Author Interviews, Diabetes, Race/Ethnic Diversity / 29.06.2021

MedicalResearch.com Interview with: Mary de Groot, Ph.D. Associate Professor Immediate Past President, Health Care and Education, American Diabetes Association Acting Director, Diabetes Translational Research Center Indianapolis, IN 46202  MedicalResearch.com: What is the background for this study? Response: The experience of quarantine in the context of epidemics has been shown to have significant emotional effects including depression, anxiety, shock, and trauma that not only effect people in the context of quarantine, but up to 2-3 years beyond the end of the quarantine period (Brooks et al., 2020).  The COVID-19 pandemic has had extraordinary impacts on health and mental health in the general population across the globe including increased rates of depression and anxiety compared to pre-pandemic levels (Xiong, 2020; Wilson, 2020; Luo, 2020). There is some early evidence that the pandemic adversely affected people with diabetes as well (Fisher, 2020; Alessi, 2020). It is important to explore the emotional impact of the COVID-19 pandemic for people with diabetes given the particular risk factor that diabetes (along with other metabolic diseases) represents for mortality if the virus is acquired. We conducted a longitudinal web-based survey of N=2210 adults with and without diabetes to assess the emotional correlates of COVID-19 in terms of depression, diabetes distress, perceived stress and anxiety.  We present the baseline (measured in May/June of 2020) and 6-month follow up (measured in November/December 2020) findings. (more…)
Author Interviews, Dermatology, FDA / 06.06.2019

MedicalResearch.com Interview with: Stephanie L. Kuschel, MD Indiana University School of Medicine Indianapolis, IN, 46202 Robert Dellavalle, MD, PhD, MSPH Professor of Dermatology and Public Health University of Colorado School of Medicine Colorado School of Public Health Chief, Dermatology Service US Department of Veterans Affairs Eastern Colorado Health Care System Denver, CO 80220  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Physicians can serve as external experts and voting members of FDA advisory committee panels, which help determine if a drug is acceptable for the US market. Considering that financial conflicts of interest (FCOI) have been shown to influence voting member habits, the FDA has regulations in place to minimize these FCOI. However, the FDA can grant waivers for some financially conflicted individuals if they meet certain requirements (like offering key insights that may out-weigh the risk of a possible FCOI). Additionally the FDA does not make stipulations regarding post-advisory role financial relationships. In fact, many former FDA committee advisors later engage in financial relationships with pharmaceutical companies. Some worry these post-hoc financial relationships could pose an ethical dilemma whereby future FDA advisory members are incentivized to alter their voting habits in expectation of future rewards. Others argue the situation may be more complex than expected. For example, the author of one study, found that while there was evidence for a pro-industry voting bias among committee members with exclusive financial relationships to the sponsoring manufacturer (of the drug under review), this was not the case for members with nonexclusive financial ties to both the sponsor and its competitors 1. Furthermore, the author found that advisors with many corporate ties were (on average) actually more likely than their peers without any financial ties to vote against the sponsor. The author argued that these advisors were more likely to be experienced researchers, and their voting habits may reflect their experience evaluating medical research. While this author and others have offered valuable insights into financial relationships of advisors during their advisory role, unfortunately little information is available regarding post-advisory role financial relationships and whether these relationship have any influence on the integrity of the voting process. The purpose of our study was to review Open Payment data on industry payments to former physician FDA dermatologic drug committee members.  (more…)