Allergies, Anemia, Author Interviews, FDA / 18.11.2015

MedicalResearch.com Interview with: Cunlin Wang, MD, PhD Division of Epidemiology I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration MedicalResearch: What is the background for this study? What are the main findings? Dr. Wang:  IV Iron has been known for its risk of anaphylactic reaction, but there has been little research on the comparative safety of individual IV Iron products from a large population-based study. This study included 688,183 new users of IV iron not on dialysis from the U.S. Medicare program over a ten-year span (January 2003 to December 2013). The main findings of the study are:  the risk for anaphylaxis at first exposure was higher for iron dextran than non-dextran IV iron products combined (iron sucrose, gluconate and ferumoxytol).  When individual IV Iron products were compared, the data suggested that iron dextran has the highest risk of anaphylaxis and Iron sucrose has the lowest risk, estimated both at the first time exposure and after cumulative exposures.  The low and high molecular weight dextran products could not be individually identified during most of study period. However,  from January 2006 through March 2008, during which the use of two dextran products could be distinguished, there was very low use of high molecular weight dextran (Dexferrum@). This suggested that the study results likely represent the risk of the low molecular weight dextran (Infed@). (more…)
Author Interviews, STD / 18.11.2015

MedicalResearch.com Interview with: Dr Pam Sonnenberg  Reader in Infectious Disease Epidemiology Research Department of Infection & Population Health University College London London MedicalResearch: What is the background for this study? What are the main findings? Dr. Sonnenberg:  This study strengthens growing evidence that Mycoplasma genitalium (MG) is a sexually transmitted infection (STI). Analyses of over 4500 of urine samples from Britain’s third National Survey of Sexual Attitudes and Lifestyles (Natsal-3) showed that MG was prevalent in up to 1% of the general population aged 16-44, who had reported at least one sexual partner. Prevalence was much higher in those who had reported more than four sexual partners in the past year – 5.2% in men and 3.1% in women. Absence of the infection in over 200 16-17 year olds who had not had vaginal, anal, or oral sex provided further evidence that MG is transmitted sexually. The study also analysed risk factors for  Mycoplasma genitalium, such as ethnicity, number of partners, and areas of deprivation. There were strong associations with risky sexual behaviours, with similar behavioural risk factors to other known STIs. The authors found that men of Black ethnicity and those living in the most deprived areas were more likely to test positive for MG. Over 90% of Mycoplasma genitalium in men and over two-thirds of MG cases in women were in those aged 25–44 years; an age group who would not be included in STI prevention measures currently aimed at young people in Britain. Interestingly, the majority of participants who tested positive for MG did not report any STI symptoms in the last month. Over half of women did not report any symptoms, but among those who did, bleeding after sex was most common. Over 90% of MG positive men did not report any symptoms. (more…)
Annals Internal Medicine, Author Interviews, Critical Care - Intensive Care - ICUs, Technology / 18.11.2015

MedicalResearch.com Interview with: Daniel Niven MD, MSc, FRCPC Department of Critical Care Medicine Department of Community Health Sciences O'Brien Institute for Public Health Cumming School of Medicine, University of Calgary  Medical Research: What is the background for this study? Dr. Niven: Fever (temperature 38.0 degrees Celsius or higher) and hypothermia (temperature less than 36.0 degrees Celsius) are commonly included in diagnostic criteria for certain disorders, influence clinical decision making, and are associated with an increased risk for death in select patient populations. Therefore, accurately measuring body temperature is important. Unfortunately, the accuracy of many commonly employed thermometers is not well defined.  Medical Research: What are the main findings? Dr. Niven: This systematic review and meta-analysis examined the accuracy of thermometers measuring temperature from peripheral sites (for example, forehead measurement devices) relative to central sites (for example, the bladder) in adults and children. From 75 studies and 8,682 patients, this meta-analysis found that the majority of commonly used peripheral thermometers do not have clinically acceptable accuracy among adults and children. This was especially the case for patients with fever and hypothermia, where peripheral temperature measurements may be as much as 1 to 2 degrees higher or lower than actual body temperature. Sensitivity for detection of fever was low (64%), whereas specificity was high (96%). (more…)
Author Interviews, Ovarian Cancer, Technology / 18.11.2015

MedicalResearch.com Interview with: Professor John McDonald PhD Director of its Integrated Cancer Research Center School of Biology at the Georgia Institute of Technology Medical Research: What is the background for this study? What are the main findings? Response: Ovarian cancer is a deadly disease because it cannot be diagnosed at early stages when it can be most effectively effectively treated. It has long been recognized that there is a great need for an accurate diagnostic test for early stage ovarian cancer. Until now, efforts to develop a highly accurate way to detect early stage ovarian cancer have been unsuccessful. We have used a novel approach that integrates advanced methods in analytical chemistry with advanced machine learning algorithms to identify 16 metabolites that collectively can detect ovarian cancer with extremely high accuracy (100% in the samples tested in our study) (more…)
Author Interviews, Smoking / 17.11.2015

MedicalResearch.com Interview with: Cristine D. Delnevo, PhD, MPH Chair, Professor, and Director, Center for Tobacco Studies Rutgers School of Public Health Medical Research: What is the background for this study? What are the main findings? Dr. Delnevo: We analyzed data from the 2014 National Health Interview Survey (NHIS) to examine how e-cigarette use differs by demographic subgroups and smoking status. We found that daily e-cigarette use is highest among former smokers who have quit in the past year. These recent quitters were four times more likely than current smokers to be daily e-cigarette users. Furthermore, regular use of e-cigarettes is rare among those who have never smoked and former smokers who have quit more than a year ago. This suggests that many smokers may be using e-cigarettes to quit, and that the devices are neither attracting nonsmokers nor leading to smoking relapse among long term former smokers. If e-cigarettes continue to be used as a smoking cessation tool and uptake among nonsmokers remains low, they may generate public health benefits. (more…)
Author Interviews, JAMA, Pediatrics, Respiratory / 17.11.2015

MedicalResearch.com Interview with: Leonard B. Bacharier, MD Professor of pediatrics Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine St Louis School of Medicine Washington University St Louis, Missouri  Medical Research: What is the background for this study? What are the main findings? Dr. Bacharier: Oral corticosteroids such as prednisone have become the standard of care for children whose colds tend to progress and lead to severe wheezing and difficulty breathing. “But there are some studies that suggest these treatments don’t consistently work for young children. That’s why we want to find ways to prevent upper respiratory infections from progressing to lower respiratory tract illnesses. Once the episode gets going, standard interventions are less effective than would be desired”​​​​​​​​​​​​​​​​, reported Dr. Bacharier. (more…)
Accidents & Violence, Author Interviews, Mental Health Research, PLoS / 17.11.2015

MedicalResearch.com Interview with: Simone Ullrich, PhD Senior Lecturer in Forensic Mental Health Violence Prevention Research Unit Queen Mary University of London Medical Research: What is the background for this study? What are the main findings? Dr. Ullrich: There are currently thought to be more than three hundred risk assessment instruments used by professionals such as psychiatrists, psychologists, and probation officers to assess the risks of violence and sexual offending among psychiatric patients, prisoners, and the general population. In some mental health services the hospital does not get paid unless staff have carried out a risk assessment on their patients. Producing risk assessment instruments has become an ‘industry’ and new instruments are being produced annually, on every form of violence and criminal activity. The Queen Mary research group believe that none of these instruments have any advantage over those produced before. Furthermore, their best predictions for future violence get 30% wrong. Professor Coid and colleagues believe that no further progress can be made because researchers have been too obsessed with predicting the future of whether a patient will be violent rather than looking for the causes of why they become violent. All previous studies have used special statistical techniques which are designed to measure predictive accuracy. The Queen Mary research group say there is nothing wrong with being accurate or measuring accuracy, but there is no point in trying to develop new instruments which can never improve on getting it right more than 70% of the time. It may be helpful to know that your patient has a high or low risk of being violent if you release them from hospital, but this is not going to tell you what you should do to stop them being violent. Furthermore, if the risk assessment says that their risk is high then it is likely that you will not release them. The problem is that professionals will always play safe and, although there is a good chance (around 30%) that they are totally wrong, the patient will not be released. This is probably one of the most important reasons why patients are staying longer and longer in secure mental health services. These instruments achieve little more than making healthcare professionals risk averse. The National Institute for Health Research (NIHR) funded a study where 409 male and female patients who were discharged from medium secure services in England and Wales were followed up after release into the community. They received assessments with two ‘state of the art’ assessment instruments, the HCR-20 which aims to guide clinicians in their assessment of violence, and the SAPROF, another instrument aimed to guide clinicians on which factors protect patients from becoming violent. Both instruments were developed on the basis of predictive statistics. Measures were taken with these instruments prior to release into the community, then after 6 and 12 months following discharge. Information on violence was gathered via individual case notes and a search of the police national computer. By 6 months following discharge, 54 (14%) had committed a violent act, between 6 and 12 months 43 (13%) had been violent. The authors used two methods to investigate the associations between these risk/ protective factors and violence. They first tested the standard approach of risk assessment for the factors that occurred in the past 6 months which were then used to statistically predict violence in the following 6 months (predictive model). They then used a second approach which looked at the co-occurrence of the risk/ protective factors and violence within the same 6 month time window (causal model). Using the traditional approach and looking at accuracy, the predictive model produced statistical coefficients of low size, suggesting that the risk and protective factors were poor in identifying who would be violent and who would not. Because many associations between the factors and violence were weak, few appeared useful in identifying those which should be targeted to manage future violence. Surprisingly, symptoms of major mental disorder did not show an association with violence, even though most of the patients in the study suffered from major mental disorder. It might have been expected that some patients would relapse, with more symptoms, leading to violence. When the researchers used a causal approach aiming to confirm which risk and protective factors resulted in violence, the findings were very different. Symptoms of major mental disorder, the patients’ living condition, and whether they were taking medication were highly important factors. Secondly, the effects of risk and protective factors on violence were much bigger using the causal approach. For example, the effects of violent thoughts and ruminations, being in an unstable life situation, were about 3 times stronger using the causal model. The effects of being under stress and unable to cope were more than 4 times stronger than using the traditional predictive approach. They concluded that the causal approach was much better in identifying the key factors that need to be considered in the assessment and management of violence. (more…)
Author Interviews, Gender Differences, Pediatrics, Sleep Disorders / 17.11.2015

MedicalResearch.com Interview with: Sabine Plancoulaine, MD, PhD Senior Researcher NSERM, UMR1153 Epidemiology and Statistics Sorbonne Paris Cité Research Center (CRESS), early Origin of the Child's Health And Development (ORCHAD) Team, Villejuif, France; and Paris Descartes University, Paris, France Medical Research: What is the background for this study? Dr. Plancoulaine: A decrease in children’s total sleep duration has been reported in the last decades, suggesting that more and more children are now in chronic sleep debt. There is now accumulating evidence that insufficient quantity and/or quality of sleep have a negative impact on children’s physical and mental health development, cognitive function, behaviour and academic success. Sleep disorders and short sleep duration in childhood have also been suggested as predictors of sleep disorders and short sleep duration in adolescence and adulthood. An increased risk of obesity has been shown among shorter sleeper children, especially boys.  Medical Research: What are the main findings? Dr. Plancoulaine: In our study we aimed at describing sleep duration in 3 years old children from a French pre-birth cohort (546 boys and 482 girls) and at investigating gender-specific factors associated with shorter sleep duration defined as <12h/24h. In our study, children aged 3 years slept on average 12hrs35 and 91% of them were napping. Parental presence when falling asleep (e.g. holding hands) was the only factor associated with shorter sleep duration in both gender and increased the risk by around 3 and 4 in boys and girls respectively. The other associated risk factors were more gender-specific. Among boys, each hour of TV viewing duration increased by 72% the risk of being a short sleeper and each additional standard deviation of BMI increased the risk by 31%. Among girls, adherence to a fruit and vegetables dietary pattern divided the risk of being short sleeper by 2 while being cared at home increased it by 2.5 folds. Other investigated factors were not associated (i.e. familial incomes, parental educational level, maternal age at birth, maternal pre-pregnancy BMI, maternal depression status (at birth and at 3y), gestational age, child’s birth rank, birth weight and physical activities at 3y, existence of night awakenings at 3y). (more…)
Author Interviews, Genetic Research, JAMA, Neurological Disorders / 17.11.2015

MedicalResearch.com Interview with: Kevin M. Biglan, M.D., M.P.H Professor of Neurology and the Associate Chair for Clinical Research Department of Neurology and the Center for Human Experimental Therapeutics University of Rochester School of Medicine and Dentistry Rochester, New York  Medical Research: What is the background for this study? What are the main findings? Dr. Biglan: A therapeutic goal of research in Huntington Disease (HD) is the identification of treatments that delay the progression of disease and onset of illness in individuals at risk for developing manifest HD. Designing such efficacy trials is challenging. A major hurdle is the lack of practical primary outcome measures to assess the effect of an intervention on delaying disease onset. Use of the dichotomous endpoint of clinical diagnosis as the primary outcome requires large sample sizes and long duration of follow up in order to show a significant therapeutic effect on delaying disease onset. Continuous measures that can reliably distinguish cytosine-adenine-guanine (CAG) expanded individuals in the pre-manifest period may allow for the identification of potential disease modifying therapies using relatively smaller cohorts followed for shorter periods of time. The Prospective Huntington At-Risk Observational Study (PHAROS) represents the largest observational study to clinically evaluate pre-manifest Huntington Disease wherein both research participants and investigators were unaware of Huntington Disease mutation status. Accordingly, PHAROS was uniquely designed to address, in an unbiased manner, those clinical features most associated with the CAG expansion during the prodromal phase in  Huntington Disease.  The identification of continuous outcome measures that are associated with HD in the pre-manifest period may facilitate the design and powering of future studies of potential disease modifying therapies prior to traditional motor diagnosis. (more…)
Author Interviews / 17.11.2015

MedicalResearch.com Interview with: Ming Ding, MD, DSc Departments of Nutrition and Epidemiology Harvard T.H. Chan School of Public Health Boston, MA Medical Research: What is the background for this study? Response: Coffee is one of the most commonly consumed beverages worldwide. Previous studies showed coffee consumption was associated with a lower risk of type 2 diabetes, cardiovascular disease, liver disease, and Parkinson’s disease. However, the association between coffee consumption and risk of mortality remains uncertain. Some studies showed an inverse association between moderate coffee consumption and risk of mortality, and an inverse or null association between heavy coffee consumption and risk of mortality. However, some studies found heavy coffee consumption to be associated with higher risk of mortality. Medical Research: What are the main findings? Response: With 208,501 participants and 31,956 deaths in three large cohort studies, our results showed a non-linear association of coffee consumption with total mortality in the whole population. When restricting to never smokers, coffee consumption was associated with lower risk of total mortality, and mortality due to CVD, neurological diseases, and suicide. No association of coffee consumption with cancer mortality was found. The present study provides strong evidence that long-term coffee consumption is not associated with increased risk of mortality. (more…)
Author Interviews, Hepatitis - Liver Disease, Surgical Research, Transplantation, Weight Research / 17.11.2015

MedicalResearch.com Interview with: Barry Schlansky, M.D., M.P.H Assistant Professor of Medicine Oregon Health & Science University Medical Research: What are the main findings and significance of this study? Dr. Schlansky: This study examines how obese patients fare before and after liver transplantation. Similar to other researchers, we found that obese patients do just as well as normal weight patients after liver transplantation. We were surprised, however, to find that very obese patients died more often while on the wait list before liver transplant. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology / 16.11.2015

MedicalResearch.com Interview with: Adam R. Glassman, MS Jaeb Center for Health Research Tampa, FL 33647 Medical Research: What is the background for this study? What are the main findings? Response: Diabetic retinopathy is a complication of diabetes that affects blood vessels in the retina. When diabetic retinopathy worsens to proliferative diabetic retinopathy, blood vessels in the retina can leak fluid or bleed, distorting vision. Diabetic retinopathy is the most common cause of vision loss among people with diabetes and the leading cause of blindness among working-age adults. Scatter laser treatment, also called panretinal photocoagulation, has been standard therapy for the treatment of proliferative diabetic retinopathy since the 1970s. While effective in preserving central vision, laser therapy can reduce side vision and cause swelling in an area of the retina that is important for central vision. This study aimed to find an alternative therapy that avoided these undesirable side effects. Eyes in this study were assigned randomly to treatment with intraocular anti-VEGF injections of Lucentis® or scatter laser treatment. The results of this study demonstrate that eye injections of Lucentis® are as effective for vision outcomes at 2 years as laser therapy. On average, vision among eyes treated with Lucentis® improved by about half a line on an eye chart, with virtually no improvement among eyes treated with laser therapy. Compared with laser-treated eyes, eyes treated with Lucentis injection on average had less side vision loss, less frequent development of swelling in the central retina, and fewer complex retina surgeries for retinal bleeding or retinal detachment. (more…)
Author Interviews, NYU, Surgical Research, Transplantation / 16.11.2015

Patrick Hardison was severely injured in September 2001 in Mississippi, while attempting to rescue a woman in a burning home. He had dozens of surgeries as he continued to try to work and care for his five children. These surgeries grafted skin from his legs onto his entire scalp and face. Mr. Hardison was referred to Dr. Eduardo D. Rodriguez, of NYU Langone Medical Center for consideration of facial transplantation. Three months August 14, 2015 ago Dr. Rodriguez were able to give Patrick a new face, scalp, ears and ear canals, new eyelids and the muscles that control blinking.   (more…)
Annals Internal Medicine, Asthma, Author Interviews, Pharmacology / 16.11.2015

MedicalResearch.com Interview with: Michael Miligkos, MD, MS Laboratory of Biomathematics, University of Thessaly School of Medicine Larissa, Greece Medical Research: What is the background for this study? What are the main findings? Dr. Miligkos: Asthma is one of the most common chronic diseases with and has considerable social and economic burdens. Although inhaled corticosteroids constitute the current gold standard of maintenance treatment, leukotriene-receptor antagonists (LTRAs) have the advantages of oral once- or twice- daily dosing and, apparent avoidance of the adverse effects associated with long-term corticosteroid therapy. In addition, their mechanisms of action theoretically predicts a good response in patients with specific asthma “phenotypes”. This systematic review investigated the use of all marketed LTRAs in usual licensed doses as asthma controller medications compared with placebo and found that administration of a LTRA to adults and adolescents with asthma significantly reduced the risk for an exacerbation. In trials of LTRA monotherapy, LTRAs significantly improved asthma control compared with placebo, whereas only some measures of asthma control were significantly improved in trials of LTRAs used as add-on use therapy to ICSs. (more…)
Author Interviews, Blood Clots, Orthopedics, PLoS / 16.11.2015

MedicalResearch.com Interview with: Banne Nemeth, MD and  Suzanne C. Cannegieter MD PhD Leiden University Medical Center The Einthoven Laboratory for Experimental Vascular Medicine Clinical Department of Epidemiology and Orthopedic Surgery Medical Research: What is the background for this study? What are the main findings? Dr. Nemeth: Clinicians cannot currently accurately predict who will develop venous thrombosis, but it would be very helpful to be able to identify individuals at high risk for venous thrombosis because the condition can be prevented by giving anticoagulants before a clot forms (thromboprophylaxis). The ability to predict venous thrombosis would be particularly useful in patients who have had a lower limb immobilized in a cast after, for example, breaking a bone. These patients have an increased risk of venous thrombosis compared to patients without cast immobilization. We developed and validated a prediction model to identify patients with plaster cast of the lower extremity who are at high risk to develop venous thrombosis. A clinical risk score named, L-TRIP(cast) score (Leiden Thrombosis Risk Prediction for patients with cast immobilization score), was developed containing 14 clinical risk factors such as age, sex, BMI, use of oral contraceptives and location of plaster cast. Patients that score 9 points or higher are classified as being at high risk for venous thrombosis. Clinicians may decide to prescribe thromboprophylaxis therapy for these patients. (more…)
Author Interviews, Personalized Medicine, Pharmacology / 16.11.2015

MedicalResearch.com Interview with: Diane Frenier Esq Reed Smith Corporate Partner Member of Corporate & Securities Group and Life Sciences Health Industry Group Background: Diane Frenier Esq discusses the M&A boom in the pharmaceutical and retail drug industry including a the "global study of 100 senior executives at life sciences companies by global law firm Reed Smith, in partnership with Mergermarket, reveals that 94% are planning to make an acquisition in the next year”. Medical Research: What are the main drivers behind the pursuit of cross-border life sciences deals? Ms Frenier: I think companies are trying to strengthen their capabilities in areas that are a core focus for them (e.g., in certain therapeutic areas, or for orphan drugs), and that includes adding products in those core focus areas and, in some cases, broadening geographically so they can market products in those core focus areas on a more global basis.  This will allow them to use their resources more efficiently and take advantage of saving from reducing redundancies. (more…)
Author Interviews, Columbia, Heart Disease, JACC, Transplantation / 14.11.2015

MedicalResearch.com Interview with: Raymond Givens MD PhD  Columbia University Medical Center  Medical Research: What is the background for this study? What are the main findings? Dr. Givens: Multiple listing- i.e., simultaneous placement on multiple organ transplant waiting lists- is allowed by the United Network for Organ Sharing (UNOS). Because insurance generally does not pay for the costs of transportation between multiple centers or of temporary housing, there has been concern that the multiple-listing policy gives an unfair advantage to wealthier patients. We examined the UNOS database from 2000-2013 and identified 33,928 patients who were listed for a first-time single-organ heart transplant, 2% of whom met our definition of multiple-listing. Compared to single-listed patients, multiple-listed patients lived in ZIP codes with significantly higher median incomes, and were more likely to have private insurance and less likely to be supported by Medicaid. They were also significantly more likely to have blood type O and to live in areas with higher predicted waiting times. Despite having lower listing priority at the start of the primary listing and lower predicted mortality, the multiple-listed patients were often upgraded at secondary listing and had a higher eventual transplant rate (74.4% vs 70.2%) and lower mortality rate while listed (8.1% vs 12.2%). When the multiple-listed cohort was compared against a propensity-score-matched single-listed subset the relative rare of transplant was 3.02. There were no differences in post-transplant survival. (more…)
AHA Journals, Author Interviews, Heart Disease / 14.11.2015

MedicalResearch.com Interview with: Susan Marzolini, R.Kin, PhD Scientific Associate, TRI-REPS Supervisor Toronto Rehab/UHN Cardiovascular Prevention and Rehabilitation Program Medical Research: What is the background for this study? What are the main findings? Dr. Marzolini: Coronary artery bypass graft (CABG) surgery is a leading revascularization procedure for treating coronary artery disease. Despite effective revascularization, cardiovascular risk factor control through intensive lifestyle and pharmacological treatment is essential to prevent graft deterioration and progression of atherosclerosis following surgery. Outpatient cardiac rehabilitation (CR) programs offer structured exercise, education, interdisciplinary support, counselling, and risk reduction to promote secondary prevention. These programs have been shown to improve fitness, psychosocial well-being, and significantly reduce morbidity and mortality after CABG surgery. However, while Canadian and international guidelines endorse “early” referral to CR post-cardiac event, actual practice is variable and delays are common_ENREF_9_ENREF_9_ENREF_7. Delayed entry is of concern, as there is emerging evidence that later referral and initiation of cardiac rehabilitation is associated with negative consequences on cardiovascular fitness, however this has not been examined in the post-CABG population. Therefore, we conducted a retrospective analysis of 6497 consecutively enrolled post CABG participants in a single cardiac rehabilitation program in Toronto, Canada from January 1995 to October 2012. Our objective was to examine the effects of later entry on CR outcomes (i.e., CR use, anthropometrics, and functional capacity) while accounting for demographic, environmental, and physiological correlates of longer wait-time. We found that longer wait-time to start a cardiac rehabilitation program was associated with poorer outcomes including less improvement in cardiopulmonary fitness and lower program attendance, which have been shown to confer a mortality disadvantage. Longer wait time was also associated with less improvement in body fat percentage as well as poorer completion rates. We identified that bypass patients predisposed to longer wait times, and subsequently poorer participation and outcomes, are women, those who are older, from a lower socioeconomic neighborhood, people with a more complex medical history, who are employed, have a longer drive-time to cardiac rehabilitation, and people with less social support. (more…)
AACR, Author Interviews, Duke, Immunotherapy / 14.11.2015

MedicalResearch.com Interview with: Jiayuh Lin, Ph.D. Associate Professor, College of Medicine, The Ohio State University Medical Research: What is the background for this study? What are the main findings? Dr. Jiayuh Lin: Pancreatic cancer is one of the most serious forms of cancer.  Because of the poor response to chemotherapy as conventionally used, patients with any stage of pancreatic cancer may appropriately be considered candidates for clinical trials using novel agents. IL-6 signaling plays an important role in oncogenesis and high serum IL-6 levels is a poor prognostic factor for overall survival in pancreatic cancer. Therefore, IL-6 is considered as a viable target for pancreatic cancer therapy.  We utilized a drug discovery method with Multiple Ligand Simultaneous Docking and drug repositioning to identify an existing FDA-approved drug Bazedoxifene with previously unknown biological function as an IL-6/GP130 inhibitor.  Bazedoxifene can inhibit cell viability of pancreatic cancer cells expressing IL-6 and suppressed pancreatic tumor growth in vivo. (more…)
Author Interviews, Cancer Research, Genetic Research, JAMA / 14.11.2015

MedicalResearch.com Interview with: Samuel Klempner, M.D. Assistant Professor Division of Hematology/Oncology UC Irvine Health Orange, CA 92868  Medical Research: What is the background for this study? What are the main findings? Dr. Klempner: The background for our series is the concept that little is known about the genetic landscape of rare tumors such as acinic cell tumors, and that understanding genetic changes in tumors can identify treatment options.  This paradigm can, and should, be extended beyond rare tumor types and many researchers are currently studying various tumor types.  Another important background idea is that tumor genomic alterations may be more important than that anatomic site of origin. For example, I would argue that a breast cancer that harbors an EGFR mutation common to lung cancer could be treated similar to a lung cancer based on the genomic changes. In our study we found another way that the BRAF protein and its downstream signaling may become activated through duplicating part of the protein called the kinase domain.  This genetic event causes the pathway to be always "on" which is not normal, and likely drives cancer growth.  However, BRAF kinase domain duplication appears sensitive to currently available drugs that target the BRAF pathway, as evidenced by the response in our patient.  Thus, finding this change is important and may be able to guide a more personalized therapy choice.  Importantly, we found BRAF kinase domain duplication across multiple different tumor types, suggesting this may be a recurrent event in some cancers.  A very similar finding, involving duplication of the EGFR kinase domain, was also just reported (Cancer Discovery 2015;5:1155-1163) lending further validation to this mechanism of pathway activation in cancer. (more…)
AHA Journals, Author Interviews, McGill, Stroke / 14.11.2015

MedicalResearch.com Interview with: Sophie Vincent, Medical Student McGill University and Kristian Filion, PhD FAHA Assistant Professor of Medicine Division of Clinical Epidemiology Jewish General Hospital/McGill University Medical Research: What is the background for this study? What are the main findings? Response: Patients with carotid atherosclerosis causing vascular stenosis are at increased risk of stroke, which is the third leading cause of death in the United States and in Canada. Carotid artery stenting and carotid endarterectomy are the primary surgical options for the treatment of carotid stenosis. With the assumption that an endovascular approach would offer a more favorable safety profile than open surgical procedure, the use of stenting increased significantly following its entry into the market in the 1990s. However, despite this observed increase in use, the long-term safety and efficacy of stenting relative to endarterectomy remained unclear, which is why we decided to conduct this study. Although carotid artery stenting has more favorable periprocedural outcomes with respect to myocardial infarction, hematoma, and cranial nerve palsy, the observed increased risk of stroke throughout follow-up with stenting suggests that endarterectomy remains the treatment of choice for the management of carotid stenosis. (more…)
Author Interviews, Breast Cancer, Chemotherapy, MRI / 14.11.2015

MedicalResearch.com Interview with: Dr. Franca Podo, Dr Sci Former Director of the Molecular and Cellular Imaging Unit Department of Cell Biology and Neurosciences Istituto Superiore di Sanità Rome, Italy Medical Research: What is the background for this study? What are the main findings? Dr. Podo: Population-based studies showed that triple negative breast cancers (TNBCs), i.e. those which are negative for estrogen and progesterone receptors without HER-2/neu overexpression, have a more aggressive clinical course and a 2-to-3 fold higher likelihood of distant recurrence and death from breast cancer within 5 years from diagnosis, compared with non-TNBCs. In a study published in Clinical Cancer Research (Online First 26 October 2015) Dr. F. Podo and Dr. F. Santoro (Istituto Superiore di Sanità, Rome) and Prof. F. Sardanelli (Università degli Studi di Milano, IRCCS Policlinico San Donato) in collaboration with other Italian co-authors, compared phenotype features and survival rates of invasive TNBCs versus non-TNBCs detected during the HIBCRIT-1 screening study of 501 asymptomatic women at high genetic-familial risk for breast cancer. The screening included BRCA1 and BRCA2 mutation carriers, as well as women with a strong family history of breast and/or ovarian cancer, enrolled between 2000 and 2008 in 18 centers. Data analysis from a median 9.7-year follow-up until June 2015 showed that, combining an annual screening including magnetic resonance imaging (MRI) with adequate treatment options, the mean 5-year overall survival of triple negative breast cancers was not significantly different from that of non-TNBCs (86% vs 93%), in spite of a 3-fold higher rate of cases of grade 3 invasive ductal carcinoma in the former subgroup (71% in TNBCs vs 23% in non-TNBCs). The mean disease-free survival rates were also very similar (77% vs 76%, respectively). (more…)
Aging, Author Interviews, Depression, Geriatrics / 13.11.2015

MedicalResearch.com Interview with: Helena Chui, Ph.D. CPsychol Lecturer Division of Psychology University of Bradford Bradford England  Medical Research: What is the background for this study? What are the main findings? Dr. Chui: It is debatable whether psychological well-being improves or declines with age. Findings of the age-related changes in psychological well-being, life satisfaction, and depressive symptoms, are not unequivocal. Some studies have found that people stay pretty stable in terms psychological well-being until late life. Other studies have found otherwise. My recent publication reports the findings using a 15-year longitudinal study from Australia. Results showed that as people get older, depressive symptoms increase. Both men and women reported increasingly more depressive symptoms as they aged, with women initially starting with more depressive symptoms than men. However, men showed a faster rate of increase in symptoms so that the difference in the genders was reversed at around the age of 80. (more…)
AACR, Author Interviews, NIH, Nutrition, Ovarian Cancer, Race/Ethnic Diversity / 13.11.2015

MedicalResearch.com Interview with: Bo (Bonnie) Qin, PhD Postdoctoral associate at Rutgers Cancer Institute of New Jersey Medical Research: What is the background for this study? What are the main findings? Response:  Ovarian cancer is among the top five causes of cancer death among women in the US. Compared to white women, African-American women tend to have a worse 5-year survival rate of ovarian cancer. It highlights a critical need for identifying preventive factors in African Americans, particularly through dietary modification, which is relatively low cost and low risk compared to medical treatments. We found that adherence to an overall healthy dietary pattern i.e. Alternate Healthy Eating Index (AHEI)-2010 may reduce ovarian cancer risk in African-American women, and particularly among postmenopausal women. Adherence to the current Dietary Guidelines for Americans i.e. Healthy Eating Index-2010, were also strongly associated with reduced risk of ovarian cancer among postmenopausal African-American women. (more…)
Author Interviews, JAMA, Mental Health Research, Primary Care / 13.11.2015

Shahrzad Mavandadi, PhD Research Health Science Specialist and Investigator Veterans Integrated Services Network 4 Mental Illness Research, Education, and Clinical Center Corporal Michael J. Crescenz Veterans Affairs Medical Center Philadelphia, PennsylvaniaMedicalResearch.com Interview with: Shahrzad Mavandadi, PhD Research Health Science Specialist and Investigator Veterans Integrated Services Network 4 Mental Illness Research, Education, and Clinical Center Corporal Michael J. Crescenz Veterans Affairs Medical Center Philadelphia, Pennsylvania  Medical Research: What is the background for this study? Dr. Mavandadi: Mental health (MH) conditions are underidentified and undertreated in later life.  This is particularly true among subgroups of older adults who are more vulnerable to developing mental health issues, have poor access to specialty care, and are less responsive to treatment and therapy.  Thus, we sought to evaluate longitudinal MH outcomes among low-income, community-dwelling older adults enrolled in an evidence-based, collaborative mental health care management service (i.e., the SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program).  The SUSTAIN program integrates mental health with primary care (which is where the majority of behavioral health conditions in later life are managed) and provides standardized, measurement-based, software-aided MH assessment and connection to community resources to older adults by telephone. While there is a strong evidence base for the efficacy of collaborative care models for me conditions, little is known about the amount or level of patient and provider support that is needed to achieve optimal behavioral health outcomes.  Thus, we specifically examined outcomes among older adults randomized to one of two program arms of varying intensity: MH symptom monitoring alone or mental health symptom monitoring plus MH care management.   MH care management involved care managers who provided education, counseling, and decision support to patients and their primary care providers, a licensed mental health clinician who supervised the care managers, and the use of an algorithm to help guide pharmacological and non-pharmacological treatment plans.  The sample consisted of 1018 older adults prescribed an antidepressant or anxiolytic by their non-behavioral health providers who presented with clinically significant symptoms at intake. (more…)
Author Interviews, CDC, Infections, OBGYNE, STD / 13.11.2015

MedicalResearch.com Interview with: Dr. Virginia Bowen PhD Epidemic Intelligence Service Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention,CDC  Medical Research: What is the background for this study? What are the main findings? Dr. Bowen: Congenital syphilis (CS) occurs when a mother infected with syphilis transmits the infection to her child during the course of pregnancy. Our study looked at recent trends in CS between 2008 and 2014. After four years of decline, Congenital syphilis rates increased by 38% from 2012 to 2014. The findings from this report show we are missing opportunities to screen and treat pregnant women for STDs. Syphilis in pregnant women can cause miscarriages, premature births, stillbirths, or death of newborn babies. We have effective tests and treatment for syphilis – there’s no excuse for allowing it to resurge. Every case of CS is one too many. (more…)
Author Interviews, Heart Disease, Lipids, Stanford / 13.11.2015

MedicalResearch.com Interview with: Liana Del Gobbo PhD Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA; and Life Sciences Research Organization, Bethesda, MD Medical Research: What is the background for this study? What are the main findings? Dr. Del Gobbo: Accumulating evidence suggests that nut intake lowers risk of cardiovascular disease. But the specific mechanisms by which nuts may exert beneficial effects (eg. through lowering blood cholesterol, blood pressure, inflammation, etc.) were not clear. Two prior reviews on this topic only evaluated one type of nuts, and only a few cardiovascular risk factors. To address these knowledge gaps, we performed a systematic review and meta-analysis of controlled trials to examine the effects of eating tree nuts (walnuts, pistachios, macadamia nuts, pecans, cashews, almonds, hazelnuts, Brazil nuts) on major cardiovascular risk factors including blood lipids (total cholesterol, LDL, HDL, triglycerides [TG]), lipoproteins (ApoA1, ApoB, ApoB100), blood pressure (systolic, SBP; diastolic, DBP), and inflammation (C-reactive protein, CRP) in adults 18 years or older without cardiovascular disease. A daily serving of nuts (1oz serving, or 28g per day) significantly lowered total cholesterol, LDL, ApoB, and triglycerides, with no significant effects on other risk factors, such as HDL cholesterol, blood pressure or inflammation. To give you an idea of a 1oz serving size of nuts, it is about 23 almonds, 18 cashews, 21 hazelnuts, 6 Brazil nuts, 12 macadamia nuts, 14 walnut halves, 20 pecan halves, 49 pistachios. We did not see any differences in cholesterol-lowering effects by nut type. (more…)
Author Interviews, JAMA, Mental Health Research, Pediatrics / 13.11.2015

MedicalResearch.com Interview with: Dr. Mai-Britt Guldin PhD Department of Public Health Aarhus University  Medical Research: What is the background for this study? Dr. Guldin: The background for this study is that death of a parent in childhood is experienced by 3-4% of children in Western societies, and we know such a loss is one of the most stressful and potentially harmful events in childhood. Therefore, we aimed to investigate how parental death may influence the long-term risk of suicide and how this risk differes by cause of parental death, age at loss, sex of child, socioeconomic factors and parental history of psychiatric illness.The sample size in this study is unparalleled by other studies on risk of suicide. Medical Research: What are the main findings? Dr. Guldin: The main findings were that in a population of 7.302,033 (in three Scandinavian countries), we identified 189,094 persons who lost a parent before the age of 18. Of these bereaved persons, 265 died from suicide. Compared to a control group of persons matched by age and sex, but who did not lose a parent before the age of 18, suicide was twice as common in the bereaved cohort (IRR = 2.02; 95% CI, 1.67-2.44). The risk remained high for at least 25 years of follow-up. The risk was particularly high for children who lost a parent due to suicide, but was also high for children who lost a parent due to other causes. The risk tended to be particularly high for boys who lost a mother and children losing a parent before the age of six. (more…)
Author Interviews, OBGYNE, Pediatrics, Toxin Research, Weight Research / 13.11.2015

MedicalResearch.com Interview with: Joseph M. Braun PhD Assistant Professor Department of Epidemiology in the Program in Public Health Brown University Medical Research: What is the background for this study? Dr. Braun:  Perfluoroalkyl substances are a class of chemicals used to produce stain/water repellent textiles, fire fighting foams, and non-stick coatings. Virtually all people in the US have measurable levels of several different perfluoroalkyl substances in their blood. There is concern that early life exposure to these chemicals can increase the risk of obesity by reducing fetal growth or promoting adipogenesis. What are the main findings? Dr. Braun:  Pregnant women in our study had perfluorooctanoic acid (PFOA) concentrations in their blood that were over 2-fold higher than pregnant women in the United States (median: 5.3 vs. 2.3 ng/mL) during the same time period (2003-2006). Children born to women with higher serum PFOA concentrations during pregnancy had a higher body mass index, greater waist circumference, and more body fat at 8 years of age compared to children born to women with lower serum PFOA concentrations. In addition, children born to women with higher serum PFOA concentrations during pregnancy gained more fat mass between 2 and 8 years of age than children born to women with lower PFOA concentrations. (more…)
Author Interviews, FASEB, Metabolic Syndrome, Nutrition, Weight Research / 13.11.2015

MedicalResearch.com Interview with: Suzan Wopereis, Ph.D. TNO, Microbiology and Systems Biology Group Zeist, The Netherlands Medical Research: What is the background for this study? What are the main findings? Dr. Wopereis: For the first time we could demonstrate the very subtle start of negative health effects caused by a high calorie snack diet in healthy men. We already knew about the negative consequences of such diets from so called epidemiologic studies. In such studies, scientists compare large populations (thousands of people) to better understand disease development. For example, by comparing  obese populations to a lean population, scientists could define various steps in the disease development related to obesity, like high cholesterol, onset of inflammation, high blood pressure, high glucose, etc. Yet, the early deviations from health  were difficult to study because human metabolism (the way we digest and metabolize our meals from a biochemical viewpoint)  is very flexible and able to efficiently deal with all kinds of daily stressors, such as a meal or intensive exercise. So, at TNO we decided to exploit  this flexibility by giving our healthy volunteers a ‘challenge test’, in the form of a high-fat milkshake. Next, we studied how multiple aspects of their metabolism react to such a challenge test. We showed that a snack diet for 4 weeks reduced many aspects of  flexibility of our healthy men, thus indicating very early changes in health. Both the high-fat challenge test and the integral study of many different outcomes form a novel approach of what “healthy” really means. In the study we used two groups of male volunteers. One group of 10 healthy male volunteers and one group of 9 male volunteers with Metabolic Syndrome, who had a combination of 2 or more risk factors that raises your risk for heart disease and other health problems (unhealthy cholesterol levels, high blood pressure, high blood sugar, high blood lipids, and abdominal fat). In other words, subjects with Metabolic Syndrome have a suboptimal health condition. Both groups received a high-fat milk-shake, and before and up to 8 hours after consumption of this metabolic challenge-test, blood samples were taken. In these blood samples, 61 different biomarkers were measured, such as cholesterol and blood sugar. These 61 biomarkers were used for a thorough health assessment of these 2 groups in response to the challenge test. We noted that biochemical processes related to sugar metabolism, fat metabolism and inflammation function abnormal in subjects with Metabolic Syndrome. The next step was to provide the 10 healthy male volunteers with a snack diet for 4 weeks. On top of their normal diet they had to consume an additional 1300 kcal per day, in the form of sweets and savory products such as candy bars, tarts, peanuts, and crisps. After these 4 weeks the response of the same 61 biomarkers to the challenge test was evaluated. Here, we observed that signaling molecules such as hormones regulating the control of sugar and fat metabolism and inflammation were changed, resembling the very subtle start of negative health effects. Without the use of the challenge test, we would not have been able to observe that even this short period of overfeeding induces changes in the metabolism of healthy people that resemble what happens in people with metabolic syndrome. (more…)