Author Interviews, Baylor University Medical Center Dallas, Nutrition, Weight Research / 16.08.2016

MedicalResearch.com Interview with: Meredith E. David Marketing Department Hankamer School of Business Baylor University Waco, TX 76798   MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the midst of the ongoing “obesity epidemic” in the United States and many other developed nations, programs and advice abound for encouraging individuals to manage their health and well-being through changes in food consumption. One common approach resurfaces time and time again: suggesting to the would-be dieter what foods they should avoid eating (e.g., “The following 10 foods should never be eaten . . . ,”) and/or what foods they should eat (e.g., “10 foods everyone should include in a healthy diet,”). Our research investigates the commonly heralded advice given to consumers to either focus on avoiding unhealthy foods, such as cake, or approaching and consuming healthy foods, such as kale. We demonstrate important differences in the implementation of and outcomes of these approach versus avoidance strategies for meeting one’s health-related goals. Individuals who have high self-control are generally better at reaching their goals. We investigate how individuals with varying levels of general self-control differ in the way that they apply approach and avoidance dieting strategies. Our findings, as detailed below, reveal a novel explanation of the better outcomes observed by individuals who are generally more successful in their goal pursuit. The key findings are as follows: (more…)
Author Interviews, Dermatology, Pharmacology / 15.08.2016

MedicalResearch.com Interview with: Kin F. Chan, PhD Executive Vice President of Research and Technology BioPharmX Corporation MedicalResearch.com: What is the background for this study? What are the main findings? Response: There were two studies in this series.  The purpose is to get a better understanding of the blood plasma and skin levels of minocycline in a relevant animal model (minipig) for both the oral form of minocycline (Solodyn) and topical BPX-01, and to elucidate the same for oral minocycline only in a clinical study. The results provided valuable guidance and assurance to our upcoming Clinical Phase 2b dose-ranging study design. (more…)
Author Interviews, Pain Research, Pediatrics / 15.08.2016

MedicalResearch.com Interview with: Amy Baxter MD CEO MMJ Labs LLC MedicalResearch.com: Would you tell us a little about your background? How did you develop an interest in pain management and prevention? Response: As a pediatric emergency doctor, I found it interesting that doctors could prevent pain but sometimes couldn't be bothered to do so. The lack of empathy and impatience is built into emergency training - we learn to diagnose and fix things quickly, not comfort and support. I decided to research how pain management would make procedures more successful, or faster, to convince doctors to use pain management for THEIR benefit. MedicalResearch.com: What is the background for the Buzzy(r) device? How does it impact pain sensation? Response: When my 4 year old had a horrible vaccination experience, I realized that a fast effective parent-controlled option for pain relief was needed. I knew that cold running water could eliminate the pain from a burned finger using physiology called gate control. Basically, the small pain nerves run alongside big motion nerves, so if you heavily stimulate motion you scramble the pain sensation. Rubbing a bumped elbow is another good example. Vibration alone didn't work enough for needles, but when I added ice the two sensations of cold and motion eliminated pain in 84% of seniors getting a flu shot. We got a grant from the NIH to develop and study Buzzy - it's a palm sized vibration unit with a place on the back to attach ice "wings", that freeze solid. You put them both where an injection will go for a minute or less, then move them "between the brain and the pain" while doing a needle procedure. There are about 14 studies on IV access or blood draws and 6 on injections, showing between 50 and 88% pain reduction. Several studies have demonstrated that Buzzy is truly a physiologic intervention, not a distraction: it didn't work for injections when only used for 10 seconds, too little time to block the pain nerves. But it worked really well for blood draws in severely cognitively impaired children for whom distraction wasn't an option. (more…)
Author Interviews, Ophthalmology, Stroke / 15.08.2016

MedicalResearch.com Interview with: Rong-Kung Tsai MD, PhD Professor and Director Institute of Eye Research Buddhist Tzu Chi Medical Center; Director, Institute of Medical Sciences Tzu Chi University, Hualien, Taiwan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Non-arteritic anterior ischemic optic neuropathy (NAION) is pathogenetically different from stroke, stroke is caused by thromboembolism. However, they share many (but not all) systemic vascular risk factors. Previous small scale studies got controversial results. Using the National Health Insurance Research Database (NHIRD) in Taiwan to conduct the cohort study, 414 patients were included in the NAION group and 789 in the control group (base one million beneficiaries). The incidence of NAION is 3.72/100,000 person-years in Taiwan, and patients with NAION have more chances to develop ischemic stroke (p=0.003), but not hemorrhage stroke. The subgroup analyses further showed the risk of ischemic stroke among the subjects with NAION and with comorbidities was 3.35 times higher than those without NAION. However, in patients with NAION but no comorbidities, there is no increase risk of stroke development. (more…)
Author Interviews, Heart Disease, Lipids / 14.08.2016

MedicalResearch.com Interview with: Ziyad Al-Aly, MD, FASN Assistant Professor of Medicine Washington University School of Medicine Co-Director, Clinical Epidemiology Center Associate Chief of Staff for Research and Education Veterans Affairs Saint Louis Health Care System MedicalResearch.com: What is the background for this study? What are the main findings? Response: I think the most important, and novel finding is that elevated levels of HDL-cholesterol (which is thought of as the good cholesterol) are associated with increased risk of death. Previously it was thought that high HDL (increased good cholesterol) is a good thing. We used Big Data approach (over 16 million person-years; 1.7 million people followed for over 9 years) to evaluate the relationship between HDL-Cholesterol (the good cholesterol) and risk of death. We found that low HDL is associated with increased risk of death (which is expected and consistent with prior knowledge). The novel and unexpected finding is the observation that high HDL-Cholesterol is also associated with increased risk of death. The relationship between HDL-Cholesterol levels and risk of death is a U-shaped curve where risk is increased at both ends of the HDL-C values spectrum (at both low and high end); Too low and too high is associated with higher risk of death. The findings may explain why clinical trials aimed at increasing HDL-Cholesterol levels failed to show improvement of clinical outcomes. This finding was not expected, and has not been reported previously in large epidemiologic studies such as Framingham Heart Study and others. The Framingham Heart study and others significantly advanced our understanding of the relationship between cholesterol parameters (including HDL-Cholesterol) and clinical outcomes. However, these studies are limited in that the number of patients in these cohorts was several thousands which is relatively small compared to what a Big Data approach (millions of patients) enables us to see. Big Data approach allows a more nuanced (a more detailed) examination of the relationship between HDL and risk of death across the full spectrum of HDL levels. (more…)
Author Interviews, Cleveland Clinic, Genetic Research, Heart Disease, PLoS / 14.08.2016

MedicalResearch.com Interview with: Qing Kenneth Wang PhD, MBA Huazhong University of Science and Technology Wuhan, P. R. China and Department of Molecular Cardiology The Cleveland Clinic Cleveland, Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: Coronary Artery Disease (CAD) and its complication myocardial infarction (MI or so called heart attacks) are the most common causes of deaths in the US and other parts of the world. Based on the American Heart Association statistics, 620,000 Americans have a new MI each year in the United States alone, 295 000 have a recurrent MI, and nearly 400,000 of them will die from it suddenly. Moreover, an estimated 150,000 silent first MI occur each year. CAD and MI are caused by an occlusion or blockage of a coronary artery, which disrupts blood flow to the heart region, leading to damage or death of cardiac cells, impairment of cardiac function and sudden death. Current treatment of CAD and MI relies on reperfusion therapy with reopening of the occluded coronary artery with percutaneous coronary intervention (PCA) and coronary artery bypass surgery (CABG). However, 12% of patients are not candidates for PCA or CABG due to an unfavorable occlusive pattern, diffuse coronary atherosclerosis, small distant vessels and co-morbidities. An alternative revascularization strategy has to be developed to benefit these patients. (more…)
Author Interviews, Immunotherapy, Lymphoma, Pharmacology / 14.08.2016

MedicalResearch.com Interview with: Dirk Huebner, MD Senior Medical Director Oncology Therapeutic Area Unit Takeda Pharmaceutical Company MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. Cutaneous T-cell lymphoma, also known as CTCL, is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. ADCETRIS® (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The Phase 3 ALCANZA trial compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy. The study met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm. (more…)
Author Interviews, JAMA, Smoking, Tobacco / 13.08.2016

MedicalResearch.com Interview with: Anna Pulakka PhD, Postdoctoral Researcher Department of Public Health University of Turku, Finland MedicalResearch.com: What is the background for this study? Response: Smoking is the one of the leading health risks globally. Finland, among some other countries, has set a target for a tobacco-free society by 2040. However, with the current rate of decline in smoking prevalence, the target will not be met. It is therefore important to explore new avenues for helping people to quit smoking. Recently, researchers have become more interested in availability of tobacco as one determinant for smoking habit. We have learned from cross-sectional studies that people who live in neighborhoods with many stores that sell tobacco, smoke more than those who have less tobacco stores in their neighborhood. What has been lacking is more robust evidence from longitudinal studies on the association between availability of tobacco in neighborhoods and smoking behaviours. We sought to determine whether change in the location of tobacco stores nearby people’s place of residence was associated with the odds of quitting smoking or smoking relapse in a longitudinal setting. (more…)
Author Interviews, Immunotherapy, Leukemia, Stem Cells, Transplantation / 12.08.2016

MedicalResearch.com Interview with: Felix Garzon, MD, PhD Senior Vice President Head of Clinical Development Actinium Pharmaceuticals, Inc. New York, NY 10016 MedicalResearch.com: What is the background for this study? What is goal of this Study? Response: Iomab-B (“Iomab”) was developed at the Fred Hutchinson Cancer Research Center (“the Hutch”) in Seattle, Washington. The Hutch is a pioneer in the field of bone marrow transplantation (BMT) having 3 Nobel Prizes and doctors there performed some of the first transplants for leukemia patients. Iomab-B is intended to be an induction and conditioning agent prior to a BMT for patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55. BMT is the only potentially curative option for AML i.e. for this patient population that currently has a survival prognosis of 2-6 months which means that if Iomab-B is successful it would create a new market segment and offer patients a great clinical benefit and a hope for a cure. Actinium Pharmaceuticals licensed Iomab from the Hutch in 2012 and prior to us licensing Iomab, it had been studied in almost 300 patients in several phase 1 and phase 2 clinical trials in an array of blood cancers, both leukemias and lymphomas. Actinium is now the sponsor of a pivotal phase 3 trial for Iomab-B to study its use as an induction and conditioning agent prior to a bone marrow transplantation in patients with relapsed or refractory AML who are over the age of 55. This trial, which we have named the SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial, started at the end of June 2016 and we expect to enroll 150 patients by the end of 2017. The primary endpoint of the SIERRA trial is durable complete remissions (dCR) of 6 months. The study arm will consist of Iomab-B administration followed by a  bone marrow transplantation, patients will be evaluated for dCR at 6 months after engraftment, which will be assessed at day 28 or day 56. The control arm of the study will be physician’s choice of chemotherapy and if the patient is able to achieve a complete remission (CR) they may receive a BMT or some other form of treatment with curative intent. The study is designed to evaluate if the study arm of Iomab-B and a BMT can double the dCR rate of the control arm, which is designed to replicate the current treatment regimen prior to a bone marrow transplantation . (more…)
Author Interviews, NEJM, Neurological Disorders, Surgical Research / 12.08.2016

MedicalResearch.com Interview with: Gil I. Wolfe, MD, FAAN Irvin and Rosemary Smith Professor and Chair Dept. of Neurology/Jacobs Neurological Institute Univ. at Buffalo Jacobs School of Medicine and Biomedical Sciences/SUNY Buffalo General Medical Center Buffalo, NY 14203-1126 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thymectomy has been used in myasthenia gravis (MG), in particular those patients who do not have a tumor of the thymus gland, known as a thymoma, for over 75 years without randomized data to support its use. A practice parameter in 2000 on behalf of the American Academy of Neurology stated that the benefits of thymectomy in this population of non-thymomatou smyasthenia gravis patients remained uncertain, classified thymectomy as a treatment option in this group, and called for rigorous, randomized studies. What we found is that compared to an identical prednisone protocol alone, that extended transsternal thymectomy confers significant benefits to non-thymomatous MG patients over a period of three years after the procedure. The benefits include better disease status, reduced prednisone requirements, fewer hospitalizations to manage  myasthenia gravis worsenings, and a lower symptom profile related to side effects from medications used to control the disease state. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer, Cost of Health Care / 12.08.2016

MedicalResearch.com Interview with: Wuyang Yang, M.D., M.S. Research Fellow Department of Neurosurgery Johns Hopkins Hospital Baltimore, MD 21287 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The treatment for glioblastoma (GBM) patients involves a combined approach of surgery, radiation therapy and chemotherapy. Despite advancement in the therapeutic approaches for GBM, differing socioeconomic status result in disparities in health-care access, and may superimpose a significant impact on survival of glioblastoma patients. Insurance status is an indirect indicator of overall socioeconomic status of a patient, and has been shown to correlate with survival of patients with malignant tumor in other parts of the body. We conducted the first study to determine a relationship between different types of insurance and survival of GBM patients. In our study of 13,665 cases of GBM patients, we found that non-Medicaid insured patients have a significant survival benefit over uninsured and even Medicaid insured patients. This is the first time a study describes this relationship in glioblastoma patients, and also the first to compare and quantify the likelihood of poor prognosis between different insurance categories. A difference in insurance coverage was also uncovered, and patients with insurance were more likely to be older, female, white, and married. In addition, we found that younger, female, married patients with smaller tumor size survive longer than other patients, which confirmed findings in existing literature. (more…)
Author Interviews, Clots - Coagulation, Diabetes, Heart Disease, JACC / 12.08.2016

MedicalResearch.com Interview with: Raffaele Piccolo, MD Department of Cardiology Bern University Hospital University of Bern Bern, Switzerland MedicalResearch.com: What is the background for this study? Response: Over the past two decades, the prevalence of diabetes mellitus has doubled in Western countries and future projections are even worse by showing a 55% increase by 2035 when approximately 592 million of people are expected to live with diabetes all over the world. Acute myocardial infarction still represents the most common diabetes-related complication and its occurrence is associated with a higher risk of mortality. Timely recanalization of the occluded coronary vessel with primary percutaneous coronary intervention (PCI) represents the therapy of choice for acute ST-segment elevation myocardial infarction (STEMI). Our study investigated whether the direct application of an intracoronary bolus of abciximab, which is an antiplatelet drug blocking the glycoprotein IIb/III a receptor, at the time of primary PCI improves the outcomes at 1-year follow-up compared with the standard intravenous route. The study was in individual patient-level pooled analysis of 3 randomized trials including 2,470 patients, of whom 473 (19%) had diabetes. (more…)
Author Interviews, Heart Disease, Surgical Research, Weight Research / 12.08.2016

MedicalResearch.com Interview with: Dr. Michelle R. Lent, PhD Geisinger Obesity Institute Geisinger Clinic Danville, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than one-third of adults in the United States live with obesity. Currently, the most effective treatment for obesity is bariatric surgery. Bariatric surgery patients are expected to lose 30 to 40 percent of their body weight, but not all patients are able to lose this amount of weight and others experience weight regain. Why some patients succeed in weight loss over time, while others are less successful, remains unclear. In this study, we evaluated over 200 patient characteristics in relation to long-term weight loss after bariatric surgery (7 years or longer), including gender, age and weight at the time of surgery, lab tests, medical conditions and medications, among others. We found that patients who used insulin, had a history of smoking, or used 12 or more medications before surgery lost the most weight, while patients with high cholesterol, older patients and patients with higher body mass indexes at the time of surgery lost the least amount of weight after surgery. (more…)
Author Interviews, Heart Disease, JACC, Stroke, Surgical Research / 12.08.2016

MedicalResearch.com Interview with: Josep Rodés-Cabau, MD Director, Catheterization and Interventional Laboratories Quebec Heart and Lung Institute Professor, Faculty of Medicine, Laval University Quebec City, Quebec, Canada MedicalResearch.com: What is the background for this study? Response: Transcatheter aortic valve replacement (TAVR) is increasingly used in patients with severe aortic stenosis deemed at prohibitive or high surgical risk. Recently, a randomized trial demonstrated the non-inferiority of TAVR compared to surgical aortic valve replacement in intermediate risk patients for the outcome of death and disabling stroke at 2 years. Therefore, TAVR indications are likely to expand to younger and lower risk patients in the near future. While the short-term (30-day) cerebrovascular event (CVE) rate post-TAVR has decreased over time, it remains the most dreadful complication of TAVR, and still occurs in 2% to 3% of patients. A few dedicated studies identified numerous predictors of CVE which mainly differ from one study to another. However, identifying the risk factors of CVE is of paramount relevance in clinical practice to implement preventive strategies, either instrumental (embolic protection devices) or pharmacological in high-risk patients. Thus, we performed a systematic review and meta-analysis using random-effect models to provide pooled estimates of sixteen (8 patient-related and 8 procedural-related) clinically-relevant predictors of CVE within 30 days post TAVR. (more…)
Author Interviews, Infections, Pediatrics / 12.08.2016

MedicalResearch.com Interview with: Marieke de Hoog Assistant Professor Julius Centrum voor Gezondheidswetenschappen en Eerstelijnsgeneeskunde UMC Utrecht The Netherlands  MedicalResearch.com: What is the background for this study? Response: Acute otitis media (AOM) is a prime reason for doctor consultations and antibiotic use in children. Although symptoms of AOM may resolve spontaneously, these infections have a significant impact on child and family life and carry a considerable health care and economic burden.  Acute otitis media occurring early in life, also called early-onset AOM, has been suggested as a risk factor for subsequent  Acute otitis media episodes during childhood and could therefore also impact health care resource use. Identifying the critical age-period and quantifying the long-term consequences of early-onset AOM is important to guide future management and prevention programs aiming to reduce the burden of AOM. (more…)
Author Interviews, Breast Cancer, Cost of Health Care, Johns Hopkins / 11.08.2016

MedicalResearch.com Interview with: Pedram Argani, M.D. Professor of Pathology and Principal consultant of the Breast Pathology Service Johns Hopkins Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Most pathology laboratories, at the request if clinicians, automatically (reflexively) test needle core biopsies containing ductal carcinoma in situ (DCIS) for estrogen receptor (ER) and progesterone receptor (PR). The logic for testing DCIS for these hormone receptors is that, for patients who have pure DCIS that is ER positive after surgical excision, treatment with estrogen blockers like Tamoxifen can decrease the recurrence of DCIS by a small amount, though overall survival (which is excellent) is not impacted. However, there are several factors which suggest that this reflex testing unnecessarily increases costs. • First, the ER/PR results on core needle biopsy do not impact the next step in therapy; namely, surgical excision. • Second, a subset of excisions performed for DCIS diagnosed on core needle biopsy will harbor invasive breast carcinoma, which would than need to be retested for ER/PR. • Third, because ER and PR labeling is often variable in DCIS, negative results for ER/PR in a small core biopsy specimen should logically be repeated in a surgical excision specimen with larger amounts of DICS to be sure that the result is truly negative. • Fourth, many patients with pure DCIS which is ER/PR positive after surgical excision will decline hormone therapy, so any ER/PR testing of their DCIS is unnecessary. • Fifth, PR status in DCIS has no independent value. We reviewed the Johns Hopkins experience with reflex ER/PR testing of DCIS on core needle biopsies over 2 years. We found that reflex core needle biopsy specimen testing unnecessarily increased costs by approximately $140.00 per patient. We found that ER/PR testing in the excision impacted management in only approximately one third of cases, creating an unnecessary increased cost of approximately $440.00 per patient. Extrapolating the increased cost of reflex ER/PR testing of DCIS to the 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increased costs by approximately 35 million dollars. (more…)
Author Interviews, JAMA, Obstructive Sleep Apnea, Pulmonary Disease, Sleep Disorders / 11.08.2016

MedicalResearch.com Interview with: Ken Kunisaki, MD, MS Associate Professor of Medicine Minneapolis Veterans Affairs Health Care System and University of Minnesota and Roxanne Prichard, PhD Associate Professor of Psychology and Neuroscience University of St. Thomas MedicalResearch.com: What is the background for this study? What are the main findings? Response: CPAP devices, or continuous positive airway pressure devices, are used to treat obstructive sleep apnea, a common condition that causes people to intermittently stop breathing during their sleep. This leads to poor sleep quality and often results in symptoms like excessive sleepiness in the daytime. In the United States, CPAP devices are classified by the Food and Drug Administration as Class II medical devices with possible risks; their sale requires a medical prescription. We were aware of online advertisements for secondhand, used CPAP machines, but we have not seen publications that have analyzed this practice. Once a week, our research team monitored online advertisements for secondhand CPAP devices on Craigslist.org in 18 U.S. cities and areas over a one-month period. During that time, we found 270 advertisements, most of which did not describe who previously had used the device or why it was being sold. Only 5 of the advertisements mentioned anything about the legal requirements of a prescription and 61 percent of the devices included a used mask without information about its age or how it was cleaned. CPAP devices create air pressure and attach to a nose or face mask that delivers that pressure to a patient’s airway, thereby keeping him or her breathing during sleep. The amount of air pressure delivered by the devices is adjusted for each patient and usually is determined by a medical exam that includes an overnight stay in a laboratory. Our study found that most of the Craigslist advertisements failed to mention the devices’ pressure settings—settings that were prescribed for the original owners. The average price for a CPAP device listed on Craigslist was $291, much less than the $600 to $2,000 cost of a new device. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA, Mental Health Research / 11.08.2016

MedicalResearch.com Interview with: Helene Lund-Sørensen BM Department of Biomedical Sciences Section of Cellular and Metabolic Research University of Copenhagen MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accumulating research has shown that inflammation and infections are associated with psychiatric diagnoses and interactions between infectious agents, known to affect the brain, and suicidal behavior have been reported. We find an increased risk of death by suicide among individuals hospitalized with infections. The risk of suicide increased in a dose-response relationship with the number of hospitalizations with infections and with the number of days hospitalized with infections. We also examined the risk of suicide association with the time since the last hospitalization with infection and found that infection was linked to an elevated risk with the strongest effect after 1 and 2 years compared with those without infections. (more…)
Author Interviews, Pharmacology / 11.08.2016

MedicalResearch.com Interview with: Willemien J. Kruik-Kollöffel, PharmD Medisch Spectrum Twente in Enschede Netherlands, MedicalResearch.com: What is the background for this study? Response: Safety concerns of the concomitant use of clopidogrel and proton pump inhibitors (PPIs) were published in 2009 and 2010 by the medicines regulatory agencies, including a direct healthcare professional communication. Those publications caused a lot of turmoil. We examined the association between various safety statements and prescription behavior for gastroprotective drugs in naïve patients in the Netherlands during the years 2008–2011. (more…)
Author Interviews, Cancer Research, Chemotherapy, Johns Hopkins, Pancreatic / 11.08.2016

MedicalResearch.com Interview with: Rajesh Kumar NV, Ph.D. Instructor of Oncology and Pathology Johns Hopkins University School of Medicine Baltimore, MD, USA Current Affiliation: Senior Manager, Human Therapeutics Division, Intrexon Corporation, 20358 Seneca Meadows Parkway, Germantown, MD, USA MedicalResearch.com: What is the background for this study? Response: Pancreatic cancer remains as one of the most deadly malignancies in the world. Recently, a cremophor-free and albumin-bound formulation of paclitaxel (nab-PTX, Abraxane) in combination with gemcitabine (GEM, Gemzar) is recently approved as a standard of care treatment option for patients with metastatic pancreatic cancer. Majority of the newly diagnosed pancreatic cancer patients use the nab-PTX plus GEM regimen. Currently there are over 100 clinical trials at various stages with this regimen as a backbone to approved medicines or investigational agents. Since widely available cremophor-based paclitaxel (PTX, Taxol) is a key chemotherapy component for the treatment of several human malignancies and the treatment cost of nab-PTX is relatively higher than PTX, patients, clinicians, third party payers and regulatory agencies have a substantial interest in understanding whether these two drugs provide a similar level of therapeutic efficacy in pancreatic cancer. We utilized orthotopic models of human pancreatic cancer, which were shown to better recapitulate the histologic and metastatic characteristics of disease, and compared the anticancer efficacy, effect on tumor stroma modulation, metastatic spreading to distant organs and survival following GEM, PTX, nab-PTX and combinations of GEM plus PTX or nab-PTX. The preclinical trial used a total of 300 mice with established orthotopic pancreatic tumors. The tumors used for implantation were originally resected from the primary tumors of patients with moderately differentiated and poorly differentiated pancreatic cancer. (more…)
Author Interviews, Dermatology, Technology / 11.08.2016

MedicalResearch.com Interview with: Alexander Golberg, PhD Senior Lecturer Head of Environmental Bioengineering Laboratory Porter School of Environmental Studies Tel Aviv University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Wound care costs the U.S. healthcare system more than $20 billion each year, and care required to combat skin scarring represents an additional $12 billion burden. Hypertrophic scarring after trauma and burn injury remains a major clinical challenge that leads to physical, aesthetic, functional, psychological, and social stresses in thousands of patients. This is a stubborn clinical problem very difficult to solve. Inspired by previous works that pulsed electric fields kill cells precisely in tissue (procedure called irreversible electroporaiton, developed by UC Berkeley group of Boris Rubinsky and Rafael Davalo) and these ablated tissues regenerate with minimal scarring, we decided to test whether pulsed electric fields can reduce the scar formation if we treat the wound during healing. We found that partial irreversible electroporation using 200 pulses of 250 V and 70 µs duration, delivered at 3 Hz every 20 days during a total of five therapy sessions after the initial burn injury resulted in a 57.9% reduction of the scar area in comparison with untreated scars and structural features approaching those of normal skin. Noteworthy, unlike humans, rats do not develop hypertrophic scars. Therefore, the use of a rat animal model is the limiting factor of this work. (more…)
Author Interviews, Genetic Research, JAMA, Melanoma / 11.08.2016

MedicalResearch.com Interview with: Ulrich Pfeffer, PhD Laboratory of Molecular Pathology Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliera Universitaria San Martino–IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: The melanoma of the eye or uveal melanoma is well controlled by radiotherapy or surgery but very aggressively growing metastases often develop and therapy has only marginally improved in decades. On the other hand, uveal melanoma is probably the best studied cancer in absolute: we know its development in great detail and we can make very precise prognosis. An important piece of information that is lacking is the effect of a chromosomal alteration, amplification of a part of chromosome 6, that is often encountered in a subset of uveal melanomas that show features of bad prognosis but actually perform better. Many have guessed that the immune system or more generally, inflammation might protect uveal melanomas with this alteration from progression to metastasis. Therefore we have set out to analyze a candidate gene, the putative immunomodulatory BTNL2, that is located on chromosome 6. We found highly variable expression of this gene in uveal melanoma samples where it is expressed by tumor cells and by infiltrating immune cells. The type of infiltrate is strongly associated with the risk to develop metastases. We also analyzed genetic variants of BTNL2 in 209 patients but we could not find a significant association with uveal melanoma risk. (more…)
Author Interviews, Brigham & Women's - Harvard, Environmental Risks, Toxin Research / 10.08.2016

MedicalResearch.com Interview with: Courtney C. Carignan PhD Research Fellow Department of Environmental Health Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: We used mapping technology coupled with drinking water data from EPA to identify military bases, airports, industrial sites, and wastewater treatment plants as major sources of PFOS and PFOA contamination in drinking water. These measurements suggest that at least six million people have drinking water that exceeds the recent EPA health advisorylevels for PFOA and PFOS. These are chemicals that have been historically manufactured in the US and used widely in consumer products such as stain-proof carpeting, non-stick pans and aqueous firefighting foam. They have been replaced with new generation of shorter-chain fluorinated chemicals, which also do not break down in the environment and may be similarly toxic. (more…)
Aging, Author Interviews, BMJ, Geriatrics, Mental Health Research / 10.08.2016

MedicalResearch.com Interview with: Dr. Faiza Tabassum, PhD Southampton Statistical Sciences Research Institute  University of Southampton Southampton, UK MedicalResearch.com: What is the background for this study? Response: Previous research has shown that volunteering in older age is associated with better mental and physical health, but it’s unclear whether this extends to other age groups. We aimed to examine the association of volunteering with mental health or well-being among the British population across all ages. The British Household Panel Survey (BHPS) was used which has collected information from 1991 to 2008 from over 5000 households. The published study has analysed over 66,000 responses representing the whole of the UK. The BHPS included a wide range of questions on leisure time activities, which covered the frequency of formal volunteering—from at least once a week through to once a year or less, or never. The BHPS also included a validated proxy for mental health/emotional wellbeing known as the GHQ-12. (more…)
Author Interviews, JAMA, Lipids, Pediatrics / 10.08.2016

MedicalResearch.com Interview with: Paula Lozano, MD MPH Associate Medical Director, Research and Translation Group Health Physicians Senior Investigator Group Health Research Institute Metropolitan Park East Seattle, WA 98101 MedicalResearch.com: What is the background for this study? Response: This wasn’t a study, but rather a study of studies, to support the US Preventive Services Task Force in updating its previous recommendation of I: insufficient to assess the balance of benefits and harms. We conducted two systematic evidence reviews of screening children and adolescents: 1. for familial hypercholesterolemia (FH, a genetic disorder that interferes with the body’s ability to metabolize cholesterol and can result in early coronary heart disease); and 2. for multifactorial dyslipidemia—which we defined as elevated LDL cholesterol or total cholesterol, not caused by familial hypercholesterolemia. LDL and total cholesterol were of interest because they are considered atherogenic. One of the challenges of lipid screening in youth is that blood levels of these atherogenic lipids are known to fluctuate during the course of childhood and adolescence. It’s sort of a W-shaped curve, with a peak at age 9-11 years. So for a given child, the definition of what’s an elevated LDL or total cholesterol level will change with age. Also, two-thirds of kids identified as having high cholesterol through universal screening would not go on to have high cholesterol as adults. (more…)
Author Interviews, Diabetes, JAMA, Kidney Disease / 10.08.2016

MedicalResearch.com Interview with: Ian de Boer, MD, MS Associate Professor of Medicine Adjunct Associate Professor of Epidemiology Division of Nephrology and Kidney Research Institute University of Washington, Seattle, WA MedicalResearch.com: What is the background for this study? What are the main findings? Response: From the perspective of patients with diabetes, kidney disease can be a devastating complication, leading to end stage renal disease requiring dialysis or kidney transplantation and markedly increasing the risks heart disease, stroke, peripheral vascular disease, and amputation. From a public health perspective, diabetes is the most common cause of end stage renal disease in the US, so understanding, preventing, and treating diabetic kidney disease is critical to reduce the numbers of people needing dialysis and kidney transplants. There have been major changes in the treatment of patients with diabetes over the last 30 years, so we were interested in evaluating how diabetic kidney disease was changing in this context. We observed that the clinical manifestations of kidney disease have indeed changed among US adults with diabetes over the last 30 years. Albuminuria, or elevated levels of albumin in the urine, has traditionally been thought of as the first evidence of kidney damage for people with diabetes. Reduced GFR, or a reduced ability of the kidneys to filter out waster products, has typically been thought of as a late stage of diabetic kidney disease. But from 1988 to 2014, we saw a significant decrease in the prevalence of albuminuria accompanied by a significant increase in reduced GFR. (more…)
Author Interviews, JAMA, Opiods, Toxin Research / 10.08.2016

MedicalResearch.com Interview with: Ann M. Arens, MD California Poison Control Center San Francisco, CA 94110 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prescription opioid abuse is a significant public health threat that has garnered the attention of health care providers throughout medicine. With efforts to curb the number of prescriptions for opioid pain medications, users may begin to purchase prescription medications from illegal sources. Our study reports a series of patients in the San Francisco Bay Area who were exposed to counterfeit alprazolam (Xanax®) tablets found to contain large amounts of fentanyl, an opioid 100 times more potent than morphine, and in some cases etizolam, a benzodiazepine. The California Poison Control System – San Francisco division identified eight patients with unexpected serious health effects after exposure to the tablets including respiratory depression requiring mechanical ventilation, pulmonary edema, cardiac arrest, and one fatality. Patients reportedly purchased the tablets from drug dealers, and were unaware of their true contents. In one case, a 7 month-old infant accidentally ingested a counterfeit tablet dropped on the floor by a family member. (more…)
Author Interviews, Dental Research, Heart Disease / 10.08.2016

MedicalResearch.com Interview with: John Liljestrand, DDS Department of Oral and Maxillofacial Diseases University of Helsinki MedicalResearch.com: What is the background for this study? Response: There is an increased amount of evidence supporting the hypothesis that oral inflammations increase the risk for cardiovascular diseases (CVDs). The association between marginal periodontitis, a common inflammatory disease in the tooth supporting tissues, and CVDs is well established. The link is thought to depend on transient but repeated bacteremia, endotoxemia and an increased systemic inflammatory burden. Apical periodontitis is a common manifestation of an endodontic infection, most often caused by dental caries. It is an inflammatory reaction surrounding the root tip of a tooth and it restrains the dental infection from spreading into the bone. Apical periodontitis is similar to marginal periodontitis regarding its microbial profile and ability to increase systemic inflammatory markers. Therefore, it is justified to suggest that apical periodontitis might also increase the risk for CVDs. There is only a minor amount of publications on this topic and further research is still needed.  (more…)
Author Interviews, BMJ, Psychological Science, Sexual Health / 10.08.2016

MedicalResearch.com Interview with: Steven Arnocky, PhD Associate Professor Department of Psychology Nipissing University North Bay, ON CAN  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our work was based on previous findings from hunter-gatherer populations showing that men who hunt and share meat often enjoy greater reproductive access to women.  Research in North America has shown that individuals prefer altruistic partners, especially for long-term mating, and that there may be a sex difference in these preferences such that women exhibit this preference more strongly than men. In line with this, some research has shown that men will sometimes compete with other men in order to make charitable donations to attractive female fundraisers (termed 'competitive altruism'). Taken together, these findings led us to hypothesise that individuals (and perhaps particularly men) who behave altruistically might experience greater mating success. In Study 1, undergraduate men and women completed a self-report altruism questionnaire (items such as “I have donated blood”), a personality measure, and a sexual history survey. We found that participants who scored higher on a self-report altruism measure reported they were more desirable to the opposite sex, as well as reported having more sex partners, more casual sex partners, and having sex more often within relationships. Moreover, altruism mattered more for men’s number of lifetime and casual sex partners relative to women’s. Given the possibility that in any survey research, there is a chance individual’s may report their altruism of sexual history in what they view to be a more positive light (who doesn’t want to think of themselves as altruistic!), in Study 2, we used a behavioral measure of altruism (each participant was entered onto a draw for $100, and at the end of the survey was given the choice to keep their winnings or to donate to a charity). Participants again reported on their sexual histories, as well as completed a personality measure, a scale to capture socially-desirable responding, and a measure of narcissism. Results showed that even when controlling for these potentially confounding variables, that altruists reported having more lifetime sex partners, more casual sex partners, and more sex partners over the past year. Men who were willing to donate also reported having more lifetime dating partners. (more…)