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…)
Author Interviews, JAMA, Mammograms, Outcomes & Safety, Radiology / 11.05.2016

MedicalResearch.com Interview with: Dr Sian Taylor-Phillips  PhD Assistant Professor of Screening and Test Evaluation Division of Health Sciences Warwick Medical School University of Warwick Coventry MedicalResearch.com: What is the background for this study? Dr Taylor-Phillips : Psychologists have been investigating a phenomenon of a drop in performance with time on a task called ‘the vigilance decrement’ since World War 2. In those days radar operators searched for enemy aircraft and submarines (appearing as little dots of light on a radar screen). People thought that the ability to spot the dots might go down  after too much time spent on the task. Many psychology experiments have found a vigilance decrement, but most of this research has not been in a real world setting. In this research we wanted to know whether there was a drop in performance with time on a task for breast screening readers looking at breast x-rays for signs of cancer. (Breast x-rays or mammograms show lots of overlapping tissue and cancers can be quite difficult to spot). This was a real-world randomised controlled study in UK clinical practice. In the UK NHS Breast Screening Programme two readers examine each woman’s breast x-rays separately for signs of cancer. They look at batches of around 35 women’s x-rays. At the moment  both readers look at the x-rays in the same order as each another, so if they both experience a drop in performance, it will happen at the same time. We tested a really simple idea of reversing the batch order for one of the readers, so that if they have a low ebb of performance it happens when they are looking at different women’s breast x-rays. (more…)
Author Interviews, Heart Disease, Stem Cells / 11.05.2016

MedicalResearch.com Interview with: Timothy D. Henry, MD, MSCAI Director, Division of Cardiology Cedars-Sinai Heart Institute  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Henry: Heart failure it the #1 cause of morbidity, mortality and cost in the United States today.  Patients with Class 3 heart failure, despite optimal medical therapy and device therapy have limited options beyond heart transplantation and left ventricular cyst device. Transplantation and LVAD are expensive and are challenged by both availability and complications.  Therefore, treatment for patients with ongoing symptoms despite medical therapy is an admiral goal.  Stem cell therapy appears to be an attractive choice for these patients, in particular patients with ischemic cardiomyopathy. The ATHENA trial was designed to treat patients with ischemic cardiomyopathy and ongoing ischemia with autologous adipose-derived regenerative cells.  Patients would undergo liposuction with onsite processing of their stem cells in 1 ½ - 2 hours, followed by intramyocardial injection of adipose-derived regenerative cells (ADCRs) vs. placebo. (more…)
Author Interviews, OBGYNE, Pharmacology, Science / 11.05.2016

MedicalResearch.com Interview with: Lynda Harris PhD Lecturer in Pharmaceutics University of Manchester Manchester Pharmacy School Maternal and Fetal Health Research Centre Manchester MedicalResearch.com: What is the background for this study? Dr. Harris: Pregnancy complications such as pre-eclampsia and fetal growth restriction remain a problem despite advances in antenatal care, and impact heavily on future health: small size at birth is associated with an increased risk of cardiovascular disease and diabetes in later life. Drugs to improve pregnancy outcome are severely lacking, as pregnant women are considered a high risk cohort by drug companies, who fear expensive lawsuits associated with side effects and teratogenicity. The majority of pregnancy complications are caused by a poorly growing or poorly functioning placenta. A number of potential drugs have been identified that enhance placental function in vitro, and improve fetal growth in animal models; however, there is currently no means of restricting their actions to the placenta, and systemic administration of these drugs to pregnant women is not feasible due to the risk of adverse effects in other tissues. To address this issue, we have identified a series of placental “homing peptides” which we have used to create nanocarriers for targeted delivery of drugs to the placenta. (more…)
Author Interviews, Heart Disease, University Texas, Weight Research / 11.05.2016

MedicalResearch.com Interview with: Sanghamitra Mohanty, MD MS FHRS Director, translational research, Texas Cardiac Arrhythmia Institute and Associate Professor (affiliate) Dell Medical School What is the background for this study? What are the main findings? Dr. Mohanty:  In the last few years, several trials from a research group in Australia have generated tremendous interest in life-style modifications to manage AF more effectively. These studies reported significant decrease in arrhythmia burden and symptom severity and improvement in ablation outcome in patients with paroxysmal and persistent atrial fibrillation. We investigated the impact of weight-loss on procedure outcome in terms of arrhythmia burden, quality of life and arrhythmia-free survival in long-standing persistent (LSPAF) patients undergoing catheter ablation. Our main findings were the following;
  1. In patients with long-standing persistent atrial fibrillation, weight loss improved quality of life but had no impact on symptom burden and long-term ablation outcome
  2. No change in AF type or status was detected after the weight loss
  3. Extensive ablation including pulmonary vein (PV) isolation plus ablation of posterior wall and non-PV triggers resulted in comparable outcome in both groups at 1-year follow-up, irrespective of weight-loss interventions (63.8% vs 59.3%, p=0.68).
(more…)
Author Interviews, Heart Disease, Technology, University Texas / 11.05.2016

MedicalResearch.com Interview with: Sanghamitra Mohanty, MD MS FHRS Director, translational research, Texas Cardiac Arrhythmia Institute and Associate Professor (affiliate) Dell Medical School MedicalResearch.com: What is the background for this study? Dr. Mohanty: In patients with atrial fibrillation, Focal Impulse and Rotor Modulation (FIRM)-ablation alone or in combination with pulmonary vein (PV) isolation has been documented to possibly be a better alternative to PV isolation only. However, none of those trials had a randomized study design. The current study was the first attempt to compare 3 ablation strategies namely FIRM ablation alone (group 1), FIRM +PV isolation (group 2) and PV isolation combined with ablation of non-PV triggers (group 3) in a randomized controlled trial in persistent and long-standing persistent AF. MedicalResearch.com: What are the main findings? Dr. Mohanty: Our main findings were the following: 1)      Procedure time was significantly shorter in group 3 (no FIRM ablation) compared to group 1 and 2 (with FIRM ablation) 2)      FIRM-ablation alone had very poor outcome in terms of arrhythmia recurrence (86%) 3)      FIRM ablation plus PV isolation had significantly longer procedure time and lower efficacy than PV isolation + non-PV trigger-ablation (52.4% vs 76%, p=0.02). (more…)
Author Interviews, Biomarkers, Prostate Cancer / 11.05.2016

MedicalResearch.com Interview with: Dr. Michael K. Brawer, MD Northwest Prostate Institute Northwest Hospital Seattle, Washington MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Brawer: Prolaris (Cell Cycle Progression Test) is a prostate-cancer prognostic genetic tests that determines how aggressive is a patient’s cancer.  The goal is to reduce the over treatment of tumors that are likely to be harmless while still spotting those that are lethal.  Our key study at AUA (American Urological Society) is a meta-analysis of 440 prostate cancer patients with a Gleason score less than or equal to 6 who were tested with Prolaris. (more…)
Author Interviews, Heart Disease, Kidney Stones, UCSF / 10.05.2016

MedicalResearch.com Interview with: Dr. Ryan Hsi MD Clinical Fellow, UCSF Medical School and Mathew Sorensen, MD, MS Residency Program Director Department of Urology University of Washington Director, Comprehensive Metabolic Stone Clinic Puget Sound VA MedicalResearch.com: What is the background for this study? Response: Kidney stones affect 1 in 11 people, and the incidence is rising.  When kidney stones pass, they can be very painful, and if they obstruct urinary flow as they pass, they can be a cause of kidney injury and sepsis.  It is well-known that kidney stones are associated with diseases such as coronary artery disease, obesity, diabetes, and hypertension.  Less well established is the relationship with kidney stones and pre-clinical markers of these diseases.  That is, before a person has a heart attack, a person may develop atherosclerosis first - are kidney stones associated with these early warning signs of future disease? MedicalResearch.com: What are the main findings? Response: This study evaluated the association of coronary artery calcium and kidney stones.  Coronary artery calcium is a measure of calcification of the blood vessels that supply the heart, and it is a predictor of future cardiovascular events.  Our study of the Muli-Ethnic Study of Atherosclerosis evaluated individuals who had coronary artery calcium measured and compared those who had a history of none, one, or multiple kidney stones.  We found that individuals who had a history of multiple kidney stones were associated with higher levels of coronary artery calcium. (more…)
Author Interviews, Kidney Disease, Urology / 10.05.2016

MedicalResearch.com Interview with: Hiten D. Patel, MD, MPH Resident, Urological Surgery James Buchanan Brady Urological Institute The Johns Hopkins Medical Institutions Baltimore, Maryland 21287  MedicalResearch.com: What is the background for this study? Dr. Patel: The study reports results of a systematic review contracted by the Agency for Healthcare Research and Quality based on input from stakeholders. Part of the motivation was due to the American Urological Association's desire to use the results as a basis to update relevant clinical guidelines. There are four major management options for clinically localized small renal masses diagnosed on imaging including active surveillance, thermal ablation, partial nephrectomy, and radical nephrectomy. The body of research evaluating these management options is broad, but many of the studies performing comparative analyses have limitations. Therefore, the systematic review aimed to evaluate a number of outcomes (e.g. overall survival, cancer specific survival, local recurrence, metastasis, renal function, complications, and perioperative outcomes) based on available comparative studies in the literature. (more…)