Author Interviews, NYU, Schizophrenia / 08.05.2017

MedicalResearch.com Interview with: Donald C. Goff, MD Marvin Stern Professor Vice Chair for Research Department of Psychiatry NYU Langone Medical Center MedicalResearch.com: What is the background for this study? Response: Since their introduction in the 1950’s antipsychotic drugs have been an integral part of the treatment of schizophrenia. However, over the past decade concerns have been raised about whether these drugs might negatively affect the long-term course of the illness—either by causing supersensitivity of dopamine receptors, which might make patients more prone to psychosis and relapse, or by direct toxic effects on the brain. To address these concerns, we convened a panel of international experts to review the evidence supporting these concerns, including findings from clinical studies, brain imaging studies, post-mortem examination of the brains of people treated with these drugs, and studies in which these drugs were administered to animals. (more…)
Author Interviews, JAMA, Ophthalmology / 08.05.2017

MedicalResearch.com Interview with: John H Kempen, MD, PhD Protocol Chair, MUST Trial Follow-up Study; Vice Chair, MUST Research Group Director of Epidemiology for Ophthalmology, Massachusetts Eye and Ear Harvard Medical School Editor-in-Chief, Ophthalmic Epidemiology President, Sight for Souls MedicalResearch.com: What is the background for this study? Response: Uveitis is about the fifth leading cause of blindness in the united states.  Among types of uveitis, intermediate, posterior and panuveitis are the leading causes of blindness.  Before 2005, systemic therapy with corticosteroids—supplemented when indicated with immunosuppressive drugs (most of the time)—was the primary treatment recommended for these conditions.  With approval of the fluocinolone acetonide implant in 2005 for intermediate, posterior and panuveitis, it became unclear which of the alternative treatment approaches should be the treatment of choice. The multicenter uveitis steroid treatment (must) trial was initiated in 2005 to directly compare the alternative treatments.  Systemic therapy was administered using high dose prednisone followed by tapering of corticosteroids to maintenance doses of 10 mg/day or less (generally 7.5 mg/day or less) or to zero; this was supplemented by immunosuppressive corticosteroid-sparing drugs in 88% of participants.  Implant therapy was done by initial quieting of the anterior chamber of the eye with topical, injected or systemic corticosteroids followed by surgical implant placement within 28 days (first eye) and 56 days (second eye if it was indicated).  After this, systemic corticosteroids and immunosuppressive drugs were tapered off. (more…)
Author Interviews, CMAJ, Fertility, Karolinski Institute, OBGYNE / 08.05.2017

MedicalResearch.com Interview with: Neda Razaz, PhD, MPH Postdoctoral Fellow Reproductive Epidemiology Unit Karolinska Institutet MedicalResearch.com: What is the background for this study? What are the main findings? Response: Multiple births of twins and triplets – and the associated health risks – have increased in many high-income countries, with a respective two-fold and three-fold increase in recent decades. In Canada, triplet births or higher have increased from 52.2 per 100 000 live births to 83.5 between 1991 and 2009, mainly because of an increase in fertility treatments for older women of child-bearing age. In this study we found that among twin and triplet pregnancies that were reduced to singleton or twin pregnancies, there was a substantial reduction in complications such as preterm birth and very preterm birth. Although rates of death and serious illness were not lower among all multifetal pregnancies that were reduced, pregnancies that resulted from fertility treatments did show a significant reduction in rates of death or serious illness following fetal reduction. (more…)
Author Interviews, Biomarkers, Brain Injury, Pediatrics / 07.05.2017

MedicalResearch.com Interview with: Steven Daniel Hicks, MD, PhD Assistant Professor, Division of Academic General Pediatrics College of Medicine Penn State Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are about 3 million concussions in the US each year and the majority occur in children. Parents of children with concussions commonly cite length of recovery as a major concern, but pediatricians have no objective or accurate tests for addressing this concern. Our research group previously identified small regulatory molecules called microRNAs that were altered in both the spinal fluid and saliva in children with traumatic brain injuries. In this study we investigated whether those microRNAs could predict duration of concussion symptoms. In 52 children with concussion we found a set of microRNAs that predict whether concussion symptoms would last beyond one month with over 80% accuracy. This was significantly more accurate than survey based tools such as the sports concussion assessment tool or a modified concussion clinical risk score. Interestingly, the microRNAs with predictive accuracy targeted pathways involved in brain repair and showed correlations with specific concussion symptoms. (more…)
Author Interviews, Baylor College of Medicine Houston, Merck, Rheumatology / 07.05.2017

MedicalResearch.com Interview with: Grace H. Lo MD MSc Department of Medicine, Baylor College of Medicine Medical Care Line and Research Care Line, Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety Michael E. DeBakey Medical Center, Houston, TX MedicalResearch.com: What is the background for this study? What are the main findings? Response: Osteoarthritis is the most common form of arthritis. Many people who have signs of osteoarthritis on x-rays do not necessarily complain of pain. Presently, there are no known strategies for preventing the development of pain in this group of people. This study suggests that if these people have noisy knees (otherwise known as “crepitus”), they are at higher risk for developing pain within the next year compared to the people who do not have noisy knees. Future studies that target people who have x-ray signs of osteoarthritis, who do not complain of pain, but do report noisy knees, hold the promise of identifying interventions that can prevent knee pain. (more…)
Author Interviews, Diabetes, Diabetologia, Nutrition, Pediatrics / 07.05.2017

MedicalResearch.com Interview with: Sari Niinistö, PhD Senior Researcher, Public Health Solutions, Nutrition Unit National Institute for Health and Welfare Helsinki, Finland MedicalResearch.com: What is the background for this study? Response: Previous prospective studies have observed protective association between fish-derived fat and type 1 diabetes related autoimmunity in older children. Also some other fatty acids have been associated with the risk for type 1 diabetes associated autoimmunity. We wanted to study very young children, because type 1 diabetes associated autoimmunity often begins early, already in infancy. Therefore, we investigated whether serum fatty acid levels during infancy or the main dietary sources of fatty acids (breast milk and infant formula) were related to the development of autoimmunity responses among children at increased genetic risk of developing type 1 diabetes. (more…)
Author Interviews, Blood Pressure - Hypertension, Kidney Disease / 07.05.2017

MedicalResearch.com Interview with: Tanushree Banerjee, M.S., M.Phil., Ph.D. Research Specialist, Department of General Internal Medicine, San Francisco General Hospital, University of California, San Francisco, MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prevalence of chronic kidney disease (CKD) has increased among adults with diagnosed hypertension (HTN), undiagnosed HTN and pre-hypertension as compared to normotension. However, whether CKD prevalence has changed across each of these groups is unknown. The prevalence of CKD decreased over time among persons with diagnosed, undiagnosed, and pre-hypertension while there was not any change in normotensives. (more…)
Author Interviews, Mental Health Research, Occupational Health, Social Issues / 07.05.2017

MedicalResearch.com Interview with: Tarani Chandola Professor of Medical Sociology Social Statistics Disciplinary Area of the School of Social Sciences University of Manchester MedicalResearch.com: What is the background for this study? Response: We (the authors) were particularly interested in examining evidence for the common perception that people at the top of the occupational hierarchy are the most stressed. And also what happens to people’s stress levels when they retire. We had assumed that people with poorer quality work to have decreased levels of stress when they retired. There have been other studies on this topic before, but none that have used salivary cortisol to measure physiological stress responses. We analysed changes in people’s stress levels before and after retirement, in a follow up study of over 1,000 older workers in the British civil service. Stress levels were measured by taking salivary cortisol samples across the day, from awakening until bedtime. (more…)
Author Interviews, Memory / 07.05.2017

MedicalResearch.com Interview with: Michael C. Trumbo,  Sandia National Laboratories Department of Psychology Psychology Clinical Neuroscience Center The University of New Mexico Albuquerque, NM  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The impetus for this study can be found in claims made by several commercial enterprises that you can get cognitive benefits from brain training games intended to enhance working memory (the amount of information you can hold and manipulate in your mind at one time). However, a burgeoning body of research shows working memory training games often do not provide the benefits claimed. Research led by my colleague Laura Matzen shows evidence that working memory training may actually impair other kinds of memory. A key concept in demonstrating improvement of the working memory system is task transfer – if working memory has been improved, then that improvement should be evident when attempting tasks aside from the trained task, to the extent that these new tasks utilize working memory. Brain stimulation combined with working memory training might work when training by itself falls short because stimulation allows for manipulation of brain plasticity in brain regions that are relevant to working memory task performance. If you’re improving connectivity in a brain region involved in working memory, then you should get transfer to other tasks to the extent that they rely on that same brain region. When you’re having people do tasks in the absence of brain stimulation, it’s not clear if you’re getting this general improvement in working memory brain areas. You might be getting very selective, task kind of improvements due to use of task-specific strategy development. Therefore, the current study was designed to see if noninvasive brain stimulation paired with different types of working memory training might result in improvement not only in the trained task, but in related tasks. The findings suggest that particular parings of stimulation parameters and training programs result in working memory improvement. This is important because working memory is a critical component of many everyday tasks, such as reading and language comprehension, and working memory deficits are common in a number of disease states, such as depression. Working memory decline is also evident as part of the healthy aging process, beginning as early as your mid-20s. Therefore, a safe, reliable way to improve working memory stands to benefit both healthy and clinical populations in a variety of task domains which are critical to achieving a high quality of life. (more…)
Author Interviews, Gender Differences / 07.05.2017

MedicalResearch.com Interview with: Moran Gershoni PhD Senior intern, Molecular Genetics Weizmann Institute of Science Ben Gurion University Rehovot Area, Israel MedicalResearch.com: What is the background for this study? Response: The background for this study is the question why "bad" is common? More specifically, we asked why the prevalence of some unfitted traits, like diseases and infertility, is sometimes much higher than intuitively expected? Several years ago we hypothesized that, at least in some of the cases, the relatively high prevalence of a morbid phenotype is directly arises from the fact that humans are composed of two ‘kinds’, men and women. This is since men and women share nearly the same genome but differently utilize some of it. Thus, the very same genetic code might affect men and women in a different and even in an antagonist manner. Therefore, disease-cause mutations in one sex can be neutral, or even beneficial, to the other sex. This allows such mutations to be sustained and propagated to relative high population frequencies. (more…)
Author Interviews, Blood Pressure - Hypertension, Occupational Health / 05.05.2017

MedicalResearch.com Interview with: Sandhya Manohar, MBBS, Nephrology Fellow Project mentor: Sandra M. Herrmann, MD Department of Nephrology and Hypertension Mayo Clinic, Rochester, MN MedicalResearch.com: What is the background for this study? Response: In the last few decades advances in the field of industrialization and technology has turned our world into a 24-7 work zone. Many organizations have turned to a shift system to keep up with the demands of the new world. The consequent changes to our circadian rhythm have resulted in dramatic effects to our body’s physiology. Reports have been surfacing of higher rates of diabetes, obesity, and even cancer in this shift work population. The risk of hypertension though was controversial and so we set out to review this in our meta-analysis. (more…)
Author Interviews, Pediatrics, PLoS, Toxin Research / 05.05.2017

MedicalResearch.com Interview with: Dr. Antonio J. Signes-Pastor, PhD Institute for Global Food Security Queen’s University Belfast Belfast, Northern Ireland, United Kingdom, Department of Epidemiology, Geisel School of Medicine Dartmouth College Lebanon, NH MedicalResearch.com: What is the background for this study? Response: Inorganic arsenic is a human carcinogen, which has also been associated with several adverse health effects including neurological, cardiovascular, respiratory, and metabolic outcomes. Early life exposure is of particular concern since it may adversely impact on lifetime health outcomes. If low inorganic arsenic drinking water is available the main source of exposure is the diet, especially rice and rice-based products, which are widely used during weaning and to feed infants and young children. In order to reduce exposure, the EU has recently regulated (1st January 2016) the inorganic arsenic maximum level of 0.1 mg/kg for rice products addressed to infants and young children. This level is also under consideration by the US FDA. (more…)
Author Interviews, Heart Disease, Surgical Research / 05.05.2017

MedicalResearch.com Interview with: Nayan Agarwal MD Intervention Cardiology Fellow, University of Florida, Gainesville, FL MedicalResearch.com: What is the background for this study? Response: Long term anticoagulation is indicated in patients with mechanical heart valves, prior thromboembolic events, atrial fibrillation etc, to prevent recurrent thrombo-embolic episodes. About 20-30% of these patients also have concomitant ischemic heart disease requiring percutaneous coronary intervention (PCI). Post PCI, patients require treatment with dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) to prevent stent thrombosis. Thus, these patients may end up needing triple antithrombotic therapy with oral anticoagulant (OAC) and DAPT, which increases the bleeding risk. Both American College of Cardiology(ACC) and European Society of Cardiology (ESC), currently recommend triple therapy in these patients. Recently new evidence has emerged that such patients can be managed with dual therapy of a single antiplatelet (SAPT) and OAC. Hence, we decided to do a systematic review of these studies to evaluate safety and efficacy of dual therapy of SAPT and OAC against triple therapy of DAPT and OAC. (more…)
Author Interviews, JAMA, Ophthalmology, Pediatrics / 05.05.2017

MedicalResearch.com Interview with: Rohit Varma, MD, MPH Executive Director - USC Roski Eye Institute and Dean of the Keck School of Medicine of USC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Visual impairment in early childhood has profound impact on a child’s development. It can significantly impair development of visual, motor, and cognitive function1-3 and lead to adverse psychosocial consequences. There has been a lack of accurate data characterizing the current and expected numbers of visual impairment cases among preschool children in the United States from 2015 to 2060. The number of preschool children with visual impairment is projected to increase by 26% in 2060. And 69% of these visual impairment will result from simple uncorrected refractive error such hyperopia and myopia, which can be prevented or treated by low-cost refractive correction. (more…)
Author Interviews, Heart Disease, NEJM / 05.05.2017

MedicalResearch.com Interview with: Kristian Kragholm, MD, PhD Departments of Cardiology and Epidemiology/Biostatistics, Aalborg University Hospital, Aalborg, DK MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is well known that early help from bystanders including cardiopulmonary resuscitation (CPR) before arrival of the emergency medical services can increase chances of 30-day survival by three to four times compared to situations where no bystander resuscitation was initiated. The main and novel finding of our study is that bystander interventions, in addition to increasing survival, also lowers the risk of damage to the brain and nursing home admission in 30-day survivors during the first year following out-of-hospital cardiac arrest. (more…)
Author Interviews, Dengue, Vaccine Studies / 04.05.2017

MedicalResearch.com Interview with: Dr Vianney Tricou DPhil Takeda Vaccines Singapore MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of four closely related dengue virus serotypes, and persons living in dengue endemic regions may be affected by dengue more than once in their lifetime. Some individuals with dengue fever are hospitalized and may need intensive therapy to prevent shock and death, and severe dengue is a leading cause of hospitalization and death among children and adults in some Asian and Latin American countries. About half of the world’s population lives under the threat of dengue and the disease has a significant medical and economic impact in the tropical and subtropical regions of the world where dengue is endemic. Takeda is committed to improving global public health and to developing a life-saving dengue vaccine candidate for people around the world. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four attenuated dengue virus serotypes present in the vaccine. Takeda’s Phase 1 and Phase 2 clinical study program includes 8 studies to date that assess the safety and/or immunogenicity of this candidate, before moving into Phase 3. Takeda’s ongoing Phase 2 DEN-204 study is designed to assess the safety and immunogenicity of one- and two-dose schedules of TAK-003 in 1,794 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia. As published in The Lancet Infectious Diseases in March 2017, an interim analysis of DEN-204 data indicated that TAK-003 elicited antibody responses to all four dengue serotypes in the population studied, regardless of whether they had previous dengue exposure. A second TDV dose improved antibody responses against DENV-3 and DENV-4 in children who were seronegative before vaccination. In this study, the safety profile was consistent with that observed in earlier Phase 1 and 2 studies. (more…)
Author Interviews, Heart Disease, JAMA, Kidney Disease, Surgical Research / 04.05.2017

MedicalResearch.com Interview with: Nirat Beohar, MD Vice-Chief of Cardiology Director Cardiac Catheterization Laboratory Director Structural Heart Disease Program Director Interventional Cardiology Fellowship program Cardiac Catheterization Laboratory Columbia University Division of Cardiology, Mount Sinai Medical Center Miami Beach, Miami, FL 33140 MedicalResearch.com: What is the background for this study? Response: Nirat Beohar MD, Director of the Cardiovascular Catheterization Laboratory and Vice-Chief of Cardiology at the Columbia University Division of Cardiology at the Mount Sinai Medical Center and co-authors report the effect of trans-catheter aortic valve replacement (TAVR) on subsequent renal function and outcomes in high-risk and inoperable patients presenting with baseline renal dysfunction (eGFR < 60 ml/min/1.73 m2). This was a sub-study of patients undergoing TAVR in the PARTNER 1 trial and continued access registry that was conducted in 25 centers in the United States and Canada. (more…)
Author Interviews, Gastrointestinal Disease, Immunotherapy, NEJM, UCSD / 04.05.2017

MedicalResearch.com Interview with: William J. Sandborn, MD Professor of Medicine and Adjunct Professor of Surgery Chief, Division of Gastroenterology Vice Chair for Clinical Operations, Department of Medicine Director, UCSD IBD Center University of California San Diego and UC San Diego Health System MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is still a substantial unmet need for new treatments for patients with ulcerative colitis. A previous Phase II study had suggested that tofacitinib might be effective for short term therapy of ulcerative colitis. The patients in that study for the most part had not failed anti-TNF therapy. Now we report the findings from 3 large Phase III trials, two short term trials and one long term trial, demonstrating that tofacitinib 10 mg twice daily is effective for short term therapy, and that both 5 mg and 10 mg twice daily is effective for long term therapy. We also demonstrated that tofacitinib is effective both in patients who have not failed anti-TNF therapy and patients who have failed anti-TNF therapy. The study demonstrated induction of clinical remission, clinical response and mucosal healing (flexible sigmoidoscopy improvement) over the short term, and maintenance of clinical remission, clinical response, and mucosal healing over the long term. (more…)
Author Interviews, Respiratory / 04.05.2017

MedicalResearch.com Interview with: Harri Hemilä, MD, PhD Department of Public Health University of Helsinki MedicalResearch.com: What is the background for this study? What are the main findings? Response: Some zinc lozenges intended for treating the common cold have contained zinc acetate and some others have contained zinc gluconate. There have been proposals that zinc acetate might be more optimal salt for lozenges than zinc gluconate. Therefore I compared the randomized trials that have used zinc acetate with zinc gluconate to see if there is difference between the lozenges. Although the average effect in 3 studies with zinc acetate lozenges was greater (40%) than the average effect in 4 studies with zinc gluconate lozenges (28%), that difference was explained by random variation. I also analyzed the dose dependency of the effect and found that 2 studies that used 192 and 207 mg per day elemental zinc did not find greater benefit than 5 studies that used 80 to 92 mg per day zinc. The overall average effect of zinc lozenges was 33% reduction in common cold duration and that effect seems to be reached with doses less than 100 mg per day. (more…)
AHA Journals, Author Interviews, Heart Disease, Stem Cells / 04.05.2017

MedicalResearch.com Interview with: Megan M. Monsanto, B.S. Joint Doctoral Student Department of Cell and Molecular Biology San Diego State University & University of California San Diego MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the field of cardiovascular research there is ongoing debate regarding the optimal cell population(s) to use for the treatment of patients with heart failure. A major reason being, the lack of understanding of the actions and synergism between distinct myocardial-derived stem cell populations. This prompted our group to establish a protocol to isolate multiple stem cell populations from a single human myocardial tissue sample that will allow for the discovery of new insights at the cellular level, with the ultimate goal being to achieve true myocardial regeneration upon injection back into the patient. (more…)
Author Interviews, Breast Cancer, Journal Clinical Oncology, Radiation Therapy / 04.05.2017

MedicalResearch.com Interview with: Bruce G. Haffty, MD Professor and Chair, Department of Radiation Oncology Rutgers Cancer Institute of New Jersey Rutgers Robert Wood Johnson Medical School and Rutgers New Jersey Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Shorter courses of radiation for patients treated by lumpectomy are now commonly employed. For patients receiving radiation to the chest wall and lymph nodes after mastectomy, the standard 5 to 6 week course is used and shorter courses have not been adopted. We initiated this trial of a shorter course of radiation to the chest wall and lymph nodes after mastectomy to test its feasibility, safety and outcome. (more…)
Author Interviews, Depression, Mental Health Research, Neurological Disorders, NIH / 03.05.2017

MedicalResearch.com Interview with: Ronald Cannon, Ph.D. Staff scientist at NIH’s National Institute of Environmental Health Sciences MedicalResearch.com: What is the background for this study? Response: The protein pump, P-glycoprotein, is a major obstacle to the delivery of therapeutic drugs across the blood-brain barrier and into the central nervous system (CNS). During the last 10 years, our laboratory has studied the regulation of P-glycoprotein with the hope of treating CNS diseases. MedicalResearch.com: What are the main findings? Response: Our most recent finding shows that the antidepressant, amitriptyline, suppresses P-glycoprotein pump activity. The discovery is significant because P-glycoprotein restricts most CNS targeted drugs from entering the brain. If fully translatable to human patients, suppression of P-glycoprotein could allow higher levels of CNS therapeutic drugs to reach their intended target. (more…)
AHRQ, Author Interviews, Cost of Health Care / 03.05.2017

MedicalResearch.com Interview with: Salam Abdus, Ph.D. Agency for Healthcare Research and Quality MedicalResearch.com: What is the background for this study? What are the main findings? Response: When the ACA was passed, some people were concerned that access to care for people who already had insurance would decrease because there would be so many newly insured people trying to get care. To answer this question, we reviewed eight measures of access using data from the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey (MEPS) and the Census Bureaus’ American Community Survey for the period 2008-2014 to study if change in local area insurance rate affected access to care of adults who were continuously insured for two years. Access measures that we looked at include whether they had a usual source of care, were unable to receive necessary medical care, were delayed in receiving necessary medical care, had a physical exam in the past year, had blood pressure checked, had a flu shot, experienced delays getting a doctor appointment, and problems seeing a specialist. We found no consistent evidence of negative impacts on continuously insured adults. We also looked at two subgroups of vulnerable adults: Medicaid beneficiaries and adults living in health professional shortage areas. For both continuously insured subgroups we found no consistent evidence of negative impacts. (more…)
Author Interviews, Breast Cancer, CDC, Cost of Health Care / 03.05.2017

MedicalResearch.com Interview with: Benjamin Allaire MS RTI International Research Triangle Park Durham, NC, 27709 MedicalResearch.com: What is the background for this study? Response: More than 22,000 women younger than 45 years of age were diagnosed with breast cancer in 2013. Although less than 10 percent of all breast cancers are diagnosed among women younger than age 45, the types of breast cancer these younger women face are typically more aggressive, are diagnosed at more advanced stages, and result in poorer survival compared to breast cancer in older women. Younger women may also require more intense treatment, exhibit cancers that are less responsive to treatment, and have distinct and more prevalent side effects from treatment than older women. These side effects can include poorer quality of life, fertility problems, and depression. As a result, breast cancer treatment for younger women is expensive, making them vulnerable to financial hardship. Recent research has shown that 31.8 percent of cancer survivors are likely to have cancer treatment-induced financial troubles, with higher rates among younger cancer patients. These financial difficulties cause some survivors to forego or delay necessary medical treatments. (more…)
Author Interviews, Leukemia / 03.05.2017

MedicalResearch.com Interview with: Martin J.S. Dyer, D.Phil MA FRCP FRCPath Ernest and Helen Scott Haematological Research Institute University of Leicester, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study follows on from a world-first clinical trial of a new drug to treat particular blood cancers. Results of that international clinical trial were published in the journal Blood in November 2015 and looked at the efficacy of a new inhibitor, ONO/GS-4059, in the treatment of CLL and Non-Hodgkin Lymphoma patients, refractory or resistant to current chemotherapies. ONO/GS-4059 targets BTK, a protein essential for the survival and proliferation of the tumour cells. The study opened in January 2012 and 90 patients were enrolled in different centres in the UK and in France, with 28 coming from Leicester. Patients with CLL showed the best response and most of them were still on the study after 3 years, and remarkably without notable toxicities. In the new paper, we are reporting the long-term follow-up results. This work, published in the journal Blood, was funded by the Ernest and Helen Scott Haematological Research Institute, ONO Pharmaceuticals, Gilead Pharmaceuticals and the Cancer Research UK Leicester Experimental Cancer Medicine Centre. Local charity Hope Against Cancer fund the Clinical Trials Facility based at the Leicester Royal Infirmary. This current paper describes the long term follow up and shows that in patients with CLL the remissions are durable and associated with no new toxicities. Furthermore, in collaboration with Sistemas Genomicos, a company in Valencia, we have shown that mutations associated with aggressive disease respond well to treatment with ONO/GS-4059. (more…)
Aging, Author Interviews, Cancer Research, CDC, OBGYNE / 03.05.2017

MedicalResearch.com Interview with: Mary C. White, ScD MedicalResearch.com: What is the background for this study? Response: For women between the ages of 21 to 65, Pap testing every three years, or Pap testing with HPV co-testing every five years, can prevent cervical cancers and deaths. Current recommendations state that women 65 and older and not otherwise at special risk can skip Pap tests, but only if they have had three consecutive negative Pap screening tests or two consecutive negative co-tests over the past 10 years, with the most recent done within the past five years. We used data from two federal cancer registry programs to examine how cervical cancer risk changes with age, after excluding women who have had a hysterectomy. We also examined data from a federal national health survey to examine the proportion of women who either had never been tested or had not been tested in the last 5 years. (more…)
Author Interviews, CMAJ, Infections, OBGYNE / 03.05.2017

MedicalResearch.com Interview with: Anick Bérard PhD FISPE Research chair FRQS on Medications and Pregnancy Director, Réseau Québécois de recherche sur le médicament (RQRM) Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy, University of Montreal Director, Research Unit on Medications and Pregnancy Research Center, CHU Ste-Justine MedicalResearch.com: The Danish study you cite reported a connection between antibiotics and miscarriage – why was further research of this topic necessary? Response: Given that a single study will assess an association, repetition of findings are essential in order to assess causality. For example, we were able to conclude that smoking was causing lung cancer after 10 years of observational research on the topic showing concordant associations. In addition, antibiotic prescription patterns vary from country to country, hence the importance of studying the research question in various patient populations. Finally, our cohort has validated exposure status, gestational age (first day of pregnancy) and miscarriage cases - our study was also able to look at types of antibiotics. (more…)
Author Interviews, JAMA, Pharmacology, UCLA / 03.05.2017

MedicalResearch.com Interview with: Ian Larkin, PhD Assistant Professor of Strategy UCLA Anderson School of Management MedicalResearch.com: What is the background for this study? Response: The study examined whether restrictions put in by medical centers on salesperson visits to physicians, known as “detailing,” affected subsequent physician prescribing behavior. Detailing represents the most prominent form of pharmaceutical marketing. Detailing visits allow the sharing of scientific information, but they also often involve small gifts for physicians and their staff, such as meals. Pharmaceutical companies incur far greater expenditures on detailing visits than they do on direct-to-consumer marketing, or even on research and development of new drugs. Specifically, the study examined detailing restrictions put into place by 19 academic medical centers (AMCs) in five states in the U.S. It compared changes in prescribing by thousands of AMC physicians whose practices limited typical elements of detailing visits, such as provisions of meals and educational gifts, to a carefully matched control group of similar physicians practicing in the same geographic regions but not subject to such detailing restrictions. The study, which included more than 25,000 physicians and all 262 drugs in eight major drug classes — from statins to sleep aids to antidepressants, representing more than $60 billion in aggregate sales in the United States — was, to date, by far the most comprehensive to examine the impact of detailing restrictions. The comprehensive and quasi-experimental methodology, which compared prescribing behavior before and after implementation of policies, and which included a large matched control group of physicians not subject to policy changes, was an important innovation relative to prior research. The study used prescription data from CVS Caremark, one of the largest pharmacy benefit managers in the United States. (more…)
Author Interviews, Diabetes, Pediatrics / 03.05.2017

MedicalResearch.com Interview with: Tove Fall, PhD Department of Medical Sciences Molecular Epidemiology and Science for Life Laboratory, Uppsala University Uppsala, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Type 1 diabetes is a severe chronic disease in children. There are few established risk factors, but it has been hypothesized that factors related to reduction of microbial exposure in childhood may increase the risk. We have previously shown that children in dog-owning families are at lower risk for asthma, and we now wanted to investigate the relationship of dog ownership and diabetes. We did this by studying the whole Swedish child population with record linkage across registers of health and dog ownership. We could not find evidence for an association of dog ownership and type 1 diabetes in the general population. (more…)
Author Interviews, Global Health, Heart Disease / 03.05.2017

MedicalResearch.com Interview with: Hisham Dokainish, M.D., FRCPC, FASE, FACC Associate Professor of Medicine, McMaster University Principal Investigator, Population Health Research Insitute Director of Heart Failure Services, Director of Medical Diagnostic Units & Echocardiography, Hamilton Health Sciences Hamilton, ON, Canada MedicalResearch.com: What is the background for this study? Response: Most data on mortality and prognostic factors in patients with heart failure come from North America and Europe, with little information from other regions of the world, particularly from low and middle income countries. MedicalResearch.com: What are the main findings? Response: We enrolled 5823 patients within 1 year (with 98% follow-up). Overall mortality was 16·5%: highest in Africa (34%) and India (23%), intermediate in southeast Asia (15%), and lowest in China (7%), South America (9%), and the Middle East (9%). These large regional differences in mortality persisted after multivariable adjustment for demographic, clinical, medication and socioeconomic variables. About half of the mortality risk was explained by multivariable modeling with these variables; however, the remainder was unexplained. (more…)