Author Interviews, Diabetes, Heart Disease, UCSD / 28.03.2019

MedicalResearch.com Interview with: H. Kirk Hammond, MD Professor of Medicine at University of California San Diego Basic research scientist and cardiologist San Diego Veterans' Affairs Healthcare System Dr. Hammond is winner of the 2017 William S. Middleton Award – the highest research honor in the U.S. Department of Veterans Affairs  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Worldwide, 9% of adults have diabetes, predominantly due to insulin resistance, known as Type 2 diabetes. It is associated with obesity and diets high in fat and carbohydrates. In this gene transfer study we showed that a single injection of a vector encoding a natural hormone (urocortin 2, Ucn2) increased glucose disposal and improved heart function in a model of diet-induced Type 2 diabetes in mice.  (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, Lancet, OBGYNE, Pediatrics, Weight Research / 28.03.2019

MedicalResearch.com Interview with: Liv Guro Engen Hanem, PhD Candidate Department of Clinical and Molecular Medicine Norwegian University of Science and Technology MedicalResearch.com: What is the background for this study?   Response: The antidiabetic drug metformin is increasingly used in pregnancy: to treat gestational diabetes and type 2 diabetes, and to prevent pregnancy complications related to polycystic ovary syndrome (PCOS) and obesity. Metformin passes the placenta, and the fetus is thus exposed to the drug. Although no teratogenicity has been reported, metformin might have long-term effects on offspring health. This study is a follow-up of cardiometabolic risk factors of 141 5- to 10-year-old children born in the PregMet study. This study was a double-blind, randomized controlled trial (RCT) designed to test the hypothesis that metformin given throughout pregnancy reduces the prevalence of pregnancy complications that are associated with the common endocrine disorder PCOS. Pregnant women with PCOS were randomized to receive metformin or placebo throughout pregnancy.  (more…)
Author Interviews, Brigham & Women's - Harvard, Ebola, Global Health, Lancet / 28.03.2019

MedicalResearch.com Interview with: Patrick Vinck, PhD Research Director, Harvard Humanitarian Initiative Assistant Professor, Global Health and Population T.H. Chan Harvard School of Public Health; Emergency Medicine Harvard Medical School Lead Investigator, Brigham & Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The second worst epidemic of Ebola on record is currently unfolding in the eastern part of the Democratic Republic of the Congo. Whether or not safe practices are implemented to prevent the spread of the epidemic is influenced by the behavior of individuals at-risk of contracting the Ebola Virus Disease (EVD) - Will they follow the recommendations of health professionals? Will they report suspected cases and deaths? Will they seek treatment from health professionals? Will they accept vaccines and adopt preventive behaviors? We find that belief in misinformation about Ebola is widespread and trust in authorities is generally low, likely as a result of decades of violence and poor governance and, more recently, the politicization of the Ebola response. Our analysis shows that trust and (mis-)information influence adherence to risk avoidance behavior and acceptance of vaccination. (more…)
Author Interviews, Cannabis, JAMA, Mental Health Research, OBGYNE / 28.03.2019

MedicalResearch.com Interview with: Jeremy Fine B.A. in Philosophy, Neuroscience, and Psychology Washington University in St. Louis, Class of 201 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alongside increasingly permissive marijuana use attitudes and laws, the prevalence of marijuana use among pregnant mothers has increased substantially (by 75% between 2002 and 2016), with some evidence that pregnant women may be using cannabis to combat pregnancy-related nausea. Our data came from the Adolescent Brain Cognitive Development (ABCD) Study, which included over 4,000 subjects with data on maternal marijuana use during pregnancy. Our main finding was that the children of mothers who used marijuana after learning they were pregnant had a small but significant increase in risk for psychosis in their future. (more…)
Accidents & Violence, Author Interviews, Emergency Care, NEJM, University Texas / 27.03.2019

MedicalResearch.com Interview with: Jeffrey Howard, PhD Assistant Professor Department of Kinesiology, Health and Nutrition University of Texas at San Antonio San Antonio, TX 78249 MedicalResearch.com: What is the background for this study? Response:  There is a saying that “the only winner in war is medicine”, which is the first sentence in the article.  The point of that quote is that many medical advances over the last 500 years or more have been learned or propagated as a result of war. With that as the backdrop, the purpose of our study was to provide a more comprehensive assessment of the trauma system than previous work.  We accomplished this by compiling the most complete data to-date on the conflicts, using data from both Afghanistan and Iraq, and analyzing multiple interventions/policy changes simultaneously rather than in isolation.  Previous work had focused primarily on single interventions and within more narrow timeframes.  We wanted to expand the scope to include multiple interventions and encompass the entirety of the conflicts through the end of 2017.  (more…)
Author Interviews, Breast Cancer, Chemotherapy, NEJM / 27.03.2019

MedicalResearch.com Interview with: Rita Mehta, MD, HS Clinical Professor, Chao Family Comprehensive Cancer Center University of California School of Medicine, Irvine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Most patients with HR-positive breast cancer become resistant to hormonal therapies like aromatase inhibitor-anastrozole over time, and downregulating estrogen receptor was identified as a mechanism for overcoming or delaying resistance to hormonal therapy in advanced HR-positive breast cancer. The prospective, randomized phase III S0226 trial, first reported by us in NEJM 2012, showed that the selective estrogen receptor degrader fulvestrant in combination with anastrozole significantly improved progression-free survival in 707 women with HR-positive metastatic breast cancer in first-line setting. Treatment with the selective estrogen receptor degrader (SERD) fulvestrant achieved a clinically significant and meaningful improvement in overall survival in patients with hormone receptor (HR)-positive advanced breast cancer in first-line therapy, according to the final analysis of overall survival results from the S0226 study reported by us (Mehta et al. NEJM 2019)
  • Results showed that median overall survival improved by 7.8 months with anastrozole plus fulvestrant (median overall survival = 49.8 months) compared to anastrozole (median overall survival = 42.0 months).
  • The improvement was even greater in patients with endocrine naive disease, with an absolute improvement in median overall survival of 11.9 months.
  • No new safety signals were observed with longer follow-up. 
(more…)
Anesthesiology, Author Interviews, Heart Disease, NEJM, Surgical Research / 27.03.2019

MedicalResearch.com Interview with: Dr. Giovanni Landoni Intensive Care and Anesthesia Unit Associate professor Università Vita-Salute San Raffaele  MedicalResearch.com: What is the background for this study?   Response: Patients undergoing cardiac surgery are still at risk for perioperative complications. Studies to improve clinical outcomes this setting are important. Inhaled anesthetics have pharmacological properties which reduce myocardial infarction size by 50% in laboratory and animal studies and which might decrease postoperative mortality according to aggregated published randomized data. (more…)
Author Interviews, Endocrinology, Weight Research / 27.03.2019

MedicalResearch.com Interview with: Liya Kerem, MD Fellow, Pediatric Endocrine Unit Massachusetts General Hospital for Children Harvard Medical School MedicalResearch.com: What is the background for this study?   Response: The hypothalamic neurohormone Oxytocin (OXT), shown to decrease food intake in animals and humans, is a promising novel treatment for obesity. We previously showed that in men with overweight/obesity, intranasal (IN)OXT reduced the fMRI activation in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs non-food visual stimuli. Here, we employed fMRI functional connectivity analysis, which better characterizes the exchange in information between neural systems in a context-dependent manner. We hypothesized that Oxytocin would reduce the functional connectivity of the VTA with food motivation brain areas in response to high-calorie foods.  (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, Brigham & Women's - Harvard, Dermatology, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: Seoyoung C. Kim, MD, ScD, MSCE Director, Program in Rheumatologic, Immunologic, and Musculoskeletal PharmacoEpidemiology Associate Professor of Medicine Division of Pharmacoepidemiology & Pharmacoeconomics Division of Rheumatology, Immunology and Allergy Brigham and Women's Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Given a high cardiovascular (CV) risk among patients with psoriasis and psoriatic arthritis, it is important to have more information with regard to potential effect of different treatment agents on CV risk. As the number of treatment options for psoriasis and psoriatic arthritis has been rising over the few decades, it is even more crucial to have high-quality evidence on comparative safety of different treatment options so physicians and patients can choose an agent based on the benefit-risk profile of each drug they are considering. (more…)
Author Interviews, Brigham & Women's - Harvard, Flu - Influenza, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: Sonja Kytomaa MA Research Associate Brigham and Women’s Hospital Scott D. Solomon, MD The Edward D. Frohlich Distinguished Chair Professor of Medicine Harvard Medical School Senior Physician Brigham and Women’s Hospital International Associate Editor, European Heart Journal   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Influenza is associated with an increased risk of cardiovascular events, yet few studies have explored the temporal association between influenza activity and hospitalizations, especially due to heart failure (HF). Our aim with this study was to explore the temporal association between influenza activity and hospitalizations for HF and myocardial infarction (MI) in the general population. We related the number of MI and HF hospitalizations by month, which were sampled from 4 US communities and adjudicated in the surveillance component of the Atherosclerosis Risk in Communities (ARIC) study, to monthly influenza-like illness activity, as reported by the Centers for Disease Control and Prevention. We found that a 5% increase in influenza activity was associated with a 24% increase in HF hospitalizations rates, while overall influenza was not significantly associated with MI hospitalizations. Influenza activity in the months before hospitalization was not associated with either outcome. (more…)
Author Interviews, Cost of Health Care, UCLA / 27.03.2019

MedicalResearch.com Interview with: John N. Mafi, MD, MPH Division of General Internal Medicine and Health Services Research Department of Medicine David Geffen School of Medicine at UCLA RAND Health, RAND Corporation MedicalResearch.com: What is the background for this study? What types of services are low-value in this setting?  Response: For decades we have known that offering routine preoperative testing for patients undergoing cataract surgery provides limited value, yet low-value preoperative testing persists at very high rates, even at Los Angeles County Department of Health Services, one of the largest safety net health systems in the United States. (more…)
Author Interviews, JAMA, Karolinski Institute, Pediatrics / 26.03.2019

MedicalResearch.com Interview with: Mikael Norman, MD, PhD, Professor Karolinska Institutet & Karolinska University Hospital Stockholm, Sweden  MedicalResearch.com: What is the background for this study? Response: So far, preterm birth has been difficult to predict and prevent. In particular, extremely preterm birth has continued to be an issue in terms of optimal care before and after birth, costs and long term health outcomes. Therefore, studies on how the management and outcome varies over time in these patients are important. (more…)
Author Interviews, Heart Disease, JAMA, Stem Cells / 26.03.2019

MedicalResearch.com Interview with: Annetine C. Gelijns, PhD Professor and System Chair Population Health Science and Policy Icahn School of Medicine at Mount Sinai Alan J Moskowitz, MD Professor of Population Health Science and Policy Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Where do these mesenchymal cells come from?  Response: Implantable LVADs significantly improve the survival and quality of life of advanced heart failure patients. However, these devices are associated with substantial adverse events, including infection and thromboembolic events. Moreover, whereas these devices improve myocardial function, few patients recover sufficient function to be explanted from their LVAD. These observations have focused attention on stem cells as a possible adjunctive therapy to further augment cardiac recovery. Mesenchymal precursor cells (MPCs), which are obtained from healthy donors and culture-expanded, have been shown in animal and early human studies to improve cardiac function. Using temporary weaning as a signal of cardiac recovery, we conducted an exploratory trial in the Cardiothoracic Surgical Trials Network (CTSN), which found that MPCs increased the probability of temporary weaning from full LVAD support compared to sham-control patients. Therefore, this signal of efficacy led the CTSN to design our current follow-up trial evaluating the efficacy and safety of a higher dose of MPCs in LVAD patients. (more…)
Author Interviews, Autism, Social Issues, University of Pittsburgh, Vaccine Studies / 26.03.2019

MedicalResearch.com Interview with: Beth Hoffman, B.Sc., graduate student University of Pittsburgh Graduate School of Public Health Research Assistant, University of Pittsburgh Center for Research on Media, Technology and Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vaccine refusal is a public health crisis - low vaccination rates are leading to outbreaks of deadly vaccine-preventable diseases. In 2017, Kids Plus Pediatrics, a Pittsburgh-based pediatric practice, posted a video on its Facebook pagef eaturing its practitioners encouraging HPV vaccination to prevent cancer. Nearly a month after the video posted, it caught the attention of multiple anti-vaccination groups and, in an eight-day period, garnered thousands of anti-vaccination comments. Our team analyzed the profiles of a randomly selected sample of 197 commenters in the hopes that this crisis may be stemmed if we can better understand and communicate with vaccine-hesitant parents. We determined that, although Kids Plus Pediatrics is an independent practice caring for patients in the Pittsburgh region, the commenters in the sample were spread across 36 states and eight countries. By delving into the messages that each commenter had publicly posted in the previous two years, we also found that they clustered into four distinct subgroups:
  • “trust,” which emphasized suspicion of the scientific community and concerns about personal liberty;
  • “alternatives,” which focused on chemicals in vaccines and the use of homeopathic remedies instead of vaccination;
  • “safety,” which focused on perceived risks and concerns about vaccination being immoral; and
  • “conspiracy,” which suggested that the government and other entities hide information that this subgroup believes to be facts, including that the polio virus does not exist. 
(more…)
Author Interviews, JAMA, Pediatrics, Stanford, Technology / 26.03.2019

MedicalResearch.com Interview with: Dennis P. Wall, PhD Associate Professor Departments of Pediatrics, Psychiatry (by courtesy) and Biomedical Data Science Stanford University  MedicalResearch.com: What did we already know about the potential for apps and wearables to help kids with autism improve their social skills, and how do the current study findings add to our understanding? What’s new/surprising here and why does it matter for children and families?  Response: We have clinically tested apps/AI for diagnosis (e.g.  https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002705) in a number of studies. This RCT is a third phase of a phased approach to establish feasibility and engagement through in-lab and at-home codesign with families with children with autism. This stepwise process is quite important to bring a wearable form of therapy running AI into the homes in a way that is clinically effective. What’s new here, aside from being a first in the field, is the rigorous statistical approach we take with an intent-to-treat style of analysis. This approach ensures that the effect of the changes are adjusted to ensure that any significance observed is due to the treatment.  Thus, with this, it is surprising and encouraging to see an effect on the VABS socialization sub-scale. This supports the hypothesis that the intervention has a true treatment effect and increases the social acuity of the child. With it being a home format for intervention that can operate with or without a clinical practitioner, it increases options and can help bridge gaps in access to care, such as when on waiting lists or if the care process is inconsistent.   (more…)
Author Interviews, JAMA, Pediatrics / 26.03.2019

MedicalResearch.com Interview with: Edward Bell, MD Vice Chair for Faculty Development Department of Pediatrics Professor of Pediatrics - Neonatology Carver College of Medicine University of Iowa Health Care  MedicalResearch.com: What is the background for this study? Response: The study is an analysis of what happened to the 205 babies with birth weigh below 400 grams and gestational age of 22 through 26 weeks who were born between 2008 and 2016 at 21 academic medical centers that are members of the National Institute of Child Health and Human Development Neonatal Research Network. The Network exists to collaborate in finding ways to improve the survival and health of premature and other critically-ill newborn infants. 400 grams is very small. By comparison, 1 pound is 454 grams. (more…)
Author Interviews, Endocrinology, Gender Differences, Hormone Therapy / 26.03.2019

MedicalResearch.com Interview with: Joshua Safer, MD, Executive Director Center for Transgender Medicine and Surgery Mount Sinai Health System Senior Faculty, Medicine, Endocrinology, Diabetes and Bone Disease Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? What are the main findings? Response: The standard trans feminizing hormone regimen includes estrogen both to suppress testosterone and so that the individual has sufficient circulating sex hormone in the body for good bone health. After orchiectomy, there is no need to suppress testosterone because the levels are very low and it is common to cut the estrogen dose in half.  Cis women with premature ovarian failure often take about 2 mg of estradiol daily so that dose has seemed reasonable for trans women without testes.  However, when my co-author Sira Korpaisarn and I checked estradiol levels and gonadotropins (pituitary hormones, LH and FSH) as a guide to dosing, we found that based on that testing, trans women may require higher doses of estrogens than the 2 mg that we expected. (more…)
Author Interviews, BMJ, OBGYNE, Occupational Health / 26.03.2019

MedicalResearch.com Interview with: Luise Mølenberg Begtrup Department of Occupational and Environmental Medicine, Bispebjerg Hospital, Copenhagen MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are indications that working fixed night shifts is associated with a higher risk of miscarriage. Since many women work rotating shifts including night shifts, we were interested in examining the association between the amount of night work and miscarriage. We were able to do this by use of detailed exposure data based on payroll data. (more…)
Author Interviews, Dermatology, JAMA, Pediatrics, Sleep Disorders, UCSF / 26.03.2019

MedicalResearch.com Interview with: Dr. Katrina Abuabara, MD, MA, MSCE Department of Dermatology Program for Clinical Research, University of California, San Francisco MedicalResearch.com: What is the background for this study? Response: The wellbeing and development of children is strongly influenced by parents’ physical and psychosocial health. Parents of children with chronic illness, in particular, are susceptible to poor sleep, and previous studies have found major sleep impairments among parents of children with ventilator dependency and cystic fibrosis, but few studies have examined sleep patterns among parents of children with more common chronic illnesses like atopic dermatitis (also known as eczema). (more…)
Accidents & Violence, Author Interviews, Technology / 26.03.2019

MedicalResearch.com Interview with: Cynthia Lum, PhD Professor of Criminology Law and Society George Mason University MedicalResearch.com: What is the background for this study? Response: Body-worn cameras (BWCs) are one of the most rapidly diffusing technologies in policing today, costing agencies and their municipalities millions of dollars. Recent estimates by the Bureau of Justice statistics indicate that over 60% of local police departments have already acquired BWCs. This adoption has been propelled by highly publicized officer-involved shootings and other death-in-custody events in this decade, as well as more generally by continuing concerns regarding police-citizen relationships, particularly within communities of color. All of these contexts prompt the need to better understand the impacts and effects of BWCs as they diffuse rapidly into policing. Specifically, do BWCs achieve the expectations that citizens, communities, and the police have of them? This article provides a narrative review of 70 studies, representing over 110 findings, about what we know from research across six important Body-worn cameras domains: (1) the impact of BWCs on officer behavior; (2) officer attitudes about BWCs; (3) the impact of BWCs on citizen behavior; (4) citizen and community attitudes about BWCs; (5) the impact of BWCs on criminal investigations; and (6) the impact of BWCs on law enforcement organizations. (more…)
Author Interviews, OBGYNE, Surgical Research / 25.03.2019

MedicalResearch.com Interview with: Dr. Jemianne Bautista-Jia,  MD Radiology resident Kaiser Permanente MedicalResearch.com: What is the background for this study? Response: There were a few patient experiences that took me by surprise. I had a patient come to clinic for an initial consultation for uterine fibroid embolization (UFE) and I asked her how she knew about the procedure. She told me that she heard about it on the radio. Another patient who came in told me she heard about it from a close friend. Why did these patients not hear about UFE from their primary physicians? Being a woman, I know that if I had this condition I would prefer a minimally invasive option over surgery. Surgery comes with complications, and I definitely would not want an organ removed from my body if I could avoid it. Therefore I wanted to study UAE to hopefully provide additional objective data to the scientific community to support its use for the treatment of women with fibroids. (more…)
Author Interviews, Cancer Research, Genentech, Leukemia / 25.03.2019

MedicalResearch.com Interview with: Nancy Valente, M.D. VP of Global Hematology Development Genentech Dr. Valenta discusses the announcement of the submission by Genentech of a supplemental New Drug Application to the FDA for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia  with co-existing medical conditions. MedicalResearch.com: What is the background for this study? What are the main findings of the Phase III CLL14 study?  Response: We completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. CLL is the most common form of adult leukemia and more than 20,000 new cases will be diagnosed in the U.S. this year. The sNDA is based on data from the Phase III CLL14 study, which evaluated fixed-duration Venclexta in combination with Gazyva in people with previously untreated CLL. Results showed this chemotherapy-free combination can help people with previously untreated CLL live significantly longer without their disease worsening (progression-free survival; PFS) compared to standard-of-care Gazyva plus chlorambucil. The FDA is reviewing our application under the Real-Time Oncology Review (RTOR) pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.  (more…)
Author Interviews, Gender Differences, JAMA, Pediatrics / 25.03.2019

MedicalResearch.com Interview with: Dr. David Klein MD MPH Associate Program Director National Capital Consortium (NCC) Family Medicine Residency Fort Belvoir Community Hospital Dr. Elizabeth Hisle-Gorman MSW, PhD Assistant Professor, Uniformed Services University  MedicalResearch.com: What is the background for this study?  Response: Our study, “Transgender Children and Adolescents Receiving Care in the U.S. Military Healthcare System: A Descriptive Study,” sought to analyze the number of military dependent children and adolescents who have a transgender or gender-diverse identity and receive medical care in the Military Health System (MHS), recognizing that the number has been increasing, but not knowing to what extent. Ultimately, in studying this data, we hoped to document the needs of transgender children in military families to support provision of adequate and appropriate high-quality care. (more…)
Author Interviews, Health Care Systems, JAMA / 24.03.2019

MedicalResearch.com Interview with: Maryam Guiahi, MD Associate Professor, Ob/Gyn School of Medicine University of Colorado  MedicalResearch.com: What is the background for this study? Response: The United States Conference of Catholic Bishops expects providers in Catholic Health Care Facilities to follow the Ethical and Religious Directives for Catholic Health Care Services, which places limits on reproductive and end-of-life care. Prior research has demonstrated that many patients do not anticipate religious health care restrictions, yet often face conflicts in care. We were interested in whether Catholic hospitals disclose their religious affiliation and explain to patients how this affiliation may impact the care they are offered. (more…)
Author Interviews, Depression, Dermatology / 24.03.2019

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern, Chicago, Illinois MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Atopic Dermatitis is characterized by chronic and often severe and debilitating itch, skin pain, sleep disturbances, skin lesions and multiple comorbid health conditions. The signs, symptoms and comorbidities of atopic dermatitis can lead to significant psychosocial distress and mental health burden We performed a cross-sectional, population-based study of 2893 US adults. We found that adults with atopic dermatitis had more severe symptoms scores for anxiety and depression (Hospital Anxiety and Depression anxiety). Adults with atopic dermatitis also had higher prevalences of anxiety and depression. Mean symptom scores and prevalences of anxiety and depression were even higher in adults with moderate and severe atopic dermatitis compared to those with mild atopic dermatitis. All respondents with severe PO-SCORAD, POEM and PO-SCORAD-itch scores had elevated anxiety and depression scores. Many adults with atopic dermatitis that had elevated anxiety and depression scores reported no diagnosis of anxiety or depression.  (more…)
Author Interviews, Endocrinology, Genetic Research / 24.03.2019

MedicalResearch.com Interview with: Emily J. Gallagher, MD Assistant Professor of Medicine Endocrinology, Diabetes and Bone Disease Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study? Response: Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2) is an inherited endocrine disorder characterized by the development of pheochromocytoma, medullary thyroid carcinoma (MTC) and parathyroid tumors. It occurs due to activating missense variants in the RET gene. The estimated prevalence of MEN2 is 1 per 30,000 in the general population. Through a collaboration between The Center for Genomic Health, the Charles Bronfman Institute for Personalized Medicine, and the Division of Endocrinology at Mount Sinai, our aim was to investigate the prevalence and clinical manifestations of pathogenic RET variants in the multi-ethnic BioMe Biobank. The BioMe Biobank is an electronic health record-linked biobank with exome sequencing data available for more than 30,000 patients recruited across The Mount Sinai Health System. (more…)
Allergies, Author Interviews, Brigham & Women's - Harvard, Pharmacology / 23.03.2019

MedicalResearch.com Interview with: Daniel Reker, PhD Koch Institute for Integrative Cancer Research Massachusetts Institute of Technology MedicalResearch.com: What is the background for this study? Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios. We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients. (more…)