Author Interviews, Infections, JAMA / 05.09.2017

MedicalResearch.com Interview with: Cinnamon S. Bloss, Ph.D. Associate Professor, Department of Psychiatry Department of Family Medicine and Public Health Division of Health Policy University of California, San Diego MedicalResearch.com: What is the background for this study? Response: In 2016, the FDA invited public comments on a draft environmental assessment for a proposed field trial of a genetically modified (GM) mosquito designed to suppress wild-type Aedes aegypti mosquitoes. The preliminary finding from the environmental assessment indicated the trial would be unlikely to adversely affect the environment in Key Haven, Florida, the proposed trial site. We assessed public response to this trial based on the content of public comments submitted to the FDA by requesting comment transcripts through the Freedom of Information Act. (more…)
Alzheimer's - Dementia, Author Interviews, Cognitive Issues, JAMA / 05.09.2017

MedicalResearch.com Interview with: Carol A. Derby, Ph.D. Research Professor, The Saul R. Korey Department of Neurology Research Professor, Department of Epidemiology & Population Health Louis and Gertrude Feil Faculty Scholar in Neurology Albert Einstein College of Medicine Bronx, NY 10461 MedicalResearch.com: What is the background for this study? Response: The population over the age of 85 is expected to triple in the coming decades, and with the aging of the population, the number of individuals living with dementia is projected to increase dramatically. While dementia prevalence rates are driven by demographic shift to older ages, changes in dementia incidence- the rate at which new cases are diagnosed, would also impact the proportion of the population affected in the coming decades. Recently, studies have suggested that dementia incidence rates may be declining in some populations, although the results have not been consistent. Better understanding trends in dementia rates is important for public health planning. Our objective was to determine whether there has been a change in the incidence of dementia diagnosis within a community residing group of over older adults followed by the Einstein Aging Study, at the Albert Einstein College of Medicine, in the Bronx, NY between the years 1993 and 2015. To accurately characterize trends over time in disease rates requires separating the effects of age and the effects of calendar time. Therefore, we conducted a birth cohort analysis in which we examined age specific dementia incidence rates by birth year, for individuals born between 1910 and 1940. The analysis included over 1300 individuals over the age of 70, who were free of dementia when they enrolled in the study. Dementia was diagnosed using identical criteria over the entire study period, and study recruitment was also consistent over the period. We also examined trends in cardiovascular co-morbidities that have been related to dementia risk, as well as trends in education.  (more…)
Author Interviews, BMC, OBGYNE, Pediatrics / 05.09.2017

MedicalResearch.com Interview with: Jan Alexander, MD,PhD Norwegian Institute of Public Health Oslo Norway  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study was the widespread uncertainty and general concern among the public about increasing exposure to weak radio frequency electromagnetic fields (EMF-RF). The concern on whether using your cell phone while pregnant can harm your foetus are mainly due to the extensive use of cell phones, that emit EMF-RF. Even though the RF-EMF exposure that may reach the foetus is very low, evidence from previous epidemiological studies with mothers and children are inconsistent as to whether EMF-RF emission from cell phone might harm the developing brain of the foetus. This includes also animal experiments where the exposure may be very different from that in humans. We therefore studied the association between maternal cell phone use during pregnancy and child’s neurodevelopment at 3 and 5 years. We included around 45,000 mother and their children from all over Norway from the Norwegian Mother and Child Study (MoBa study) and used language development as the outcome because we in previous studies found this parameter to be sensitive to exposure to neurotoxicants. T here was no evidence of a harmful effect of the mother using her cell phone during pregnancy on her child’s neurodevelopment at 3 and 5 years. Surprisingly, we even found that the more the mother was using her cell phone during pregnancy the better language and motor skills her child had at 3 years of age. We observed no associations when the child was 5 years old. (more…)
Author Interviews, Boehringer Ingelheim, Heart Disease, PAD / 03.09.2017

MedicalResearch.com Interview with: John Eikelboom MBBS Associate Professor, Division of Hematology & Thromboembolism Department of Medicine Canada Research Chair in Cardiovascular Medicine Canadian Institutes for Health Research McMaster University MedicalResearch.com: What is the background for this study? Response: Cardiovascular disease affects 1 in 25 persons around the world and a total of more than 300 million individuals. Thrombus formation at the site of a ruptured atherosclerotic plaque is the commonest mechanism of myocardial infarction and ischemic stroke in patients with cardiovascular disease. Aspirin is effective for the prevention of these complications but reduces the risk by only 19% during long term therapy. Rivaroxaban has previously been tested in the ATLAS ACS-2 TIMI 51 trial at doses of 2.5 mg twice daily or 5 mg twice daily on top of background antiplatelet therapy and has been shown to reduce major adverse cardiovascular events as well as mortality. We tested these same doses of rivaroxaban for the prevention of cardiovascular death, stroke or myocardial infarction in patients with stable cardiovascular disease. (more…)
Author Interviews, Heart Disease, Lipids / 03.09.2017

MedicalResearch.com Interview with: Dr Rahul Potluri Senior author and founder of the ACALM Study Unit Aston Medical School Aston University Birmingham, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: The links between hyperlipidaemia and cancer has been exciting scientists in recent years.  We have previously shown an association with breast cancer and hyperlipidaemia using a cross-sectional dataset in 2014. In 2016 we showed that in patients with the four main cancers in the UK (namely Breast, Lung, Colon and Prostate) that the presence of hyperlipidaemia improved the long term mortality and prognosis of these patients.  In this study utilising a big data, longitudinal study methodology, we looked at 16043 healthy women above the age of 40 with hyperlipidaemia and compared these to an age and gender matched control sample of 16043 healthy women without high cholesterol. We then followed up these patients and found that subsequent breast cancer rates in the women with hyperlipidaemia were 45% lower. Subsequent mortality in those patients who developed breast cancer was also 40% lower in the hyperlipidaemia group compared to the non-hyperlipidaemia controlled sample. (more…)
Author Interviews, Dermatology, University of Pennsylvania / 03.09.2017

MedicalResearch.com Interview with: Megan H. Noe MD, MPH Clinical Instructor and Post-Doctoral Research Fellow University of Pennsylvania, Department of Dermatology Perelman Center for Advanced Medicine Philadelphia, PA 19104 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous research has shown that patients with psoriasis have higher rates of hypertension, diabetes, cardiovascular disease and chronic kidney disease that may put them at an increased risk of death. Our research found that patients with psoriasis covering more than 10% of their body had almost double the risk of death than people of the same age with similar medical conditions, but without psoriasis. (more…)
Author Interviews, Dermatology, Infections / 02.09.2017

MedicalResearch.com Interview with: Kyle T. Amber, MD Department of Dermatology UC Irvine Health Irvine, CA 92697  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with autoimmune blistering diseases often requires significant immunosuppression in order to control their diseases. Pneumocystis pneumonia is an opportunistic infection that occurs in immunocompromised patients.  This study was borne out of my observation that most European experts in the treatment of autoimmune blistering disease did not give routine prophylaxis for pneumocystis. Among American dermatologists, there was far more disagreement. This was a collaborative effort of several international tertiary care centers. We demonstrated that the incidence of pneumocystis in 801 patients with autoimmune blistering disease was only 0.1%, which fell well below previous recommendations in the literature suggesting an incidence of 3.5% in order to justify prophylaxis. (more…)
Author Interviews, Heart Disease, Nutrition / 02.09.2017

MedicalResearch.com Interview with: Dr. Mahshid Dehghan, PhD Investigator- Nutrition Epidemiology Program Population Health Research Institute Senior Research Associate – Department of Medicine McMaster University MedicalResearch.com: What is the background for this study? Response: For decades, dietary guidelines have largely focused on reducing total fat and saturated fat intake based on the idea that reducing fat consumption should reduce the risk of CVD. But this did not take into account what nutrients replace saturated fats in the diet. Given that carbohydrates are relatively inexpensive, reducing fats (especially saturated fat) is often accompanied by increased carbohydrate consumption. This approach continues to influence health policy today. The guidelines were developed some 4 decades back mainly using data from some Western countries (such as Finland) where fat and saturated fat intakes were very high (eg total fat intake was >40% of caloric intake and saturated fats was >20% of caloric intake). It is not clear whether the harms seen at such high levels applies to current global intakes or countries outside North America and Europe where fat intakes are much lower. The PURE (Prospective Urban Rural Epidemiology) study is a large international cohort study of more than 157,000 people aged 35 to 70 years from 18 low-income, middle-income, and high-income countries on 5 continents. In this study, 135,335 individuals with dietary information and without cardiovascular disease at baseline were included in the study. Standardized questionnaires were used to collect information about demographics, socio-economic factors, lifestyle behaviors, health history and medication use. Standardized case-report forms were used to record data on major cardiovascular events and mortality during follow-up, which were adjudicated centrally in each country by trained physicians using standard definitions. The participants were followed-up for 7.5 years, during which time 4784 major cardiovascular events and 5796 deaths were recorded. (more…)
Author Interviews, Education, Heart Disease / 31.08.2017

MedicalResearch.com Interview with: Dr. Julien Vaucher  Physician and clinical research fellow (joint first author) Department of Internal Medicine Lausanne University Hospital Lausanne, Switzerland MedicalResearch.com: What is the background for this study? Response: Since the sixties, traditional studies have found that people who stay longer in the educational system subsequently develop less coronary heart disease. However, whether this association is causal is not clear, partly because randomised controlled trials are practically infeasible in this area. In our study, we used a genetic approach, called Mendelian randomization, that represents the next best thing to do.Based on genetic variants randomized by nature, we were able to randomize individuals according to 162 genetic markers that associate with more or less education. In other words, we used genetic markers, free from condounding factors, as proxies of education to reproduce the conditions of a trial. Then, if the genetic markers also associate together with coronary heart disease, the association between education and coronary heart disease is likely to be causal. (more…)
Author Interviews, Cannabis, Kidney Disease, UCSF / 31.08.2017

MedicalResearch.com Interview with: Dr. Julie H. Ishida MD Division of Nephrology, Department of Medicine San Francisco and San Francisco Veterans Affairs Medical Center University of California MedicalResearch.com: What is the background for this study? What are the main findings? Response: Marijuana is becoming increasingly accepted in the United States, and animal studies suggest that marijuana could affect kidney function. However, data in humans are limited to case reports of acute kidney injury related to synthetic cannabinoid use and small cohort studies of relatively short duration. Among 3,765 participants with normal kidney function in the Coronary Artery Risk Development in Young Adults or CARDIA study, my colleagues and I found that higher marijuana use was associated with lower kidney function at the start of the our study. However, we did not find that marijuana was associated with change in kidney function or albuminuria, which is a sign of kidney damage, over long-term follow-up. (more…)
Author Interviews, MRI, Schizophrenia / 31.08.2017

MedicalResearch.com Interview with: Irina Rish PhD IBM T.J. Watson Research Center Yorktown Heights, NY 10598  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Schizophrenia is a chronic and severe psychiatric disorder that affects roughly about 1% of population. Although it is not as common as other mental disorders, such as depression, anxiety, and attention deficit disorder (ADD), and so on, schizophrenia  is perhaps one of  the most debilitating psychiatric disorders,  preventing people from normal  functioning in daily life. It is characterized primarily by a range of psychotic symptoms, including hallucinations (false auditory, visual or tactile perceptions detached from reality), as well as delusions, disorganized thoughts, speech and behavior, and multiple other symptoms including difficulty showing (and recognizing) emotions, poor executive functioning, inattentiveness, problems with working memory,  and so one. Overall, schizophrenia has a devastating impact not only on patients and their families, but on the economy, as it was estimated to cost the US about 2% off  gross national product in treatment costs, missed work, etc. Thus, taking steps towards better understanding of the disease can potentially lead to more accurate early diagnosis and better treatments. In this work, the objective was to identify "statistical biomarkers' of schizophrenia from brain imaging data (specifically, functional MRI), i.e. brain activity patterns that would be capable of accurately discriminating between schizophrenic patients and controls, and reproducible (stable) across multiple datasets. The focus on both predictive accuracy (generalization to previously unseen subjects) as well as on stability (reproducibility) across multiple datsets differentiates our work from majority of similar studies in neuroimaging field that tend to focus only on statistically significant differences between such patterns on a fixed dataset, and may not reliably generalize to new data. Our prior work on neuroimaging-based analysis of schizoprenia http://journals.plos.org/plosone/article/related?id=10.1371/journal.pone.0050625, as well as other research in the field, suggest that disrupted functional connectivity can be a much more informative source of discriminative patterns than local changes in brain activations, since schizophrenia is well known to be a "network disease", rather than a localized one. (more…)
Author Interviews, Diabetes, Heart Disease, Pharmacology / 31.08.2017

MedicalResearch.com Interview with: Todd Hobbs, MD Vice President and Chief Medical Officer Novo Nordisk North America  MedicalResearch.com: Would you tell us a little about liraglutide? How does it work to control diabetes/blood sugar?  Response: Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration (FDA) in 2010 to help lower blood sugar in adults with type 2 diabetes. Victoza® is the #1 prescribed (GLP-1) receptor agonist. Victoza® is a non-insulin, once-a-day medication that helps lower blood sugar levels in adults with type 2 diabetes by increasing glucose-dependent insulin release, inhibiting glucagon secretion, and slowing gastric emptying. On August 25, the FDA approved a new indication for Victoza®, making it the only type 2 diabetes treatment approved to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. (more…)
OBGYNE, Pediatrics, Weight Research / 30.08.2017

MedicalResearch.com Interview with: Leanne M. Redman MS, PhD LPFA Endowed Fellowship Associate Professor Pennington Biomedical Research Center Baton Rouge, Louisiana  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Two well-documented risk factors for aberrant weight gain and obesity is whether your mother was obese when she was pregnant and the amount of weight she gained. Up until now few studies have asked questions about whether the pattern of weight gain in pregnancy affect outcomes in offspring, such as birth weight. In a cohort of over 16,000 pregnant women and infants, we found that regardless of the obesity status (BMI) of the mother at the time of pregnancy, weight gain that occurs up until week 24, had the strongest effect on infant birth weight. Infants born to mothers who had weight gain in excess of the 2009 IOM guidelines from conception until week 24, had a 2.5 times higher likelihood of being born large for gestational age. The weight gain that occurred after 24 weeks until delivery, did not attenuate this risk. (more…)
Author Interviews, Heart Disease, Lancet, Nutrition / 30.08.2017

MedicalResearch.com Interview with: Ms Victoria Miller Population Health Research Institute DBCVS Research Institut McMaster University, Hamilton, ON Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: PURE study is prospective urban rural epidemiology study that included aged 35 to 70 years from 26 low-income, middle-income, and high-income countries on 5 continents. Data were collected at the community, household, and individual levels. Standardized questionnaires were used to collect information about demographic factors, socio-economic status (education, income, and employment), lifestyle (smoking, physical activity, and alcohol intake), health history and medication use. Standardized case-report forms were used to record data on major cardiovascular events and mortality during follow-up, which were adjudicated centrally in each country by trained physicians using standard definitions. Participants’ habitual food intake was recorded using country-specific (or region specific in India) validated food frequency questionnaires (FFQs) at baseline. The median follow up is 7.4 years and we are aiming for follow up people at least for 15 years. During 7.4 years of follow up more than 6000 CVD and 7000 mortality recorded. Higher fruit, vegetable and legume intake is associated with a lower risk of cardiovascular, non-cardiovascular and total mortality. Our findings show the lowest risk of death in those who consume three to four servings (equivalent to 375-500 grams per day) of fruits, vegetables and legumes per day, with little additional benefit for intake beyond that range. When examined separately, fruit intake is associated with lower risk of cardiovascular, non-cardiovascular and total mortality, while legume intake is inversely associated with non-cardiovascular and total mortality. For vegetables, raw vegetable intake is more strongly associated with lower risk of total mortality compared to cooked vegetable intake. (more…)
Author Interviews, Cognitive Issues, JAMA, Sleep Disorders / 30.08.2017

MedicalResearch.com Interview with: Yue Leng, M.Phil, MD, PhD Postdoctoral Research Fellow Department of Psychiatry, University of California, San Francisco SFVAMC  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sleep-disordered breathing (SDB) is a very common but treatable condition in older adults. Recent evidence has suggested a link between SDB and cognitive decline in the elderly, but previous studies have been conflicting and have used different methods to examine SDB or cognition. Therefore, it is difficult to draw conclusion on the consistency of this association based on each individual study. Moreover, because each study has reported on specific domains using different scales, it is unclear if Sleep-disordered breathing has differential effects on cognitive domains. The current study is the first to quantitively synthesize all published population-based studies, which covers a total of over 4 million adults, and concluded that people with Sleep-disordered breathing were 26% more likely to develop cognitive impairment than those without SDB. They also had slightly worse performance in executive function but not in global cognition or memory.  (more…)
Annals Internal Medicine, Author Interviews, Cleveland Clinic, Heart Disease, Social Issues / 30.08.2017

MedicalResearch.com Interview with: Jarrod Dalton PhD Department of Quantitative Health Sciences Cleveland Clinic , Cleveland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accurate risk assessment is critical for identifying patients who are at high risk of cardiovascular events such as heart attacks and strokes. We evaluated the performance of a widely-used risk assessment tool against the socioeconomic position of patients’ neighborhoods of residence. This tool, called the Pooled Cohort Equations Risk Model, or PCERM, was developed in 2013 jointly by the American College of Cardiology and the American Heart Association (ACC/AHA). We found that the PCERM model accurately characterized risk among patients from affluent communities, but performed more poorly among patients from disadvantaged communities. In particular, for these patients, major cardiovascular events occurred at rates that were as much as 2-3 times than predicted from the PCERM model. (more…)
Author Interviews, Osteoporosis, Pharmacology / 30.08.2017

MedicalResearch.com Interview with: Dieter Bromme, Ph.D. Professor and Canada Research Chair The University of British Columbia Faculty of Dentistry Vancouver, BC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Every three seconds somebody will fracture a bone because of osteoporosis. Several treatments are available to slow down bone loss but all of them have shortcomings ranging from poor bone quality to various side effects. Thus new treatment strategies and novel drug targets are needed that promise efficacy without significant adverse reactions. One of the novel promising targets was cathepsin K, a protease solely responsible for the degradation of our organic bone matrix. Major efforts and funds were spent by the pharmaceutical industry to develop potent and selective cathepsin K inhibitors. These inhibitors were highly effective in preserving bone in clinical trials. Despite the good news, cathepsin K inhibitors were never approved because of various non-skeletal side effects. We hypothesized that these side effects are not caused by off-target effects (drugs react with undesired targets) but by on-target effects. Most drugs that target enzymes are active site-directed compounds and thus will stop the entire activity of the target enzyme. If the target is a multifunctional enzyme, safety problems are preprogrammed. Based on our studies to understand the molecular mechanism of collagen degradation by cathepsin K, we developed the concept of ectosteric enzyme inhibition, which allowed us to identify highly selective collagenase inhibitors of this protease. In our study, we used a red sage-derived small molecule that selectively blocked the collagenase activity of cathepsin K and thus consequently bone degradation in an osteoporosis mouse model without affecting other known functions of the protease. The crucial difference might be that the red sage inhibitor did not block the cathepsin K-mediated degradation of TGF-ß1, a growth factor involved in fibrotic pathologies described in the clinical trials. TGF-ß1 degradation is blocked by these inhibitors and thus accumulates in tissues, causing fibrosis. (more…)
Author Interviews, Mental Health Research, PLoS, University of Pennsylvania / 29.08.2017

MedicalResearch.com Interview with: Yuanyuan Xie, PhD Postdoctoral Researcher Department of Neuroscience University of Pennsylvania Philadelphia, PA 19104 MedicalResearch.com: What is the background for this study? What are the main findings? Response: I joined Dr. Richard Dorsky’s lab in mid 2013 after a lab switch toward the end of the fourth year in my PhD. By then, the Dorsky lab at the University of Utah had published zebrafish lef1 mutants with a hypothalamic neurogenesis phenotype. I was asked to perform an RNA-sequencing (RNA-seq) experiment to identify Lef1-dependent genes. In doing so, I also characterized the cellular phenotype in the hypothalamus of our zebrafish mutants in a greater detail. The first transition of this project happened when I proposed in late 2013 to test whether Lef1’s function was conserved in the mouse hypothalamus. Dr. Dorsky liked that idea, but told me that I could only pursue that idea if there was a Lef1-flox mouse strain available, because he did not want me to delay my graduation after a lab switch by making a new mouse line. Fortunately, a quick google search located the right mouse line published from the group of Dr. Hai-Hui Xue, who was generous enough to share some mice with us. Because the Dorsky lab was a zebrafish lab by then, we collaborated with Dr. Edward Levine to maintain our mice under his animal protocol. I was initially trained by Dr. Levine and his lab specialist Anna Clark for general mouse colony management. After Dr. Levine moved to Vanderbilt University in early 2016, we began to maintain our mice under Dr. Camille Fung’s animal protocol. Dr. Dorsky also supported me in attending a 3-week Cold Spring Harbor Laboratory Course on Mouse Development, Stem Cells & Cancer in mid 2015, which made me much more confident in handling mouse work afterwards. (more…)
Alzheimer's - Dementia, Author Interviews, Gender Differences, Genetic Research, JAMA / 29.08.2017

MedicalResearch.com Interview with: Arthur W. Toga PhD Provost Professor of Ophthalmology, Neurology, Psychiatry and The Behavioral Sciences, Radiology and Engineering Ghada Irani Chair in Neuroscience Director, USC Mark and Mary Stevens Neuroimaging and informatics institute USC Institute for Neuroimaging and Informatics Keck School of Medicine of USC University of Southern California Los Angeles, CA  90032  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The ε4 allele of the Apolipoprotein E (APOE) gene is the main genetic risk factor for late-onset Alzheimer's disease.  This study reexamines and corrects the sex-dependent risks that white men and women with one copy of the ε4 allele face for developing Alzheimer's disease using a very large data set of 57,979 North Americans and Europeans from the Global Alzheimer's Association Interactive Network (GAAIN). The study results show that these men and women between the ages of 55 and 85 have the same odds of developing Alzheimer's disease, with the exception that women face significantly higher risks than men between the ages of 65 and 75.  Further, these women showed increased risk over men between the ages of 55 and 70 for mild cognitive impairment (MCI), which is often a transitional phase to dementia. (more…)
Author Interviews, Cancer Research, HIV, JAMA / 29.08.2017

MedicalResearch.com Interview with: Fahad Mukhtar MD MPH Department of Epidemiology and Biostatistics College of Public Health University of South Florida, Tampa MedicalResearch.com: What is the background for this study? What are the main findings? Response: Studies done in the 80s and 90s showed that patients with Kaposi sarcoma may be at risk of having secondary tumors. As a result of changes that have taken place in the demographics of patients affected with HIV/AIDS as well as Kaposi’s sarcoma, we hypothesized that tumors that follow Kaposi sarcoma might have also changed. We analyzed the incidence of second tumors developing after Kaposi sarcoma using the Surveillance Epidemiology and End Result (SEER) data. Our result indicated that the incidence of secondary tumors following Kaposi sarcoma have decreased after the emergence of antiretroviral therapy. However, we observed a significantly higher than expected number of cancer of the anus, liver, tongue, penis lymphomas, and acute lymphocytic leukemia developing in patients with Kaposi sarcoma in the era of antiretroviral therapy. (more…)
Author Interviews, Heart Disease, JAMA, Lipids, UCLA / 28.08.2017

MedicalResearch.com Interview with: Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study identifies the clinical and economic consequences of treating a population of patients with established atherosclerotic cardiovascular disease (ASCVD ) at high-risk of cardiovascular (CV) events and defines the cost-effectiveness of the PCSK-9 inhibitor evolocumab under various clinical scenarios. The analysis is based on the clinical outcomes from the Repatha Outcomes Study (FOURIER) in patients with established atherosclerotic cardiovascular disease (ASCVD), such as those who have already had a heart attack or stroke who require additional therapy. This is the first cost-effectiveness assessment of evolocumab using a model based on a high-quality outcomes trial, combined with U.S. clinical practice data. The analysis identifies the types of high-risk patients for whom this therapy is both clinically beneficial and cost-effective. This study utilized cost-effectiveness and value thresholds employed by the World Health Organization and the American College of Cardiology/American Heart Association. Evolocumab was found to exceed generally accepted cost-effectiveness thresholds at current list price. However, this medication could be a cost-effective treatment for patients with established ASCVD in the U.S. when the net price is at or below $9,669 per year. (more…)
AHA Journals, Author Interviews, Genetic Research, Heart Disease, Lipids, UCLA / 28.08.2017

MedicalResearch.com Interview with: Tamer Sallam, MD PhD Assistant Professor of Medicine Co-Director UCLA Center for Lipid Management Lauren B. Leichtman and Arthur E. Levine CDF Investigator Assistant Director, STAR Program Division of Cardiology, Department of Medicine David Geffen School of Medicine at UCLA Los Angeles, California 90095-1679 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is extension of our previous work published in Nature showing that a gene we named LeXis (Liver expressed LXR induced sequence) plays an important role in controlling cholesterol levels. What is unique about  LeXis is that it belongs to a group of newly recognized mediators known as long noncoding RNAs. These fascinating factors were largely thought to be unimportant and in fact referred to as “junk DNA” prior the human genome project but multiple lines of evidence suggest that they can be critical players in health and in disease. In this study we tested whether we can use  LeXis “gene therapy”  to lower cholesterol and  heart disease risk. This type of approach is currently approved or in testing for about 80 human diseases. Our finding was that a single injection of LeXis compared with control significantly  reduced heart disease burden in mouse subjects. Although the effect size was moderate we specifically used a model that mimics a very challenging to treat human condition known as familial hypercholesterolemia..Familial hypercholesterolemia is one of the most common genetic disorders affecting up to 2 million Americans and characterized by 20 fold  fold increase risk of early heart attacks and often suboptimal response to currently available treatments. (more…)
Author Interviews, Coffee, Weight Research / 28.08.2017

MedicalResearch.com Interview with: Robin Dando, PhD Assistant Professor Director, Cornell Sensory Evaluation Facility Department of Food Science Cornell University Ithaca, NY 14853  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study arose from a previous paper I authored in the Journal of Neuroscience, where we found Adenosine receptors in taste.  We managed to prove that they were there to amplify sweet signals.  This led us to wonder, what about the foods we consume, that would come into contact with these receptors in taste buds. It just happens that a lot of us habitually consume a powerful blocker of adenosine receptors every morning.  Caffeine.  So is our coffee impairing sweet signals?  It turns out when we gave people sweetened coffee containing caffeine, they judged it as less sweet than the same coffee without the caffeine, sampled on a different day.  Interestingly, this persisted, and sweet solutions they tested afterwards were still a little less sweet. Finally, just for kicks, we asked them to rate how much caffeine they thought was in either coffee, and how much more alert it made them feel.  Turns out, there was no difference.  They couldn’t tell which was deacf, and either coffee gave them just as much of an alertness boost. (more…)
Author Interviews, Stem Cells, Technology / 25.08.2017

MedicalResearch.com Interview with: John Arnone Chairman and CEO American CryoStem Corporation MedicalResearch.com: What is the background for this your company American CryoStem? Response: American CryoStem Corporation (CRYO) was founded in 2008, to allow individuals, researchers and physicians to collect-process-store stem cells derived from adipose tissue (fat) to prepare for their current or future use. Over the years the Company has become a biotechnology pioneer, standardizing adipose tissue derived technologies (Adult Stem Cells) for the fields of Regenerative and Personalized Medicine. The Company operates a state-of-art, FDA-registered, clinical laboratory in New Jersey and licensed laboratories in Hong Kong, China and Tokyo, Japan, which operate on our proprietary platform, dedicated to the collection, processing, bio-banking, culturing and differentiation of adipose tissue (fat) and adipose derived stem cells (ADSCs) CRYO maintains a strategic portfolio of intellectual property, 18 patents that surround the Companies proprietary technology which supports a growing pipeline of stem cell applications and biologic products. We are leveraging our proprietary platform and our developed product portfolio to create a domestic and global footprint of licensed laboratory affiliates, physicians networks and research organizations who purchase tissue collection, processing and storage services and consumables from the Company. CRYO’s laboratory stem cell bank/line products are characterized adult human Mesenchymal Stem Cell (MSC's) derived from adipose tissue that work in conjunction with our 13 patented (non-animal) medium lines. The Company's R&D efforts are focused on university and private collaborations to discover, develop and commercialize ADSC therapies by utilizing our standardized collection-processing-storage methodology and laboratory products combined with synergistic technologies to create jointly developed regenerative medicine applications and intellectual property. (more…)
Accidents & Violence, Author Interviews, BMJ / 25.08.2017

MedicalResearch.com Interview with: Dr. Vivian Mcalister, M.B., CCFP(C), FRCSC, FRCS(I), FACS Professor - Department of Surgery London Health Sciences Centre University Hospital London, Ontario, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study was performed by medical and nursing officers who were all deployed to the war zone. We were deeply concerned about the type of injuries we were seeing. They were more awful than any we had seen before. We were familiar with reviews of antipersonnel landmine injuries that were reported by Red Cross surgeons in the 1990s. The injuries that we were dealing with were from antipersonnel IEDs more than landmines. We decided to do a formal prospective study for two reasons: first was to carefully describe the pattern of injury so we could develop new medical strategies, if possible, to help victims. The second reason was to catalogue these injuries so we could impartially and scientifically report what we were witnessing. (more…)
Author Interviews, Cancer Research, Cost of Health Care, HPV, University Texas / 25.08.2017

MedicalResearch.com Interview with: David R. Lairson, PhD Professor of health economics Department of Management, Policy, and Community Health The University of Texas Health Science Center at Houston (UTHealth) School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study of oropharyngeal cancer treatment cost was initiated by the Head and Neck Cancer Surgery Department at the University of Texas MD Anderson Cancer Center as part of a larger study of the economic and health consequences of human papillomavirus (HPV) related conditions in Texas.  State specific information is required for policy-makers to consider future investments in cancer prevention based on HPV immunization and cancer screening.  The cost estimates at $140,000 per case for the first two years of treatment are substantially higher than previous estimates.  They indicate the potential savings associated with cancer prevention and partially justify increased investment in immunization efforts. (more…)
Author Interviews, Heart Disease / 25.08.2017

MedicalResearch.com Interview with: James A. Reiffel, M.D Professor Emeritus of Medicine Special Lecturer in Medicine Dept of Medicine Cardiology Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atrial fibrillation is a common arrhythmia (multi-millions of Americans) and carries with it a risk of stroke and of heart failure (among others) if not treated preventively. In many people, atrial fibrillation comes to attention because of symptoms, but not in all. The chances of developing Atrial fibrillation are substantially increased in certain populations of patients, such as the ones we enrolled in our study.  Continuous monitoring of such patients, as we did, and as others have also done recently, though in smaller numbers of patients, can detect otherwise unsuspected atrial fibrillation, which can lead to treatment before complications arise. We found that using such monitoring, when monitored for 18 months, almost 1 in 3 patients had atrial fibrillation detected, as did 40% by 30 months. Intermittent monitoring, including by cell phones, may detect some atrial fibrillation but it is not nearly as effective as the type of monitoring we did and so many patients will be missed by lesser monitoring methods. (more…)
Accidents & Violence, Author Interviews, Sexual Health / 25.08.2017

MedicalResearch.com Interview with: Anthony J. Rosellini, Ph.D. Research Assistant Professor Center for Anxiety and Related Disorders Department of Psychological & Brain Sciences Boston University Boston, MA 02215 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sexual assault among service members is a significant concern of the Department of Defense (DoD) and U.S. Army. Although the annual rate of sexual assault among soldiers is believed to be decreasing, there have also been increases in the number of victims coming forward to report their experiences. The DoD and Army have responded by creating a framework of universal prevention in which all soldiers are required to participate in relatively brief programs aimed at decreasing rates of sexual assault. More intensive preventive interventions could be required, but would only be cost-effective if targeted at a subset of soldiers who are most likely to perpetrate sexual assault. The goal of this study was to use DoD and U.S. Army administrative records that are available for all soldiers to develop prediction models for sexual assault perpetration. We used the records from all 821,807 male soldiers who served between 2004 and 2009 to develop separate models to predict assaults directed against within-family and non-family adults and minors. (more…)
Author Interviews, Genetic Research, JAMA, Pancreatic, Surgical Research / 25.08.2017

MedicalResearch.com Interview with: Nancy You, MD, MHSc, FACS Department of Surgical Oncology The University of Texas MD Anderson Cancer Center Houston  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study was motivated by the emerging promise of precision medicine and the emerging evidence that immunotherapy may have phenomenal efficacy in particular molecular subtypes of cancers.  This specific molecular subtype shows deficiency in DNA mismatch repair mechanisms and therefore is thought to be more immunogenic.  DNA mismatch repair deficiency can arise from germline defects such as in the case of patients with Lynch Syndrome, an inherited cancer syndrome, or from epigenetic inactivation DNA mismatch repair genes. Overall, pancreas cancer has seen limited success with conventional chemotherapy.  In our study, we demonstrated that there is a particular molecular subtype of pancreas cancer that is characterized by defect in DNA mismatch repair genes and by microsatelie instability that has a different prognosis than other pancreas cancers.  This subtype of pancreas cancer is suspected to also respond to immunotherapy. (more…)