Author Interviews, Education, Heart Disease, JAMA, Social Issues / 14.06.2017

MedicalResearch.com Interview with: Yasuhiko Kubota, MD, MPH Visiting Scholar Division of Epidemiology and Community Health School of Public Health University of Minnesota, Minneapolis, MN MedicalResearch.com: What is the background for this study? Response: Educational inequality is one of the most important socioeconomic factors contributing to cardiovascular disease. Since education is usually completed by young adulthood, educational inequality may affect risk of cardiovascular disease early in the life course. We thought it would be useful to calculate the lifetime risk of cardiovascular disease according to educational levels in order to increase public awareness of the importance of education. Thus, our aim was to evaluate the association of educational attainment with cardiovascular disease risk by estimating the lifetime risks of cardiovascular disease using a US. biracial cohort. Furthermore, we also assessed how other important socioeconomic factors were related to the association of educational attainment with lifetime risk of cardiovascular disease. (more…)
ASCO, Author Interviews, Breast Cancer / 14.06.2017

MedicalResearch.com Interview with: Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, UTMDACC, Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine Program Director, Department of Breast Medical Oncology Susan G. Komen Interdisciplinary Breast Fellowship Program The University of Texas MD Anderson Cancer Center Houston, TX MedicalResearch.com: What is the background for this study? Response: The MONALEESA-2 trial is a double-blind, randomized, Phase III trial that evaluated efficacy and safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not previously been treated for their advanced disease. MedicalResearch.com: What are the main findings? o Updated findings from the Phase III MONALEESA-2 trial confirm the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a treatment option for HR+/HER2- advanced or metastatic breast cancer: • After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) compared to 16.0 months (95% CI: 13.4-18.2) for letrozole alone. • The progression-free survival rate at two years was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone. • In women with measurable disease, 55% of patients saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% of patients with letrozole plus placebo. • Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo. o The safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities were similar to that observed at the first interim analysis. • The most common grade 3/4 laboratory abnormalities for Kisqali plus letrozole compared to letrozole alone were decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%). (more…)
Author Interviews, Biomarkers, Pancreatic / 13.06.2017

MedicalResearch.com Interview with: Rajesh Kumar NV, Ph.D. Instructor of Oncology and Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA Current affiliation Senior Manager, Human Therapeutics Division, Intrexon Corporation Germantown, MD MedicalResearch.com: What is the background for this study? Response: Pancreatic ductal adenocarcinoma (a.k.a. pancreatic cancer) is one of the most deadly of all types of cancer and currently the third leading cause of cancer-related death in United States. Current therapeutic options for pancreatic cancer involve combination cytotoxic chemotherapy, which yield only minimal survival benefit. A multitude of Phase III clinical trials have failed to demonstrate efficacy, largely due to the aggressive growth of pancreatic tumors. Metabolic reprogramming is a hallmark of cancer cells, including pancreatic cancer. Altered metabolism is central to the pathogenesis of pancreatic cancer and contributes to promotion of proliferation, survival, invasiveness and chemo-resistance of cancer cells. Pharmacologic strategies targeting cancer metabolism might therefore represent a promising approach towards the development of effective drugs against pancreatic cancer. We utilized a clinically relevant and genetically characterized platform of patient-derived pancreatic cancer xenografts, which we originally created from the freshly resected pancreatic cancer tissues of patients, to explore the in vivo anti-tumor efficacy of a panel metabolic inhibitors and investigated whether mutational status, gene expression and metabolite profile of tumors correlate with the sensitivity to metabolic inhibitors. To our knowledge, this is the largest preclinical trial which enrolled a large number of animals (over 500 mice) with established human pancreatic tumors for the comprehensive evaluation of key metabolic inhibitors in pancreatic cancer.  (more…)
Author Interviews, Diabetes, Pediatrics / 13.06.2017

MedicalResearch.com Interview with: Prof. Dr. Thomas Danne Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc Kinder und Junden Krankenhaus MedicalResearch.com: What is the background for this study? What are the main findings? Response: The double-blind, placebo controlled, Phase 3 study known as inTandem2 randomized 782 adult patients from 99 sites in the EU and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured. The mean baseline A1C levels after the six-week optimization period were 7.8%, 7.7% and 7.7% for patients randomized to the placebo, 200mg and 400mg arms, respectively (A1C was 8.4% across all dose arms prior to insulin optimization). The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial has a double-blind long term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 258 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg dose arm (p<0.001) and 0.35% in the 400mg dose arm (p<0.001). In response to regulatory input, a secondary endpoint to measure “net clinical benefit” was defined for this study as the proportion of patients at week 24 who achieved the standard of care A1C goal of less than 7.0% without any episode of severe hypoglycemia or DKA. 15% of patients in the placebo arm, 32% in the 200 mg dose arm and 32% in the 400mg dose arm achieved this endpoint (p<0.001 for both treatment arms). (more…)
Accidents & Violence, Alcohol, Author Interviews, Cannabis, Columbia / 13.06.2017

MedicalResearch.com Interview with: Guohua Li DrPH, MD Professor and Director Center for Injury Epidemiology and Prevention Department of Epidemiology Mailman School of Public Health Columbia University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Drugged driving has become a serious problem in the United States in the recent years due to increased consumption of marijuana and opioids. About 20% of fatally injured drivers used two or more substances, with alcohol-marijuana being the most commonly detected polydrug combination. Our study of over 14000 fatal 2-car crashes indicates that drivers testing positive for alcohol, marijuana, or both are significantly more likely to be responsible for initiating these crashes than those using neither of the substances. Specifically, compared to drivers not using alcohol and marijuana, the risk of being responsible for initiating fatal crashes increases 62% for those testing positive for marijuana and negative for alcohol, 437% for those testing positive for alcohol and negative for marijuana, and 539% for those testing positive for both alcohol and marijuana. These results suggest that when used in combination, alcohol and marijuana have a positive interaction on the risk of fatal crash initiation. The most common driver error leading to fatal 2-car crashes is failure to keep in proper lane, followed by failure to yield right of way and speeding. (more…)
Author Interviews, Exercise - Fitness, Gender Differences, JAMA, Pediatrics, Surgical Research / 13.06.2017

MedicalResearch.com Interview with: Mackenzie M. Herzog, MPH PhD Candidate, Injury Epidemiology The University of North Carolina at Chapel Hill  MedicalResearch.com: What is the background for this study? Response: In 1999, a study by Arendt et al. reported that women were more likely to tear their ACL than men while playing the same sport. Since then, numerous studies have investigated this sex difference in ACL injury, and many prevention programs targeting youth athletes have been developed and tested. Although randomized trials have demonstrated the value of injury prevention programs in reducing the risk of ACL injury, the overall impact of these programs has not been examined in the general population. Our study investigated the net impact of research and prevention efforts over nearly 20 years in reducing ACL injuries by assessing time trends of ACL reconstruction, a consequence of ACL injury, among commercially-insured individuals in the United States. (more…)
Author Interviews, Merck, Pharmacology / 13.06.2017

MedicalResearch.com Interview with: Roy F Chemaly, M.D., M.P.H., F.A.C.P., F.I.D.S.A Professor, Department of Infectious Diseases, Director, Infection Control and Employee Health, Division of Internal Medicine Director of the clinical virology research program,Department of infectious diseases Infection control and employee health The University of Texas MD Anderson MedicalResearch.com: Would you briefly explain the significance of CMV infections? What is the background for this study? Response: Cytomegalovirus (CMV) is one of the most important causes of infectious complications following organ transplantation and is a significant cause of illness and death in patients who have undergone allogeneic hematopoietic cell transplantation (allo-HCT). For more than 20 years, we have been managing this infection and trying to develop effective strategies to control it, but to no one’s satisfaction; CMV infection is still associated with significant morbidity and mortality in this high-risk population. Most transplant centers have adopted preemptive antiviral therapy as the strategy of choice for HCT patients.1 While anti-CMV drugs have decreased the incidence of CMV diseases, their use for prophylaxis has not been associated with improved outcomes.1 Demographic and transplant trends heighten the need for new anti-CMV agents. In the U.S, 83% of people aged 60 and older are CMV seropositive. These older patients received 8% of all hematopoietic-cell transplants in 2000-2006, a figure that jumped to 22% in 2007-2013. As Baby Boomers age, many more allogeneic transplant patients will be CMV seropositive. Therefore, prophylactic antiviral compounds that could effectively control viral replication, and restrict some pathologic processes of CMV diseases, could potentially lessen the complications associated with CMV infection and possibly reduce all-cause mortality. (more…)
Author Interviews, CDC, Infections, Outcomes & Safety / 13.06.2017

MedicalResearch.com Interview with: Elizabeth A. Soda, MD Epidemic Intelligence Service Divison of Bacterial Diseases National Center of Immunization and Respiratory Diseases CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Legionella is a waterborne bacterium responsible for Legionnaires’ disease, an often severe pneumonia. Legionnaires’ disease primarily affects certain groups of individuals such as those ≥50 year of age, current or former smokers, and those with chronic diseases or weakened immune systems. Health care facilities often have large and complex water systems and care for vulnerable populations that are susceptible to developing Legionnaires’ disease. Thus preventing hospitalized patients from developing Legionnaires’ disease is the ultimate goal. This analysis aimed to describe health care-associated Legionnaires’ disease in 2015 from the 21 U.S. jurisdictions that completely reported their health care-associated Legionnaires’ disease cases to the CDC’s Supplemental Legionnaires’ Disease Surveillance System (SLDSS). Over 2,800 cases of Legionnaires’ disease cases were reported to SLDSS by the 21 jurisdictions, and 553 (20%) were considered health care associated. The analysis showed 16 of the 21 (76%) jurisdictions had at least one case of Legionnaires’ disease definitely related to a stay in a hospital or long-term care facility. In total there were 85 (3%) definite health care-associated Legionnaires’ disease cases (as defined by continuous exposure to a hospital or long-term facility for the entire 10 days before symptom onset) that resulted from 72 different health care facilities. Additionally, 20 of 21 jurisdictions (95%) reported 468 (17%) possible health care-associated Legionnaires’ disease cases (as defined by any exposure to a health care facility for a portion of the 10 days before symptom onset) that resulted from approximately 415 different health care facilities. While approximately 9% of Legionnaires’ disease cases overall are fatal, this report showed a case fatality of 25% for definite health care-associated cases. (more…)
Author Interviews, Pharmacology / 12.06.2017

MedicalResearch.com Interview with: Huseyin Naci, PhD Assistant Professor of Health Policy LSE Health Department of Social Policy London School of Economics and Political Science London, United Kingdom  MedicalResearch.com: What is the background for this study? What are the main findings? Response: An increasing proportion of novel therapeutic agents are entering the market on the basis of expedited development and approval programs. The Food and Drug Administration's (FDA) Accelerated Approval pathway is one such expedited approval program. In our study, we examined the dynamics of research on drugs receiving accelerated approvals. We were particularly interested in the timing and characteristics of research studies including drugs with accelerated approvals. Our primary findings are the following:
  • First, there is an abundance of research on drugs receiving accelerated approvals. Yet, the majority of this research (about 70%) is of poor quality. Ideally, these drugs are evaluated in so-called randomised controlled trials to establish their efficacy and safety. However, only about a third of all existing studies are randomised controlled trials.
  • Second, a substantial share (about 30%) of the existing research on these drugs is in areas not approved by the FDA. This may be indicative of industry research practices in trying to prioritise identification of new uses for drugs receiving accelerated approvals instead of strengthening their evidence base.
  • Third, when focusing on well-designed studies, only about a half actually evaluate the effectiveness of the accelerated approval drugs. The rest appears to use the accelerated approval drug as background therapy. Interestingly, these two types of studies are conducted concurrently. In other words, while one research group is trying to find out if an accelerated approval drug is effective, other research groups are already using it as part of a background regimen when testing the effectiveness of another, potentially newer drug
(more…)
Author Interviews, Cancer, Cancer Research, Hepatitis - Liver Disease, Race/Ethnic Diversity / 12.06.2017

MedicalResearch.com Interview with: Farhad Islami, MD PhD Strategic Director, Cancer Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Liver cancer is one of the leading causes of cancer death in the United States, accounting for nearly 29,000 deaths per year, with variations in occurrence by race/ethnicity and state. We examined trends in liver cancer incidence, survival, and mortality in the United States and provided liver cancer mortality rates by race/ethnicity at the national and state level. State-level statistics are particularly important as they can inform state cancer control and prevention planning. We also provided detailed information on prevalence and trends in major risk factors for liver cancer and interventions to prevent or reduce their burden, to make our article a comprehensive yet concise source of information on liver cancer statistics, risk factors, and interventions in the United States. (more…)
Author Interviews, Biomarkers, Heart Disease, Lipids / 12.06.2017

MedicalResearch.com Interview with: Amane Harada, PhD Senior Researcher Central Research Laboratories, Sysmex Corporation Kobe, Japan Ryuji Toh, MD, PhD Associate Professor Division of Evidence-based Laboratory Medicine Kobe University Graduate School of MedicineRyuji Toh, MD, PhD Associate Professor Division of Evidence-based Laboratory Medicine Kobe University Graduate School of Medicine Kobe, Japan  MedicalResearch.com: What is the background for this study? Response: High-density lipoprotein (HDL) exhibits a variety of anti-atherogenic functions including anti-inflammatory and anti-oxidative functions as well as promoting reverse cholesterol transport. However, it has been reported that HDL may lose its anti-atherogenic properties and become “dysfunctional” HDL under pathological conditions. Recent studies have demonstrated that cholesterol efflux capacity of HDL is a better predictor of CVD than HDL-C, suggesting that not only the quantity, but also the quality of HDL may significantly modulate and predict the progression of cardiovascular disease. However, the conventional procedure for efflux capacity assay requires radiolabeling and cells, and the procedures are time consuming. Therefore, its clinical application is impractical. To solve those problems, we have recently developed a new assay system to evaluate the capacity of HDL to accept cholesterol, named “uptake capacity”. (more…)
Author Interviews, BMJ, Cannabis, Pediatrics / 12.06.2017

MedicalResearch.com Interview with: Dr Michelle Taylor PhD Senior Research Associate in Epidemiology MRC Integrative Epidemiology Unit (IEU) School of Social and Community Medicine University of Bristol Bristol UK MedicalResearch.com: What is the background for this study? Response: Many previous studies have looked at adolescent cannabis use, however most of these look at use at a single time point, for example whether an individual has ever used cannabis at age 16 years, or how regularly a person uses cannabis at age 18. However, as young people do not initiate use at the same time or follow the same pattern of use, using measures at a single time point does not always tell the whole story. We used a form of statistical modelling using data taken over the course of adolescence to try and characterise underlying patterns of cannabis use across adolescence. We used data from the Avon Longitudinal Study of Parents and Children which had information on cannabis use at six time points between the ages of 13 and 18 years. (more…)
Author Interviews, Breast Cancer / 12.06.2017

MedicalResearch.com Interview with: Marco D. Huesch, MBBS, PhD Department of Radiology Milton S. Hershey Medical Center Hershey, PA   MedicalResearch.com: What is the background for this study? Response: Public health depends on coordinated actions between patients, payors and providers. Important preventative care and evidence-based screenings need to be understood and sought out by patients, need to be reimbursed by or subsidized by insurance plans, and offered and recommended by physicians and care team members. Women’s breast health is a good example of how – in theory – all these come together and allow women to obtain regular screenings for breast cancer through mammograms. Yet it is commonly accepted that perhaps as many as 1 in 3 women are not adequately screened or are not screened at all. In this study we hypothesized that a prominent global celebrity, Ms Angelina Jolie’s, highly public announcement of her own risk-reducing surgery to prevent breast cancer and her recommendation to women to understand whether they were at high risk might spur uptake of breast screenings at our institution. (more…)
Author Interviews, Cancer Research, Geriatrics, JAMA, Johns Hopkins / 12.06.2017

MedicalResearch.com Interview with: Nancy Schoenborn, MD Assistant Professor Division of Geriatric Medicine and Gerontology Johns Hopkins University School of Medicine Nancy Schoenborn, MD Assistant Professor Division of Geriatric Medicine and Gerontology Johns Hopkins University School of Medicine MedicalResearch.com: What are the main findings? Response: A lot of cancer screenings are not expected to save lives until up to 10 years later; however, the side effects of the test happen right away. Because of this, clinical guidelines have recommended against routine screening for those patients who will not live long enough to benefit but may experience the potential harm of the test in the short term. However, many patients with limited life expectancy still receive screening and clinicians are worried about how patients would react if they recommended that patients stop screening. This research is important because it is the first study that explores how patients think about the decision of stopping cancer screening and how patients want to talk to their doctors about this issue. Understanding patient perspectives would help improve screening practices and better align recommendations and patient preference. (more…)
Author Interviews, JAMA, Nutrition, Stanford / 12.06.2017

MedicalResearch.com Interview with: Bradley P. Turnwald MS Stanford University, Department of Psychology Stanford, California MedicalResearch.com: What is the background for this study? Response: This study tested an intervention to encourage people to consume healthier foods. Encouraging healthy eating is difficult because many people think that healthy foods do not taste good, and most people prioritize taste over health when choosing what to eat. In fact, lab studies suggest that people rate foods as less tasty, less enjoyable, and less filling when they are labeled as healthy compared to when the same foods are not labeled as healthy. A recent study from the Stanford Mind & Body Lab published last month in Health Psychology showed that healthy foods are even described with less tasty, exciting, and indulgent descriptions compared to standard items on the menus of top-selling chain restaurants in America. This led us to ask the question, what if healthy foods were described with the tasty and indulgent descriptions that are typically reserved for the more classic, unhealthy foods? (more…)
Author Interviews, Depression, Pharmacology / 12.06.2017

MedicalResearch.com Interview with: Greta A Bushnell, MSPH Doctoral Candidate, Department of Epidemiology UNC, Gillings School of Global Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with depression may be co-prescribed a benzodiazepine at antidepressant initiation for a short period for a variety of reasons. Reasons include reducing concurrent anxiety and insomnia, reducing depression severity more quickly, and improved antidepressant continuation. However, there are concerns with benzodiazepines including dependency. As such, benzodiazepines are usually recommended for only short-term treatment. Prior to our study, little was known about a) how often new simultaneous antidepressant and benzodiazepine prescribing occurred among patients initiating antidepressant treatment for depression or b) whether new simultaneous users became long-term benzodiazepine users. In a large commercial insurance database, we identified adults aged 18-64 years with depression who initiated an antidepressant from 2001 to 2014. We found that 11% of adults simultaneously initiated benzodiazepine treatment, which increased from 6% in 2001 to a peak at 12% in 2012. We observed similar antidepressant treatment length at six months in simultaneous new users and among patients initiating antidepressants only. The majority of simultaneous new users had only one benzodiazepine prescription fill before benzodiazepine discontinuation; however, 12% were identified as long-term benzodiazepine users. (more…)
Author Interviews, Gender Differences / 12.06.2017

MedicalResearch.com Interview with: Olivia Choy Ph.D. candidate in Criminology Department of Criminology, University of Pennsylvania University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The higher rate of offending among males compared to females is a well-documented phenomenon. However, little is known about what accounts for this gender difference. As males have been found to have significantly lower heart rates than females and lower resting heart rates have been associated with higher levels of offending, we tested whether low heart rate may partly account for the gender gap in crime. Resting heart rate at age 11 accounted for 5.4% to 17.1% of the gender difference in crime at age 23. (more…)
Author Interviews, Boehringer Ingelheim, Cost of Health Care, Heart Disease / 12.06.2017

MedicalResearch.com Interview with: Sabine Luik, M.D. Senior vice president, Medicine & Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is the first real-world, matched head-to-head study comparing all cause healthcare costs and healthcare resource utilization (HCRU) among novel oral anticoagulants (NOACs). The study analyzed claims data from 70,898 newly-diagnosed NVAF patients who were newly treated with Pradaxa, rivaroxaban or apixaban. The analysis found that Pradaxa was associated with lower all-cause costs and HCRU compared to rivaroxaban. Compared to apixaban, Pradaxa was associated with similar all-cause costs and hospitalizations, but higher all-cause outpatient and pharmacy HCRU. (more…)
Author Interviews, Diabetes, Vegetarians, Weight Research / 12.06.2017

MedicalResearch.com Interview with: Hana Kahleova, MD, PhD Director of Clinical Research at Physicians Committee for Responsible Medicine Physicians Committee for Responsible Medicine Charles University in Prague MedicalResearch.com: What is the background for this study? What are the main findings? Response: The vegetarian diet was found to be almost twice as effective in reducing body weight, resulting in an average loss of 6.2kg compared to 3.2kg for the conventional diet. Using magnetic resonance imaging, we studied adipose tissue in the subjects’ thighs to see how the two different diets had affected subcutaneous, subfascial and intramuscular fat. We found that both diets caused a similar reduction in subcutaneous fat. However, subfascial fat was only reduced in response to the vegetarian diet, and intramuscular fat was more greatly reduced by the vegetarian diet. (more…)
Author Interviews, JAMA, Surgical Research / 12.06.2017

MedicalResearch.com Interview with: Virginia Sun, RN, PhD Assistant Professor Division of Nursing Research and Education Department of Population Sciences Cancer Control and Population Sciences Program City of Hope Duarte, CA 91010  MedicalResearch.com: What is the background for this study? Response: Surgery is one of the most effective and important treatment strategies for cancer. Surgical procedures are by definition invasive, and patients are at risk for unpleasant symptoms, impaired functional status, and poor quality of life. Traditionally, mortality has been the sole measure to assess the risk of most surgical procedures. However, as surgical mortality has sharply declined, focus has shifted toward other endpoints, including patient-centered outcomes. There are critical gaps to assessing and integrating patient-centered outcomes into the surgical oncology workflow. We conducted this proof-of-concept study to assess the feasibility and acceptability of a wireless monitoring approach for patient-centered outcomes before and after a major abdominal cancer surgery. (more…)
ASCO, Author Interviews, Cancer Research, Vaccine Studies / 12.06.2017

MedicalResearch.com Interview with: Chrisann Kyi, MD Fellow, Division of Hematology and Medical Oncology Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place, Box 1079 New York, NY 10029 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Mutation-derived tumor antigens (MTAs or neoantigens) arise as a direct result of somatic mutations, including nucleotide substitutions, insertions, and deletions that occur during carcinogenesis. These somatic variations can be characterized via genetic sequencing and used to identify MTAs with predictive computational genomics and algorithms. To be a good candidate for a cancer vaccine, a mutated cancer protein must be visible and recognized by T cells, the soldiers of the immune system, so that they in turn can be educated to seek out and destroy cancer cells that bear the mutated protein. At annual ASCO conference this year, we are presenting an exciting clinical trial investigating the feasibility, safety, and immunogenicity of a personalized MTA-based multi-peptide vaccine in the adjuvant treatment for multiple solid tumors. In this trial, the patient’s own tumor is used to manufacture a cancer vaccine according to the mutations in their individual tumor. This vaccine is then given back to the patient in the adjuvant setting. The clinical trial is currently open and accruing at Tisch Cancer Center at Mount Sinai Hospital, NY (more…)
Author Interviews, Outcomes & Safety / 11.06.2017

MedicalResearch.com Interview with: Antonio García-Romero IE University – IE Business School Madrid, SpainAntonio García-Romero IE University – IE Business School Madrid, Spain MedicalResearch.com: What is the background for this study? Response: There is an increasing need for new approaches capable of measuring the “real” effects of research on society. People are interested in knowing what benefits are obtained from scientific research. Our aim in this project was to develop a valid methodology capable of measuring the effects from scientific research on some healthcare outcomes such as the average length of stay in a hospital. Our central hypothesis is that the more research is carried out in hospitals, the more efficient the hospitals are regarding the length of stay (LOS). (more…)
Aging, Author Interviews, Geriatrics / 10.06.2017

MedicalResearch.com Interview with: Raya Elfadel Kheirbek, MD, MPH Geriatrician and Palliative Care Physician Washington DC VA Medical Center Associate Professor of Medicine George Washington University School of Medicine and Health Sciences MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the past decade, there has been a shift in the concept of successful aging from a focus on life span to health span. We all want to age gracefully “expecting” optimal health, quality of life and independence. Centenarians are living examples to the progress we have made in health care. They are the best example of successful aging since they have escaped, delayed or survived the major age-related diseases and have reached the extreme limit of human life. However, little is known about Veterans Centenarians’ incidence of chronic illness and its impact on survival. Utilizing the VA Corporate Data Warehouse (CDW), I worked with my colleagues’ researchers and identified 3,351 centenarians who were born between 1910 and 1915. The majority were white men who served in World War II and had no service related disability. The study found that 85 % of all the centenarians had no incidence of major chronic conditions between the ages of 80 and 99 years of age. The data demonstrate that Veteran centenarians tend to have a better health profile and their incidence of having one or more chronic illness is lower than in the general population. (more…)
Author Interviews, Diabetes / 10.06.2017

MedicalResearch.com Interview with: Katrina Donahue MD, MPH Professor, Director of Research, UNC Family Medicine. Co-Director, North Carolina Newtork Consortium (NCNC). Chapel Hill, NC MedicalResearch.com: What is the background for this study? Response: Type 2 diabetes is an epidemic affecting one in 11 people in the United States. For those treated with insulin, checking blood sugar with a finger stick at home is an accepted practice for monitoring the effects of insulin therapy. However, the majority of patients with type 2 diabetes are not treated with insulin. These patients, too, are often recommended glucose monitoring, despite an ongoing debate about its effectiveness in controlling diabetes or improving how patients feel. Currently, 75 percent of non-insulin treated type 2 diabetes patients perform regular blood glucose testing at home, generally at the recommendation of a provider. “The MONITOR Trial” is the first large pragmatic study examining glucose monitoring in the United States. (more…)
Addiction, Author Interviews, Cost of Health Care, Opiods, PLoS / 10.06.2017

MedicalResearch.com Interview with: A. Simon Pickard, PhD Professor, Dept of Pharmacy Systems, Outcomes and Policy University of Ilinois at Chicago College of Pharmacy MedicalResearch.com: What is the background for this study? What are the main findings? Response: The heroin epidemic, which has left virtually no part of American society unscathed, can be viewed as an illness.  Unlike some illnesses, however, it was largely manufactured by stakeholders in the healthcare system, wittingly or unwittingly. The main finding, that heroin addiction costs us just over $50 billion per year, is likely a conservative estimate. (more…)
ASCO, Author Interviews, Breast Cancer, Merck, NYU / 10.06.2017

MedicalResearch.com Interview with: Sylvia Adams, MD Associate Professor of Medicine Breast Cancer and Cancer Immunotherapy Programs NYU Langone Medical Center Cancer Institute/Clinical Cancer Center New York, NY 10016   MedicalResearch.com: What is the background for the Keynote-086 trial ? What are the main findings? Response: This study is the largest immunotherapy study to date presented in metastatic triple negative breast cancer. This phase 2 trial studied the efficacy and safety of pembrolizumab (P) as single agent in a very aggressive disease and had two cohorts, a cohort of previously untreated patients (Cohort B) and a cohort with patients who had received prior chemotherapy lines in the metastatic setting (Cohort A). The study showed that single agent pembrolizumab can elicit durable responses in a subset of patients. This was found regardless of tumoral PD-L1 expression but appeared to be much more frequent in women without prior chemotherapy treatments in the metastatic setting. Survival is especially promising for patients responding to therapy. (more…)
Author Interviews, Breast Cancer, JAMA, Surgical Research / 10.06.2017

MedicalResearch.com Interview with: Monica Morrow, MD, FACS Chief, Breast Service Department of Surgery Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan Kettering MedicalResearch.com: What is the background for this study? Response: Although we know that bigger surgery does not result in better patient outcomes in breast cancer, since 2005 rates of lumpectomy have been decreasing accompanied by an increase in bilateral mastectomy for unilateral cancer. High rates of second surgery after initial lumpectomy are one deterrent for patients. In 2013 the SSO and ASTRO developed an evidence based consensus guideline endorsing no ink on tumor as the standard negative margin width for women with stage 1 and 2 cancer having breast conserving surgery with whole breast irradiation. The purpose of our study was to examine time trends in the use of additional surgery after lumpectomy before and after guideline dissemination and to determine the impact of these trends on final rates of breast conservation. (more…)
Author Interviews, Gastrointestinal Disease, Pediatrics, Weight Research / 10.06.2017

MedicalResearch.com Interview with: Raylene Reimer, PhD, RD Professor, Faculty of Kinesiology University of Calgary Department of Biochemistry & Molecular Biology Cumming School of Medicine Full Scientist Alberta Children's Hospital Research Institute MedicalResearch.com: What is the background for this study? Response: The human gut microbiota is a complex and dynamic population of microorganisms that benefit the human host through a variety of microbial activities (e.g. production of vitamins, immune regulation, utilization of dietary fiber). Despite these benefits however, it is now recognized that disruption of the microbiota (dysbiosis) can upset homeostasis and contribute to diseases such as obesity and type 2 diabetes. Manipulation of the gut microbiota to prevent or treat chronic disease is now an area of intense scientific and clinical interest. Dietary prebiotics, such as inulin and oligofructose, are used selectively by host microorganisms to confer a health benefit. Prebiotics have previously been shown to reduce body fat, improve appetite control and reduce blood glucose in adults with overweight or obesity. (more…)
Author Interviews, Emory / 09.06.2017

MedicalResearch.com Interview with: Dr. Robert Liu, PhD Silvio O. Conte Center for Oxytocin and Social Cognition Center for Translational Social Neuroscience Department of Biology Graduate Program in Neuroscience Emory University, Atlanta, Georgia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study describes for the first time some of the novel brain mechanisms underlying how social relationships are formed.  In this case we studied the formation of a pair bond in voles.  Pair bonding in voles is not exactly the same as love in humans, but we believe that pair bonding in voles likely shares many of the underlying neural mechanisms as falling in love in humans, such as developing a rewarding feeling towards your partner. Basically, we discovered that rhythmic oscillations of groups of neurons in the prefrontal cortex, an area of the brain that is involved in decision making and executive function, can control the strength of oscillations at a different frequency in populations of neurons in the nucleus accumbens, an area that is involved in pleasure and reward, as well as addiction.  We show that the strength of that PFC-NAc control predicted how quickly animals would begin to show affectionate behavior, analogous to people who may fall in love quicker than others.  But the most intriguing thing was that when animals mated for the first time, the strength of the control of the reward system by the decision making circuit increased, and the greater the increase in that control, the faster the animal started huddling or showing affection toward its partner.  We think that this cortical control of the reward system allows for the neural encoding of the partner’s features (odors, sounds) to become stamped into the reward system, so that the partner becomes rewarding themselves.  Indeed in studies in humans, parts of the striatum, to which the nucleus accumbens belongs, become activated when men look at images of their lovers or when mothers look at images of babies. We not only observed that during pair bond formation the cortex controls rhythmic activity within the reward system, but we actually recreated that communication using a highly innovative technique that allows us to control neural activity using light.  We expressed a light sensitive protein in the cortical neurons that project to the reward system, and then light stimulated those projections in the reward system in animals at the same frequency as normally happens during mating, but in this case the animals were not allowed to mate. By simply recreating the neural oscillatory control of the cortex of the reward area when the female was near the male, we biased how affectionately she acted towards him. We think that the implications for this is not restricted to forming bonds or falling in love, but tells us something fundamental about how certain brain circuits communicate with each other to build social relationships, to make us feel pleasure from being with others that we like.  We believe that by understanding how social cues get instantiated into the brain’ reward system, we may ultimately be able to use this information to help people with impairments in the forming strong social relationships, such as in autism or schizophrenia. (more…)
Author Interviews, Autism, MRI / 09.06.2017

MedicalResearch.com Interview with: Joseph Piven, MD The Thomas E. Castelloe Distinguished Professor of Psychiatry UNC School of Medicine Director of the Carolina Institute for Developmental Disabilities Co-senior author of the study MedicalResearch.com: What is the background for this study? What are the main findings? Response: Babies with older siblings with autism are at an increased risk (20%) of getting autism over the general population (1%).  Infants who later are diagnosed with autism don’t have any of the stigmata of autism in the first year of life. The symptoms of autism unfold in the first and particularly in the second year of life and beyond. We have evidence to support the idea that behavioral symptoms of autism arise from changes in the brain that occur very early in life. So we have employed MRI and computer analyses to study those early brain changes and abnormalities in infancy to see if early brain changes at 6 months of age can predict whether babies at high-risk of developing autism will indeed develop the condition at age two. For this particular study, we used data from MRIs of six-month olds to show the pattern of synchronization or connection across brain regions throughout the brain and then predict which babies at high familial risk of developing autism would be most likely to be diagnosed with the condition at age two. (more…)