Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE, Pediatrics, Weight Research / 02.01.2020

MedicalResearch.com Interview with: Elvira Isganaitis, M.D., M.P.H. Pediatric Endocrinologist, Joslin Diabetes Center Assistant Professor of Pediatrics, Harvard Medical School Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response: The concept that a mother's nutrition prior to and during pregnancy is important for health outcomes in the offspring is now well accepted. For example, women intending to get pregnant must take prenatal vitamins, and are encouraged to attain a healthy weight before conception. However, much less is known about how a father's nutritional status may influence childhood health outcomes.  Based on studies in animals, exposure to undernutrition, high-fat diet, or stressful experiences in fathers can result in increased risk of obesity and diabetes in the offspring. These effects are mediated in part by epigenetic mechanisms (i.e. changes in gene expression due to differences in DNA methylation, histones, or other non-genetic mechanisms). (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, JAMA, Supplements / 16.12.2019

MedicalResearch.com Interview with: Pieter A. Cohen, MD Department of Medicine, Cambridge Health Alliance Somerville, Massachusetts Harvard Medical School Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: There has been increasing interest in the use of over-the-counter supplements to help improve memory and cognitive function.  However, prior studies have suggested that these types of supplements might contain unapproved investigational drugs. (more…)
Author Interviews, Brigham & Women's - Harvard, Global Health, JAMA, Pediatrics, Vaccine Studies / 09.12.2019

MedicalResearch.com Interview with: Emily Parker Hyle, M.D. Assistant Professor of Medicine Massachusetts General Hospital MedicalResearch.com: What is the background for this study? Response: We found that many children who were planning to travel internationally were eligible for MMR vaccination prior to departure but often did not receive it - especially if they were aged 6 months to 6 years. That is because most children do not routinely receive their first dose of MMR till 12-15 months of age and their second dose of MMR till 4-6 years of age. However, ACIP recommendations are different for children who are traveling internationally. The risk of being infected with measles is much higher outside of the US, so it is recommended that children older than 1 year have had 2 MMR vaccinations and that children 6-12 months receive 1 MMR vaccination prior to travel. MMR vaccination is a safe and effective way to greatly reduce the risk of measles infection.  (more…)
Author Interviews, Brigham & Women's - Harvard, Colon Cancer, JAMA, Omega-3 Fatty Acids / 26.11.2019

MedicalResearch.com Interview with: MINGYANG SONG, MD, ScD Assistant Professor, Epidemiology Harvard T.H. Chan School Of Public Health Assistant Professor of Medicine Clinical and Translational Epidemiology Unit Massachusetts General Hospital MedicalResearch.com: What is the background for this study? Response: Increasing data indicate that high intake of omega-3 fatty acid may reduce the risk of colorectal cancer. Since effects of nutritional factors on risk of cancer, a slow-developing disease, typically emerge only after several years, it is useful to study the effect of preventive agents on cancer precursors such as colorectal polyps. Colorectal polyps are small growths on the lining of the colon or rectum. Most polyps are harmless, but some can become cancerous. (more…)
Author Interviews, Brigham & Women's - Harvard, Cannabis, JAMA, Pediatrics / 26.11.2019

MedicalResearch.com Interview with: Bertha K. Madras PhD Director, Laboratory of Addiction Neurobiology Psychobiologist, Substance Use Disorders Division, Basic Neuroscience Division Professor of Psychobiology, Department of Psychiatry Harvard Medical School MedicalResearch.com: What is the background for this study? Parent use of marijuana is rising, and I wondered whether this could be associated with offspring use of specific substances and across several substances
  • Several fathers have confided in me that they used marijuana to bond with their sons. They became horrified after witnessing their sons progress to using other drugs, especially heroin.
  • In general, living with a parent using substances or having substance use disorders is an explicit risk for use of substances among young offspring. Yet, few studies have directly examined whether parental marijuana use elevates the risk for opioid misuse among adolescent and young adults living with parents.  Most importantly and to the best of our knowledge, none of the existing research  simultaneously explored frequency of  parental marijuana use and whether it related to adolescent and young adult offspring’s marijuana, tobacco, alcohol use, and opioid misuse.
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Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Rheumatology / 13.11.2019

MedicalResearch.com Interview with: Natalie McCormick, Ph.D. Post-Doctoral Research Fellow Clinical Epidemiology Program Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital Department of Medicine, Harvard Medical School Arthritis Research Canada  MedicalResearch.com: What is the background for this study? Response: Biologic disease-modifying anti-rheumatic drugs (bDMARDs) have improved the health and productivity of many people living with moderate-to-severe inflammatory rheumatic diseases. They are also among the highest-spend drugs in the USA, with substantial out-of-pocket costs that pose barriers to treatment initiation and adherence. To understand the drivers of ongoing bDMARD spending growth, and effective ways of containing costs, we analysed drug spending data for all bDMARD claims in Medicare Part D, Part B fee-for-service, and Medicaid over 2012 to 2016, isolating the impact of changes in drug prices from changes in utilisation.  (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Dermatology, JAMA, Rheumatology / 09.11.2019

MedicalResearch.com Interview with: Emily S. Ruiz, MD, MPH Director, High-Risk Skin Cancer Clinic, Dana Farber/Brigham and Women’s Cancer Center Assistant Professor, Harvard Medical School, Dermatology Brigham And Women's Faulkner Hospital  MedicalResearch.com: What is the background for this study? Response: Innovation in oncology has led to increased development and market entry of anticancer drugs. For example, from 2009 to 2013, the US FDA approved 51 oral and systemic anticancer drugs for 63 indications. Prices for anticancer drugs have risen faster than inflation over time, especially for older drugs, and prices in the US have largely been set by market forces rather than novelty or efficacy. Understanding the evolving cancer economic landscape requires consideration of annual and cumulative rates of change for key metrics, such as total spending, drug cost per beneficiary, out-of-pocket cost, and utilization. This study sought to weigh the proportional impacts of rising drug costs and utilization on increased Medicare Part D spending for a cohort of oral anticancer drug utilized from 2013-2017.  (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Diabetes, JAMA / 02.10.2019

MedicalResearch.com Interview with: Andrew Sumarsono, MD UT Southwestern Medical Center MedicalResearch.com: What is the background for this study?   Response: There are currently 12 types of medications used to treat type 2 diabetes. With approximately 30 million adults living with diabetes in the United States, the rising cost of insulin has raised concerns about the affordability of diabetes care. We evaluated trends in total spending and number of prescriptions of all diabetes therapies among Medicare Part D beneficiaries between 2012 and 2017. (more…)
Alcohol, Alzheimer's - Dementia, Author Interviews, Brigham & Women's - Harvard, Cognitive Issues / 30.09.2019

MedicalResearch.com Interview with: Manja Koch Dr. oec. troph. (Ph.D. equivalent) Research Associate Department of Nutrition Harvard T.H. Chan School of Public Health Majken K. Jensen, PhD Associate Professor of Nutrition Harvard T.H. Chan School of Public HealthMajken K. Jensen, PhD Associate Professor of Nutrition Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease and other dementias are highly prevalent conditions. According to the Alzheimer’s Association, 50 million people are currently living with Alzheimer’s disease or other dementias worldwide. Given the lack of a cure or even disease-modifying therapies for most dementias, the identification of risk factors or factors that prevent or delay the onset of dementia remains of paramount concern. Alcohol is a globally consumed beverage and light-to-moderate alcohol consumption, defined as up to one drink per day for women and up to two drinks per day for men, tends to be associated with lower risk of cardiovascular disease, a major risk factor for dementia. However, the effects of light-to-moderate alcohol intake on the brain are less clear.  (more…)
Allergies, Author Interviews, Brigham & Women's - Harvard, CMAJ, Dermatology, Heart Disease / 30.09.2019

MedicalResearch.com Interview with: Hyon K. Choi, MD, DrPH Professor of Medicine, Harvard Medical School Director, Gout and Crystal Arthropathy Center Director, Clinical Epidemiology and Health Outcomes Division of Rheumatology, Allergy, and Immunology Department of Medicine, Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Allopurinol is a very common and generally safe medication prescribed to lower serum urate levels, most commonly to patients with gout. However, it can be associated with very rare but serious cutaneous adverse events which includes Stevens-Johnson syndrome and toxic epidermal necrolysis. Prior studies have demonstrated several risk factors for these types of cutaneous adverse events, including presence of chronic kidney disease, older age, female sex, higher initial dose of allopurinol, and the HLA-B*5801 allele, which is more commonly found in Asians and Black patients. A prior study in Taiwan suggested that heart disease (ischemic heart disease and heart failure) may also be associated with an increased risk of hospitalizations for these cutaneous adverse reactions related to allopurinol. Thus, our goal was to investigate this association using a general population cohort from Canada. Using Population Data BC, we found that heart disease was in fact independently associated with an increased risk of hospitalization for these cutaneous adverse reactions. (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, Nutrition, Weight Research / 24.09.2019

MedicalResearch.com Interview with: Deirdre K Tobias, ScD Associate Epidemiologist, Brigham and Women’s Hospital Assistant Professor, Harvard Medical School nuts-nutrition-weight-obesityMedicalResearch.com: What is the background for this study? What types of nuts are helpful? Peanuts included?  Response: We did not have the granularity in our study to evaluate too many individual nut types, and did not perform head-to-head comparisons between types of nuts. All seemed to be better for long-term weight control compared with the snacks like potato chips that we know are not great for us on a regular basis. (more…)
AstraZeneca, Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 10.09.2019

MedicalResearch.com Interview with: Dr. David Berg MD Senior Fellow in Cardiovascular Medicine and Critical Care Medicine Brigham and Women’s Hospital Postdoctoral Research Fellow with the TIMI Study Group. MedicalResearch.com: What is the background for this study? Response: Heart failure is a frequent and important complication of type 2 diabetes mellitus (T2DM), but there are limited tools for identifying which patients with T2DM are at the highest risk of developing heart failure. In this study, we developed and validated the TIMI Risk Score for Heart Failure in Diabetes [TRS-HF(DM)], a novel clinical risk score that identifies patients with T2DM who are at heightened risk for hospitalization due to heart failure. Fortunately, the risk score also identifies patients who have the greatest absolute reduction in the risk of hospitalization for heart failure with a new class of glucose-lowering therapies called sodium-glucose cotransporter-2 (SGLT2) inhibitors.  (more…)
Author Interviews, Brigham & Women's - Harvard, Clots - Coagulation, Diabetes, Heart Disease, Lancet / 08.09.2019

MedicalResearch.com Interview with: Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC Professor of Medicine, Harvard Medical School Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy (DAPT) is known to improve outcomes in patients with acute coronary syndromes (ACS), prior myocardial infarction (MI), or recent coronary stenting. What was unknown is whether patients with diabetes and stable coronary artery disease – a group generally believed to be at high ischemic risk – would benefit from initiation of long-term DAPT with low-dose aspirin plus ticagrelor versus low-dose aspirin (plus placebo). This is what THEMIS was designed to test, with THEMIS-PCI designed prospectively to examine those patients specifically who had a history of previous percutaneous coronary intervention (PCI). (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Chemotherapy / 04.09.2019

MedicalResearch.com Interview with: Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Cancer drugs are prescribed to the patients based on results from trials. Usually, these are superiority trials meaning the cancer drugs prove that they are better than the treatment we already have. Recently, more and more cancer drugs are approved on the basis of non-inferiority trials. In these trials, the cancer drugs only prove that they are not worse than the treatment we already have ( instead of proving they are better). Such an approach is considered justified if the new drug provides any other benefit such as lower cost, easy to administer or improved quality of life. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Medicare / 28.08.2019

MedicalResearch.com Interview with: Jose F. Figueroa, MD, MPH Instructor , Harvard Medical School, Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Hospitalizations related to ambulatory-care sensitive conditions are widely considered a key measure of access to high-quality ambulatory care. It is included as a quality measure in many national value-based care programs. To date, we do not really know whether rates of these avoidable hospitalizations are meaningfully improving for Medicare beneficiaries over time. (more…)
AHA Journals, Author Interviews, Brigham & Women's - Harvard, Heart Disease, Nutrition, Vegetarians / 22.08.2019

MedicalResearch.com Interview with: Megu Baden, MD, PhD Department of Nutrition Harvard T. H. Chan School of Public Health Boston, MA02115  MedicalResearch.com: What is the background for this study? Would you give an example of healthful vs non-healthful plantbased diet? Response: Plant-based diets are recommended for health and recently also for their environmental benefits. However, most previous studies defined it as either vegetarian or non-vegetarian, and importantly, without differentiation for the quality of plant foods. As you know, not all plant foods are equally good to our health. Therefore, to capture the quality of plant-based diets, we established overall, healthful and unhealthful plant-based diet indices. A higher score on the overall plant based diet index indicates greater intake of all types of plant foods and less of animal foods. A higher score on the healthful plant based diet index indicates greater intake of only healthy plant foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea/coffee), and less of less healthy plant foods (fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets/desserts) and animal foods. A higher score on the unhealthful plant based diet index indicates greater intake of only less healthy plant foods, and less of healthy plant foods and animal foods. In this study, we used these plant-based diet indices and investigated the associations between 12-year changes in plant-based diet quality and subsequent total and cause-specific mortality in two large US cohorts. (more…)
Author Interviews, Brigham & Women's - Harvard, Global Health, Infections, Lancet, Pediatrics / 21.08.2019

MedicalResearch.com Interview with: Tori Cowger, MPH Ph.D Student | Population Health Sciences Department of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: Globally, approximately one million cases of tuberculosis disease (TB) and 233,000 TB-related deaths occurred among children aged younger than 15 years during 2018. TB in children and adolescents is clinically and epidemiologically heterogeneous, making diagnosis, care, and prevention challenging. Understanding this heterogeneity can inform TB care and prevention efforts, and efforts to eliminate disparities in TB incidence and mortality in these groups. In this study, we describe the epidemiology of TB among children and adolescents in the United States, and report TB incidence rates for US territories and freely associated states and by parental country of birth, which have not been previously described. (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Genetic Research / 19.08.2019

MedicalResearch.com Interview with: Tengteng Wang, PhD, MSPH, MBBS Postdoctoral Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Channing Division of Network Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Chronic inflammation is a key player in the development of multiple cancer types, including breast cancer. Aspirin is one of the major non-steroidal anti-inflammatory drugs (NSAIDs) which clearly has anti-inflammatory properties. Given this, substantial evidence from laboratory and population studies suggests that taking aspirin may reduce the risk of developing breast cancer. However, the association of aspirin use with death outcomes following breast cancer diagnosis remains inconclusive and inconsistent across studies. Therefore, we choose to focus on mortality outcomes in this paper and we hypothesized that the inconsistent results for aspirin in relation to mortality could be due to differences in the association by patients’ biological profiles, specifically DNA methylation profiles here.  (more…)
Author Interviews, Brigham & Women's - Harvard, Opiods / 06.08.2019

MedicalResearch.com Interview with: Lauren A. Hoffman, Ph.D. Research Fellow Recovery Research Institute Center for Addiction Medicine Massachusetts General Hospital Harvard Medical School MedicalResearch.com: What is the background for this study?   Response: In 2017, an estimated 11.4 million Americans reported past-year opioid misuse1 and opioid-related overdose accounted for more than 47,000 deaths2. Prior research has helped further our understanding of the prevalence and consequences of opioid misuse, but we know substantially less about recovery from opioid use problems. Recovery-focused research conducted to-date has largely focused on alcohol use disorder, the most common type of substance use disorder. Characterizing recovery from opioid use problems and the pathways that individuals take to resolve such problems can ultimately help identify effective ways to address opioid misuse. Using data from the first national probability-based sample of US adults who have resolved a significant substance use problem (National Recovery Survey3), we provide the first national prevalence estimate of opioid recovery, and characterize treatment/recovery service use and psychological well-being in individuals who resolved a primary problem with opioids, relative to individuals who resolved a primary alcohol problem. We focused our cross-sectional investigation of service use and well-being on 2 time-horizons associated with continued vulnerability: <1 year since problem resolution (early-recovery) and 1 – 5 years since problem resolution (mid-recovery). (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, Race/Ethnic Diversity / 05.08.2019

MedicalResearch.com Interview with: Muhammad Ali Chaudhary, MD Research Scientist Center for Surgery and Public Health Department of Surgery Brigham and Women’s Hospital Harvard Medical School Harvard T. H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: Many studies have documented disparities in cardiovascular care for minorities, specifically African Americans compared to white patients. Coronary artery bypass grafting (CABG) is a common procedure in the United States, and the outcomes and post-surgical care for African Americans tend to be worse. We examined whether patients insured through TRICARE — a universal insurance and equal-access integrated healthcare system that covers more than 9 million active-duty members, veterans and their families — experienced these disparities. We found no racial disparities in quality-of-care outcomes, providing insights about the potential impacts of universal insurance and an equal-access health care system. The study included 8,183 TRICARE patients, aged 18-64, who had undergone CABG. The study took its data from TRICARE health care claims from the Military Health System Data Repository for the years of 2006 to 2014. (more…)
Accidents & Violence, Author Interviews, Brigham & Women's - Harvard, JAMA, Ophthalmology / 01.08.2019

MedicalResearch.com Interview with: Daejoon Alex Hwang, PhD Instructor in Ophthalmology Investigator, Schepens Eye Research Institute of Mass. Eye and Ear Harvard Medical School MedicalResearch.com: What is the background for this study?   Response: Yellow night driving glasses are sold with promises to reduce headlight glare from oncoming traffic and help aging individuals see better at night. Despite a 1997 ruling by the Federal Trade Commission against one company’s claims, the products still remain popular online. We tested three commercially available yellow lens night driving glasses and compare their effectiveness with clear lens glasses on our novel headlight glare simulator in the driving simulator. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, ENT, Surgical Research / 25.07.2019

MedicalResearch.com Interview with: Vinay K. Rathi, MD Otolaryngology Resident | Massachusetts Eye and Ear Project Manager | Partners Ambulatory Care MBA Candidate | Harvard Business School  MedicalResearch.com: What is the background for this study?  Response: This study is a secondary subgroup analysis that follows on the heels of a recently published study in The New England Journal of Medicine (NEJM) examining physician reimbursement for surgical procedures in the Medicare Physician Fee Schedule (PFS), which both public and private insurers use to determine payment rates for clinician services. Although it is widely understood that physician time (i.e., the amount of physician time required to perform a procedure) is perhaps the most important factor used to determine payment rates, the Centers for Medicare and Medicaid Services (CMS) has historically relied upon limited and potentially biased survey data to estimate physician time. Leveraging time data from American College of Surgeons National Quality Improvement Program, the authors of the recent NEJM study demonstrated that CMS does not appear to systematically misestimate intraoperative times, but there are substantial discrepancies that may result in over- or undercompensation for certain procedures and specialties. (more…)
Annals Thoracic Surgery, Author Interviews, Beth Israel Deaconess, Brigham & Women's - Harvard, Geriatrics, Heart Disease, Primary Care / 23.07.2019

MedicalResearch.com Interview with: Christina C. Wee, MD, MPH Associate Professor of Medicine Harvard Medical School Director , Obesity Research Program Division of General Medicine Beth Israel Deaconess Medical Center (BIDMC) Associate Program Director, Internal Medicine Program, BIDMC Deputy Editor of the Annals of Internal Medicine MedicalResearch.com: What is the background for this study? Response: New research is showing that for many people without diagnosed heart disease, the risk of bleeding may outweigh the benefits of taking a daily aspirin particularly in adults over 70 years of age.  The American Heart Association and the American College of Cardiology recently updated their guidelines and now explicitly recommend against aspirin use among those over the age of 70 who do not have existing heart disease or stroke. Our study found that in 2017,  a quarter of adults aged 40 years or older without cardiovascular disease – approximately 29 million people – reported taking daily aspirin for prevention of heart disease. Of these, some 6.6. million people did so without a physician's recommendation. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Nutrition, Weight Research / 22.07.2019

MedicalResearch.com Interview with: Frank Qian, MPH Department of Nutrition Harvard T. H. Chan School of Public Health Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: Plant-based diets have really grown in popularity in the last several years, particularly among the younger generation in the United States, many of whom are adopting a plant-based or vegetarian/vegan diet. However, the quality of such a diet can vary drastically. While many prior studies have demonstrated beneficial associations for risk of type 2 diabetes with healthful plant-based foods such as fruits, vegetables, nuts/seeds, whole grains, and legumes, the opposite is true for less healthful plant-based foods such as potatoes and refined grains such as white rice. In addition, some animal-based foods, such as dairy and fish, have shown protective associations against the development of type 2 diabetes, so strict vegetarian diets which exclude these foods may miss out on the potential benefits. Given these divergent findings, we sought to pool all the available data from prior cohort studies to analyze whether the overall association of a diet which emphasizes plant-based foods (both healthful and unhealthful) are related to risk of type 2 diabetes. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Lung Cancer, Radiation Therapy / 10.06.2019

MedicalResearch.com Interview with:   Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School Radiation Oncology Brigham and Women's Hospital       Katelyn M. Atkins MD PhD Harvard Radiation Oncology Program Dana-Farber Cancer Institute Brigham and Women’s Hospital Boston, Massachusetts     MedicalResearch.com: What is the background for this study? What are the main findings? 
  • Lung cancer remains the leading cause of cancer-related death worldwide and nearly half of patients will require radiation therapy as part of their care.
  • Cardiac toxicity following radiotherapy has been well-studied in breast cancer and lymphomas, however the impact of cardiac toxicity following lung cancer radiotherapy has historically been under-appreciated due to the high risk of lung cancer death.
  • Recent studies highlighting cardiac toxicity following lung cancer radiotherapy have been limited by small numbers of patients and, to our best knowledge, have not included validated cardiac event endpoints defined by the American Heart Association (AHA)/American College of Cardiology (ACC).
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Author Interviews, Brigham & Women's - Harvard, Prostate Cancer, Weight Research / 10.06.2019

MedicalResearch.com Interview with: Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study. (more…)
Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, JAMA / 02.06.2019

MedicalResearch.com Interview with: I-Min Lee, MD, ScD Professor of Medicine, Harvard Medical School Professor of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: While we have many studies showing that physical activity is beneficial for health, there are few data on steps and health, particularly long-term health outcomes.  An expert committee – the 2018 Physical Activity Guidelines Advisory Committee, which reviewed the scientific evidence to support the recently released Physical Activity Guidelines for Americans, 2nd edition – noted this (i.e., the relation between steps and health outcomes) to be a critical gap in knowledge, since many individuals are using wearables and monitoring their step counts. We often hear the number 10,000 steps cited as a daily goal, but the basis for this number is unclear. It likely originated as a marketing tool: in 1965, the Yamasa Clock and Instrument Company, Japan sold a pedometer called “Manpo-kei” – “ten thousand steps meter” in Japanese. For many older people, 10,000 steps/day can be a very daunting goal; thus, we wanted to investigate whether this was necessary for lower mortality rates in older women.  Additionally, steps taken can be fast or slow, and there are no published studies on step intensity and long-term health outcomes.  Note that walking pace and step intensity are not the same concept: walking pace gauges intensity when walking purposefully (e.g., for exercise or transportation), while step intensity assesses an overall best natural effort in our daily life. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: Bishal Gyawali  MD PhD
  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada
MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists. Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review. Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Lipids / 28.05.2019

MedicalResearch.com Interview with: Samia Mora, MD, MHS Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Preventive Medicine Boston, MA 02115  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk. To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy. (more…)
Author Interviews, Brigham & Women's - Harvard, Opiods, Orthopedics, Pain Research, Surgical Research / 16.05.2019

MedicalResearch.com Interview with: Marilyn M. Heng, MD, MPH, FRCSC Orthopaedic Trauma Surgeon Assistant Professor of Orthopaedic Surgery Harvard Medical School  MedicalResearch.com: What is the background for this study?   Response: The ultimate background for this study does come from the larger context of the opioid epidemic that is seen worldwide but particularly in North America. Orthopaedic surgeons should take responsibility as being among the top prescribers of opioids. The more specific background that led to this specific study was the observation that several colleagues would insist that a drug like hydromorphone was so dangerous that they would not prescribe it but seemed okay prescribing large amounts of oxycodone.  It seemed like an urban myth that the type of opioid was what made it dangerous, so that led us to do the study to see if there was evidence for that.  (more…)