Author Interviews, Hepatitis - Liver Disease, JAMA, Kaiser Permanente, Pharmacology / 10.06.2019

MedicalResearch.com Interview with: 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.  (more…)
Author Interviews, Cost of Health Care, Heart Disease, JAMA, University of Pennsylvania / 07.06.2019

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Dermatology, FDA / 06.06.2019

MedicalResearch.com Interview with: 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.  (more…)
Accidents & Violence, Author Interviews, Cost of Health Care, JAMA, Surgical Research, University of Michigan / 05.06.2019

MedicalResearch.com Interview with: Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Traumatic injury has a tendency to be thought of as a disease that preferentially impacts younger people.  We wanted to explore the prevalence and impact of traumatic injury within the population of patients for whom Medicare is the third party payer.  (more…)
ASCO, Author Interviews, Biomarkers, Melanoma, NYU / 02.06.2019

MedicalResearch.com Interview with: David Polsky, MD, PhD Dermatologist and Director of the Digmented Lesion Service Mahrukh M. Syeda, MS Research Associate Ronald O. Perelman Department of Dermatology NYU Langone Health MedicalResearch.com: What is the background for this study? Response: Several studies of metastatic melanoma patients have demonstrated that measuring circulating tumor DNA (ctDNA) associates with their disease burden and survival.  Generally, patients with detectable pre-treatment ctDNA levels and/or detectable ctDNA at various time intervals after starting treatment have shorter survivals than patients with lower pre-treatment or on-treatment ctDNA levels.  Studies have varied in their methods to detect ctDNA, the thresholds chosen to call a sample positive or negative, and the follow up time point for measurement, if any. In this study, we examined pre-treatment and week 4 on-treatment plasma samples from patients enrolled in Combi-D, the Phase III, randomized, double-blind trial of the BRAF and MEK inhibitors Dabrafenib and Trametinib, which led to FDA approval of the combination therapy for patients with unresectable stage III/IV melanoma. Only patients with BRAF V600E or V600K mutations identified from tumor genotyping were enrolled in the clinical trial. (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, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did. (more…)
Anesthesiology, Author Interviews, Duke, OBGYNE, Opiods, Pain Research, Surgical Research / 29.05.2019

MedicalResearch.com Interview with: Ashraf Habib, MDChief of the Division of Women’s Anesthesia and Professor of AnesthesiologyDuke University Ashraf Habib, MD Chief of the Division of Women’s Anesthesia Professor of Anesthesiology Duke University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This was a multicenter study conducted in 13 clinical sites in the United States enrolling patients undergoing elective Cesarean-section and receiving spinal anesthesia. 186 patients were enrolled and randomized to receive EXPAREL, a long-acting, non-opioid option to manage postsurgical pain, administered via transversus abdominis plane (TAP) field block, mixed with plain bupivacaine or TAP block with plain bupivacaine alone. A TAP block numbs the nerves that supply the abdominal wall. We presented the data at the 51st Annual Meeting of the Society of Obstetric Anesthesia and Perinatology (SOAP) in Phoenix, AZ. We aimed to collect clinical evidence that a multimodal postsurgical pain regimen using a TAP block with EXPAREL (bupivacaine liposome injectable suspension) together with regularly scheduled acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) could reduce opioid consumption more so than a standard multimodal pain control approach that combines TAP block with standard bupivacaine, regularly scheduled acetaminophen, and NSAIDs. (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, Exercise - Fitness, JAMA, Mental Health Research, Pediatrics, UCLA / 29.05.2019

MedicalResearch.com Interview with: Molly C. Easterlin, MD Fellow, UCLA National Clinician Scholars Program Clinical Instructor, Pediatrics, Cedars-Sinai Medical Center  MedicalResearch.com: What is the background for this study? Response: Adverse childhood experiences or ACEs (including physical or emotional neglect or abuse, sexual abuse, domestic abuse, exposure to household substance misuse or mental illness, parental separation or divorce, and parental incarceration) are common with about half of children experiencing 1 and one-quarter of children experiencing 2 or more. Children exposed to adverse childhood experiences have worse mental health throughout life, including higher rates of depression and anxiety. However, little is known about what factors improve long-term mental health in those exposed to ACEs. Additionally, as far as we are aware, no studies have looked at team sports participation as a potential factor that may be associated with improved mental health among those with adverse childhood experiences. (more…)
Author Interviews, Epilepsy, FDA / 29.05.2019

MedicalResearch.com Interview with: Dr. Steven S. Chung, MD Executive Director and Program Chair Neuroscience Institute and Director of the Epilepsy Program Banner – University Medical Center MedicalResearch.com: What is the background for this study? How is Nayzilam different from other treatments for epilepsy? Who/How is it administered?  Response: NAYZILAM is the first medication and only FDA-approved nasal option for treating seizure clusters. NAYZILAM allows for administration by a non-healthcare professional to patients when a seizure cluster occurs, which could provide significant value to patients who currently have limited treatment options for SC. The effectiveness of NAYZILAM was established in a randomized, double-blind, placebo-controlled trial (Study 1; NCT 01390220). Study 1 was conducted in two phases: an open-label Test Dose Phase followed by a randomized, double-blind, placebo-controlled, Comparative Phase. In the Test Dose Phase, tolerability was assessed in 292 patients. Patients were excluded from participation in the Comparative Phase if they failed to meet pre-defined blood pressure, heart rate, sedation, electrocardiogram, and peripheral oxygen saturation criteria. In the Comparative Phase, 201 patients treated a single seizure cluster episode in an outpatient setting. Numerical differences in favor of NAYZILAM were observed on each of the components of the treatment success responder definition; termination of seizure(s) within 10 minutes after initial dose of study drug (80.6 versus 70.1%) and the absence of seizure recurrence between 10 minutes and 6 hours after the initial dose of study drug (58.2 versus 37.3%). Study 1 also evaluated the occurrence and time to next seizure after the initial blinded dose of study drug. A smaller proportion of NAYZILAM-treated patients experienced the next seizure within 24 hours after the initial blinded dose of study drug (37.3% versus 46.3%). NAYZILAM-treated patients experienced a statistically longer time-to-next-seizure than the placebo group.   (more…)
Author Interviews, Baylor University Medical Center Dallas, Gastrointestinal Disease / 28.05.2019

MedicalResearch.com Interview with: Dr. Rhonda Souza, MD Baylor University Medical Center Center for Esophageal Research Dallas, TX 75246  MedicalResearch.com: What is the background for this study?   Response: Eosinophilic esophagitis (EoE) is a modern disorder of the esophagus caused by an allergy to certain foods. EoE causes esophageal symptoms like difficulty swallowing and heartburn and is diagnosed when biopsies of the esophagus taken during endoscopy show numerous eosinophils, which are a type of inflammatory blood cell.  There are few established treatments for EoE. One such treatment is a diet that eliminates the offending food allergens, and another is to use steroids to reduce the number of eosinophils in the esophagus. However, the most common treatment for adults with eosinophilic esophagitis is to use proton pump inhibitors (PPIs), which block the proton pumps in stomach cells that make acid.  In earlier studies, we found that PPIs also can block proton pumps in esophageal cells.  Those proton pumps are activated by chemicals that the body produces in response to allergens including interleukin (IL)-13 or IL-4.  Il-13 and IL-4, which cause the esophagus to produce eotaxin-3, a molecule that attracts eosinophils. What remained unknown, however, was the mechanism whereby these interleukins activate proton pumps in the EoE esophagus. In our present study, we explored whether IL-4 works by increasing calcium levels in esophageal cells from EoE patients. (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, JAMA, Mental Health Research, Surgical Research, UCSF / 27.05.2019

MedicalResearch.com Interview with: Carter Lebares, MD Assistant Professor of Surgery Director, Center for Mindfulness in Surgery Department of Surgery, UCSF  MedicalResearch.com: What is the background for this study?  Response: This study was inspired by extensive evidence of the effectiveness of mindfulness-based interventions (MBIs) for mitigating stress and enhancing performance in other high-stress populations like police and the military.  We know that overwhelming stress is related to burnout and to cognitive errors - two critical issues within surgery, today. This prompted us to tailor and streamline an MBI specifically for surgeons, and to test it in our trainees. (more…)
Author Interviews, Frailty, Hospital Readmissions, JAMA, Stanford, Surgical Research / 27.05.2019

MedicalResearch.com Interview with: hospital-frailty-surgeryKara Anne Rothenberg.MD Postdoctoral Research Fellow, Vascular Surgery Shipra Arya, MD SM FACS Associate Professor of Surgery Stanford University School of Medicine MedicalResearch.com: What is the background for this study? Response: There is a growing body of literature showing that frailty, a syndrome where patients have increased vulnerability to a stressor (such as surgery), is associated with increased postoperative complications, failure to rescue, and hospital readmissions. The Risk Analysis Index (RAI), is an easy to use frailty measurement tool that better predicts postoperative mortality than age or comorbidities alone. As the rates of outpatient surgeries rise nationwide, we noted that most of the surgical frailty studies focus only on inpatient surgeries. Elective, outpatient surgery is generally considered low risk for complications and unplanned readmissions, however we hypothesized that for frail patients, it might not be. (more…)
Author Interviews, Heart Disease, JAMA, NIH, Stroke / 27.05.2019

MedicalResearch.com Interview with: Lenore J. Launer, PhD. Chief Neuroepidemiology Section Intramural Research Program National Institute on Aging MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of cerebral infarction on MRI can be as high as 30% in community-based studies. These lesions detected on brain MRI, are often clinically silent, but are associated with impairments in cognitive and physical function and can increase the risk for clinical events. For a large number, the origin of these brain lesions is unknown. There is also a lack of population-based data on unrecognized myocardial infarction, which is associated with an increased for clinical coronary disease and mortality. Unrecognized MI was detected in 17% of participants using state-of-the-art cardia MRI, a more sensitive measure of the lesions, than the standard ECG. We investigated the contribution to these lesions of recognized and unrecognized myocardial infarction [MI] identified on cardiac MRI. We found both recognized and unrecognized myocardial infarction increased the risk for cerebral infarction, and that in particular unrecognized MI was associated with cerebral infarction of embolic origins of an unknown source. Given their prevalence, unrecognized MI may be an underestimated contributor to the risk for cerebral infarction in older persons.  (more…)
Addiction, Author Interviews, OBGYNE, Pediatrics, Tobacco Research, UCSD / 25.05.2019

MedicalResearch.com Interview with: Davide Dulcis, PhD Associate Professor Department of Psychiatry, UCSD School of Medicine University of California, San Diego La Jolla, CA 92093-0603 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Previous studies in humans have shown that pre-natal and early life exposure to nicotine can lead to altered children behavior and propensity for drug abuse, but the precise mechanisms involved are still unclear. In this pre-clinical study we showed how nicotine “primes” neurons of the mouse brain’s reward center for a fate they normally would not have taken, making them more susceptible to the effects of nicotine when the animals are again exposed to nicotine later in life, said Dr. Benedetto Romoli, first author of the research article.   (more…)
Author Interviews, Hearing Loss, JAMA, NIH, NYU / 24.05.2019

MedicalResearch.com Interview with: Jan Blustein, MD PhD Professor of Health Policy and Medicine Wagner Graduate School and School of Medicine New York University, New York MedicalResearch.com: What is the background for this study?   Response: The National Institutes of Health (NIH), the nation’s largest public funder of health research, provides annual reports about levels of funding for many diseases and conditions.  These reports, issued as part of the NIH’s Research, Condition and Disease Categorization (RCDC) process, allow members of the public to track funding across key conditions and across time. Hearing loss is not included among the reported conditions. This runs counter to two of the NIH’s stated goals, according to researcher Jan Blustein (M.D., Ph.D.), professor of health policy and medicine at New York University’s Robert F. Wagner Graduate School of Public Service, in a Research Letter in the May 15th issue of the Journal of the American Medical Association Otolaryngology and Head & Neck Surgery. “First, the NIH is committed to transparency about how it divides funds across diseases and conditions,” said Dr. Blustein.  “Second, it has said that it will prioritize its funding to those conditions that cause the greatest disease burden.”  Hearing loss causes great disease burden, ranking 10th in the U.S. among all conditions as a contributor to Disability Adjusted Life Years (a widely-used measure of disease burden), according to the World Health Organization. (more…)
Author Interviews, Hospital Readmissions, JAMA, Neurology, Outcomes & Safety, University of Pennsylvania / 20.05.2019

MedicalResearch.com Interview with: Sameed Khatana, MD 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: There has been a growing use of quality metrics and indices in the US healthcare system. Much attention has been paid to quality measurement programs used by public payors, however, the use of such programs by commercial payors is much less studied. "Centers of excellence" are one type of quality designation program that is growing in use by commercial payors where certain hospitals are determined to be "high quality" for a certain disease state or procedure based on meeting certain criteria. For some people, this is even impacting the choice of providers and hospitals they can use by payors. We evaluated centers of excellence programs from three large commercial payors, Aetna, Cigna and Blue Cross Blue Shield, targeted at cardiovascular diseases and interventions and examined publicly reported outcomes for all hospitals performing percutaneous coronary interventions (cardiac stenting) in New York State.  (more…)
Author Interviews, Emory, Heart Disease, JAMA, Pediatrics, Sugar / 19.05.2019

MedicalResearch.com Interview with: Jean A. Welsh, RN, MPH, PhD Departments of Epidemiology and Pediatrics Emory University Wellness Department, Children’s Healthcare of Atlanta Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: As the evidence has accumulated regarding the health risks associated with sugar-sweetened beverages, I’ve wondered about fruit juices.  Though they have a kind of healthy halo, their main ingredients are the same as sugar-sweetened beverages, sugar and water.  We know that young children drink a lot of fruit juice, and I’ve wondered if older children and adults might switch to drinking more as concern grows about soft drinks and other sugar-sweetened beverages. (more…)
Author Interviews, Education, Neurology, NYU / 17.05.2019

MedicalResearch.com Interview with: Dr. Rebecca Stainman Dr. Arielle Kurzweil MD Adult Neurology Program Director New York University School of Medicine NYU Langone Health MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Physician burnout is prevalent. Neurologists have among the highest burnout rates, ranked third among specialties in a 2011 study, and over half of US Neurologists report at least 1 symptom of burnout in a 2016 survey.  Efforts to address burnout in training programs have mostly been aimed at implementing wellness curricula and offering mental health resources. Training neurology residents to effectively identify, address, and help impaired colleagues is equally crucial in these efforts, yet there is a paucity of literature on this topic. We used simulation as a means of addressing this topic, via identifying and addressing an impaired colleague through an objective structured clinical examination (OSCE).  (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…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Orthopedics, Osteoporosis, Surgical Research / 15.05.2019

MedicalResearch.com Interview with: Elaine W. Yu, MD, MMSc Assistant Professor,  Harvard Medical School Director, Bone Density Center Endocrine Unit, Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Roux-en-Y gastric bypass (RYGB) is a popular surgical weight loss procedure.  We have previously shown that gastric bypass leads to rapid high-turnover bone loss. Bariatric procedures are being increasingly performed in older adults, and the clinical consequences of gastric bypass-associated skeletal changes in this vulnerable population have been unclear to date.  Thus, we used Medicare claims data to investigate fracture risk among older adults after gastric bypass, and in comparison to adults who received another bariatric procedure called adjustable gastric banding (AGB), which is thought to have fewer negative bone effects. In our analysis, we found that patients undergoing Roux-en-Y gastric bypass were 73% more likely to fracture than those undergoing AGB. Importantly, we found that hip fracture risk increased nearly 180% after RYGB, and that fracture rates in patients aged 65 or older were similar to the overall group.  (more…)
Annals Internal Medicine, Author Interviews, Critical Care - Intensive Care - ICUs, Infections, University of Pittsburgh / 15.05.2019

MedicalResearch.com Interview with: Minh-Hong Nguyen, MD Infectious Diseases Professor of Medicine Director, Transplant Infectious Diseases Director, Antimicrobial Management Program Department of Medicine University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Blood cultures, the gold standard for diagnosing blood stream infections, are insensitive and limited by prolonged time to results. Early institution of appropriate antibiotics is a crucial determinant of improved outcomes in patients with sepsis and blood stream infections (BSI). For these reasons, development of rapid non-culture diagnostic tests for blood stream infections is a top priority. The T2Bacteria panel is the first direct from blood, non-culture test cleared by FDA for diagnosis of blood stream infections .  It detects within 4-6 hours the 5 most common ESKAPE bacteria that are frequent causes of hospital infection, and which are often multi-drug resistant.  This study shows that the T2Bacteria panel rapidly and accurately diagnosed and identified ESKAPE bacterial BSIs, and identified probable and possible BSIs that were missed by blood cultures (in particular among patients who were already receiving antibiotics). (more…)
Author Interviews, Cost of Health Care, Kidney Disease, UCLA / 14.05.2019

MedicalResearch.com Interview with: Chris Childers, MD, PhD Division of General Surgery David Geffen School of Medicine at UCLA Los Angeles, CA 90095 MedicalResearch.com: What is the background for this study? Response: Patients with end-stage renal disease – poorly functioning kidneys – often have to receive dialysis. This typically requires a patient to visit an outpatient clinic several times a week to have their blood filtered by a machine. Over the past few years, two for-profit companies have increased their control over the outpatient dialysis market – DaVita and Fresenius. Combined they control approximately ¾ of the market.  A number of concerns have been raised against these for-profit companies suggesting that the quality of care they deliver may be worse than the care delivered at not-for-profit companies. But, because they control so much of the market and because patients have to receive dialysis so frequently, patients may not have much choice in the clinic they visit. Medicare covers patients who are 65 years or older and also patients on dialysis regardless of age.  Medicare pays a fixed rate for dialysis which they believe is adequate to cover the clinics' costs. However, if a patient also has private insurance, the insurer is required to pay for dialysis instead of Medicare. Whereas Medicare rates are fixed by the federal government, private insurers have to negotiate the price they pay, and may pay much more as a result. (more…)
Author Interviews, Medical Imaging, Mental Health Research, UCSD / 13.05.2019

MedicalResearch.com Interview with: Dr. Mingxiong Huang, PhD Professor, Electrical and Computer Engineering University of California, San Diego MedicalResearch.com: What is the background for this study?   Response: Combat-related mild traumatic brain injury (mTBI) is a leading cause of sustained impairments in military service members and Veterans. Yet, conventional neuroimaging techniques such as magnetic resonance imaging (MRI) and computed tomography (CT) are typically insensitive to physiological alterations caused by mild and some moderate TBIs. With funding from the VA, we have pursued in developing sensitive imaging markers based on magnetoencephalography (MEG) for mTBI. This paper reflects the news MEG findings in this research field.  (more…)
Author Interviews, Biomarkers, Cancer Research, Colon Cancer, JAMA, Karolinski Institute / 13.05.2019

MedicalResearch.com Interview with: Louise Olsson MD PhD Senior researcher Department of Molecular Medicine and Surgery Colorectal Surgery Karolinski Institute Stockholm, Sweden  MedicalResearch.com: What is the background for this study? What are the main findings? Response: I read a very interesting paper back in 2006 “Detection and quantification of mutation in the plasma of patients with colorectal cancer”. Only some 60 % of patients with early colorectal cancer were detectable in this way whereas patients with stage IV disease all had a high concentration of APC mutations in their plasma. So the prospects of using the method for example, screening of primary colorectal cancer seemed limited but I thought wow, this is the test to detect recurrences and generalized disease during follow-up after surgery for colorectal cancer. After some discussion we started to collect plasma samples from patients at the hospital where I worked and that´s how my research began. (more…)
Author Interviews, JAMA, Opiods, Primary Care, University of Michigan / 11.05.2019

MedicalResearch.com Interview with: Kao-Ping Chua, M.D., Ph.D. Department of Pediatrics Susan B. Meister Child Health Evaluation and Research Center University of Michigan, Ann Arbor MedicalResearch.com: What is the background for this study?   Response: Doctor and pharmacy shopping is a high-risk behavior in which patients obtain opioid prescriptions from multiple prescribers and fill them at multiple pharmacies. Because this behavior is associated with a high risk of overdose death, there have been many efforts to help clinicians detect doctor and pharmacy shopping among patients prescribed opioids. For example, 49 states have a prescription drug monitoring program that provides information on patients’ prior controlled substance prescriptions. In contrast, there has been little attention to the possibility that patients prescribed opioids may have family members who are engaged in opioid doctor and pharmacy shopping. Such family members may divert opioids prescribed to patients because of their access to these opioids. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, Johns Hopkins, Lipids / 09.05.2019

MedicalResearch.com Interview with: Rajesh Kumar NV, Ph.D. Affiliation during the study: Senior Manager, Human Therapeutics Division, Intrexon Corporation, Germantown, MD, USA Current affiliation: Translational Research Program Manager, Oncology Drug Discovery, Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine Baltimore, MD,   MedicalResearch.com: What is the background for this study? Response: Clostridium difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Clostridium difficile infection is the most frequent form of colitis in hospitals and nursing homes and affects millions of patients in the United States and abroad. Clostridium difficile associated disease (CDAD) is a global public health challenge where even mild to moderate infections at times can quickly progress to a fatal disease if not treated promptly. OG253 is a novel lantibiotic in development for the treatment of CDAD. Lantibiotics are antimicrobial peptides whose chemical structure includes a bridge maintained by the non-canonical amino acid lanthionine. The primary objective of our study was to evaluate the repeated dose toxicokinetics and any possible side effects of OG253 as enteric-coated capsules following daily oral administrations of three different doses (6.75, 27 and 108 mg/day) for a single day or seven consecutive days in both genders of rats. An enteric-coated capsule of OG253 was formulated in an attempt to circumvent the proteolytic degradation of OG253 in the upper digestive tract and specifically deliver this lantibiotic to the distal portion of the small intestine. (more…)