no direct financial conflicts were identified; the majority of identified conflicts were institutional or collaborative in nature. The analysis revealed that 35 percent of conflicts were self-reported by review panel members. Importantly, peer review panel managers identified 65 percent of conflicts. These results underscore the important role administrators who organize review panels play in identifying conflicts of interest. (more…)