Author Interviews, Brigham & Women's - Harvard, Cancer Research, Genetic Research, Melanoma, Prostate Cancer / 23.11.2020

MedicalResearch.com Interview with: Saud H AlDubayan, M.D. Instructor in Medicine, Harvard Medical School Attending Physician, Division of Genetics, Brigham and Women's Hospital Computational Biologist, Department of Medical Oncology, Dana-Farber Cancer Institute Associate Scientist, The Broad Institute of MIT and Harvard  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The overall goal of this study was to assess the performance of the standard method currently used to detect germline (inhered) genetic variants in cancer patients and whether we could use recent advances in machine learning techniques to further improve the detection rate of clinically relevant genetic alterations. To investigate this possibility, we performed a head to head comparison between the current gold-standard method for germline analysis that has been universally used in clinical and research laboratories and a new deep learning analysis approach using germline genetic data of thousands of patients with prostate cancer or melanoma. This analysis showed that across all different gene sets that were tested, the deep learning-based framework was able to identify additional cancer patients with clinically relevant germline variants that went undetected by the standard method. For example, several patients in our study also had germline variants that are associated with an increased risk of ovarian cancer, for which the surgical removal of the ovaries (at a certain age) is highly recommended. However, these genetic alterations were only identified by the proposed deep learning framework.     (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Prostate Cancer, Social Issues / 18.11.2020

MedicalResearch.com Interview with: David-Dan Nguyen, MPH Research Fellow | Center for Surgery and Public Health Brigham and Women's Hospital Medical Student | McGill University  MedicalResearch.com: What is the background for this study? Response: In 2017, the US Preventive Services Task Force updated its recommendation for PSA screening for prostate cancer from a grade D to a grade C for men aged 55 to 69 years. This updated recommendation endorsed shared decision making and harmonizes with the guidelines of the American Urological Association and the American Cancer Society which also recommend shared decision making for PSA screening. Shared decision making is a meaningful dialogue between the physician and the patient that namely includes a review of risks and expected outcomes of screening as well as the patient’s preferences and values. Understandably, the patient’s ability to critically assess the medical information provided (i.e. their health literacy) likely influences this process. We sought to characterize the effect of health literacy on shared decision making for PSA screening. We used data from 2016 when PSA screening for prostate cancer was not recommended by the US Preventive Services Task Force — in other words, we also sought to understand how health literacy impacted screening rates in the context of countervailing guidelines on PSA screening. (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, JAMA, McGill, Mental Health Research / 17.11.2020

Editor's note: This piece discusses suicide. If you have experienced suicidal thoughts or have lost someone to suicide and want to seek help, you can contact the Crisis Text Line by texting "START" to 741-741 or call the Suicide Prevention Lifeline at 800-273-8255.  MedicalResearch.com Interview with: David-Dan Nguyen, MPH Research Fellow | Center for Surgery and Public Health, Brigham and Women's Hospital Medical Student | McGill University MedicalResearch.com: What is the background for this study? Response: There is ongoing concern about the side-effects of finasteride, a drug used for the management of alopecia and benign prostatic hyperplasia. These concerns have led to the coining of the “post-finasteride syndrome” which remains controversial. Indeed, there is conflicting evidence on the post-finasteride syndrome/adverse events associated with finasteride. We wanted to contribute to this conflicting body of evidence by examining suicidality, depression, and anxiety reports linked to finasteride use using the WHO’s pharmacovigilance database, VigiBase. Such pharmacovigilance databases are useful for the study of rare adverse events that are suspected to be associated with medication use. (more…)
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus / 05.11.2020

MedicalResearch.com Interview with: Duane Wesemann, MD, PhD Div. of Rheumatology, Immunology and Allergy Brigham and Women's Hospital Boston, MA 02115 Wesemann Lab   MedicalResearch.com: What is the background for this study? Response: There is a lot of variability in how long antibodies to pathogens are produced in humans.  Some infections and vaccinations like measles induce high levels of antibodies that can be produced for a lifetime.  Other infections or vaccinations induce only short lived antibody responses. Also, some people make longer lasting antibodies compared to others.   We wanted to ask what the antibody durability dynamics looked like after COVID-19 and if we could tease out any insights—both with regard to COVID-19 as well as in general.  (more…)
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus, Inflammation, JAMA / 21.10.2020

MedicalResearch.com Interview with: David E. Leaf, MD, MMSc, FASN Assistant Professor of Medicine, Harvard Medical School Director of Clinical and Translational Research in Acute Kidney Injury Division of Renal Medicine, Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: The data for this study were derived from a multicenter cohort study of over 4,000 critically ill patients with COVID-19 admitted to ICUs at 68 sites across the US, as part of the Study of the Treatment and Outcomes in Critically Ill Patients with COVID-19 (STOP-COVID). STOP-COVID was initiated by David E. Leaf, MD, MMSc and Shruti Gupta, MD, MPH, from the Division of Renal Medicine at Brigham and Women’s Hospital and Harvard Medical School. It was initiated in March, 2020 as an unfunded, grassroots network, and now includes over 400 collaborators from 68 sites across the US. Using this data, we used a ‘target trial emulation’ approach to examine whether early administration of the monoclonal antibody, tocilizumab, reduces mortality in critically ill patients with COVID-19. Target trial emulation, a novel method of analyzing observational data, is the idea of simulating a randomized control trial to reduce bias.  (more…)
Author Interviews, Kidney Disease / 16.10.2020

MedicalResearch.com Interview with: Mallika Mendu, MD, MBA MedicalDirector of Clinical Operations Brigham and Women’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: African-Americans with chronic kidney disease have poorer outcomes with respect to hypertension control, timely nephrology referral, progression to end stage renal disease, placement of vascular access and transplantation compared to other racial groups. For the past two decades a race multiplier has been applied in equations that estimate glomerular filtration rate (a proxy for kidney function) for African-Americans. We sought to determine whether what the impact of the race multiplier term was on care delivered to African-Americans, by using our health system-wide CKD registry. We were particularly focused on advanced CKD patient outcomes, knowing that there are health disparities that could be potentially exacerbated.

The original CKD-EPI and MDRD studies showed an association between African-American race with higher measured GFR at the same blood creatinine concentration. However, there have been concerns raised about the application of the race multiplier to all African-American patients. First, there is no clear biological explanation for the association, the identification of Black race was unclear in some of the cohorts used in these studies, and there is vast genetic and ancestral heterogeneity among those who self-identify as black. The use of the race multiplier also ignores the fact that race is a social, not biological construct.

We found that with the removal of the race multiplier, up to one in every three African-American patients would be reclassified as having a more severe stage of CKD, with one-quarter of African-American patients going from stage 3 to stage 4. We also found that with the removal of the race multiplier, 64 patients would have had an eGFR <20, the threshold for referral for kidney transplant, and none of these patients were referred, evaluated or waitlisted for transplant. This is in contrast, to those African-American patients with an eGFR <20 with the race multiplier applied, who had a higher odds of being referred, evaluated or waitlisted for transplant compared to other racial groups (Odds ratio of 2.28, compared to White cohort).

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Author Interviews, Brigham & Women's - Harvard, Fertility, Technology / 16.09.2020

MedicalResearch.com Interview with: Hadi Shafiee, PhD Assistant Professor, Harvard Medical School Brigham and Women's Hospital Department of Medicine MedicalResearch.com: What is the background for this study? What are some of the characteristics that AI uses to identify blastocysts witha better chance of successful implantation?  Response: In-vitro fertilization (IVF), while a solution to many infertile couples is still extremely inefficient with a success rate of nearly 30% and is both mentally, physically, and economically taxing to patients. The IVF process involves the insemination of eggs and the culture of embryos externally in a fertility lab before transferring the developed embryo to the mother. A major challenge in the field is deciding on the embryos that need to be transferred during IVF, such that chances of a healthy birth are maximal and any complications for both mother and child are minimal. Currently, the tools available to embryologists when making such are extremely limited and expensive, and thus, most embryologists are required to make these life-altering decisions using only their observational skills and expertise. In such scenarios, their decision-making process is extremely subjective and tends to be variable. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology / 09.09.2020

MedicalResearch.com Interview with: Jennifer Huang, MD  Dr. Huang is a pediatric dermatologist at Boston Children’s Hospital and Dana-Farber Cancer Institute. She is an Associate Professor of Dermatology at Harvard Medical School. Dr. Huang is a member of the Society for Pediatric Dermatology. Connie Zhong, MD, MSc Dr. Zhong is an intern at Brigham and Women’s Hospital She will be doing her dermatology residency at the Harvard Combined Dermatology Program. She is a member of the Society for Pediatric Dermatology.  MedicalResearch.com: What is the background for this study? Response: Pediatric nonmelanoma skin cancers (NMSC) are rare and when they do occur, are often associated with genetic/predisposing skin conditions or iatrogenic risk factors. There are some pediatric patients who develop NMSCs who do not have identifiable risk factors. The objective of our study was to describe the demographic and clinical features of these children without identifiable risk factors and compare them with those who have either genetic or iatrogenic risk factors. We conducted a retrospective study at 11 tertiary care institutions across North America through the Pediatric Dermatology Research Alliance (PeDRA) (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology / 03.09.2020

MedicalResearch.com Interview with: Yin Zhang MD Research Fellow in Medicine Brigham and Women's Hospital and Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Among modern hair dyes, permanent hair dye is the most popular type, and is the most aggressive and extensively used type that has posed the greatest potential concern about cancer risk. Monitoring and investigating the carcinogenic hazard to people from personal use of permanent hair dyes has major public health implications. In 2008, the World Health Organization's International Agency for Research on Cancer, after comprehensive reviewed prior evidence, classified occupational exposure to hair dyes as a probable carcinogen to humans (group 2A), whereas personal use of hair dyes was not classifiable as to its carcinogenicity to humans (Group 3). Data on hair dye safety has also been continuously monitored by the USFDA. Prior epidemiological evidence may have been influenced by not discriminating between personal and occupational exposure, an inability to distinguish types and colors of hair dyes used, imprecise assessment of several critical domains of exposure history (duration, frequency and cumulative dose), and inadequate control for potential confounding. (more…)
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus, JAMA, Social Issues / 21.08.2020

MedicalResearch.com Interview with: Monik Carmen Jimenez, Sc.D Assistant Professor of Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: We wanted to get a comprehensive picture of the epidemiology of COVID-19 in carceral facilities that included jails and was not restricted solely to prisons. We utilized publicly available data collected in Massachusetts, pursuant to a court order. These data included prison and jail systems and were used to calculate rates of confirmed cases of COVID-19 and testing rates among incarcerated individuals. We were also able to compare those to changes in the population size within each system. (more…)
Author Interviews, COVID -19 Coronavirus, Flu - Influenza, JAMA / 19.08.2020

MedicalResearch.com Interview with: Jeremy Samuel Faust, M.D., M.S., M.A., FACEP Brigham & Women's Hospital Department of Emergency Medicine Division of Health Policy and Public Health Instructor, Harvard Medical School President, Roomful of Teeth Vocal Arts Project (www.roomfulofteeth.org)  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We sought to compare the initial covid-19 outbreak in NYC to the peak of the 1918 H1N1 pandemic in that same city. We found that the covid-19 pandemic was associated with more than 70% as many deaths per capita (monthly) as 1918 H1N1 was. But because baseline mortality rates are about 1/2 of what they were a century ago, death rates were over 400% of usual rates in March and April of this year compared to recent years, while 1918 was "merely" over 280% of usual death rates from prior years leading up to it. (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Osteoporosis / 28.07.2020

MedicalResearch.com Interview with: Daniel Hal Solomon, MD, MPH Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Rheumatology, Immunology Boston, MA 02115 Editor’s note: Prolia® is the trade name for denosumab.  MedicalResearch.com: What is the background for this study? Response: We conducted this study to assess whether delays in denosumab (injections were associated with an increased risk of fractures. In a prior study, we found that the improvements in bone mineral density were reduced among patients who delayed injections. (more…)
Author Interviews, COVID -19 Coronavirus / 26.07.2020

MedicalResearch.com Interview with: Jonathan Li, MD MMSc Assistant Professor of Medicine Harvard Medical School Division of Infectious Diseases Brigham and Women’s Hospital  MedicalResearch.com: Why did you do this study? Response: The accurate diagnosis of COVID-19 is critical for our patients in order to receive appropriate care, and for infection control and public health. In the US, the gold standard for COVID diagnosis is sampling through a nasopharyngeal swab (NP)  but is that really the best way to diagnose COVID?  As many of your viewers may have experienced first hand, nasopharyngeal swabs require inserting a long swab into the back of the nose, which is incredibly uncomfortable for the patient, technically-challenging for the health care worker, and requires equipment and reagents that are in short supply. There are also alternative sampling methods for COVID diagnosis. In Asia, oropharyngeal sampling(OP), or swabbing the back of the mouth, are commonly used and in my hospital, the Brigham and Women’s Hospital, we frequently test sputum as well for inpatients.  But there’s a lot of confusion in the field about which of these methods is the most sensitive? We undertook this study to try to bring some clarity to this question of what is the most sensitive way to diagnose COVID and detect SARS-CoV-2? (more…)
Author Interviews, Brigham & Women's - Harvard, Geriatrics, Lipids / 08.07.2020

MedicalResearch.com Interview with: Ariela Orkaby, MD, MPH Geriatrics & Preventive Cardiology Associate Epidemiologist Division of Aging, Brigham and Women's Hospital Assistant Professor of Medicine, Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Statins are cholesterol lowering medications that have been proven to prevent heart attacks, strokes and death in middle-aged adults. Current guidelines for cholesterol lowering therapy are uncertain as to treatment for older adults due to a lack of available data, even though older adults are at the highest risk of heart disease and death. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Sleep Disorders / 01.07.2020

MedicalResearch.com Interview with: Dr. Rebecca Robbins, PhD MS Fellow at Brigham & Women's Hospital and Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Sleep difficulties are common among older adults and are associated with cognitive decline. We used data collected over 10 years from a large, nationally representative longitudinal survey of adults over the age of 50 in the U.S. We examined the relationship between specific sleep difficulties and cognitive function over time. MedicalResearch.com: What are the main findings?  Response: Our results show that early difficulty falling asleep and early morning awakenings, when experienced "most nights" of the week, were each associated with worse cognitive function. Conversely, reports of waking feeling rested was associated with better cognitive function, over time.   (more…)
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, NEJM, Pediatrics / 24.06.2020

MedicalResearch.com Interview with: Christopher P. Landrigan, MD, MPH Chief, Division of General Pediatrics, Boston Children’s Hospital Director, Sleep and Patient Safety Program, Brigham and Women's Hospital William Berenberg Professor of Pediatrics, Harvard Medical School Boston Children's Hospital Boston, MA 02115 MedicalResearch.com: What is the background for this study? Response: An enormous body of literature demonstrates that sleep deprivation adversely affects the safety and performance of resident physicians, as well as individuals across other occupations.  Resident physicians are at greatly increased risk of suffering motor vehicle crashes and needlestick injuries, and are at substantially increased risk of making medical errors, when working on traditional schedules that include 24-hour shifts. We previously conducted a randomized controlled trial in two intensive care units that found resident physicians made 36% fewer medical errors when a scheduling intervention was introduced that eliminated 24-hour shifts but held resident workload constant. The current study, ROSTERS, was a 6-center study that again introduced a scheduling intervention to eliminate 24-hour shifts in intensive care units.  Due to varying resources and unit organization across sites, each hospital developed its own staffing plan to accommodate the intervention​. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Heart Disease, JACC, Lipids / 23.05.2020

MedicalResearch.com Interview with: Robert P. Giugliano, MD, SM Senior Investigator, TIMI Study Group Cardiovascular Medicine Brigham and Women's Hospital Professor of Medicine Harvard Medical School Boston, MA  MedicalResearch.com: What is the background for this study? Response: Some prior studies had suggested that lipid lowering therapies were associated with impaired cognition.  We sought to explore this question in a prospectively designed substudy of the large FOURIER randomized, double-blind clinical trial utilizing patient self-surveys administered the end of the study to determine whether patients themselves noticed any changes in cognition over the duration of the trial. The survey tool was a shortened version of the Everyday Cognition Questionnaire (see attached) that asks patients 23 questions that assess memory and executive function (including subdomains of planning, organization, and divided attention). The questions are in the format of "Compared to the beginning of the study, has there been any change in .....", and are graded as 1=better/no change, 2=questionable/occasionally worse, 3=consistently a little worse, 4=consistently much worse. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Social Issues / 27.02.2020

MedicalResearch.com Interview with: Nancy J. Donovan, M.D. Chief, Division of Geriatric Psychiatry Brigham and Women’s Hospital Assistant Professor of Psychiatry Harvard Medical School Boston, MA 02115  MedicalResearch.com: What is the background for this study? Response: Prior research has shown that widowed older adults are more likely to experience cognitive decline than those who are married. However, there have been no prior studies of widowhood as a risk factor for cognitive decline due to Alzheimer’s disease, the most common cause of severe cognitive impairment. (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, Gender Differences, JAMA, Melanoma / 12.02.2020

MedicalResearch.com Interview with: Arash Mostaghimi, MD, MPA, MPH Director, Inpatient Dermatology , Brigham and Women's Hospital Instructor, Harvard Medical School Department of Dermatology Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Smaller studies have demonstrated increased risk for skin cancer among gay men.  Prior to this study this data had not been confirmed in a nationally representative database. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Dermatology, JAMA, Rheumatology / 09.11.2019

MedicalResearch.com Interview with: Emily S. Ruiz, MD, MPH Director, High-Risk Skin Cancer Clinic, Dana Farber/Brigham and Women’s Cancer Center Assistant Professor, Harvard Medical School, Dermatology Brigham And Women's Faulkner Hospital  MedicalResearch.com: What is the background for this study? Response: Innovation in oncology has led to increased development and market entry of anticancer drugs. For example, from 2009 to 2013, the US FDA approved 51 oral and systemic anticancer drugs for 63 indications. Prices for anticancer drugs have risen faster than inflation over time, especially for older drugs, and prices in the US have largely been set by market forces rather than novelty or efficacy. Understanding the evolving cancer economic landscape requires consideration of annual and cumulative rates of change for key metrics, such as total spending, drug cost per beneficiary, out-of-pocket cost, and utilization. This study sought to weigh the proportional impacts of rising drug costs and utilization on increased Medicare Part D spending for a cohort of oral anticancer drug utilized from 2013-2017.  (more…)
AstraZeneca, Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 10.09.2019

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

MedicalResearch.com Interview with: Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC Professor of Medicine, Harvard Medical School Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy (DAPT) is known to improve outcomes in patients with acute coronary syndromes (ACS), prior myocardial infarction (MI), or recent coronary stenting. What was unknown is whether patients with diabetes and stable coronary artery disease – a group generally believed to be at high ischemic risk – would benefit from initiation of long-term DAPT with low-dose aspirin plus ticagrelor versus low-dose aspirin (plus placebo). This is what THEMIS was designed to test, with THEMIS-PCI designed prospectively to examine those patients specifically who had a history of previous percutaneous coronary intervention (PCI). (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Medicare / 28.08.2019

MedicalResearch.com Interview with: Jose F. Figueroa, MD, MPH Instructor , Harvard Medical School, Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Hospitalizations related to ambulatory-care sensitive conditions are widely considered a key measure of access to high-quality ambulatory care. It is included as a quality measure in many national value-based care programs. To date, we do not really know whether rates of these avoidable hospitalizations are meaningfully improving for Medicare beneficiaries over time. (more…)
Author Interviews, Brigham & Women's - Harvard, Opiods / 06.08.2019

MedicalResearch.com Interview with: Lauren A. Hoffman, Ph.D. Research Fellow Recovery Research Institute Center for Addiction Medicine Massachusetts General Hospital Harvard Medical School MedicalResearch.com: What is the background for this study?   Response: In 2017, an estimated 11.4 million Americans reported past-year opioid misuse1 and opioid-related overdose accounted for more than 47,000 deaths2. Prior research has helped further our understanding of the prevalence and consequences of opioid misuse, but we know substantially less about recovery from opioid use problems. Recovery-focused research conducted to-date has largely focused on alcohol use disorder, the most common type of substance use disorder. Characterizing recovery from opioid use problems and the pathways that individuals take to resolve such problems can ultimately help identify effective ways to address opioid misuse. Using data from the first national probability-based sample of US adults who have resolved a significant substance use problem (National Recovery Survey3), we provide the first national prevalence estimate of opioid recovery, and characterize treatment/recovery service use and psychological well-being in individuals who resolved a primary problem with opioids, relative to individuals who resolved a primary alcohol problem. We focused our cross-sectional investigation of service use and well-being on 2 time-horizons associated with continued vulnerability: <1 year since problem resolution (early-recovery) and 1 – 5 years since problem resolution (mid-recovery). (more…)
Author Interviews, Dermatology, JAMA / 01.08.2019

MedicalResearch.com Interview with: Eunyoung Cho, Sc.D. Associate Professor Director of Research, Department of Dermatology The Warren Alpert Medical School of Brown University Associate Professor, Department of Epidemiology Brown School of Public Health Channing Division of Network Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Cutaneous squamous cell carcinoma (SCC) is a common skin cancer in people with fair skin. Vitamin A is a fat-soluble vitamin that is naturally present in many foods such as green leafy vegetables, fruits including cantaloupe, apricots, and mangos, and dairy products. We studied whether vitamin A intake is beneficial against SCC risk because there are few ways to prevent skin cancer. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

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

MedicalResearch.com Interview with: Samia Mora, MD, MHS Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Preventive Medicine Boston, MA 02115  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk. To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JAMA, Radiation Therapy, Technology / 19.04.2019

MedicalResearch.com Interview with: Raymond H Mak, MD Radiation Oncology Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? 
  • Lung cancer remains the most common cancer, and leading cause of cancer mortality, in the world and ~40-50% of lung cancer patients will need radiation therapy as part of their care
  • The accuracy and precision of lung tumor targeting by radiation oncologists can directly impact outcomes, since this key targeting task is critical for successful therapeutic radiation delivery.
  • An incorrectly delineated tumor may lead to inadequate dose at tumor margins during radiation therapy, which in turn decreases the likelihood of tumor control.
  • Multiple studies have shown significant inter-observer variation in tumor target design, even among expert radiation oncologists
  • Expertise in targeting lung tumors for radiation therapy may not be available to under-resourced health care settings
  • Some more information on the problem of lung cancer and the radiation therapy targeting task here:https://www.youtube.com/watch?v=An-YDBjFDV8&feature=youtu.be
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Author Interviews, Brigham & Women's - Harvard, Lipids, Stroke / 16.04.2019

MedicalResearch.com Interview with: Pamela M. Rist, ScD Assistant Professor of Medicine, Harvard Medical School Brigham and Women's Hospital, Division of Preventive Medicine Boston, MA 02215  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although hypercholesterolemia is a risk factor for ischemic stroke, some prior studies have observed an inverse association between total and low-density lipoprotein (LDL) cholesterol and risk of hemorrhagic stroke.  However, many studies were not able to study this association specifically among women. Our main result was very low levels of low-density lipoprotein (LDL) cholesterol or low levels of triglycerides were associated with an increased risk of hemorrhagic stroke among women. (more…)
Author Interviews, Brigham & Women's - Harvard, Gender Differences, JAMA, Surgical Research / 16.04.2019

MedicalResearch.com Interview with: Nelya Melnitchouk, MD,MSc Director, Program in Peritoneal Surface Malignancy, HIPEC Dr. Melnitchouk is an associate surgeon at Brigham and Women’s Hospital (BWH) and Brigham and Women’s Faulkner Hospital (BWFH) and instructor of surgery at Harvard Medical School. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current literature on women in surgery show that female physicians, particularly those in procedural specialties, face many challenges in balancing responsibilities between work and home. We hypothesized that these challenges may affect career satisfaction more negatively for physician mothers in procedural specialties than those in nonprocedural specialties. In our study, we found that physician mothers in procedural specialties who had more domestic responsibilities were more likely to report a desire to change careers than those in nonprocedural specialties.  (more…)