Clinical Evaluation Report (CER) Medical Writer

Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)  in compliance with the European Union (EU) Medical Device Regulation (MDR).  Perform Literature Reviews using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical information about the device is available for use within the company.  Contribute to successful transfers of research results into the MDR-compliant CER.

  • Work with all interested parties to ensure that the clinical evaluation (per MDR) is conducted including clinical testing of all indications/changes in a timely manner to meet feasibility goals and all regulatory deadlines.
  • Ensure sites provide adequate ongoing clinical recruitment and submission of data to client and provide tabular data to regulatory as the basis of clinical reports.
  • Support scientific abstract submission and use clinical data as the basis for preparation of presentations.
  • Advise colleagues in R&D department on new technical and clinical developments.
  • Work closely with cross-functional teams to interpret device performance information in clinical settings and in patient use.
  • Perform research as needed to provide applicable information about new technology in Diagnostic Imaging
  • Participate in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing
  • Identify issues that need resolution to ensure safety and effectiveness of the products.
  • Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
  • Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
  • Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
  • Represent Clinical Affairs and demonstrate leadership in complex product development teams by identifying and interpreting relevant clinical regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
  • Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.
  • Lead clinical evaluation efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
  • Review and approve product labeling, promotional materials, and advertising materials to ensure consistency with the Clinical Evaluation Report.
  • Review clinical and human factors protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance. Engage with Medical Affairs in the development and approval of Clinical Evaluation Report to assure the documents meet regulatory requirements.
  • Ensures FDA device listings and facility registrations are maintained.
  • Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
  • Coordinate and respond to requests for product information, and questionnaires requested by customers.
  • Remain current on regulations affecting medical device products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.
  • Identify ways to improve the efficiency of current work process and execute them.
  • Carry out the above tasks without supervision.
  • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment
  • Interest in and passion for research, bringing medical innovations to market and working in multidisciplinary teams
  • Good communication skills, written and verbal
  • Available to travel domestically approximately 25%, with occasional international travel.

Coronavirus 2019 : Natural Preparedness for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) disease, known as Coronavirus disease-2019 (COVID-19)

Coronavirus COVID-19

Picture: An isolate from the first U.S. case of COVID-19, the illness caused by coronavirus.Credit…Centers for Disease Control via Reuters.

“To be clear, SARS-CoV-2 is not the flu. It causes a disease with different symptoms, spreads and kills more readily, and belongs to a completely different family of viruses. This family, the coronaviruses, includes just six other members that infect humans. Four of them—OC43, HKU1, NL63, and 229E—have been gently annoying humans for more than a century, causing a third of common colds. The other two—MERS and SARS (or “SARS-classic,” as some virologists have started calling it)—both cause far more severe disease. Why was this seventh coronavirus the one to go pandemic? Suddenly, what we do know about coronaviruses becomes a matter of international concern.” Why the Coronavirus Has Been So Successful, The Atlantic

This article was inspired by the work of Jon Barron shown here: https://www.jonbarron.org/colds-flus-infectious-diseases/using-anti-pathogens. To combat the coronavirus, I have stocked my medicine cabinet with the following anti-viral pathogen natural products. In addition to providing the names and doses of the products, after each one, I provide the ten most recent citations from PubMed.gov pertaining to that substance and viruses.

  1. AHCC (Active Hexose-Correlated Compound) – 500 mg, taken on an empty stomach up to four capsules per day at outset of symptoms
  2. Olive Leaf Extract (Olea europaea) (standardized to minimum 20% oleuropein) – 500 mg, taken with food once or twice per day.
  3. Oil of Oregano (Origanum vulgare) (leaf) (10:1 extract) – 150 mg, taken up to four gelcaps per day with water
  4. Star Anise Oil – 1 fluid oz, blended and diluted with extra virgin olive oil or extra virgin coconut oil
  5. Minced Garlic — 1 tbsp added to main meal

 

AHCC (Active Hexose-Correlated Compound)

“Mushrooms have been used for various health conditions for many years by traditional medicines practiced in different regions of the world although the exact effects of mushroom extracts on the immune system are not fully understood. AHCC® is a standardized extract of cultured shiitake or Lentinula edodes mycelia (ECLM) which contains a mixture of nutrients including oligosaccharides, amino acids, and minerals obtained through liquid culture. AHCC® is reported to modulate the numbers and functions of immune cells including natural killer (NK) and T cells which play important roles in host defense, suggesting the possible implication of its supplementation in defending the host against infections and malignancies via modulating the immune system. Here, we review in vivo and in vitro effects of AHCC® on NK and T cells of humans and animals in health and disease, providing a platform for the better understanding of immune-mediated mechanisms and clinical implications of AHCC®.” Shin MS, Park HJ, Maeda T, Nishioka H, Fujii H, Kang I. The Effects of AHCC®, a Standardized Extract of Cultured Lentinura edodes Mycelia, on Natural Killer and T Cells in Health and Disease: Reviews on Human and Animal Studies. J Immunol Res. 2019;2019:3758576. Published 2019 Dec 20. doi:10.1155/2019/3758576 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942843/

Possible therapeutic role of a highly standardized mixture of active compounds derived from cultured Lentinula edodes mycelia (AHCC) in patients infected with 2019 novel coronavirus.

Di Pierro F, et al. Minerva Gastroenterol Dietol 2020. PMID 32162896
The outbreak of SARS-CoV-2 disease (COVID-19) is currently, March 2020, affecting more than 100000 people worldwide and, according to the WHO (World Health Organization), a pandemic is shortly expected. The virus infects the lower respiratory tract and causes severe pneumonia and mortality in approximately 10% and 3-5%, respectively, of cases, mainly among the elderly and/or people affected by other diseases. AHCC is an α-glucan-based standardized mushroom extract that has been extensively investigated as an immunostimulant both in animals and/or in humans affected by West Nile virus, influenza virus, avian influenza virus, hepatitis C virus, papillomavirus, herpes virus, hepatitis B virus and HIV by promoting a regulated and protective immune response. Although the efficacy of AHCC has not yet been specifically evaluated with respect to SARS-CoV-2 disease, its action in promoting a protective response to a wide range of viral infections, and the current absence of effective vaccines, could support its use in the prevention of diseases provoked by human pathogenic coronavirus, including COVID-19.

The prognostic factors between different viral etiologies among advanced hepatocellular carcinoma patients receiving sorafenib treatment.

Yeh ML, et al. Kaohsiung J Med Sci 2019. PMID 31254328 Free article.
Pre-treatment clinical data and viral hepatitis markers were collected and analyzed with their outcomes. The primary endpoint of the study was overall survival. …There were different prognostic factors stratified by viral etiologies in aHCC patients receiving sorafenib. Viral eradication increased survival in chronic hepatitis C patients….
Ito T, et al. Nutr Cancer 2014 – Clinical Trial. PMID 24611562
The objective of this study was to evaluate the safety and effectiveness of a mushroom product, active hexose correlated compound (AHCC), on chemotherapy-induced adverse effects and quality of life (QOL) in patients with cancer. Twenty-four patients with cancer received their first cycle of chemotherapy without AHCC and then received their second cycle with AHCC. …
Roman BE, et al. Nutr Res 2013 – Clinical Trial. PMID 23351405
In this study, we hypothesized that AHCC will also improve the immune responses of healthy individuals to influenza vaccine. …Immediately post-vaccination, the AHCC group began supplementation with AHCC (3 g/d). Flow cytometric analysis of lymphocyte subpopulations revealed that AHCC supplementation increased NKT cells (P < .1), and CD8 T cells (P < .05) post-vaccination compared to controls. …
Nogusa S, et al. Nutr Res 2009. PMID 19285605
We hypothesized that AHCC supplementation would influence the immune response to influenza infection in a dose-dependent manner. …In conclusion, these data suggest that the effects of AHCC on the immune response to influenza infection are dose dependent and that low-dose AHCC supplementation improves the response to influenza infection despite no effect on total NK cell cytotoxicity….
Wang S, et al. J Nutr 2009. PMID 19141700 Free PMC article.
AHCC administration in aged mice attenuated viremia levels but led to no difference in mortality rate. Overall, our data suggests that AHCC enhances protective host immune responses against WNV infection in young and aged mice. Dietary supplementation with AHCC may be potentially immunotherapeutic for WNV-susceptible populations….
Momiyama K, et al. Cancer Chemother Pharmacol 2009. PMID 19011857
CONCLUSIONS: The percentage of Th2 cells increased in LC patients with aHCC as the efficacy of intra-arterial combination chemotherapy decreased. These results indicated that intra-arterial chemotherapy might be not useful for patients with aHCC, because it induces Th2 dominant host immunity….

Th1/Th2 balance: an important indicator of efficacy for intra-arterial chemotherapy

Nagai H, et al. Cancer Chemother Pharmacol 2008. PMID 18259753
The aim of this study was to assess the influence of intra-arterial combination chemotherapy on the Th1/Th2 balance in LC patients with aHCC. …RESULTS: Thirteen of the 21 aHCC patients (group R) showed an objective response, but the other 8 patients (group N) showed no response. …
Ritz BW, et al. J Nutr 2006. PMID 17056815
However, the effects of AHCC on the response to viral infections have not been studied. In this study, young C57BL/6 mice were supplemented with 1 g AHCC/(kg body weight x d) for 1 wk prior to and throughout infection with influenza A (H1N1, PR8). …These data suggest that AHCC supplementation boosts NK activity, improves survival, and reduces the severity of influenza infection in young mice. …

 

OLIVE LEAF EXTRACT

“The olive tree (Olea europaea) is native to the Mediterranean region. Olive leaf extract has a long history of use against illnesses in which microorganisms play a major role. In more recent years, studies of olive leaf extracts (containing oleuropein, calcium elenolate, and/or hydroxytyrosol) were effective in eliminating a very broad range of organisms, including bacteria, viruses, parasites, yeast, mold, and fungi.25 Pio Maria Furneri, Anna Piperno, Antonella Sajia, and Giuseppe. “Antimycoplasmal Activity of Hydroxytyrosol, Antimicrob Agents.” Chemother. 2004 December; 48(12): 4892–4894. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC529223/ , 26 Harold E. Renis. “Inactivation of Myxoviruses by Calcium Elenolate.” Antimicrobial Agents and Chemotherapy Aug. 1975, p. 194-199. http://aac.asm.org/cgi/reprint/8/2/194.pdf In addition, Olive leaf has demonstrated antiviral activity against both HIV infection and replication,27 Lee-Huang S1, Zhang L, Huang PL, Chang YT, Huang PL. “Anti-HIV activity of olive leaf extract (OLE) and modulation of host cell gene expression by HIV-1 infection and OLE treatment.” Biochem Biophys Res Commun. 2003 Aug 8;307(4):1029-37. http://www.ncbi.nlm.nih.gov/pubmed/12878215 primarily by blocking the entry of the virus into host cells in the body’s immune system.28 Bao J1, Zhang DW, Zhang JZ, Huang PL, Huang PL, Lee-Huang S. “Computational study of bindings of olive leaf extract (OLE) to HIV-1 fusion protein gp41.” FEBS Lett. 2007 Jun 12;581(14):2737-42. http://www.ncbi.nlm.nih.gov/pubmed/17537437

Studies have also shown that oleuropein exhibits a significant antiviral activity against respiratory syncytial virus and para-influenza type 3 virus.29 Ma SC, He ZD, Deng XL, But PP, et al. “In vitro evaluation of secoiridoid glucosides from the fruits of Ligustrum lucidum as antiviral agents.” Chem Pharm Bull. 2001;49:1471–1473. http://www.jstage.jst.go.jp/article/cpb/49/11/49_11_1471/_pdf In addition, it has been found to be effective against viral hemorrhagic septicemia rhabdovirus, a highly deadly and infectious virus that afflicts over 50 species of both freshwater and marine water fish. 30 Micol V, Caturla N, Perenz-Fons L, Mas L, Perez L, Estepa A. “The olive leaf extract exhibits antiviral activity against viral haemorrhagic septicaemia rhabdovirus (VHSV)” Antivir Res. 2005;66:129–136. http://www.ncbi.nlm.nih.gov/pubmed/15869811 There are studies that demonstrate that olive leaf extracts augment the activity of the HIV-RT inhibitor 3TC. In fact, cell-to-cell transmission of HIV was inhibited in a dose-dependent manner, and replication was inhibited in an in vitro experiment.31 Lee-Huang S, Zhang L, Chang YY, Huang PL. “Anti-HIV activity of olive leaf extract (OLE) and modulation of host cell gene expression by HIV-1 infection and OLE treatment.” Biochem Biophys Res Commun. 2003;307:1029–1037. http://www.ncbi.nlm.nih.gov/pubmed/12878215 One of the suspected targets for olive leaf extract action is the HIV-1 gp41 (surface glycoprotein subunit), which is responsible for HIV entry into normal cells. In order to establish HIV protein targets of olive leaf extract and its inhibitory action at the molecular level, researchers reported a joint theoretical and experimental effort has been carried out to help achieve this goal.32 Lee-Huang S, Huang PL, Zhang D, Lee JW, Bao J, et al. “Discovery of small-molecule HIV-1 fusion and integrase inhibitors oleuropein and Hydroxytyrosol: Part I.” Integrase Inhibition Biochem Biophys Res Commun. 2007;354:872–878. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2790717/

Source: Jon Barron, Using Anti-Pathogens

[Comparison of Antiviral Effect of Olive Leaf Extract and Propolis with Acyclovir on Herpes Simplex Virus Type 1].

Altındiş M, et al. Mikrobiyol Bul 2020. PMID 32050880 Turkish. Free article.
In this in vitro study, olive leaf extract (OLE) and propolis alone or in combination with acyclovir were investigated for their antiviral efficacy in HSV-1.Toxic doses of OLE, propolis, and dimethyl sulfoxide, propolis diluent, for Hep-2 (ATCC, CCL-23) cells were determined by conventional cell culture. Using “endpoint” method, the viral dose infecting half of the cell culture (TCID50) was calculated, and viral quantity was determined with Spearman-Karber method. …

 

Oil of Oregano

Antifungal Activity of Selected Natural Preservatives against Aspergillus westerdijkiae and Penicillium verrucosum and the Interactions of These Preservatives with Food Components

Schlösser I and Prange A. J Food Prot 2019. PMID 31538828
The present study examined the influence of primary food components on the antifungal activity of the essential oil of Origanum vulgare, carvacrol, thymol, eugenol, and trans-cinnamaldehyde against Penicillium verrucosum and Aspergillus westerdijkiae. …The presence of oil had the strongest influence. At a concentration of 1% oil, the antifungal activity decreased significantly, and at 10% oil, almost no inhibition was observed. …

Star Anise Oil (Pimpinella Anisum)

[Potential antiviral therapeutics for 2019 Novel Coronavirus]

Li H, et al. Zhonghua Jie He He Hu Xi Za Zhi 2020. PMID 32164080 Chinese.
Antiviral drugs commonly used in clinical practice, including neuraminidase inhibitors (oseltamivir, paramivir, zanamivir, etc.), ganciclovir, acyclovir and ribavirin, are invalid for 2019-nCoV and not recommended. …

Screening for antiviral activities of isolated compounds from essential oils

Astani A, et al. Evid Based Complement Alternat Med 2011.
Essential oil of star anise as well as phenylpropanoids and sesquiterpenes, for example, trans-anethole, eugenol, β-eudesmol, farnesol, β-caryophyllene and β-caryophyllene oxide, which are present in many essential oils, were examined for their antiviral activity against herpes simplex virus type 1 (HSV-1) in vitro. Antiviral activity was analyzed by plaque reduction assays and mode of antiviral action was determined by addition of the drugs to uninfected cells, to the virus prior to infection or to herpesvirus-infected cells. Star anise oil reduced viral infectivity by >99%, phenylpropanoids inhibited HSV infectivity by about 60-80% and sesquiterpenes suppressed herpes virus infection by 40-98%. Both, star anise essential oil and all isolated compounds exhibited anti-HSV-1 activity by direct inactivation of free virus particles in viral suspension assays. All tested drugs interacted in a dose-dependent manner with herpesvirus particles, thereby inactivating viral infectivity. Star anise oil, rich in trans-anethole, revealed a high selectivity index of 160 against HSV, whereas among the isolated compounds only β-caryophyllene displayed a high selectivity index of 140. The presence of β-caryophyllene in many essential oils might contribute strongly to their antiviral ability. These results indicate that phenylpropanoids and sesquiterpenes present in essential oils contribute to their antiviral activity against HSV.

Chemical Constituents of Essential Oils Possessing Anti-Influenza A/WS/33 Virus Activity

Choi HJ. Osong Public Health Res Perspect 2018. PMID 30584499 Free PMC article.
The chemical composition detected by GC-MS analysis, differed amongst the 3 most potent anti-viral essential oils (marjoram, clary sage and anise oils) except for linalool, which was detected in all 3 essential oils. CONCLUSION: This study demonstrated anti-influenza activity in 11 essential oils tested, with marjoram, clary sage and anise essential oils being the most effective at reducing visible cytopathic effects of the A/WS/33 virus. …

Antiviral and immunostimulating effects of lignin-carbohydrate-protein complexes from Pimpinella anisum.

Lee JB, et al. Biosci Biotechnol Biochem 2011. PMID 21389629 Free article.
Three antiviral and immunostimulating substances (LC1, LC2 and LC3) were isolated from a hot water extract of seeds of Pimpinella anisum by combination of anion-exchange, gel filtration and hydrophobic interaction column chromatographies. …

Efficacy of anise oil, dwarf-pine oil and chamomile oil against thymidine-kinase-positive and thymidine-kinase-negative herpesviruses.

Koch C, et al. J Pharm Pharmacol 2008. PMID 18957177
The effect of anise oil, dwarf-pine oil and chamomile oil against different thymidine-kinase-positive (aciclovir-sensitive) and thymidine-kinase-negative (aciclovir-resistant) herpes simplex virus type 1 (HSV-1) strains was examined. …No significant effect on viral infectivity could be achieved by adding these compounds during the replication phase. These results indicate that anise oil, dwarf-pine oil and chamomile oil affected the virus by interrupting adsorption of herpesviruses and in a different manner than aciclovir, which is effective after attachment inside the infected cells. …

Inhibitory effect of essential oils against herpes simplex virus type 2

Koch C, et al. Phytomedicine 2008. PMID 17976968
In order to determine the mode of the inhibitory effect, essential oils were added at different stages during the viral infection cycle. …These results indicate that essential oils affected HSV-2 mainly before adsorption probably by interacting with the viral envelope. …

 

Garlic

Garlic for the common cold.

Lissiman E, et al. Cochrane Database Syst Rev 2014 – Review. PMID 25386977 Free PMC article.
Background Garlic is alleged to have antimicrobial and antiviral properties that relieve the common cold, among other beneficial effects. …The trial reported 24 occurrences of the common cold in the garlic intervention group compared with 65 in the placebo group (P value < 0.001), resulting in fewer days of illness in the garlic group compared with the placebo group (111 versus 366). …

The effect of Allium sativum (Garlic) extract on infectious bronchitis virus in specific pathogen free embryonic egg.

Mohajer Shojai T, et al. Avicenna J Phytomed 2016. PMID 27516987 Free PMC article.
This study evaluated the inhibitory effects of garlic extract on IBV. MATERIALS AND METHODS: The constituents of garlic extract were detected by gas chromatography. …CONCLUSION: The garlic extract had inhibitory effects on IBV in the chickens embryo….

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Combining Research, Safety, and Epidemiology

Risk Management Consulting (RMC), a health services research firm, offers Research, Safety, and Epidemiology services with experience in the healthcare consulting and biopharmaceutical industries. RMC provides the health care system, biopharmaceutical industry, academia, and the Federal Government with “real-world” data to improve the quality, safety, and affordability of healthcare. RMC’s projects range from retrospective to large-scale, prospective studies in the areas of drug, vaccine, and medical device safety surveillance, risk management, pharmacoepidemiology, health outcomes, pharmacoeconomics, and comparative effectiveness research.

 

Lead the business operations of the Safety and Epidemiology business unit and oversee a team of scientists in the execution of pharmacoepidemiology, risk management, and medical product safety studies for a portfolio of clients in the biopharmaceutical industry. 
  • Business operations management
    • Set the strategic direction and priorities for the Safety and Epidemiology business unit.
    • Plan, direct, and control the resources and efforts of the Safety and Epidemiology business unit, including the development and implementation of the hiring plan.
    • Mentor and develop associates to support the growth and success of Safety and Epidemiology team.
    • Lead analysis for resources (e.g., people, funding, materials, and support) to complete projects and recommend changes.
    • Lead the evaluation of business unit performance against plan to review successes, shortfalls, and areas of concern.
  • Research portfolio management
    • Operational accountability of all Safety and Epidemiology projects.
    • Support principal investigators and project managers in the proactive identification of potential bottlenecks, gaps, and risk areas as it relates to scope, budget, and timeline, and escalation to senior leadership.
    • Track current and projected financial status of research projects.
    • Support research leads in the development of timely, accurate, and high quality project deliverables.
  • Business development support
    • Lead the development of study proposals in response to a Request for Proposal, including the scope of work, budget, and timeline framework around each proposal.
    • Work collaboratively with Business Development Directors to facilitate proposal submission, bid defense preparations, and contract execution.

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CMS Shared Savings Program

Background

The Affordable Care Act (ACA) included provisions to expand value-based purchasing; broaden quality reporting; improve the level of performance feedback available to providers; and create incentives to enhance quality, improve beneficiary outcomes, and increase the value of care. Confidential physician feedback reporting was initially implemented under Section 131 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and later expanded by section 3003 of the Affordable Care Act of 2010 (ACA). MIPPA and subsequently ACA, directed the Centers for Medicare & Medicaid Services (CMS) to provide confidential information to physicians and medical practice groups about the resource use and quality of care they provide to their Medicare patients, including quantification and comparisons of patterns of resource use/cost among physicians and medical practice groups. In addition to the expansion of Physician Feedback reporting, section 3007 of the Affordable Care Act also required CMS to begin applying a value-based payment modifier under the Medicare Physician Fee Schedule (PFS) in 2015. CMS has incorporated these requirements, set forth in legislation, into its Physician Value initiatives, which incorporate the Physician Feedback and Value-Based Modifier Programs. These programs are part of CMS’ aim to transform Medicare from a passive payer role to that of an active purchaser of higher quality, more efficient health care.

 

Section 3022 of ACA added Section 1899 to Title XVIII of the Social Security Act and required the Secretary to establish the Medicare Shared Savings Program (Shared Savings Program), with the intention of the development of Accountable Care Organizations (ACOs) in Medicare. The Shared Savings Program was implemented in January 2012 to help doctors, hospitals, and other health care provides better coordinate care for Medicare patients through ACOs. By focusing on the needs of patients and linking payment rewards to outcomes, this leading ACA delivery system reform will help improve the health of individuals and communities while lowering the growth in Medicare costs. CMS published two proposals to strengthen the Shared Savings Program and finalized the proposals in the June 9, 2015 and June 10, 2016 Federal Registers.

 

Currently, we are proposing policies in the CY2017 PFS to align the Medicare Shared Savings Program with the proposals for the Quality Payment Program, to take beneficiary preferences for ACO assignment into consideration, and to improve beneficiary protections when ACOs are approved to use the skilled nursing (SNF) 3-day waiver rule. We also are proposing to refine and further implement the value-based payment modifier. To do so, we need to assess and analyze current policy options and proposed rule comments to finalize the regulation.

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The State of Cancer Research

DHT Image“Most current research is a waste of time and money. It is magic bullet nonsense. Take the search for the cancer gene. Are there genes that give one a predisposition for getting cancer? Absolutely. This is exactly what the Baseline of Health talks about when it refers to your Personal Health Line at the time of birth.

But looking for a cancer cure by finding the cancer gene will do nothing to eliminate all of the other factors responsible for cancer. And we already know how small a role the cancer gene plays in the onset of cancer: there has been an 8-fold to 17-fold increase in the incidence of cancer in the last hundred years, but not even one-millionth of 1 percent of that increase can be related to genes.

Genes evolve over hundreds of thousands (if not millions) of years, which means that the so-called cancer gene has had no impact on the huge increase we’ve seen since 1900. Virtually 90 percent of the cancer that we see today cannot possibly have anything to do with genes. So, at best, genes are responsible for only a small percentage of the minimal cancer rates we had in the early 1900s, and finding the cancer gene will affect only that tiny percentage of cancer. Genes may create tendencies, but in most cases they are not the underlying cause. Bottom line: look not for a cure in the cancer gene.

There is, however, a ray of hope in the world of medical research. In the last few years, medical research has started committing resources to the development of methods to harness and enhance the body’s natural tendency to defend itself against malignant tumors. Immunotherapy represents a new and powerful weapon in the arsenal of anticancer treatments. Sometimes referred to as biological response modifiers or as biological therapies, these new treatments–such as interferons and other cytokines, monoclonal antibodies, and vaccine therapies–have generated renewed interest and research activity in immunology.”

From Jon Barron of jonbarron.org

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Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.

“Screening, they say, is only part of the story. “The magnitude of the changes alone suggests that other factors must be involved,” they wrote. None of the studies showing the effect of increased screening for colon cancer have indicated a 50 percent reduction in mortality, they wrote, “nor have trials for screening for any type of cancer.”

Then there are hip fractures, whose rates have been dropping by 15 to 20 percent a decade over the past 30 years. Although the change occurred when there were drugs to slow bone loss in people with osteoporosis, too few patients took them to account for the effect — for instance, fewer than 10 percent of women over 65 take the drugs.

Perhaps it is because people have gotten fatter? Heavier people have stronger bones.

Heavier bodies, though, can account for at most half of the effect, said Dr. Steven R. Cummings of the California Pacific Medical Center Research Institute and the University of California at San Francisco. When asked what else was at play, he laughed and said, “I don’t know.”

Dementia rates, too, have been plunging. It took a few reports and more than a decade before many people believed it, but data from the United States and Europe are becoming hard to wave off. The latest report finds a 20 percent decline in dementia incidence per decade, starting in 1977.

A recent American study, for example, reports that the incidence among people over age 60 was 3.6 per 100 in the years 1986-1991, but in the years 2004-2008 it had fallen to 2.0 per 100 over age 60. With more older people in the population every year, there may be more cases in total, but an individual’s chance of getting dementia has gotten lower and lower.

There are reasons that make sense. Ministrokes result from vascular disease and can cause dementia, and cardiovascular risk factors are also risk factors for Alzheimer’s disease. So the improved control of blood pressure and cholesterol levels should have an effect. Better education has also been linked to a lower risk of Alzheimer’s disease, although it is not known why. But the full explanation for the declining rates is anyone’s guess. And the future of this trend remains a contested unknown.

The exemplar for declining rates is heart disease. Its death rate has been falling for so long — more than half a century — that it’s no longer news. The news now is that the rate of decline seems to have slowed recently, although it is still falling. While heart disease is still the leading cause of death in the United States, killing more than 600,000 people a year, deaths have fallen 70 percent from their peak. The usual suspects: Better treatment, better prevention with drugs like statins and drugs for blood pressure, and less smoking, are, of course, helping drive the trend. But they are not enough, heart researchers say, to account fully for the decades-long decline.

The heart disease effect has been examined by scientist after scientist. Was it a result of better prevention, treatment, lifestyle changes?

All three played a role, researchers said.”