Author Interviews, Dengue / 10.07.2015

MedicalResearch.com Interview with: Dr. Eng Eong Ooi BMBS PhD FRCPath Associate Professor & Deputy Director Program in Emerging Infectious Diseases Duke-NUS Graduate Medical School Singapore Medical Research: What is the background for this study? What are the main findings? Response: Dengue prevention continues to rely exclusively on vector control guided by disease and virologic surveillance. The latter has focused on detecting changes in the prevalence of the four antigenically distinct viral serotypes as, in general terms, herd immunity depends on long-lived serotype-specific antibodies.  However, epidemiological observations have indicated that a small number of changes within the viral genome have also been associated with several major outbreaks, without any change in viral serotype.  Identifying the genetic changes that alter viral fitness epidemiologically would thus be important to differentiate strains that have a greater potential of causing epidemics and targeted for control. Using the 1994 outbreak in Puerto Rico as a case in point, we identified nucleotide substitutions in the 3’ untranslated region (3’UTR) of the viral genome as critical determinants of dengue virus’ epidemiological fitness.  Mechanistically, mutations in the 3’UTR altered secondary viral RNA structures and changed the relative proportion of genomic to subgenomic RNA of the virus in infected cells.  The epidemiologically fitter viruses produced larger amounts of subgenomic to genomic RNA.  This subgenomic RNA then binds a host protein, TRIM25, which is a E3 ubiquitin ligase that polyubiquitylates RIG-I to amplify and sustain signalling for type-I interferon expression.  By binding to TRIM25, the subgenomic RNA of dengue virus inhibits the activation and thus enzymatic function of TRIM25.  We suggest that with reduced interferon expression, the virus was thus able to spread more effectively from cell to cell within the infected individuals to reach viremia levels for further subsequent mosquito-borne transmission. (more…)
Author Interviews, BMJ, CDC, OBGYNE / 10.07.2015

Jennita Reefhuis, PhD Epidemiologist with CDC National Center on Birth Defects and Developmental DisabilitiesMedicalResearch.com Interview with: Jennita Reefhuis, PhD Epidemiologist with CDC National Center on Birth Defects and Developmental Disabilities Medical Research: What is the background for this study? Dr. Reefhuis: There are previous reports on the link between birth defects and SSRIs. However, the results across some of these studies conflicted. It is not clear whether one SSRI might be safer than other SSRIs. Medical Research: What are the main findings? Dr. Reefhuis: Reassuringly, we found that the five earlier reported links between specific birth defects and sertraline were not found again. We did find that some birth defects occur two to three times more frequently among babies born to mothers who took paroxetine and fluoxetine in early pregnancy. (more…)
Author Interviews, Dermatology, NEJM / 10.07.2015

Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg 07.04.2009 | Prof. Dr. Kristian Reich,  Dermatologikum Hamburg, Hamburg, Germany, 07.04.2009 | [© (c) Martin Zitzlaff, Emilienstr.78, 20259 Hamburg, Germany, Tel. +491711940261, http://www.zitzlaff.com, martin@zitzlaff.com, Postbank Hamburg BLZ 20010020 Kto.-Nr. 10204204, MwSt. 7%, Veroeffentlichung nur gegen Honorar (MFM) und Belegexemplar, mit Namensnennung] MedicalResearch.com Interview with: Prof. Dr. med. Kristian Reich DERMATOLOGIKUM HAMBURG Hamburg Medical Research: What is the background for this study? What are the main findings? Prof. Reich: The Phase 2b X-PLORE study compared a new generation biologic therapy, guselkumab - an inhibitor of IL–23, with the anti–tumor necrosis factor (TNF)–alpha agent adalimumab (Humira®) and placebo in the treatment of moderate-to-severe plaque-type psoriasis. It showed that up to 86 percent of patients treated with guselkumab achieved a Physician’s Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study’s primary endpoint.  Interestingly, levels of efficacy were higher for several guselkumab doses through week 16 when compared to adalimumab. Improvements with guselkumab continued through week 40 with every eight- or twelve-week maintenance treatment.   (more…)
Author Interviews, Heart Disease, JAMA / 09.07.2015

MedicalResearch.com Interview with: Dr Emanuele Di Angelantonio FESC FAHA University Lecturer | University of Cambridge Director | MPhil in Public Health, University of Cambridge Deputy Director | NIHR Biomedical Research Unit in Donor Health and Genomics Honorary Consultant | NHS Blood and Transplant Department of Public Health and Primary Care Strangeways Research Laboratory Cambridge, UK Medical Research: What is the background for this study? What are the main findings? Response: Previous research as mainly focused on individual with one cardiometabolic condition alone and, despite it could be expected that having more than one condition poses a greater risk, this is the first study that is able to precisely quantify how much is worst. Furthermore, given that the conditions we study (diabetes, heart attack, and stroke) share several risk factors, it could be expected that the combination of these will not be  multiplicative. We were somewhat surprised to find that participants who had 1 condition had about twice the rate of death; 2 conditions, about 4 times the rate of death; and all 3 conditions, about 8 times the rate of death. We  estimated that at the age of 60 years, men with any two of the cardiometabolic conditions studied would on average have 12 years of reduced life expectancy, and men with all three conditions would have 14 years of reduced life expectancy. For women at the age of 60 years, the corresponding estimates were 13 years and 16 years. The figures were even more dramatic for patients at a younger age. At the age of 40 years, men with all three cardiometabolic conditions would on average have 23 years of reduced life expectancy; for women at the same age, the corresponding estimate was 20 years. (more…)
Author Interviews, Biomarkers, Melanoma / 09.07.2015

MedicalResearch.com Interview with: Mario Mandalà, MD Department of Oncology and Haematology Papa Giovanni XXIII Hospital Bergamo, Italy Medical Research: What is the background for this study? Dr. Mandalà: In addition to their established molecular mechanism of action, growing evidence suggests that the therapeutic efficacy of BRAFi relies on additional factors that affect the tumor–host interactions, including the enhancement of melanoma antigen expression and the increase in immune response against tumor cells.  Preclinical data show that oncogenic BRAF contributes to immune evasion, and that targeting this mutation may increase the melanoma immunogenicity. Data in vitro or from animal models propose PD-L1 as a potential mechanism that favors BRAFi resistance through the modulation of host immune responses. However, demonstration of this hypothesis in the clinical setting is lacking. Medical Research: What are the main findings? Dr. Mandalà: In the present study, we have evaluated, in a homogeneous series of MMP treated with BRAFi, the association of tumoral PD-L1 IHC expression and the density of TIMC with RR, PFS and OS. Results provide the first proof-of-principle clinical evidence of the predictive and prognostic relevance of PD-L1 IHC expression and density of immune cell infiltration in BRAFV600 mutated MMP receiving BRAFi. (more…)
Author Interviews, Biomarkers, Infections / 09.07.2015

Yingfu Li, PhDProfessor, Dept of Biochemistry and Biomedical Sciences and Dept of Chemistry and Chemical Biology McMaster University, Hamilton, CanadaMedicalResearch.com Interview with: Yingfu Li, PhD Professor, Dept of Biochemistry and Biomedical Sciences and Dept of Chemistry and Chemical Biology McMaster University, Hamilton, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Li: Simple, accurate and sensitive diagnostic tests are highly sought-after in modern medicine. Take bacterial infection as an example. Many microbial pathogens pose serious threats to public health and are responsible for many annual outbreaks that result in numerous human illnesses and deaths. Early and accurate detection of specific pathogens has long been recognized as a crucial strategy in the control of infectious diseases because such a measure can provide timely care of patients, prevent potential outbreaks, and minimize the impact of on-going epidemics. To detect the infection early, we need highly sensitive tests. We have developed a molecular device made of DNA that can be turned on by a molecule of choice, such as a biomarker for a disease. When it gets switched on, the system will undergo massive signal amplification allowing for extremely sensitive detection of the target molecule. The test has the best sensitivity ever reported for a detection system of this kind – it is as much as 10,000 times more sensitive than other detection systems. The scientific report can be found at http://onlinelibrary.wiley.com/doi/10.1002/anie.201503182/abstract (more…)
Author Interviews, Nature, OBGYNE / 08.07.2015

Shawn L. Chavez, Ph.D Assistant Scientist/Professor Oregon National Primate Research Center OHSU | Oregon Health & Science UniversityMedicalResearch.com Interview with: Shawn L. Chavez, Ph.D Assistant Scientist/Professor Oregon National Primate Research Center OHSU | Oregon Health & Science University Medical Research: What is the background for this study? Dr. Chavez: This study builds upon a previous study also published in Nature Communications in 2012, which demonstrated that chromosomally normal and abnormal 4-cell human embryos can be largely distinguished by combining the timing intervals of the first three cell divisions with the presence or absence of a dynamic process called cellular fragmentation. The current study further combines time-lapse imaging of embryo development and full chromosome analysis with high throughout single-cell gene expression profiling to assess the chromosomal status of human embryos up to the 8-cell stage. Medical Research: What are the main findings? Dr. Chavez: The key findings of this research were that by measuring the duration of the first cell division, one can identify which embryos are chromosomally normal versus abnormal even earlier in development. By examining gene expression at a single-cell level, we were able to correlate the chromosomal make-up of an embryo to a subset of 12 genes that are activated prior to the first cell division. These genes likely came from either the egg or sperm and can be used to predict whether an embryo will be chromosomally normal or abnormal within the first 30 hours of development. (more…)
Author Interviews, Education, Johns Hopkins, Outcomes & Safety, Surgical Research / 08.07.2015

Judy Huang, M.D. Professor of Neurosurgery Program Director, Neurosurgery Residency Program Fellowship Director, Cerebrovascular Neurosurgery Johns Hopkins HospitalMedicalResearch.com Interview with: Judy Huang, M.D. Professor of Neurosurgery Program Director, Neurosurgery Residency Program Fellowship Director, Cerebrovascular Neurosurgery Johns Hopkins Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Huang: Residents are medical school graduates who are in training programs working alongside and under supervision of more senior physicians, known as attendings. Patients are sometimes wary of having residents assist in their operations, but an analysis of 16,098 brain and spine surgeries performed across the United States finds that resident participation does not raise patient risks for postoperative complications or death. (more…)
Author Interviews, Cancer Research, JNCI / 08.07.2015

Aung Ko Win, MBBS MPH PhD Research Fellow NHMRC Early Career Clinical Research Fellow Centre for Epidemiology and Biostatistics Melbourne School of Population and Global Health The University of Melbourne VIC 3010 AustraliaMedicalResearch.com Interview with: Aung Ko Win, MBBS MPH PhD Research Fellow NHMRC Early Career Clinical Research Fellow Centre for Epidemiology and Biostatistics Melbourne School of Population and Global Health The University of Melbourne VIC 3010 Australia Medical Research: What is the background for this study? Response: At least 1 in 1,000 people in the population have a mutation in one of the mismatch repair genes that causes Lynch syndrome. These people have a very high risk of bowel cancer (colorectal cancer): if nothing is done, about half would develop the disease. The main risk reduction method for these people is to have regular colonoscopy screening every year. Almost nothing is known whether or not lifestyle factors and medications can modify the risk of bowel cancer for people with Lynch syndrome. A study was conducted to investigate the associations between aspirin and ibuprofen intake and the risk of bowel cancer, by studying 1,858 people with Lynch syndrome who were recruited into the Colon Cancer Family Registry from Australia, New Zealand, Canada and the USA. This is the largest study to date investigating the associations between aspirin, ibuprofen and bowel cancer risk for people with Lynch syndrome. (more…)
Author Interviews, Cancer Research, Genetic Research, JAMA / 08.07.2015

Aung Ko Win, MBBS MPH PhD Research Fellow NHMRC Early Career Clinical Research Fellow Centre for Epidemiology and Biostatistics Melbourne School of Population and Global Health The University of Melbourne VIC 3010 AustraliaMedicalResearch.com Interview with: Aung Ko Win, MBBS MPH PhD Research Fellow NHMRC Early Career Clinical Research Fellow Centre for Epidemiology and Biostatistics Melbourne School of Population and Global Health The University of Melbourne VIC 3010 Australia Medical Research: What is the background for this study? What are the main findings? Response: About 2-5% of uterine cancer are associated with an underlying genetic condition mainly Lynch syndrome. Lynch syndrome is caused by a mutation in one of the mismatch repair genes. At least 1 in 1000 people in the population have a mutation that causes Lynch syndrome and these people have a very high risk of cancers mainly bowel and uterine cancers. One in three women with a mutation in one of the mismatch repair genes are likely to develop a uterine cancer in their lifetime. The only way to reduce the risk of uterine cancer for these women is to remove the uterus. There is no current recommendation for screening method to detect uterine cancer early. Almost nothing is known about if and how lifestyle factors and hormonal factors can modify their risk of uterine cancer. By studying 1128 women with a mutation that causes Lynch syndrome who were recruited from Australia, New Zealand, Canada and the USA, we found that later age at first menstrual cycle, having one or more live births, and using hormonal contraceptive use for one year or longer were associated with a lower risk of uterine cancer. (more…)
Author Interviews, Breast Cancer, Endocrinology, Lancet, Menopause / 08.07.2015

MedicalResearch.com Interview with: Dr. Jürg Bernhard Ph.D. International Breast Cancer Study Group Coordinating Center and Bern University Hospital, Inselspital, Bern, Switzerland Medical Research: What is the background for this study? What are the main findings? Response: In the combined analysis of the SOFT and TEXT trials, the aromatase inhibitor exemestane was more effective than tamoxifen in preventing breast cancer recurrence in young women (premenopausal) who also receive ovarian function suppression (OFS) as adjuvant (post-surgery) treatment for hormone-sensitive early breast cancer, providing a new treatment option for these women. These trials were conducted by the International Breast Cancer Study Group (IBCSG) and involved more than 4700 patients of over 500 centers in 27 countries. Now we present patient-reported quality of life outcomes from these trials. In the TEXT and SOFT trials, patients assigned exemestane+OFS reported more detrimental effects of bone or joint pain, vaginal dryness, greater loss of sexual interest and difficulties becoming aroused, while patients assigned tamoxifen+OFS were more affected by hot flushes and sweats. Global quality of life domains (mood, ability to cope and physical well-being) were similar between the randomized treatment groups. (more…)
Author Interviews, Diabetes, Weight Research / 08.07.2015

Subhadra Gunawardana DVM, Ph.D Research Associate Professor Department of Molecular Physiology & Biophysics Vanderbilt University Medical Center Nashville, TN 37232MedicalResearch.com Interview with: Subhadra Gunawardana DVM, Ph.D Research Associate Professor Department of Molecular Physiology & Biophysics Vanderbilt University Medical Center Nashville, TN 37232 Medical Research: What is the background for this study? What are the main findings? Response: For many years the general consensus has been that insulin replacement is essential for treating type 1 diabetes. Recent studies increasingly show that extra-pancreatic hormones, particularly those arising from adipose tissue, can compensate for insulin, or entirely replace the function of insulin under appropriate circumstances. Our work on mouse models show that type 1 diabetes can be effectively reversed without insulin, through subcutaneous transplantation of embryonic brown adipose tissue (BAT). BAT transplantation leads to replenishment of recipients' white adipose tissue; dramatic decrease of inflammation; secretion of a number of beneficial adipokines; and fast and long-lasting euglycemia. Insulin-independent glucose homeostasis is established physiologically, through a combination of endogenously generated hormones arising from the transplant and/or newly-replenished white adipose tissue. Medical Research: What should clinicians and patients take away from your report? Response: If translated to human patients, this approach could provide a cure for type 1 diabetes that does not require regular exogenous administration of insulin or any other compound, and would thus avoid the many inherent difficulties with such therapies. (more…)
AHA Journals, Author Interviews, Connective Tissue Disease, Heart Disease, NYU / 08.07.2015

Mohamed Boutjdir, PhD, FAHADirector of the Cardiovascular Research Program VA New York Harbor Healthcare System Professor, Depts of Medicine, Cell Biology and Pharmacology, State University of New York Downstate Medical Center and NYU School of Medicine, New York, NYMedicalResearch.com Interview with: Mohamed Boutjdir, PhD, FAHA Director of the Cardiovascular Research Program VA New York Harbor Healthcare System Professor, Depts of Medicine, Cell Biology and Pharmacology, State University of New York Downstate Medical Center and NYU School of Medicine, New York, NY Medical Research: What is the background for this study? What are the main findings? Dr. Boutjdir: Patients with autoimmune diseases including Sjogren’s syndrome, systemic lupus erythematosus and other connective tissue diseases who are seropositive for anti-SSA/Ro antibodies may present with corrected QTc prolongation on the surface ECG. This QTc prolongation can be arrhythmogenic and lead to Torsades de Pointes fatal arrhythmia. In our study, we established for the first time an animal model for this autoimmune associated QTc prolongation that is reminiscent of the clinical long QT2 syndrome. We also demonstrated the functional and molecular mechanisms by which the presence of the anti-SSA/Ro antibodies causes QTc prolongation by a direct cross-reactivity and then block of the hERG channel (Human ether-a-go-go-related gene). This hERG channel is responsible for cardiac repolarization and its inhibition causes QTc prolongation. We were able to pinpoint to the target epitope at the extracellular pore forming loop between segment 5 and segment 6 of the hERG channel. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Lifestyle & Health / 08.07.2015

Liana C. Del Gobbo, PhDPostdoctoral Research Fellow Friedman School of Nutrition Science & Policy Tufts University Boston MAMedicalResearch.com Interview with: Liana C. Del Gobbo, PhD Postdoctoral Research Fellow Friedman School of Nutrition Science & Policy Tufts University Boston MA Medical Research: What is the background for this study? What are the main findings? Dr. Del Gobbo: Heart failure most commonly develops in adults over 65 years old- the most rapidly growing portion of the US population. The condition greatly reduces the quality of life of older adults. Heart failure is the leading cause of hospitalizations in the US among those on Medicare, and is associated with large  health care costs. Prevention is key for reducing the burden of this disease. A detailed analysis of factors that might help prevent heart failure, such as a person's pattern of eating (as well as individual foods), in addition to other lifestyle factors (eg. smoking, physical activity, etc), had not been previously examined all together, in the same study. To get a fuller picture of how to prevent this condition, this study examined the relative importance of dietary habits and other lifestyle factors for development of heart failure. Our paper shows that older adults can cut their risk in half by adhering to a few healthy lifestyle factors, including moderate physical activity, modest alcohol consumption (eg. more than one drink/week, but not more than 1-2 drinks/day), not smoking, and maintaining a healthy weight. (more…)
Author Interviews, Infections, Surgical Research / 08.07.2015

Paul M. Sethi, MD Orthopaedic & Neurosurgery Specialists Greenwich, CT MedicalResearch.com Interview with: Paul M. Sethi, MD Orthopaedic & Neurosurgery Specialists Greenwich, CT MedicalResearch: What is the background for this study? Dr. Sethi: Propionibacterium acnes is one of the most significant pathogens in shoulder surgery; the cost of a single infection after shoulder arthroplasty may be upwards $50,000. Residual P. acnes may be found on the skin 29% of the time immediately after surgical skin preparation and in 70% of dermal biopsy specimens. Identifying more ideal skin preparation may help reduce the risk of infection. MedicalResearch: What is the purpose of this study? Dr. Sethi: The purpose of this study was to evaluate the ability of topical benzoyl peroxide (BPO) cream, along with chlorhexidine skin preparation, to reduce the chance of identifying residual bacteria after skin preparation. Our hypothesis was that adding topical benzoyl peroxide to our skin preparation would reduce the number of positive P. acnes cultures identified during surgery. (more…)
Author Interviews, Insomnia, JAMA, Mental Health Research / 07.07.2015

Jason Ong, Ph.D., CBSM Associate Professor, Department of Behavioral Sciences Director, Behavioral Sleep Medicine Training Program Rush University Medical CenterMedicalResearch.com Interview with: Jason Ong, Ph.D., CBSM Associate Professor, Department of Behavioral Sciences Director, Behavioral Sleep Medicine Training Program Rush University Medical Center Medical Research: What is the background for this study? What are the main findings? Response: Insomnia is a very common sleep problem that was previously thought to be related to another medical or psychiatric condition.  Evidence now supports the notion that insomnia can emerge as a disorder distinct from the comorbid condition.  In this study, we evaluated the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), the most widely used nonpharmacologic treatment for insomnia, in the context of medical and psychiatric comorbidities. We conducted a systematic review and meta-analysis of 37 studies and found that 36% of patients who received cognitive behavioral therapy for insomnia were in remission at post-treatment compared to 17% who received a control or comparison condition.  CBT-I had medium to large effects for improving sleep quality and reducing the amount of time awake in bed.  Positive findings were also found on the comorbid condition, with greater improvements in psychiatric conditions compared to medical conditions. (more…)
Author Interviews, Heart Disease, Nature / 07.07.2015

Dr. Gary K OwensRobert M. Berne Cardiovascular Research Center University of Virginia, Charlottesville, VirginiaMedicalResearch.com Interview with: Dr. Gary K Owens Ph.D Robert M. Berne Cardiovascular Research Center University of Virginia, Charlottesville, Virginia Medical Research: What is the background for this study? Dr. Owens: The leading cause of death in the USA and worldwide is cardiovascular disease with many of the clinical consequences including heart attacks (myocardial infarctions) and strokes being secondary consequences of atherosclerosis, commonly referred to as hardening of the arteries. Importantly, a heart attack is not caused by gradual narrowing of a large coronary artery by the atherosclerotic plaque, but rather is caused by acute rupture of a plaque that results in a catastrophic thrombotic event that can completely occlude a major coronary artery shutting off blood supply to a major heart region. Similarly, rupture of a plaque can result in formation of a thrombus that breaks off and circulates to a cerebral vessel where it can occlude blood flow to a brain region leading to a stroke. As such, it is critical to understand the mechanisms that regulate the stability of plaques, and the likelihood of plaque rupture. The general dogma among clinicians and cardiovascular researchers has been that atherosclerotic plaques that have an abundance of macrophages and macrophage-derived foam cells relative to smooth muscle cells (SMC), the cells that normally line all of your blood vessels, are less stable and more prone to rupture with subsequent clinical consequences. However, the evidence for this is based on use of methods that are unreliable in identifying which cells within the plaque are truly derived from macrophages versus SMC, and even more importantly, what mechanisms regulate phenotypic transitions of these cells that are critical in the pathogenesis of this disease. Indeed, results of studies in cultured smooth muscle cells and macrophages have shown that each cell can express markers of the other cell type in response to stimuli likely to be present within advanced atherosclerotic lesions while down-regulating expression of their typical cell selective markers. As such, previous studies in the field have likely mis-identified which cell is which in many cases. The goals of our studies were to clearly identify which cells within advanced atherosclerotic lesions are derived from SMC, to determine the various phenotypes exhibited by these cells and their functional role in lesion pathogenesis,  and to determine what regulates these phenotypic transitions. (more…)
Author Interviews, Cancer Research, Dermatology / 07.07.2015

Wen-Qing Li Ph.D Department of Dermatology Warren Alpert Medical School Department of Epidemiology, School of Public Health, Brown University, Providence, RIMedicalResearch.com Interview with: Wen-Qing Li Ph.D Department of Dermatology Warren Alpert Medical School Department of Epidemiology, School of Public Health, Brown University, Providence, RI Medical Research: What is the background for this study? Response: Rosacea is a chronic inflammatory cutaneous disorder and may be an end-organ response in a systemic disorder. We systemically examined the association between personal history of rosacea and risk of cancer based on 75088 whites in the Nurses’ Health Study II, during a follow-up of 20 years. Medical Research: What are the main findings? Response: We suggest possible associations between personal history of rosacea and an increased risk of thyroid cancer and Basal Cell Cancer. Analyses did not find significant associations for other individual cancer types.  (more…)
Author Interviews, Diabetes, Lipids, Ophthalmology / 06.07.2015

Dr Ruth Hogg, Lecturer Centre for Experimental Medicine (formerly Centre for Vision and Vascular Science) Institute of Clinical Science Block Belfast Northern IrelandMedicalResearch.com Interview with: Dr Ruth Hogg, Lecturer Centre for Experimental Medicine (formerly Centre for Vision and Vascular Science) Institute of Clinical Science Block Belfast Northern Ireland Medical Research: What is the background for this study? What are the main findings? Dr. Hogg: The development of Diabetic macular edema (DME) in patients with diabetes can result in severe visual loss.  Understanding the factors driving the development of these conditions is important for developing effective treatments.  The role of lipids has been suggested by previous studies however as the evidence overall appeared to have significant uncertainty we decided to undertake a systematic review and where possible perform a meta-analysis or results. The study revealed that the evidence of a relationship between blood lipid levels and Diabetic macular edema from cohort and case control studies was strong but evidence from the randomised control trials (RCTs) was weak.  The RCTS evaluated however were often not designed to look at Diabetic macular edema as an primary outcome, and this was often part of a secondary analysis leaving uncertainty over the power to detect the association.  (more…)
Author Interviews, BMJ, Cost of Health Care, Medicare / 06.07.2015

Joshua P. Cohen Ph.D Research Associate Professor Tufts Center for the Study of Drug Development Boston, MassachusettsMedicalResearch.com Interview with: Joshua P. Cohen Ph.D Research Associate Professor Tufts Center for the Study of Drug Development Boston, Massachusetts Medical Research: What is the background for this study? Dr. Cohen: Florbetapir 18F was the first radioactive diagnostic agent approved by the US Food and Drug Administration for positron emission tomography imaging of the brain to evaluate amyloid â neuritic plaque density. Medical Research: What are the main findings? Dr. Cohen: Medicare has restricted coverage of florbetapir in the US, whereas conspicuously the UK NHS decided to reimburse the radiopharmaceutical. Note, the British NHS is generally more restrictive with regard to coverage of new technologies than the Centers for Medicare and Medicaid Services. Historically Medicare has rejected coverage of 25% of diagnostics approved by the FDA, but covers all FDA approved drugs administered in the physician’s office. Furthermore, Medicare has subjected labeled use of diagnostics, including a half-dozen Alzheimer's diagnostics, to its coverage with evidence development program while not subjecting any labeled uses of drugs to coverage with evidence development. In sum, diagnostics are subject to a level of scrutiny by Medicare that is rarely given Medicare Part B drugs (physician-administered). (more…)
Author Interviews, Biomarkers, Radiation Therapy / 06.07.2015

MedicalResearch.com Interview with: Dr Ananya Choudhury Consultant and Honorary Senior Clinical Lecturer, Clinical Oncology The Christie NHS Foundation Trust, Wilmslow Road Withington, Manchester, UK Medical Research: What is the background for this study? What are the main findings? Response: Although more than half of newly diagnosed cancer patients are treated with radiotherapy, it is still not possible to select patients who will respond and tolerate radiotherapy compared to those who do not. There has been a lot of work done to try and isolate intrinsic biomarkers which will identify either radio-responsive or radio-resistant disease. We have undertaken a systematic view summarising the evidence for biomarkers as predictors of radiotherapy. Despite identifying more than 500 references during a systematic literature search, we found only twelve studies which fulfilled our inclusion criteria. Important exclusion criteria included pre-clinical studies, studies with no control population and a sample size of less than 100 patients. Only 10 biomarkers were identified as having been evaluated for their radiotherapy-specific predictive value in over 100 patients in a clinical setting, highlighting that despite a rich literature there were few high quality studies suitable for inclusion. The most extensively studied radiotherapy predictive biomarkers were the radiosensitivity index and MRE11; however, neither has been evaluated in a randomised controlled trial. (more…)
Author Interviews, Cognitive Issues, FASEB / 05.07.2015

Milan Fiala, M.D. Research Professor, UCLA Department of Surgery Los Angeles, CAMedicalResearch.com Interview with: Milan Fiala, M.D. Research Professor, UCLA Department of Surgery Los Angeles, CA Medical Research: What is the background for this study? What are the main findings? Dr. Fiala: Omega-3 fatty acid supplementation is well-known to public for its health benefits in cardiovascular diseases and putative benefits against “Minor Cognitive Impairment” reported in other studies . This study shows that omega-3 protected against oxidation and resveratrol improves the immune system against amyloid-beta in the brain,  probably by increasing its clearance from the brain by the immune system. Overall the patients taking the drink seemed to preserve their memory better for up to 2 years than expected based on previous studies. However, our study was small and not controlled by a placebo, which may present a bias.   (more…)
Author Interviews, Gastrointestinal Disease / 05.07.2015

MedicalResearch.com Interview with: Louise Emilsson, MD PhD, Postdoc Primary Care Research unit Vårdcentralen Värmlands Nysäter and Institute of Health and Society University of Oslo MedicalResearch: What is the background for this study? Dr. Emilsson: Genetics is considered an important factor in the development of celiac disease and other autoimmune diseases. For e.g. the prevalence of celiac disease is about 10% in first-degree relatives of celiac patients compared to about 1% in the general population. Several earlier genome-wide association study (GWAS) studies have established shared genetic features also in-between different autoimmune diseases, however, very little is known about the risk of developing other autoimmune diseases in relatives of celiac patients. Therefore we assessed the risk of several other non-celiac autoimmune diseases (Crohn’s disease, type 1 diabetes mellitus, hypothyroidism, hyperthyroidism, psoriasis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus or ulcerative colitis) in all first degree relatives and spouses of Swedish celiac patients. MedicalResearch: What are the main findings? Dr. Emilsson: The main finding is that both first-degree relatives (+28%) and spouses (+20%) are at increased risk of other autoimmune diseases. There are several plausible explanations for these findings. One is of course that individuals with celiac disease and their first-degree relatives share a genetic autoimmune predisposition, another potential explanation involves shared environment (relevant for both first-degree relatives and spouses) but finally we cannot rule out that a certain degree of increased awareness of signs and symptoms in both first-degree relatives and spouses might lead to more examinations and thereby diagnoses (so-called ascertainment bias). Probably all these mechanisms contributed to the finding. (more…)
Author Interviews, BMJ, Cost of Health Care / 04.07.2015

Igho Onakpoya MD MSc Clarendon Scholar University of Oxford Centre for Evidence-Based Medicine Nuffield Department of Primary Care Health Sciences Oxford UKMedicalResearch.com Interview with: Igho Onakpoya MD MSc Clarendon Scholar University of Oxford Centre for Evidence-Based Medicine Nuffield Department of Primary Care Health Sciences Oxford UK MedicalResearch: What is the background for this study? What are the main findings? Dr. Onakpoya: Several orphan drugs have been approved for use in Europe. However, the drugs are costly, and evidence for their clinical effectiveness are often sparse at the time of their approval. We found inconsistencies in the quality of the evidence for approved orphan drugs. We could not identify a clear mechanism through which their prices drugs are determined. In addition, the costs of the branded drugs are much higher than their generic or unlicensed versions. MedicalResearch: What should clinicians and patients take away from your report? Dr. Onakpoya: Because of inconsistencies in the evidence regarding the benefit-to-harm balance of orphan medicines, coupled with their high prices, clinicians and patients should assess whether the orphan drugs provide real value for money before making a decision about their use for a medical condition. (more…)
Author Interviews, Columbia / 03.07.2015

Prof. Patrick L Kinney Ph.D. Professor of Environmental Health Sciences and Director, Columbia Climate and Health Program Mailman School of Public Health Columbia University, New York, NYMedicalResearch.com Interview with: Prof. Patrick L Kinney Ph.D. Professor of Environmental Health Sciences and Director, Columbia Climate and Health Program Mailman School of Public Health Columbia University, New York, NY Medical Research: What is the background for this study? Dr. Kinney: Many previous assessments have concluded that climate change will lead to large reductions in winter mortality. Medical Research: What are the main findings? Dr. Kinney: We carried out analyses that contradict this conclusion.  We argue that climate change won’t have much impact one way or the other on winter mortality. (more…)
Author Interviews, Columbia, Diabetes, NEJM, Weight Research / 03.07.2015

Dr. F. Xavier Pi-Sunyer MD Division of Endocrinology and Obesity Research Center Columbia University, New YorkMedicalResearch.com Interview with: Dr. F. Xavier Pi-Sunyer MD Division of Endocrinology and Obesity Research Center Columbia University, New York Medical Research: What is the background for this study? What are the main findings? Dr. Pi-Sunye: In a large randomized trial, the drug Liraglutide was compared to placebo in overweight and obese non-diabetic volunteers. Over 52 weeks, in combination with diet and increased physical activity, Liraglutide lowered body weight by 8.4 kg as compared to 2.8 kg in placebo. 63% vs 27% lost at least 5% of baseline weight, 33% vs 10% lost more than 10% of baseline weight. (more…)
Author Interviews, Depression, Sexual Health, Testosterone / 03.07.2015

Michael S. Irwig MD Division of Endocrinology Medical Faculty Associates George Washington UniversityMedicalResearch.com Interview with: Michael S. Irwig MD Division of Endocrinology Medical Faculty Associates George Washington University Medical Research: What is the background for this study? What are the main findings? Response: Many factors are associated with lower testosterone levels and many men who have their testosterone levels checked have non-specific depressive symptoms. The main finding is a remarkably high rate of depression and depressive symptoms (56%) in men who are referred for borderline testosterone levels. Other significant findings include a prevalence of overweight and obesity higher than the general population. (more…)