Author Interviews, Environmental Risks, JAMA, Smoking / 17.09.2019

MedicalResearch.com Interview with: Sairam Jabba, Ph.D Senior Research Associate Department of Anesthesiology Duke University Durham, NC 27710 MedicalResearch.com: What is the background for this study? Response: Pulegone is a potential carcinogen contained in several mint oils. Due to its carcinogenic properties, FDA banned pulegone last year as a food additive. Previous chemical analytical studies from CDC have demonstrated that several mint/menthol-flavored e-cigarette liquids and snuff tobacco products contain pulegone in significant amounts. FDA currently does not regulate pulegone in e-cigarettes and snuff products and the health risk associated with it for the users is not well understood.  (more…)
Annals Internal Medicine, Author Interviews, Environmental Risks, Gastrointestinal Disease / 14.09.2019

MedicalResearch.com Interview with: Philipp Schwabl, MD Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna Vienna, Austria MedicalResearch.com: What is the background for this study? Response: There is a lot of research published about microplastics being present in the ocean and subsequently also being found in the gut of sea animals, however there were no investigations if also humans involunterily ingest microplastics. This gave us rationale to perform a pilot study. (more…)
Author Interviews, Dermatology, Environmental Risks / 28.08.2019

MedicalResearch.com Interview with: Guy German PhD Associate Professor Director of Graduate Studies Department of Biomedical Engineering Binghamton University Binghamton, NY 13902  MedicalResearch.com: What is the background for this study? Response: Photoageing from the sun is widely known to occur. The most obvious result of it is early onset of wrinkles. However we are trying to understand if solar light can degrade the mechanical integrity of human skin. Moreover, while solar ultraviolet (UV) light is considered to have the most damaging effect on the skin, the UV range that is most harmful remains a topic of significant debate. This research studies how different UV ranges and dosages impacts the mechanical integrity of the outermost layer of skin, called the stratum corneum. This tissue layer sits above the layers of melanin in skin, the pigment responsible for tanning. When stratum corneum ruptures, it stops working as a barrier to the outside world and can increase the risk of infections. (more…)
Author Interviews, Environmental Risks, Global Health / 22.08.2019

MedicalResearch.com Interview with: Cong Liu, PhD Department of Environmental Health School of Public Health Fudan University Shanghai 200032, China MedicalResearch.com: What is the background for this study? Response: Numerous time-series studies have examined the short-term associations between particulate air pollution (PM10 and PM2.5) exposures and daily mortality. However, most evidence has been obtained from studies in single cities, regions, or countries. There are challenges in comparing these results and in synthesizing effect estimates because of different modeling approaches and potential publication bias. Furthermore, there has never been a global representative concentration-response function for risk assessment and policy making. We and our co-authors established the Multi-City Multi-Country (MCC) Collaborative Research Network to perform a global assessment of the effects of weather or climate on mortality. This network allowed us to examine and compare the associations of PM concentrations with daily mortality at the global, regional, and country level with the use of a standardized analytic framework. (more…)
Author Interviews, BMJ, Environmental Risks, Ophthalmology / 21.08.2019

MedicalResearch.com Interview with: Professor Suh-Hang Hank Ju, PhD Kaohsiung Medical University Taiwan MedicalResearch.com: What is the background for this study? Response: Nitrogen dioxide (NO2) and carbon monoxide (CO) are 2 major traffic pollutants, which have been shown to increase a risk for respiratory and cardiovascular diseases. We previously showed that chronic exposure of NO2 is also associated with dementia. age-related macula degeneration (AMD) is a leading cause of blindness. Given the increase of traffic pollutants in many urbanized cities, we investigated whether these two traffic pollutants are associated with the development of age-related macula degeneration in Taiwan. (more…)
Author Interviews, Environmental Risks, JAMA, NIH, Pulmonary Disease / 13.08.2019

MedicalResearch.com Interview with: Joel Kaufman, MD, MPH, Professor   Environmental & Occupational Health Sciences, Medicine, and Epidemiology University of Washington  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Increasingly, it is recognized that chronic lung diseases like emphysema occur in nonsmokers and rates of these diseases are continuing to increase.  We really need to understand what’s causing chronic lung disease. Air pollutants are known to make disease worse in people with prior lung disease, but little is known about whether long-term exposure to air pollutants can cause chronic lung disease. We found that higher residential concentrations of air pollutants—especially ozone and traffic-related air pollutants—are associated with changes in the lung—emphysema-like changes in the lung.  The associations were strong and suggest that air pollution may be an important contributor to chronic lung disease.  (more…)
Author Interviews, Environmental Risks, NYU, Pediatrics, Weight Research / 26.07.2019

MedicalResearch.com Interview with: Melanie Jacobson, PhD, MPH NYU School of Medicine New York, N.Y.  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study was about exposure to bisphenols, which are synthetic chemicals found in aluminum can linings, plastics, thermal paper receipts and other consumer products, and their association with obesity among a nationally representative sample of US children and adolescents. We found that children who had greater levels of these chemicals in their urine were more likely to be obese compared with children with lower levels. (more…)
Author Interviews, Environmental Risks / 26.07.2019

MedicalResearch.com Interview with: Patricia Pendry Ph.D. Associate Professor of Human Development Graduate Faculty in Prevention Science Washington State University CAHNRS Pullman, WA 99164  MedicalResearch.com: What is the background for this study? Response: Over the last decade, university students have reported increasingly high levels of academic stress, depressive symptomology, anxiety, and suicidal ideation. This is a serious problem as students who report these symptoms tend to have lower GPAs and are more likely to drop out of college. Since academic stress is considered an inevitable part of college life, it is important that we identify effective academic stress management programs. One stress management approach that has been enthusiastically received by University administrators and students is the use of campus-based Animal Visitation Programs (AVPs). Established in nearly 1,000 U.S. college campuses to date, most AVPs provide the general student population the opportunity to engage in 5-30 minutes of petting of animals in small-group settings. While students much enjoy these types of programs, relatively little sound scientific evidence is known about the efficacy of such programs to actually reduce stress. We thus embarked on a study that experimentally teased out the effects of hands-on interaction from the effects of waiting in line while watching others engage in hands-on interactions, sitting quietly without social media or other stimuli, or watching pictures of the same animals on students’ level of salivary cortisol, a stress hormone that has been linked to various physical and mental health outcomes. (more…)
Author Interviews, CDC, Environmental Risks, Infections / 02.07.2019

MedicalResearch.com Interview with: Radhika Gharpure MPH DVM Epidemic Intelligence Service Officer CDC MedicalResearch.com: What is the background for this report? Would you tell us about cryptosporidiosis infections?  Where is is found? How is it transmitted? Response: The data from our most recent report looked at outbreaks caused by Cryptosporidium (Crypto) in the United States during 2009 – 2017. Outbreaks have increased an average of 13% each year. Crypto, a parasite, is spread through the poop of infected humans or animals. People can get sick after they swallow the parasite in contaminated water or food or after contact with infected people or animals. Crypto is the leading cause of disease outbreaks in the United States linked to water, specifically outbreaks linked to pools or water playgrounds. (more…)
Alcohol, Author Interviews, Environmental Risks / 02.07.2019

MedicalResearch.com Interview with: alcohol, bottles, Dr Andrew Turner, PhD Associate Professor (Reader) in Environmental Sciences School of Geography, Earth and Environmental Sciences MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This study was part of a wider study to look at potentially toxic metals in everyday household and consumer products. The main findings here are that many enameled bottles, mainly used to store alcoholic beverages, contain very high levels of cadmium and lead in the décor.   (more…)
Author Interviews, Environmental Risks, Genetic Research, Prostate Cancer / 20.06.2019

MedicalResearch.com Interview with: Emanuela Taioli, MD, PhD, Director of the Institute for Translational Epidemiology Icahn School of Medicine at Mount Sinai Asociate director for Population Science Tisch Cancer Institute  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: An excess incidence of prostate cancer has been identified among World Trade Center responders. We wanted to study if this excess was associated with exposure to WTC dust The results suggest that respiratory exposure to WTC dust can induce inflammatory and immune responses in prostate tissue. Chronic inflammation could facilitate prostate cancer development Taken together, our results suggest that World Trade Center prostate cancer cases have a distinct gene expression pattern that may be the result of exposure to specific carcinogens during the WTC attacks. WTC dust-exposed rat prostate displayed unique changes in gene expression and immune cell infiltrates after acute dust exposure, suggesting that the effect of exposure may be measured locally in target organs such as prostate. In addition, some of the genes overexpressed in rat normal prostates as a consequence of exposure are also overexpressed in human prostate cancer tissues, suggesting a link between exposure, local immune dysregulation, and prostate cancer development (more…)
Author Interviews, Environmental Risks, JAMA, Weight Research / 12.06.2019

MedicalResearch.com Interview with: Lead author: Yong-Moon (“Mark”) Park, MD, PhD Postdoctoral fellow Epidemiology Branch National Institute of Environmental Health Sciences   Senior author: Dale P. Sandler, PhD Chief, Epidemiology Branch, National Institute of Environmental Health Sciences National Institutes of Health MedicalResearch.com: What is the background for this study?   Response: A few studies had suggested that exposure to artificial light while sleeping was associated with obesity. However, the previous studies were cross-sectional, so we really do not know which came first - exposure to artificial light while sleeping or obesity. Another problem was that previous studies did not fully account for other characteristics that could affect this association, such as sleep duration and quality, calorie intake and dietary patterns, and physical activity. We studied nearly 44,000 women ages 35-74 from across the US who are enrolled in the Sister Study cohort. Women had body weight characteristics measured at baseline and provided self-reported information on weight at baseline and follow-up – on average 5.7 years later. (more…)
Author Interviews, Environmental Risks, Nutrition, Race/Ethnic Diversity / 04.06.2019

MedicalResearch.com Interview with: Joe F. Bozeman III, MS, CEM, Ph.D. Candidate Chair, Gordon Research Seminar (Industrial Ecology) University of Illinois at Chicago (UIC) Institute for Environmental Science and Policy MedicalResearch.com: What is the background for this study?   Response: This study is actually a part of my dissertation which explores how climate change, human health, and other socioecological factors can be used to manage food-energy-water impacts. After establishing environmental impact and climate change adaptation implications of food consumption across major U.S. demographic groups in a previous study, my colleagues and I decided it would be interesting to investigate how food spending and household income correlate with food-consumption environmental impacts. Our efforts led to the development of a novel quantitative metric (i.e., food-consumption impact per dollar spent [FCI$]) which encompasses land, water, and greenhouse gas emission impacts of basic foods; the amount spent on food; and socioeconomic status. All major food groups are included in this study. (more…)
Author Interviews, Cancer Research, Environmental Risks, University Texas, Urology / 08.05.2019

MedicalResearch.com Interview with: Stephen B. Williams, MD, FACS Chief, Division of Urology Associate Professor, Urology and Radiology Robert Earl Cone Professorship Director of Urologic Oncology Director of Urologic Research Co-Director Department of Surgery Clinical Outcomes Research Program University of Texas Medical Branch at Galveston MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite prior studies evaluating cancer in those living near and working in oil refineries, there remains a gap in knowledge regarding proximity to oil refineries and risk of bladder cancer. Aromatic amines have been associated with increased risk of various cancers including bladder cancer. Texas is a home to the largest numbers of oil refineries in the US. Our goal was to evaluate if there was a link between bladder cancer and living in close proximity to an oil refinery in Texas. Our data did suggest that living within 10 miles of an oil refinery was associated with a small increase in risk of bladder cancer. These data support further research to validate these findings. (more…)
Author Interviews, Dermatology, Environmental Risks, FDA, JAMA / 06.05.2019

MedicalResearch.com Interview with: David Strauss, MD, PhD Director, Division of Applied Regulatory Science U.S. Food and Drug Administration Center for Drug Evaluation and Research MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is unknown whether most active ingredients in sunscreens are absorbed. FDA has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies. This randomized clinical trial demonstrated systemic exposure of 4 commonly used sunscreen active ingredients on application of sunscreen products under maximal use conditions consistent with current sunscreen labeling. All 4 sunscreen active ingredients tested resulted in exposures exceeding 0.5 ng/mL.  (more…)
Author Interviews, Environmental Risks, Heart Disease, JAMA, Toxin Research / 29.04.2019

MedicalResearch.com Interview with: Monica Lind, PhD, Professor, Environmental toxicologist Occupational and Environmental Medicine Uppsala University Hospital Visiting adress: Dag Hammarskjölds väg 60 Uppsala Sweden MedicalResearch.com: What is the background for this study? Response: Previous studies in workers exposed to very high levels of polychlorinated biphenyls (PCBs) have suggested hazardous health effects. However, circulating PCB levels are detected in almost all indivuduals in industrialized countries, but the health effects of moderately elevated levels as seen in the general population are not well established. We investigated levels of PCBs in around 1,000 individuals, all aged 70 years, randomly chosen from the City of Uppsala, Sweden. (more…)
Author Interviews, Environmental Risks, JAMA, Pediatrics, Primary Care, Toxin Research, USPSTF / 23.04.2019

MedicalResearch.com Interview with: Alex H. Krist, MD, MPH Vice-Chairperson, U.S. Preventive Services Task Force Professor of family medicine and population healt Virginia Commonwealth University  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Exposure to lead can have serious lifelong effects on the health and wellbeing of children. There is no safe level of lead exposure, so finding and removing any source of lead exposure is essential. In its review of the evidence, the Task Force found that more research is needed to determine what primary care clinicians can do to help prevent and treat the health problems that can result from lead exposure in childhood and pregnancy. (more…)
Author Interviews, Environmental Risks, JAMA, Lymphoma, Occupational Health, Toxin Research / 23.04.2019

MedicalResearch.com interview with: Sylvain Lamure, MD, Hematologist, Principal Investigator Pascale Fabbro-Peray, MD, PhD , Epidemiologist, Senior Investigator University of Montpellier, France MedicalResearch.com: What is the background for this study? Response: Occupational exposure to pesticides is a well-documented associated factor for non-Hodgkin lymphoma. The main biological mechanisms of both pesticides and chemotherapy are genotoxicity and reactive oxygen species generation. Cellular adaptation among patients exposed to low doses of genotoxic and oxidative compounds might hinder chemotherapy efficiency in lymphoma patients. T hus, we have investigated the association of occupational exposure with response to immunochemotherapy and survival in the subgroup of diffuse large B cell lymphoma, whose treatment is standardized. (more…)
Author Interviews, Environmental Risks, Global Health, Pediatrics, Toxin Research / 20.04.2019

MedicalResearch.com Interview with: Madhav P. Bhatta, PhD, MPH Associate Professor, Epidemiology & Global Health College of Public Health Kent State University Kent, OH 44242 MedicalResearch.com: What is the background for this study? Response: Lead exposure, especially in children, in any amount is harmful. Lead poisoning is a growing global environmental health problem with increasing lead-related diseases, disabilities, and deaths.  While exposure to lead in US children, in general, has significantly declined in the last three to four decades certain sub-groups of US children such as African Americans, immigrants and resettled refugees, and those from lower socioeconomic backgrounds are still vulnerable to environmental lead exposure. Previous studies among resettled refugee children in the United States had found 4- to 5-times higher prevalence of elevated blood lead level (EBLL) when compared to US-born children. However, most of the studies were conducted when EBLL was defined as blood lead level ≥ 10 µg/dL. In 2012, the US Centers for Disease Control and Prevention changed the reference value for EBLL to ≥ 5 µg/dL. Moreover, because the countries of origin for US resettled refugees change over time, it is important to have epidemiologic studies that provide the current information on EBLL among these vulnerable new US immigrant children. Using blood lead level data from the post-resettlement medical screening, our study examined the prevalence of elevated blood lead level at the time of resettlement among former refugee children who were settled in the state of Ohio from 2009-2016. We had a large and diverse sample (5,661 children from 46 countries of origin) of children for the study, which allowed us to assess EBLL in children from several countries of origin that had not been previously studied. (more…)
Author Interviews, Environmental Risks, Pediatrics, Toxin Research / 20.04.2019

MedicalResearch.com Interview with: Ms. Jacqueline Chiofalo, MPA Director of Policy Research & Analysis The Institute for Family Health Astoria, New York  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Exposure to lead is dangerous and has been banned from use in residential dwellings. However, residual sources of lead still exist. Few studies have examined pediatric lead poisoning between public (NYCHA) and private housing units, and no recent studies performed in New York City. Our study used retrospective chart analysis of routine child lead testing to examine the difference in blood lead levels between the two housing types. Our data showed that children seen in our health centers who lived in New York City public housing had significantly lower mean blood lead levels and fewer children were found with levels over the CDC reference range of 5 μg/dL compared to children who lived in private housing.  (more…)
Asthma, Author Interviews, Environmental Risks, Lancet, Pediatrics / 12.04.2019

MedicalResearch.com Interview with: Ploy Pattanun Achakulwisut, PhD Postdoctoral Scientist in Climate change, Air pollution, and Public Health Milken Institute School of Public Health (Anenberg Group The George Washington University, D.C  MedicalResearch.com: What is the background for this study? Response: Dozens of epidemiological studies have found positive and generally statistically significant associations between long-term exposure to traffic-related air pollution (TRAP) and asthma development in children. The evidence is most robust for nitrogen dioxide (NO2), a major component of and commonly used surrogate for the complex TRAP mixture. Recent reviews conducted by the US Environmental Protection Agency and Health Canada concluded that there is “likely a causal relationship” between long-term NO2 exposure and pediatric asthma development. Using NO2 as a proxy for TRAP, our study provides the first global estimate of the number of new asthma cases among children that are attributable to traffic pollution, using fine spatial-scale global datasets that can resolve within-city and near-roadway NO2 exposures. (more…)
Author Interviews, Cognitive Issues, Environmental Risks, Pediatrics, Toxin Research / 12.04.2019

MedicalResearch.com Interview with: Edson R. Severnini PhD Assistant Professor Of Economics And Public Policy Carnegie Mellon University MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Although lead has been banned from gasoline, paint, and other substances in the United States and many other countries around the world, the legacy of lead use is a critical environmental and public health issue. Surface soil contamination, in particular, has been long recognized as an important pathway of human lead exposure, and is now a worldwide health concern. This study estimates the causal effects of exposure to lead in topsoil on cognitive ability among 5-year-old children. We draw on individual level data from the 2000 U.S. Census, and USGS data on lead in topsoil covering a broad set of counties across the United States. We find that higher lead in topsoil increases considerably the probability of 5-year-old boys experiencing cognitive difficulties such as learning, remembering, concentrating, or making decisions. Living in counties with topsoil lead concentration above the national median roughly doubles the probability of 5-year-old boys having cognitive difficulties. This harmful effect does not seem to extend to 5-year-old girls, potentially due to the natural protection of estrogen.  (more…)
Author Interviews, Environmental Risks, JAMA, Mental Health Research, Pediatrics / 28.03.2019

MedicalResearch.com Interview with: “air pollution, beijing” by 大杨 is licensed under CC BY 2.0Joanne B. Newbury, PhD ESRC Postdoctoral Fellow King’s College London Social, Genetic & Developmental Psychiatry Centre Institute of Psychiatry, Psychology & Neuroscience London, United Kingdom MedicalResearch.com: What is the background for this study? Response: Urban living is one of the most well-established risk factors for adult psychotic disorders such as schizophrenia. However, less is known about the role of the urban environment in subclinical psychotic experiences in childhood and adolescence, such as hearing voices and extreme paranoia. These early psychotic experiences are a developmental risk factor for adult psychotic disorders and a range of other serious mental health problems such as depression and anxiety. It is therefore important that we understand what factors might contribute to the development of early psychotic experiences so that we might be able to intervene and prevent their onset and progression. In a cohort of over 2000 UK-born children (The Environmental Risk Longitudinal Twin Study), we have previously shown that subclinical psychotic experiences are also around twice as common among children and teenagers raised in urban versus rural settings. We have also shown that this appears to be partly explained by social features in urban neighbourhoods such as higher crime levels and lower levels of social cohesion. However, no studies have examined the potential link between air pollution and psychotic experiences. This is despite air pollution being a major health problem worldwide (particularly in cities), and despite emerging evidence linking air pollution to the brain.  (more…)
Author Interviews, Duke, Endocrinology, Environmental Risks, Thyroid Disease, Weight Research / 27.03.2019

MedicalResearch.com Interview with: Christopher D. Kassotis, Ph.D. NRSA Postdoctoral Research Scholar Stapleton Lab Duke University Nicholas School of the Environment Durham, NC 27708  MedicalResearch.com: What is the background for this study? What are the main findings?
  • So this was something that Heather Stapleton had been curious about for years, as she's been one of several researchers characterizing the hundreds of chemicals that have been measured in indoor house dust. Before I came to Duke, one of her PhD students had measured the ability of many common indoor contaminants to activate the peroxisome proliferator activated receptor gamma (PPARg). The majority of these chemicals did, often quite well, which led to them testing indoor house dust extracts, also finding that the majority of dust extracts were also able to do so at very low levels. As PPARg is often considered the master regulator of fat cell development, the next obvious question was whether these common contaminants (and house dust) could promote fat cell development in cell models. My first work at Duke evaluated a suite of common indoor contaminants, finding that many of these chemicals could promote fat cell development, and that low levels of house dust extracts did as well.
  • We next explored this more systematically in a group of adults involved in a thyroid cancer cohort (this was just recently published in Science of the Total Environment: https://www.sciencedirect.com/science/article/pii/S0048969719307715?dgcid=author
  • In this study we evaluated the extent to which house dust extracts could promote fat cell development in a common cell model, and associated this with the metabolic health of adults living in these homes. We found that the greater extent of fat cell development was associated with significantly greater thyroid stimulating hormone concentrations (control residents only, with no evidence of thyroid dysfunction) and lower free triiodothyronine (T3) and thyroxine (T4). We further found a significant and positive association between extent of fat cell development and the body mass index (BMI) of all adults in the study. So this suggested that the indoor environment might play a role in the BMI and metabolic health of residents, and we next wondered if this would be more pronounced in children, who may be exposed to these contaminants during a critical window of development.
  • The next step, for our current work, was to substantiate these effects in a larger group of households, each with children.
  • Our major conclusions thus far have been that ~80% of house dust extracts promote significant fat cell development in a cell model - either via development from precursor cells into mature fat cells, measured via accumulation of lipids into the cells, or via the proliferation of those precursor fat cells. We also reported positive correlations of fat cell development with the concentrations of 70 different contaminants in the dust from these homes, suggesting that mixtures of contaminants are likely all acting weakly to produce these effects in combination. We’ve also begun to assess the other chemicals present in dust - chemistry can be either targeted (measuring concentrations of specific known chemicals in a sample), or non-targeted, where you try and determine the identity of the other chemicals in a sample. This has greater utility for identifying many more chemicals, though you will often not get chemical concentrations from this, nor absolute confirmed identification - just varying degrees of certainty based on evidence. Thus far we report approximately 35,000 chemicals in house dust samples across this study, and differential analyses have begun to pick out the few (less than 10 in each case) chemicals most differentially expressed between samples that exhibit high degrees of fat cell development in the lab vs inactive samples, for example, or which are differentially present in the homes of children categorized as obese or overweight. We are now working to confirm identity of these select contaminants that are more likely to be causative factors in the results we have observed.
(more…)
Author Interviews, Dermatology, Environmental Risks, FDA / 21.03.2019

MedicalResearch.com Interview with: Anna Benevente Director of product, labeling, and ingredient review at Registrar Corp (registrarcorp.com), an FDA consulting firm that helps companies comply with FDA regulations. She has been assisting companies with U.S. FDA regulations since 2009. She and her team have researched thousands of products to determine whether they meet FDA requirements for compliance. In February 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to put into effect a final monograph for over-the-counter (OTC) sunscreen drug products.  If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States.  Given the effect this rule could have on the pharmaceutical and cosmetic industries, MedicalResearch.com sat down with Anna Benevente, Director of Product, Labeling, and Ingredient Review at FDA consulting firm Registrar Corp, to dig deeper into the article they recently published on the rule. MedicalResearch.com:  What is the background for this announcement? Response:  FDA issues monographs for specific types of over-the-counter (OTC) drug products, which establish conditions under which a drug may be marketed without FDA approval of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The conditions that are established by the monograph include the active ingredients that have been deemed generally recognized as safe and effective (GRASE) and statements that must appear on the labeling in the form of a Drug Facts panel. Sunscreens have never had an effective final monograph.  Instead, they have been largely regulated under enforcement discretion since 2001, when FDA issued a stay on a final monograph for OTC sunscreen drug products. The Sunscreen Innovation Act (SIA) of 2014 calls for FDA to establish a final monograph for OTC sunscreen by November 26, 2019. If finalized, the rule proposed in February would lift the stay on the final monograph and amend certain regulations for OTC sunscreen drug products. MedicalResearch.com:  What is enforcement discretion? Response: FDA rulemaking can take a considerable amount of time.  During this process, FDA may issue guidance or an enforcement policy that specifies stipulations under which the Agency permits the marketing of certain products in the absence of codified regulations.  While these documents are not legally-binding, they often outline provisions where FDA states that the Agency does not intend to take regulatory action.  These provisions are often incorporated into an FDA rule, as we are seeing in the case of this new rule for sunscreen. MedicalResearch.com:  Would you explain what GRASE ingredients are? Response: When FDA establishes a monograph for an OTC drug product, the Agency reviews scientific data on ingredients used for that product and classifies them into three categories: Category I: The ingredient is generally recognized as safe and effective for its intended use. Category II: The ingredient is not generally recognized as safe and effective for its intended use.  This ingredient may be not safe as a whole, may be not be safe for the specific intended use, or may not be effective for the specific intended use relative to its health risk. Category III: There is insufficient scientific data to determine whether the ingredient is safe and effective for its intended use. While a monograph is still in the rulemaking stage, FDA permits the marketing of products formulated with active ingredients that are deemed Category I or Category III. At this time, industry may submit data to support a Category I designation for a Category III ingredient. When the final monograph is published, FDA no longer uses the terms "Category I", "Category II", and "Category III."  Those ingredients that were deemed Category I become "monograph conditions," while Category II and III ingredients become "nonmonograph conditions" and may not be marketed after the compliance date identified in the final rule. Q: What are the main products that would require a label change? Response:The statement of identity for all sunscreen products would be required to list the sunscreen active ingredients in alphabetical order followed by “Sunscreen” and the product’s dosage form (e.g. “Titanium Dioxide, Zinc Oxide Sunscreen Lotion”).  Additionally, the rule proposes formatting changes to sunscreen labels that would make SPF, broad spectrum, and water resistance statements more prominent. The rule would require all products over 15 SPF to satisfy broad spectrum testing requirements and the associated labeling requirements for broad spectrum products.  Products under 15 SPF that do not satisfy broad spectrum requirements would be required to include “*See Skin Cancer/Skin Aging Alert” next to the SPF value as a reference to the warning required under 21 CFR 201.327(d)(2). (more…)
Author Interviews, Environmental Risks, Heart Disease, Nutrition / 05.12.2018

MedicalResearch.com Interview with: Dr. Lowell H. Steen, Jr., M.D. Interventional Cardiologist Loyola University Medical Center Dr. Steen discusses how holiday treats & stress can increase the risk of heart attack. MedicalResearch.com: What are the main factors that are linked to an increase in heart related adverse events during the Christmas holiday season? Who is most at risk?  Response: The increase in holiday season heart-related hospitalizations and deaths are due to a variety of behaviors such as putting off seeking medical help until after the holidays, overeating rich foods, strenuous travel, excessive alcohol consumption and stressful family interactions. These factors can all trigger heart issues. Factors such as age, diabetes, high cholesterol and smoking all increase heart risk. Additionally, those with high blood pressure, which is a leading risk factor for heart disease and stroke, are exceptionally at risk and should celebrate the hectic holiday season with caution.  (more…)
Author Interviews, Environmental Risks, JAMA, Melanoma / 24.11.2018

MedicalResearch.com Interview with: Reza Ghiasvand, PhD Oslo Centre for Biostatistics and Epidemiology Faculty of Medicne University of Oslo Oslo, Norway  MedicalResearch.com: What is the background for this study? Response: Melanoma is the most dangerous type of skin cancer. It is estimated that about 288,000 individuals will be diagnosed and about 61,000 will die from it in 2018, with the majority of patients in Australia, New Zealand, Europe and North America. Ultraviolet (UV) exposure (from both the sun and tanning beds) is the most important preventable risk factor for melanoma. However, the association between UV exposure and melanoma is complex and does not accord with a simple model in which risk increases directly with exposure. An individual risk of melanoma also depends on personal characteristics such as skin color and skin sensitivity to the UV exposure, hair color, number of moles, and age. It has been hypothesized that the pattern of UV exposure may play a role in melanoma development in different body sites. For example, melanoma on the trunk (chest and back) has been linked to the recreational UV exposure such as sunbathing and frequent sunburns in people with high number of moles on their body. In contrast, melanomas on the head and neck have been linked to constant sun exposure such as occupational UV exposure, mainly in older people. Epidemiologic and molecular evidence in support of this hypothesis has been published based on analyses of small datasets. Also, melanoma on legs and arms is less studied under this hypothesis. In our study, we examined UV exposure (sunbathing, sunburn and sunbed use) and pigmentary factors (skin, eye, and hair color, freckling, and number of moles), and risk of melanoma on different body sites. We used information from the Norwegian Women and Cancer Study, a population-based cohort study that started in 1991, and includes more than 161,000 Norwegian women followed for an average of 18 years. (more…)
Author Interviews, Environmental Risks / 19.11.2018

MedicalResearch.com Interview with: Dr. Gilbert Rochon, III PH.D., MPH Adjunct Professor, Dept. of Global Health Management & Policy Tulane University’s School of Public Health & Tropical Medicine Senior Consultant with MSF Global Solutions, LLC New Orleans MedicalResearch.com: What is the background for this study? Response: Having observed the frequency with which President Donald Trump characterized changes in regulatory policies and funding levels with respect to public health and the environment as eliminating or curtailing "unnecesssary Obama-era regulations," I became curious as to the full extent and impact of such deregulation and under-funding of health and environmental safeguards. In the process, I found it necessary to review federal government contributions to public health and the environment under all previous presidents.  (more…)
Author Interviews, Autism, Environmental Risks, JAMA, Pediatrics / 16.11.2018

MedicalResearch.com Interview with: "Cairo Air Pollution with less smog - Pyramids1" by Nina Hale is licensed under CC BY 2.0Lief Pagalan, MSc Faculty of Health Sciences, Simon Fraser University Research Trainee, Centre for Hip Health and Mobility Vancouver Coastal Health Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pregnant women more heavily exposed to air pollution had higher chances of having children with autism spectrum disorder (ASD). The causes of ASD are not fully understood, but this study adds to the growing evidence that environmental risk factors have a role to play. Our study found an association between autism spectrum disorder in the children of women more heavily exposed to air pollution. We observed these results using well-defined cases of ASD and in Vancouver, Canada, which typically has lower air pollution. These findings are consistent with studies done in the U.S., Israel, and Taiwan, which have also found an increased risk of ASD from exposure to air pollution.  (more…)
Author Interviews, Dermatology, Environmental Risks / 15.11.2018

MedicalResearch.com Interview with: Audra Stinchcomb, PhD Principal Investigator Professor of Pharmaceutical Sciences University of Maryland School of Pharmacy MedicalResearch.com: What is the background for this study?   Response: We have been studying the heat effects and repeated dose effects on the absorption of drugs across the skin for more than 5 years.  We were curious to see if the effects we saw on gel, cream, and ointment pharmaceuticals also occurred with sunscreen. Sunscreens are typically used in the hot sun and with reapplication every 80 minutes or so, depending on the product and user. (more…)