Author Interviews, Melanoma, Technology / 21.06.2016

MedicalResearch.com Interview with: Orit Markowitz, MD Director of Pigmented Lesions and Skin Cancer The Mount Sinai Hospital and Assistant Professor of Dermatology Icahn School of Medicine at Mount Sinai Director of Pigmented lesions clinic Brooklyn VA, Adjunct Professor, Dermatology SUNY Downstate Medical Center, Brooklyn, NY Chief of Dermatology Queens General Hospital, Jamaica, NY MedicalResearch.com Editors’ Note: As part of an ongoing series of occasional article on cancer prevention, Dr. Markowitz from The Mount Sinai Hospital discusses skin cancer and the use Optical Coherence Tomography in skin cancer diagnosis and treatment. MedicalResearch.com: How common is the problem of non-melanoma skin cancer? Are they difficult to detect and treat? Dr. Markowitz: Skin cancer is the most commonly diagnosed cancer in the United States. Non melanoma skin cancers, including basal cell carcinomas and squamous cell carcinomas, are the most common malignancies of the skin, constituting around 80 percent of all skin cancers. The annual cost of treating skin cancers in the U.S. is estimated at $8.1 billion, with $3.3 billion for melanoma. (more…)
Annals Internal Medicine, Author Interviews, Cost of Health Care, Hepatitis - Liver Disease / 20.06.2016

MedicalResearch.com Interview with: J. Morgan Freiman, MD Infectious disease research fellow Boston Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Freiman:  There are 130-150 million persons infected with chronic HCV with 75% of all cases occurring in low- and middle- income countries (LMICs). Diagnosis is a 2-step process that starts with screening for exposure with an assay that detects antibodies to HCV (anti-HCV), followed by nucleic acid testing (NAT) for persons with reactive anti-HCV to measure HCV ribonucleic acid (RNA) and confirm active viremia. In LMICs diagnostic capacity is low, and fewer than 1% of patients are aware of their infection. Additionally, a significant proportion of patients who test positive for anti-HCV are lost to follow-up before nucleic acid testing. The 2-step diagnostic process is thus a major bottleneck to the HCV cascade of care. Testing for hepatitis C virus core antigen (HCVcAg) is a potential replacement for NAT. Our systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for 5 commercially available HCVcAg tests compared with NAT. We found that HCVcAg assays with signal amplification have high sensitivity, high specificity, and have the potential to replace NAT in settings with high HCV prevalence. (more…)
Accidents & Violence, Author Interviews, Ophthalmology, Technology / 20.06.2016

MedicalResearch.com Interview with: Jeff C. Rabin, O.D., M.S., Ph.D., F.A.A.O., Dipl. Vision Science Professor and Assistant Dean for Graduate Studies, Research and Assessment Chief, Visual Neurophysiology Service University of the Incarnate Word Rosenberg School of Optometry San Antonio, TX MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Rabin: The use of hand-held cellphones during driving has been widely banned but the impact of hands-free communication on visual performance remained unclear. Therefore, we used a standard automobile Bluetooth device suspended above our visual display and determined that hands-free communication significantly delayed response time to detect low contrast black-white and color targets. Moreover, hands-free communication decreased sensitivity of “color-blind” subjects to detect targets corresponding to their color deficiency and all subjects showed a tendency for decreased sensitivity for detection of small, low contrast black-white targets. (more…)
Addiction, Author Interviews, Cocaine, Science / 20.06.2016

MedicalResearch.com Interview with: Dr Karen Ersche PhD University of Cambridge Department of Psychiatry Brain Mapping Unit Herchel Smith Building Cambridge UK MedicalResearch.com: What is the background for this study? Dr. Ersche: Cocaine addiction is a major public health problem that is associated with significant harm - not just for the individual, but also for their families and for society as a whole. Without medically proven pharmacological treatments, therapeutic interventions mainly rely on psychosocial approaches, but behaviour in people with cocaine addiction remains extremely difficult to change. The impetus for this study was to find out why people with cocaine addiction are so resistant to change. One possibility would be that they have a strong tendency to develop habits, which means that they show patterns of behaviour that are not under direct voluntary control. (more…)
Author Interviews, Health Care Systems / 20.06.2016

MedicalResearch.com Interview with: Renuka Tipirneni, MD, MSc Clinical Lecturer in Internal Medicine University of Michigan Department of Internal Medicine, Division of General Medicine North Campus Research Complex, Bldg 16, Rm 472C Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Tipirneni: One year after Medicaid expansion in Michigan, 600,000 individuals had enrolled in the program and there was concern that new enrollees would crowd doctor’s offices and new patients would not be able to get an appointment. We found that the opposite occurred – primary care appointment availability for new Medicaid patients increased. This study builds on a previous study looking at what happened in the first four months after Medicaid expansion. In the earlier study, we found that appointment availability for new Medicaid patients had increased in the first few months after expansion. Even though the number of enrollees in the Medicaid expansion program doubled since then, the new study found that appointment availability remained increased for new Medicaid patients one year after expansion. (more…)
Author Interviews, Primary Care, Vitamin K / 20.06.2016

MedicalResearch.com Interview with: Michael Allan, MD CCFP Professor of Family Medicine and Director of Evidence Based Medicine Faculty of Medicine & Dentistry University of Alberta MedicalResearch.com: What is the background for this study? Dr. Allan: A large volume of observational (lower-level) research links lower Vitamin D levels with a long list of health concerns. Other non-clinical studies show the biochemical and physiological actions of Vitamin D could impact many health states. These factors have led many clinicians and scientists to advocate strongly for Vitamin D supplementation. However, this type of research can draw false connections. Therefore, we must examine high-quality randomized studies to determine if Vitamin D supplement can help people live longer, have improved health or avoid negative health outcomes. (more…)
Author Interviews, Mental Health Research, Pediatrics, Psychological Science, Radiology / 19.06.2016

MedicalResearch.com Interview with: Dr. Luca Passamonti MD Department of Clinical Neurosciences University of Cambridge MedicalResearch.com: What is the background for this study? Dr. Passamonti: We wanted to study if the brain of young people with two different forms of conduct disorder (CD) (https://en.wikipedia.org/wiki/Conduct_disorder), a neuropsychiatric disease associated with severe and persistent antisocial behaviors (weapon use, aggression, fire-setting, stealing, fraudulent behavior), was different from that of young peers with no such abnormal behaviors. There is already evidence that conduct disorder may have a biological basis (i.e., reduced levels of cortisol under stress) and brain alterations but a whole “map” of the brain in conduct disorder studying cortical thickness was never been done before. (more…)
Annals Internal Medicine, Author Interviews, Pharmacology / 17.06.2016

MedicalResearch.com Interview with: Steven Woloshin, MD Professor of The Dartmouth Institute Professor of Medicine Professor of Community and Family Medicine New Hamphsire MedicalResearch.com: What is the background for this study? Dr. Woloshin: Drug companies are required by law to post results of trials used to support drug applications to the FDA on the clinicaltrials.gov website - but it is not clear whether posted results are complete and accurate. Recent studies attempting to validate posted results by comparing them to corresponding peer reviewed medical journal publications suggest that discrepancies are relatively common. But it is which source is more likely to be correct. We tried to validate posted results against an arguably better gold standard, the drug approval packages from the FDA (ie, the medical and statistical reviews posted on the drugs@fda.gov website). FDA reviews have an advantage over peer reviewed publications: unlike medical journal editors and peer reviewers, FDA has access to the individual participant data from the trials. This means FDA can see all the trials and all the outcomes (avoiding sleective publication) and it means FDA can independently reanalyze according to what they believe to be the best statistical practices (data can be analyzed in many ways - and different decisions, for example, how to account for missing data, can yield very different results). (more…)
Author Interviews, OBGYNE, Race/Ethnic Diversity / 17.06.2016

MedicalResearch.com Interview with: Luisa N. Borrell, DDS, PhD Professor Department of Epidemiology & Biostatistics Graduate School of Public Health & Health Policy City University of New York MedicalResearch.com: What is the background for this study? Dr. Borrell: Racial/ethnic disparities in birth outcomes in the United States are well documented, with non-Hispanic Black women exhibiting the worst outcomes. Several hypotheses have been proposed as explanation to this finding such as the weathering hypothesis and cumulative or chronic experiences of social inequality and racism. However, these hypotheses have only accounted for the stress burden associated with the mother’s race/ethnicity, as her race/ethnicity has been the sole information used to determine the child’s race/ethnicity, ignoring the possible stress associated with the father’s race/ethnicity. We used NYC birth- and death-linked data from 2000 to 2010 to examine the added effect of paternal race/ethnicity on adverse birth outcomes (low birth weight [LBW], small for gestational age [SGA], preterm births, and infant mortality [IM]) among NYC women. (more…)
AHA Journals, Author Interviews, Heart Disease, Technology, Yale / 17.06.2016

MedicalResearch.com Interview with: Dr. James V. Freeman MD Assistant professor of cardiology and Assistant Clinical Professor of Nursing Internal Medicine Yale School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Freeman: Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost-effectiveness compared to anticoagulation has not been evaluated using all available contemporary trial data. We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost-effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of PROTECT AF and PREVAIL randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios (ICER) compared to warfarin and dabigatran were $20,486 and $23,422 per quality adjusted life year (QALY), respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 QALYs, respectively) and more costly. (more…)
Author Interviews, Heart Disease, Outcomes & Safety / 17.06.2016

MedicalResearch.com Interview with: Sahil Agrawal MD, MD Heart and Vascular Center St. Luke’s University Health Network Bethlehem, PA 18015 MedicalResearch.com: What is the background for this study? Dr. Agrawal: Patients admitted on a weekend have previously been known to have poorer outcomes compared to patients admitted on weekdays for various acute illnesses. With the advent of early fibrinolytic therapy and subsequently, emergent primary percutaneous coronary interventions (PCI), such discrepancies in outcomes have been largely resolved for ST-segment elevation myocardial infarctions (STEMI). In contrast, treatment of non-ST segment elevation myocardial infarction (NSTEMI) has remained less stringent such that invasive coronary angiography and potential intervention is often delayed for those presenting on a weekend rather than a week day. According to current ACC/AHA guidelines for NSTEMI, an early invasive strategy (EIS) is the preferred method of management unless barred by presence of contraindications (comorbid conditions) or patients’ preference. We were interested in investigating differences in utilization of EIS between patients admitted on a weekend versus those admitted on a weekday for an NSTEMI, and to evaluate the impact of such differences on in-hospital mortality in such patients. (more…)
AHA Journals, Author Interviews, Columbia, Compliance, Heart Disease / 17.06.2016

MedicalResearch.com Interview with: Ian Kronish, MD, MPH Florence Irving Assistant Professor of Medicine Center for Behavioral Cardiovascular Health Columbia University Medical Center MedicalResearch.com: What is the background for this study? Dr. Kronish: Prior studies have shown that adherence to statins is suboptimal both in patients prescribed statins for primary prevention and in high-risk patients who are prescribed statins to prevent recurrent events. But, to our knowledge, prior studies had not examined the impact of a hospitalization for a myocardial infarction (MI) on subsequent adherence to statins. We wondered whether the hospitalization would serve as a wake-up call that led patients to become more adherent after the MI. At the same time, we were concerned that the physical and psychological distress that arises after a hospitalization for an MI may lead to a decline in statin adherence. (more…)
AHA Journals, Author Interviews, CT Scanning, Diabetes, Heart Disease / 17.06.2016

MedicalResearch.com Interview with: Prof. David A. Halon MB ChB, FACC, FESC Associate Professor of Clinical Medicine Technion, Israel Institute of Technology. Director, Interventional Cardiology Lady Davis Carmel Medical Center Haifa, Israel MedicalResearch.com: What is the background for this study? Prof. Halon: Type 2 diabetics are well known to have more cardiovascular events than non-diabetics but even among diabetics this risk is heterogeneous and some remain at very low risk. It remains uncertain if additional diagnostic modalities over and above clinical risk scores may be helpful in defining which diabetics are at high risk for an adverse event. We performed a study using cardiac CT angiography (CCTA) in 630 type 2 diabetics 55-74 years of age with no history of coronary artery disease to examine if CTA findings would have additional prognostic value over traditional risk scores for cardiovascular or microvascular based events over 7.5 years of follow-up. (more…)
Author Interviews, Depression, JAMA, OBGYNE, Pediatrics / 17.06.2016

MedicalResearch.com Interview with: Mari Videman Senior Consultant in Child Neurology BABA Center Children’s Hospital, Helsinki University Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Depression and anxiety are common during pregnancy, and up to 5% of all pregnant women are treated with serotonin uptake inhibitors (SRI). It is now known that SRIs do not cause major malformations in humans, however recent animal studies have suggested that fetal early SRI exposure may cause changes in brain microstructure and neuronal signaling. Prior human studies have shown that fetal SRI exposure leads to transient postnatal adaptation syndrome, as well as to an increased risk of developing childhood depression. We used electroencephalography (EEG) and advanced computational methods to assess both the local and global cortical function of the newborn brain. We found that several aspects of newborn brain activity are affected by exposuse to SRI during pregnancy. Most importantly, the communication between brain hemispheres, and the synchronization between cortical rhythms were weaker in the SRI-exposed newborns. These changes were most likely related to SRI exposure, because they did not correlate with the psychiatric symptoms of the mothers. (more…)
Author Interviews, OBGYNE, Pediatrics, Social Issues / 17.06.2016

MedicalResearch.com Interview with: Kelli A. Komro, MPH, PhD, Professor Director of Graduate Studies Behavioral Sciences and Health Education Jointly Appointed, Epidemiology Rollins School of Public Health Emory University Atlanta, GA 30322 MedicalResearch.com: What is the background for this study?  Dr. Komro: Epidemiologists have done a thorough job describing the income-health gradient, which shows a clear association between income and health. That is, as income increases, exposure to health risks and premature mortality decreases. Each step down on the income ladder decreases one’s health for many reasons related to material resources, physical environment exposures and social circumstances. The income to health association begins at birth, and more than one in four women giving birth in the U.S. are below the poverty level, putting nearly 1 million babies at risk each year. Low-income mothers are more likely to give birth prematurely, to have low birth weight babies, and to suffer the death of their infant during the post-neonatal period (28 to 364 days old). Given the importance of the income-health gradient, we set out to test the health effects of policies that are designed to increase economic security among low-income families. Our main question is: Do policies designed to reduce poverty and improve family economic security also improve health? One relevant policy is minimum wage laws. A federal minimum wage was first enacted in 1938. The real value (in 2015 dollars) of the federal minimum wage reached a high of $10.85 in 1968. The current federal rate is $7.25. Many cities and states have passed minimum wage laws that are higher than the federal rate, and currently there is a range of minimum wage increases under active public and policymaker discussion. Given that some states pass minimum wage standards and others do not, and that laws within states change over time, we took advantage of all the changes that have occurred to design a natural experiment. Our natural experiment examined the effects of state minimum wage laws on infant health. (more…)
Author Interviews, Blood Pressure - Hypertension, Cleveland Clinic, JAMA / 16.06.2016

MedicalResearch.com Interview with: Krishna Patel, MD, PG Y3 Resident Internal Medicine Residency Program Cleveland Clinic Cleveland, OH 44195 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Patel: In our outpatient resident clinic practice, we found that patients with poorly controlled hypertension presenting with blood pressures in the hypertensive urgency range (SBP>=180mmHg or DBP >=110 mmHg) but with no symptoms of end-organ damage were common, however there was no clear cut manner in which these patient's blood pressures were treated. According to the comfort level of the physician, these patients were managed in the office and on serial outpatient visits and some of the patients would be referred to the emergency department for management of these elevated blood pressures. Given there was not much prior literature on this topic, we decided to study the prevalence and short term cardiovascular outcomes for this population of patients. We found that hypertensive urgency is quite common in the office setting (4.6% in our study). In absence of symptoms of end organ damage, the short term risk of major cardiovascular events was very low around 1%, and patients who were referred to the ED for management of blood pressures had a lot of unnecessary testing and more hospital admissions than those who were managed as an outpatient. (more…)
Aging, Author Interviews, Gender Differences / 16.06.2016

MedicalResearch.com Interview with: Kathleen Fischer, PhD Department of Biology UAB | University of Alabama Birmingham Birmingham, AL MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Fischer: Aging is by far the greatest risk factor for most of the chronic, non-communicable diseases (e.g. cardiovascular disease, cancer, diabetes). By discovering the basic mechanisms responsible for aging we can find ways to extend healthy and productive life and reduce the burdens of chronic disease and disability experienced by individuals and society. Sex differences in longevity can provide novel insights into the basic biology of aging; however this aspect of aging has been largely ignored. Demographic data show that women outlive men in every society during every historical period and in every geographic area. In spite of this robust survival advantage, women suffer far greater morbidity late in life—a phenomenon described as the morbidity-mortality paradox. It is not clear whether this is a general mammalian pattern or something unique to humans. Research on sex differences in aging and age-related diseases in humans and a range of species will be crucial if we are going to identify the basic mechanisms responsible for the patterns we observe. (more…)
Author Interviews, JAMA, Schizophrenia / 16.06.2016

MedicalResearch.com Interview with: Kate Merritt PhD Post-Doctoral Research Worker NOC Study (Nitric Oxide in Cognition) Institute of Psychiatry De Crespigny Park London MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Merritt: Research has indicated that levels of one of the main chemicals in the brain, glutamate, may be abnormal in schizophrenia. Almost sixty studies have measured glutamate levels in schizophrenia, however the findings are inconsistent, and it is thought that changes in glutamate levels may vary with the length or the severity of illness. This study therefore analysed all the published reports of glutamate in schizophrenia. The main findings are that, overall, schizophrenia is associated with elevated glutamate in several brain regions; namely the medial temporal cortex, the basal ganglia and the thalamus. These changes also differed with the stage of illness; in the medial frontal cortex, glutamate was increased in people at risk for developing schizophrenia, but not in people who had been diagnosed with schizophrenia for several years, whereas in the medial temporal lobe the opposite pattern was detected. (more…)
AHRQ, Author Interviews, Cost of Health Care / 16.06.2016

MedicalResearch.com Interview with: Celeste M. Torio, Ph.D., M.P.H Scientific Review Officer AHRQ MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Torio: Hospital care expenditures constitute the largest single component of health care spending. These expenses are of significant concern to policymakers because of their impact on governments, consumers and insurers. MedicalResearch.com: What are the main findings? • Aggregate hospital costs for 35.6 million hospital stays totaled $381.4 billion in 2013. • Septicemia, osteoarthritis, newborn infants, complication of device, and acute myocardial infarction are the five most expensive conditions, and account for 1/5 of the total aggregate costs for hospitalizations. • Sixty-three percent of aggregate hospital costs were covered by Medicare and Medicaid, while 28 percent were covered by private insurance and 5 percent were covered by the uninsured. (more…)
Author Interviews, Pediatrics, Pediatrics, Toxin Research / 16.06.2016

MedicalResearch.com Interview with: Leland McClure, PhD Director in Medical Affairs for Quest Diagnostics Fellow of the American Board of Forensic Toxicology MedicalResearch.com: What is the background for this study? Dr. McClure: Quest Diagnostics is the leading provider of diagnostic information services, providing clinical lab testing to about one in three American adults each year. As a result, we've amassed the largest private clinical laboratory database in the United States, based on 20 billion data points from lab testing. Quest uses this data (in de-identified, HIPAA compliant form) to perform research -- called Quest Diagnostics Health Trends(TM) -- to reveal insights on important health issues to inform clinical patient management and health policy. Other Health Trends reports have focused on diabetes, pregnancy and influenza, among others. (more…)
Author Interviews, Erectile Dysfunction, Melanoma, PLoS / 16.06.2016

MedicalResearch.com Interview with: Anthony Matthews Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine London, United Kingdom MedicalResearch.com: What is the background for this study? Dr. Mathews: :The drug Viagra, which is used to treat erectile dysfunction, is one of a class of drugs called PDE5 inhibitors. Laboratory studies of cells from the skin cancer, malignant melanoma, suggest that PDE5 inhibitors might promote their growth, so there have been some concerns that people using these drugs might have an increased risk of malignant melanoma. Two previous studies comparing melanoma rates in PDE5 inhibitor users and non-users came to differing conclusions so we wanted to look further into this. To carry out the study we used anonymised GP records from the UK identifying over 150,000 men with a PDE5 inhibitor prescription, and over 500,000 men of a similar age, and from the same areas, who didn’t have a PDE5 inhibitor prescription. We then looked for later diagnoses of malignant melanoma to see how people’s exposure to PDE5 inhibitors affected their future risk of being diagnosed with melanoma. (more…)
Author Interviews, Colon Cancer, JAMA / 16.06.2016

MedicalResearch.com Interview with: Jennifer S. Lin, MD, MCR, FACP Director, Kaiser Permanente Research Affiliates Evidence-based Practice Center Investigator, The Center for Health Research, Kaiser Permanente Northwest Portland, OR 97227 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Lin: Our systematic review was commissioned by the USPSTF, in tandem with a separate modeling exercise, to help update their 2008 colorectal cancer screening recommendations. Since the previous recommendation, there has been a wealth of new evidence, including more evidence on the long-term effectiveness of flexible sigmoidoscopy for reducing colorectal cancer mortality, the screening accuracy and decreasing radiation exposure from CT colonography, and the screening accuracy for a number FDA-approved stool tests using fecal immunochemical testing (FIT). While we have large, well-designed RCTs demonstrating that screening for colorectal cancer using flexible sigmoidoscopy and older generation stool testing reduces colorectal cancer mortality, these screening tests are no longer widely used in the United States. Well-designed diagnostic accuracy studies of screening colonoscopy, CT colonography, and various stool based tests using FIT demonstrate adequate sensitivity and specificity to detect adenomas and/or colorectal cancer, making each of them viable screening options. However, each screening option has potential harms associated with their use, particularly those allowing for direct visualization of the colon. Colonoscopy harms include perforations and major bleeding events. CT colonography requires exposure to radiation; and CT colonography not uncommonly results in detection of extra-colonic findings which necessitate additional diagnostic follow-up which may result in a benefit or harm. (more…)
Author Interviews, Heart Disease, Kidney Disease / 15.06.2016

MedicalResearch.com Interview with: Burns C. Blaxall, PhD, FAHA, FACC, FAPS Director of Translational Science, Heart Institute Co-Director, Heart Institute Research Core & Biorepository Professor, UC Department of Pediatrics MedicalResearch.com: What is the background for this study? Dr. Blaxall: The development of kidney disease subsequent to chronic heart failure is known clinically as cardiorenal syndrome 2, and is associated with dual organ failure and reduced survival. Furthermore, patients undergoing invasive cardiac procedures that require heart-lung bypass are at significant risk for developing kidney injury. According to the National Kidney Foundation, cardiorenal syndrome 2 presents a considerable economic burden of around $30 billion annually. Previous work has demonstrated the role of G protein-coupled receptor (GPCR) signaling and the activation of G protein βγ (Gβγ) subunits in the development and progression of heart failure, however little is known regarding the role of this signaling pathway in kidney disease. (more…)
Author Interviews, CDC, HIV, Sexual Health, Technology / 15.06.2016

MedicalResearch.com Interview with: Dr. James M. Smith Ph.D Laboratory Branch, Division of HIV/AIDS Prevention Centers for Disease Control and Prevention Atlanta, Georgia MedicalResearch.com: What is the background for this study? Dr. Smith: Our laboratory has been developing a macaque model for testing drug release, safety and efficacy of intravaginal rings (IVR) for preexposure prophylaxis (PrEP) against HIV for several years. The initial studies involved both matrix rings, where the drug is dispersed in the silicone matrix of the device, and reservoir rings, which are essentially a polymer tube filled with drug. In collaboration with the Oak Crest Institute of Science and Auritec Pharmaceuticals, Inc., we began testing a new type of intravaginal ring, the pod-IVR. In this innovative design the ring itself is a scaffold that contains compressed polymer-coated drug tablets, or pods, within the ring. Each pod is separate, allowing for a customizable release rate for each drug by varying the number and diameter of the drug release ports for each individual pod. The macaque pod-IVR can accommodate up to six pods whereas the human pod-IVR can accommodate up to 10 pods. The IVR design was developed to allow the delivery of drug combinations and for simple, cost-effective manufacturing. (more…)
Author Interviews, Hematology, HIV, Stem Cells, Transplantation / 15.06.2016

MedicalResearch.com Interview with: Joseph Alvarnas, MD Associate clinical professor Department of hematology and Director of value-based analytics City of Hope National Medical Center Duarte, CA MedicalResearch.com: What is the background for this study? Dr. Alvarnas: Patients with HIV infection have a significantly increased risk of non-Hodgkin lymphoma and Hodgkin lymphoma. Prior to the availability of effective anti-retroviral therapy, HIV-infected patients with lymphoma had very poor treatment outcomes. Following the availability of effective anti-HIV therapy, patient outcomes for HIV-infected patients now parallel those of non-infected patients. Historically, however, HIV infection has been used as a criterion for not offering patients autologous blood stem cell transplantation outside of centers with unique expertise. The purpose of this trial was to evaluate outcomes, complication rates, and immunological reconstitution of HIV-infected patients following autologous blood stem cell transplantation. (more…)
Author Interviews, Diabetes, Pharmacology / 15.06.2016

MedicalResearch.com Interview with: Professor Philip Home D.M., D.Phil Professor of Diabetes Medicine Newcastle University MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Home: MK1293 is a biosimilar insulin designed with the same amino acid sequence, manufacturing process and formulation as originator insulin glargine (Lantus). This is the clinical proving study in type 1 diabetes, being a 24-week randomized study in 508 participants between MK1293 and Lantus. The primary efficacy endpoint of non-inferiority of HbA1c was met, as was a secondary of equivalence (difference in change from baseline 0.04 (95% CI -0.11, 0.19) %-units), with other measures including hypoglycaemia, insulin antibodies and adverse events also consistent with similarity. (more…)
Author Interviews, Circadian Rhythm, Sleep Disorders, Weight Research / 15.06.2016

MedicalResearch.com Interview with: Kelly Glazer Baron, PhD, MPH, C. B.S.M. Diplomate, Academy of Cognitive Therapy Northwestern University Feinberg School of Medicine Chicago, IL 60611 MedicalResearch.com: What is the background for this study? What are the main findings? Response: In contrast to several previous studies, being a late sleeper was not associated with higher BMI (good news for late sleepers!!) but it was associated with less healthy behaviors, more fast food, fewer vegetables, lower dairy. It may be possible that these late sleepers who are able to get enough sleep can compensate for their poor diet by controlling overall calories or it could possibly lead to weight gain over time if their habits continue over time. (more…)
Annals Internal Medicine, Author Interviews, Chemotherapy, Heart Disease, Karolinski Institute, Leukemia / 15.06.2016

MedicalResearch.com Interview with: Torsten Dahlén MD Centre for Hematology Karolinska University Hospital Solna Stockholm Sweden MedicalResearch.com: What is the background for this study?  Dr. Dahlén: Patients diagnosed with CML have had a dramatic increase in life-expectancy since the widespread introduction of tyrosine kinase inhibitors (TKI) in 2001. However, treatment is today regarded as life-long. We thus need to observe for late-effects of continuous TKI exposure. Recent reports have demonstrated a linkage between TKI treatment, especially more potent 2nd and 3rd generation drugs, and to the occurrence of peripheral arterial occlusive disease (PAOD). This study aimed to use real-world data utilizing Swedish population based registries together with the dedicated Swedish CML registry which contains data and follow-up on more than 98% of all CML patients diagnosed in Sweden since 2002. (more…)
Author Interviews, JAMA, Pharmacology, UCSD, Weight Research / 15.06.2016

MedicalResearch.com Interview with: Siddharth Singh, MD, MS Postdoctoral Fellow, NLM/NIH Clinical Informatics Fellowship Division of Biomedical Informatics Clinical Assistant Professor of Medicine, Division of Gastroenterology, Department of Internal Medicine, University of California San Diego, La Jolla MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Singh: Over the last 4 years, four new medications have been approved for long-term use for weight loss by the FDA. We sought to evaluate the comparative effectiveness and tolerability of these medications through a systematic review and network meta-analysis. Based on 28 trials in over 29,000 overweight or obese patients, we observed that magnitude of weight loss achieved with these agents is variable, ranging from 2.6kg with orlistat to 8.8kg with phentermine-topiramate. Over 44-75% of patients are estimated to lose at least 5% body weight, and 20-54% may lose more than 10% of body weight; phentermine-topiramate was the most efficacious, whereas lorcaserin was the best tolerated. (more…)