16 May Insurers Can Pay High Cost of Hepatitis C Drugs, But Not Benefit If Patient Switches Plans
Posted at 19:04h
in Author Interviews, Cost of Health Care, Gastrointestinal Disease, Hepatitis - Liver Disease
MedicalResearch.com Interview with:
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Dr. Darius Lakdawalla[/caption]
Darius Lakdawalla PhD
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation
School of Pharmacy
Professor in the Sol Price School of Public Policy
University of Southern California
MedicalResearch.com: What is the background for this study?
Dr. Lakdawalla: New treatments for hepatitis-C are highly effective but also involve high upfront costs. Because they effectively cure the disease, all the costs of treatments are paid over a short period of time – about three months – but the benefits accrue for the rest of a patient’s life. This creates problems for the private health insurance system, where patients switch insurers. The insurer that pays the bill for the treatment might not be around to enjoy the benefits of averting liver damage, liver transplants, and other costly complications associated with hepatitis-C.
Dr. Jack Resneck[/caption]
Jack Resneck, Jr, MD
Professor and Vice-Chair of Dermatology
Core Faculty, Philip R. Lee Institute for Health Policy Studies
UCSF School of Medicine
MedicalResearch.com: What is the background for this study?
What are the main findings?
Dr. Resneck: Telemedicine, when done right, can improve access and offer convenience to patients. We have seen proven high-quality care in telemedicine services where patients are using digital platforms to communicate with their existing doctors who know them, and where doctors are getting teleconsultations from other specialists about their patients. But our study shows major quality problems with the rapidly growing corporate direct-to-consumer services where patients send consults via the web or phone apps to clinicians they don’t know.
Most of these sites aren’t giving patients a choice of the clinician who will care for them or disclosing the credentials of those clinicians – patients should know whether their rash is being cared for by a board-certified dermatologist, a pain management specialist, or a nurse practitioner who usually works in an emergency department. Some of these sites are even using doctors who aren’t licensed in the US. We also found that these sites were regularly missing important diagnoses, and prescribing medications without discussing risks and side-effects, putting patients at risk. We observed that if you upload photos of a highly contagious syphilis rash but state that you think you have psoriasis, most clinicians working for these direct-to-consumer sites will just agree with your self-diagnosis and prescribe psoriasis medications, leaving you with a contagious STD.
Perhaps the biggest problem with many of these sites is the lack of coordinating care for patients – most of them didn’t offer to send records to a patient’s existing local doctors. And when patients end up needing in-person care if their condition worsens, or they have a medication side-effect, those distant clinicians often don’t have local contacts, and are unable to facilitate needed appointments.
Chloe Barrera MPH
ORISE Fellow
Centers for Disease Control and Prevention
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Previous studies have been inconsistent in whether introduction of solid foods to babies before 4 months may be associated with later obesity. In our analysis of more than a thousand babies followed through the first year of life and contacted again at 6 years, we did not find this association.
Dr. Benjamin D. Sommers[/caption]
Benjamin D. Sommers, MD, PhD
Assistant Professor of Health Policy & Economics
Harvard T. H. Chan School of Public Health / Brigham & Women's Hospital
Boston, MA 02115
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Molly E. Frean[/caption]
Molly E. Frean
Data Analyst
Department of Health Policy and Management
Harvard T.H. Chan School of Public Health
Boston, MA 02115
MedicalResearch.com: What is the background for this study?
Dr. Sommers: We conducted this study in an effort to see how Native Americans have fared under the Affordable Care Act. In addition to the law's expansion of coverage via Medicaid and tax credits for the health insurance marketplaces, the law also provided support for Native Americans’ health care specifically through continued funding of the Indian Health Service (IHS). We sought to see how both health insurance coverage patterns and IHS use changed in the first year of the law's implementation.
Dr. Tyler VanderWeele[/caption]
Dr. Tyler VanderWeele PhD
Professor of Epidemiology
Department of Epidemiology
Department of Biostatistics
Harvard T. H. Chan
School of Public Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. VanderWeele: There have been some prior studies on religious service attendance and mortality. Many of these have been criticized for poor methodology including the possibility of reverse causation – that only those who are healthy can attend services, so that attendance isn’t necessarily influencing health. We tried to address some of these criticisms with better methodology. We used repeated measures of attendance and health over time to address this, and a very large sample, and controlled for an extensive range of common causes of religious service attendance and health. This was arguably the strongest study on the topic to date and addressed many of the methodological critiques of prior literature. We found that compared with women who never attended religious services, women who attended more than once per week had 33% lower mortality risk during the study period. Those who attended weekly had 26% lower risk and those who attended less than once a week had 13% lower risk.
Dr. Wisit Cheungpasitporn[/caption]
Wisit Cheungpasitporn, MD, Nephrology Fellow
Project mentor: Stephen B. Erickson, MD
Departments of Nephrology and Hypertension
Mayo Clinic, Rochester, MN
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Cheungpasitporn: The prevention and management of hypertension continue to be major public health challenges. Studies have shown the benefits of napping, including reduction of fatigue and improvement of alertness, mood and work performance. However, there have also been increasing reported associations between napping and cardiovascular disease, diabetes mellitus, strokes, and higher mortality from all causes. The risk of hypertension in adults who regularly take a nap is controversial.
Dr. Shipra Arya[/caption]
Shipra Arya MD, SM
Assistant Professor, Division of Vascular Surgery
Emory University School of Medicine
Assistant Professor of Epidemiology (Adjunct)
Rollins School of Public Health
Staff Physician, Atlanta VA Medical Center
Director, AVAMC Vascular Lab and Endovascular Therapy
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Arya: Peripheral Arterial Disease is the next cardiovascular epidemic. It is poorly recognized and not adequately treated compared to heart disease – and research is lacking on the optimal use of statins for PAD patients. Very few randomized clinical trials have been done specifically in PAD patients to assess the impact of statins on cardiovascular outcomes and none on limb related outcomes. The 2013 ACC/AHA guidelines for cholesterol lowering medications recommends high intensity statins for PAD patients extrapolated from the level 2 and 3 evidence and empirically based on CAD and stroke data.
In this study we looked at the amputation and mortality risk based on statin dosage in a large cohort of patients from the VA population and found that high intensity statins are associated with a significant reduction in limb loss (~30%) and mortality (~25%) in PAD patients followed by a smaller risk reduction [~23% for amputation risk reduction and 20% reduction in mortality risk] by low-moderate intensity statins as compared to no statin therapy.
Dr. Ambay Pandey[/caption]
Ambarish Pandey, MD
Cardiology Fellow, PGY5
University of Texas Southwestern Medical Center
Dallas, Texas
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Pandey: Previous studies have reported an underutilization of guideline based heart failure therapies among patients with heart failure (HF) and end-stage renal diseases. However, it is not known if the proportional use of these evidence-based medical therapies and associated clinical outcomes among these patients has changed over time. In this study, we observed a significant increase in adherence to heart failure process of care measures over time among dialysis patients with no significant change in clinical outcomes over time.
Dr. Meghan Azad[/caption]
Meghan Azad PhD
Assistant Professor, Department of Pediatrics & Child Health and Community Health Sciences
University of Manitoba
Associate Investigator, Canadian Healthy Infant Longitudinal Development (CHILD) Study
MedicalResearch.com: What is the background for this study?
Dr. Azad: It is well known that maternal nutrition plays a key role in “programming” fetal development and infant weight gain, but the impact of artificial sweetener consumption during this critical period has not been extensively studied. Some animal research suggests that consuming artificial sweeteners during pregnancy can predispose offspring to develop obesity, but this has never been studied in humans, until now.
Mallory Kidwell[/caption]
Mallory Kidwell, B.A.
Project Coordinator at the 
Dr. Michael McGeachie[/caption]
Michael McGeachie, PhD
Instructor in Medicine
Harvard Medical School
Channing Division of Network Medicine
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study?
Dr. McGeachie: In asthma, and in general but particularly in asthma, a person’s level of lung function has a big impact on his or her quality of life, level of respiratory symptoms and complications, and general morbidity. In asthma, low lung function leads to greater severity and frequency of asthma symptoms. Asthma is a common childhood illness, affecting 9-10% of children. Many children grow out of asthma as they become adults, but other asthmatics remain effected through adulthood, which can lead to a lifetime of respiratory symptoms and chronic airway obstruction, including chronic obstructive pulmonary disease (COPD).
If you consider lung function longitudinally, throughout development, plateau, and decline, different people and different asthmatics tend to exhibit different patterns of lung function. Healthy, non-asthmatic people tend to have a period of rapid lung function increase in adolescence, a plateau of lung function level in their late teens and early 20s, and starting around 25 or so a slow, gradual decline of lung function that continues throughout old age. We call this Normal Growth of lung function. However, some people exhibit Reduced Growth, where they don’t reach their expected maximum lung function for a person of the same age, sex, height, and race. Others can show Early Decline, who might reach a normal maximum but then begin to decline immediately without a plateau or with a truncated plateau. We hypothesized that these patterns, Reduced Growth and Early Decline, might have different baseline indicators, precursors, outcomes, and risk of developing COPD.
Dr. Geoffrey Liu[/caption]
Dr. Geoffrey Liu, MD MSC
Princess Margaret Hospital/Ontario Cancer Institute
University of Toronto
Toronto, Ontario
Canada
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Liu: Cetuximab is a monoclonal antibody therapy used in metastatic colorectal cancer patients when other chemotherapy options have been exhausted. Currently, the only useful biomarker to determine whether metastatic colorectal cancer patients will benefit from the drug, cetuximab, is whether patients carry a RAS mutation in their tumours. We evaluated additional biomarkers using samples from a Phase III clinical trial led by the Canadian Cancer Trials Group and the Australasian Gastrointestinal Trials Group. Our study identified a germline, heritable biomarker, a FCGR2A polymorphism, that further identifies an additional subgroup of patients who would benefit most from receiving cetuximab. This is important because the drug does have toxicity and is expensive to use; patients who are found not to likely benefit from this drug can go on quickly to try other agents, including participation in clinical trials.
Dr. Debra Silverman[/caption]
Dr. Debra Silverman Sc.D
Branch Chief and Senior Investigator in the Occupational and Environmental Epidemiology Branch, Division of Cancer Epidemiology & Genetics
National Cancer Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Silverman: We know that bladder cancer mortality rates have been elevated in northern New England for at least five decades. Incidence patterns in Maine, New Hampshire and Vermont are similar—about 20% higher than those for the United States overall. Elevated rates have been observed in both men and women, suggesting the role of a shared environmental etiologic factor.
A unique feature of northern New England is that a high proportion of the population uses private wells as their primary source of drinking water. The well water may contain low-to-moderate levels of arsenic. There are two possible sources of this arsenic contamination:
Dr. Gabriele Messina[/caption]
Gabriele Messina, MD Dr.PH MSc
Research Professor of Public Health
University of Siena
Department of Molecular and Developmental Medicine
Area of Public Health. Room: 2057
Siena, Italy
MedicalResearch.com: What is the background for this study?
Dr. Messina: Studies conducted in the 1970s and 1980s conferred to environmental surfaces a marginal role in the transmission of health care associated infections (HAIs). Today, it is demonstrated that several pathogens such as C. difficile, VRE (Vancomycin-resistant Enterococcus) and MRSA (Methicillin-resistant Staphylococcus aureus) can survive even for months on inanimate surfaces. Up to 40% of HAIs can be spread by the hands of doctors and hospital staff after touching infected patient and/or contaminated surfaces; furthermore, people hospitalized in rooms previously occupied by patients infected by microorganism that can persist on surfaces present an increased risk to develop HAIs.
Ms. Leigh Purvis[/caption]
Leigh Purvis, MPA
Director of Health Services Research
AARP Public Policy Institute
MedicalResearch.com Editor’s Note: The May AARP Bulletin has a important article “Black Market Meds Are Flooding the Nation’s Pharmacies And Hospitals” by Joe Eaton, discussing the growing problem of counterfeit medications entering the US pharmaceutical supply chain. Ms. Leigh Purvis of the AARP Policy Institute discussed this important issue for the readers of MedicalResearch.com. Ms. Purvis’ areas of expertise include prescription drug pricing, biologic drugs, and Medicare prescription drug coverage.
MedicalResearch.com: Is pharmaceutical theft and fraud a new or growing problem?
Ms. Purvis: I think it’s safe to say that pharmaceutical theft is a growing problem. Skyrocketing prices have made pharmaceuticals a lucrative target for criminals. Trucks transporting pharmaceuticals are a common target, although some thieves have stolen prescription drugs directly from manufacturers’ warehouses.
Pharmaceutical fraud is also a growing concern. FDA does a great deal to ensure the safety of US pharmaceuticals. However, problems can still arise, particularly when people purchase drugs online.
Dr. Shuhei Miyashita[/caption]
Dr. Shuhei Miyashita PhD
Lecturer in Intelligent Robotics
Department of Electronics
University of York, Heslington
York, UK
MedicalResearch.com: What is the background for this device? What are some of the obstacles you and your team face in the development?
Dr. Miyashita: We are developing medical technology that is less invasive and more
autonomous and thus can provide safe and consistent outcomes. The
biggest challenge is how to build a capable medical robot that is
clinically safe. Addressing this challenge requires finding
bio-compatibe materials, safe means of transportation in the body, a
way to reconfigure the robot from pill shape to unfolded shape, and
precise multi-mode control for the location and function of the robot.
Dr. Michael Miller[/caption]
Michael Miller, MD, FACC, FAHA
Professor of Cardiovascular Medicine, Epidemiology & Public Health
University of Maryland School of Medicine
Staff Physician, Baltimore VAMC
Director, Center for Preventive Cardiology
University of Maryland Medical Center
Baltimore, Maryland
MedicalResearch.com: What is the background for this study?
Dr. Miller: It has become an article of faith that HDL (the good cholesterol) is an independent risk factor for heart disease. However, previous studies did not examine the importance of HDL after accounting for both LDL (bad cholesterol) and triglycerides (blood fats). This is important because HDL is associated with LDL and triglycerides. We hypothesized that if HDL is truly an independent risk factor, then low HDL levels in isolation would continue to be linked to an increased risk of heart disease while high HDL levels would continue to protect the heart even if LDL and triglycerides levels were elevated.
Dr. Mathias Buttmann[/caption]
PD Dr. Mathias Buttmann
Senior Consultant Neurologist and Head of the Multiple Sclerosis Outpatient Clinic
University of Wuerzburg
Wuerzburg, Germany
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Buttmann: The synthetic anthracenedione mitoxantrone is approved for disease-modifying treatment of patients with aggressive forms of relapsing or secondary progressive multiple sclerosis (MS). It has been known for years that this DNA-intercalating agent increases the risk of acute myeloid leukemia. We performed a retrospective cohort study to investigate whether mitoxantrone also increases the risk for other types of malignancies. We included all 677 mitoxantrone-treated multiple sclerosis patients who were seen at our large German academic MS centre between 1994 and 2007 and collected follow-up information on the occurrence of malignancies, death and causes of death as of 2011. Follow-up was complete in 676 patients. The median age at mitoxantrone initiation was 41 years and the median follow-up duration was 8.7 years. We identified 37 patients with a malignancy after mitoxantrone initiation, among them 4 cases of acute myeloic leukemia and 7 cases of colorectal cancer.
Compared to the general population matched for sex, age and year of occurrence, we calculated an 1.5-fold increased incidence of any type of malignancy, a tenfold increased incidence of acute myeloic leukemia and a threefold increased incidence of colorectal cancer, while the incidence of other types of malignancies was not increased. Higher age at mitoxantrone initiation but neither higher cumulative mitoxantrone dose nor treatment with other immuosuppressive agents was identified as a malignancy risk factor. Fifty-five patients had died, among them 12 from a malignancy. Our study confirmed previous reports on an increased incidence of acute myeloic leukemia after mitoxantrone treatment and newly described an association between mitoxantrone therapy and an increased incidence of colorectal cancer.
Dr. Hans Hoerauf[/caption]
Prof. Dr. med. Hans Hoerauf
Direktor der Augenklinik
Universitätsmedizin Göttingen
Göttingen
MedicalResearch.com: What is the background for this study?
Dr. Hoerauf: Two treatment options, anti-vascular endothelial growth factors (anti-VEGFs) and corticosteroids, with different mechanisms of action are available for the treatment of macular edema secondary to Central Retinal Vein Occlusion (CRVO). Our study, COMRADE-C, is the first head-to-head study to investigate the clinical efficacy and safety of the European labels of ranibizumab (anti-VEGF) versus dexamethasone intravitreal implant (corticosteroid) in patients with CRVO over six months.
Dr. Katarina Truvé[/caption]
Katarina Truvé PhD
Swedish University of Agricultural Sciences and
Kerstin Lindblad-Toh
Uppsala University
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Truvé: Gliomas are malignant brain tumors that are rarely curable. These tumors occur with similar frequencies in both dogs and humans. Gliomas in dogs are strikingly similar at the biological and imaging level to human tumor counterparts. Some dog breeds such as Boxer and Bulldog are at considerably higher risk of developing glioma. Since these breeds at high risk are recently related, they are most likely carrying shared genetic risk factors. Our goal was therefore to use the dog genome to locate genes that may be involved in the development of glioma in both dogs and humans. We found a strongly associated locus and identified three candidate genes, DENR, P2RX7 and CAMKK2 in the genomic region. We have shown that CAMKK2 is lower expressed in glioma tumors than normal tissue in both dogs and human, and it has been reported that the associated canine mutation in P2RX7 results in a decrease in receptor function.
Dr. Maryam Farvid[/caption]
MedicalResearch.com Interview with:
Maryam Farvid, Ph.D.
Visiting Scientist
Department of Global Health and Population
Harvard T.H. Chan School of Public Health
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Farvid: Breast cancer is one of the most frequently diagnosed cancers and is the second leading cause of cancer deaths among women in the United States. While we know many breast cancer risk factors, few of them are easily modified. Further, evidence suggests that exposure to carcinogens and anti-carcinogens in early life may play an important role. According to this study, what women eat as teens or young adults could affect their breast cancer risk in the future. Teenage girls who eat a lot of fruits may have a lower risk of breast cancer later in life. The risk of breast cancer among women who reported the highest amount of 
Dr-Daniel Benjamin[/caption]
Dr. Daniel J. Benjamin PhD
Associate Professor (Research), USC, 2015-present
Associate Professor (with tenure), Cornell, 2013-2015
Assistant Professor, Cornell University, 2007-2013
Research Associate, NBER, 2013-present
Faculty Research Fellow, NBER, 2009-2013
MedicalResearch.com: What is the background for this study?
Dr. Benjamin: Educational attainment is primarily determined by environmental factors, but decades of twin and family studies have found that genetic factors also play a role, accounting for at least 20% of variation in educational attainment across individuals. This finding implies that there are genetic variants associated statistically with more educational attainment (people who carry these variants will tend on average to complete more formal education) and genetic variants associated statistically with less educational attainment (people who carry these variants will tend on average to complete less formal education). But none of these genetic variants had been identified until our 2013 paper on educational attainment. That paper, which studied a sample of roughly 100,000 individuals, identified 3 genetic variants associated with educational attainment, each of which has a very small effect. In the current paper, we expanded our sample to roughly 300,000 individuals, with the goal of learning much more about the genetic factors correlated with educational attainment.
Danielle Schoffman[/caption]
Danielle E. Schoffman
PhD Candidate
Department of Health Promotion, Education, and Behavior
Arnold School of Public Health
University of South Carolina
Columbia, SC 29208
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In recent years, there has been large growth in the fast casual (e.g., Panera, Chipotle) restaurant sector, and there is a general perception among consumers that these restaurants are a healthier and fresher alternative to fast food. When we encourage participants in our research studies to reduce their fast food intake, they often ask if these fast casual restaurants also count. We were interested in looking at the calorie data for entrees at both restaurant types to see if they lined up with these assumptions.
We analyzed the calorie content of entrées at 34 fast food and 28 fast casual restaurants, and found that fast food entrées had an average of 760 calories per entrée compared to 561 for fast food entrées . Also, a greater proportion of fast casual restaurant entrées exceeded the median of 640 calories per entrée.
Dr. T. Dianne Langford[/caption]
Dr. T. Dianne Langford PhD
Associate Professor, Neuroscience and Neurovirology
Lewis Katz School of Medicine
Temple University
MedicalResearch.com: What is the background for this study?
Dr. Langford: The ocular-motor system has been shown to reflect neural damage, and one of ocular-motor functions, near point of convergence (NPC), was reported to worsen after a sport-related concussion (Mucha et al. Am J Sport Med). But the effects of subconcussive head impact, a milder form of head injury in the absence of outward symptoms remains unknown. Prior to this study, we found that in a controlled soccer heading experimental paradigm decreased NPC function, and even 24h after the headings, NPC was not normalized back to baseline (Kawata et al. 2016 Int J Sport Med). To extend our findings from the human laboratory study, we launched longitudinal clinical studies in collaboration with the Temple football team, to see if repetitive exposure to subconcussive head impacts negatively affects NPC.
Dr. Brian Boxer Wachler[/caption]
Dr. Brian Boxer Wachler MD
Boxer Wachler Vision Institute
Beverly Hills, California
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: As an eye surgeon, I observed patients tended to have more age spots on the left side of their faces. I was examining a patient with Keratoconus and after I noted her age spots on her left cheeks, I began to look into this phenomenon. It turns out there are many studies that found more skin cancer on the left side of the face compared to the right side of the face. In Australia (where people drive on the left side of the road) it’s the opposite – more skin cancer on the right side of the face. Our study found that cars on average have significantly lower UVA (ultraviolet A) protection in the side windows compared to windshields which have universally high UVA protection. I believe this can be the missing link that can explain higher rates of skin cancer on the side of the face by the driver’s window. There are also more cataracts in left eyes vs right eyes. There was no relationship between high-end cars and low-end cars for side window UV protection – in other words many more pricey cars had just as poor side window UV protection as less expensive cars.