Author Interviews, Lancet, Macular Degeneration, Ophthalmology / 18.05.2017

MedicalResearch.com Interview with: Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with wet age-related macular degeneration (AMD) have increased levels of vascular endothelial growth factor (VEGF) in their eyes resulting in growth of abnormal blood vessels that leak fluid into the retina and reduce vision. The current treatment is to inject proteins that block VEGF which initially provides a very good effect, but repeated injections are needed. Patients sometimes are unable to keep up the frequency of visits and injections needed to keep the disease quiet and over time there is often gradual loss of vision. The aim of this study was to test a new approach through which a viral vector is injected into the eye resulting in production of a protein that block VEGF in the eye reducing the need for repeated injections. These are the major findings: 1) Intravitreous injection of an AAV2 vector expressing a protein that blocks vascular endothelial growth factor (VEGF) was safe and well-tolerated. (2) 5 of 10 patients injected with the highest dose (2 × 10¹⁰ vector genomes) had measurable levels of the therapeutic protein in samples removed from the front of the eye- all of these patients had no or very low levels of anti-AAV2 serum antibodies and 4 of the 5 patients who did not show expression had high anti-AAV2 serum antibodies (3) Eleven patients had fluid in or under the retina before vector injection and 6 of them showed substantial reduction of the fluid which is the desired outcome. (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers / 18.05.2017

MedicalResearch.com Interview with: Ali Yilmaz, PhD Beaumont Research Institute Beaumont Health, Royal Oak, MI MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alzheimer's disease (AD) is a neurodegenerative disorder that is characterized by the accumulation of β-amyloid plaques and tau tangles. Mild cognitive impairment (MCI) is progressive degree of impairment that is greater than might be attributed to normal age-related cognitive decline, but is not so severe as to merit a diagnosis of dementia. MCI is thought to be a transitional state between normal aging and AD sufferers phenotypically converting to AD at a rate of 10% per year. Currently there is no cure and few reliable diagnostic biomarkers for AD. As we live longer there is an ever increasing demand for valid and reliable biomarkers of Alzheimer's disease; not only because it will help clinicians recognize the disease in its earliest symptomatic stages but will also be important for developing novel treatment of AD. Using 1D H NMR metabolomics, we biochemically profiled saliva samples collected from healthy-controls (n = 12), mild cognitive impairment (MCI) sufferers (n = 8), and Alzheimer’s disease (AD) patients (n = 9). We accurately identified significant concentration changes in 22 metabolites in the saliva of MCI and AD patients compared to controls. (more…)
ASCO, Author Interviews, Cancer Research, Genetic Research / 18.05.2017

MedicalResearch.com Interview with: Roy Mano, MD and David Margel, MD, PhD Department of Urology, Rabin Medical Center Petach Tikva, Israel MedicalResearch.com: What is the background for this study? Response: According to previous reports, male BRCA mutation carriers have a higher risk of developing malignancies of the prostate, pancreas, breast, colon and melanoma. While malignancy screening protocols for female BRCA carriers are well established and widely implemented, little is known about the optimal screening protocol for male BRCA carriers, and current screening protocols focus on malignancies of the breast and prostate rather than offer a comprehensive screening protocol for all BRCA associated malignancies. (more…)
Author Interviews, Prostate, Urology / 18.05.2017

MedicalResearch.com Interview with: Dr. Nikhil K. Gupta and Kevin McVary, MD, FACS Professor, Department of Surgery Chair, Division of Urology Southern Illinois University School of Medicine MedicalResearch.com: What is the background for this study? Response: Male lower urinary tract symptoms due to benign prostatic hyperplasia, or LUTS due to BPH, have most commonly been treated with a combination of medication, such as alpha-blockers and 5-alpha reductase inhibitors, and surgery, such as transurethral resection of prostate (TURP) and Greenlight photovaporization of prostate (PVP). These treatments, however, have potentially serious adverse and sexual side effects. Minimally invasive surgical therapies (MIST) for LUTS due to BPH have tried to thread the needle between medications and invasive surgery, giving effective relief of symptoms with minimal anesthetic need while preserving sexual function. Previously developed MISTs have been unable to provide durable relief of symptoms, causing patients to undergo multiple treatments in a short period of time, and have been limited by prostate size and conformation, e.g. the inability to treat a middle lobe or median bar. LUTS due to BPH is also very strongly and likely causally linked with obesity, and obesity seems to have an effect on the efficacy of treatment as well, as obesity affects response to medication and tends to dampen the treatment effect of TURP. Convective Radiofrequency Water Vapor Energy ablation of the prostate, named Rezūm®, is a new MIST that uses radiofrequency to generate energy in the form of water vapor. The water vapor acts as a convective energy source and, once injected into the treatment area, distributes itself evenly within the treated tissue, causing uniform necrosis througout the treated area. This mechanism using convection is in contrast to previous technologies using conductive heat energy, which created a heat gradient with tissue closest to the heat source receiving the largest amount of energy and tissue farthest from the heat source receiving almost no energy. Thus conductive energy has a different effect on different parts of the treated area. With Rezūm, MRI studies have shown that the water vapor creates a uniform treatment effect while staying within collagen barriers, obeying natural tissue planes and affecting only the intended treatment areas. The purpose of this study was to determine the efficacy of Rezūm in treatment of LUTS due to BPH, examine the treatment's effect on sexual function, and to determine whether obesity affected treatment efficacy. (more…)
Abuse and Neglect, JAMA, Surgical Research, Weight Research / 18.05.2017

MedicalResearch.com Interview with: Andrew Ibrahim, M.D., M.Sc Institute for HealthCare Policy and Innovation University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: The laparoscopic gastric band was approved by the FDA in 2001 and widely adopted for the surgical treatment of morbid obesity. Reported rates of reoperation to revise or remove the device ranged from 4 to 60 percent in small scale studies, but no population estimates in the United States existed. In a review of Medicare Claims data between 2006 and 2013, we observed that reoperation was common with 18% of patients requiring at least one reoperation. More over, we found that on average, patients who did need a reoperation often underwent an average of 3.8 additional procedures. Taken together, nearly half (47%) of the $470 million paid by Medicare for device related procedures was for reoperations. (more…)
AHRQ, Author Interviews, JAMA, Outcomes & Safety / 18.05.2017

MedicalResearch.com Interview with: John Oliver DeLancey, MD, MPH Resident, Department of Urology Research Fellow, Surgical Outcomes and Quality Improvement Center Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We initially looked at the star ratings for hospitals that we considered to provide excellent care, and it did not seem that this was reflected in the star ratings. Therefore, we sought to examine which factors were associated with the likelihood of receiving a high or low star rating. When we examined these associations, we found that academic and community hospitals, who reported nearly all of the measures included, had disproportionally lower star ratings than Critical Access or Specialty hospitals, who reported on average about half of the measures used to generate the star ratings. (more…)
Author Interviews, Emergency Care, JAMA, Stroke / 18.05.2017

MedicalResearch.com Interview with: Ryan A. McTaggart M.D. Assistant Professor of Diagnostic Imaging, Neurology, and Neurosurgery @mobilestroke4U Warren Alpert School of Medicine Brown University Rhode Island Hospital MedicalResearch.com: What is the background for this study? Response: Stroke is the #1 cause of disability and 5th leading cause of death. Mechanical thrombectomy (direct mechanical removal of the obstructing blood clot) is a dramatically effective treatment for the most devastating of all acute ischemic strokes – emergency large vessel occlusion (ELVO). Access to this treatment can be optimized with the use of 1) mobile stroke unit technology, 2) changing our Emergency medical services triage algorithms so that stroke matches that of trauma (using field severity to transport the right patient, to the right hospital, the first time, whenever possible), and 3) improving in-hospital processes at Primary Stroke Centers (PSCs) so that patients with suspected ELVO who present to a PSC (a hospital that does not offer mechanical thrombectomy) do not get left behind and untreated. This study reflects an effort to address and improve the third item. (more…)
Author Interviews, Sexual Health, Urology / 18.05.2017

MedicalResearch.com Interview with: Dr. Michael Krychman, MD Executive Director: The Southern California Center for Sexual Health and Survivorship, Medical Director: Sexual Medicine at Hoag Hospital Newport Beach CA Clinical faculty member University of Southern California Los Angeles, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: This post hoc analysis pooled data from three 24-week, double-blind, placebo-controlled studies (VIOLET, DAISY, and BEGONIA) of flibanserin in premenopausal women with acquired, generalized HSDD5-7. Patients who received flibanserin 100 mg once daily at bedtime (qhs) or placebo were included in the analysis. The Female Sexual Function Index (FSFI) consists of 19 items across 6 domains. Scores range from 2 to 36. Higher scores indicate better sexual functioning. Scores under 26 indicate sexual dysfunction. Analysis of covariance was used to evaluate changes from the first week to week 24 in the FSFI domain and total scores were compared for flibanserin 100 mg qhs versus placebo. For patients who discontinued study participation prior to week 24, the last postbaseline observation was carried forward (LOCF). Results found that treatment with flibanserin 100 mg qhs produced statistically significant improvement, relative to placebo, on all domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction and pain) in premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). (more…)
Alzheimer's - Dementia, Author Interviews, Depression, JAMA / 18.05.2017

MedicalResearch.com Interview with: Archana Singh-Manoux, PhD Research Professor (Directeur de Recherche) Epidemiology of ageing & age-related diseases INSERM  France Honorary Professor University College London, UK  MedicalResearch.com: What is the background for this study? Response: Depressive symptoms are common in dementia patients. Previous studies, based on older adults, show depressive symptoms in late life to be associated with an increased risk of dementia. These studies do not allow conclusions to be drawn on the causal nature of the association between depressive symptoms and dementia. (more…)
Author Interviews, Exercise - Fitness, Geriatrics, NEJM, Weight Research / 17.05.2017

MedicalResearch.com Interview with: Dennis T. Villareal, MD Professor of Medicine Division of Endocrinology, Diabetes & Metabolism Baylor College of Medicine Staff Physician, Michael E DeBakey VA Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of obesity in the elderly is rapidly increasing, given that the baby boomers are becoming senior citizens, but we do not know how best to manage obesity in the elderly population. Weight loss is the cornerstone of management for obesity but weight loss in the elderly is controversial because weight loss could cause not only fat loss but also muscle mass and bone mass losses, that could worsen rather than improve frailty. We tested the hypothesis that weight loss plus exercise training, especially resistance training, would improve physical function the most compared to other types of exercise (aerobic training or combined aerobic and resistance training added to diet-induced weight loss). Previous studies especially in younger adults have shown that combining aerobic with resistance exercise could lead to interference to the specific adaptations to each exercise, and thus less gain in strength with combined exercise compared to resistance training alone. On the other hand, contrary to our hypothesis, we found that there was no interference between aerobic and resistance exercise, and the most effective mode to improve physical function and thus reverse frailty was in fact weight loss plus the combination of aerobic and resistance exercise, which was also associated with some preservation of muscle and bone mass. (more…)
Author Interviews, Macular Degeneration, Ophthalmology, Technology / 17.05.2017

MedicalResearch.com Interview with: Dr Felicity de Cogan PhD Institute of Inflammation and Ageing University of Birmingham MedicalResearch.com: What is the background for this study? Response: The University of Birmingham has a unique approach to developing technologies. By locating chemists, engineers, biologists and clinicians in the same department it revolutionised the way research problems are solved. Initially, Felicity de Cogan was researching cell penetrating peptides (CPP) and their uses in microbiology. However, after joining forces with Neuroscientists, Dr Lisa Hill and Professor Ann Logan at the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre (NIHR SRMRC) together with the clinicians and Vision Scientists, Dr Mei Chen and Professor Heping Xu at the Queen’s University Belfast it became evident that there was huge potential to deliver drugs in the eye. This was the start of the project and it developed rapidly from there. (more…)
AHA Journals, Author Interviews, Heart Disease / 17.05.2017

MedicalResearch.com Interview with: Elsayed Z. Soliman MD, MSc, MS, FAHA, FACC Director, Epidemiological Cardiology Research Center (EPICARE) Professor, Department of Epidemiology and Prevention Professor, Department of Internal Medicine, Cardiology Section Wake Forest School of Medicine Medical Center Blvd, Winston Salem, NC 27157 MedicalResearch.com: What is the background for this study? Response: We already know that left ventricular hypertrophy (LVH, which is the most common complication of high blood pressure, is associated with an increased risk of cardiovascular disease (CVD). We also know that successful management of high blood pressure (BP) leads to regression of LVH and improved CVD outcomes in patients with hypertension. However, it is unknown whether intensive BP lowering beyond that recommended would reduce the risk of LVH in patients with hypertension, and whether reducing the risk of LVH explains the reported CVD benefits of intensive BP lowering in this population. Therefore, we examined the differential impact of intensive BP lowering (target systolic BP (SBP). (more…)
Author Interviews, Cancer Research, NYU, Smoking / 17.05.2017

MedicalResearch.com Interview with: Moon-shong Tang, PhD Professor of Environmental Medicine, Pathology and Medicine New York University Langone School of Medicine Tuxedo Park, New York 10987 MedicalResearch.com: What is the background for this study? Response: E-cigarettes (E-cigs) are designed to deliver the stimulant nicotine through aerosols, commonly referred as vapors. Nicotine is dissolved in organic solvents such as glycerin and propylene glycol. The nicotine is then aerosolized by controlled electric heating. E-cigs do not use tobacco leaves and E-cig smoke does not involve the burning process. Hence, E-cig smoke (ECS) contains only nicotine and the gas phase of the solvent. Because ECS contains neither carcinogens nor allergens or odors from the tobacco burning process, E-cigs have been promoted as an invention that can deliver a TS ‘high’ without TS negative effects. The population of E-cig users is rapidly rising, particularly in young adults. It has been estimated that 16% of high school students are E-cig smokers. Therefore, the health effects of E-cig smoke, particularly its carcinogenicity, deserve careful scrutiny. (more…)
Accidents & Violence, Author Interviews, JAMA, Surgical Research / 17.05.2017

MedicalResearch.com Interview with: Alan Cook, MD, FACS Director, Trauma Research Program Chandler Regional Medical Center Clinical Assistant Professor, Department of Surgery University of Arizona College of Medicine - Phoenix Chandler, AZ 85224 and Frederick B. Rogers MD, MS, FACS Trauma Surgeon Lancaster General Health/Penn Medicine Adjunct Professor of Surgery University of Pennsylvania College of Medicine Department of Surgery MedicalResearch.com: What is the background for this study? What are the main findings? Response: The morbidity and mortality from pulmonary emboli (PE) are considerable. They range in severity from a problem amenable to outpatient medical management to fatal. Trauma patients are often ineligible for chemoprophylaxis due to the risk for life-threatening bleeding. Yet traumatic injury can increase a person’s likelihood of having a pulmonary embolus via an array of mechanical and humoral pathways. The vena cava filter (VCF) offered the possibility of PE prophylaxis for patients otherwise vulnerable to PE risk. Use of VCF grew and the rate of use increased even more after the introduction of the retrievable VCF. Our study sought to determine if any temporal variation in VCF use has occurred and investigate if an contemporaneous change in the diagnosis of PE has taken place. We used three databases to allow a telescoping window of observation from a single state, Pennsylvania (PTOS), to a convenience of sample of trauma centers across the country (NTDB), and finally a national, population-based sample of all hospital discharges in the US (NIS). A temporal trend was observed in all three datasets with differing magnitudes and time points of change. The variation of vena cava filter use was most pronounced in the PTOS and least dramatic in the NIS, The rate of PE was essentially unchanged during the same period. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care / 17.05.2017

MedicalResearch.com Interview with: Eric Roberts, PhD Post-doctoral fellow Department of Health Care Policy Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Increasing consolidation of health care providers has raised regulatory concerns that less competition will lead to higher health care prices and possibly lower quality care for patients. On the other hand, some industry observers have contended that larger and higher-priced practices are better able invest in systems to support care management, and ultimately, better patient care. In this study, we examined whether larger and higher-priced physician practices provided better and more efficient care to their patients. Higher-priced physician groups were paid an average of 36% more by commercial insurers, and were substantially larger than lower-priced practices located within the same geographic areas. Despite large differences in practices’ prices and size, we found few differences in their patients’ quality and efficiency of care. For example, when we compared patients who received care in high-priced versus low-priced practices, we found no differences in patients’ overall care ratings, physician ratings, access to care, physician communication, and use of preventive services. We also found no differences in patients’ hospital admissions or total spending, suggesting that higher-priced practices were not managing their patients’ care more efficiently than their lower-priced counterparts. We did find that patients in higher-priced practices were more likely to receive recommended vaccinations, review of their medications, and results of medical tests, and that they spent less time in the waiting room for a scheduled doctor’s appointment. However, once practice prices exceeded the average for their geographic area, we observed no further gains in quality on most of these measures. (more…)
Author Interviews, Prostate Cancer, Urology / 17.05.2017

MedicalResearch.com Interview with: Keyan Salari, MD, PhD Resident in Urologic Surgery Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the Garraway Lab at the Dana-Farber Cancer Institute and the Broad Institute of Harvard and MIT MedicalResearch.com: What is the background for this study? Response: Active surveillance is an effective strategy addressing the problem of over treatment of clinically indolent prostate cancer, but data on the role of active surveillance in younger men is limited. Younger men diagnosed with prostate cancer are typically counseled to undergo treatment as opposed to surveillance of their prostate cancer. To potentially expand the role of active surveillance to younger patient populations, we undertook this study evaluating the outcomes of younger men under 60 years of age who elected to pursue active surveillance of their prostate cancer. (more…)
Author Interviews, Biomarkers, Prostate Cancer, Urology / 17.05.2017

MedicalResearch.com Interview with: Eric A. Klein, MD Chairman, Glickman Urological and Kidney Institute Cleveland Clinic MedicalResearch.com: Which of these results did you find most interesting or surprising? Response: What’s most interesting is that the IsoPSA assay redefines how PSA is measured, which links it more closely to the underlying biology of cancer. Current assays measure only the concentration of PSA, which can be affected by conditions other than cancer – BPH most commonly, but also infection and inflammation – which limits its diagnostic accuracy for finding cancer. Its been known for several decades that PSA exists in multiple different forms in the bloodstream in patients with prostate cancer. These novel molecules arise because cancer cells have deranged cellular metabolism that result in the generation of new species of PSA, making their measurement more tightly linked to the presence or absence of cancer and even the presence of high grade cancer (where cellular metabolism is even more disordered). The IsoPSA assay is the first assay to measure all of these isoforms and thus has better diagnostic accuracy for cancer. (more…)
Author Interviews, Dermatology, OBGYNE / 16.05.2017

MedicalResearch.com Interview with: Alexander Egeberg, MD PhD Gentofte Hospital Department of Dermatology and Allergy Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: An issue that frequently arise in clinical practice is the question from patients whether they should discontinue their therapy if they want to have children. Since immunosuppressant agents are frequently used for a number of conditions, and discontinuation could lead to disease flaring, assessment of the potential impact of such drugs on birth outcomes is important. In our study, we examined birth outcomes in children whose father had received treatment with methotrexate, azathioprine, cyclosporine, and mycophenolate mofetil in the time leading up to conception. Importantly, we found no increased risk of congenital abnormalities, low birth weight, or preterm birth associated with paternal treatment with these drugs. (more…)
Author Interviews / 16.05.2017

MedicalResearch.com Interview with: ACCCMark S. Soberman, MD MBA FACS President, Association of Community Cancer Centers Medical Director, Oncology Service Line Chief Physician Executive, Monocacy Health Partners Frederick Regional Health System MedicalResearch.com: How will the online program prepare health care providers and patient advocates to help patients navigate the financial implications of cancer? Response: The Association of Community Cancer Centers (ACCC) Financial Advocacy Boot Camp is a dynamic online curriculum.  The interactive learning modules are easy to navigate and contain helpful features to support learning, including quizzes and supplemental resources. Each module is less than a half-hour long, so participants can work at their own pace while accessing the on-demand courses 24-7. The Financial Advocacy Boot Camp has 14 learning modules. Topics include:
  1. Financial Advocacy Fundamentals. Review the basics of financial advocacy and gain an understanding of public and private health insurance coverage options.
  2. Enhancing Communication. Develop strategies to improve communication among the care team, engage patients on financial concerns, and find various distress screening tools.
  3. Improving Insurance Coverage. Learn how to help cancer patients get better health insurance coverage to reduce the out-of-pocket burden and tap into resources to reduce financial toxicity.
  4. Maximizing External Assistance. Delve into external assistance programs and other sources of assistance available for patients with public health insurance, private insurance, or no insurance.
  5. Improving Financial Advocacy Services. Learn to track cost savings for patients and your facility. Apply different tracking methods and reporting tools to evaluate your financial advocacy program and identify opportunities for continuous improvement.
(more…)
Author Interviews, Infections, Vaccine Studies / 15.05.2017

MedicalResearch.com Interview with: AbivaxJean-Marc Steens, M.D. Chief Medical Officer of Abivax MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antiretroviral therapy (ART) has had an enormous impact on the HIV pandemic since its introduction almost 20 years ago. Most patients treated with ART achieve undetectable or near undetectable plasma levels of the virus. This means that although HIV is controlled, it is not completely eliminated. The virus remains in the body, usually contained in dormant cells (known as the HIV reservoir) that are widely distributed, including to the central nervous system, the gut mucosa, the lymph nodes and other sites. If ART is stopped, the virus rebounds. The goal of any curative therapy would be to eliminate the virus or ensure there is sustained remission in the absence of ART, which until now have been unsuccessful. Abivax’s Phase 2 clinical study with ABX464 demonstrated, for the first time, a reduction in HIV reservoirs in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs). In the ABX464-004 trial, 30 HIV patients received either ABX464 or matching placebo in addition to their current antiretroviral treatment over 28 days. The viral load at the start of the study was well controlled with boosted darunavir. After the 28-day treatment period, all treatments were interrupted until viral load rebound. Baseline and day 28 blood samples were taken to assess the potential effect of ABX464 on the HIV reservoir in PBMCs. Safety was the primary endpoint in the trial. ABX464 was well tolerated, with no severe adverse events in the treatment group. Amongst evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction in viral DNA copies/mPBMCs was observed in 7/14 treated patients (mean change of -40%, ranging from -27% to -67%) and no responders were observed in the placebo group. Responders were defined as patients who had a decrease greater than 25% in total HIV DNA in PBMCs and a reduction of at least 50 copies. Total HIV DNA in PBMC has been validated as a widely accepted biomarker for measuring the HIV reservoir. Specifically, in untreated patients, total HIV DNA load influences the course of the infection and is therefore clinically relevant. In addition, a correlation exists between the pool of HIV-1 DNA and the replication-competent reservoir. (more…)
Author Interviews, Biomarkers, Genetic Research, Personalized Medicine / 15.05.2017

MedicalResearch.com Interview with: 3D SignaturesJason Flowerday, CEO Director of 3D Signatures  MedicalResearch.com: What is the background for 3D Signatures? Response: 3D Signatures, and its clinical lab tests, which incorporate its proprietary TeloViewTM software analytics, is the culmination of over 20 years of ground-breaking research conducted by Dr. Sabine Mai and her colleagues. It is the only technology in the world that quantifies genomic instability, which is the hallmark of cancer and other proliferative diseases at the whole-cell level. By measuring the degree of genomic instability from different tissues, TeloViewTM has produced clinically actionable distinctions in the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers including Alzheimer’s disease. The results have been exceptional and represent a universal biomarker platform across all disease areas that the company has investigated to date. (more…)
Author Interviews, CMAJ, Diabetes, OBGYNE / 15.05.2017

MedicalResearch.com Interview with: Dr. Gillian Booth PhD Researcher at St. Michael's and the Institute for Clinical Evaluative Sciences (ICES) MedicalResearch.com: What is the background for this study? What are the main findings? Response: The impact of climate change on health is becoming increasingly relevant given the rise in global air temperature, and there is growing evidence supporting a link between air temperature, metabolic function, and energy expenditure. We know from animal models and small studies in humans that cold exposure and activate a type of fat known as brown fat and it appears that this process can improve sensitivity to insulin. However no studies have yet looked at air temperature and the development of diabetes. So we decided to examine the relationship between outdoor air temperature and gestational diabetes – a temporary form of diabetes that arises in the second trimester of pregnancy. (more…)
Author Interviews, JAMA, Thyroid / 15.05.2017

MedicalResearch.com Interview with: Dr. C. Seth Landefeld MD U.S. Preventive Services Task Force and Chairman of the department of Medicine and Spencer Chair in Medical Science Leadership University of Alabama at Birmingham (UAB) School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thyroid cancer is rare in the United States, and the evidence shows that screening for it leads to an increase in new diagnoses without affecting the number of people who die from it. This is because screening people without signs or symptoms for thyroid cancer often identifies small or slow-growing tumors that might never affect a person during their lifetime. After reviewing the evidence, the Task Force found little evidence on the benefits of screening for thyroid cancer and considerable evidence that treatment, which is often unnecessary, can cause significant harms. Additionally, in places where universal screening has been implemented, it hasn’t helped people live longer, healthier lives. (more…)
Author Interviews, Blood Pressure - Hypertension, Compliance / 15.05.2017

MedicalResearch.com Interview with: Dr. Gupta Pankaj Consultant Metabolic Physician/Chemical Pathologist Dr. Patel Prashanth - Consultant Metabolic Physician/Chemical Pathologist Department of Metabolic Medicine and Chemical Pathology University Hospitals of Leicester NHS Trust, UK   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Non-adherence or patients not taking their medications as prescribed is known since the time of Hippocrates. It is the key reason why blood pressure is well controlled in only around 50% of patients with hypertension, despite the availability of good medicines. Non-adherence leads to poorer cardiovascular outcomes and is thought to cost $100 billion to the US health economy. A crucial reason for the lack of progress in improving adherence has been the previous lack of a clinically useful objective measure. We and others have developed a robust and reliable biochemical screening method to assess for non- adherence to antihypertensive medications in urine or blood using a technique called liquid chromatography-tandem mass spectrometry.  We have previously reported a single centre study that demonstrated high rates of non-adherence in patients attending a hypertension clinic. Since, then we have set up a National Centre for Adherence Testing (NCAT, [email protected]) in the Department of Metabolic Medicine and Chemical Pathology, University Hospitals of Leicester NHS Trust (UHL) and receive samples from around 25 hypertension clinics across UK. This study analysed data from~1400 patients consisting of samples received in UHL and also from a cohort of patients in the Czech Republic. (more…)
Author Interviews, Cancer Research, Mediterranean Diet, Nutrition / 15.05.2017

MedicalResearch.com Interview with: Antonio Giordano MD PhD Sbarro Institute for Cancer Research and Molecular Medicine and Center for Biotechnology
College of Science and Technology
Temple University, Philadelphia, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Mediterranean diet is considered to be one of the healthiest nutrition patterns. Tomatoes, in particular, which are consumed worldwide, and a basic ingredient of the Mediterranean diet, have been postulated to have a cancer preventive role at least for some tumor types, although few studies analyzed the effects of tomatoes in their entirety in different stages of cancer progression. Here, we focused on an in vitro model of gastric cancer because it is still one of the most common and deadly cancers and its development is strongly influenced by certain eating habits. Our results showed a possible role of tomatoes against typical neoplastic features. The treatment with tomato extracts affected the ability of cancer cell growth both in adherence and in semisolid mediums. Moreover, tomato extracts affected key processes within the cell; they hindered migration ability, arrested cell cycle through the modulation of retinoblastoma tumor suppressor family proteins and specific cell cycle inhibitors, and induced cancer cell death through apoptosis. (more…)
Author Interviews, Genetic Research, Ophthalmology / 15.05.2017

MedicalResearch.com Interview with: Zheng-Rong Lu, Ph.D. M. Frank Rudy and Margaret Domiter Rudy Professor of Biomedical Engineering Department of Biomedical Engineering Case Western Reserve University Cleveland, OH 44106 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Genetic vision disorders are a major cause of severe vision loss and blindness, especially in children and young adults. Currently, there are no approved therapies to treat these types of disorders. This study focused on one such disease known as Leber’s congenital amaurosis type 2 (LCA2). Patients with LCA2 are born with some degree of vision loss, and are often legally blind by early adulthood. LCA2 is a recessive disease caused by a mutation in one of the genes responsible for visual processing. LCA2 is a good candidate for gene therapy, and clinical trials underway to test viral vectors that deliver a healthy copy of the mutated gene into the eye have demonstrated considerable therapeutic efficacy. These trials have validated the feasibility of gene therapy to treat this disease, however viral vectors are limited by potential safety issues, complex preparation methods, and limitations on the size of genes that can be delivered. In this study, we successfully treated LCA2 in mice for 120 days by delivering the gene responsible for LCA2 in a synthetic lipid nanoparticle instead of a viral vector. Our delivery system, called ECO, specifically targets the cells in the retinal pigmented epithelium, where the mutation behind LCA2 occurs. Our nanoparticle delivery system is easy to produce, safe, and has unlimited cargo capacity. Most important, our nanoparticle gene delivery system is a platform that can be used to deliver any gene into the retina, opening the door for safe and effective gene therapy for any genetic vision disorder. (more…)
Author Interviews, Cost of Health Care, Kidney Disease / 13.05.2017

MedicalResearch.com Interview with: Shaum Kabadi HEOR Director at AstraZeneca MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than 20 million adults – roughly 1 in 10 adults – in the US are estimated to have chronic kidney disease (CKD), and this population is expected to grow as the US population ages. Patients with CKD are at high risk for progression to end-stage renal disease (ESRD), a condition requiring dialysis or kidney transplantation to maintain patients’ long-term survival. The cost of treating ESRD patients was over $40 billion in public and private funds in 2009. Prior research shows per-person annual Medicare expenses attributable to CKD were $1,700 for Stage 2, $3,500 for Stage 3, and $12,700 for Stage 4. Additional research is required to understand the economic burden of CKD by stage in a contemporary cohort of commercially insured patients with non-dialysis-dependent (NDD)-CKD. This retrospective cohort study utilized data from the HealthCore Integrated Research Environment, which contained medical and pharmacy administrative claims integrated with laboratory result values from 14 regionally dispersed Anthem health plans in the US. Of 16,030 patients identified with CKD, the mean (SD) estimated glomerular filtration rate (eGFR) (all in mL/min/1.73 m2) in 2014 was 44.3 (±18.7), and the breakdown by eGFR levels was: Stage 1 (≥90) 3%, Stage 2 (60–89) 13%, Stage 3a (45–59) 27%, Stage 3b (30–44) 35%, Stage 4 (15–29) 19%, and Stage 5 (<15) 3%. Mean age across all stages was 67.4 years, and 47% were women. Hospitalization rate (%) and number of outpatient encounters (visits per patient per year) by stage were: Stage 1 (11.6%, 19.8), Stage 2 (14.9%, 22.5), Stage 3a (16.2%, 23.6), Stage 3b (23.7%, 29.5), Stage 4 (30.7%, 36.3), and Stage 5 (30.8%, 61.7) (p-trend). (more…)
Author Interviews, Gastrointestinal Disease, Lancet, Vaccine Studies / 13.05.2017

MedicalResearch.com Interview with: Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MALeslie Williams, BS, RN, MBA Director, Founder, President and Chief Executive Officer and Dr Robert P Anderson MBChB BMedSc PhD FRACP Chief Scientific Officer ImmusanT, Cambridge, MA MedicalResearch.com: What is the background for this study? Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period. (more…)
Author Interviews, Eating Disorders / 13.05.2017

MedicalResearch.com Interview with: Cynthia Bulik, PhD, FAED Founding director of the UNC Center of Excellence for Eating Disorders and Professor at Karolinska Institutet in Stockholm, Sweden. MedicalResearch.com: What is the background for this study? Response: Researchers and clinicians from around the world came together to create the most powerful genome-wide association study of anorexia nervosa to date. Via this global collaboration, we were able to identify the first significant locus that influences risk for anorexia nervosa. We have known that anorexia is heritable for over a decade, but now we are actually identifying which genes are implicated. This is the first one identified! (more…)
AHA Journals, Author Interviews, Baylor College of Medicine Houston, Heart Disease, Lipids / 13.05.2017

MedicalResearch.com Interview with: Julia M. Akeroyd, MPH Center for Innovations in Quality, Effectiveness, and Safety (IQuESt) Michael E. DeBakey Veteran Affairs Medical Center Salim S Virani, MBBS, Ph.D. Baylor College of Medicine MedicalResearch.com: What is the background for this study? Response: In the recently published Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial, treatment with evolocumab resulted in a 15% relative (1.5% absolute) risk reduction of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD) at a median follow-up of 2.2 years. Given the high cost of evolocumab, there is a need to identify what proportion of ASCVD patients would qualify for evolocumab based on FOURIER entry criteria and how eligibility would change if maximal doses of evidence-based lipid lowering therapies were required. (more…)