Medicare’s Inconsistent Drug Coverage Policies Can Impede Access To New Technologies

Joshua P. Cohen Ph.D Research Associate Professor Tufts Center for the Study of Drug Development Boston, MassachusettsMedicalResearch.com Interview with:
Joshua P. Cohen Ph.D
Research Associate Professor
Tufts Center for the Study of Drug Development
Boston, Massachusetts

Medical Research: What is the background for this study?

Dr. Cohen: Florbetapir 18F was the first radioactive diagnostic agent approved by the US Food and Drug Administration for positron emission tomography imaging of the brain to evaluate amyloid â neuritic plaque density.

Medical Research: What are the main findings?

Dr. Cohen: Medicare has restricted coverage of florbetapir in the US, whereas conspicuously the UK NHS decided to reimburse the radiopharmaceutical. Note, the British NHS is generally more restrictive with regard to coverage of new technologies than the Centers for Medicare and Medicaid Services. Historically Medicare has rejected coverage of 25% of diagnostics approved by the FDA, but covers all FDA approved drugs administered in the physician’s office. Furthermore, Medicare has subjected labeled use of diagnostics, including a half-dozen Alzheimer’s diagnostics, to its coverage with evidence development program while not subjecting any labeled uses of drugs to coverage with evidence development. In sum, diagnostics are subject to a level of scrutiny by Medicare that is rarely given Medicare Part B drugs (physician-administered).

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No Definitive Biomarker Predicts Cancer Response To Radiation Therapy

MedicalResearch.com Interview with:
Dr Ananya Choudhury

Consultant and Honorary Senior Clinical Lecturer, Clinical Oncology
The Christie NHS Foundation Trust,
Wilmslow Road
Withington, Manchester, UK

Medical Research: What is the background for this study? What are the main findings?

Response: Although more than half of newly diagnosed cancer patients are treated with radiotherapy, it is still not possible to select patients who will respond and tolerate radiotherapy compared to those who do not. There has been a lot of work done to try and isolate intrinsic biomarkers which will identify either radio-responsive or radio-resistant disease. We have undertaken a systematic view summarising the evidence for biomarkers as predictors of radiotherapy.

Despite identifying more than 500 references during a systematic literature search, we found only twelve studies which fulfilled our inclusion criteria. Important exclusion criteria included pre-clinical studies, studies with no control population and a sample size of less than 100 patients.

Only 10 biomarkers were identified as having been evaluated for their radiotherapy-specific predictive value in over 100 patients in a clinical setting, highlighting that despite a rich literature there were few high quality studies suitable for inclusion. The most extensively studied radiotherapy predictive biomarkers were the radiosensitivity index and MRE11; however, neither has been evaluated in a randomised controlled trial. Continue reading

Omega-3 fatty Acid Supplementation May Benefit Mild Cognitive Impairment

Milan Fiala, M.D. Research Professor, UCLA Department of Surgery Los Angeles, CAMedicalResearch.com Interview with:
Milan Fiala, M.D.

Research Professor, UCLA Department of Surgery
Los Angeles, CA

Medical Research: What is the background for this study? What are the main findings?

Dr. Fiala: Omega-3 fatty acid supplementation is well-known to public for its health benefits in cardiovascular diseases and putative benefits against “Minor Cognitive Impairment” reported in other studies . This study shows that omega-3 protected against oxidation and resveratrol improves the immune system against amyloid-beta in the brain,  probably by increasing its clearance from the brain by the immune system. Overall the patients taking the drink seemed to preserve their memory better for up to 2 years than expected based on previous studies. However, our study was small and not controlled by a placebo, which may present a bias.   Continue reading

Celiac Disease Implies Higher Risk of Other Autoimmune Diseases

MedicalResearch.com Interview with:
Louise Emilsson, MD PhD, Postdoc
Primary Care Research unit
Vårdcentralen Värmlands Nysäter and Institute of Health and Society
University of Oslo

MedicalResearch: What is the background for this study?

Dr. Emilsson: Genetics is considered an important factor in the development of celiac disease and other autoimmune diseases. For e.g. the prevalence of celiac disease is about 10% in first-degree relatives of celiac patients compared to about 1% in the general population. Several earlier genome-wide association study (GWAS) studies have established shared genetic features also in-between different autoimmune diseases, however, very little is known about the risk of developing other autoimmune diseases in relatives of celiac patients. Therefore we assessed the risk of several other non-celiac autoimmune diseases (Crohn’s disease, type 1 diabetes mellitus, hypothyroidism, hyperthyroidism, psoriasis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus or ulcerative colitis) in all first degree relatives and spouses of Swedish celiac patients.

MedicalResearch: What are the main findings?

Dr. Emilsson: The main finding is that both first-degree relatives (+28%) and spouses (+20%) are at increased risk of other autoimmune diseases. There are several plausible explanations for these findings. One is of course that individuals with celiac disease and their first-degree relatives share a genetic autoimmune predisposition, another potential explanation involves shared environment (relevant for both first-degree relatives and spouses) but finally we cannot rule out that a certain degree of increased awareness of signs and symptoms in both first-degree relatives and spouses might lead to more examinations and thereby diagnoses (so-called ascertainment bias). Probably all these mechanisms contributed to the finding.

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Evidence of Value of Orphan Drugs Inconsistent

Igho Onakpoya MD MSc Clarendon Scholar University of Oxford Centre for Evidence-Based Medicine Nuffield Department of Primary Care Health Sciences Oxford UKMedicalResearch.com Interview with:
Igho Onakpoya MD MSc

Clarendon Scholar
University of Oxford
Centre for Evidence-Based Medicine
Nuffield Department of Primary Care Health Sciences
Oxford UK

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Onakpoya: Several orphan drugs have been approved for use in Europe. However, the drugs are costly, and evidence for their clinical effectiveness are often sparse at the time of their approval.

We found inconsistencies in the quality of the evidence for approved orphan drugs. We could not identify a clear mechanism through which their prices drugs are determined. In addition, the costs of the branded drugs are much higher than their generic or unlicensed versions.

MedicalResearch: What should clinicians and patients take away from your report?

Dr. Onakpoya: Because of inconsistencies in the evidence regarding the benefit-to-harm balance of orphan medicines, coupled with their high prices, clinicians and patients should assess whether the orphan drugs provide real value for money before making a decision about their use for a medical condition.
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Warming Climate May Not Reduce Winter Mortality

Prof. Patrick L Kinney Ph.D. Professor of Environmental Health Sciences and Director, Columbia Climate and Health Program Mailman School of Public Health Columbia University, New York, NYMedicalResearch.com Interview with:
Prof. Patrick L Kinney Ph.D.
Professor of Environmental Health Sciences and
Director, Columbia Climate and Health Program
Mailman School of Public Health
Columbia University, New York, NY

Medical Research: What is the background for this study?

Dr. Kinney: Many previous assessments have concluded that climate change will lead to large reductions in winter mortality.

Medical Research: What are the main findings?

Dr. Kinney: We carried out analyses that contradict this conclusion.  We argue that climate change won’t have much impact one way or the other on winter mortality.

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Diabetes Medication Reduced Weight and Improved Metabolic Parameters in Obese Patients

Dr. F. Xavier Pi-Sunyer MD Division of Endocrinology and Obesity Research Center Columbia University, New YorkMedicalResearch.com Interview with:
Dr. F. Xavier PiSunyer MD
Division of Endocrinology and Obesity Research Center
Columbia University, New York

Medical Research: What is the background for this study? What are the main findings?

Dr. Pi-Sunye: In a large randomized trial, the drug Liraglutide was compared to placebo in overweight and obese non-diabetic volunteers. Over 52 weeks, in combination with diet and increased physical activity, Liraglutide lowered body weight by 8.4 kg as compared to 2.8 kg in placebo. 63% vs 27% lost at least 5% of baseline weight, 33% vs 10% lost more than 10% of baseline weight.
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Low Testosterone Linked To Obesity and Depression In Men

Michael S. Irwig MD Division of Endocrinology Medical Faculty Associates George Washington UniversityMedicalResearch.com Interview with:
Michael S. Irwig MD
Division of Endocrinology Medical Faculty Associates
George Washington University

Medical Research: What is the background for this study? What are the main findings?

Response: Many factors are associated with lower testosterone levels and many men who have their testosterone levels checked have non-specific depressive symptoms. The main finding is a remarkably high rate of depression and depressive symptoms (56%) in men who are referred for borderline testosterone levels. Other significant findings include a prevalence of overweight and obesity higher than the general population.

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Study Compares Two Surgical Techniques To Relieve Migraine Headaches

MedicalResearch.com Interview with:
Dr. Bahman Guyuron MD

Cleveland and Lyndhurst, Ohio From the Department of Plastic Surgery, University Hospital Case Medical Center; and the American Migraine Center

Medical Research: What is the background for this study?

Dr. Guyuron: Through several studies including retrospective, prospective pilot, prospective randomized, prospective randomized study with sham surgery, prospective randomized study with 5 year follow up, basic science analysis comparing the nerves of the patients who do not have migraine to those who do not have migraine headaches we have demonstrated efficacy of migraine surgery and the rational for effectiveness of this operation. The later study demonstrated that the patients who experience migraine headaches may have deficiency in myelin membrane protecting the peripheral nerves. Four other centers have reported similar experience independently.

Medical Research: What are the main findings?

Dr. Guyuron: Most of the surgical procedures that the I have developed for migraine surgery in the forehead, occipital area and the nose focus on decompression of the nerves. However, in dealing with some of the temporal migraine headaches involving the zygomticotemporal branch of the trigeminal nerve we perform neurectomy for years. The nature of the this procedure which involves removing a small segment this 1 mm nerve, is unsettling to us, the patients and the neurologist. The purpose of this study was to compare the outcome of the neurectomy to decompression for the patients with temporal headaches.

Medical Research: What should clinicians and patients take away from your report?

Dr. Guyuron: The study demonstrated the there is no statistical difference between the outcome migraine surgery in temple area using neurectomy or nerve decompression. Based this study the clinician can use either technique having the some level of confidence. Should the decompression fail it would offer an opportunity for a plan B which would be removing a segment of the nerve.

Citation:

A Prospective Randomized Outcomes Comparison of Two Temple Migraine Trigger Site Deactivation Techniques

Guyuron B1, Harvey D, Reed D.

Plast Reconstr Surg. 2015 Jul;136(1):159-65. doi: 10.1097/PRS.0000000000001322.

Dr. Bahman Guyuron MD, & Cleveland and Lyndhurst (2015). Study Compares Two Surgical Techniques To Relieve Migraine Headaches

Biomarker Predicts Bladder Cancer Response To Treatment

MedicalResearch.com Interview with:
Chao Cheng, Ph.D.
Assistant Professor
Department of Genetics
Institute for Quantitative Biomedical Sciences
Geisel School of Medicine at Dartmouth
Hanover NH, 03755

Medical Research: What is the background for this study?

Dr. Cheng: Bladder cancer is a common tumor type, with non-muscle-invasive bladder cancer (NMIBC) representing the majority of cases. Bacillus Calmette-Guerin (BCG) treatment is an effective immunotherapy that is commonly used to treat cancers of this subtype. However, this treatment fails to suppress tumor recurrence in up to 40% of patients. For this reason, biomarkers that predict the recurrence/progression of bladder cancer and patient response to BCG therapy are needed to tailor treatment strategies to individual patients.

Medical Research: What are the main findings?

Dr. Cheng: We had previously developed an E2F4 signature that consisted of the E2F4 transcription factor and its target genes identified by ChIP-seq and ChIP-chip experiments. Here, we found that the E2F4 signature is predictive of the progression of both non-muscle-invasive and muscle-invasive bladder cancer. Furthermore, this signature is also predictive of patient responsiveness to intravesical BCG immunotherapy. Our results suggest that patients with positive E2F4 scores (indicating high E2F4 activity) benefit significantly from BCG therapy, while the progression of patients with negative E2F4 scores (indicating low E2F4 activity) does not show significant difference from untreated patients.

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