Alcohol, Author Interviews, Genetic Research, Nature, University of Pennsylvania / 05.04.2019

MedicalResearch.com Interview with: Henry R. Kranzler, MD Professor of Psychiatry Perelman School of Medicine University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alcohol consumption and alcohol use disorder (AUD) are moderately heritable traits.  To date, genome-wide association studies (GWAS) have not examined these traits in the same sample, which limits an assessment of the extent to which genetic variation is unique to one or the other or shared. This GWAS examined a large sample (nearly 275,000 individuals) from the U.S. Veterans Affairs Million Veteran Program (MVP) for whom data on both alcohol consumption and alcohol use disorder diagnoses were available from an electronic health record.  We identified 18 genetic variants that were significantly associated with either alcohol consumption, AUD, or both. Five of the variants were associated with both traits, eight with consumption only, and five with alcohol use disorder only.  (more…)
Author Interviews, Gout, NIH, OBGYNE / 04.04.2019

MedicalResearch.com Interview with: Jack A. Yanovski, MD, PhD Senior Investigator Section on Growth and Obesity, DIR, NICHD National Institutes of Health Hatfield Clinical Research Center Bethesda, MD 20892‐1103 MedicalResearch.com: What is the background for this study? Response: Studies of both mouse models and people suggest that obesity induced inflammation may promote insulin resistance and progression to diabetes. Others have proposed that suppressing this chronic, low level inflammation may slow the onset of diabetes. Nod-like Receptor Family Pyrin Domain Containing 3 (NLRP3) has recently been shown to play a strong role in promoting the inflammatory state in obesity. Colchicine, traditionally used to suppress or prevent inflammation in gout and other disorders is believed to inhibit formation of the NLRP3 inflammasome. Our group hypothesized that colchicine would improve obesity associated inflammation in adults with metabolic syndrome who had not yet developed type 2 diabetes. (more…)
AHA Journals, Author Interviews, Heart Disease, Karolinski Institute / 02.04.2019

MedicalResearch.com Interview with: Gabriel Riva, Graduate Student Department of Medicine, Solna (MedS), Karolinka Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: During the last decade there has been a gradual adoption of compression-only CPR, as an option to conventional CPR with chest compressions and rescue breaths, in international CPR guidelines. The simplified technique is recommended for bystanders who are untrained and in "telephone assisted CPR". One of the reasons was the assumption that more people would actually do CPR with the simplified technique.  We could in this nationwide study running over 3 guideline periods demonstrate a 6-fold higher proportion of patients receiving compression-only CPR and a concomitant almost doubled rate of CPR before emergency medical services arrival over time. This very large increase in simplified CPR was surprising to us, especially considering there has never been any public campaigns promoting compression-only CPR in Sweden and training still include compressions and ventilations.  New first aid certified students will go through these updates to ensure the best possible assistance for emergencies. (more…)
Author Interviews, Cancer Research, FDA, JAMA / 01.04.2019

MedicalResearch.com Interview with: Emerson Chen, MD Chief Fellow, Hematology-Oncology, PGY-6 Oregon Health & Science University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many cancer drugs are approved annually giving the appearance of innovation; however, some drugs may have been approved because of a lower bar. Use of lesser endpoints like response rate (how tumor shrinks) and progression-free survival (how tumor has delayed growth) have been proposed to speed trials when compared against traditional endpoints like overall survival (how long patients might live). Using published trials that led to cancer drug approval from 2006 to 2017, we estimated how long it would take to get each of these three endpoints across all cancer drugs and indications to see how much time we could save by using these weaker but faster endpoints. We see that many trials using overall survival used less time than anticipated, and many trials using response rate or progression-free survival actually took quite a bit of time.  In part that is due to researchers needing to document the duration of the response. But, whatever the reason, the time to get each of the three endpoints is actually more similar than different, and we estimate that our current use of  these faster endpoints are saving us only 11 months compared to using only overall survival. (more…)
Author Interviews, Health Care Systems, Outcomes & Safety, University of Pennsylvania / 01.04.2019

MedicalResearch.com Interview with: Kira L. Ryskina  MD MS Assistant Professor Of Medicine Division of General Internal Medicine Perelman School of Medicine, University of Pennsylvania  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Post-acute care in skilled nursing facilities (SNF or sometimes called subacute rehab) is a very common discharge destination after a hospital stay. Patients discharged to these facilities represent more clinically complex and high-need patients than patients discharged home. We wanted to understand how soon after discharge from the hospital to a skilled nursing facility are patients seen by a physician. We found that first visits by a physician or advanced practitioner (a nurse practitioner or physician assistant) for initial medical assessment occurred within four days of SNF admission in 71.5 percent of the stays. However, there was considerable variation in days to first visit at the regional, facility, and patient levels. One in five initial physician visits occurred more than 4 days after admission to skilled nursing facilities.  In 10.4 percent of stays there was no physician or advanced practitioner visit. Much of the variability in visit timing had to do with SNF characteristics and geography compared to patient clinical or demographic characteristics. Patients who did not receive a physician visit had nearly double the rates of readmissions or deaths compared to patients who were seen.  (more…)
Author Interviews, Breast Cancer, Exercise - Fitness, Heart Disease, JAMA, UCLA / 29.03.2019

MedicalResearch.com Interview with: Christina M. Dieli-Conwright, PhD, MPH, FACSM, CSCS Assistant Professor of Research Director, Integrative Center for Oncology Research in Exercise Division of Biokinesiology & Physical Therapy, Ostrow School of Dentistry Department of Medicine, Keck School of Medicine University of Southern California Los Angeles, CA 90033  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This study was designed to assess the effects of an aerobic and resistance exercise on metabolic dysregulation in sedentary, obese breast cancer survivors, however we further examined the effects on cardiovascular disease risk measured by the Framingham Risk Score, reported here. Our findings indicated that exercise, indeed, reduces the risk of cardiovascular disease in this population.  (more…)
Author Interviews, Cancer Research, Cannabis, End of Life Care, NYU / 28.03.2019

MedicalResearch.com Interview with: Arum Kim, MD Assistant Professor Medicine and Rehabilitation Medicine NYU School of Medicine Director of the Supportive Oncology Program Perlmutter Cancer Center MedicalResearch.com: What is the background for this study?   Response: There is increasing interest in medical marijuana and its applications for patients with cancers. Despite increasing access, little is known regarding doses of cannabinoids - specifically delta-8-tetrahydrocannabinol (delta-8-THC)  and cannabidiol (CBD), methods of drug delivery, and differences in patterns of use between cancer and non-cancer patients. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JAMA / 28.03.2019

MedicalResearch.com Interview with: Isaac Chua MD Instructor of Medicine at Harvard Medical School Boston, Massachusetts  MedicalResearch.com: What is the background for this study?   Response: Opioids are routinely prescribed for cancer-related pain, but little is known about the prevalence of opioid-related hospitalizations for patients with cancer. Although opioid addiction among patients with cancer is estimated to be as high as 7.7%, our understanding of opioid misuse is based on small, preliminary studies. In light of the wider opioid epidemic, oncologists and palliative care clinicians frequently balance providing patients with legitimate access to opioids while protecting them and the general public from the risks of prescribing these medications. (more…)
Author Interviews, Diabetes, Heart Disease, UCSD / 28.03.2019

MedicalResearch.com Interview with: H. Kirk Hammond, MD Professor of Medicine at University of California San Diego Basic research scientist and cardiologist San Diego Veterans' Affairs Healthcare System Dr. Hammond is winner of the 2017 William S. Middleton Award – the highest research honor in the U.S. Department of Veterans Affairs  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Worldwide, 9% of adults have diabetes, predominantly due to insulin resistance, known as Type 2 diabetes. It is associated with obesity and diets high in fat and carbohydrates. In this gene transfer study we showed that a single injection of a vector encoding a natural hormone (urocortin 2, Ucn2) increased glucose disposal and improved heart function in a model of diet-induced Type 2 diabetes in mice.  (more…)
Author Interviews, Brigham & Women's - Harvard, Ebola, Global Health, Lancet / 28.03.2019

MedicalResearch.com Interview with: Patrick Vinck, PhD Research Director, Harvard Humanitarian Initiative Assistant Professor, Global Health and Population T.H. Chan Harvard School of Public Health; Emergency Medicine Harvard Medical School Lead Investigator, Brigham & Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The second worst epidemic of Ebola on record is currently unfolding in the eastern part of the Democratic Republic of the Congo. Whether or not safe practices are implemented to prevent the spread of the epidemic is influenced by the behavior of individuals at-risk of contracting the Ebola Virus Disease (EVD) - Will they follow the recommendations of health professionals? Will they report suspected cases and deaths? Will they seek treatment from health professionals? Will they accept vaccines and adopt preventive behaviors? We find that belief in misinformation about Ebola is widespread and trust in authorities is generally low, likely as a result of decades of violence and poor governance and, more recently, the politicization of the Ebola response. Our analysis shows that trust and (mis-)information influence adherence to risk avoidance behavior and acceptance of vaccination. (more…)
Accidents & Violence, Author Interviews, Emergency Care, NEJM, University Texas / 27.03.2019

MedicalResearch.com Interview with: Jeffrey Howard, PhD Assistant Professor Department of Kinesiology, Health and Nutrition University of Texas at San Antonio San Antonio, TX 78249 MedicalResearch.com: What is the background for this study? Response:  There is a saying that “the only winner in war is medicine”, which is the first sentence in the article.  The point of that quote is that many medical advances over the last 500 years or more have been learned or propagated as a result of war. With that as the backdrop, the purpose of our study was to provide a more comprehensive assessment of the trauma system than previous work.  We accomplished this by compiling the most complete data to-date on the conflicts, using data from both Afghanistan and Iraq, and analyzing multiple interventions/policy changes simultaneously rather than in isolation.  Previous work had focused primarily on single interventions and within more narrow timeframes.  We wanted to expand the scope to include multiple interventions and encompass the entirety of the conflicts through the end of 2017.  (more…)
Author Interviews, Duke, Endocrinology, Environmental Risks, Thyroid Disease, Weight Research / 27.03.2019

MedicalResearch.com Interview with: Christopher D. Kassotis, Ph.D. NRSA Postdoctoral Research Scholar Stapleton Lab Duke University Nicholas School of the Environment Durham, NC 27708  MedicalResearch.com: What is the background for this study? What are the main findings?
  • So this was something that Heather Stapleton had been curious about for years, as she's been one of several researchers characterizing the hundreds of chemicals that have been measured in indoor house dust. Before I came to Duke, one of her PhD students had measured the ability of many common indoor contaminants to activate the peroxisome proliferator activated receptor gamma (PPARg). The majority of these chemicals did, often quite well, which led to them testing indoor house dust extracts, also finding that the majority of dust extracts were also able to do so at very low levels. As PPARg is often considered the master regulator of fat cell development, the next obvious question was whether these common contaminants (and house dust) could promote fat cell development in cell models. My first work at Duke evaluated a suite of common indoor contaminants, finding that many of these chemicals could promote fat cell development, and that low levels of house dust extracts did as well.
  • We next explored this more systematically in a group of adults involved in a thyroid cancer cohort (this was just recently published in Science of the Total Environment: https://www.sciencedirect.com/science/article/pii/S0048969719307715?dgcid=author
  • In this study we evaluated the extent to which house dust extracts could promote fat cell development in a common cell model, and associated this with the metabolic health of adults living in these homes. We found that the greater extent of fat cell development was associated with significantly greater thyroid stimulating hormone concentrations (control residents only, with no evidence of thyroid dysfunction) and lower free triiodothyronine (T3) and thyroxine (T4). We further found a significant and positive association between extent of fat cell development and the body mass index (BMI) of all adults in the study. So this suggested that the indoor environment might play a role in the BMI and metabolic health of residents, and we next wondered if this would be more pronounced in children, who may be exposed to these contaminants during a critical window of development.
  • The next step, for our current work, was to substantiate these effects in a larger group of households, each with children.
  • Our major conclusions thus far have been that ~80% of house dust extracts promote significant fat cell development in a cell model - either via development from precursor cells into mature fat cells, measured via accumulation of lipids into the cells, or via the proliferation of those precursor fat cells. We also reported positive correlations of fat cell development with the concentrations of 70 different contaminants in the dust from these homes, suggesting that mixtures of contaminants are likely all acting weakly to produce these effects in combination. We’ve also begun to assess the other chemicals present in dust - chemistry can be either targeted (measuring concentrations of specific known chemicals in a sample), or non-targeted, where you try and determine the identity of the other chemicals in a sample. This has greater utility for identifying many more chemicals, though you will often not get chemical concentrations from this, nor absolute confirmed identification - just varying degrees of certainty based on evidence. Thus far we report approximately 35,000 chemicals in house dust samples across this study, and differential analyses have begun to pick out the few (less than 10 in each case) chemicals most differentially expressed between samples that exhibit high degrees of fat cell development in the lab vs inactive samples, for example, or which are differentially present in the homes of children categorized as obese or overweight. We are now working to confirm identity of these select contaminants that are more likely to be causative factors in the results we have observed.
(more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: Seoyoung C. Kim, MD, ScD, MSCE Director, Program in Rheumatologic, Immunologic, and Musculoskeletal PharmacoEpidemiology Associate Professor of Medicine Division of Pharmacoepidemiology & Pharmacoeconomics Division of Rheumatology, Immunology and Allergy Brigham and Women's Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Given a high cardiovascular (CV) risk among patients with psoriasis and psoriatic arthritis, it is important to have more information with regard to potential effect of different treatment agents on CV risk. As the number of treatment options for psoriasis and psoriatic arthritis has been rising over the few decades, it is even more crucial to have high-quality evidence on comparative safety of different treatment options so physicians and patients can choose an agent based on the benefit-risk profile of each drug they are considering. (more…)
Author Interviews, Brigham & Women's - Harvard, Flu - Influenza, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: Sonja Kytomaa MA Research Associate Brigham and Women’s Hospital Scott D. Solomon, MD The Edward D. Frohlich Distinguished Chair Professor of Medicine Harvard Medical School Senior Physician Brigham and Women’s Hospital International Associate Editor, European Heart Journal   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Influenza is associated with an increased risk of cardiovascular events, yet few studies have explored the temporal association between influenza activity and hospitalizations, especially due to heart failure (HF). Our aim with this study was to explore the temporal association between influenza activity and hospitalizations for HF and myocardial infarction (MI) in the general population. We related the number of MI and HF hospitalizations by month, which were sampled from 4 US communities and adjudicated in the surveillance component of the Atherosclerosis Risk in Communities (ARIC) study, to monthly influenza-like illness activity, as reported by the Centers for Disease Control and Prevention. We found that a 5% increase in influenza activity was associated with a 24% increase in HF hospitalizations rates, while overall influenza was not significantly associated with MI hospitalizations. Influenza activity in the months before hospitalization was not associated with either outcome. (more…)
Author Interviews, Cost of Health Care, UCLA / 27.03.2019

MedicalResearch.com Interview with: John N. Mafi, MD, MPH Division of General Internal Medicine and Health Services Research Department of Medicine David Geffen School of Medicine at UCLA RAND Health, RAND Corporation MedicalResearch.com: What is the background for this study? What types of services are low-value in this setting?  Response: For decades we have known that offering routine preoperative testing for patients undergoing cataract surgery provides limited value, yet low-value preoperative testing persists at very high rates, even at Los Angeles County Department of Health Services, one of the largest safety net health systems in the United States. (more…)
Author Interviews, JAMA, Karolinski Institute, Pediatrics / 26.03.2019

MedicalResearch.com Interview with: Mikael Norman, MD, PhD, Professor Karolinska Institutet & Karolinska University Hospital Stockholm, Sweden  MedicalResearch.com: What is the background for this study? Response: So far, preterm birth has been difficult to predict and prevent. In particular, extremely preterm birth has continued to be an issue in terms of optimal care before and after birth, costs and long term health outcomes. Therefore, studies on how the management and outcome varies over time in these patients are important. (more…)
Author Interviews, Autism, Social Issues, University of Pittsburgh, Vaccine Studies / 26.03.2019

MedicalResearch.com Interview with: Beth Hoffman, B.Sc., graduate student University of Pittsburgh Graduate School of Public Health Research Assistant, University of Pittsburgh Center for Research on Media, Technology and Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vaccine refusal is a public health crisis - low vaccination rates are leading to outbreaks of deadly vaccine-preventable diseases. In 2017, Kids Plus Pediatrics, a Pittsburgh-based pediatric practice, posted a video on its Facebook pagef eaturing its practitioners encouraging HPV vaccination to prevent cancer. Nearly a month after the video posted, it caught the attention of multiple anti-vaccination groups and, in an eight-day period, garnered thousands of anti-vaccination comments. Our team analyzed the profiles of a randomly selected sample of 197 commenters in the hopes that this crisis may be stemmed if we can better understand and communicate with vaccine-hesitant parents. We determined that, although Kids Plus Pediatrics is an independent practice caring for patients in the Pittsburgh region, the commenters in the sample were spread across 36 states and eight countries. By delving into the messages that each commenter had publicly posted in the previous two years, we also found that they clustered into four distinct subgroups:
  • “trust,” which emphasized suspicion of the scientific community and concerns about personal liberty;
  • “alternatives,” which focused on chemicals in vaccines and the use of homeopathic remedies instead of vaccination;
  • “safety,” which focused on perceived risks and concerns about vaccination being immoral; and
  • “conspiracy,” which suggested that the government and other entities hide information that this subgroup believes to be facts, including that the polio virus does not exist. 
(more…)
Author Interviews, JAMA, Pediatrics, Stanford, Technology / 26.03.2019

MedicalResearch.com Interview with: Dennis P. Wall, PhD Associate Professor Departments of Pediatrics, Psychiatry (by courtesy) and Biomedical Data Science Stanford University  MedicalResearch.com: What did we already know about the potential for apps and wearables to help kids with autism improve their social skills, and how do the current study findings add to our understanding? What’s new/surprising here and why does it matter for children and families?  Response: We have clinically tested apps/AI for diagnosis (e.g.  https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002705) in a number of studies. This RCT is a third phase of a phased approach to establish feasibility and engagement through in-lab and at-home codesign with families with children with autism. This stepwise process is quite important to bring a wearable form of therapy running AI into the homes in a way that is clinically effective. What’s new here, aside from being a first in the field, is the rigorous statistical approach we take with an intent-to-treat style of analysis. This approach ensures that the effect of the changes are adjusted to ensure that any significance observed is due to the treatment.  Thus, with this, it is surprising and encouraging to see an effect on the VABS socialization sub-scale. This supports the hypothesis that the intervention has a true treatment effect and increases the social acuity of the child. With it being a home format for intervention that can operate with or without a clinical practitioner, it increases options and can help bridge gaps in access to care, such as when on waiting lists or if the care process is inconsistent.   (more…)
Author Interviews, Dermatology, JAMA, Pediatrics, Sleep Disorders, UCSF / 26.03.2019

MedicalResearch.com Interview with: Dr. Katrina Abuabara, MD, MA, MSCE Department of Dermatology Program for Clinical Research, University of California, San Francisco MedicalResearch.com: What is the background for this study? Response: The wellbeing and development of children is strongly influenced by parents’ physical and psychosocial health. Parents of children with chronic illness, in particular, are susceptible to poor sleep, and previous studies have found major sleep impairments among parents of children with ventilator dependency and cystic fibrosis, but few studies have examined sleep patterns among parents of children with more common chronic illnesses like atopic dermatitis (also known as eczema). (more…)
Allergies, Author Interviews, Brigham & Women's - Harvard, Pharmacology / 23.03.2019

MedicalResearch.com Interview with: Daniel Reker, PhD Koch Institute for Integrative Cancer Research Massachusetts Institute of Technology MedicalResearch.com: What is the background for this study? Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios. We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients. (more…)
Author Interviews, Clots - Coagulation, Duke, Heart Disease, NEJM / 21.03.2019

MedicalResearch.com Interview with: Renato D. Lopes MD, MHS, PhD Professor of Medicine Division of Cardiology Duke University Medical Center Duke Clinical Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: In patients with acute coronary syndromes (ACS), approximately 20% to 30% of those with nonvalvular atrial fibrillation (NVAF) have concomitant coronary artery disease (CAD), and 5 to 10% of patients who undergo PCI have NVAF. These patients often receive both antiplatelet therapy and oral anticoagulants; and how best to combine these agents to minimize bleeding risk without compromising protection against thrombosis is an important unanswered question. Analysis of results for bleeding indicated no significant interaction between the two randomization factors permitting independent analysis of results for the two key comparisons. The first showed that apixaban was both non-inferior and significantly superior to VKA for the primary outcome with a 31% reduction in the relative risk for bleeding. Aspirin significantly increased the relative risk for bleeding versus placebo by 89%. Results for the composite of death and hospitalization showed that apixaban resulted in a relative risk reduction of 17%, primarily driven by a reduction in all cause hospitalization. There was no significant difference between results for aspirin versus placebo for this outcome. Analysis of the composite of death and ischemic events indicated no significant differences in results for apixaban versus VKA or aspirin versus placebo. (more…)
Author Interviews, Duke, Heart Disease, JAMA / 21.03.2019

MedicalResearch.com Interview with: Renato D. Lopes MD, MHS, PhD Professor of Medicine Division of Cardiology Duke University Medical Center Duke Clinical Research Institute Alexander C. Fanaroff, MD, MHS Division of Cardiology and Duke Clinical Research Institute Duke University, Durham, North Carolina MedicalResearch.com: What is the background for this study? What are the main findings? Response: About ten years ago, a group of researchers examined the evidence supporting guideline recommendations in cardiology for the first time. Quite surprisingly, they found that only 11% of recommendations in American College of Cardiology/American Heart Association (ACC/AHA) guidelines were supported by evidence from randomized controlled trials, the highest level of evidence. The researchers called for greater collaboration among investigators and funders in identifying key research questions, development of streamlined clinical trial methods, and expansion of funding for clinical research. Over the past 10 years, some of these steps have been taken, but it is unclear how the evidence supporting guideline recommendations has changed. We therefore analyzed the 51 current cardiovascular guideline documents -- 26 from the ACC/AHA and 25 from the European Society of Cardiology (ESC) -- including 6,329 recommendations. Overall, 8.5% of recommendations in ACC/AHA guidelines and 14.3% of recommendations in ESC guidelines were supported by evidence from randomized controlled trials. When looking specifically at guidelines that have been updated, we found no significant changes in the proportion of recommendations supported by evidence from randomized controlled trials. (more…)
Author Interviews, Dermatology, Environmental Risks, FDA / 21.03.2019

MedicalResearch.com Interview with: Anna Benevente Director of product, labeling, and ingredient review at Registrar Corp (registrarcorp.com), an FDA consulting firm that helps companies comply with FDA regulations. She has been assisting companies with U.S. FDA regulations since 2009. She and her team have researched thousands of products to determine whether they meet FDA requirements for compliance. In February 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to put into effect a final monograph for over-the-counter (OTC) sunscreen drug products.  If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States.  Given the effect this rule could have on the pharmaceutical and cosmetic industries, MedicalResearch.com sat down with Anna Benevente, Director of Product, Labeling, and Ingredient Review at FDA consulting firm Registrar Corp, to dig deeper into the article they recently published on the rule. MedicalResearch.com:  What is the background for this announcement? Response:  FDA issues monographs for specific types of over-the-counter (OTC) drug products, which establish conditions under which a drug may be marketed without FDA approval of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The conditions that are established by the monograph include the active ingredients that have been deemed generally recognized as safe and effective (GRASE) and statements that must appear on the labeling in the form of a Drug Facts panel. Sunscreens have never had an effective final monograph.  Instead, they have been largely regulated under enforcement discretion since 2001, when FDA issued a stay on a final monograph for OTC sunscreen drug products. The Sunscreen Innovation Act (SIA) of 2014 calls for FDA to establish a final monograph for OTC sunscreen by November 26, 2019. If finalized, the rule proposed in February would lift the stay on the final monograph and amend certain regulations for OTC sunscreen drug products. MedicalResearch.com:  What is enforcement discretion? Response: FDA rulemaking can take a considerable amount of time.  During this process, FDA may issue guidance or an enforcement policy that specifies stipulations under which the Agency permits the marketing of certain products in the absence of codified regulations.  While these documents are not legally-binding, they often outline provisions where FDA states that the Agency does not intend to take regulatory action.  These provisions are often incorporated into an FDA rule, as we are seeing in the case of this new rule for sunscreen. MedicalResearch.com:  Would you explain what GRASE ingredients are? Response: When FDA establishes a monograph for an OTC drug product, the Agency reviews scientific data on ingredients used for that product and classifies them into three categories: Category I: The ingredient is generally recognized as safe and effective for its intended use. Category II: The ingredient is not generally recognized as safe and effective for its intended use.  This ingredient may be not safe as a whole, may be not be safe for the specific intended use, or may not be effective for the specific intended use relative to its health risk. Category III: There is insufficient scientific data to determine whether the ingredient is safe and effective for its intended use. While a monograph is still in the rulemaking stage, FDA permits the marketing of products formulated with active ingredients that are deemed Category I or Category III. At this time, industry may submit data to support a Category I designation for a Category III ingredient. When the final monograph is published, FDA no longer uses the terms "Category I", "Category II", and "Category III."  Those ingredients that were deemed Category I become "monograph conditions," while Category II and III ingredients become "nonmonograph conditions" and may not be marketed after the compliance date identified in the final rule. Q: What are the main products that would require a label change? Response:The statement of identity for all sunscreen products would be required to list the sunscreen active ingredients in alphabetical order followed by “Sunscreen” and the product’s dosage form (e.g. “Titanium Dioxide, Zinc Oxide Sunscreen Lotion”).  Additionally, the rule proposes formatting changes to sunscreen labels that would make SPF, broad spectrum, and water resistance statements more prominent. The rule would require all products over 15 SPF to satisfy broad spectrum testing requirements and the associated labeling requirements for broad spectrum products.  Products under 15 SPF that do not satisfy broad spectrum requirements would be required to include “*See Skin Cancer/Skin Aging Alert” next to the SPF value as a reference to the warning required under 21 CFR 201.327(d)(2). (more…)
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, End of Life Care, JAMA / 21.03.2019

MedicalResearch.com Interview with: Joanna Paladino, MD Director of Implementation, Serious Illness Care Program | Ariadne Labs Brigham and Women's Hospital | Harvard T.H. Chan School of Public Health Palliative Care | Dana-Farber Cancer Institute Instructor | Harvard Medical School and Dr. Rachelle Bernacki MD MS Director of Quality Initiatives Psychosocial Oncology and Palliative Care Senior Physician, Assistant Professor of Medicine Harvard Medical School Dr. Paladino's responses: MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Paladino: People living with serious illness face many difficult decisions over the course of their medical care. These decisions, and the care patients receive, should be guided by what matters most to patients, including their personal values, priorities, and wishes. These conversations don’t often happen in clinical practice or do so very late in the course of illness, leaving patients exposed to getting care they don’t want. Doctors and nurses want to have these important discussions, but there are real challenges, including insufficient training and uncertainties about when and how to start the conversation. We designed an intervention with clinical tools, clinician training, and systems-changes to address these challenges. When tested in a randomized clinical trial in oncology, we found that the intervention led to more, earlier, and better conversations between oncology clinicians and their patients with life-limiting cancer. These findings demonstrate that it is possible to ensure reliable, timely, and patient-centered serious illness conversations in an outpatient oncology practice. (more…)
Addiction, Author Interviews, CDC, Emory / 20.03.2019

MedicalResearch.com Interview with: CDR Andrew Geller, MD Medical Officer, Medication Safety Program Division of Healthcare Quality Promotion, CDC Atlanta GA 30329 MedicalResearch.com: What is the background for this study? Response: There has been a lot of recent attention on drug overdoses in the United States, particularly fatal overdoses which involve opioids. But the overall frequency with which patients end up in the emergency department (ED) due to nonmedical use of medications across the US is unknown.
  • Nonmedical use refers to a spectrum of circumstances, including intentionally using more medication than is recommended in an attempt to treat a health condition (therapeutic misuse) to using medication to attain euphoria or get “high” (abuse).
With this analysis, we wanted to focus on the acute harms to individual patients from nonmedical use of all medications, in order to help target prevention efforts.
  • Specifically, we used data from a nationally-representative sample of hospital EDs to identify the medications with the highest numbers of emergency visits for harms following nonmedical use of medications and to identify the patient groups with the highest risks. 
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Author Interviews, BMJ, CT Scanning, Lung Cancer, University of Pittsburgh / 14.03.2019

MedicalResearch.com Interview with: Panayiotis (Takis) Benos, Ph.D. Professor and Vice Chair for Academic Affairs Department of Computational and Systems Biology Associate Director, Integrative Systems Biology Program Department of Computational and Systems Biology, SOM and Departments of Biomedical Informatics and Computer Science University of Pittsburgh    MedicalResearch.com: What is the background for this study? What are the main findings? Response: Low-dose computed tomography (LDCT) scans is the main method used for early lung cancer diagnosis.  Early lung cancer diagnosis significantly reduces mortality.  LDCT scans identify nodules in the lungs of 24% of the people in the high-risk population, but 96% of these nodules are benign.  Currently there is no accurate way to discriminate benign from malignant nodules and hence all people with identified nodules are subjected to follow up screens or biopsies.  This increases healthcare costs and creates more anxiety for these individuals.  By analyzing a compendium of low-dose computed tomography scan data together with demographics and other clinical variables we were able to develop a predictor that offers a promising solution to this problem.  (more…)
Anesthesiology, Author Interviews, Dermatology, JAMA, NYU, Pediatrics / 14.03.2019

MedicalResearch.com Interview with: Roy G. Geronemus, M.D. Director, Laser & Skin Surgery Center of New York Clinical Professor of Dermatology New York University Medical Center New York, NY 10016 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We made the observation in clinical practice that port wine stain birthmarks can be safely and effectively treated in early infancy without the need for general anesthesia. This observation is particularly important because of the FDA warnings regarding multiple exposures to general anesthesia under the age of 3 and the potential impact on neurocognitive development as these patients require multiple treatments. (more…)
Author Interviews, Brigham & Women's - Harvard, NEJM, Opiods / 13.03.2019

MedicalResearch.com Interview with: Wenjia Zhu, PhD. Marshall J. Seidman Fellow Department of Health Care Policy Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The current opioid epidemic continues to cause deaths and tremendous suffering in the United States, driven in large part by overuse of prescription opioids. Of special concern are new opioid prescriptions, i.e. opioids given to patients who have not used opioids before, which research tells us are an important gateway to long-term opioid use, misuse, overdoes and death. Recently, in their efforts to curb over prescribing of opioids, the CDC issued guidelines (December 2015 in draft form; March 2016 in final version) to encourage opioid prescribers to limit the use, duration and dose of opioids, particularly opioids to first-time users. Despite these, little is known about the prescribing of opioids to first-time users on a national scale, particularly among commercially insured patients. In this study, we examined national monthly trends in the rate at which opioid therapy was started among commercially insured patients. Using administrative claims from Blue Cross Blue Shield Association commercial insurers from 2012 to 2017, we analyzed more than 86 million commercially insured patients across the United States. (more…)
Author Interviews, Heart Disease, Imperial College, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: Prof. Kosh Ray, MB ChB, MD, MPhil Faculty of Medicine, School of Public Health Chair in Public Health (Clinical) Imperial College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bempedoic acid is the first in class of a new therapy for lowering LDL cholesterol. This is the largest and longest study to date with this therapy and involved about 2200 pts with patients with either established cardiovascular disease or familial hypercholestrolaemia and in whom LDL was > 70mg/dl or 1.8 mmol/L despite maximally tolerated statins. %0% were on high intensity statins and the majority of the rest on moderate intensity. The aim was to show long term safety 1 year and efficacy at 24 weeks and at 1 year.  (more…)