Author Interviews, Health Care Systems, JAMA, Pharmacology, University of Pittsburgh / 31.10.2024

MedicalResearch.com Interview with: Katie J. Suda, PharmD, M.S., FCCP Professor of medicine with tenure Associate Director, Center for Pharmaceutical Policy and Prescribing University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? Response: Our pharmaceutical supply chain is global where the manufacturing process for one drug may occur in multiple countries. Sometimes there are breakdowns in the pharmaceutical supply chain which may threaten access to medicines. Breakdowns in the supply chain occur for medicines manufactured in the U.S. and by international partners. While breakdowns in the supply chain occur for hundreds of drugs each year, not all result in a decrease in available supply (a “drug shortage”) because of action taken by manufacturers, pharmacies and drug regulators (e.g., the U.S. Food and Drug Administration [FDA]). Drug shortages are a critical concern to public health as pharmacies, clinicians, and patients struggle to identify safe and effective alternatives. In addition, drug shortages have been associated with adverse patient outcomes and medication safety events. Recently, drug shortages have gotten worse with shortages occurring with increasing frequency and lasting longer. There has also been a shift in the types of medicines in shortage from drugs primarily used in hospitals, such as injectables, to oral medicines frequently used to manage outpatient conditions. Countries have different regulatory authority and policy which may impact how drug supply chain breakdowns result in drug shortages. We wanted to know if there are differences between the U.S. and Canada in the frequency that national drug shortages occur after supply chain breakdowns are reported in both countries. Canada is a good comparator to the U.S. because Canada has similar drug regulatory standards and manufacturing inspections. Prescription drug coverage is also similar for the two countries where half of prescriptions are reimbursed through public insurance and half through private insurance and out-of-pocket. (more…)
Author Interviews, Cancer Research, University of Pittsburgh / 09.05.2024

MedicalResearch.com Interview with: Roderick J. O’Sullivan PhD Associate Professor Department of Pharmacology and Chemical Biology UPMC Hillman Cancer Center University of Pittsburgh Pittsburgh, PA MedicalResearch.com: What is the background for this study? Response: For a few years, my group has had the good fortune of collaborating with Dr. Ivan Ahel. Ivan is a world leader in the field of ADP-ribosylation. His work has identified major gaps in our understanding of ADP-ribosylation. This includes his lab discovering that DNA bases can be ADP-ribosylated in bacteria and that a poorly characterized enzyme known as TARG1 could be involved in that process. In discussing this work with Ivan, we were confident that DNA ADP-ribosylation also exists in human cells and that showing this could be pretty important. The problem was that identifying a part of the genome where it might be present, so we could study it, was not so obvious and challenging. But we had a hunch that telomeres could be one part of the genome where it could happen!! Telomeres are really special structures located at the ends of each human chromosome. They demarcate the physical end of each chromosome and prevent chromosomes from becoming entangled – which if it happens, is catastrophic for cells. Our hunch was based on the evidence from other studies that telomeres are natural targets of PARP1, the enzyme that catalyzes most of the ADP-ribosylation in human cells. I then discussed this idea with Anne Wondisford, a medical scientist trainee in the lab, who liked the idea and designed a series of experiments to test it. (more…)
Author Interviews, Breast Cancer, Mammograms / 07.12.2022

MedicalResearch.com Interview with: Wendie Berg, MD, PhD, FACR Professor of Radiology University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: Mammography misses many cancers in women with a personal history of breast cancer (PHBC). MRI improves early detection of cancer in women with PHBC and the American College of Radiology recommends adding MRI every year for women with PHBC and dense breasts or diagnosis by age 50 but not every woman can tolerate MRI. Contrast-enhanced mammography (CEM) appears to be a good alternative to MRI.  Our study examined performance of CEM after tomosynthesis in women with PHBC.  We first trained our radiologists in CEM (Berg WA et al JBI 2021) and two radiologists interpreted both tomosynthesis and CEM on every participant. (more…)
Author Interviews, Dermatology, Immunotherapy, NEJM, University of Pittsburgh / 06.10.2022

MedicalResearch.com Interview with: Rohit Aggarwal, MD, MS Rheumatology, Professor of Medicine Medical Director, Arthritis and Autoimmunity Center Sub-Specialty Education Coordinator Division of Rheumatology Department of Medicine University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: Dermatomyositis is a rare autoimmune inflammatory disease that affects muscles and skin, although muscular forms without skin symptoms and vice versa are also seen. The exact etiology of the disease is not known but is thought to be immune-mediated with many patients having highly specific autoantibodies. There is no cure for dermatomyositis, but several types of treatment have been successfully used in the last years including different kinds of immunosuppressants (e.g. steroids) and intravenous immune globulins (IVIG) to improve the patient’s condition. So far, none of these treatments was approved for use in dermatomyositis based on large, randomized, placebo-controlled trials. Their effectiveness was mainly deduced from clinical experience and from small clinical trials. The ProDERM study was the first large, pivotal, randomized placebo-controlled trial to evaluate the efficacy and safety of intravenous immune globulin (IVIG) in dermatomyositis patients. (more…)
Author Interviews, Health Care Systems / 14.04.2022

MedicalResearch.com Interview with: James H. Baraldi University of Pittsburgh MedicalResearch.com:  What is the background for this study?  Response: Researchers investigating pharmaceuticals and medical devices in randomized controlled trials (RCTs) often receive payments from the manufacturers of these investigational products. In many cases these payments are not dedicated to the express purpose of research, but rather consist of consulting fees and compensation for travel and lodging and food and beverage. As part of the 2010 Affordable Care Act, the US government passed the Physician Payment Sunshine Act to increase transparency of this type of funding. The law required manufacturers reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program to disclose to the Centers for Medicare and Medicaid Services information regarding investigator payments. This information became freely and publicly available on the Open Payments website with the earliest data from 2013. Not only have the pharmaceutical and medical device manufacturers disclosed the investigators’ payment information, but the investigators themselves have had to do so in accordance with the requirements of the journals in which they publish their findings or in accordance with the requirements of the International Committee of Medical Journal Editors (ICMJE). (more…)
Author Interviews, Gender Differences, JAMA, Surgical Research, University of Pittsburgh / 21.05.2020

MedicalResearch.com Interview with: Sara P. Myers, M.D., Ph.D. University of Pittsburgh School of Medicine  MedicalResearch.com: What is the background for this study? Response: Compared to other fields, medicine, and especially academic surgery and its subspecialties, trail with respect to gender diversity. Considering that these fields were traditionally male-dominated, two issues that may present ongoing challenges to the retention and promotion of women are pro-male bias and negative stereotypes about women. Training specific to pursuing a surgical career begins in residency, so it is important to understand how these issues affect motivation and achievement during this formative period. In our study we first evaluated the association between pro-male bias and research-related career engagement using a survey methodology, and then looked at whether evoking negative stereotypes about women was associated with reduced performance on a simulated technical skill assessment called the Fundamentals of Laparoscopic Surgery (FLS) assessment.  (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, 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, 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…)