Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE / 12.06.2018

MedicalResearch.com Interview with: Sheryl L. Rifas-Shiman, MPH Lead Research Analyst Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Landmark Center Boston, MA 02215  MedicalResearch.com: What is the background for this study? Response: Caesarean delivery rates remain high and variable across hospitals, regions, and countries. Caesarean delivery may be a risk factor for childhood obesity, possibly because delivery route can influence the intestinal microbiomes, which may influence energy regulation. Previously reported associations of caesarean delivery with childhood obesity may be confounded by maternal BMI and sociocultural factors. To address this possibility, we studied sibling pairs from the Linked CENTURY Study, a longitudinal clinical database of well-child visits in Massachusetts linked to each child’s birth certificate, to isolate the effect of caesarean delivery from most other factors. (more…)
Abuse and Neglect, Author Interviews, Breast Cancer, JAMA, MD Anderson / 08.06.2018

MedicalResearch.com Interview with: Naoto Tada Ueno, M.D., Ph.D., F.A.C.P. Executive Director, Morgan Welch Inflammatory Breast Cancer Research Program and Clinic Section Chief, Section of Translational Breast Cancer Research, Department of Breast Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TXNaoto Tada Ueno, M.D., Ph.D., F.A.C.P. Executive Director, Morgan Welch Inflammatory Breast Cancer Research Program and Clinic Section Chief, Section of Translational Breast Cancer Research, Department of Breast Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX   MedicalResearch.com: What is the background for this study? What are the main findings? Response: The best outcome of inflammatory breast cancer (IBC) is dependent on achieving a pathological completed response after neoadjuvant chemotherapy for primary inflammatory breast cancer, which is the most aggressive type of breast cancer. We have conducted extensive preclinical work, which showed that EGFR is a potential therapeutic targets of IBC. Based on this preclinical data, we have conducted a phase II study to determine the pathological complete response rate of panitumumab plus neoadjuvant chemotherapy for HER2 negative primary inflammatory breast cancer.  (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, Environmental Risks, Melanoma, Transplantation / 08.06.2018

MedicalResearch.com Interview with: “Sunscreen” by Tom Newby is licensed under CC BY 2.0Rebecca Ivy Hartman, M.D Instructor in Dermatology Brigham and Women's Hospital Boston MA 02115 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Organ transplant recipients (OTR) are at 100-fold higher risk to develop certain skin cancers compared to the general population due to immunosuppression, and thus preventing skin cancer in this population is critical. Our study found that in a high-risk Australian OTR population, only half of patients practiced multiple measures of sun protection regularly. However, after participating in a research study that required dermatology visits, patients were over 4-times more likely to report using multiple measures of sun protection regularly. Patients were more likely to have a positive behavioral change if they did not already undergo annual skin cancer screening prior to study participation. (more…)
ASCO, Author Interviews, Breast Cancer, Brigham & Women's - Harvard / 06.06.2018

MedicalResearch.com Interview with: Dr. Aditya Bardia  MD, MPH Assistant Professor, Medicine Harvard Medical School Attending Physician, Medical Oncology Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hormone receptor-positive (HR+)/ and human epidermal growth factor receptor 2-negative (HER2-) breast cancer is the most common sub-type of breast cancer. While metastatic HR+/HER2- breast cancer is initially treated with endocrine therapy-based combinations, including CDK 4/6 inhibitors, patients eventually have disease progression, but the response rate to standard chemotherapy is low (~10-15 percent, post-taxane setting). In particular, patients with visceral disease have a poor prognosis. In this trial, we evaluated the efficacy of sacituzumab govitecan in patients with metastatic HR+/HER2- breast cancer, who had measurable disease and had received prior therapies for metastatic breast cancer. We observed an overall response rate of 31 percent in a heavily pre-treated population (prior number of therapies for metastatic breast cancer = 5; number of patients with prior CDK 4/6 inhibitor use = 69 percent). The responses were durable (median duration of response = 7.4 months). Neutropenia was the main adverse event noted (grade 3 neutropenia = 42 percent), and two patients (3.7 percent) discontinued the clinical trial due to adverse events. The response rate in patients with visceral metastaseswas 27 percent.  (more…)
Author Interviews, Kidney Disease, Neurological Disorders, Pain Research, UCSF / 06.06.2018

MedicalResearch.com Interview with: Dr. Julie H. Ishida MD Department of Medicine, Division of Nephrology University of California, San Francisco and San Francisco Veterans Affairs Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Gabapentin and pregabalin are used for the management of symptoms such as neuropathic pain, itching, and restless leg syndrome in patients receiving hemodialysis. However, hemodialysis patients may be particularly vulnerable to adverse events related to these agents, which are cleared by the kidney, but there is limited data evaluating their risk in this population. Gabapentin and pregabalin use were associated with risk for altered mental status, fall, and fracture, and in some cases, even at doses that would be considered safe for use in this population.  (more…)
ASCO, Author Interviews, Dermatology, Melanoma, Merck, University of Pittsburgh / 05.06.2018

MedicalResearch.com Interview with: Dr. Diwakar Davar, MD Assistant Professor of Medicine Division of Hematology/Oncology University of Pittsburgh  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The optimal surveillance strategy to detect recurrence in cutaneous melanoma remains elusive. Risk of recurrence increases with higher stage, and is especially high for patients with stage IIIC disease. Although consensus guidelines agree on surveillance imaging for high-risk (stage IIB-IIIC) MEL, there is no consensus regarding optimal frequency/modality in these patients. NCCN guidelines suggest chest radiography (CXR) at 6- to 12-month intervals for stage IA-IIA melanoma  patients; although this is controversial. There exists a great deal of practice variation in the surveillance of these patients. (more…)
Author Interviews, Endocrinology, Social Issues, University of Pennsylvania / 01.06.2018

MedicalResearch.com Interview with: “Monkeys” by Dmitry Baranovskiy is licensed under CC BY 2.0Yaoguang Jiang PhD Postdoctoral Researcher PLATT Lab University of Pennsylvania  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Oxytocin (OT) and arginine vasopressin (AVP) are important neuropeptides known to influence social behaviors in a wide array of mammals. In humans, OT is widely referred to as the ‘prosocial’ hormone and is thought to promote social functions in neurotypical individuals as well as those diagnosed with autism spectrum disorder (ASD). Currently, dozens of ongoing clinical trials in the US are trying to evaluate the therapeutic potential of these neuropeptides in remedying social deficits associated with disorders such as ASD. Yet there are significant gaps in our knowledge especially regarding the neurobiological basis of OT and AVP function. Most importantly, we are unclear which brain areas and pathways these neuropeptides act on to influence social behavior. Additionally, due to strong similarity in molecular structure, OT can bind to AVP receptors with high affinity and vice versa, making it difficult to rule out the possibility that, for example, the behavioral effect of exogenous oxytocin is mediated through the AVP system. Both of these questions have been thoroughly investigated in rodents, but unfortunately the same thing cannot be said for humans. Our study aims to bridge the gap between rodent and human literature on neuropeptide function by studying rhesus macaque monkeys. These monkeys resemble human beings not only in their social behaviors, but also in the neural network that is supporting those behaviors. In this study we show that treating one male macaque monkey intranasally with aerosolized OT relaxes his spontaneous social interactions with another monkey. Oxytocin reduces differences in social behavior between dominant and subordinate monkeys, thereby flattening the status hierarchy.Oxytocin also increases behavioral synchrony within a pair, perhaps through increased attention and improved communication. Intranasal delivery of aerosolized AVP reproduces the effects of OT with greater efficacy. Remarkably, all behavioral effects are replicated when either OT or AVP is injected focally into the anterior cingulate gyrus (ACCg), a brain area linked to empathy, vicarious reward, and other-regarding behavior. ACCg lacks post-synaptic OT receptors but is rich in post-synaptic AVP receptors, suggesting exogenous OT may shape social behavior, in part, via nonspecific binding, particularly when available at supra-physiological concentrations.  (more…)
Author Interviews, Cancer Research, Leukemia, Nature, University of Pennsylvania / 01.06.2018

MedicalResearch.com Interview with: Dr. J Joseph Melenhorst, PhD Director, Product Development & Correlative Sciences laboratories (PDCS) Adjunct Associate Professor Penn Medicine Center for Cellular Immunotherapies University of Pennsylvania MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by CLL and CAR T cells?  Response: We started treating patients with a form of blood cancer called CLL (chronic lymphocytic leukemia) using a form of gene therapy wherein we engineer the patient’s own immune cells – T cells – with a tumor targeting molecule: The CAR, which stands for chimeric antigen receptor. When we engineer the patient’s immune cells we use a vehicle, in this case virus, that inserts the payload – the CAR – into the patient’s DNA. The virus disappears, and the CAR stays. Where this CAR inserts itself is unpredictable, but we always get stably engineered cells.  (more…)
Author Interviews, Duke, Education, Heart Disease, JAMA / 01.06.2018

MedicalResearch.com Interview with: Pamela S. Douglas, MD, MACC, FASE, FAHA Ursula Geller Professor of Research in Cardiovascular Disease Duke University School of Medicine Durham, NC 27715     MedicalResearch.com: What is the background for this study? What are the main findings? Response: For any profession to succeed, it needs to attract top talent. We surveyed internal medicine residents to find out what they valued most in their professional development, how they perceived cardiology as field and how these two areas are associated with  their choosing a career in cardiology or another specialty. We found that trainees were seeking careers that had stable hours, were family friendly and female friendly, while they perceived cardiology to  have adverse work conditions, interfere with family life and to not be diverse. We were able to predict career choice with 89-97% accuracy from these responses; the predictors are mix of things that attract to cardiology and those that are deterrents. For men, the attractors outnumber the deterrents, for women its just the opposite. (more…)
Author Interviews, JAMA, Thromboembolism, University of Michigan / 31.05.2018

MedicalResearch.com Interview with: Paul Grant, MD Associate Professor of Medicine Associate Chief Medical Information Officer Director, Perioperative and Consultative Medicine Division of Hospital Medicine Department of Internal Medicine Michigan Medicine University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is well known that hospitalized medical patients are at risk for venous thromboembolism VTE, but the severity of patient risk can vary significantly. National guidelines have consistently stated that low-risk patients should not receive VTE prophylaxis beyond early ambulation. In this retrospective cohort study, we analyzed data from 52 hospitals participating in the Michigan Hospital Medicine Safety consortium. Trained medical record abstractors at each hospital collected data from 44,775 medical patients including VTE risk factors, type of VTE prophylaxis administered, and contraindications to pharmacologic prophylaxis. Individual patient risk of VTE was determined using the Padua risk assessment model. Of the 32,549 low-risk patients, 77.9% received excess venous thromboembolism prophylaxis as either pharmacologic prophylaxis (30.6%), mechanical prophylaxis (20.8%), or both (26.5%). In the 12,226 high-risk patients, VTE prophylaxis was underused in 22% of patients. The rates of inappropriate prophylaxis varied considerably by hospital.  (more…)
Author Interviews, Cost of Health Care, Critical Care - Intensive Care - ICUs, End of Life Care, NEJM, University of Pittsburgh / 30.05.2018

MedicalResearch.com Interview with: Douglas B. White, M.D., M.A.S. Director of the Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center’s Program on Ethics and Decision Making in  Department of Critical Care Medicine University of Pittsburgh  MedicalResearch.com: What is the background for this study?  Response: We set out to test the effectiveness of PARTNER (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building). PARTNER is delivered by the interprofessional team in the ICU, consisting of nurses, physicians, spiritual care providers, social workers and others who play a part in patient care. The program is overseen by nurse-leaders in each ICU who receive 12 hours of advanced communication skills training to support families. The nurses meet with the families daily and arrange interdisciplinary clinician-family meetings within 48 hours of a patient coming to the ICU. A quality improvement specialist helps to incorporate the family support intervention into the clinicians’ workflow. PARTNER was rolled out at five UPMC ICUs with different patient populations and staffing. It was implemented in a staggered fashion so that every participating ICU would eventually get PARTNER. Before receiving PARTNER, the ICUs continued their usual methods of supporting families of hospitalized patients. None of the ICUs had a set approach to family communication or required family meetings at regular intervals before receiving PARTNER. A total of 1,420 adult patients were enrolled in the trial, and 1,106 of these patients’ family members agreed to be a part of the study and its six-month follow-up surveys. The patients were very sick, with about 60 percent dying within six months of hospitalization and less than 1 percent living independently at home at that point. (more…)
Author Interviews, Columbia, OBGYNE, Toxin Research / 29.05.2018

MedicalResearch.com Interview with: Marianthi-Anna Kioumourtzoglou ScD Assistant Professor Environmental Health Sciences Mailman School of Public Health Columbia University  MedicalResearch.com: What is the background for this study? Response: The prevalence of neurodevelopmental disorders, like attention deficit/hyperactivity disorder (ADHD) has been increasing. One of the hypothesized risk factors for increased risk for neurodevelopmental disorders is a class of chemicals known as endocrine disrupting chemicals (EDCs). These chemicals are known to interfere with the endocrine system, i.e. the system that uses hormones to control and coordinate metabolism, reproduction and development. Several high production volume chemicals, ubiquitously present in commercial products, are known or suspected endocrine disruptors. Because of their widespread use in consumer products, the population-wide exposure to known and suspected EDCs is very high. Recently, there has been increased attention in the potential effects of EDCs on neurodevelopment that span multiple generations. Animal studies have provided evidence that exposure to EDCs, such as phthalates and bisphenol A (BPA), alter the behavior and social interactions in mice in three to five generations after exposure. However, evidence of such multi-generational impacts of EDC exposure on neurodevelopment in humans is unavailable, likely because of the lack of detailed information on exposures and outcomes across generations. For this study we leveraged information from a nationwide cohort, the Nurses’ Health Study II (NHSII), to investigate the potential link between exposure to diethylstilbestrol (DES) and third generation ADHD, i.e. ADHD among the grandchildren of the women who used DES while pregnant. DES is a very potent endocrine disruptor that was prescribed between 1938 and 1971 to pregnant women thought to prevent pregnancy complications. In the United States, between 5 and 10 million women are estimated to have used DES, although the exact number is not known. DES was banned in 1971, when was linked to vaginal adenocarcinomas (a rare cancer of the reproductive system) in the daughters of the women who had used it during pregnancy. Since then, DES has been also linked to multiple other reproductive outcomes in DES daughters, as well as with some reproductive outcomes in the grandchildren of the women who used it, such as hypospadias and delated menstrual regularization. However, to our knowledge, no study to date has evaluated the association between DES, or any other EDC, and multigenerational neurodevelopment. (more…)
Author Interviews, JAMA, Melanoma, UCLA / 24.05.2018

MedicalResearch.com Interview with: Joann G. Elmore, MD, MPH Professor of Medicine David Geffen School of Medicine at UCLA Director of the UCLA National Clinician Scholars Program Affiliate Professor of Medicine, University of Washington School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In a recent study published in 2017 in the British Medical Journal, our team found that pathologists disagreed on their diagnoses of some melanocytic skin biopsy lesions and early stage invasive melanoma more than 50% of the time. This concerning level of disagreement was particularly true for diagnoses in the middle of the disease spectrum, such as atypical lesions and melanoma in situ.  For example, Figure 1 from this paper shows the diagnoses of 36 pathologists who interpreted the same glass slide of a skin biopsy using their own microscopes; the diagnoses ranged from a benign lesion to invasive melanoma. Since that study, the American Joint Committee on Cancer has released new guidelines for melanoma staging. Given this change, we wanted to examine whether the updated guidelines improved the reliability of melanoma diagnosis. We found that using the new guidelines improved the accuracy of pathologists’ diagnoses for invasive melanoma (Elmore J, et al, JAMA Network Open 2018).  (more…)
Author Interviews, JAMA, NIH / 23.05.2018

MedicalResearch.com Interview with: Jennifer Villani, PhD, MPH Office of Disease Prevention National Institutes of Health MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The US Preventive Services Task Force (USPSTF) develops recommendations for the delivery of clinical preventive services based on the highest quality scientific evidence available. We performed a comprehensive assessment of the sources of funding for the research studies in this evidence base. The results showed that government agencies supported the most articles (56%), with the remaining support coming from nonprofits or universities (32%), and industry (17%). The National Institutes of Health was the single largest funder of research articles underlying the USPSTF recommendations.  (more…)
Author Interviews, Brain Injury, Environmental Risks, Science, UCSF / 22.05.2018

MedicalResearch.com Interview with: “Space Shuttle Model” by terren in Virginia is licensed under CC BY 2.0Susanna Rosi, PhD Director of Neurocognitive Research Brain and Spinal Injury Center Professor in the departments of Physical Therapy and Rehabilitation Science and of Neurological Surgery UCSF MedicalResearch.com: What is the background for this study? What are the main findings? Response: NASA and private space companies like SpaceX plan to send humans to the red planet within the next 15 years — but among the major challenges facing future crewed space missions is how to protect astronauts from the dangerous cosmic radiation of deep space. In this study we identified the first potential treatment for the brain damage caused by exposure to cosmic rays — a treatment can be given after exposure and that prevents memory impairment in mice exposed to simulated space radiation. (more…)
Author Interviews, Depression, Emory, Heart Disease, JAMA / 22.05.2018

MedicalResearch.com Interview with: Viola Vaccarino, MD, PhD Department of Epidemiology and Division of Cardiology Professor, Department of Medicine Emory University School of Medicine Atlanta, Georgia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies have shown that people with depression tend to have lower heart rate variability (HRV), an index of autonomic nervous system dysregulation derived by monitoring the electrocardiogram over time, usually for 24 hours. Other literature, however, has pointed out that autonomic dysregulation (as indexed by reduced HRV) may also cause depression. Thus, the direction of the association between reduced HRV and depression still remains unclear. In addition, these two characteristics could share common pathophysiology, making shared familial background and genetic factors potential determinants of this association. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Opiods, University of Pittsburgh / 21.05.2018

MedicalResearch.com Interview with: Jason Kennedy, MS Research project manager Department of Critical Care Medicine University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Most previous studies of opioid use in health care have focused on the outpatient setting. But opioids are often introduced during hospitalization. That’s something clinicians can control, so we looked at inpatient prescription of these drugs to identify targets that may reduce opioid use once patients are out of the hospital. We analyzed the medical records of 357,413 non-obstetrical adults hospitalized between 2010 and 2014 at 12 University of Pittsburgh Medical Center (UPMC) hospitals in southwestern Pennsylvania. The region is one of the areas of the country where opioid addiction is a major public health problem. We focused on the 192,240 patients who had not received an opioid in the year prior to their hospitalization – otherwise known as “opioid naïve” patients. Nearly half (48 percent) of these patients received an opioid while hospitalized.  After discharge, those patients receiving hospital opioids were more than twice as likely to report outpatient opioid use within 90-days (8.4 percent vs. 4.1 percent). Patients who receive an opioid for most of their hospital stay and patients who are still taking an opioid within 12 hours of being discharged from the hospital appear more likely to fill a prescription for opioids within 90 days of leaving the hospital.  (more…)
ADHD, Author Interviews, Columbia, JAMA, Toxin Research / 21.05.2018

MedicalResearch.com Interview with: Marianthi-Anna Kioumourtzoglou ScD Assistant Professor Environmental Health Sciences Mailman School of Public Health Columbia University  Marianthi-Anna Kioumourtzoglou ScD Assistant Professor Environmental Health Sciences Mailman School of Public Health Columbia University  MedicalResearch.com: What is the background for this study? Response: The prevalence of neurodevelopmental disorders, like attention deficit/hyperactivity disorder (ADHD) has been increasing. One of the hypothesized risk factors for increased risk for neurodevelopmental disorders is a class of chemicals known as endocrine disrupting chemicals (EDCs). These chemicals are known to interfere with the endocrine system, i.e. the system that uses hormones to control and coordinate metabolism, reproduction and development. Several high production volume chemicals, ubiquitously present in commercial products, are known or suspected endocrine disruptors. Because of their widespread use in consumer products, the population-wide exposure to known and suspected EDCs is very high. Recently, there has been increased attention in the potential effects of EDCs on neurodevelopment that span multiple generations. Animal studies have provided evidence that exposure to EDCs, such as phthalates and bisphenol A (BPA), alter the behavior and social interactions in mice in three to five generations after exposure. However, evidence of such multi-generational impacts of EDC exposure on neurodevelopment in humans is unavailable, likely because of the lack of detailed information on exposures and outcomes across generations. For this study we leveraged information from a nationwide cohort, the Nurses’ Health Study II (NHSII), to investigate the potential link between exposure to diethylstilbestrol (DES) and third generation ADHD, i.e. ADHD among the grandchildren of the women who used DES while pregnant. DES is a very potent endocrine disruptor that was prescribed between 1938 and 1971 to pregnant women thought to prevent pregnancy complications. In the United States, between 5 and 10 million women are estimated to have used DES, although the exact number is not known. DES was banned in 1971, when was linked to vaginal adenocarcinomas (a rare cancer of the reproductive system) in the daughters of the women who had used it during pregnancy. Since then, DES has been also linked to multiple other reproductive outcomes in DES daughters, as well as with some reproductive outcomes in the grandchildren of the women who used it, such as hypospadias and delated menstrual regularization. However, to our knowledge, no study to date has evaluated the association between DES, or any other EDC, and multigenerational neurodevelopment. (more…)
Author Interviews, Duke, Mental Health Research / 21.05.2018

MedicalResearch.com Interview with: Maxwell Elliott Clinical psychology PhD student Working with Ahmad Hariri and the Moffitt & Caspi lab Duke University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The traditional clinical science model identifies individuals who meet specific criteria for mental illness diagnoses (e.g. Depression, Anxiety) and compares them to “healthy” controls to find brain correlates of mental illness.  However, this approach often overlooks the high rates of comorbidity and shared symptamatology across mental illnesses. Emerging research has identified a general factor of psychopathology that accounts for shared risk among internalizing, externalizing, and thought disorders across diverse samples. This general factor of psychopathology has been called the p-factor. In our study we investigate the brain correlates of the p-factor using a data-driven analysis of resting state functional connectivity. We find that higher p-factor scores and associated risk for common mental illness maps onto hyper-connectivity between visual association cortex and both frontoparietal and default mode networks. (more…)
Author Interviews, Infections, Leukemia, MD Anderson, Transplantation / 20.05.2018

MedicalResearch.com Interview with: Roy F. Chemaly, MD, MPH F.A.C.P., F.I.D.S.A. Department of Infectious Diseases Infection Control and Employee Health Division of Internal Medicine MD Anderson Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: CytomegalovirusCMV infection is a common cause of morbidity and mortality in allo-HCT recipients. Evidence suggests that CMV infection has not only an enormous clinical burden, but a substantial economic burden as well. We conducted this study at MD Anderson to determine the economic and clinical burden of preemptive therapy (PET) for CMV infection. Between 2012 and 2015, 100 consecutive patients hospitalized at our institution for allo-HCT who experienced reactivation of CMV and were treated pre-emptively, were enrolled. The majority of patients were men (55%), who had underlying leukemia (73%), and underwent matched unrelated donor transplant (59%). At the time of hospitalization, most patients had acute GvHD (62%), and were on steroids (58%) within 30 days of CMV reactivation which occurred at a median of 32 days post-HCT (2 -174). A total of 192 episodes of PET occurred in the 100 allo-HCT recipients within 1 year post-HCT. PET consisted of ganciclovir (41%), foscarnet (40%), and valganciclovir (38%). IVIG was also used as adjunct therapy in 20% of episodes. Progression to Cytomegalovirus disease occurred in 4 patients (4%) and mainly affected the GI tract. Mean length of stay for patients treated with ganciclovir or foscarnet was 32 days (2-141) and 41 days (1-177), respectively. The average direct cost per patient admitted for PET was $126,038 ($7,866-$641,841) and the mean cost of CMV antiviral drug per hospitalization was $6,096 for IVIG, $2,410 for foscarnet, $836 for ganciclovir, and $780 for valganciclovir. Serious side effects from PET were observed in 35% of patients on ganciclovir and 12% of patients on foscarnet. Total direct cost per encounter was significantly higher in patients who had serious side effects from foscarnet. All-cause mortality was 59% at 1 year post-transplant. (more…)
AHA Journals, Author Interviews, Genetic Research, Heart Disease, Lipids, Vanderbilt / 18.05.2018

MedicalResearch.com Interview with: Wei-Qi Wei, MD, PhD Assistant Professor Department of Biomedical Informatics Vanderbilt University Nashville, TN 37203 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study was motived by the clinical observation that some patients develop coronary heart disease events despite taking statins, one of our most effective drugs to reduce cardiovascular risk. We collected data within the eMERGE network of people taking statins and monitored them for development of coronary heart disease events over time.  We  conducted a genome-wide association study of those with events compared to those without events. Our results showed that single nucleotide polymorphisms (SNPs) on the LPA gene were associated with a significantly increased risk of coronary heart disease events. Individuals with the variant were 50% more likely to have an event. More importantly, even among patients who achieved ideal on-treatment LDL cholesterol levels (<70 mg/dL), the association remained statistically significant. We then did a phenome-wide association study to see if other diseases or conditions were associated with these LPAvariants. The major associated conditions were all cardiovascular. This sort of study can highlight potential other indications for a drug targeting this pathway and suggest potential adverse events that might be experienced from targeting this pathway. Clearly, more and larger studies will be needed to truly understand the potential risks and benefits of a future drug targeting this pathway.  (more…)
Author Interviews, Epilepsy, Neurological Disorders, NYU, Pharmaceutical Companies / 17.05.2018

MedicalResearch.com Interview with: https://www.gwpharm.com/epilepsy-patients-caregivers/patientsAnup Patel, M.D. Section Chief of Neurology Interim Division Chief of Neurology Nationwide Children’s Hospital MedicalResearch.com: What is the background for this study? Response: The study evaluated kids and adults with an epilepsy syndrome (Lennox Gastaut Syndrome – LGS) that is often difficult to treat and does not respond well to current medical treatment.  The study was a double blind randomized control trial evaluating how well a plant based, liquid solution, cannabidiol (CBD) product made by Greenwich Biosciences called Epidiolex helped to treat drop seizures (the most common seizure type in LGS) and how safe it was compared to placebo.  Two doses (10 mg/kg/day and 20 mg/kg/day) were evaluated compared to placebo. (more…)
Author Interviews, Biomarkers, Breast Cancer, Technology, University of Michigan / 16.05.2018

MedicalResearch.com Interview with: Greg Thurber, PhD Assistant Professor Department of Chemical Engineering Assistant Professor Department of Biomedical Engineering University of Michigan  MedicalResearch.com: What is the background for this study? Response: Most current disease screening strategies rely on either blood tests, where the physician can obtain information on specific disease molecules but has no idea where they originated in the body, or anatomical imaging, where the physician can see changes in the structure of tissues but doesn’t have any molecular information. We wanted to develop a method that could provide both molecular information and an image of where these molecules were located. We know from decades of research in cancer that this is a molecular disease, so providing molecular information to the physician will help improve detection and diagnosis. Breast cancer screening provides an excellent opportunity to apply this approach to improve detection. Currently, estimates indicate that we are overspending $4 billion per year on the overdiagnosis and overtreatment of breast cancer because we cannot accurately determine which patients need treatment and which can be safely monitored with no intervention. Despite this problem with overdiagnosis, however, screening saves lives…we simply need a better way. Molecular imaging has the capability of providing both molecular information and the location within the body. However, most of these techniques are expensive and use ionizing radiation, meaning there is a small risk of actually causing cancer. This is not acceptable for screening large numbers of otherwise healthy patients. To avoid this risk and provide a safe, inexpensive, and relatively easy method for patients to undergo screening, we decided to develop near-infrared fluorescent imaging agents that can be taken as a pill. The goal is for the patient to simply take a pill a day or two before their visit, and then the physician shines near-infrared light on the breast tissue to detect tumors where they ‘light up’ by giving off a different color of light. (more…)
Author Interviews, NEJM, Stroke, University Texas / 16.05.2018

MedicalResearch.com Interview with: Dr. S. Claiborne "Clay" Johnston MD, PhD Dean Vice President for Medical Affairs Frank and Charmaine Denius Distinguished Dean’s Chair Dell Medical School The University of Texas at Austin MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prior studies have shown that the risk of a stroke or other ischemic events is high in the days to weeks after a TIA or minor stroke. We sought to test whether blocking platelet aggregation more effectively with clopidogrel plus aspirin could reduce this risk compared to aspirin alone.  We found that the combination did reduce risk of major ischemic events.  It also showed a small increase in risk of major hemorrhage, but for most people the benefits would outweigh the potential risk. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 15.05.2018

MedicalResearch.com Interview with: Jeremy O'Connor, MD Section of General Internal Medicine Department of Internal Medicine Postdoctoral Fellow, National Clinician Scholars Program Yale University MedicalResearch.com: What is the background for this study?   Response: There has been a lot of enthusiasm for the use of novel therapies in cancer care, and in particular for novel anticancer agents known as immune checkpoint inhibitors. But very little is known about how quickly providers have adopted immune checkpoint inhibitors into clinical practice. Existing studies suggest, in fact, that the process of clinical adoption is slow, with conventional wisdom holding that it takes an average of 17 years for new evidence to change practice. Our study evaluated whether the adoption of novel therapies might be much faster in certain contexts with the early use of immune checkpoint inhibitors as a notable example. (more…)
Alzheimer's - Dementia, Author Interviews, Personalized Medicine, University of Pennsylvania / 15.05.2018

MedicalResearch.com Interview with: David A. Wolk, MD Associate Professor Department of Neurology Co-Director, Penn Memory Center Associate Director, Alzheimer’s Disease Core Center University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Mild Cognitive Impairment (MCI) is a state when individuals have mild memory problems, but not enough to impact day-to-day function.  Many patients with MCI are on the trajectory to developing Alzheimer’s Disease dementia, but about half will not and remain stable.  As such, patients with MCI are often uncertain about the likelihood they should expect to decline in the future which obviously may be associated with considerable anxiety and this may delay opportunities for them to plan for the future or begin therapeutic interventions. This study examined the degree to which amyloid PET, which detects the amyloid pathology of Alzheimer’s Disease, a measure of shrinkage of the hippocampus with MRI, and cognitive measures predicted development of dementia over 3 years.  We found that each of these measures enhances prediction of whether an individual will or will not develop dementia in the future.  If all of these measures are positive, one has a very high risk of progression whereas if amyloid PET and the MRI measurement are normal, there is very little risk of progression. (more…)
Author Interviews, Genetic Research, JAMA, UCSF / 12.05.2018

MedicalResearch.com Interview with: Allison W. Kurian, M.D., M.Sc. Associate Professor of Medicine (Oncology) and of Health Research and Policy Director, Women’s Clinical Cancer Genetics Program Stanford University School of Medicine Stanford, CA 94305-5405  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Changes in genetic sequencing technology and regulation have allowed much cheaper testing of many more genes in recent years. We investigated how these changes have affected hereditary cancer risk evaluation in women newly diagnosed with breast cancer. The main findings are that more comprehensive multiple-gene sequencing tests have rapidly replaced more limited tests of two genes (BRCA1 and BRCA2) only. This has helped patients by doubling the chance of finding an important gene mutation that can change their treatment options. However, there are important gaps in how this new, more comprehensive sequencing is used: more testing delays and more uncertain results, particularly among racial/ethnic minority women.  (more…)
Author Interviews, Biomarkers, Brigham & Women's - Harvard, Orthopedics, Pain Research / 11.05.2018

MedicalResearch.com Interview with: “osteopathic treatment for sciatica” by betterhealthosteopathy is licensed under PDM 3.0Daniel Albrecht, PhD Research Fellow in Radiology, Harvard Medical School Research Fellow, Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: A great deal of preclinical work in animal models of pain has established that activation of peripheral immune cells or, in the central nervous system (brain and spinal cord), immune cells called “glia” (microglia and astrocytes) play a key role in the establishment and/or maintenance of persistent pain. For instance, if you pharmacologically block activation of these cells in the nervous system, you are able to reduce/inhibit/prevent pain behaviors, e.g. in animals who have received a nerve injury. This observation is very exciting, because it suggests that blocking neuroinflammation may be a viable way of treating pain. However, the evidence linking human chronic pain with neuroinflammation has so far been limited. In this study we show, for the first time, that patients with chronic sciatica (that is, back pain that shoots down the leg) demonstrate elevations in the levels of a protein called the translocator protein (TSPO) in the spinal cord and in the nerve roots. Because TSPO is a marker of neuroinflammation, our results suggest that sciatica is associated with neuroinflammation. While on average patients do show elevations in the levels of the TSPO, we also saw significant variability across individuals. Importantly, patients that show stronger elevations (in the nerve roots) were those who benefit the most from receiving a local anti-inflammatory treatment (epidural spinal injection). This makes sense: patients whose nerve roots are inflamed benefit from an anti-inflammatory treatment. Those whose nerve roots aren’t inflamed, don’t receive the same benefit. In the latter case, the source of the inflammation and pain may not be the nerve roots, but may be the spinal cord, or, as we showed in a previous paper (Loggia et al., Brain 2015), the brain.  (more…)
FDA, Infections, Vaccine Studies / 08.05.2018

MedicalResearch.com Interview with: Lisa Danzig, MD Chief Medical Office PaxVax MedicalResearch.com: Would you briefly explain what is meant by Chikungunya infection?  Whom does it primarily affect?  How is it transmitted and what the  complications? Response: Chikungunya is caused by the chikungunya virus (CHIKV), an arthropod-borne virus (arbovirus) spread by infected mosquitos. Infection with chikungunya virus results in severe, often debilitating joint pain in infected patients, known as arthralgia. Symptoms can include intense discomfort in joints, such as the wrists, fingers, ankles, and feet, in the knees and in the hips or shoulders. Those affected can also frequently suffer from headaches, fever, and severe muscle pain, rashes on the torso and limbs and swelling in one or more cervical lymph nodes. Individuals who are at a higher risk for contracting chikungunya include infants, elderly and those with chronic conditions. The virus is a small, spherical, enveloped, positive-strand RNA virus. The virus is transmitted by the Aedes aegypti and Aedes albopictus mosquito, which originated in Africa, first spreading to Asia and recently expanding to the western hemisphere.  Outbreaks are rapid and widespread.  In February 2005 a major outbreak of chikungunya occurred in the islands of the Indian Ocean after which over 1.9 million cases have been reported in India, Indonesia, Maldives, Myanmar and Thailand. Chikungunya spread has been identified in 45 countries in the Americas alone with more than 1.7 million suspected cases reported to the Pan American Health Organization since 2015, increasing the incidence of the disease and risk to U.S. travelers. In 2016 there were approximately 60,000 cases of chikungunya across India. Beyond the Indian subcontinent, the Caribbean, Central America and South America, inhabitants and travelers visiting sub-Saharan Africa and Southeast Asia are also at risk. (more…)