Author Interviews, Heart Disease, Statins / 26.12.2014

Beth Taylor, PhD Director of Exercise Physiology Research Department of Preventive Cardiology Hartford Hospital Hartford, CT 06102MedicalResearch.com Interview with: Beth Taylor, PhD Director of Exercise Physiology Research Department of Preventive Cardiology Hartford Hospital Hartford, CT 06102 Medical Research: What is the background for this study? Dr. Taylor:  Statins reduce incidence of cardiac events, and thus are extremely effective drugs. However, they may cause muscle side effects such as pain, weakness and soreness (i.e., statin myalgia) in up to 10% of patients. One potential mechanism underlying statin myalgia may be the depletion of Coenzyme Q10, a mitochondrial transport element used in energy production, as statin therapy produces a 30-50% reduction in intramuscular Coenzyme Q10. Seven previous studies to date have produced conflicting results, yet CoQ10 supplementation is used by many patients and recommended by many clinicians despite the absence of definitive results. The purpose of the present study was to assess the effect of CoQ10 on muscle pain, muscle strength and aerobic performance in confirmed myalgics (i.e., patients who tested positive for  myalgia during a randomized, double-blinded cross-over trial of statin therapy vs. placebo to confirm myalgia prior to CoQ10 treatment). Medical Research: What are the main findings? Dr. Taylor:  The first main finding was that after our randomized double-blind cross-over run-in phase, only 35.8% of patients experienced myalgia on simvastatin and did not experience it on placebo, what we term true or confirmed statin myalgia, and 17.5% of patients had no symptoms on simvastatin or placebo which could have been because the dose we selected was too low.  However, 29.2% experienced pain on placebo but not on simvastatin and 17.5% experienced pain on both simvastatin and placebo during the confirmation phase. Secondly, we found that Coenzyme Q10 supplementation had no effect on the incidence and severity of myalgia, time to onset of pain, muscle strength, or aerobic performance.  Serum levels of CoQ10 went up, suggesting dosing worked, and LDL-C went down similarly in both groups, suggesting the statin was not compromised. Therefore we did not find an observable effect of CoQ10 on any muscle outcome. Finally, there were no reductions from baseline in muscle strength or aerobic performance when statins were combined with placebo in our verified statin myalgics. This is notable because while there have been observational reports of decreased muscle strength and aerobic performance in statin myalgics, there have been few rigorous assessments of muscle strength and aerobic performance with statins and myalgia. In our previous study, the The Effect of STatins On Skeletal Muscle Performance (STOMP) trial , we randomized healthy, statin-naïve patients to atorvastatin 80 mg daily or placebo for 6 months, confirming myalgia via a challenge-dechallenge protocol. In that study, we also found no significant differences in the two groups  in muscle and exercise performance, and thus the present results confirm those findings. (more…)
Author Interviews, HIV, JAMA / 26.12.2014

Jared Baeten, MD PhD Professor, Departments of Global Health and Medicine Adjunct Professor, Department of Epidemiology University of Washington Seattle, WA 98104MedicalResearch.com Interview with: Jared Baeten, MD PhD Professor, Departments of Global Health and Medicine Adjunct Professor, Department of Epidemiology University of Washington Seattle, WA 98104 Medical Research: What is the background for this study? What are the main findings? Dr. Baeten: The medication tenofovir disoproxil fumarate is used widely for the treatment of HIV-1 infection and, more recently, as pre-exposure prophylaxis (PrEP) to protect against HIV-1 infection for at-risk HIV-1 uninfected persons.  Its use has been associated with declines in the estimated glomerular filtration rate (eGFR) when used as part of antiretroviral treatment by HIV-1 infected persons, but limited data are available for risk when used as PrEP for HIV-1 prevention. Using data from the largest randomized, placebo-controlled trial of PrEP, among heterosexual women and men in Africa, eGFR changes were assessed during prospective follow-up in those receiving pre-exposure prophylaxis and compared to those receiving placebo.  PrEP use resulted in a small (-1.59 mL/min/1.73m2, 95% CI -2.44, -0.74) but statistically significant decline in eGFR that was non-progressive over a median of 18 months and a maximum of 36 months of follow-up.  PrEP use was not accompanied by a substantial increase in the risk of clinically relevant (≥25%) eGFR decline. (more…)
Author Interviews, Heart Disease, NYU / 26.12.2014

Dr. Glenn I. Fishman MD Professor; William Goldring Professor of Medicine Vice Chair Research Dept of Medicine Director of the Leon H. Charney Division of Cardiology NYU LangoneMedicalResearch.com Interview with: Dr. Glenn I. Fishman MD Professor; William Goldring Professor of Medicine Vice Chair Research Dept of Medicine Director of the Leon H. Charney Division of Cardiology NYU Langone Medical Research: What is the background for this study? What are the main findings? Dr. Fishman: Sudden cardiac arrest (SCA) due to life-threatening ventricular arrhythmias is one of the leading causes of death in the US. Conditions that predispose to SCA can be acquired, as in atherosclerotic coronary artery disease, or inherited in the form of mutated cardiac ion channels, i.e. ion channelopathies. Mutations in the SCN5A cardiac sodium channel gene have been linked to progressive cardiac conduction disorders as well as atrial and ventricular arrhythmias. Understanding the mechanistic basis for lethal arrhythmias in cardiac sodium channelopathy patients has been limited in part due to the lack of adequate model systems that replicate human physiology. To address this limitation, we have developed the first genetically modified porcine model of an inherited channelopathy. A mutation in the SCN5A gene first identified in a child with the arrhythmic condition Brugada syndrome was introduced into the pig genome. Mutant pig hearts displayed conduction abnormalities and ventricular fibrillation bearing striking resemblance to the human condition. (more…)
Author Interviews, Case Western, Nature, Neurological Disorders / 26.12.2014

Bradley T. Lang, PhD Researcher, Jerry Silver Lab Department of Neurosciences Case Western Reserve University School of MedicineMedicalResearch.com Interview with: Bradley T. Lang, PhD Researcher, Jerry Silver Lab Department of Neurosciences Case Western Reserve University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Lang: In the late 1980’s, Jerry Silver, PhD, discovered the presence of chondroitin sulfate proteoglycans in the developing nervous system, which form barriers to prevent aberrant growth. He has been building on this finding for more than 30 years, attempting to understand why the adult spinal cord is incapable of regenerating, or why axons don’t grow where they don’t. He has found that the glial scar, which surrounds the site of neural trauma, is incredibly rich in proteoglycans, which prevent regeneration in the spinal cord. In 2009 we collaborated with a group at Harvard to discover the very first receptor for chondroitin sulfate proteoglycans, protein tyrosine phosphatase-sigma, or PTPsigma. Medical Research: What are the main findings? Dr. Lang: The findings in this paper are twofold. We first describe a novel mechanism of regeneration failure, where regenerating axons become stabilized within a gradient of chondroitin sulfate proteoglycan, completely preventing motility. This finding helps explain why axons persist in the vicinity of the glial scar after injury indefinitely, with little to no regeneration potential—they are simply embedded within the scar. We were able to model this interaction in a petri dish to screen for drugs that were capable of promoting motility. The second finding in the manuscript is the discovery and characterization of a novel peptide therapeutic that binds to the receptor for chondroitin sulfate proteoglycans and releases inhibition. Most importantly, this drug was given systemically, similar to a daily insulin injection, avoiding complications due to direct nervous system infusion/injection. After several weeks of treatment (which began 1 day after injury), rats with severe spinal cord injury regained coordinated locomotion, bladder control, and/or balance. In total, 21/26 treated animals regained some function. (more…)
Author Interviews, Education, Stroke / 26.12.2014

dr-gustavo-saposnikMedicalResearch.com Interview with: Gustavo Saposnik, MD, MSc., FAHA, FRCPC Director, Stroke Outcomes Research Center Co-Director, Stroke Program - Research & Innovation Associate Professor & Clinician Scientist Departments of Medicine (Neurology) and Health Policy, Management and Evaluation (HPME) St. Michael’s Hospital University of Toronto Medical Research: What is the background for this study? What are the main findings? Dr. Saposnik: There is some controversy around worse outcomes at the beginning of academic year. Physicians recently graduated from medical schools begin their training and assume responsibilities for patient care in teaching hospitals, usually bearing the first-line duty for managing patients. Consequently, less experienced staff having new roles may influence access to care and contribute to adverse outcomes in patients managed at the beginning of academic year - the so-called “July Effect”. for example, increase of medication errors and in-hospital mortality in July has been reported from teaching hospitals. In our large cohort study, comprising 10,319 stroke patients, 882 (8.5%) were admitted in July. Those patients were 28% less likely to receive thrombolysis (clot-buster treatment) (12% vs. 16%; odds ratio (OR), 0.72; 95% confidence interval (CI), 0.59-0.89) and 22% less likely to receive stroke unit care (62% vs. 68%; 0.78; 0.68-0.90). July admissions were not associated with either of higher death at 30 days (adjusted OR, 95% CI; 0.88, 0.74-1.03) or poor functional outcome (0.92, 0.74-1.14). Results remained consistent in the sensitivity analysis by including both July and August as part of the ‘July effect’. (more…)
Author Interviews, Genetic Research, Neurological Disorders, PNAS, Scripps / 26.12.2014

Elizabeth A. Thomas, Ph.D. Associate Professor Department of Molecular and Cellular Neuroscience The Scripps Research InstituteMedicalResearch.com Interview with: Elizabeth A. Thomas, Ph.D. Associate Professor Department of Molecular and Cellular Neuroscience The Scripps Research Institute   Medical Research: What is the background for this study? What are the main findings? Response: Increasing evidence has demonstrated that epigenetic factors can profoundly influence gene expression, and in turn, influence resistance or susceptibility to disease.  Epigenetic drugs, such as histone deacetylase (HDAC) inhibitors, are finding their way into clinical practice, and are being proposed for therapeutic use in several neurological disorders.  Our previous studies have shown that selective HDAC inhibitors can cause beneficial effects in mouse models of Huntington’s disease, improving symptoms, and reducing severity of the disease.  Our current studies show that one such compound can alter DNA methylation, an epigenetic mark that can be inherited, leading to changes in gene expression that are seen in the parent mouse exposed directly to the drug, as well as in offspring from the drug-treated male mice.  Concurrent with these changes, we observed that offspring from drug-treated males shown improved disease symptoms, showing a delay in disease onset and a reduction of motor and cognitive symptoms that included improved performance in tests of balance, speed and memory. These finding have significant implications for human health as they enforce the concept that ancestral drug exposure may be a major molecular factor that can affect disease outcome in a subsequent generation.  One exciting aspect of our study is that the parental drug treatment made the offspring better, not worse, like other compounds known to cause transgenerational effects. (more…)
Author Interviews, Depression, Weight Research / 26.12.2014

MedicalResearch.com Interview with: Xiaoling Xiang School of Social Work, University of Illinois at Urbana-Champaign Urbana, IL 61801 Medical Research: What is the background for this study? What are the main findings? Response: The adverse health consequences of obesity have been well documented, but the psychological risks of obesity are less clear. The study examined the long-term impact of obesity on the onset of depression in a sample of middle-aged and older adults who were initially free of clinically relevant depressive symptoms. We found that being overweight or obese significantly predicted onset of clinically relevant depressive symptoms during the 16 years of follow-up. Unhealthy weight appeared to have a stronger, adverse impact on depressive symptoms among females and non-Hispanic whites compared with their male and ethnic minority counterparts. (more…)
Author Interviews, JAMA, Obstructive Sleep Apnea, Pediatrics, University Texas, UT Southwestern / 26.12.2014

Ron B. Mitchell, MD Professor of Otolaryngology and Pediatrics William Beckner Distinguished Chair in Otolaryngology Chief of Pediatric Otolaryngology UT Southwestern and Children's Medical Center Dallas ENT Clinic Dallas, TX 75207MedicalResearch.com Interview with: Ron B. Mitchell, MD Professor of Otolaryngology and Pediatrics William Beckner Distinguished Chair in Otolaryngology Chief of Pediatric Otolaryngology UT Southwestern and Children's Medical Center Dallas ENT Clinic Dallas, TX 75207 Medical Research: What is the background for this study? What are the main findings? Dr. Mitchell: The “gold standard” for the diagnosis of and quantification of obstructive sleep apnea (OSA) is polysomnography (PSG or a ‘sleep study’). However, the majorities of T&A procedures are done without PSG and are based on a clinical diagnosis. This is because PSG is expensive, requires overnight observation and is often unavailable. It is important to diagnose and quantify OSA as it allows for surgical planning and predicts the need and type of treatment after surgery. We used data from the Childhood Adenotonsillectomy (CHAT) study; a large multicenter trial (RCT), to look at the ability of clinical parameters to predict the severity of obstructive sleep apnea in children scheduled for a T&A. The main findings of the study are that certain clinical parameters such as obesity and African American race as well as high scores on certain validated questionnaires (such as the pediatric sleep questionnaire- PSQ) are associated, but cannot predict OSA severity. PSG remains the only way to measure objectively the severity of OSA. (more…)
Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, Weight Research / 26.12.2014

Rania Mekary, MS, Ph.D. Harvard School of Public Health Nutrition Department Boston, Ma 02115MedicalResearch.com Interview with: Rania Mekary, MS, Ph.D. Harvard School of Public Health Nutrition Department Boston, Ma 02115   Medical Research: What is the background for this study? What are the main findings? Dr. Mekar: Findings on weight training and waist circumference (WC) change have been controversial.  Moreover, a lot of people focus on aerobic and only aerobic workout... They are not to be blamed because aerobic workout (e.g. jogging) relies mostly on fat as a source of energy while anaerobic workout (e.g. resistance) relies mostly on carbohydrates. Our study, however, showed that resistance training over the long-term was the most inversely associated with waistline change (aka abdominal fat), even more than aerobic exercise. We also justified physiologically why it is the case... It has to do with the greater Excess Post-exercise Oxygen Consumption (EPOC) as compared with aerobic training and also to the muscle adaptation and its increase in mitochondria which leads to more lipid oxidation upon engaging in anaerobic workout over the long-term. (more…)
Author Interviews, Blood Pressure - Hypertension, Stroke / 24.12.2014

Dr. Johan Sundström MD PhD Department of Medical Sciences & Uppsala Clinical Research Center, Uppsala University Uppsala, Sweden.MedicalResearch.com Interview with: Dr. Johan Sundström MD PhD Department of Medical Sciences & Uppsala Clinical Research Center Uppsala University Uppsala, Sweden.   Medical Research: What is the background for this study? What are the main findings? Dr. Sundström: High blood pressure is the most important risk factor for premature death globally. The number of people with hypertension is increasing, with one billion people currently affected worldwide. Most of these have mild hypertension (a systolic blood pressure of 140 to 159 mm Hg and/or a diastolic blood pressure of 90 to 99 mm Hg) and no previous cardiovascular disease. The optimal management of this large group is uncertain, as no single trial of blood pressure lowering has provided clear evidence of treatment benefits for such persons. In this systematic review and meta-analysis of 13 randomized controlled trials including more than 15000 people with mild hypertension and without previous known cardiovascular disease, blood pressure-lowering drug therapy decreased strokes by 28%, cardiovascular deaths by 25%, and total deaths by 22%. Achieved blood pressure reduction and numbers of events were small. (more…)
Author Interviews, Emergency Care, Radiology / 24.12.2014

Ania Z. Kielar, MD, FRCPC Department of Radiology at the University of Ottawa The Ottawa Hospital, Ottawa, Ontario,CanadaMedicalResearch.com Interview with: Ania Z. Kielar, MD, FRCPC Department of Radiology at the University of Ottawa The Ottawa Hospital, Ottawa, Ontario,Canada Medical Research: What is the background for this study? What are the main findings? Dr. Kielar: One of the goals of imaging is to provide homogeneous and consistent, high-quality care for patients using available equipment.  In our hospital system, we had two separate hospitals that merged to form one teaching centre over 15 years ago.  Most processes and protocols are same between the two hospital sites as a result of having the same administration and the same University affiliation. Also,  the same residents and staff  rotate through the emergency departments and radiology departments at both hospitals.  One variable that persists is the location of the CT scanner.  At one center a space was created to place a CT scanner in the Emergency Department. At the other site, the CT scanner is in the radiology department.  For non-trauma cases, we wanted to see if the difference in distance of the scanner with respect to  the emergency department location, has a role in the time required to obtain CT scan from the time it is requested ,as well as the time to final patient disposition. We defined final patient disposition to include admission, subspecialty consultation or discharge home. Medical Research: What are the main findings? Dr. Kielar:  We found that there was a statistically significant difference in the time between requested CT and time to completion of the CT between the two hospital sites. It was faster when the CT scanner was located in the emergency department.  This was in the range of 16 minutes ,which is longer than simply the time required to walk over (and back) to the the CT scanner from the emergency department. We also found a statistically significant difference in the time of the final patient disposition.  Of note, there was no statistically significant difference noted in the time to obtain a CT scan as well as the preliminary radiology interpretation for patients with hyperacute conditions such as suspected abdominal aortic aneurysm rupture, regardless of the location of the CT scanner with respect to the ED. (more…)
Author Interviews, Cost of Health Care, JAMA, Pediatrics / 24.12.2014

Dr. Ricardo Mosquera MD Assistant professor of Pediatrics at The University of Texas Health Science Center at Houston Medical School Clinic Director, UT Physicians, of the UTHealth Medical School.MedicalResearch.com Interview with: Dr. Ricardo Mosquera MD Assistant professor of Pediatrics at The University of Texas Health Science Center at Houston Medical School Clinic Director, UT Physicians, of the UTHealth Medical School. Medical Research: What is the background for this study? What are the main findings? Dr. Mosquera: There is not strong scientific evidence to support the use of medical homes.  Medical homes have not been demonstrated to decrease adverse outcomes or costs in children. Such benefits are most likely for high-risk children with chronic illness.  We conducted a rigorous and well designed, randomized controlled trial to determine if an enhanced medical home providing comprehensive care decreases serious illness  (death, prolonged hospitalization>7 days, or intensive care unit admissions) and/or cost among high-risk chronically ill children. An enhanced medical home decreased both adverse outcomes (decreased serious illness, hospitalizations, PICU admissions, and serious illness by ~50%) and cost (~$10.000 less per child/year). (more…)
Author Interviews / 24.12.2014

dr-justus-verhagenMedicalResearch.com Interview with: Justus V. Verhagen, Ph.D. Associate Fellow, The John B. Pierce Laboratory Associate Professor, Dept. Neurobiology, Yale School Of Medicine New Haven, CT 06519 Medical Research: What is the background for this study? Dr. Verhagen: The study explores how the part of the brain that encodes odors (the Olfactory Bulb, OB) works. It is much studied, but much remains to be learned about the Olfactory Bulb. It used to be thought that odors were encoded by spatial patterns of activity across the Olfactory Bulb alone. Due to advances in the resolution in imaging, it has become clear that odor coding is a highly dynamic process. We learned that after each sniff a pattern of activity evolves across the Olfactory Bulb, some areas activating sooner, some later. This suggested that the odor code is a spatial AND a temporal map, in other words, more like playing a brief movie than showing a brief picture after each sniff. We tested whether this was true by using a relatively new method called “Optogenetics”, which allows us to accurately control the activity across the Olfactory Bulb. (more…)
Accidents & Violence, Author Interviews / 23.12.2014

Dr. Anne McCartt PhD Senior Vice President, Research Insurance Institute for Highway Safety Arlington, VirginiaMedicalResearch.com Interview with: Dr. Anne McCartt PhD Senior Vice President, Research Insurance Institute for Highway Safety Arlington, Virginia Medical Research: What is the background for this study? What are the main findings? Dr. McCartt: Motor vehicle crashes are a significant public health problem in the U.S., and that’s especially true for teenagers. Teen drivers have crash rates three times those of drivers 20 and older per mile driven. Immaturity leads to speeding and other risky habits, and inexperience means teens often don’t recognize or know how to respond to hazards. The type of vehicle a teenager drives has a  big effect on the degree of risk. Nevertheless, the main finding of our study is that many teenagers are driving – and dying in – the least protective types of vehicles. Nearly 30 percent of drivers ages 15-17 who died in highway crashes during 2008-12 were driving mini or small cars. Eight-two percent of the teenagers were driving vehicles that were at least 6 years old, and nearly half were driving vehicles that were at least 11 years old. Small cars are problem because they don’t afford as much crash protection as bigger, heavier vehicles. Older vehicles are less likely to have the best crash test ratings, and usually lack electronic stability control (ESC) or side airbags as standard features, despite the proven effectiveness of these technologies. Parents are obviously concerned about safety. In a separate survey we found that safety ranked highest among the reasons for choosing a particular vehicle. Most parents knew that a midsize or larger vehicle was safer than a small one, but their knowledge about which safety features to seek out wasn’t very current. When asked what safety features they insisted on for their teen driver, people most frequently mentioned frontal airbags and safety belts. Only 5 percent of respondents mentioned ESC. (more…)
Alcohol, Author Interviews, Insomnia / 23.12.2014

Michael Nadorff, PhD, Assistant professor Mississippi State University Starkville, Miss.MedicalResearch.com Interview with: Michael Nadorff, PhD, Assistant professor Mississippi State University Starkville, Miss. Medical Research: What is the background for this study? What are the main findings? Dr. Nadorff: A growing literature has found that insomnia symptoms are associated with suicidal behavior, and several studies suggest that this relation may be independent of several different forms of psychopathology.  However, little research has examined the role sleep disorders, such as insomnia, play in explaining why known risk factors, such as alcohol use, are associated with suicidal behavior.  In our study, we examined whether insomnia symptoms explained a significant portion of the relation between alcohol symptoms and suicide risk.  We found that for both men and women insomnia symptoms explained a significant amount of the variance in the relation between alcohol use and suicide risk. (more…)
Author Interviews, Infections, Pediatrics / 23.12.2014

MedicalResearch.com Interview with: Femi Oshin Consultant in Communicable Disease Control Devon, Cornwall & Somerset PHE Centre and Dan Murphy Cornwall & Isles of Scilly Health Protection Team, Cornwall, UK Medical Research: What is the background for this study? What are the main findings? Response: Salmonella disease are significant infections, particularly so in children. Ownership of reptiles kept as pets has risen sharply in recent years, as has Salmonella infections in children. Our study found children living in homes with a reptile as a pet are more likely to require hospitalisation from Salmonella infection, and the risk appears to increase with decreasing age of the child. (more…)
Author Interviews, Herpes Viruses / 23.12.2014

MedicalResearch.com Interview with: Professors Lynda A. Morrison, Ph.D. and John E. Tavis, Ph.D. Dept. of Molecular Microbiology and Immunology Saint Louis University School of Medicine St. Louis, MO 63104 Medical Research: What is the background for this study? What are the main findings? Response: A number of viruses use enzymes in the nucleotidyl transferase superfamily (NTS) to carry out their genome replication. These enzymes include the RNaseH and integrase of HIV and the RNaseH of hepatitis B virus (HBV). Herpesviruses also encode proteins with functions that are consistent with NTS enzymes. We therefore tested compounds known or suspected to inhibit the HBV RNaseH for their capacity to reduce herpes simplex virus (HSV)-1 and HSV-2 in cell culture assays. We found that certain compounds from several different chemical families could inhibit HSV replication up to 1 million-fold, and were effective down to concentrations that are already in the same range as existing anti-herpesvirus drugs. Many of the same compounds that inhibited HSV-1 and HSV-2 also inhibited another human herpesvirus, cytomegalovirus. Importantly, we showed that these new inhibitory compounds have a different mechanism of action than acyclovir, a nucleoside analog that is the standard of care. In addition, the new compounds we identified could inhibit the replication of acyclovir-resistant HSV-1 and HSV-2. (more…)
Author Interviews, Autism, Toxin Research / 23.12.2014

MedicalResearch.com Interview with: Raanan Raz, PhD Visiting Scientist Harvard School of Public Health Medical Research: What is the background for this study? What are the main findings? Dr. Raz: Air pollution contains various toxicants that have been found to be associated with neurotoxicity and adverse effects on the fetus in utero. Several studies have explored associations of air pollution with autism spectrum disorders (ASD). These studies suggest increased chances of having a child with autism spectrum disorders with higher exposures to diesel particulate matter (PM), criteria pollutants and some organic materials as well as closer proximity to a freeway. (more…)
Author Interviews, CDC, HPV, OBGYNE, Vaccine Studies / 22.12.2014

dr-pedro-moroMedicalResearch.com Interview with: Pedro Moro MD MPH Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention Medical Research: What is the background for this study? What are the main findings? Dr. Moro: Gardasil® is a human papillomavirus (HPV) vaccine recommended for all girls and boys at age 11 or 12, and teens and young adults who did not get the vaccine when they were younger. Because there is limited safety data available on use of the vaccine during pregnancy, it is not currently recommended for pregnant women. However, some pregnant women will inadvertently receive Gardasil® because they do not yet know that they are pregnant at the time of vaccination. The study reviewed non-manufacturer reports to the Vaccine Adverse Event Reporting System (VAERS) about pregnant women who received Gardasil®. VAERS is a national vaccine safety surveillance program co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts reports of health problems that occur after any US-licensed vaccine (these are called adverse events). VAERS may also accept reports not describing any health problem but vaccination errors (for example, administration of a vaccine not recommended to a particular group of people like pregnant women). VAERS is an early-warning system and cannot generally assess if a vaccine caused an adverse event. After reviewing all non-manufacturer reports of Gardasil vaccination during pregnancy, this study found no unexpected patterns of safety issues for pregnant woman who received Gardasil®, or for their babies. This finding is reassuring and reconfirms the safety of this vaccine for pregnant women, as was previously reported by the pregnancy registry maintained by Gardasil®’s manufacturer. (more…)
Author Interviews / 22.12.2014

Turhan Canli, Ph.D. Associate Professor, Psychology and Radiology Director, SCAN (Social, Cognitive, and Affective Neuroscience) Center Senior Fellow, Center for Medical Humanities, Compassionate Care, and Bioethics Stony Brook University Stony Brook, NY 11794MedicalResearch.com Interview with: Turhan Canli, Ph.D. Associate Professor, Psychology and Radiology Director, SCAN (Social, Cognitive, and Affective Neuroscience) Center Senior Fellow, Center for Medical Humanities, Compassionate Care, and Bioethics Stony Brook University Stony Brook, NY 11794 Medical Research: What is the background for this study? What are the main findings? Response: I was struck by two aspects of major depression treatment. First, that today's drug treatments are not much different from those used decades ago, with no real progress in treatment effectiveness. In severe cases of major depression, antidepressants may give some symptom relief, but for less severe cases, the effectiveness of antidepressants is not clinically relevant. Second, recurrence rates remain stubbornly high: patients with diagnosed MDD have a lifetime recurrency rate of 50%. We are not treating depression; at best, we reduce symptoms. (more…)
Author Interviews, PLoS, Weight Research / 22.12.2014

Elina Helander, PhD Personal Health Informatics Department of Signal Processing Tampere University of Technology, Tampere, FinlandMedicalResearch.com Interview with: Elina Helander, PhD Personal Health Informatics Department of Signal Processing Tampere University of Technology, Tampere, Finland Medical Research: What is the background for this study? What are the main findings? Dr. Helander: Frequent or at least regular self-weighing is a part of behavioral therapy in many weight programs. However, self-weighing frequency typically varies over time. We analyzed almost 3,000 weight observations from 40 overweight individuals that participated in a 1-year health promotion program. These individuals were instructed to weigh themselves daily but eventually had varying self-weighing frequencies. We examined how different self-weighing frequencies of the same individual were linked with weight changes. We found that weight loss generally occurred during daily weighing. When there were longer breaks in self-weighing such as one month or more, there was a risk of weight gain.  We also computed a theoretical minimum self-weighing frequency for having no weight gain that was 5.8 days in our study. That corresponds approximately weekly weighing. (more…)
Author Interviews, HIV, Nature, UCLA / 22.12.2014

David Gerberry PhD Center for Biomedical Modeling, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, University of California, Los Angeles, CaliforniaMedicalResearch.com Interview with: David Gerberry PhD Assistant Professor Department of Mathematics and Computer Science Xavier University, Cincinnati, Ohio   Medical Research: What is the background for this study? What are the main findings? Response: In an attempt to control the spread of HIV, governments in sub-Saharan Africa are considering providing antiretroviral drugs to people who do not have the virus but are at risk for becoming infected. Such drugs are known as pre-exposure prophylaxis, or PrEP.  Given the cost of PrEP, an important question is how to maximize the impact of interventions given a fixed level of prevention resources. A common strategy is to target resources to the individuals that are at the highest risk for infection.  This group of people is often referred to as the "core group" and can be thought of as sex workers, clients of sex workers and other individuals that are at very high risk for infection.  While targeting this core group is ideal and would result in the most cost-effectiveness interventions, being able to identify these individuals is difficult in practice and they are often unwilling to participate in the intervention; take pre-exposure prophylaxis or change their behavior for example.  From a mathematical perspective it is also very difficult to quantify their increased level of risk.  For example, is a sex worker at 5 times, 25 times, 100 times or 1000 times the risk for HIV infection?  Without this quantification, it is impossible to estimate the cost-effectiveness of a targeted strategy. In our work, we build an intervention strategy based on geographical targeting.  This takes advantage of the fact that HIV incidence is much higher in certain geographical locations than others.  Therefore, individuals in these areas are at increased risk for HIV infection.  Most importantly, such an intervention is feasible because reliable data exists across much of sub-Saharan Africa for the severity of the HIV epidemic in different regions.  To illustrate our ideas we used mathematical modeling to consider resource allocation in South Africa and found that targeting the provinces with highest HIV incidence would prevent 40% more infections than a plan that ignored geographic variation while using the same amount of resources. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Kidney Disease, University of Pittsburgh / 22.12.2014

MedicalResearch.com Interview with: Florentina E. Sileanu BS Center for Critical Care Nephrology and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center Departments of Critical Care Medicine and Department of Biostatistics, University of Pittsburgh Graduate School of Public Health and Dr. John A. Kellum, MD, MCCM Professor of Medicine, Bioengineering and Clinical & Translational Science Vice Chair for Research Center for Critical Care Nephrology, University of Pittsburgh School of Medicine Pittsburgh, PA Medical Research: What is the background for this study? What are the main findings? Response: Acute Kidney Injury (AKI) affects millions of Americans each year resulting in increased short and long-term complications including need for dialysis and death. Many trials recruiting subjects at risk for AKI have focused on those with other (e.g. cardiovascular and respiratory) organ failures because these patients are at highest for AKI. However, patients without these conditions might not be at low-risk for AKI. We explored whether Acute Kidney Injury occurring as a single organ failure or occurring before other organ failures would be associated with the same outcomes as in sicker patients. Using a large, academic medical center database, with records from July 2000 through October 2008, we identified a "low-risk" cohort as patients without cardiovascular and respiratory organ failures defined as not receiving vasopressor support or mechanical ventilation within the first 24 hours of ICU admission. We were able to show that low-risk patients have a substantial likelihood of developing AKI and that the relative impact on mortality of AKI is actually greater for low-risk patients (OR, 2.99; 95% 2.62-3.41) than for high-risk patients (OR, 1.19; 95% 1.09-1.3). (more…)
Author Interviews, Infections, PLoS / 22.12.2014

Leonard A. Mermel DO FACP, FIDSA, FSHEA Professor of Medicine, Warren Alpert Medical School of Brown University and Division of Infectious Diseases, Rhode Island Hospital Providence, Rhode IslandMedicalResearch.com Interview with: Leonard A. Mermel DO FACP, FIDSA, FSHEA Professor of Medicine, Warren Alpert Medical School of Brown University and Division of Infectious Diseases, Rhode Island Hospital Providence, Rhode Island Medical Research: What is the background for this study? What are the main findings? Dr. Mermel: While talking to infectious diseases physicians some years ago in Israel, Greece, and Thailand, I learned that unlike my experiene here in the US, most of the bloodstream infections they see are far and away due to Gram-negative bacteria.  So, a hypothesis was generated, namely that the likelihood of Gram-negative bacteremia compared to Gram-positive bacteremia was greater the closer to the equator.  A writing group was formed, colleagues around the world graciously shared their data.  The main finding is that in fact, we unequivocally found that the likelihood of Gram-negative, compared to Gram-positive bacteremia is more common closer to the equator.  This difference was greatest during the warmer months of the year.  We also found that the % GDP spent on healthcare in a given country is also associated with more Gram-negative than Gram-positive bacteremia.  These findings may reflect differences in the human microbiome as one gets closer or farther from the equator as has been recently demonstrated, differences in survival of Gram-negative compared to Gram-positive bacteria under certain environmental conditions, and likely reflects differences in public health and other factors. (more…)
Author Interviews, Infections, Vaccine Studies / 22.12.2014

Thomas Wisniewski MD Lulu P. and David J. Levidow Professor of Neurology Professor; Director Aging and Dementia New York University School of Medicine Dept. of Neurology, Psychiatry and Pathology New York, NY 10016MedicalResearch.com Interview with: Thomas Wisniewski MD Lulu P. and David J. Levidow Professor of Neurology Professor; Director Aging and Dementia New York University School of Medicine Dept. of Neurology, Psychiatry and Pathology New York, NY  10016 Medical Research: What is the background for this study? What are the main findings? Dr. Wisniewski: Chronic wasting disease (CWD) infects large numbers of deer and elk, with the potential to infect humans. Currently no prionosis has an effective treatment.  This is a relatively new prion disease that has many similarities to bovine spongiform encephalopathy which spread to humans to produce new variant Creutzfeldt-Jakob disease. Chronic wasting disease is the most infectious prion disease to date; having the potential to spread by aerosol. Previously, we have demonstrated we could prevent transmission of prions in a proportion of susceptible mice with a mucosal vaccine. In the current study, white-tailed deer were orally inoculated with attenuated Salmonella expressing PrP, while control deer were orally inoculated with vehicle attenuated Salmonella. Once a mucosal response was established, the vaccinated animals were boosted orally and locally by application of polymerized recombinant PrP onto the tonsils and rectal mucosa. The vaccinated and control animals were then challenged orally with CWD-infected brain homogenate. Three years post CWD oral challenge all control deer developed clinical CWD (median survival 602 days), while among the vaccinated there was a significant prolongation of the incubation period (median survival 909 days; p=0.012 by Weibull regression analysis) and one deer has remained CWD free both clinically and by RAMALT and tonsil biopsies. This negative vaccinate has the highest titers of IgA in saliva and systemic IgG against PrP. Western blots showed that immunoglobulins from this vaccinate react to PrPCWD. We document the first partially successful vaccination for a prion disease in a species naturally at risk. (more…)
Author Interviews, Cognitive Issues, Metabolic Syndrome / 22.12.2014

Prof. Giovambattista Desideri Università degli Studi dell'Aquila Direttore UOC Geriatria e Lungodegenza Geriatrica Scuola di Specializzazione in Geriatria Scuola di Specializzazione in Medicina d'Emergenza-UrgenzaMedicalResearch.com Interview with: Prof. Giovambattista Desideri Università degli Studi dell'Aquila Direttore  UOC Geriatria e Lungodegenza Geriatrica Scuola di Specializzazione in Geriatria Scuola di Specializzazione in Medicina d'Emergenza-Urgenza Medical Research: What is the background for this study? What are the main findings? Dr. Desideri: Over the past decade, there has been an accumulating body of evidence that indicates that the consumption of cocoa flavanol-containing products can improve vascular function. Though much research has focused on the cardiovascular system, there is reason to believe that some of the benefits of cocoa flavanol consumption could extend also to the brain which is a heavily vascularized tissue that depends on regular blood flow to meet its metabolic demands. Thus, the current study tested the hypothesis that the regular inclusion of cocoa flavanols for 8 weeks could positively affect cognitive function in cognitively-intact older adults. The effects of cocoa flavanol ingestion on various cardiometabolic endpoints, including blood pressure and insulin sensitivity, were also evaluated given consistent evidence of positive effects of flavanols on these outcomes and the potentially influential role of these outcomes on cognitive function. Medical Research: What are the main findings? Dr. Desideri:The study enrolled 90 men and women aged 61-85 years with no evidence of cognitive dysfunction who were assigned to one of three flavanol groups, consuming a drink containing high (993 mg), intermediate ( 520 mg) or low (48 mg) amounts of cocoa flavanols every day for 8 weeks. Among those individuals who regularly consumed either the high-or intermediate-flavanol drinks, there were significant improvements in some measures of age-related cognitive dysfunction.  In the high- and intermediate-flavanol groups, both systolic and diastolic blood pressures were reduced and insulin resistance was significantly improved.   It is not yet fully understood how cocoa flavanols bring about improvements in cognitive function, but the study results suggest that the improvements in insulin resistance and blood pressure could be revealing. (more…)
Author Interviews, Breast Cancer, JNCI / 21.12.2014

MedicalResearch.com Interview with: Dr Ranjit Manchanda Consultant Gynaecological Oncologist, St Bartholomew’s Hospital, London, UK Honorary Sr Lecturer, Women’s Cancer, EGA Institute for Women's Health, University College London, UK  and Professor Ian Jacobs Vice President, The University of Manchester Dean & Head School of Medicine Faculty of Medical & Human Sciences, Director MAHSC (Manchester Academic Health Science Centre) Medical Research: What is the background for this study? What are the main findings? Dr. Jacobs:  Background- Women carrying a BRCA1/2 gene alteration have a very high risk of developing breast and ovarian cancer and men carrying this alteration have an increased risk of prostate and breast cancer. Approximately 45-65% women who have this inherited genetic change will develop breast cancer and 15-35% ovarian cancer. They also have a 50% chance of passing these genes on to their children. At risk individuals can access available options of screening and prevention through the National Health Service (NHS). Some population groups across the world are known to have a higher frequency of BRCA 1/2 gene alterations than others. One example is Ashkenazi Jews who have a 1 in 40 likelihood of having a BRCA1/2 gene alteration. This is 10-20 times higher than in the general non-Jewish population. At present in the UK, genetic testing is available within the NHS to individuals who have a strong family history of cancer. However, many people are not aware of their family history or its significance and do not seek advice. Many other individuals with BRCA1/2 gene alterations do not have a family history at all. The current approach misses a large number of people at risk who could benefit from knowing about their BRCA 1/2 mutation status and the ability to access opportunities for prevention or screening. In order to address this the GCaPPS study has investigated the best method of screening for risk of inherited (familial) cancer by exploring the alternative approach of offering the genetic test to all men and women >18 years in the Ashkenazi Jewish population. It does so by comparing the benefits and disadvantages of: (i) The current system of testing only those with a family history and (ii) The new option of testing everyone in the population. Main Findings: Over half of the BRCA1/BRCA2 carriers detected did not give a strong family history of cancer and would not have been identified by current family history based testing criteria used in the NHS (National Health Service) in the UK and most health systems internationally. Reassuringly population-based genetic testing in Ashkenazi Jews did not adversely affect short term psychological health or quality-of-life. A health economic analysis indicated that population-based screening for BRCA-mutations in Ashkenazi Jewish women ≥30years would be highly cost-effective compared to the traditional family history based approach. Such an approach if implemented could reduce the incidence of and deaths from breast and ovarian cancer as well as reducing cost and save the NHS funds. (more…)
Author Interviews, Pediatrics, Toxin Research, University Texas / 21.12.2014

Ying Xu Assistant Professor, Ph.D. Department of Civil, Architectural and Environmental Engineering University of Texas, AustinMedicalResearch.com Interview with: Ying Xu Assistant Professor, Ph.D. Department of Civil, Architectural and Environmental Engineering University of Texas, Austin Medical Research: What is the background for this study? What are the main findings? Response: Phthalates have been widely used as plasticizers to enhance the flexibility of polyvinyl chloride (PVC) products.  They are ubiquitous and persistent indoor pollutants and may result in profound and irreversible changes in the development of human reproductive tract. In this study, we found that the emissions of phthalates and phthalate alternatives increase significantly with increasing temperature.  We developed an emission model and validated the model via chamber experiments.  Further analysis showed that, in infant sleep microenvironments, an increase in the temperature of mattress can cause a significant increase in emission of phthalates from the mattress cover and make the concentration in breathing zone about four times higher than that in the room, resulting in potentially high exposure.  In residential homes, an increase in the temperature from 25 to 35 ºC can elevate the gas-phase concentration of phthalates by more than a factor of 10, but the total airborne concentration may not increase that much for less volatile compounds. (more…)
Author Interviews, Endocrinology, JCEM, Menopause, UCLA / 20.12.2014

Carolyn J. Crandall, MD, MS Professor of Medicine David Geffen School of Medicine at University of California, Los Angeles UCLA Medicine/GIM Los Angeles, CA 90024MedicalResearch.com Interview with: Carolyn J. Crandall, MD, MS Professor of Medicine David Geffen School of Medicine UCLA Medicine/GIM Los Angeles, California 90024 Medical Research: What is the background for this study? What are the main findings? Dr. Crandall: In a large group of postmenopausal women aged 50-79, we found that women who reporting having hot flashes at baseline had increased risk of hip fracture during the subsequent 8 years of observation, nearly double the risk compared with women who did not have hot flashes at baseline. (more…)