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Author Interviews, Geriatrics, Pharmacology / 13.05.2016

MedicalResearch.com Interview with: Leigh Purvis, MPA Director of Health Services Research AARP Public Policy Institute MedicalResearch.com Editor’s Note: The May AARP Bulletin has a important article “Black Market Meds Are Flooding the Nation’s Pharmacies And Hospitals” by Joe Eaton, discussing the growing problem of counterfeit medications entering the US pharmaceutical supply chain. Ms. Leigh Purvis of the AARP Policy Institute discussed this important issue for the readers of MedicalResearch.com. Ms. Purvis’ areas of expertise include prescription drug pricing, biologic drugs, and Medicare prescription drug coverage.  MedicalResearch.com: Is pharmaceutical theft and fraud a new or growing problem? Ms. Purvis: I think it’s safe to say that pharmaceutical theft is a growing problem. Skyrocketing prices have made pharmaceuticals a lucrative target for criminals. Trucks transporting pharmaceuticals are a common target, although some thieves have stolen prescription drugs directly from manufacturers’ warehouses. Pharmaceutical fraud is also a growing concern. FDA does a great deal to ensure the safety of US pharmaceuticals. However, problems can still arise, particularly when people purchase drugs online. (more…)
Author Interviews, Technology / 13.05.2016

MedicalResearch.com Interview with: Dr. Shuhei Miyashita PhD Lecturer in Intelligent Robotics Department of Electronics University of York, Heslington York, UK MedicalResearch.com: What is the background for this device? What are some of the  obstacles you and your team face in the development? Dr. Miyashita: We are developing medical technology that is less invasive and more autonomous and thus can provide safe and consistent outcomes. The biggest challenge is how to build a capable medical robot that is clinically safe. Addressing this challenge requires finding bio-compatibe materials, safe means of transportation in the body, a way to reconfigure the robot from pill shape to unfolded shape, and precise multi-mode control for the location and function of the robot. (more…)
AHA Journals, Author Interviews, Heart Disease, Lipids / 13.05.2016

MedicalResearch.com Interview with: Michael Miller, MD, FACC, FAHA Professor of Cardiovascular Medicine, Epidemiology & Public Health University of Maryland School of Medicine Staff Physician, Baltimore VAMC Director, Center for Preventive Cardiology University of Maryland Medical Center Baltimore, Maryland MedicalResearch.com: What is the background for this study? Dr. Miller: It has become an article of faith that HDL (the good cholesterol) is an independent risk factor for heart disease. However, previous studies did not examine the importance of HDL after accounting for both LDL (bad cholesterol) and triglycerides (blood fats).  This is important because HDL is associated with LDL and triglycerides. We hypothesized that if HDL is truly an independent risk factor, then low HDL levels in isolation would continue to be linked to an increased risk of heart disease while high HDL levels would continue to protect the heart even if LDL and triglycerides levels were elevated. (more…)
Author Interviews, Cancer Research, Colon Cancer, Immunotherapy, Leukemia, Multiple Sclerosis, Neurology / 13.05.2016

MedicalResearch.com Interview with: PD Dr. Mathias Buttmann Senior Consultant Neurologist and Head of the Multiple Sclerosis Outpatient Clinic University of Wuerzburg Wuerzburg, Germany  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Buttmann: The synthetic anthracenedione mitoxantrone is approved for disease-modifying treatment of patients with aggressive forms of relapsing or secondary progressive multiple sclerosis (MS). It has been known for years that this DNA-intercalating agent increases the risk of acute myeloid leukemia. We performed a retrospective cohort study to investigate whether mitoxantrone also increases the risk for other types of malignancies. We included all 677 mitoxantrone-treated  multiple sclerosis patients who were seen at our large German academic MS centre between 1994 and 2007 and collected follow-up information on the occurrence of malignancies, death and causes of death as of 2011. Follow-up was complete in 676 patients. The median age at mitoxantrone initiation was 41 years and the median follow-up duration was 8.7 years. We identified 37 patients with a malignancy after mitoxantrone initiation, among them 4 cases of acute myeloic leukemia and 7 cases of colorectal cancer. Compared to the general population matched for sex, age and year of occurrence, we calculated an 1.5-fold increased incidence of any type of malignancy, a tenfold increased incidence of acute myeloic leukemia and a threefold increased incidence of colorectal cancer, while the incidence of other types of malignancies was not increased. Higher age at mitoxantrone initiation but neither higher cumulative mitoxantrone dose nor treatment with other immuosuppressive agents was identified as a malignancy risk factor. Fifty-five patients had died, among them 12 from a malignancy. Our study confirmed previous reports on an increased incidence of acute myeloic leukemia after mitoxantrone treatment and newly described an association between mitoxantrone therapy and an increased incidence of colorectal cancer. (more…)
Author Interviews, Ophthalmology / 13.05.2016

MedicalResearch.com Interview with: Prof. Dr. med. Hans Hoerauf Direktor der Augenklinik Universitätsmedizin Göttingen Göttingen   MedicalResearch.com: What is the background for this study? Dr. Hoerauf: Two treatment options, anti-vascular endothelial growth factors (anti-VEGFs) and corticosteroids, with different mechanisms of action are available for the treatment of macular edema secondary to Central Retinal Vein Occlusion (CRVO). Our study, COMRADE-C, is the first head-to-head study to investigate the clinical efficacy and safety of the European labels of ranibizumab (anti-VEGF) versus dexamethasone intravitreal implant (corticosteroid) in patients with CRVO over six months. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Genetic Research, PLoS / 13.05.2016

MedicalResearch.com Interview with: Katarina Truvé PhD Swedish University of Agricultural Sciences and Kerstin Lindblad-Toh Uppsala University MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Truvé: Gliomas are malignant brain tumors that are rarely curable. These tumors occur with similar frequencies in both dogs and humans. Gliomas in dogs are strikingly similar at the biological and imaging level to human tumor counterparts. Some dog breeds such as Boxer and Bulldog are at considerably higher risk of developing glioma. Since these breeds at high risk are recently related, they are most likely carrying shared genetic risk factors. Our goal was therefore to use the dog genome to locate genes that may be involved in the development of glioma in both dogs and humans. We found a strongly associated locus and identified three candidate genes, DENR, P2RX7 and CAMKK2 in the genomic region. We have shown that CAMKK2 is lower expressed in glioma tumors than normal tissue in both dogs and human, and it has been reported that the associated canine mutation in P2RX7 results in a decrease in receptor function. (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Nutrition, Pediatrics / 13.05.2016

MedicalResearch.com Interview with: Maryam Farvid, Ph.D. Visiting Scientist Department of Global Health and Population Harvard T.H. Chan School of Public Health MedicalResearch: What is the background for this study? What are the main findings? Dr. Farvid: Breast cancer is one of the most frequently diagnosed cancers and is the second leading cause of cancer deaths among women in the United States. While we know many breast cancer risk factors, few of them are easily modified. Further, evidence suggests that exposure to carcinogens and anti-carcinogens in early life may play an important role. According to this study, what women eat as teens or young adults could affect their breast cancer risk in the future. Teenage girls who eat a lot of fruits may have a lower risk of breast cancer later in life. The risk of breast cancer among women who reported the highest amount of dietary fruits during high school, about 2.9 servings of fruit a day, was 25 percent lower, compared with those who had eaten the lowest amount, about 0.5 serving of fruit a day. We also analyzed individual fruit and vegetable intake and risk of breast cancer: greater consumption of apple, banana, and grapes during adolescence, as well as oranges and kale for young adult was significantly associated with a reduced risk. (more…)
Author Interviews, Education, Genetic Research, Nature / 13.05.2016

MedicalResearch.com Interview with: Dr. Daniel J. Benjamin PhD Associate Professor (Research), USC, 2015-present Associate Professor (with tenure), Cornell, 2013-2015 Assistant Professor, Cornell University, 2007-2013 Research Associate, NBER, 2013-present Faculty Research Fellow, NBER, 2009-2013  MedicalResearch.com: What is the background for this study? Dr. Benjamin: Educational attainment is primarily determined by environmental factors, but decades of twin and family studies have found that genetic factors also play a role, accounting for at least 20% of variation in educational attainment across individuals. This finding implies that there are genetic variants associated statistically with more educational attainment (people who carry these variants will tend on average to complete more formal education) and genetic variants associated statistically with less educational attainment (people who carry these variants will tend on average to complete less formal education). But none of these genetic variants had been identified until our 2013 paper on educational attainment. That paper, which studied a sample of roughly 100,000 individuals, identified 3 genetic variants associated with educational attainment, each of which has a very small effect. In the current paper, we expanded our sample to roughly 300,000 individuals, with the goal of learning much more about the genetic factors correlated with educational attainment. (more…)
Author Interviews, Nutrition / 12.05.2016

MedicalResearch.com Interview with: Danielle E. Schoffman PhD Candidate Department of Health Promotion, Education, and Behavior Arnold School of Public Health University of South Carolina Columbia, SC 29208  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In recent years, there has been large growth in the fast casual (e.g., Panera, Chipotle) restaurant sector, and there is a general perception among consumers that these restaurants are a healthier and fresher alternative to fast food. When we encourage participants in our research studies to reduce their fast food intake, they often ask if these fast casual restaurants also count. We were interested in looking at the calorie data for entrees at both restaurant types to see if they lined up with these assumptions. We analyzed the calorie content of entrées at 34 fast food and 28 fast casual restaurants, and found that fast food entrées had an average of 760 calories per entrée compared to 561 for fast food entrées . Also, a greater proportion of fast casual restaurant entrées exceeded the median of 640 calories per entrée. (more…)
Artificial Sweeteners, Author Interviews, Brain Injury, JAMA, Neurological Disorders, Ophthalmology / 12.05.2016

MedicalResearch.com Interview with: Dr. T. Dianne Langford PhD Associate Professor, Neuroscience and Neurovirology Lewis Katz School of Medicine Temple University MedicalResearch.com: What is the background for this study? Dr. Langford: The ocular-motor system has been shown to reflect neural damage, and one of ocular-motor functions, near point of convergence (NPC), was reported to worsen after a sport-related concussion (Mucha et al. Am J Sport Med). But the effects of subconcussive head impact, a milder form of head injury in the absence of outward symptoms remains unknown.  Prior to this study, we found that in a controlled soccer heading experimental paradigm decreased NPC function, and even 24h after the headings, NPC was not normalized back to baseline (Kawata et al. 2016 Int J Sport Med). To extend our findings from the human laboratory study, we launched longitudinal clinical studies in collaboration with the Temple football team, to see if repetitive exposure to subconcussive head impacts negatively affects NPC. (more…)
Author Interviews, JAMA, Ophthalmology / 12.05.2016

MedicalResearch.com Interview with: Dr. Brian Boxer Wachler MD Boxer Wachler Vision Institute Beverly Hills, California MedicalResearch.com: What is the background for this study? What are the main findings? Response: As an eye surgeon, I observed patients tended to have more age spots on the left side of their faces.  I was examining a patient with Keratoconus and after I noted her age spots on her left cheeks, I began to look into this phenomenon.  It turns out there are many studies that found more skin cancer on the left side of the face compared to the right side of the face.  In Australia (where people drive on the left side of the road) it’s the opposite – more skin cancer on the right side of the face.   Our study found that cars on average have significantly lower UVA (ultraviolet A) protection in the side windows compared to windshields which have universally high UVA protection.  I believe this can be the missing link that can explain higher rates of skin cancer on the side of the face by the driver’s window. There are also more cataracts in left eyes vs right eyes.  There was no relationship between high-end cars and low-end cars for side window UV protection – in other words many more pricey cars had just as poor side window UV protection as less expensive cars. (more…)
AHA Journals, Author Interviews, Race/Ethnic Diversity, Stroke / 12.05.2016

MedicalResearch.com Interview with: Lucas Ramirez, M.D Resident Physician | LAC-USC Medical Center USC Keck School of Medicine | Class of 2013  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Ramirez: Prior studies have shown differences in stroke rates in certain geographical regions among age and racial groups. Few studies have analyzed these differences on a national level.  Our study found that nationally, stroke hospitalization have decreased, though among blacks and young age groups, they have increased. (more…)
Author Interviews, Gastrointestinal Disease, Microbiome, Nature, Technology / 12.05.2016

MedicalResearch.com Interview with: Prof. Dr. Paul Wilmes Associate Professor Head of the Eco-Systems Biology Research Group Luxembourg Centre for Systems Biomedicine University of Luxembourg Luxembourg MedicalResearch.com: What is the background for this intestinal model? Dr. Wilmes: Changes in the human gastrointestinal microbiome are associated with several diseases. To infer causality, experiments in representative models are essential. Widely used animal models exhibit limitations. Therefore, we set out to develop the HuMiX model which allows co-culture of human and microbial cells under conditions representative of the gastrointestinal interface. (more…)
Author Interviews, JAMA, Weight Research / 12.05.2016

MedicalResearch.com Interview with: Shoaib Afzal, MD, PhD Department of Clinical Biochemistry Copenhagen General Population Study Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences University of Copenhagen, Copenhagen, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Afzal: Previous findings indicate that while average BMI has increased over time in most countries, the prevalence of cardiovascular risk factors may be decreasing among obese individuals. Thus, the BMI associated with the lowest all-cause mortality may have changed over time. This study included three cohorts from the same general population enrolled at different times: the Copenhagen City Heart Study in 1976-1978 (n = 13,704) and 1991-1994 (n = 9,482) and the Copenhagen General Population Study in 2003-2013 (n = 97,362). The increased risk for all-cause mortality that was associated with obesity compared to normal weight decreased from 30% in 1976-1978 to 0% in 2003-2013, that is, over a 30-year period. In addition, the optimal BMI for lowest all-cause mortality increased by 3.3 from 23.7 in 1976-1978 through 24.6 in 1991-1994 to 27 in 2003-2013. Another interesting finding in this study is that the optimal BMI in relation to lowest mortality is placed in the overweight category in the most recent 2003-2013 cohort. (more…)
Author Interviews, Heart Disease, Transplantation / 12.05.2016

MedicalResearch.com Interview with: Jaimin Trivedi, MD, MPH Instructor Department of Cardiovascular and Thoracic Surgery University of Louisville Louisville, KY 40202 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Trivedi: There is a donor heart shortage in United States and certain donor hearts are likely to be turned down because the donors required cardiopulmonary resuscitation (CPR) prior to procurement. The rationale behind conducting the study was to identify impact of donor CPR and its duration on recipient survival after transplantation. Our findings show that presence of CPR and duration of CPR does not adversely impact the post heart transplant survival. The study also shows that ejection fraction and peak cardiac troponins between the CPR and non-CPR donors were comparable at time of transplant suggesting recovery of cardiac function. (more…)
Author Interviews, Heart Disease, JAMA, Social Issues / 12.05.2016

MedicalResearch.com Interview with: Erica Spatz, MD, MHS Assistant Professor, Section of Cardiovascular Medicine Center for Outcomes Research and Evaluation Yale University School of Medicine/Yale-New Haven Hospital New Haven, CT 06520 MedicalResearch.com: What is the background for this study? What are the main findings?  Dr. Spatz: Rates of heart attack have declined during the last 15 years. But whether communities of different economic status or in different geographic regions experienced similar declines is unknown, especially as efforts to prevent cardiovascular disease and manage heart attacks may not have been equally successful in communities with different resource capacity. Our study shows that trends in the incidence of and mortality from heart attack were similar in low, average and high income communities. However, low-income communities had higher hospitalization rates than average and high income communities throughout the 15 year study period. Interestingly mortality rates were similar. (more…)
Author Interviews, Kaiser Permanente, OBGYNE, Pediatrics, Weight Research / 12.05.2016

MedicalResearch.com Interview with: Anny H. Xiang, PhD Kaiser Permanente Southern California Department of Research & Evaluation MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Xiang: Previous studies have identified a link between maternal obesity, diabetes and/or excessive gestational weight gain and long-term obesity risk in children. Our study examined the interplay among all four factors associated with childhood obesity: pre-pregnancy obesity, gestational weight gain, gestational diabetes and breastfeeding. To our knowledge, the interplay among these factors and their independent contributions to childhood obesity with data from a large and multi-ethnic cohort under current standard clinical care had not been previously studied. The study included 15,710 women who delivered babies at Kaiser Permanente medical facilities in Southern California in 2011. The key findings were:
  • A woman being obese (BMI of 30.0 or higher) prior to getting pregnant increased the odds of her child being overweight at age 2 by more than two-fold compared to women who had a normal pre-pregnancy weight (BMI between 18.5 and 25), after adjusting for weight gain during pregnancy, gestational diabetes and breastfeeding.
  • A woman being overweight (BMI between 25.0 and 29.9) prior to pregnancy was associated with 50 percent increased odds of her child being overweight at age 2.
  • Excessive weight gain during pregnancy was associated with 23 percent increased odds of a child being overweight at age 2 compared to women who had healthy weight gain during pregnancy after adjusting for pre-pregnancy weight, gestational diabetes and breastfeeding.
  • Breastfeeding for at least six months was associated with a 24 percent reduction for the odds of a child being overweight at age 2 regardless of a mother’s pre-pregnancy weight, gestational diabetes or excessive weight gain during pregnancy.
  • Gestational diabetes was not associated with the risk of a child being overweight at age 2. Women with gestational diabetes in this cohort were treated following standard clinical practice and had 40-49 percent lower rate of excessive weight gain during pregnancy and similar breastfeeding rates compared to women without gestational diabetes.
Excessive weight gain was defined according to Institute of Medicine guidelines, with normal-weight women gaining more than 35 pounds, overweight women gaining more than 25 pounds and obese women gaining more than 20 pounds during their pregnancy. Children were considered overweight at age 2 if their BMI was greater than the 85th percentile for their age and sex, based on growth charts from the Centers for Disease Control and Prevention. (more…)
Author Interviews, Biomarkers, Prostate Cancer, Urology / 12.05.2016

MedicalResearch.com Interview with: Jonathan Shoag MD Urology Resident at Cornell Department of Urology and Dr. Jim C. Hu MD Ronald Lynch Professor of Urologic Oncology Professor of Urology Director, Lefrak Center for Robotic Surgery Attending Urologist, New York-Presbyterian Hospital (Cornell campus) MedicalResearch.com: What is the background for this study? Response: Prostate Specific Antigen (PSA) is a blood test that is used to detect prostate cancers and to follow a cancer’s response to treatment. PSA was widely implemented as a screening tool for prostate cancer in the early 1990s, and became a routine test during an annual physical for men over 40. Doctors started using it because values above a “normal” threshold were associated with a greater risk of prostate cancer. Following the adoption of PSA screening in the early 1990s, there has been a large increase in the number of men diagnosed with cancer, and a decrease of approximately 50% in the rate of prostate cancer death. The PLCO trial was a large randomized trial designed and funded by the National Cancer Institute (NCI) to determine the effect of PSA screening on death from prostate cancer. The trial found that men randomized/assigned to prostate cancer screening had the same number of prostate cancer deaths as men in the control group of the trial, arguing that PSA screening does not decrease prostate cancer mortality. This was a major piece of evidence used by the United States Preventative Services Task Force (USPSTF) to form its 2012 recommendation against PSA screening. The argument was that in spite of the other evidence showing a benefit to PSA testing, including US epidemiologic trends, and another large randomized trial showing PSA screening was effective (the ERSPC), we now had good evidence showing no benefit to PSA testing in the US. Since 2012 we have seen dramatic declines in prostate cancer screening in the US as a result. (more…)
Accidents & Violence, Author Interviews, Cannabis / 11.05.2016

MedicalResearch.com Interview with: Mr. Brian C. Tefft Senior Research Associate AAA Foundation for Traffic Safety MedicalResearch.com: What is the background for this study? What are the main findings? Response: In December 2012, a new law took effect in Washington state that effectively legalized the possession and use of small amounts of marijuana by adults aged 21 years and older for recreational purposes, and also created a legal limit for driving under the influence of marijuana such that having a concentration of 5.00 nanograms or greater of delta-9-tetrahydrocannabinol (THC, the main psychoactive chemical in marijuana) per milliliter of whole blood while driving in the state of Washington is per se driving under the influence. Data from population-based surveys indicate that the proportion of Washington state residents who report using marijuana increased after this law took effect; however, not much was known about the impact of this new law on traffic safety in the state. To investigate the traffic safety impact of the new law, we examined drug test results from drivers involved in motor vehicle crashes that occurred in years 2010 – 2014 in Washington and resulted in the death of at least one person within 30 days of the crash. Specifically, we looked at the proportion of all drivers involved in fatal crashes who had detectable THC in their blood at or shortly after the time of the crash, which generally suggests that the driver had used marijuana within the past few hours. Results showed that from 2010 through 2013, approximately 8-9% of drivers in fatal crashes each year were positive for THC, and that proportion was basically flat from 2010 through 2013. In 2014, the proportion basically doubled, to 17%. Our modelling suggests that an increasing trend in the proportion of drivers who were positive for THC began in late 2013, about 9-10 months after the new law took effect. (more…)
Author Interviews, Pediatrics, Sleep Disorders, Weight Research / 11.05.2016

MedicalResearch.com Interview with: Ofir Turel, Ph.D Professor, Information Systems and Decision Sciences California State University, Fullerton Scholar in Residence, Department of Psychology University of Southern California MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Turel: The study emerged as a response to the growing societal concern regarding potentially problematic information system use” lifestyles”, including videogame addiction, among adolescents. Much research in this domain has focused on negative psychological (e.g., reduced wellbeing, depression) and social/life functioning (e.g., reduction in normal activities, diminished school performance). Less is known regarding potential physiological outcomes of videogame addiction. Interestingly, the increase in videogame addiction-like symptoms among adolescents happened in conjunction with an increase in sleep curtailment and obesity in this population. These are too growing concerns in North America and perhaps elsewhere. Medical research implies that these three phenomena may be related. Hence, we hypothesized that videogame addiction will be associated with increased sleep curtailment and increased abdominal adiposity; and consequently, indirectly, with cardio-metabolic deficits. Our findings suggest that videogame addiction predicts reduced sleep duration which in turn, predicts increased abdominal adiposity. Abdominal adiposity was associated with increased blood pressure, insulin resistance and triglycerides and reduced high density lipoprotein cholesterol levels. Hence, sleep curtailment is an important mediating factor that helps translating videogame addiction into cardio-metabolic deficiencies. (more…)
Author Interviews, Opiods, Pain Research / 11.05.2016

MedicalResearch.com Interview with: Richard M. Mangano, PhD Chief Scientific Officer at Relmada Therapeutics Dr. Mangano has extensive experience leading global R&D programs in both large and small pharmaceutical companies including positions in discovery and clinical research at Hoffmann-La Roche, Lederle Laboratories, Wyeth Research and Adolor Corporation. He served as acting Therapeutic Area Director for Neuroscience at Wyeth before joining Adolor as Vice President of Clinical Research and Development. Dr. Mangano’s expertise includes multiple IND/CTC submissions and NDA/MAA approvals in psychiatry, neurology and gastrointestinal therapeutic areas. Dr. Mangano is also an adjunct professor in the Department of Pharmacology and Physiology at the Drexel University School of Medicine. He lectures in the Drug Discovery and Development Program and in the Psychiatry Department’s Resident Training Program.  He has authored 30 peer reviewed publications and over 120 abstracts and presentations. Dr. Mangano holds a B.S degree in Chemistry from Iona College and a PhD degree in Biochemistry from Fordham University. Prior to joining the pharmaceutical industry, he was a research faculty member of the Maryland Psychiatric Research Institute at the University of Maryland School of Medicine. Dr. Mangano discusses the opioid addiction and the development of abuse-resistant medications. MedicalResearch.com: What is the background for the development of abuse-resistant medications? How extensive is the problem of opioid addiction? Dr. Mangano: Recognizing the growing incidence of opioid abuse, misuse, and overdose in the United States, pharmaceutical companies, with the guidance of the FDA, are developing products that can mitigate abuse, while recognizing the importance of maintaining the availability of opioid analgesics for the millions of patients in this country who suffer from pain. Approximately two million people in the U.S. are addicted to opioids. The market for products that treat opioid dependence has grown significantly due to the rapidly escalating problem of prescription opioid misuse and abuse, a recent resurgence of heroin use, and the growing number of physicians treating opioid dependence. One of our product candidates, REL-1028 (BuTab), is a proprietary formulation of buprenorphine designed to treat both opioid addiction and moderate to severe chronic pain. Although there is the potential for addiction to buprenorphine, the risk is lower because it is a “partial agonist” of the mu opioid receptor compared with “full agonist” opioids like heroin, morphine, oxycodone, and hydrocodone. As a result, products containing buprenorphine, such as BuTab, should have reduced risk of abuse and physical dependence and would be controlled in Schedule III of the Controlled Substances Act (as opposed to the more restrictive Schedule II). We are also considering a formulation that would include an opioid antagonist that would not interfere with analgesia when taken orally as prescribed but would block the action of buprenorphine if it were to be inhaled or injected. (more…)
Author Interviews, Heart Disease, Johns Hopkins, Nature, Technology / 11.05.2016

MedicalResearch.com Interview with: Natalia Trayanova PhD, FHRS, FAHA Murray B. Sachs Endowed Chair Professor of Biomedical Engineering Joint Appointment, Medicine Johns Hopkins University Institute for Computational Medicine Johns Hopkins University Baltimore, MD MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Trayanova: The methodology for modeling cardiac electrical function has matured sufficiently that we can now create computational models of the electrical functioning of the entire heart. My research is focused on translating this methodology into the clinic. The goal is to create, if you will, "a virtual heart for every patient", that will enable the physician to play our scenarios that manifest the heart dysfunction in the given patient, and to enable physicians to make personalized decisions about patient treatment. The present paper is the first application of this overall vision. The motivation for this particular paper was that determining which patients are at risk for sudden cardiac death represents a major unmet clinical need. Patients at risk receive life-saving implantable defibrillators (ICDs), but because of the low sensitivity and specificity of current approach (based on low ejection fraction), risk assessment is inaccurate. Thus, many patients receive ICDs without needing them, while others die of sudden cardiac death because they are not targeted for ICD therapy under the current clinical recommendations. Our goal was to develop a non-invasive personalized virtual-heart risk assessment tool that has the potential to ultimately prevent sudden cardiac death and avoid unnecessary ICD implantations. (more…)
Author Interviews, MRI, Prostate Cancer, Urology / 11.05.2016

MedicalResearch.com Interview with: Dr. Vikas Gulani MD, PhD Director, MRI, University Hospitals Case Medical Center Associate Professor, Radiology CWRU School of Medicine Cleveland, OH  MedicalResearch.com: What is the background for this study? Dr. Gulani: For men that have a suspicion for prostate cancer either via the prostate specific antigen (PSA) test or a digital rectal exam, the current standard of care is to perform a transrectal ultrasound (TRUS) guided biopsy to detect cancer. The problem with TRUS biopsy is that most tumors are not visible on ultrasound and hence many significant cancers are missed. At the same time this strategy detects a high number of low risk, indolent cancers, and leads to overtreatment of disease that would be better left untreated. Diagnostic MRI and MRI-guided biopsy (cognitive, ultrasound-MR fusion, or in-gantry) have been shown to be effective in detecting clinically significant prostate cancer. However, despite these advantages there is reluctance to incorporate MRI into standard practice because it is perceived to be expensive. Our goal was to determine if this presumption is true, and evaluate the cost-effectiveness of the MRI-guided techniques most commonly used. MedicalResearch.com: What are the main findings? Dr. Gulani: We found that every MRI strategy we evaluated was cost-effective compared to standard biopsy. Cognitive MRI guided biopsy – where the operator performs an ultrasound biopsy based on knowledge of lesion location from the MRI – was the most cost-effective strategy compared to standard biopsy. In-gantry MRI yielded the highest net health benefits as measured in quality adjusted life years. (more…)
Author Interviews, Biomarkers, Cancer Research, Genetic Research, MD Anderson / 11.05.2016

MedicalResearch.com Interview with: Dr. Han Liang PhD Associate Professor and Deputy Department Chair, Department of Bioinformatics and Computational Biology The University of Texas MD Anderson Cancer Center Faculty Member, Baylor College of Medicine Houston, TX MedicalResearch: What is the background for this study? What are the main findings? Dr. Liang: An individual’s sex has been long recognized as a key factor affecting the risk of cancer development and management. However, previous studies on the sex effect have been limited to individual genes, single molecular data types, and single cancer lineages. We performed a comprehensive analysis of molecular differences between male and female patients in a diversity of cancer types and revealed two sex-effect groups. One group contains a small number of sex-affected genes, whereas the other shows much more extensive sex-biased molecular signatures. More than half of clinically actionable genes (e.g., therapeutic targets or biomarkers) show sex-biased signatures. (more…)
Author Interviews, Pain Research, Psychological Science / 11.05.2016

MedicalResearch.com Interview with: Dominik Mischkowski, co-author of the study Former Ph.D. student at Ohio State Now at the National Institutes of Health MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Mischkowski: We tested in two double blind experiments whether the popular physical painkiller acetaminophen reduces empathy for the pain of other people. In the first experiment (N=80), participants completed measures of empathy (i.e., perceived pain and personal distress) while reading hypothetical about the physical and social mishaps of other people. We found that acetaminophen reduced empathy for pain in these scenarios. In Study 2 (N=114), we replicated and extending these findings, showing that acetaminophen also decreased empathy (i.e., perceived pain, personal distress, and empathic concern) for another study participant experiencing ostracism or painful noise blasts. Furthermore, noise unpleasantness accounted for the effect of acetaminophen on empathy for noise pain. (more…)
Author Interviews, Breast Cancer, Cost of Health Care, Radiation Therapy / 11.05.2016

MedicalResearch.com Interview with: Jayant S Vaidya MBBS MS DNB FRCS PhD Professor of Surgery and Oncology, Scientific Director, Clinical Trials Group, Division of Surgery and Interventional Science, University College London Whittington Health - Clinical Lead for Breast Cancer Royal Free Hospital University College London HospitalJayant S Vaidya MBBS MS DNB FRCS PhD  Professor of Surgery and Oncology, Scientific Director, Clinical Trials Group, Division of Surgery and Interventional Science, University College London Whittington Health - Clinical Lead for Breast Cancer Royal Free Hospital University College London Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Vaidya: TARGIT-A randomised clinical trial (ISRCTN34086741) compared giving TARGIT IORT during lumpectomy vs. traditional EBRT given over several weeks after lumpectomy for breast cancer; local-recurrence-free-survival was similar in the two arms of the trial, particularly when TARGIT was given simultaneously with lumpectomy. Also, there were significantly fewer deaths from other causes with TARGIT IORT. This study calculated journeys made by patients with breast cancer to receive their radiotherapy, using the geographic and treatment data from a large randomised trial. The study then assessed the same outcomes (travel distances, travel time and CO2emissions) in two semi-rural breast cancers—the results of this assessment confirm and reinforce the original results: the benefit of the use of TARGIT for patients from two semi=rural breast centres was even larger (753 miles (1212 km), 30 h, 215 kg CO2 per patient). (more…)
Abuse and Neglect, Author Interviews, NYU, Pharmacology, Urology / 11.05.2016

MedicalResearch.com Interview with: Dr. Jed Kaminetsky MD Clinical Assistant Professor Department of Urology NYU Langone Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Kaminetsky: Nocturia is a voiding disorder not well treated by available drugs for overactive bladder and benign prostatic hypertrophy. Desmopressin stimulates the kidneys to concentrate the urine which results in a greatly reduced volume of urine formation for a period of time. Serenity Pharmaceuticals has spent many years developing a low dose nasal spray version of desmopressin called Noctiva specifically for nocturia. The study reported now is a large, placebo controlled phase 3 trial to confirm the statistical efficacy and clinical benefit of this treatment for nocturia. (more…)
Author Interviews, Cost of Health Care, Education, JAMA / 11.05.2016

MedicalResearch.com Interview with: Dr. James Song-Jeng Yeh, MD Brigham and Women's Hospital Boston MA MedicalResearch.com: What is the purpose for this study? Dr. Yeh: A number of factors influence physicians’ prescribing behavior, including physician’s knowledge and understanding of the drugs.  Pharmaceutical detailing and financial incentives may affect such behavior.  My interest in evidence-based medicine and how medical knowledge is translated into practice lead me to think about how physicians’ financial relationships with the pharmaceutical industry may affect prescribing patterns. In our study, we linked the Massachusetts physicians open payment database with the Medicare drug prescription claims database to determine if financial relationships with the industry are associated with increased brand-name statin drug prescribing.  The open payment database reports payments that physicians receive from pharmaceutical and medical device industries.  The open payment database when linked to the drug prescription claims database allowed us to answer this question. We looked at year 2011, when two of the most commonly prescribed brand-name statin drugs (Lipitor and Crestor) were not yet available in generic formulation. The outcome measured was what percentage of all statin prescription claims (both generic and brand-name) were brand-names. (more…)
Author Interviews, Biomarkers, JAMA, Pediatrics / 11.05.2016

MedicalResearch.com Interview with: Chris Adamopoulos MD and Angelo Livolsi MD Unit of Cardiopediatrics, Hautepierre University Hospital Strasbourg, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: Apparent life-threatening events (ALTEs) predominantly affect children younger than one year. Fifty percent of these events remain unexplained, which causes great concern to parents and physicians. Yet, there is no easily detectable biomarker associated with these potentially serious, unexplained events. In our previous research we found a very high expression of muscarinic (parasympathetic) receptors in cardiac tissues of infants who died from sudden infant death syndrome (SIDS). In the present study we investigated the expression of the same muscarinic receptors in the peripheral blood of infants who experienced explained and unexplained life-threatening events at the highest end of severity. Our results showed that the infants who experienced unexplained severe events had strikingly higher receptor’s levels (20 to 50 times higher) than the infants with severe events of known cause. (more…)