AACR, Author Interviews, Biomarkers, Chemotherapy, Colon Cancer, MD Anderson / 10.11.2015

[caption id="attachment_19099" align="alignleft" width="114"]Van K. Morris, M.D. Assistant Professor, GI Medical Oncology University of Texas – M.D. Anderson Cancer Center Houston, TX 77030 Dr. Morris[/caption] MedicalResearch.com Interview with: Van K. Morris,  M.D. Assistant Professor, GI Medical Oncology University of Texas – M.D. Anderson Cancer Center Houston, TX 77030  Medical Research: What is the background for this study? What are the main findings? Dr. Van K Morris: BRAF V600E mutations are associated with poor clinical outcomes for patients with metastatic colorectal cancer.  Patients were enrolled in a phase I clinical trial with the BRAF inhibitor vemurafenib, the anti-EGFR antibody cetuximab, and irinotecan.  Blood  samples were collected every two weeks with each dose, and plasma was analyzed for changes in the fraction of mutant BRAF V600E allele relative to wild-type BRAF allele with time.  Trends in circulating free DNA (cfDNA) changes were compared with radiographic changes by RECIST 1.1 criteria to examine this technique as a marker for response to therapy. For patients who had a response radiographically, drastic reductions in the BRAF V600E allele fraction were observed even after two weeks of starting therapy, well before the first restaging scan.  Patients who did not have responses radiographically had less  dramatic changes relative to baseline in the BRAF V600E allele fraction.  This technique analyzing cfDNA from plasma was validated using two different approaches – digital droplet PCR and next-generation sequencing by Guardant Health.  Sequencing of cfDNA was also compared in pretreatment and post-progression samples, and novel mutations in MEK1 and GNAS were observed uniquely in post-progression samples.
AHA Journals, Author Interviews, Duke, Education, Gender Differences, Heart Disease / 10.11.2015

[caption id="attachment_19201" align="alignleft" width="160"]Pamela S. Douglas, MD, MACC, FASE, FAHA Ursula Geller Professor of Research in Cardiovascular Disease Duke University School of Medicine Dr. Douglas[/caption] MedicalResearch.com Interview with: Pamela S. Douglas, MD, MACC, FASE, FAHA Ursula Geller Professor of Research in Cardiovascular Disease Duke University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Douglas: The impetus for our study was the concern that cardiology as a profession might be enhanced by greater diversity. By not attracting women in larger numbers (9% of FACCs are female), our fellowships have incomplete access to the talent pool of outstanding residents, and we do not have a diverse group of clinicians to care for our increasingly diverse patient population, or of researchers to explore potentially important health care disparities. Our findings were twofold: first, job descriptions for men and women cardiologists are dramatically different. Men are much more likely to do invasive procedures while women are more likely to see patients and perform imaging/noninvasive tests.  While there were slightly more women working part time than men this was still rare, and the difference in number of days worked was just 6, across an entire year. The second finding was that there was a significant difference in compensation. Unadjusted, this was over $110, 000 per year; after very robust adjustment using over 100  personal, practice, job description and productivity measures, the difference was $37, 000 per year, or over a million dollars across a career. A separate independent economic analysis of wage differentials yield a similar difference of $32,000 per year.
Author Interviews, Duke, JAMA, Pharmacology, Stroke / 10.11.2015

[caption id="attachment_19166" align="alignleft" width="137"]Ying Xian, PhD Assistant Professor of Medicine. Member in the Duke Clinical Research Institute Dr. Ying Xian[/caption] MedicalResearch.com Interview with: Ying Xian, PhD Assistant Professor of Medicine. Member in the Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Xian: Intravenous tissue plasminogen activator (tPA) is the only FDA approved medical therapy to reduce disability and improve outcomes for patients with acute ischemic stroke. But treatment with tPA also carries the risk of symptomatic intracranial hemorrhage (sICH), which is often fatal. Nearly half of ischemic stroke patients are taking antiplatelet drugs such as aspirin and/or clopidogrel prior to stroke. We found these patients had higher risk for sICH when treated with tPA. But the risk is relatively small. For every 147 patients on aspirin treated with tPA, only 1 more symptomatic intracranial hemorrhage as compared with those treated with tPA without prior antiplatelet therapy. The risk is slightly higher among those on dual antiplatelet therapy of aspirin and clopidogrel (number needed to harm 60). Despite the higher bleeding risk, patients treated with tPA on prior antiplatelet therapy appeared to have better functional outcomes in terms of ambulatory status and modified Rankin scale than those not on prior antiplatelet therapy. Therefore, overall the benefits of thrombolytic therapy may outweigh the risks.
AACR, Author Interviews, Cancer, Cancer Research, University Texas / 10.11.2015

MedicalResearch.com Interview with: Xifeng Wu, M.D., Ph.D, Professor, Epidemiology Stephanie Melkonian, Ph.D University of Texas M. D. Anderson Cancer Center Medical Research: What is the background for this study? What are the main findings? Response: This study examines dietary intake of meat-cooking mutagens and genetic risk factors associated with kidney cancer in a population of 659 kidney cancer patients and 699 matched healthy control subjects from the community. We calculated the intake of several cancer-causing carcinogens that are produced when certain types of meat are cooked over an open flame and at high temperatures resulting in the burning, smoking or charring of the meat (for example, during barbequing or pan-frying). We found that kidney cancer patients consumed more red and white meat when compared to the healthy individuals, and also had higher intake of these cancer-causing chemicals created through the meat cooking process. These results suggest that meat intake, and the way we cook our meat, may potentially be linked to risk of kidney cancer. Additionally, we found that individuals with certain genetic variants were more likely to be susceptible to the harmful effects of the cancer-causing mutagens created during the process of cooking meat.
Author Interviews, Duke, Heart Disease, Pharmacology / 10.11.2015

[caption id="attachment_19231" align="alignleft" width="200"]Lauren Cooper, MD Fellow in Cardiovascular Diseases Duke University Medical Center Duke Clinical Research Institute Dr. Cooper[/caption] MedicalResearch.com Interview with: Lauren Cooper, MD Fellow in Cardiovascular Diseases Duke University Medical Center Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Cooper: Heart failure guidelines recommend routine monitoring of serum potassium and renal function in patients treated with a mineralocorticoid receptor antagonist (MRA). Specific monitoring recommendations include: within 2-3 days of initiation of the drug, again at 7 days, monthly for at least 3 months, then every 3 months thereafter. However, no large studies had evaluated compliance with these safety recommendations in routine clinical practice. Using Medicare claims data from 2011, we evaluated monitoring of serum creatinine and potassium levels among patients with heart failure initiated on an MRA. After MRA initiation, rates of guideline-recommended laboratory monitoring of creatinine and potassium were low. Of 10,443 Medicare beneficiaries included in this study, 91.6% received pre-initiation testing; however, only 13.3% received appropriate testing in the first 10 days after drug initiation and 29.9% received appropriate testing in the first 3 months. Only 7.2% of patients received guideline-recommended laboratory monitoring both before and after MRA initiation. Chronic kidney disease was associated with a greater likelihood of appropriate testing (relative risk, 1.83; 95% CI, 1.58-2.13), as was concomitant diuretic use (relative risk, 1.78; 95% CI, 1.44-2.21).
Author Interviews, Brigham & Women's - Harvard, Cancer Research / 10.11.2015

Dr. Priscilla Kaliopi Brastianos MD Instructor, Medicine, Harvard Medical School Assistant Physician in Medicine Hematology/Oncology, Massachusetts General HospitalMedicalResearch.com Interview with: Dr. Priscilla Kaliopi Brastianos MD Instructor, Medicine, Harvard Medical School Assistant Physician in Medicine Hematology/Oncology, Massachusetts General Hospital Medical Research: What is the background for this study? What are the main findings? Response: Craniopharyngiomas are rare brain tumors that can cause serious problems because of their location near critical structures in the brain, such as optic and other cranial nerves, the pituitary gland and the hypothalamus. Not only does the growing tumor compromise neurological and hormonal functions by impinging on these structures, but treatment by surgical removal or radiation therapy can produce the same symptoms by damaging adjacent tissues. In addition, since the tumor adheres to these nearby critical structures, complete removal is difficult, which can lead rapid recurrence. Medical therapies have not been effective for craniopharyngiomas, namely because we did not understand the molecular underpinnings of these tumors. Last year, we performed genomic characterization of craniopharyngiomas, with the goal to identify potential therapeutic targets. We were surprised to find that nearly all papillary craniopharyngiomas have BRAF mutations, which are the same mutations that have been found in melanoma. We recently had the opportunity to translate our results to the clinic. A 38 year old patient presented to our institution, requiring 4 urgent neurosurgeries in 2 months for his papillary craniopharyngioma. When we presented a fifth time, we treated him with a therapy that targets his BRAF mutation. After just 4 days of therapy, his tumor had shrunk by nearly 25%. Similar to what is done in BRAF mutant melanoma, we added a MEK inhibitor to his treatment. By day 34 of therapy, his tumor was more than 80% smaller. We  also detected the BRAF mutation in this patient’s blood.
Author Interviews, Cancer Research, Endocrinology, Journal Clinical Oncology, Menopause, NIH / 07.11.2015

MedicalResearch.com Interview with: Elizabeth K. Cahoon, PhD Radiation Epidemiology Branch Division of Cancer Epidemiology and Genetics, National Cancer Institute National Institutes of Health Department of Health and Human Services Bethesda, MD Medical Research: What is the background for this study? What are the main findings? Dr. Cahoon: Although basal cell carcinoma (BCC) is the most common cancer in the United States, there is relatively little research on risk factors since few population-based cancer registries do not capture information on this malignancy. Sun exposure (in particular ultraviolet radiation) is the primary risk factor for basal cell carcinoma, but less is known about other factors that may affect this risk. A previous study found a relationship between menopausal hormone therapy (MHT) use and increased risk of BCC in a population of Danish women. In our study we looked to see if factors related to estrogen exposure from multiple sources was associated with basal cell carcinoma risk in a large, nationwide, prospective study. These included use of oral contraceptives or menopausal hormone therapy, but also reproductive factors (like age at menarche and menopause). We observed that women who experienced natural menopause later in life were more likely to develop basal cell carcinoma compared to women who had natural menopause at a younger age. In addition, women who reported using menopausal hormone therapy for one year or longer were more likely to develop basal cell carcinoma compared to women who did not report MHT use. Women who reported natural menopause and menopausal hormone therapy use for 10 or more years had the highest risk of basal cell carcinoma, compared to women with no menopausal hormone therapy use.
Author Interviews, Breast Cancer, Education, NYU/NYMC, Radiology / 06.11.2015

[caption id="attachment_19146" align="alignleft" width="200"]Jiyon Lee, M.D. Assistant Professor of Radiology, NYU School of Medicine NYU Cancer Institute, Breast Imaging Center New York, New York 10016 Dr. Lee[/caption] MedicalResearch.com Interview with: Jiyon Lee, M.D. Assistant Professor of Radiology, NYU School of Medicine NYU Cancer Institute, Breast Imaging Center New York, New York 10016 Medical Research: What is the background for this study? What are the main findings? Dr. Lee:   Even before the USPSTF changed their breast screening guidelines in 2009, I conducted community outreach to help educate others on my area of expertise, breast imaging and breast screening. I presented lay friendly, illustrated, and practical explanations in a structured talk, about the big picture and the salient details, in a way that I would want if I were not a breast radiologist. As is customary for such community outreach, we solicited feedback from attendees. It was gratifying to hear the positive responses. That they wished for such education for others served as a clarion call that is understandable. Education should be objective and noncoercive.  “Knowledge is power,” but only if complete and accurate. Breast cancer is still a common disease, we are all at least at average risk, and screening is still standard of care.  Much of the debate surrounding screening mammography centers on the age of onset of screening and the optimal screening interval. The USPSTF states that shared-decision making between women and their providers may occur, especially for women in 40-49 year group.  But the TF does not stipulate when or how or by whom this talk will ensue, and notice that their guidelines refer to film mammography, and “biennial” mammography. Since the time of this manuscript, the American Cancer Society issued new guidelines on 10/20/2015 that among its bullet points emphasized annual mammography for women 45-54 years and deemphasized clinical breast exam, while supporting option to start annually at age 40 with shared decision making to weigh what are referred to as “risks” and benefits. Although the fine print does reaffirm that annually starting at age 40 is the screening model that saves the most lives, the ACS is encouraging deliberate value judgment regarding “risks” and “harms.” Their fine print is also intimating that women 55 and over have nondense tissue and that their cancers are indolent. The ensued publicity and mixed messaging have caused another cycle of confusion regarding breast cancer screening. As the experts in this field of image-based screening, radiologists have opportunity to clarify and contextualize the issues and details of the screening discussion, and can do so with objectivity, respect for all sides of the debate, and compassion. All responsible ways to continually educate both women and all providers will enable both sides to engage in the discussion fairly. Because as we discourage paternalistic medicine and promote shared decision making, it’s not fair play if all responsible sides do not get fair say. Do realize that not all women see providers regularly, and depending on the medical subspeciality, not all providers are mentioning screening til women reach a certain age and may not relay importance of the physical exam components that complement imaging. This article specifically highlights how such direct and interactive public education can effect potential benefit in two ways.
  • First, directly reduce one of the core criticisms about screening: the “anxiety” that women may experience, which is heavily weighed as a “harm” of screening.  Most women do not experience high anxiety, and are glad to have a test that may help them. And education can help demystify much of the process and protocol, and explain up to what may be that patient’s next test results if she engages in screening at all. No one can tell that.
  • Two, education can directly increase one of the necessary components of shared decision making that is presumed in implementing breast screening: informing women. The pre- and post-lecture questionnaire, along with fact-based quiz questions, provided insight and enabled learning opportunity for the audience that are not usual for community outreach.  Education that keeps on going—and is shareable!-- after the lecture is done.
Author Interviews, Lifestyle & Health, NIH / 05.11.2015

[caption id="attachment_19130" align="alignleft" width="110"]Sarah K. Keadle, PhD, MPH Cancer Prevention Fellow Nutritional Epidemiology Branch Division of Cancer Epidemiology and Genetics National Cancer Institute Dr. Keadle[/caption] MedicalResearch.com Interview with: Sarah K. Keadle, PhD, MPH Cancer Prevention Fellow Nutritional Epidemiology Branch Division of Cancer Epidemiology and Genetics National Cancer Institute   Medical Research: What is the background for this study? What are the main findings? Dr. Keadle: Television viewing is extremely prevalent in the U.S. Ninety-two percent of Americans have a television at home and watching TV consumes more than half of their available leisure time, potentially displacing more physical activities. Previous studies have reported a relationship between TV viewing and increased risk of death from the two most common causes of death in the U.S., cancer and heart disease. In our study, we followed more than 221,000 healthy Americans aged 50-71 years old for 14 years to look at this relationship. We confirmed the association with increased risk of death from cancer and heart disease. In addition, we found that TV viewing was associated with an increased risk of six other causes of death, including diabetes, influenza/pneumonia, Parkinson’s disease, and liver disease. Also, compared to individuals who watched less than one hour per day, those who watched 3-4 hours of TV per day were 15% more likely to die from any cause, and individuals who watched seven or more hours of TV per day were 47% more likely to die over the study period.
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Immunotherapy, NEJM / 05.11.2015

[caption id="attachment_18967" align="alignleft" width="175"]Toni Choueiri, MD Clinical Director, Lank Center for Genitourinary Oncology Director, Kidney Cancer Center Senior Physician Dana Farber Cancer Institute Associate Professor of Medicine, Harvard Medical School Dr. Toni Choueiri[/caption] MedicalResearch.com Interview with: Toni Choueiri, MD Clinical Director, Lank Center for Genitourinary Oncology Director, Kidney Cancer Center Senior Physician Dana Farber Cancer Institute Associate Professor of Medicine Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Choueiri: In the METEOR trial, we aimed to compare cabozantinib, a novel VEGFR, MET, AXL inhibitor to everolimus, a standard 2nd line option in advanced RCC. There is an unmet in this setting. Cabozantinib resulted in a median PFS of 7.4 months compared to 3.8 months with everolimus. Responses also were 4-times higher with cabozantinib-treated patients. At the interim OS analysis, there was a strong trend favoring cabozantinib. 
Author Interviews, Cancer Research, JAMA, MD Anderson / 05.11.2015

[caption id="attachment_19067" align="alignleft" width="114"]William N. William Jr., MD Associate Professor Chief, Head and Neck Section Department of Thoracic / Head and Neck Medical Oncology The University of Texas M. D. Anderson Cancer Center Houston, TX Dr. William[/caption] MedicalResearch.com Interview with: William N. William Jr., MD Associate Professor Chief, Head and Neck Section Department of Thoracic / Head and Neck Medical Oncology The University of Texas M. D. Anderson Cancer Center Houston, TX Medical Research: What is the background for this study? What are the main findings? Dr. William: Oral pre-malignant lesions are often characterized as white and/or red patches in the mouth and are considered risk factors for oral cancer. This is why it might be best for people to go get oral cancer screening done if they suspect that there might be a problem. However, not all oral pre-malignant lesions will turn into cancer, but when this happens, surgery is usually recommended, many times leading to serious speech and swallowing dysfunction. Chemoprevention is the use of compounds to prevent cancers from happening before they occur. One of the greatest challenges in developing chemopreventive agents is to identify the population at highest cancer risk. The Erlotinib Prevention of Oral Cancer (EPOC) trial involved 379 patients at five sites across the country. All had premalignant lesions in their mouths. Following study enrollment, participants were evaluated for LOH, a chromosomal abnormality characterized by the loss of chromosomal regions, which include tumor suppressor genes. Patients who tested positive for LOH were considered to be at high risk for oral cancer and were randomized to receive either erlotinib (an EGFR inhibitor drug) or a placebo for one year. The study’s primary endpoint was to determine if fewer patients treated with erlotinib would develop oral cancer, compared to those that received placebo. The EPOC study demonstrated that LOH predicted a higher oral cancer risk. LOH-negative patients had a three-year cancer-free survival rate of 87 percent compared to 74 percent for the LOH-positive group. However, patients who took erlotinib showed no statistical difference in terms of cancer-free survival rates after three years: 74 percent for participants given erlotinib compared to 70 percent for those taking placebo. Patients with both LOH and EGFR copy number gains had the highest incidence of cancer, but still did not benefit from erlotinib.
Author Interviews, NYU/NYMC, Technology / 05.11.2015

MedicalResearch.com Interview with: Dustin T. Duncan, ScD Assistant Professor Department of Population Health and Dr. Paul Krebs PhD Assistant Professor in the Department of Population Health New York University School of Medicine  Medical Research: What is the background for this study? What are the main findings? Dr.  Krebs: Everyone seems to be talking about health apps, but there was no quality research on what was actually happening in the US with regard to these apps. Knowing why people use and don’t use health-related apps is critical for advancing this area of healthcare. In terms of main findings, we found that a little over half of Americans are using a health-related app, primarily in the domains of fitness and nutrition. We also found greater use among minority populations, younger persons, among people who were obese, and those with higher incomes. Surprisingly we found that about 40% of people would not pay anything for a health app. Hidden costs and difficulty of data entry were main reasons people stopped using them. Dr. Duncan: Little is know about health app use, which was surprising to us—especially because many people have smartphones so downloading a health app can easy. We wanted to understand the landscape of health app use and patterns in the US to ultimately improve the population’s health.
Author Interviews, Brigham & Women's - Harvard, Nutrition, Race/Ethnic Diversity / 04.11.2015

MedicalResearch.com Interview with: Daniel (Dong) Wang  Doctoral Student Departments of Nutrition and Epidemiology Harvard T. H. Chan School of Public Health Boston, MA 02115 Medical Research: What is the background for this study? What are the main findings? Response: Over the past more than one decade, many changes related to nutrition and food supply have happened and therefore influence individuals' dietary behaviors and ultmately dietary quality. Also, the changes in dietary quality may impact the disease burden, measured by avoided major chronic disease cases and premature deaths. Therefore, in this study, we were trying to understand 1) how the dietary quality in US population changed from 1999 to 2012, and 2) how changes in dietary quality over time impacted disease and premature death. The quality of the US diet, measured by the Alternate Healthy Eating Index, improved modestly from 39.9 to 48.2 from 1999 through 2012, but the dietary quality of US population remains far from optimal (the optimal score is 110). There is huge room existing for further improvements. We also found that even the modest improvements in dietary quality that we observed contributed to substantial reductions in disease burden, which is measured by avoided disease cases and premature deaths. We estimated that healthier eating habits cumulatively prevented 1.1 million premature deaths over the 14 years, and the difference in dietary quality between 1999 and 2012 resulted in 12.6% fewer type 2 diabetes cases, 8.6% fewer cardiovascular disease cases, and 1.3% fewer cancer cases. Among different key components of healthy diets, despite a large reduction in consumption of trans fat, as well as a relatively large reduction in sugary beverages, most key components of healthy diets showed only modest or no improvements. The improvement in dietary quality was greater among persons with higher socioeconomic status and healthier body weight. African Americans had the poorest dietary quality, which was accounted for by lower incomes and education. The gaps in dietary quality persisted or even widened from 1999 to 2012.
AHA Journals, Author Interviews, Duke, Outcomes & Safety, Stroke, Surgical Research / 04.11.2015

MedicalResearch.com Interview with: Soko Setoguchi-Iwata, M.D MPH Adjunct Associate Professor Department of Medicine Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting vs Carotid Endarterectomy in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians performing stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated  Carotid Artery Stenting proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with an mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations.  
Author Interviews, Nutrition, PLoS, University Texas, Weight Research / 04.11.2015

Dr. Marcia C. de Oliveira Otto MD PhD Division of Epidemiology, Human Genetics and Environmental Sciences The University of Texas Health Science Center School of Public Health, Houston, TexasMedicalResearch.com Interview with: Dr.  Marcia C. de Oliveira Otto MD PhD Assistant professor  Division of Epidemiology, Human Genetics and Environmental Sciences The University of Texas Health Science Center School of Public Health, Houston, Texas  Medical Research: What is the background for this study? What are the main findings?  Dr. Otto: Eat a variety of foods, or food diversity, is a long standing public health recommendation because it is thought to ensure adequate intake of essential nutrients, to prevent excessive intakes of less healthy nutrients such as refined sugars and salt, thus promoting good health. However there hasn’t been empiric evidence from populational studies testing this hypothesis. In our study, we characterized three metrics of diet diversity and evaluated their association with metabolic health using data from 6,814 participants in the Multi-Ethnic Study of Atherosclerosis, including whites, blacks, Hispanic-Americans, and Chinese-Americans in the United States, including the total count (number of different foods eaten in a week), evenness (the distribution of calories across different foods consumed), and dissimilarity (the differences in food attributes relevant to metabolic health, such as fiber, sodium or trans-fat content). We then evaluated how diet diversity was associated with change in waist circumference five years after the beginning of the study and with onset of Type 2 diabetes ten years later. We also examined the relationship between diet quality and the same metabolic outcomes. Diet quality was measured using established scores such as the Dietary Approaches to Stop Hypertension (DASH) and the Alterative Healthy Eating (AHEI) score. When evaluating both food count and evenness, we found no associations with either increase in waist circumference or incidence of diabetes. In other words, more diversity in the diet was not linked to better metabolic outcomes. Participants with greater food dissimilarity actually experienced more central weight gain, with a 120 percent greater increase in waist circumference than participants with lower food dissimilarity. Contrary to what we expected, our results showed that participants with greater diversity in their diets, as measured by dissimilarity, had worse diet quality. They were eating less healthy foods, such as fruits and vegetables, and more unhealthy foods, such as processed meats, desserts and soda. When evaluating diet quality, we found about a 25 percent lower risk of developing Type 2 diabetes after 10 years of follow up in participants with higher diet quality. There was no association between diet quality scores and change in waist circumference. 
Author Interviews, Cost of Health Care, JAMA, Pharmacology, Sloan Kettering / 04.11.2015

MedicalResearch.com Interview with: Dr. Elizabeth D. Kantor PhD MPH Assistant Attending Epidemiologist Memorial Sloan Kettering Cancer Center

Medical Research: What is the background for this study? What are the main findings? Dr. Kantor: We know that use of prescription drugs represents a major expenditure in the United States and research suggests that use of prescriptions has increased. However, much of what we know is derived from information on expenditures, is outdated, or is limited to certain populations, such as older adults or those with a given clinical condition. For example, a number of studies have looked at things like use of drugs used to control condition x among persons with condition x, but that doesn't tell us about use of that class of drugs in the population. It’s important that we continue to monitor use of prescription drugs in the population, as practice patterns are continually evolving as the population ages, the health needs of the population change, drugs enter/exit the market, scientific knowledge advances, and policies change. We therefore sought to create an updated comprehensive reference on prescription drug use among US adults using nationally representative data from the National Health And Nutrition Examination Survey, a continuous survey conducted by the Centers for Disease Control and Prevention. We examined trends in use of prescription drugs over 7 cycles, ranging from 1999-2000 to 2011-2012 (the sample size per cycle ranged from 4,861 to 6,212).Participants were asked about use of prescription medications over the prior 30 days, from which we were able to estimate the prevalence of use within each survey cycle. We then looked at trends in prescription drug use, both overall and within drug classes. In our study, we observed that use of any prescription medications increased over the study period, with 51% of adults reporting any prescription medication use in 1999-2000 and 59% reporting any use in 2011-2012. We also observed an increase in polypharmacy (or use of 5 or more prescription drugs) over the study period, with approximately 8% of adults reporting use of 5 or more drugs in 1999-2000, as compared to 15% in 2011-2012. Polypharmacy was much more common among older adults: 24% of adults ages 65 and older reported use of 5 or more drugs in 1999-2000 and 39% reported use of 5 or more drugs in 2011-2012. At first glance, one might take a look at these results and think that this is probably because the US population is aging and people tend to take more drugs as they age. But we found that the increase in overall prescription drug use and polypharmacy persisted even after accounting for the aging of the US population. This means that something else is driving the observed increase in use of prescription drugs. We also found that use of the majority of drug classes increased over the study period. For example, among commonly used drug classes, we observed marked increases in use of drugs taken to control high cholesterol, high blood pressure, and diabetes. We also observed marked increases in some less commonly used drug classes, such as muscle relaxants. Interestingly, if we look at the ten most commonly used drugs in 2011-2012, we can see that most are taken for conditions associated with cardiometabolic disease This raises the question of how much of this increase in prescription drug use may be attributable to overweight/obesity, as we know that the prevalence of obesity has increased among US adults.
Author Interviews, Brigham & Women's - Harvard, JAMA, McGill, Pharmacology / 04.11.2015

MedicalResearch.com Interview with: Tewodros Eguale, MD, PhD Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada Research Fellow in Medicine Brigham and Women's Hospital Medical Research: What is the background for this study? Dr. Eguale: Off-label prescribing is common and has been identified as a potentially important contributor to preventable adverse drug events (ADE). Significant deleterious effects were reported with off-label use of some drugs. Moreover, studies in children, where drugs are often used without sufficient scientific investigation, have shown that off-label uses increase the risk of ADE.  In adults, there has been no systematic investigation of the effects of off-label use in real world situation. The lack of knowledge is related to the methodological challenges of measuring off-label use and its effects; specifically the lack of link between prescribed drugs and their indication for use. The Medical Office of the XXI Century (MOXXI) electronic health record (EHR), developed by team of researchers at McGill University, facilitates the documentation of treatment indications, reasons for discontinuation of drug orders and adverse drug event. These new features provided the first opportunity to systematically monitor and evaluate off-label use and the occurrence of adverse drug events.  This study took advantage of the use of this new generation of software in a network of primary care practices to systematicaly evaluate the effect of off-label use on ADEs.
Author Interviews, Columbia, Compliance, HIV, JAMA, Pediatrics / 04.11.2015

[caption id="attachment_18947" align="alignleft" width="165"]Dr. Louise Kuhn PhD Professor, Epidemiology Sergievsky Center Columbia University Dr. Kuhn[/caption] MedicalResearch.com Interview with: Dr. Louise Kuhn PhD Professor, Epidemiology Sergievsky Center Columbia University  Medical Research: What is the background for this study? What are the main findings? Dr. Kuhn: Ritonavir-boosted lopinavir-based antiretroviral therapy is recommended as first-line treatment for HIV-infected infants and young children while efavirenz is recommended for adults and older children. There are several advantages of transitioning HIV-infected children to efavirenz-based treatment as they get older.  These advantages include the possibility of once-daily dosing, simplification of co-treatment for tuberculosis, avoidance of some metabolic toxicities, preservation of ritonavir-boosted lopinavir for second-line treatment, and alignment of adult and pediatric treatment regimens. However, there have been concerns about possible reduced viral efficacy of efavirenz-based treatment in children exposed to nevirapine for prevention of mother-to-child transmission.  This is because efavirenz and nevirapine are in the same drug class and the majority of children who become infected despite exposure to nevirapine used for prevention have mutations in their virus that usually predict resistance to this drug class. In this study, we randomized HIV-infected children to two different treatment strategies: In the control strategy they remained on their initial ritonavir-boosted lopinavir regimen; in the alternative strategy they transitioned to an efavirenz-based regimen.  All children had been exposed to nevirapine used (unsuccessfully) to prevent mother to child HIV transmission and were virologically-suppressed (HIV in blood < 50 copies/ml) at the time of enrollment into the study.  We observed excellent virological control in both groups with fewer than 3% of children having levels of HIV in their blood greater than 1000 copies/ml.  Sustained suppression of virus in blood below 50 copies/ml throughout follow-up was achieved in 82% of the children transitioned to efavirenz-based treatment compared to 72% of children remaining on the control treatment.
Author Interviews, Biomarkers, Brigham & Women's - Harvard, Cancer Research / 03.11.2015

[caption id="attachment_19018" align="alignleft" width="137"]Bakhos A. Tannous, Ph.D. Associate Professor of Neurology Harvard Medical School Director, Experimental Therapeutics and Molecular Imaging Lab Director, Interdepartmental Neuroscience Center Director, MGH Viral Vector Development Facility Massachusetts General Hospital Charlestown, MA 02129 Dr. Tannous[/caption] MedicalResearch.com Interview with: Bakhos A. Tannous, Ph.D Associate Professor of Neurology Harvard Medical School Director, Experimental Therapeutics and Molecular Imaging Lab Director, Interdepartmental Neuroscience Center Director, MGH Viral Vector Development Facility Massachusetts General Hospital Charlestown, MA 02129 Medical Research: What is the background for this study? What are the main findings? Dr. Tannous: In recent years, it has become apparent that, in addition to their role in promoting blood clotting, platelets take up protein and RNA molecules from tumors, possibly playing a role in tumor growth and metastasis. Working with our collaborators Dr. Thomas Wurdinger and Pieter Wesseling at the VU Medical Center, Amsterdam, the Netherlands, we found that the RNA profiles of tumor-educated platelets – those that have taken up molecules shed by tumors – can (1) distinguish healthy individuals and patients with six different types of cancer, (2) determine the location of the primary tumor and (3) identify tumors carrying mutations that can guide therapeutic decision making and personalized medicine.
Author Interviews, NYU/NYMC, Weight Research / 03.11.2015

[caption id="attachment_19026" align="alignleft" width="144"]Brian Elbel, PhD MPH Associate professor, Department of Population Health NYU Langone Medical Center and at NYU’s Wagner Graduate School of Public Service Dr. Brian Elbel[/caption] MedicalResearch.com Interview with: Brian Elbel, PhD MPH Associate professor, Department of Population Health NYU Langone Medical Center and at NYU’s Wagner Graduate School of Public Service  Medical Research: What is the background for this study? What are the main findings? Dr. Elbel: Since New York City implemented in 2008 its mandatory calorie counts in all chain restaurants, including in fast-food eateries, public health officials and the general public have wondered what impact it’s having on curbing the obesity epidemic gripping the nation and the city. An estimated third of adult Americans are obese (with a body mass index of 30 or more), and that number is expected to rise to 42 percent by 2030, among the highest of any country in the developed world. Our study looks at the effects of so-called calorie counts some six years out from when the law took effect. Between 2013 and 2014, a team of NYU Langone researchers analyzed the receipts of some 7,699 diners at fast-food restaurants in NYC and in nearby NJ cities to see if the menu labels reduced the overall number of calories that consumers of fast food order and presumably eat. Our research team compared calories consumed at fast-food eateries with and without calorie labels. Researchers found that the average number of calories bought by patrons at each sitting between 2013 and 2014 was statistically the same as those in a similar survey we conducted in 1,068 fast-food diners in 2008, when New York City initially imposed menu labeling. Diners were surveyed at major fast-food chains: McDonald’s, Burger King, KFC, and Wendy’s. Calorie counts in the 2013-2014 analysis averaged between 804 and 839 per meal at menu-labeled restaurants, and between 802 and 857 per meal at non-labeled eateries; whereas, they averaged 783 per meal for labeled restaurants and 756 per meal for non-labeled restaurants shortly after the policy was introduced. For the surveys, diners entering the fast-food restaurant were asked to return their itemized receipt to research assistants and answer some follow-up questions in person in exchange for two dollars. Our study suggests that menu labeling, in particular at fast-food restaurants, will not on its own lead to any lasting reductions in calories consumed.
Author Interviews, Emory, Flu - Influenza, Vaccine Studies / 02.11.2015

[caption id="attachment_18978" align="alignleft" width="142"]Saad Omer MBBS MPH PhD Associate Professor Emory Vaccine Center Associate Professor Global Health and Epidemiology Rollins School of Public Health Emory University Dr. Saad Omer[/caption] MedicalResearch.com Interview with: Saad Omer MBBS MPH PhD Associate Professor Emory Vaccine Center Associate Professor Global Health and Epidemiology Rollins School of Public Health Emory University MedicalResearch: Can you give us a little background on this study? Dr. Omer: My background is in global health, epidemiology and pediatrics and I have been fortunate to conduct field and clinical vaccine trials in a number of countries and with multiple infectious diseases including influenza, polio, measles and pneumococcal vaccines. We were familiar with the data on investigating the potential effects of statins on other infections i.e. sepsis and community acquire pneumonia including Dr. Vandermeer’s study in 2012 suggesting that “statin use may be associated with reduced mortality in patients hospitalized with influenza”. Statins have lipid-lowering effects but they also exhibit anti-inflammatory and immunomodulatory properties. For lack of a better image, I think of statins as acting like a ‘big hammer made of Jell-O’: they have a broad, small dampening effect on immune response (as opposed to a narrow or deep effect).
Antibiotic Resistance, Author Interviews, Dermatology, NYU/NYMC, Pharmacology / 30.10.2015

[caption id="attachment_18899" align="alignleft" width="185"]Arielle Nagler MD Instructor, Department of Ronald O. Perelman Department of Dermatology NYU Langone Medical Center Dr. Nagler[/caption] MedicalResearch.com Interview with: Arielle Nagler MD Instructor, Department of Ronald O. Perelman Department of Dermatology NYU Langone Medical Center Medical Research: What is the background for this study of acne patient who eventually require isotretinoin? Dr. Nagler: Isotretinoin is a highly effective medication for the treatment of severe acne. In fact, it is the only medication that has been shown to provide patients with a durable cure for acne. However, its use is limited by its known teratogenicity as well as controversies regarding its relationship with psychiatric disturbances and inflammatory bowel disease. For many patients, systemic antibiotics provide an effective treatment for inflammatory acne. However, antibiotics do not provide the long term clearance that isotretinoin provides. Moreover, antibiotics are getting increasing attention due to fears of emerging bacterial resistance. There has been a recent emphasis on limiting antibiotic use in acne. As a result, this study sought to understand antibiotic use patterns amongst patients who eventually received isotretinoin. 
Author Interviews, Nature, NYU/NYMC, Weight Research / 28.10.2015

[caption id="attachment_18828" align="alignleft" width="150"]Dr. Margaret E. Rice, PhD Professor, Department of Neuroscience and Physiology Neurosurgery NYU Langone Medical Center Dr. Margaret Rice[/caption] MedicalResearch.com Interview with: Dr. Margaret E. Rice, PhD Professor, Department of Neuroscience and Physiology Neurosurgery NYU Langone Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Rice: Insulin is released from the pancreas into the bloodstream in response to a rise in circulating glucose levels when we eat. In most cells in the body, including those of liver and muscle, insulin acts at insulin receptors to promote glucose transport and other metabolic functions. Insulin also enters the brain and acts at brain insulin receptors, particularly in the hypothalamus where insulin acts as a satiety signal to indicate that we are full and should stop eating. The rising incidence of obesity, in which circulating insulin levels are chronically elevated, suggests insulin may play a role in other brain regions, as well, including regions that regulate motivation and reward. Indeed, our new studies introduce a new role for insulin as a reward signal that acts in the dorsal striatum to enhance release of dopamine.  Dopamine is a key neurotransmitter in reward systems; most drugs of abuse enhance release of dopamine, which contributes to their addictive properties. We found that insulin, at levels found in the brain by the end of a meal, enhances dopamine release by activating insulin receptors on acetylcholine-containing striatal cells that boost dopamine release. Consistent with a role of insulin in signaling reward, companion behavioral studies in rodents indicate that insulin signaling in the striatum communicates the reward value of an ingested meal, and thereby influences food choices. These studies reveal the dual nature of insulin in the brain, which not only tells us when to stop eating, but also influences what we eat.
Author Interviews, Breast Cancer, NYU/NYMC, Surgical Research / 26.10.2015

Mihye Choi, M.D., F.A.C.S. Associate Professor of Surgery NYU Plastic Surgery NYU Langone Medical CenteMedicalResearch.com Interview with: Mihye Choi, M.D., F.A.C.S. Associate Professor of Surgery NYU Plastic Surgery NYU Langone Medical Center Medical Research: Would you tell us a little about yourself and your interests in plastic surgery? Dr. Choi: I wanted to be a surgeon first, then I fell in love with plastic surgery after seeing a cleft lip repair as a medical student.  It was amazing to watch the ingenuity of the design and the skills needed to repair a baby's face.  I felt that it was the highest gift a doctor can bestow, so that a child can go forward with life in confidence and all the promise that life holds.  After finishing plastic surgery training, I developed expertise in breast reconstruction over the years.  I feel breast reconstruction combines the science and art of surgery.
Author Interviews, Columbia, OBGYNE, Weight Research / 26.10.2015

Elizabeth M. Widen, PhD, RD Postdoctoral Fellow in the Department of Medicine, Institute of Human Nutrition & Department of Epidemiology Columbia University Mailman School of Public Health New York, NY 10032MedicalResearch.com Interview with: Elizabeth M. Widen, PhD, RD Postdoctoral Fellow in the Department of Medicine, Institute of Human Nutrition & Department of Epidemiology Columbia University Mailman School of Public Health New York, NY 10032 Medical Research: What is the background for this study? What are the main findings? Dr. Widen: The Columbia Center for Children’s Environmental Health Mothers and Newborns Study was started in 1998 and is based in Northern Manhattan and the South Bronx. Pregnant African American and Dominican mothers were enrolled from 1998 to 2006, and mothers and their children have been followed since this time. Pregnancy weight gain and maternal size and body fat was measured at seven years postpartum, allowing us to examine the role of nutrition in pregnancy on long-term maternal health. We found that high pregnancy weight gain, above the Institute of Medicine 2009 guidelines, was associated with long-term weight retention and higher body fat at seven years postpartum among women who began pregnancy with underweight, normal weight and modest overweight body mass index (BMI). These findings suggest that prepregnancy BMI and high pregnancy weight gain have long-term implications for maternal weight-related health, especially among mothers who begin pregnancy with lower prepregnancy BMI values.
Author Interviews, Cost of Health Care, Critical Care - Intensive Care - ICUs, Johns Hopkins / 26.10.2015

[caption id="attachment_18835" align="alignleft" width="160"]Joseph M Carrington DO, MHA Department of Medicine - PGY3 Johns Hopkins University/Sinai Hospital Dr. Carrington[/caption] MedicalResearch.com Interview with: Joseph M Carrington DO, MHA Department of Medicine - PGY3 Johns Hopkins University/Sinai Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Carrington: This study looked at a total of 886 patients at a community hospital. We were faced with the dilemma that our ICU beds were frequently over utilized with severely ill patients for whom our interventions had minimal impact. This prevented patients who were less ill from coming to the ICU who may have benefited from our services. We made a hospital wide culture change to lower ICU admission thresholds. Any patient felt to be "borderline" received an automatic ICU evaluation without any push-back. The result of these earlier interventions was a decrease in complications from patients decompensating in the ED and floors. In turn, the overall ICU length of stay, mortality, and ICU transfers all decreased. By decreasing these overall complications and mortality, our number of ICU over-utilizes decreased. This saved our hospital an annualized amount of over $2 million and freed up ICU beds and resources.
Author Interviews, Critical Care - Intensive Care - ICUs, Electronic Records, Infections, Mayo Clinic / 26.10.2015

[caption id="attachment_18793" align="alignleft" width="125"]Dr. Pablo Moreno Franco Assistant Professor of Medicine MAYO Clinic Dr. Franco[/caption] MedicalResearch.com Interview with: Dr. Pablo Moreno Franco MD Assistant Professor of Medicine MAYO Clinic Medical Research: What is the background for this study? What are the main findings? Dr. Pablo Franco: Early alerts and prompt management of patient with severe sepsis and septic shock (SS/S) starting in the emergency department (ED) have been shown to improve mortality and other pertinent outcomes. With this in mind, we formed a multidisciplinary sepsis and shock response team (SSRT) in September 2013. Automated electronic sniffer alerted ED providers for possible sepsis and when S/SS was identified, they were encouraged to activate SSRT. SSRT-Compliance-Study-Cohort Two blinded reviewers retrospectively abstracted data on clinical trajectory and outcomes of all patients with sepsis and SS/S admitted at a single academic medical center between September 2013 and September 2014. Given importance of timely recognition and interventions in S/SS, we specifically focused on 2 periods: 0-4 hours and 4-12 hours after hospital admission. Additionally, we compared the compliance to “standard of care” between the SSRT pre-implementation period and the study period. There were 167 patients admitted with sepsis, among which there were 3 SSRT activations and sepsis mortality was 3.6%. There were 176 patients with SS, SSRT was called in 42 (23%) and SS mortality was 8.5%. CCS was involved in 66 patients and mortality was 6.9% if SSRT was activated, versus 21.6% if SSRT was not activated. There were 76 patients with septic shock, SSRT was called in 44 (57%) and septic shock mortality was 25%. Critical Care Service (CCS) was involved in 68 patients and mortality rates with and without SSRT were 30.9% and 15.4%, respectively. The all-or-none compliance with applicable goals of resuscitation improved from the baseline 0% to over 50% at the study period end. Overall observed/expected sepsis mortality index improved from 1.38 pre-SSRT to 0.68 post-SSRT implementation.
Alcohol, Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology / 26.10.2015

[caption id="attachment_18787" align="alignleft" width="200"]Shaowei Wu, MD, PhD Department of Dermatology, Warren Alpert Medical School Brown University, Providence, Rhode Island Department of Dermatology Brigham and Women’s Hospital and Harvard Medical School Boston, Massachusetts Dr. Shaowei Wu[/caption] MedicalResearch.com Interview with: Shaowei Wu, MD, PhD Department of Dermatology, Warren Alpert Medical School Brown University, Providence, Rhode Island Department of Dermatology Brigham and Women’s Hospital and Harvard Medical School Boston, Massachusetts Medical Research: What is the background for this study? What are the main findings? Response: Basal cell carcinoma (BCC) of the skin is the most prevalent cancer in the US, and is responsible for substantial morbidity and billions of dollars of health care expenditures. Knowledge on the modifiable risk factors of BCC is required for targeted prevention of cancer incidence. Alcohol consumption is a well-known risk factor for human cancer and has been linked to a number of cancers, including breast, prostate, pancreatic, and colon cancers. Interestingly, a large epidemiological study has reported a positive association between alcohol consumption and increased prevalence of severe sunburn, an established skin cancer risk factor. It is hypothesized that metabolites of alcohol (e.g., acetaldehyde) can serve as photosensitizers and promote skin carcinogenicity in the presence of UV radiation. However, epidemiological evidence for the association between alcohol consumption and BCC risk has been limited and a few previous studies on this topic have yielded conflicting results. Therefore we conducted a comprehensive prospective study to investigate this question using data from three large cohorts including the Nurses’ Health Study (1984-2010), Nurses’ Health Study II (1989-2011), and Health Professionals Follow-up Study (1986-2010). We documented a total of 28,951 incident Basal cell carcinoma cases over the study follow-up. We found that increasing alcohol intake was associated with an increased Basal cell carcinoma risk in both women and men. In the combined analysis with all 3 cohorts, those who consumed 30 grams or more alcohol per day had a 22% higher risk of developing BCC when compared to nondrinkers. This increased risk was consistent in people with different levels of sun exposure. We also found that BCC risk was associated with alcohol intake levels more than a decade ago, suggesting that alcohol may have a lagged effect that can persist for a long-term period. Among the individual alcoholic beverages, white wine and liquor were positively associated with Basal cell carcinoma risk whereas red wine and beer were not associated with BCC risk. This difference may be due to some other chemicals accompanying alcohol in the specific beverages. For example, red wine contains higher amounts of phenolic compounds compared to white wine, and these compounds have antioxidant activities which may be beneficial for counteracting the potential carcinogenic properties of alcohol and its metabolites.
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