Author Interviews, Heart Disease, Race/Ethnic Diversity / 28.02.2023

MedicalResearch.com Interview with: Dr. Muchi Ditah Chobufo MD MPH Cardiology Fellow West Virginia University MedicalResearch.com: What is the background for this study? Response: Ischemic heart diseases are a significant cause of morbidity and mortality in the USA. Also, there exists alarming ethnic disparities in mortality rates following acute myocardial infarction. To this effect, significant efforts have been deployed over the years to curb its burden and reduce extant disparities. It is in this light that we set out to analyze general and ethnic specific trends in acute myocardial infarction related age adjusted mortality rates (AAMR) in the entire USA from 1999-2020.  (more…)
Author Interviews, COVID -19 Coronavirus, Nature, OBGYNE, Pediatrics / 28.02.2023

MedicalResearch.com Interview with: Dr Jessica Miller, PhD Murdoch Children’s Researcher and Professor David Burgner, Murdoch Children’s Group Leader, Infection and Immunity Murdoch Children’s Research Institute Royal Children's Hospital Victoria Australia   MedicalResearch.com: What is the background for this study? Response: Early reports following the initial COVID-19 lockdowns showed huge variation in changes to preterm birth and stillbirth rates, deeming it difficult to understand the pattern worldwide. It was uncertain if the observed variations were due to differences in study design and methodology, immediate impacts of lockdowns or changes in health service utilization. Previous reports from single populations or facilities were unlikely to be representative of the population and could not be compared across populations. Lockdowns affected health, social and economic factors that could lead to reductions in preterm birth rates. Changes in hygiene practices and abruptions to traffic following lockdown led to alterations in non-COVID infections and air pollution, which are known to trigger inflammation and contribute to preterm birth. Given the uncertainty in the earlier reports, we aimed to conduct a rigorous, standardised analysis using high-quality, total-population data from across the world in order to summarize and compare rates across countries. Our large global study included 52 million births between 2015-2020 from 26 countries and represents one of the first large-scale analyses of birth outcomes during the early months of COVID-19. (more…)
Author Interviews / 09.07.2021

MedicalResearch.com Interview with: David Strauss, MD, PhD Director, Division of Applied Regulatory Science David Keire, PhD Director, Office of Testing and Research U.S. Food and Drug Administration Center for Drug Evaluation and Research  MedicalResearch.com: What is the background for this study? Response: In 2019, the US Food and Drug Administration (FDA) received a citizen petition indicating that ranitidine, a widely used prescription and over-the-counter drug, contained the probable human carcinogen N-nitrosodimethylamine (NDMA). In addition, the petitioner proposed that ranitidine could convert to NDMA in humans; however, this was based on a small clinical study with limitations and an in vitro study that included high level of supplemental nitrite. In response, the FDA immediately alerted the public and began an investigation. The FDA’s initial research found that the procedures previously used to quantify NDMA were not appropriate for assessing its presence in ranitidine, owing to the use of high temperatures that could convert ranitidine to NDMA during that analysis. New lower-temperature analytical methods found that the amounts of NDMA contained in ranitidine products were 3,000-fold lower than those reported in the citizen petition; however, these lower amounts of NDMA were still above the FDA-acceptable level and could increase over time, prompting the FDA to request the market withdrawal of ranitidine products. The FDA noted, however, that if ranitidine products could be manufactured to control NDMA amounts, they could be allowed back on the market—but additional information would first be needed to understand whether NDMA could form in vivo from ranitidine in humans. (more…)