Aging, Author Interviews, Cognitive Issues, JAMA, Mayo Clinic, Weight Research / 01.02.2016

MedicalResearch.com Interview with: Rosebud O. Roberts, M.B., Ch.B. Mayo Clinic Rochester, Minn.  Medical Research: What is the background for this study? Dr. Roberts: Decline in weight has been observed 10-20 years prior to onset of dementia. We wanted to study whether this decline also occurs for mild cognitive impairment (an intermediate stage in the progression from normal cognition to dementia). Medical Research: What are the main findings? Dr. Roberts: The main finding was that there was indeed a decline in weight (from the maximum weight in midlife to weight assessed in late life) was associated with a increased risk of mild cognitive impairment. (more…)
Author Interviews, Microbiome, Nature, NYU, OBGYNE / 01.02.2016

MedicalResearch.com Interview with: Maria Dominguez-Bello, PhD Associate Professor, Department of Medicine, Division of Translational Medicine NYU Langone Medical Center and Jose Clemente, PhD Assistant Professor, Departments of Genetics and Genomic Sciences, and Medicine Icahn School of Medicine at Mount Sinai       Medical Research: What is the background for this study? What are the main findings? Response: Humans and animals are a composite of their own cells and microbes. But where they get their microbes from?  For mammals, labor and birth are major exposures to maternal vaginal bacteria, and infants are born already with a microbiota acquired from the mother. Mom’s birth canal is heavily colonized by bacteria that are highly related to milk: some will use milk components and become dominant during early development, an important window for maturation of the immune system, the intestine and the brain. Thus, the maternal vaginal microbiota is thought to be of high adaptive value for newborn mammals. Indeed, studies in mice confirm that microbes acquired at birth are important to develop adequate immune and metabolic responses, and the mature adult microbiome will continue to modulate host metabolism and immunity. Humans are the only mammals that interrupt the exposure to maternal vaginal microbiota, by delivering babies by Cesarean section. C-sections save lives of babies and moms, and they are estimated necessary in 10-15% of the cases. But most Western countries have rates above 30%, with the notable exception of the Scandinavian countries, Holland and Japan, which have excellent health systems and low maternal-infant mortality rates. Previous work by us an others has shown that infants born by C-section acquire different microbiota at birth, and those differences are sustained over time, altering the normal age-dependent maturation of the microbiome. The fundamental questions are then, can we restore the microbiota of Cesarean delivered babies? And if we can, does that reduce the associated disease risks? In relation to the first question, we present here the results of a pilot study in which infants born by Cesarean delivery were exposed to maternal vaginal fluids at birth. A total of 18 infants were recruited for the study. Seven of them were vaginally delivered, the remaining 11 were born by scheduled C-section. Among the C-section infants, 4 were exposed to maternal vaginal fluids at birth and 7 were not. We sampled all infants and their mothers for the first month of life across different body sites (oral, skin, anal, maternal vagina) and determined the microbiome composition on a total of over 1,500 samples. (more…)
Author Interviews, Compliance, JAMA, Technology / 01.02.2016

MedicalResearch.com Interview with: Dr. Clara Chow PhD Director of the Cardiovascular division The George Institute, Westmead Hospital Sydney, Australia Medical Research: What is the background for this study? What are the main findings? Dr. Chow: Text messaging has immense potential in healthcare. Not only for supporting medication adherence, but we have shown in the “TEXT ME” study its ability to simultaneously influence multiple lifestyle domains like increasing physical activity, embarking on healthier diets and reducing smoking rates. With increasing penetration of mobile phone use in developed as well as developing countries, there is a potential for wider reach, however there remains a need to evaluate the value of text messaging programs in various patient populations to establish the generalizability of these research findings. (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology / 01.02.2016

MedicalResearch.com Interview with: Victor Allen Neel, MD, PhD Director, Dermatologic Surgery Massachusetts General Hospital Medical Research: What is the background for this study? Dr. Neel: Seborrheic keratoses (SKs) are the very common, warty brown skin lesions that are found on the face, chest and back of most people over forty. They affect every race and they increase in size and frequency with age. Although they are not dangerous, they can mimic dangerous conditions and are cosmetically unappealing. There is a high demand in the field of dermatology by both patients and physicians for a topical treatment. Currently there no FDA-approved drugs that have been shown to be effective at removing them. Medical Research: What are the main findings? Dr. Neel: Although seborrheic keratoses are the most common benign tumors in humans, very little was known about what causes them. Our paper was the first to study the biology of SKs in the laboratory, identify the key proteins controlling their abnormal growth and to pinpoint a potential treatment for commercial development. We found that the enzyme called Akt was activated in seborrheic keratoses. Inhibiting this enzyme with a compound called A44 caused the SK cells to undergo "apoptosis,"  or programmed cell death. Normal skin cells were unaffected by A44. (more…)
Author Interviews, Dermatology, Gastrointestinal Disease, Genetic Research / 01.02.2016

MedicalResearch.com Interview with: Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital University of Copenhagen Hellerup, Denmark Medical Research: What is the background for this study? What are the main findings? Dr. Egeberg: A recent genome-wide association study (GWAS) identified 90 shared genetic regions associated with celiac disease, type 1 diabetes mellitus, multiple sclerosis, and rheumatoid arthritis, respectively. Similarly, a newly published GWAS identified shared risk loci between rosacea, type 1 diabetes, and celiac disease. In the present study of 6,759 patients with rosacea and 33,795 control subjects, rosacea was associated with a 2 to 3-fold higher risk of these four conditions, particularly among women. (more…)
Author Interviews, BMJ, Colon Cancer, Gastrointestinal Disease, Global Health / 31.01.2016

MedicalResearch.com Interview with: Dr. Melina Arnold Section of Cancer Surveillance International Agency for Research on Cancer Lyon, France MedicalResearch.com: What is the background for this study? What are the main findings?  Dr. Arnold: In this study, we looked at patterns and time trends in the incidence in and mortality from colorectal cancer on the global scale. In the analyses, we used data from the Globocan database, Cancer Incidence in Five Continents, both hosted by the International Agency for Research on Cancer (IARC), and the World Health Organisation mortality database. We documented a ten-fold variation in colorectal cancer incidence and mortality rates worldwide. We also found distinct gradients across human development levels, meaning that changes in patterns and trends of this cancer could be linked to economic development and that the adoption of a Western lifestyle may have a role. While incidence and mortality rates are on the increase in many countries in socioeconomic transition, stabilizing or decreasing trends are seen in highly-developed countries where rates remain among the highest in the world. These observations point to widening disparities and an increasing burden in transitioning countries. (more…)
Author Interviews, Diabetes, Lancet / 31.01.2016

MedicalResearch.com Interview with: Dr Abbas Dehghan PhD Assistant Professor, Department of Epidemiology Erasmus University Medical Centre Rotterdam, Netherlands MedicalResearch.com: What is the background for this study? Dr. Dehghan: Diabetes is an important health treat given its serious complications including cardiovascular disease, blindness, kidney failure, and lower-extremity amputations. Descriptive studies have so far either reported the prevalence of diabetes which is a snapshot of the percentage of people who have diabetes or the risk that people will develop diabetes in next 5 or 10 years. These estimates are not optimal since they overlook the risk of developing diabetes later in life. We calculated the lifetime risk of type 2 diabetes which is the risk that every person carries to develop type 2 diabetes up to end of his life. Moreover, we provided estimates for prediabetes, a high risk status that people experience before developing diabetes, and need for insulin therapy that might indicates severity of the disease. MedicalResearch.com: What are the main findings?  Dr. Dehghan: Our data suggest that the lifetime risk of developing prediabetes for a normoglycemic individual aged 45 years is one in two, and one in three nondiabetic individuals aged 45 years will develop diabetes. Three-quarters of individuals with prediabetes at age 45 years will eventually progress to diabetes, and half of the patients with diabetes at the same age will start insulin treatment. Stratification by BMI showed that normoglycemic people with healthy weight at age 45 years had a significantly lower prediabetes lifetime risk compared with overweight and obese individuals. Stratification by waist circumference showed similar effects on lifetime risks for diabetes in individuals with prediabetes. Similarly, in individuals with diabetes, the lifetime risk for insulin use among patients with diabetes was higher with increasing BMI and waist circumference. (more…)
Author Interviews, Brigham & Women's - Harvard, UCSF, Zika / 31.01.2016

MedicalResearch.com Interview with: Mary E. Wilson, MD Visiting Professor of Epidemiology and Biostatistics School of Medicine, University of California San Francisco Adjunct Professor of Global Health and Population Harvard T.H. Chan School of Public Health Boston, Massachusetts  Medical Research: What is the background for this study? Response: Zika virus infections are spreading explosively in the Americas. This flavivirus infection, spread by Aedes mosquitoes, is new to the Americas, so the majority clinicians have little knowledge of the infection and its potential complications. The country most affected so far is Brazil, where more than a million infections have been reported in less than a year. Infection has also spread to at least 20 other countries in the Americas (the Caribbean, Mexico, Central and South America). Prior to 2007 Zika virus was known to cause infections only in Africa and Asia. Since then, it has spread and caused epidemics in Micronesia, French Polynesia, Easter Island, and since 2015 in Brazil. Most of the movement of the virus from one region to another is via travelers who are infected and then are bitten by mosquitoes in a new region. In Brazil an increase in cases of infants born with microcephaly (small head) has been noted coincident with the Zika epidemic, and the virus has been recovered from amniotic fluid and from fetal tissue, suggesting that Zika infection during pregnancy may cause microcephaly in the developing fetus. An increase in cases of Guillain-Barre syndrome has also been observed during this and previous outbreaks. Studies are underway to determine if Zika virus is the cause of microcephaly and Guillain-Barre syndrome.In Brazil an increase in cases of infants born with microcephaly (small head) has been noted coincident with the Zika epidemic, and the virus has been recovered from amniotic fluid and from fetal tissue, suggesting that Zika infection during pregnancy may cause microcephaly in the developing fetus. An increase in cases of Guillain-Barre syndrome has also been observed during this and previous outbreaks. Studies are underway to determine if Zika virus is the cause of microcephaly and Guillain-Barre syndrome. Most countries in the Americas, including the United States, are infested with types of mosquitoes that are competent to transmit the virus, but weather conditions also have to be warm enough to permit the virus to disseminate in the mosquito so that it can be transmitted to another person. The symptoms of Zika virus infection are typically mild and self-limited  – fever, aches, rash, and conjunctivitis. In fact, the majority of those infected have no symptoms. Because the virus can enter the bloodstream even in asymptomatic infected persons, there is concern that the virus could be spread by blood transfusion, if a person donates blood during the short period (probably a few days at most) when virus is in the blood. Other reasons for the paper are to highlight what is known about some of the insect repellents and to point out important gaps in our knowledge of their use and urgent research needs. (more…)
Author Interviews, Autism, Genetic Research, JAMA, Schizophrenia / 30.01.2016

MedicalResearch.com Interview with: Andrea J. Gonzalez-Mantilla, M.D. Postdoctoral Fellow Andres Moreno-De-Luca, M.D. Investigator I Autism & Developmental Medicine Institute Department of Radiology Geisinger Health System Danville, PA 17822 Medical Research: What is the background for this study? What are the main findings? Response: Developmental brain disorders (DBD), such as autism, intellectual disability, and schizophrenia are a group of heterogeneous conditions characterized by deficits that affect multiple functional domains, such as cognition, behavior, communication, and motor skills. Previous studies provide strong evidence of common underlying molecular pathways and shared genetic causes among apparently different DBDs. Large-scale genomic studies of individuals with developmental brain disorders have found that identifying multiple, independent de novo pathogenic loss-of-function (pLOF) variants in the same gene among unrelated individuals is a powerful statistical approach to reliably identify disease-causing genes. However, genomic data from smaller cohorts and case reports are not routinely pooled with data from larger studies. Moreover, most previous studies have been restricted to cohorts of individuals ascertained based on a single diagnosis (e.g., a study will focus on only individuals with a diagnosis of autism and not consider other genomic data from individuals with a different diagnosis). Therefore, genomic data from individuals across DBD are not being jointly analyzed in search of pLOF variants in the same gene that may help build evidence for a causative role in developmental brain disorders. In this study, we carried out data mining of previously published data to identify genes related to the DBD phenotype. We expanded the aforementioned method and developed a multilevel data-integration approach, which capitalizes on three genotype-phenotype data sources: (1) genomic data from structural and sequence pLOF variants, (2) phenotype data from six apparently distinct DBD (autism, intellectual disability, epilepsy, schizophrenia, bipolar disorder and attention-deficit/hyperactivity disorder), and (3) data from large scale studies, smaller cohorts, and case reports. We identified 241 candidate genes for developmental brain disorders, including 17 genes that had not previously been associated with developmental brain disorders. (more…)
Author Interviews, Herpes Viruses, Ophthalmology, Vaccine Studies / 30.01.2016

MedicalResearch.com Interview with: Frederick W. Fraunfelder, MD MBA Chairman and Roy E. Mason and Elizabeth Patee Mason Distinguished ProfessorDepartment of Ophthalmology Missouri University School of Medicine Director of the Missouri University Health Care’s Mason Eye Institute Medical Research: What is the background for this study? What are the main findings? Dr. Fraunfelder: The background starts with a paper by Hwang et al (Cornea. 2013 Apr;32(4):508-9.Reactivation of herpes zoster keratitis in an adult after varicella zoster vaccination. Hwang CW Jr1, Steigleman WA, Saucedo-Sanchez E, Tuli SS.) After reading this paper, I started keeping track of keratitis cases that were reported to my registry (www.eyedrugregistry.com) and also to the FDA and WHO spontaneous reporting databases. We found case reports in adults and children of keratitis occurring soon after vaccination, and we presented this at the American Academy of Ophthalmology’s annual meeting that we just held in Las Vegas in November 2015. The main findings are that in rare instances, relatively speaking, herpes infection can occur in the cornea of the eye within days to weeks after vaccination. This may especially be true in adults who have had shingles in the past which caused a keratitis in the past. This keratitis may reoccur after the vaccination, and primary care providers should inquire about this past medical/ocular history and advise of the risk of recurrent keratitis after the vaccination for shingles. (more…)
Author Interviews, Mineral Metabolism, Nutrition / 30.01.2016

MedicalResearch.com Interview with: Simin Nikbin Meydani, D.V.M., Ph.D. Director, JM USDA-HNRCA at Tufts University Professor of Nutrition and Immunology Friedman School of Nutrition Science and Policy and Sackler Graduate School at Tufts University Boston, MA 02111 Medical Research: What is the background for this study? Dr. Meydani: A significant number of older people are zinc deficient which can result in a compromised immune system which weakens as the body ages, making older adults more susceptible to infections and higher incidence and morbidity from pneumonia. Older adults with impaired immune response, particularly T cell-mediated function, have a higher susceptibility to infections and cancer. Our research team from the Jean Mayer USDA Human Nutrition Research Center on Aging created a small double-blind, placebo-controlled trial involved adults age 65 or older from three Boston-area nursing homes to determine the feasibility of increasing serum zinc concentrations in older adults. The full findings are published in The American Journal of Clinical Nutrition. These results have a significant public health implication for the older adults because it shows directly that correction of a nutrient deficiency can improve immune response in older adult (a biological function which consistently has been shown to be impaired with aging). (more…)
Author Interviews, Cost of Health Care, Emergency Care / 30.01.2016

MedicalResearch.com Interview with: Jonathan Pinkney MD FRCP Professor of Medicine Plymouth University and Peninsula Schools of Medicine and Dentistry Centre for Clinical Trials and Population Studies Plymouth Science Park Phase 1 Honorary Consultant Physician Diabetes and Endocrinology University Medicine Derriford Hospital Plymouth Hospitals NHS Trust Plymouth UK Medical Research: What is the background for this study? Dr. Pinkney: The background is that the study was funded by the National Institute for Health Research in response to a call for research on the problem of unscheduled emergency admissions to hospitals in the UK. The rates of patient attendance at emergency departments and subsequent acute admissions to hospitals have risen year on year. Rising numbers of admissions have significant knock-on effects for acute hospitals including crowding in emergency departments, pressures on staffing, and disruption of elective treatment because of high rates of bed occupancy. The increase in admissions has been associated largely with increased short stay admissions. As a result, there has been an increasing view that a significant proportion of acute medical admissions may not be necessary, and in this respect may be said to be avoidable. There had been relatively limited research on how hospitals can best reduce these avoidable admissions. The main aims of the study were to investigate how senior staff in four major acute hospitals in south west England endeavour to avoid unnecessary acute admissions, and to examine a range of different systems in place in different hospitals to avoid unnecessary admissions. We called this project the "3A" or Avoidable Acute Admissions study. The 3A study was a mixed methods study with a strong emphasis on the narrative experience of patients, carers and healthcare professionals in the emergency departments and associated units of these four acute hospitals. The quantitative component of the study was an application of Value Stream Mapping (VSM), a technique from lean theory, and this was used to identify and measure points of delay in the patient journey. (more…)
Author Interviews, BMJ, Heart Disease, Tobacco, Toxin Research / 29.01.2016

MedicalRearch.com Interview with: Maciej Goniewicz, PhD, PharmD Assistant Professor of Oncology, Department of Health Behavior Roswell Park Cancer Institute (RPCI Medical Research: What is the background for this study? What are the main findings? Dr. Goniewicz: In addition to nicotine and its solvents (like propylene glycol and vegetable glycerin), a majority of e-cigarettes contain flavorings. Users of e-cigarettes can choose their favorite flavor among hundreds of various options, including fruit, coffee, menthol, vanilla, chocolate, candy flavors, and tobacco.  Although many flavorings used in e-cigarettes are recognized as safe when used in food products, little is known about their potential toxicity when inhaled. In this study we measured one such flavoring, benzaldehyde. This flavoring is commonly used in food and cosmetics. We know that there is little to no toxicity if we eat this compound or if we apply it on our skin. However, workers who regularly inhale a high concentration of benzaldehyde often report irritation of their eyes and throat. In this study, we tested 145 e-cigarette products, and we found benzaldehyde in 108 products. Interestingly, the highest levels of benzaldehyde were detected in cherry-flavored products.  (more…)
Author Interviews, Mayo Clinic, Melanoma / 29.01.2016

MedicalResearch.com Interview with: Mariah L. White, MD Department of Radiology Mayo Clinic Rochester, MN 55905 Medical Research: What is the background for this study? Dr. White: Stage IV (metastatic) melanoma carries a poor prognosis with median survival of 6 to 10 months, claiming over 9000 lives per year in the United States. There is evidence that aggressive focal treatment in patients with oligometastatic disease with complete eradication of all clinical disease can result in durable remissions and potentially improve overall survival. Oligometastatic disease is typically defined as metastatic disease limited to 5 or fewer lesions. Thermal ablation is an alternative local management strategy to resection of limited sites of distant spread.  Similar to surgical management of oligometastatic disease it can be used in conjunction with systemic medical therapy or as an alternative in those patients where SMT is not well tolerated or unable to achieve complete remission. (more…)
Author Interviews, Cost of Health Care, Nutrition / 29.01.2016

MedicalResearch.com Interview with: Rajan Anthony Sonik Lurie Institute for Disability Policy Heller School for Social Policy and Management Brandeis University Waltham, MA Medical Research: What is the background for this study? What are the main findings? Response: We know that food insecurity (experiencing hunger, insufficient food, or concerns about having enough food) is associated with a host of health problems, ranging from behavior health conditions to iron deficiencies. However, understanding the relationship between food insecurity and healthcare utilization and cost patterns has been more difficult to assess with available data. Presumably, rises in food insecurity should worsen health, which in turn should increase healthcare utilization and ultimately costs. To examine this topic, I actually looked at this in the opposite way by asking if a decrease in food insecurity might lead to decrease in costs. The opportunity to do so arose in the form of the April 2009 increase in benefit levels for the Supplemental Nutrition Assistance Program (SNAP; formerly the Food Stamps Program) that were part of the American Recovery and Reinvestment Act (commonly referred to as the “stimulus package”). SNAP has been shown to alleviate food insecurity, and so this increase in benefits created the chance to explore my question. I analyzed Massachusetts data from October 2006 to August 2012 using interrupted time series models and found that inpatient Medicaid cost growth in Massachusetts fell by 73% (p = 0.003) after the increase in SNAP benefits. Moreover I found that decreased admissions were the primary driver of this outcome rather any patterns in health care inflation. In addition, I found that, for people with selected chronic illnesses that create heightened sensitivity to food insecurity, the drop in cost growth was even greater (the diseases studied were sickle cell disease, diabetes, malnutrition/failure to thrive, inflammatory bowel disease, asthma, and cystic fibrosis). (more…)
Author Interviews, BMJ, Nutrition / 29.01.2016

MedicalResearch.com Interview with: Helmut Schröder,  Ph.D. Head Cardiovascular Epidemiology and Nutrition Research Group, CIBER Epidemiology and Public Health Senior Research Scientist Cardiovascular Risk and Nutrition Research Group (CARIN-ULEC) IMIM-Hospital del Mar Medical Research Institute Parc de Recerca Biomèdica de Barcelona Barcelona,Spain Medical Research: What is the background for this study? What are the main findings? Dr. Schröder: A healthy diet is paramount for physical and mental health. Healthy dietary patterns are more expensive than unhealthy choices. But it is unknown how increases in individual diet cost, driven by rising food prices, affects consumers’ food choices and, consequently, overall diet quality. It is of particular concern that low diet quality is more often found in segments of the population with the lowest socioeconomic status. The he aim of our research was to determine the prospective association between changes in individual diet cost and changes in diet quality in the REGICOR (Registre Gironí del Cor) cohort, a representative Spanish population. Additionally, we determined the impact of changes in diet cost on body weight. We have found that an increase in the energy-adjusted diet cost predicted a shift to a healthier diet and to better weight management. Diet quality strongly increased if money previously spent on unhealthy food choices such as fast food and pastry is instead spent on vegetables and fruits. Furthermore, we have seen that a 1.4€ increase in average spending on food is associated with the consumption of 74 grams more vegetables and 52 grams more fruit, per person per day, for a 1000 kcal diet. Conversely, a reduction of 0.06€ in average spending is linked to a decrease of 121 grams of vegetables and 94 grams of fruit, as well as increased consumption of foodstuffs like fast food and baked goods. (more…)
Author Interviews, Breast Cancer, Radiation Therapy / 29.01.2016

MedicalResearch.com Interview with: Quyen Chu, MD, MBA, FACS Charles Knight Professor in Surgery Professor of Surgery Chief, Surgical Oncology Director, Surface Malignancies Program Feist-Weiller Cancer Center Louisiana State University Health Sciences Center, Shreveport Medical Research: What is the background for this study? What are the main findings? Dr. Chu: In 2004, national treatment recommendations changed for a select group of elderly breast cancer patients with the Cancer and Leukemia Group B (CALGB) 9343 trial. Research found that postoperative radiation therapy was not needed to prolong survival in a select group of women 70 or older, mainly those with a small, estrogen receptor (ER) positive tumor, and receiving anti-hormone therapy.  Even with this information, nearly two thirds of the women who fit these criteria were still receiving radiation therapy after undergoing a lumpectomy although it has been proven to be safe to omit. We found that as a nation, we are mostly not following the national guideline on breast cancer treatment and that the possible side effects of RT can be avoided. Medical Research: What should clinicians and patients take away from your report? Dr. Chu: Clinicians and patients should take away from this report that in U.S. women 70 or older with stage I, ER+ breast cancer and receiving anti-hormone therapy, radiation therapy is overly utilized as it is not needed to prolong survival.   (more…)
Author Interviews, Exercise - Fitness, Nutrition, Protein, Weight Research / 29.01.2016

MedicalResearch.com Interview with: Professor Stuart M. Phillips Ph.D., FACSM, FACN Department of Kinesiology, McMaster University, Canada Exercise Metabolism Research Group – Protein Metabolism Research Lab Director, Physical Activity Centre for Excellence Medical Research: What is the background for this study? What are the main findings? Prof. Phillips: During weight loss with diet only people lose both muscle and fat and muscle. The long-term health consequences of losing metabolically active muscle versus fat are not likely to be beneficial. In the context of this study we thought perhaps the preservation of muscle would also be important in very active young men. We wanted to see whether when men were in a very large energy deficit (40% less energy than they required) higher protein (2.4 g/kg/d) could preserve muscle mass and still result in increased function (strength) and fitness. Our results show that during a marked energy deficit that consumption of 2.4 g protein/kg/d was more effective than consumption of a diet containing 1.2 g protein/kg/d in promoting increases in LBM (1.2 vs 0.1kg increase) and losses of fat mass (-4.8kg vs. -3.5kg) when combined with a high volume of resistance and anaerobic exercise. (more…)
Author Interviews, Immunotherapy / 29.01.2016

MedicalResearch.com Interview with: Dr. Mark Heffernan PhD Dr. Mark Heffernan is a Nexvet co-founder, and has served as Chief Executive Officer and a member of the Nexvet board of directors since April 2011. In 2003, Dr. Heffernan co-founded Opsona Therapeutics Ltd., an Irish biotechnology company focused on human mAbs for inflammatory and oncology diseases. He also worked in R&D and business development roles for two Australia biotechnology companies, Antisense Therapeutics Limited and Metabolic Pharmaceuticals Pty Ltd., for a number of years. Dr. Heffernan has a BSc in Biochemistry and Pharmacology and a Ph.D. in Biochemistry from Monash University (Australia). MedicalResearch.com: Tell me about Nexvet and its background? What is the company’s mission statement or goal? Dr. Heffernan:   Nexvet is a public (NASDAQ: NVET) clinical-stage biopharmaceutical company focused on developing and commercializing novel, species-specific biologics for companion animals (pets). We were founded five years ago and our mission has been to transform animal medicine by leading the introduction of biologic therapies (monoclonal antibodies and therapeutic proteins) into everyday veterinary practice. Many chronic conditions stand to benefit from biologic options, just as they have in human medicine, such as inflammation and cancer. Taking products with validation in human medicine is part of Nexvet’s development strategy, which leverages human data from these innovative therapies and rapidly advances the veterinary equivalents. MedicalResearch.com: Can you tell us about the PETization™ platform? What is it designed to do? Dr. Heffernan:   PETization™ is Nexvet’s proprietary approach to monoclonal antibody (mAb) candidate design. It uses an algorithmic approach, ‘crunching’ libraries of natural antibody sequence data to rapidly design mAbs that are “100% species-specific” to a target species. This significantly reduces the risk of an immunogenic reaction, while preserving the parent (or ‘starting’) mAb’s affinity for its target. PETization has demonstrated a reduction in the time and cost typically associated with the development of monoclonal antibodies using conventional methods, such as CDR grafting and its affinity maturation. Thus far Nexvet has used PETization to successfully convert human and rodent mAbs into canine, feline and equine mAbs. These candidates have demonstrated safety and efficacy across the clinical development spectrum including proof-of-concept (every species) right through to late-stage pivotal studies (in dogs). (more…)
Author Interviews, Biomarkers, Heart Disease, JACC / 29.01.2016

MedicalResearch.com Interview with: Joseph Yeboah MD, MS Heart and Vascular Center of Excellence Assistant Professor, Cardiology Maya Angelou Center for Health Equity Epidemiology & Prevention Wake Forest University School of Medicine  Medical Research: What is the background for this study? What are the main findings? Dr. Yeboah: In 2013 the American College of Cardiology/American Heart Association introduced a new way of atherosclerotic cardiovascular disease (ASCVD) risk assessment. The document also recommended the use of additional risk markers including coronary artery calcium (CAC), ankle brachial index, high sensitivity C-reactive protein, family history of ASCVD, to refine ASCVD risk assessment for primary prevention. The goal of this study was to assess the utility of these recommended additional risk markers for primary ASCVD risk assessment in the most ethnically diverse prospective cohort in the USA. We found that among the additional risk markers considered in this analysis, only coronary artery calcium modestly improved primary ASCVD risk assessment. (more…)
Author Interviews, Brigham & Women's - Harvard, Johns Hopkins, Race/Ethnic Diversity, Surgical Research / 29.01.2016

MedicalResearch.com Interview with: Adil H. Haider, MD, MPH Kessler Director for the Center for Surgery and Public Health Brigham and Women's Hospital Harvard Medical School, and the Harvard T.H. Chan School of Public Health Deputy Editor of JAMA SurgeryAdil H. Haider, MD, MPH Kessler Director for the Center for Surgery and Public Health Brigham and Women's Hospital  Harvard Medical School, and the Harvard T.H. Chan School of Public Health Deputy Editor of JAMA Surgery  Medical Research: What is the background for this study? Dr. Haider: Racial/Ethnic disparities have been identified in multiple surgical fields. They are thought to be caused by a complex interplay of patient-, provider-, and systems-level factors. As healthcare professionals, providers play a key role in the care and outcomes that patients experience. However, despite published research about the existence of disparities, it remains unknown the extent to which surgeons perceive that racial/ethnic disparities exist. Medical Research: What are the main findings? Dr. Haider: In a pilot study designed to assess the extent to which US surgeons report awareness of racial/ethnic disparities, only 36.6% agreed that racial/ethnic disparities exist in healthcare. Even fewer, 11.6% acknowledged that disparities were present in their hospital or clinic, and a mere 4.7% reported disparities in their personal practice. (more…)
Author Interviews, BMJ, Nutrition, Weight Research / 29.01.2016

MedicalResearch.com Interview with: Monica L. Bertoia, MPH, PhD Instructor in Medicine, Channing Division of Network Medicine Brigham and Women’s Hospital & Harvard Medical School Research Associate, Department of Nutrition Harvard T. H. Chan School of Public Health Boston, MA 02115 Medical Research: What is the background for this study? What are the main findings? Response: Most weight loss studies have focused on one type of flavonoid, the flavan-3-ols found in green tea, and are limited to small numbers of overweight and obese study participants. We examined 7 subclasses of flavonoids and weight change in 124,086 healthy adults who reported their diet and weight repeatedly over up to 24 years. (more…)
Abuse and Neglect, Accidents & Violence, Author Interviews, JAMA, Mental Health Research / 29.01.2016

MedicalResearch.com Interview with: Tracie O. Afifi, PhD Associate Professor of Epidemiology CIHR New Investigator (2013-2018) Departments of Community Health Sciences and Psychiatry College of Medicine, Faculty of Health Sciences University of Manitoba  Medical Research: What is the background for this study? Dr. Afifi: Recent studies in the US have examined predictors and correlates of suicide among solider, but none of these studies have investigated the potential role that child abuse exposure may play in suicide-related outcomes. In addition no representative military and civilian comparisons from any country have examined possible differences in the prevalence of child abuse exposure and the potential differences in the relationships between child abuse exposure and suicide-related outcomes in these populations. This study uses nationally representative military and civilian samples from Canada. Medical Research: What are the main findings? Dr. Afifi: Child abuse was more prevalent among Regular Forces personnel (47.7%) and Reserve Forces personnel (49.4%) compared to the Canadian general population (33.1%). Child abuse exposure was associated with an increased likelihood of suicidal thoughts, plans, and attempts in military and civilian populations, with associations weaker for many outcomes in military personnel relative to civilians. Deployment-related trauma was associated with past-year suicidal thoughts and suicide plans. However, relative to deployment-related trauma, child abuse exposure had a more robust association with suicide-related outcomes. (more…)
Author Interviews, BMJ, Mental Health Research, Pediatrics, Pharmacology / 29.01.2016

MedicalResearch.com Interview with: Tarang Sharma, PhD candidate  Nordic Cochrane Centre, Rigshospitalet University of Copenhagen, Faculty of Health and Medical Sciences, Denmark Medical Research: What is the background for this study? What are the main findings? Response: These newer antidepressants are some of the most prescribed medications in the world and previous research in the area has suggested an increased suicide risk on these drugs in young people, but only when unpublished clinical study report data is used. Such risk is missing when the published articles are considered due to severe selective reporting and publication bias. In our study we found that the research design of most of the trials was very poor and there were major discrepancies in the reporting, leading to the under-estimation of harms. Despite these problems we still found that both suicidality and aggression were more than doubled in children and adolescents on antidepressants compared to those on placebo. (more…)
Author Interviews, Immunotherapy, NEJM, Transplantation, UCSF / 29.01.2016

MedicalResearch.com Interview with: Dr. Flavio Vincenti, M.D Clinical Professor of Medicine and Surgery Departments of Medicine and Surgery Endowed Chair in Kidney Transplantation University of California, San Francisco San Francisco, CA 94143 Medical Research: What is the background for this study? What are the main findings? Dr. Vincenti: This is a phase 3 study of belacept immunosuppression as compared to cyclosporine based immunosuppression in renal transplant recipients randomly assigned to 2 treatments arms of belatacept and a controlled arm consisting of cyclosporine. The main finding of this study is that Belatacept, a fusion receptor protein that blocks co-stimulation and is administered intravenously on the maintenance of a 4 weekly maintenance therapy, had superior outcomes at 5 and 7 years as compared to patients on a CsA-based regimen. The 7 year data show that patients on either arm of belatacept had a 43 percent risk reduction of deaths or grafts loss as compared to patients treated with cyclosporine. In addition, belatcept patients had significantly better preservation of renal function throughout the 7 years of follow up and had lower incidence of donor specific antibodies. Nephrotoxicity from cyclosporine and donor specific antibodies are important causes of late graft loss. (more…)
Addiction, ADHD, Author Interviews, Eating Disorders / 29.01.2016

MedicalResearch.com Interview with: Dr. Kenneth Koblan PhD Sunovion Pharmaceuticals Inc. Fort Lee, NJ and Marlborough, MA Medical Research: What is the background for this study? Dr. Koblan: Assessing abuse potential is important in the clinical development process for any therapy affecting the central nervous system, especially those that may act on dopamine and norepinephrine neurotransmitter systems. Human abuse liability studies are conducted to evaluate the abuse potential associated with drugs that affect the central nervous system. Drugs that increase dopamine levels may be associated with stimulant effects and abuse (e.g., cocaine and amphetamine), whereas drugs that increase serotonin and/or norepinephrine levels are not generally associated with recreational abuse (e.g., selective serotonin reuptake inhibitors). Among drugs with effects on dopamine neurotransmission, slowing the rate of absorption is thought to reduce abuse potential, and increasing the rate of elimination is thought to reduce rewarding effects and abuse liability due to sustained elevations in drug concentrations resulting in sustained inhibition of dopamine transporters (DAT). Dasotraline is an investigational dopamine and norepinephrine reuptake inhibitor from Sunovion in late-stage development to evaluate its use in treating the symptoms of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder (BED). Dasotraline has slow absorption and elimination that supports the potential for plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval at steady state. (more…)
Author Interviews, Cancer, Colon Cancer, Surgical Research / 29.01.2016

More on Colon Cancer on MedicalResearch.com MedicalResearch.com Interview with: Samantha Hendren, MD, MPH Associate Professor of Surgery Colorectal Surgery University of Michigan  Medical Research: What is the background for this study? What are the main findings? Response: We studied colorectal cancer nationally, and found that about 1 in 7 colorectal cancer patients in the U.S. (that is, 14.7%) is diagnosed before the age of 50.  We also found that these younger colorectal cancer patients were diagnosed when their cancers were more advanced (higher “stage”, meaning more of them had spread to lymph nodes and/or to other organs).  Part of the reason for this is that these young patients are often diagnosed only after their cancers start to cause symptoms such as anemia, bowel bleeding or a blockage in the colon. The age of 50 is when screening for colorectal cancer is started in the U.S.  This study means that a pretty large proportion of colorectal cancers are  happening in people who are too young to receive screening tests.  To put this in context, breast cancer screening often begins at age 40, and less than 5% of invasive breast cancers occur in women under that age. Our study found that about 15% of colorectal cancers are diagnosed before the screening age of 50. Fortunately, the young patients with colorectal cancer do a little better than you might predict, knowing that they are diagnosed at a worse cancer “stage”.  For the young patients under 50, about 68% survived 5 years, while about 67% of the patients 50 and older survived 5 years.  It looks like patients’ young age helps them in their cancer treatment and survival; our study found that treatment may be a bit more aggressive in the younger patients. (more…)
Author Interviews, Brigham & Women's - Harvard, Diabetes, Diabetologia, Sleep Disorders / 29.01.2016

MedicalResearch.com Interview with: Dr. Yanping Li Research Scientist Harvard T.H.Chan School of Public Health Boston, MA 02115

Medical Research: What is the background for this study? What are the main findings? Dr. Li: Sleeping difficulty is a common disorder but always lack of attention from both the patients and physicians. Our study finds that women with sleeping difficulty is associated with a higher risk of type 2 diabetes. (more…)
Author Interviews, JAMA, Smoking / 29.01.2016

MedicalResearch.com Interview with: John Cunningham, PhD Senior Scientist, Social & Epidemiological Research Centre for Addiction and Mental Health Toronto, Ontario  Medical Research: What is the background for this study? What are the main findings? Dr. Cunningham: Nicotine Replacement Therapy (NRT) has been found to improve tobacco cessation success rates in clinical trials where there is accompanying behavioral support. However, population survey data has indicated that people who purchase NRT as part of a quit attempt are no more successful at quitting smoking than people who don’t use NRT as part of their quit attempt. While causal statements about the effectiveness of NRT cannot be made based on the population survey findings, it does raise concerns about the effectiveness of NRT when there is no accompanying behavioral support. Our trial used an interesting design where participants were recruited for a longitudinal survey about their patterns of smoking. As part of this survey, participants were asked if they would be interested in nicotine patches to help them quit smoking, if they were offered for free. Of those participants who said they were interested, a randomized half were actually sent a five-week supply of nicotine patches. The other half of participants were not sent the nicotine patches and were, in fact, unaware that nicotine patches were sent to others in the trial. Participants were followed-up at 8 weeks and 6 months, with those participants receiving free-of-charge nicotine patches being more likely to report current abstinence compared to those participants not sent the free nicotine patches (30-day self-reported abstinence at 6-months was 7.6% versus 3.0% respectively; odds ratio (OR), 2.65; 95% CI, 1.44 - 4.89, p = .002). (more…)
Author Interviews, Emergency Care, Social Issues / 29.01.2016

MedicalResearch.com Interview with: Jessica Moe MD, MA, PGY4 FRCPC Emergency Medicine MSc (Candidate) Clinical Epidemiology RCPS Emergency Medicine Residency Program University of Alberta Edmonton, Alberta Medical Research: What is the background for this study? What are the main findings? Dr. Moe: Patients who leave the emergency department (ED) prior to completing their care account for a substantial number of annual visits; some of these patients are at high medical risk. We used the National Hospital Ambulatory Medical Care Survey from 2009-2011 to examine a nationally representative sample of patients who left the ED prior to completing care. Our work suggests that, among patients who leave the ED prematurely, the degree of medical risk may be related to whether or not these patients saw a medical professional prior to leaving the ED. Patients who leave prior to medical evaluation are generally younger and present with lower acuity visits, whereas patients who leave after medical evaluation tend to be older, are more likely to arrive by ambulance and have higher acuity visits. (more…)