About Marie Benz MD FAAD

Physician in practice over 30 years. Editor of MedicalResearch.com. All interviews conducted exclusively for MedicalResearch.com by Marie Benz, MD.

Head Tilt Can Assert Dominance

Posted on June 16, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Zachary Witkower

Zachary Witkower
University of British Columbia
PhD Student

MedicalResearch.com: What is the background for this study?

Response: When we form judgments about other people –what their personality is like, or how they are feeling at the moment– we tend to focus our attention towards their face. This is not surprising, as facial shape and facial expressions contain all kinds of information that can be used to inform judgments.

However, faces are almost never viewed in isolation. Instead, faces are almost always viewed as they rest upon the face’s physical foundation: the head. Yet little is known about how head position might influence judgments about personality or social status, or – importantly – how head position might change the way faces are perceived. In the present research, we examined how and why head position might influence social judgments made from the face. Continue reading →

Could Breast Milk from Overweight Moms Play a Role in Childhood Obesity?

Posted on June 16, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Nuss

Henry J. Nuss, Ph.D.
Assistant Professor
Louisiana State University Health Sciences Center
School of Public Health
New Orleans, LA

MedicalResearch.com: What is the background for this study?

Response: Childhood obesity rates in the U.S. have been increasing within the past 30 years. We can point to things like sedentary lifestyle, energy-dense, nutrient-poor foods and savvy marketing techniques of large food corporations that target kids and their parents to buy food items that aren’t healthy. That said, we do know that women who have an unhealthy weight status (as measured by BMI ≥ 25) tend to have offspring that eventually attain an unhealthy weight status themselves. Aside from environmental factors, could this be due to maternal programming or perhaps something in the breastmilk? Or both? We saw some interesting research that showed breastfed infants/toddlers born to asthmatic moms were more likely to develop asthma. Furthermore, this association became stronger the longer the infants/toddlers were breastfed. The conclusion here is that it must be something in the breastmilk.

We knew that asthma and obesity are both inflammatory in nature and that there are specific pro- and anti-inflammatory and obesogenic bioactive compounds in human breastmilk. Some have been studied before but there were no studies at the time that tied all of the pieces together. If we could target specific compounds in the milk that were associated with unhealthy growth patterns in infants then we could perhaps be more specific in how we fight this problem.

Continue reading →

Insulin Costs Rise But Mostly Not Paid For Out-of-Pocket by Patients

Posted on June 16, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:
Dr. Hui Shao, MBBS, MHA, PhD
CDC

MedicalResearch.com: What is the background for this study?

Response: 23.1 million people in the U.S. have diagnosed diabetes and 7.4 million regularly use one or more types of insulin. Spending on insulin accounts for a large portion of the costs associated with diabetes. Affordability of insulin has become a public health concern in recent years as high spending on insulin imposes a large financial burden on the national health care system and is associated with poor adherence and health outcomes.

MedicalResearch.com: What are the main findings?

Response: In this study, we analyzed the recent trends in usage and total payments, and patients’ out-of-pocket (OOP) payments for insulin by type in privately insured Americans (MarketScan Claims database) 2003-2017. We estimated total payment and out-of-pocket payment for a 30-day/yearly supply of different types of insulin and found that, on average, inflation-adjusted annual total payments for insulin increased yearly by around 6% ($153) between 2003 and 2012 and by around 13% ($592) between 2011 and 2017. Similar increase patterns were observed across insulin types.

The major driver for increases in average total payments for a 30-day supply of insulin were explained by increases in payments for existing products and not by changes in the market share of insulin types. In contrast, out-of-pocket payments increased only marginally, suggesting that the increase in insulin spending was not paid directly by the patient.

MedicalResearch.com: What should readers take away from your report?

Response: The average annual total payment increased substantially during the study period, from $1,982 per year in 2003 to $6,360 per year in 2017 (in inflation-adjusted in 2017$). Total payments for insulin have been increasing since 2003 but were at much higher rates after 2011. In contrast, annual out-of-pocket costs increased only marginally from $390 to $451 during the same period, suggesting that the sharp payment increases were not paid out of pocket by the patient. The payment increase occurred across all insulin types, suggesting a lack of inexpensive alternatives in the insulin market. Even for human insulin, the cheapest form of insulin, the average payment for a 30-day supply caught up with insulin analogs in 2017.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Our study population is those with private insurance with the fee for service. Additional research is needed to help determine if similar spending patterns are observed in persons with other types of health insurance, especially those with high-deductible plans and those without health insurance.

Further research in this area could also help us determine the cause of rising insulin costs, and inform decision-making at all levels, which could reduce insulin cost, or slow the consistent increase in cost.

MedicalResearch.com: Is there anything else you would like to add?

Response: There are no additional comments or disclosures. For more information about how the CDC works to prevent and control diabetes visit https://www.cdc.gov/diabetes/index.html.

Citation: ADA 2019 abstract

Trend in Total Payment and Out-of-Pocket Payment on a Yearly Supply of Oral Antidiabetic Drug Types among U.S. Adults with Private Health Insurance from 2003 to 2016

HUI SHAO, MICHAEL LAXY, STEPHEN R. BENOIT, YILING J. CHENG, EDWARD GREGG and PING ZHANG

Diabetes 2019 Jun; 68 (Supplement 1): 1239-P. https://doi.org/10.2337/db19-1239-P

Jun 16, 2019 @ 12:58 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Opioid ‘Deaths of Despair’ Don’t Explain Mortality Gap

Posted on June 16, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Geronimus

Arline T. Geronimus Sc.D
Professor, Health Behavior and Health Education
School of Public Health
Research Professor
Population Studies Center
Institute for Social Research
University of Michigan
Member, National Academy of Medicine

MedicalResearch.com: What is the background for this study?

Response: The gap in life expectancy between less and more educated Americans grew over the last 30 years, a deeply troubling fact. We are alone among western nations in these trends. We aimed to determine what causes of death account for this growing educational gap in life expectancy and whether the gap has continued to grow in the most recent years.

Disturbingly, we found the educational gap in life expectancy has continued to grow.

Why? A common theory is that this growing inequality is due to the opioid epidemic. Some even speculate that the less educated are dying from a composite of what they call “deaths of despair” – opioid and other drug overdose, suicide and alcoholic liver disease – with the theory being that as less educated and working class Americans have faced job loss and stagnating wages, they experience hopelessness and despair and turn to drugs, alcohol, or even suicide to ease or end their pain and feelings of hopelessness.

However, while opioid, suicide and alcoholic liver disease deaths have increased among white youth and young adults and is cause for concern, this does not imply that these deaths should be grouped together as “deaths of despair” (DOD) or that they explain the growing educational gaps in life expectancy across all groups – men, women, whites, blacks, or older as well as younger adults.

Continue reading →

TAVR vs Surgical Aortic Valve Replacement Among Low-Risk Patients With Aortic Stenosis

Posted on June 16, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Fausto Biancari, Professor of Surgery, University of Turku, Finland Professor of Cardiothoracic Surgery, University of Oulu, Finland Heart Center, T-Hospital, Hämeentie Turku, Finland

Prof. Biancari

Fausto Biancari, MD, PhD
Professor
University of Turku and University
Oulu, Finland

MedicalResearch.com: What is the background for this study?

Response: Current data is scarce regarding the short- and midterm benefit of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic valve stenosis.

MedicalResearch.com: What are the main findings?

Response: In this observational study on 2841 low-risk patients with aortic valve stenosis from the Finnish nationwide FinnValve registry, propensity score matching analysis showed similar 30-day and three-year survival after TAVR and SAVR.

Continue reading →

Gender Differences in Bothersome Restless Legs Syndrome of Sleep

Posted on June 16, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Stefani

Ambra Stefani, MD
Sleep Disorders Clinic
Department of Neurology
Innsbruck Medical University
Innsbruck, Austria

MedicalResearch.com: What is the background for this study?

Response: Restless legs syndrome (RLS) is a common neurological disorder, affecting up to 10% of the general population in Europe and North America. It is a sensorimotor disorder characterized by unpleasant sensations and an urge to move, mainly involving the legs. These symptoms appear or worsen in the evening/at night and improve with movement.

Background for this study was the idea that there might be gender differences in the phenotypical presentation of RLS, as the pathogenesis of this disease is multifactorial and gender specific factors also play a role.

Continue reading →

Past and Present Smoking Raises Risk of Dermatology Surgery Complications

Posted on June 14, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Maher

Ian A. Maher, MDDepartment of Dermatology
St Louis University, St Louis, Missouri

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: One of our wonderful trainees at Saint Louis University was interested in the role of smoking in flap failures. Dogma has been that smoking was a major risk factor for flap failures. Looking at our database as well as published data, flap failures are a rare event, so rare as to be difficult to definitively associate with anything. We decided to look more broadly at complications both acute (infections failures) and chronic (mainly cosmetic scarring associated) in flaps and grafts. Continue reading →

Use of AV Grafts Drops in Dialysis Patients, But Still Room For Improvement

Posted on June 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Hicks

Caitlin W. Hicks, M.D., M.S.
Assistant Professor of Surgery
Recipient of the Department of Surgery
Rothman Early Career Development Award for Surgical Research
Johns Hopkins Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Arteriovenous fistula are associated with better long-term patency, lower rates of infection, and lower long-term costs compared to arteriovenous graft. As a result, the Fistula First Catheter Last Guidelines recommend placement of an arteriovenous fistula over an AVG whenever possible.

We looked at individual physician utilization of AVF vs AVG for first-time AV access in Medicare beneficiaries. We found that the median physician utilization rate for AVG was only 18%, but that 21% of physicians use AVG in more than 34% of cases, which is above currently recommended practice guidelines.

Continue reading →

Metagenomic Sequencing Enhanced Diagnosis of Meningitis and Encephalitis Infections

Posted on June 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Chiu

Dr. Charles Chiu, M.D./Ph.D.
Professor, Laboratory Medicine and Medicine / Infectious Diseases
Director, UCSF-Abbott Viral Diagnostics and Discovery Center
Associate Director, UCSF Clinical Microbiology Laboratory
UCSF School of Medicine

MedicalResearch.com: What is the background for this study? Would you describe what is meant by metagenomic sequencing?

Response: Metagenomic next-generation sequencing (mNGS) is the use of technology to generate millions of sequence reads to diagnose infection sin patients by characterizing the full range of potential pathogens (bacteria, viruses, fungi, and parasites) in a single sample. Although shown to be a promising diagnostic tool for infectious diseases in case reports and limited case series (Chiu and Miller Nature Reviews Genetics 20, 341-355 (2019)), to date the “real-life” utility of this approach for patient care has hitherto not been demonstrated. This study is the first prospective, multi-center study of clinical mNGS testing for the diagnosis of neurological infections in acutely ill hospitalized patients presenting with meningitis and/or encephalitis.

Continue reading →

PCSK9 Inhibitor (evolocumab) Added to Statin Lowered Risk of Cardiovascular Events in Kidney Disease Patients

Posted on June 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Charytan

David Charytan, MD MSc
Chief, Nephrology Division
NYU Langone Medical Center
New York, NY 10010

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Cardiovascular events are much more frequent in patients with impaired kidney function (chronic kidney disease), and cardiovascular disease is the most common cause of death in advanced chronic kidney disease. This risk remains high despite the use of standard medical therapies including statins, the most commonly used cholesterol lowering agents.

The PCSK9 inhibitor evolocumab is a new class of highly potent cholesterol lowering medications that can further reduce the risk of cardiovascular events in patients already taking statins. We analyzed data from the FOURIER trial, which randomized study patients with clinically evident atherosclerosis and an LDL cholesterol level >=70 mg/dL or HDL cholesterol level >= while on a statin, to assess the safety and efficacy of evolocumab, a PCSK9 inhibitor, compared with placebo in individuals with mild to moderate chronic kidney disease.

There were several major findings

a) evolocumab appears to be equally safe in individuals with preserved and mild to moderately impaired kidney function
b) evolocumab appears to have preserved efficacy at preventing cardiovascular events as kidney function declines.
c) We were unable to detect any significant impact on kidney function.
In addition, because the baseline risk of cardiovascular events is much higher in individuals with chronic kidney disease, the absolute benefits of treatment with evolocumab appear to be magnified as kidney function declines. Continue reading →

PTSD: Comparative Effectiveness of Medications, Psychotherapeutic and Combination Treatments

Posted on June 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Gerger

Dr. Heike Gerger | Senior Postdoc
University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy
Basel | Switzerland

MedicalResearch.com: What is the background for this study?

Response: Posttraumatic stress disorder (PTSD) is one of the most prevalent mental disorders, with a high risk of chronicity, comorbidity, and functional impairment. PTSD is complicated to treat, and the debate on the most efficacious treatment approach is ongoing. Treatment guidelines for the treatment of PTSD typically recommend different types of trauma-focused psychotherapeutic treatments as first-line PTSD treatment. However, concerning pharmacological therapies recommendations are inconsistent.

Continue reading →

Turn Off the Smartphone and TV at Night To Reduce Risk of Weight Gain

Posted on June 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Park

Lead author: Yong-Moon (“Mark”) Park, MD, PhD
Postdoctoral fellow
Epidemiology Branch
National Institute of Environmental Health Sciences

Dr. Sandler

Senior author: Dale P. Sandler, PhD
Chief, Epidemiology Branch, National Institute of Environmental Health Sciences
National Institutes of Health

MedicalResearch.com: What is the background for this study?

Response: A few studies had suggested that exposure to artificial light while sleeping was associated with obesity. However, the previous studies were cross-sectional, so we really do not know which came first – exposure to artificial light while sleeping or obesity. Another problem was that previous studies did not fully account for other characteristics that could affect this association, such as sleep duration and quality, calorie intake and dietary patterns, and physical activity.

We studied nearly 44,000 women ages 35-74 from across the US who are enrolled in the Sister Study cohort. Women had body weight characteristics measured at baseline and provided self-reported information on weight at baseline and follow-up – on average 5.7 years later.

Continue reading →

Aspirin for Primary Prevention of Cardiovascular Events

Posted on June 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Mehta

J.L. Mehta, MD, PhD

Distinguished Professor of Medicine and Physiology and Biophysics

Stebbins Chair in Cardiology

University of Arkansas for Medical Sciences

Central Arkansas Veterans Healthcare System

Little Rock, AR 72205

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Aspirin is commonly used for primary prevention of cardiovascular disease events in a variety of subjects around the world. Recent studies, however, show that routine use of aspirin without assessment of risk for cardiovascular disease events may not be appropriate, and may even be harmful. Continue reading →

Are Younger People Really Addicted to Their Smartphones?

Posted on June 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Ms. Davidson

Brittany I. Davidson MA
Doctoral Researcher in Information Systems
University of Bath

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Typically, research interested in the impact of technology, or more specifically, smartphones on people and society, use surveys to measure people’s usage. Almost always, these studies claim potential harms from using smartphones, like depression, anxiety, or poorer sleep. However, these studies simply ask people about their behaviour rather than actually measuring it.

In our study, we took 10 widely used surveys to measure screen time, which typically asks how often people use their smartphone or how problematic their usage is. We compared this to people’s objective smartphone usage from Apple Screen time (e.g., minutes spend on iPhone, number of times they picked up their phone, and the number of notifications received).

We found that there is a large discrepancy between what people self-report and what they actually do with their iPhone. This is highly problematic as the sweeping statements that claim smartphones (or technology more generally) have a negative impact on mental health are not based on solid and robust evidence at this time, which leaves much to be desired in terms of what we really know about the impacts of technology use on people.

Continue reading →

More Scooters Means More Head and Face Injuries

Posted on June 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Bresler

Amishav Bresler MD
Department of Otolaryngology – Head and Neck Surgery
Rutgers – New Jersey Medical School

MedicalResearch.com: What is the background for this study?

Response: This study was inspired by a personal experience with the rental scooters.

The most recent American Academy of Otolaryngology-Head and Neck Surgery annual conference was in Atlanta this year. At the time of the conference, the scooter rental industry had recently entered the region. A friend of mine, another ENT resident, was encouraging others to use these scooters for transportation for both the novelty and convenience. However, he didn’t even have a helmet!

Here was a well-educated doctor who takes call for craniofacial injuries, who was about to get on a scooter without a helmet. This experience made me wonder if scooters were dangerous scooters and their overall impact on public health.

In terms of the backgroud, the personal transportation industry is undergoing a revolution. The search for efficient and environmentally-friendly urban transportation ignited an ongoing debate in the United States regarding the role of motorized scooters. Although known to be a popular method of transportation in Europe and Asia, motorized scooters have only recently begun to make inroads in the United States. The gradual rise in popularity has been attributed to their convenience, affordability, and status as a “green” alternative to vehicles with combustion engines. These advantages combined with the fact electric scooters enable users to travel longer distances than conventional scooters present an attractive method of transportation to school, work, and leisure.

Continue reading →

Islet Cell Transplantation Can Give Some Diabetics Long Term Glucose Control

Posted on June 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Alejandro

Dr. Rodolfo Alejandro, MD
Professor of Medicine
University of Miami Miller School of Medicine
Co-Director of the Cell Transplant Center
Director/Attending Physician of the Clinical Cell Transplant Program
Diabetes Research Institute
www.DiabetesResearch.org

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In type 1 diabetes, the insulin-producing islets cells of the pancreas have been mistakenly destroyed by the immune system, requiring patients to manage their blood sugar levels through a daily regimen of insulin therapy. Islet transplantation has allowed some patients to live without the need for insulin injections after receiving a transplant of donor cells. Some patients who have received islet transplants have been insulin independent for more than a decade, as DRI researchers have published. Currently, islet transplantation remains an experimental procedure limited to a select group of adult patients with type 1 diabetes.Although not all subjects remain insulin independent, like the subjects described in this presentation, after an islet transplant a significant number of them continue with excellent graft function for over 10 years that allows them to have near-normal glucose metabolism in the absence of severe hypoglycemia on small doses of insulin.

In 2016, the National Institutes of Health-sponsored Clinical Islet Transplantation Consortium reported results from its Food and Drug Administration (FDA)-authorized Phase 3 multi-center trial, of which the DRI was a part, indicating that islet transplantation was effective in preventing severe hypoglycemia (low blood sugar levels), a particularly feared complication in type 1 diabetes that can lead to seizures, loss of consciousness and even death.

The study was a significant step toward making islet transplantation an approved treatment for people with type 1 diabetes and reimbursable through health insurance, as it is in several other countries around the world. Continue reading →

Apple or Pear? Body Shape Not Determined Just by Fat

Posted on June 11, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Karastergiou

Kalypso Karastergiou, MD, PhD
Assistant Professor, Medicine, Endocrinology, Diabetes and Bone Disease
Diabetes, Obesity and Metabolism Institute
Icahn School of Medicine at Mount Sinai

MedicalResearch.com: What is the background for this study?

Response: Multiple studies, epidemiological as well as clinical, have established that body shape is an important and independent predictor of cardiovascular and metabolic disease risk and ultimately total mortality. Subjects that preferentially store weight in the abdominal area (often described as android, upper-body or apple-shape obesity) are at increased risk, whereas those who preferentially store weight in the lower body, in the gluteofemoral area (gynoid, lower-body or pear-shape), appear to be protected. The former is more common in men, whereas the latter in women, especially premenopausal women.

The overarching questions in the field are:

What factors determine body shape?
Why are subjects with lower-body shape protected?
Can we exploit the physiological and pathophysiological mechanisms involved to improve stratification, prevention or treatment of obesity and related diseases?

Continue reading →

Updated Expert Consensus Statement on Platelet Function/Genetic Testing for Guiding P2Y12 Receptor-Inhibitor Treatment in PCI

Posted on June 11, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Prof. Sibbing

Prof. Dr. med. Dirk Sibbing, MHBA, FESC
Oberarzt, Medizinische Klinik und Poliklinik I
Ludwig-Maximilians-Universität (LMU) München
Chairperson ESC Working Group on Thrombosis
München, Germany

MedicalResearch.com: What is the background for this consensus statement? What are the main findings that led to these conclusions?

Response: The availability of different P2Y₁₂ receptor inhibitors (clopidogrel, prasugrel, ticagrelor) with varying levels of potency has enabled physicians to contemplate individualized treatment concepts. Such concepts may include escalation or de-escalation of P2Y₁₂ inhibiting therapy.

Alternative DAPT strategies may be chosen according to the clinical setting (stable coronary artery disease vs. acute coronary syndrome), the stage of the disease (early vs. chronic treatment) and patient risk for ischemic and bleeding complications. As always in clinical medicine, guidance by means of biomarkers or risk scores is always helpful and warranted. Here specifically, a tailored DAPT approach may be potentially guided by platelet function (PFT) or genetic testing. Continue reading →

Cardiac Radiation Can Increase Mortality in Lung Cancer Patients

Posted on June 10, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Mak

Raymond H Mak, MD
Assistant Professor of Radiation Oncology
Harvard Medical School
Radiation Oncology
Brigham and Women’s Hospital

Dr. Atkins

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).

Continue reading →

Fat Distribution Linked to Advanced and Fatal Prostate Cancer

Posted on June 10, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Dickerman

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.

Continue reading →

FDgard® Combination of Caraway Oil and L-Menthol for Treatment of Functional Dyspepsia

Posted on June 10, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Chey

William D. Chey, M.D., F.A.C.G.
Director, Division of Gastroenterology
Michigan Medicine Gastroenterology Clinic
Ann Arbor, Michigan

MedicalResearch: What is the background for this study? Would you tell us what is meant by Functional Dyspepsia?

Response: Functional dyspepsia (FD or meal-triggered indigestion) is a very common disorder affecting 11 percent – 29.2 percent of the world’s population, making it comparable in prevalence to Irritable Bowel Syndrome (IBS). However, unlike IBS, there is no FDA approved product to treat FD. Sufferers are often treated off-label with prescribed proton pump inhibitors (PPIs), histamine type-2 receptor antagonists (H2RAs), antidepressants, and prokinetics. While offering relief to a portion of FD patients, some of these have been associated with adverse events. Functional dyspepsia can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.

In functional dyspepsia, which is typically recurring, meal-triggered indigestion with no known organic cause, the normal function and sensation of the stomach and intestines are altered. FD is accompanied by symptoms such as epigastric pain or discomfort, epigastric burning, postprandial fullness, inability to finish a normal sized meal, heaviness, pressure, bloating in the upper abdomen, nausea, and belching. When doctors diagnose FD, they often identify patients as those who have these symptoms for at least three months, with symptom onset six months previously.

Caraway oil and peppermint oil have a history of helping some patients with functional dyspepsia. In multiple clinical studies, the combination of caraway oil and peppermint oil has been shown to manage FD and its accompanying symptoms, such as reducing the intensity of epigastric pain, pain frequency, dyspeptic discomfort, and the intensity of sensations of pressure, abdominal heaviness and fullness significantly better than control

Continue reading →

Hepatitis C Treatment: Study Finds No Liver, Kidney or Cardiovascular Adverse Effects

Posted on June 10, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. McGlynn

Elizabeth A. McGlynn, PhD
Vice President for Kaiser Permanente Research
Executive Director
Kaiser Permanente Center for Effectiveness and Safety

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue. We found no evidence of increased risks of significant side effects associated with taking these drugs. In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events: death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia. Continue reading →

The Vitamin D and Type 2 Diabetes Study

Posted on June 9, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Anastassios G. Pittas, M.D MS Professor Co-Director, Diabetes and Lipid Center; Tufts University School of Medicine

Dr. Pittas

Anastassios G. Pittas, M.D MS
Professor
Co-Director, Diabetes and Lipid Center;
Tufts Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Observational studies have consistently reported an association between low blood vitamin D level and development of type 2 diabetes. However, whether vitamin D supplementation lowers risk of developing diabetes is not known. We designed and conducted the Vitamin D and diabetes (D2d) study to answer this question. We randomized 2,423 people with prediabetes to 4,000 IU/day of vitamin D3 or placebo and followed them for new-onset diabetes with blood tests every 6 months for an average of 2.5 years. About 80% of participants had sufficient vitamin D level at baseline (25-hydroxyvitamin D level >= 20 ng/mL). The trial was designed to show a reduction of 25% or more in diabetes risk with vitamin D.

The study was unable to show a reduction of 25% or more. At the end of the study, there was a 12% reduction in risk of developing diabetes with vitamin D, which missed statistical significance (hazard ration 0.88; 95% confidence interval 0.75 to 1.04). In a small subgroup of participants with vitamin D deficiency at baseline (25-hydroxyvitamin D level < 12 ng/mL) there was 62% reduction in risk of diabetes with vitamin D (hazard ration 0.38; 95% confidence interval 0.18 to 0.80).

Continue reading →

Midlife Type 2 Diabetes Mellitus Linked to Increased Risk of Ischemic Stroke

Posted on June 9, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:
Rongrong Yang, PhD candidate
Tianjin Medical University

MedicalResearch.com: What is the background for this study?

Response: Worldwide, cerebrovascular disease (CBD) and type 2 diabetes mellitus (T2DM) are common disorders that have become among the top ten leading causes of death, killing approximately 8 million people in 2016. Both T2DM and CBD are complex genetic and lifestyle-related disorders. Genetic and familial environmental factors (e.g. foetal environment, maternal smoking and childhood socioeconomic status) have been shown to be involved in the development of both conditions. Accumulating evidence from previous studies suggests that T2DM is independently associated with an increased risk of CBD, especially ischemic CBD.

Continue reading →

Some Patients Can Be Rechallenged After Immune Adverse Events from Checkpoint Inhibitors

Posted on June 7, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:
Prof. Olivier Lambotte, MD, PHD
Professor of Internal Medicine
Paris XI University Medical School
Research Director
Control of Chronic Viral Infections Department

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Immune checkpoint inhibitors (ICIs) anti-programmed death-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) have proven efficacy in the treatment of many cancers but patients may experience immune-related adverse events (irAEs). Immune checkpoint inhibitors is usually stopped when grade 2 or higher irAE occur. Data are very limited on the safety of resuming treatment after such an event.

We studied all adult patients referred to the ImmunoTOX toxicity review board at the Gustave Roussy cancer center (Villejuif, France) in 2015-2017 with irAE grade 2 or higher for whom the rechallenge was questioned. Among 93 patients with a broad spectrum of cancers, 40 patients (43%) were rechallenged with the same anti-PD-1 or anti-PD-L1. The rechallenged and non-rechallenged groups did not differ in terms of age, time to initial irAE, irAE severity, or steroid use. With a median follow-up period of 14 months, the same irAE or a different irAE occurred in 22 patients (55%). The second irAEs were not more severe than the first. Earlier initial toxicity was associated with more frequent irAE recurrence.

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Medicaid Expansion Linked to Reduced Deaths from Heart Disease

Posted on June 7, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Khatana

Sameed Khatana, MD, MPH
Fellow, Cardiovascular Medicine, Perleman School of Medicine
Associate Fellow,
Leonard Davis Institute of Health Economics
University of Pennsylvania

MedicalResearch.com: What is the background for this study?

Response: The Affordable Care Act (ACA) led to the largest increase in Medicaid coverage since the beginning of the program. However, a number of states decided not to expand eligibility. Studies of prior smaller expansions in Medicaid, such as in individual states, have suggested evidence of improved outcomes associated with Medicaid expansion. Additionally, studies of Medicaid expansion under the ACA of certain health measures such as access to preventive care and medication adherence have suggested some improvements as well. However, there have been no large, population-level studies to examine whether Medicaid expansion under the ACA led to changes in mortality rates. Given, a high burden of cardiovascular risk factors in the uninsured, we examined whether states that had expanded Medicaid had a change in cardiovascular mortality rates after expansion, compared to states that have not expanded Medicaid.

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Kidney Transplant: Alternative Immunosuppressant Regimens with Belatacept (NULOJIX®) May Improve Outcomes

Posted on June 6, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Alloway

Rita R. Alloway, PharmD, FCCP
Research Professor of Medicine
Director, Transplant Clinical Research
University of Cincinnati
College of Medicine, Department of Internal Medicine
Division of Nephrology
Kidney C.A.R.E. Program
(Clinical Advancement, Research & Education)
Cincinnati OH 45267

MedicalResearch.com: What is the background for this study?

Response: Transplant recipients are required to take lifelong immunosuppression to sustain the function of their transplant. Unfortunately these immunosuppressants have significant side effects. The most significant of these side effects are worsening kidney function, hypertension, hypercholesterolemia, post transplant diabetes, tremors and headaches. Researchers focused on improving post transplant outcomes are looking for immunosuppressant regimens with similar efficacy while minimizing harmful side effects.

Tacrolimus and steroids are the immunosuppressants associated with the worst side effect profiles. This study eliminated both of these immunosuppressants and replace tacrolimus with belatacept. Belatacept is a once monthly intravenous infusion with a more favorable side effect profile compared to tacrolimus. In addition, since it is a monthly infusion, adherence can improved compared to an oral medication taken twice daily.

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Medicaid Expansion Reduced Racial Disparities in Cancer Treatment

Posted on June 6, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Adamson

Blythe J.S. Adamson, PhD, MPH
Senior Quantitative Scientist
Flatiron Health

MedicalResearch.com: What is the background for this study?

Response: Racial disparities in access and outcomes have been documented across the full trajectory of cancer-related care. This includes access to prevention and screening, to early diagnosis, treatment, survival and other health outcomes. While these disparities have been well documented, finding mechanisms to reduce disparities is more challenging. One potential mechanism to reduce treatment disparities is to improve access to insurance coverage. The Affordable Care Act (ACA), passed in March 2010, included as its overall goals the improvement in healthcare quality and access, and enhancing equity in treatment and outcomes. The ACA allowed states to expand Medicaid to poor and near-poor adults, and this was implemented by many states starting in 2014. In addition, the ACA established private insurance marketplaces with income-based premium subsidies and limits on out-of-pocket spending for qualifying low-income enrollees.

Prior research has demonstrated that ACA Medicaid expansions are associated with increased coverage and improved overall access for cancer survivors; and for newly diagnosed patients, the ACA was associated with increased coverage and shifts to earlier stage diagnosis for some cancers. To our knowledge, no research has yet demonstrated that the ACA coverage expansions affected the process of cancer care, specific cancer treatments received or specific treatment outcomes, let alone whether disparities were reduced. In this study we looked at the time from advanced/metastatic diagnosis to start of systemic treatment for black vs. white patients and based on whether they were diagnosed at a time and in a state that had vs. had not implemented Medicaid expansion. Our study hypothesis was that Medicaid expansion reduced disparity in timely treatment of black patients compared to white patients with advanced cancer. We defined timely treatment as start of systemic therapy within 30 days of advanced/metastatic diagnosis.

This is a retrospective observational study, not a randomized controlled trial. In other words, we selected a cohort of patients diagnosed with advanced or metastatic cancers over time and observed whether they received timely treatment. The Flatiron Health EHR-derived database was the principal data source for this research. Flatiron contributing practices include 280 cancer community based clinics and academic hospital outpatient settings (~800 sites of care) representing more than 2.2 million patients with cancer in the United States. Practices are located in 40 states. To produce the database, Flatiron extracted data from structured fields, including demographics, and recorded medication orders and administrations. Flatiron also abstracted unstructured data, using technology assisted review by highly trained clinicians. Abstracted data include diagnosis date, stage, and prescribed oral anticancer medications. The database used for research purposes was de-identified. We also used data from the Kaiser Family Foundation which has tracked Medicaid implementation policies for over twenty years, and the US Bureau of Labor Statistics from which we pulled state-year unemployment rates.

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Some Physicians Who Advise FDA Later Form Financial Relationships with Pharmaceutical Companies

Posted on June 6, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Stephanie L. Kuschel, B.A Indiana University School of Medicine Indianapolis, IN, 46202

Dr. Kuschel

Stephanie L. Kuschel, MD
Indiana University School of Medicine
Indianapolis, IN, 46202

Robert Dellavalle, MD, PhD, MSPH
Professor of Dermatology and Public Health
University of Colorado School of Medicine
Colorado School of Public Health
Chief, Dermatology Service
US Department of Veterans Affairs
Eastern Colorado Health Care System
Denver, CO 80220

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Physicians can serve as external experts and voting members of FDA advisory committee panels, which help determine if a drug is acceptable for the US market. Considering that financial conflicts of interest (FCOI) have been shown to influence voting member habits, the FDA has regulations in place to minimize these FCOI. However, the FDA can grant waivers for some financially conflicted individuals if they meet certain requirements (like offering key insights that may out-weigh the risk of a possible FCOI). Additionally the FDA does not make stipulations regarding post-advisory role financial relationships. In fact, many former FDA committee advisors later engage in financial relationships with pharmaceutical companies. Some worry these post-hoc financial relationships could pose an ethical dilemma whereby future FDA advisory members are incentivized to alter their voting habits in expectation of future rewards. Others argue the situation may be more complex than expected.

For example, the author of one study, found that while there was evidence for a pro-industry voting bias among committee members with exclusive financial relationships to the sponsoring manufacturer (of the drug under review), this was not the case for members with nonexclusive financial ties to both the sponsor and its competitors ¹. Furthermore, the author found that advisors with many corporate ties were (on average) actually more likely than their peers without any financial ties to vote against the sponsor. The author argued that these advisors were more likely to be experienced researchers, and their voting habits may reflect their experience evaluating medical research.

While this author and others have offered valuable insights into financial relationships of advisors during their advisory role, unfortunately little information is available regarding post-advisory role financial relationships and whether these relationship have any influence on the integrity of the voting process. The purpose of our study was to review Open Payment data on industry payments to former physician FDA dermatologic drug committee members. Continue reading →

Are Some Dog Breeds More Likely to Bite?

Posted on June 6, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Essig

Dr. Garth Essig, MD
Otolaryngologist
The Ohio State University Wexner Medical Center.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Dog bites are a significant yet modifiable public health concern, but the true magnitude is difficult to estimate with such wide ranges in reporting, severity of injury and varieties of breeds that bite. We reviewed bites from reports in the literature and from two regionally distinct medical centers.

We concluded that bite frequency and severity could be attributed to certain breeds in this sample, if the breed is known. Our study also acknowledged the significant risk of biting with the mixed breed population, which creates a dilemma with identification.

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Author Archives: Marie Benz MD FAAD

About Marie Benz MD FAAD

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Metagenomic Sequencing Enhanced Diagnosis of Meningitis and Encephalitis Infections

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PTSD: Comparative Effectiveness of Medications, Psychotherapeutic and Combination Treatments

Turn Off the Smartphone and TV at Night To Reduce Risk of Weight Gain

Aspirin for Primary Prevention of Cardiovascular Events

Are Younger People Really Addicted to Their Smartphones?

More Scooters Means More Head and Face Injuries

Islet Cell Transplantation Can Give Some Diabetics Long Term Glucose Control

Apple or Pear? Body Shape Not Determined Just by Fat

Updated Expert Consensus Statement on Platelet Function/Genetic Testing for Guiding P2Y12 Receptor-Inhibitor Treatment in PCI

Cardiac Radiation Can Increase Mortality in Lung Cancer Patients

Fat Distribution Linked to Advanced and Fatal Prostate Cancer

FDgard® Combination of Caraway Oil and L-Menthol for Treatment of Functional Dyspepsia

Hepatitis C Treatment: Study Finds No Liver, Kidney or Cardiovascular Adverse Effects

The Vitamin D and Type 2 Diabetes Study

Midlife Type 2 Diabetes Mellitus Linked to Increased Risk of Ischemic Stroke

Some Patients Can Be Rechallenged After Immune Adverse Events from Checkpoint Inhibitors

Medicaid Expansion Linked to Reduced Deaths from Heart Disease

Kidney Transplant: Alternative Immunosuppressant Regimens with Belatacept (NULOJIX®) May Improve Outcomes

Medicaid Expansion Reduced Racial Disparities in Cancer Treatment

Some Physicians Who Advise FDA Later Form Financial Relationships with Pharmaceutical Companies

Are Some Dog Breeds More Likely to Bite?